CN112190635A - Cicada throat spray and application thereof - Google Patents

Cicada throat spray and application thereof Download PDF

Info

Publication number
CN112190635A
CN112190635A CN202011091439.1A CN202011091439A CN112190635A CN 112190635 A CN112190635 A CN 112190635A CN 202011091439 A CN202011091439 A CN 202011091439A CN 112190635 A CN112190635 A CN 112190635A
Authority
CN
China
Prior art keywords
treatment
parts
cicada
tic
throat
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202011091439.1A
Other languages
Chinese (zh)
Inventor
马融
张喜莲
戎萍
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
FIRST AFFILIATED HOSPITAL OF TIANJIN UNIVERSITY OF TRADITIONAL CHINESE MEDICINE
Original Assignee
FIRST AFFILIATED HOSPITAL OF TIANJIN UNIVERSITY OF TRADITIONAL CHINESE MEDICINE
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by FIRST AFFILIATED HOSPITAL OF TIANJIN UNIVERSITY OF TRADITIONAL CHINESE MEDICINE filed Critical FIRST AFFILIATED HOSPITAL OF TIANJIN UNIVERSITY OF TRADITIONAL CHINESE MEDICINE
Priority to CN202011091439.1A priority Critical patent/CN112190635A/en
Publication of CN112190635A publication Critical patent/CN112190635A/en
Pending legal-status Critical Current

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/59—Menispermaceae (Moonseed family), e.g. hyperbaena or coralbead
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/63—Arthropods
    • A61K35/64—Insects, e.g. bees, wasps or fleas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/534—Mentha (mint)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/80—Scrophulariaceae (Figwort family)
    • A61K36/808—Scrophularia (figwort)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/04—Drugs for disorders of the respiratory system for throat disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Botany (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medical Informatics (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • Insects & Arthropods (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Psychology (AREA)
  • Virology (AREA)
  • Dispersion Chemistry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Animal Husbandry (AREA)
  • Rheumatology (AREA)
  • Zoology (AREA)

Abstract

The invention relates to a cicada throat spray and application thereof, and the cicada throat spray comprises the following main components in parts by weight: 6-10 parts of radix tinosporae, 6-10 parts of boat-fruited sterculia seed, 6-10 parts of blackberrylily rhizome, 10-15 parts of radix scrophulariae, 3-6 parts of periostracum cicadae, 3-6 parts of mint and 0.1-0.5 part of borneol. The invention also provides application of the cicada spray throat preparation in preparation of a medicine for assisting in treating children tic disorder. The cicada spray throat agent can assist in treating the vocal tic disorder of children (external wind-induced tic syndrome), improve the vocal tic symptom and the traditional Chinese medicine syndrome, is convenient for children patients to carry and use, has high safety, and provides a new idea for clinically treating the children's tic disorder.

Description

Cicada throat spray and application thereof
Technical Field
The invention belongs to the field of traditional Chinese medicine compositions; in particular to a cicada spray throat agent and application thereof as a medicine for adjuvant therapy of children tic disorder.
Background
Tic Disorders (TD) are a neurodevelopmental disorder disease which is caused in children or adolescents and mainly characterized by involuntary, rapid, purposeless, and repeated motor-kinetic and/or vocal tic twitching at one or more parts, and some children patients may have a variety of behavioral problems such as attention-deficit hyperactivity disorder, obsessive-compulsive disorder, sleep disorder, and mood disorder. Because the tic disorder can be diagnosed only according to the medical history and clinical symptoms at present, a definite and uniform diagnostic standard is lacked, so that the epidemiological research of the tic disorder becomes a difficult point. Therefore, the research of cross-region, large sample and prospective is still lacked at home and abroad. According to current survey, twitch disorder is better to develop in children of 5-10 years old, and boys are more than girls, and the proportion of the boys to the girls is (3-5): 1.
the tic disorder has various clinical manifestations, mainly the motor tic and the vocal tic, wherein the vocal tic is the first symptom accounting for 12% -37%, the symptom is mainly the abnormal sound caused by the muscle twitching of the throat, pharynx, oral cavity, etc., and can be expressed as the pronunciation of the voice, the kayage in the throat, the sound of kayage, the voice of fluke, the sound of screaming, the dog barking and the foul voice, etc. Exercise tics may involve the twitching of muscles in various parts of the limb, and may be manifested as eye pinching, nasal wrinkling, head shaking, shoulder shrugging, belly bulging, limb trembling, and the like. In addition to tic symptoms, the infant patient may be accompanied by mood or behavior disorders such as depressive anxiety, bipolar disorder, low gallbladder volume, impulsivity, violent behavior, etc., which are apt to cause the attention of the surrounding people or jeopardize the study and life of the infant patient.
The etiology and pathogenesis of tic disorder are not clearly studied, and the pathogenesis of tic disorder is related to genetic factors, neuro-biochemistry, neuroimmunity, psychological conditions, environment and other factors. The western medicine treatment method mainly comprises drug treatment and psychological behavior intervention treatment. The current commonly used medicines for treating tic disorder mainly comprise haloperidol, tiapride, aripiprazole, cola and the like, but various adverse reactions such as extrapyramidal reaction, somnolence, hypodynamia and the like often occur, so that the body of a child patient is damaged, and the compliance is poor. Psychobehavioral intervention therapy includes habit reversal training, comprehensive behavioral intervention, exposure and response prevention, cognitive behavioral therapy, etc., but has limited clinical efficacy, and has low popularity because of fewer psychotherapists and generally low acceptance of people. Therefore, a green, safe, effective and easily accepted treatment method is very important, and is the characteristic advantage of the traditional Chinese medicine treatment.
The children tic disorder is not named uniformly in traditional Chinese medicine, and is generally classified into slow infantile convulsion, liver wind, convulsion and the like according to clinical manifestations. Most doctors believe that wind pathogen is the main pathological factor, as said in Su Wen-Yin Yang correspondence theory: "wind victory tends to move". Wind pathogen can be divided into external wind and internal wind, so the pathogenesis of tic disorder is characterized by both external wind and internal wind. The internal organs of the children are delicate and tender, the body-shape and qi are not sufficient, the children are very easy to be attacked by exogenous wind, the exogenous wind enters lung and defensive organs through mouth and nose, the wind is yang pathogen and stagnates in the interior, and then the wind is transformed into heat and is communicated with liver qi, so that the liver wind moves inwards, the internal and external pathogens are combined, and the twitching occurs. The traditional Chinese medicine treatment of tic disorder comprises methods of decoction, acupuncture, massage, ear acupuncture and the like, which are safe and effective, but are unacceptable for children patients to persist for a long time. Therefore, the research of simpler and more effective treatment methods is one of the future directions.
Disclosure of Invention
The invention aims to provide a cicada throat spray which can be used for assisting in treating vocal tic disturbance (external wind-induced syndrome) of children and improving vocal tic symptoms and traditional Chinese medicine symptoms.
The technical scheme adopted by the invention is as follows:
a cicada throat spray comprises the following main components in parts by weight: 6-10 parts of radix tinosporae, 6-10 parts of boat-fruited sterculia seed, 6-10 parts of blackberrylily rhizome, 10-15 parts of radix scrophulariae, 3-6 parts of periostracum cicadae, 3-6 parts of mint and 0.1-0.5 part of borneol.
More preferably, the ingredients of the cicada spray throat agent further comprise 1-3 parts of stevia rebaudiana.
The invention also provides a preparation method of the cicada spray throat agent, which comprises the following steps: decocting with water for 25 min to obtain liquid with crude drug concentration of 0.05 g/ml.
The invention also provides a using method of the golden cicada throat spray, and the specifications of the golden cicada throat spray are as follows: 50 ml/bottle. The usage and dosage are as follows: spraying on the pharyngeal isthmus and the posterior pharyngeal wall for 4-6 years old, and spraying for 4 times; spraying 5 times at age of 7-12 years old; above 13 years old, 6 times a day.
The invention also provides application of the cicada spray throat preparation in preparation of a medicine for assisting in treating children tic disorder.
Preferably, the child's tic disorder is vocal tic.
The invention also provides a composition for treating children tic disorder, which comprises cicada spray throat agent and traditional Chinese medicine decoction; the Chinese medicinal decoction is YINQIAOSAN, XIFENGZHITONG decoction, CHAIGUILONGMU decoction or ZHITANG decoction.
The pharmacology related to the invention is as follows:
wherein the principal drug is radix tinosporae, the ministerial drug is semen Scaphii Lychnophori, rhizoma Belamcandae, radix scrophulariae, periostracum Cicadae, and herba Menthae, the adjuvant drug is Borneolum Syntheticum, and the messenger drug is stevia rebaudiana. The radix tinosporae has the effects of clearing away heat and toxic materials, relieving sore throat and relieving pain. The tinospora root is bitter in taste and cold in nature, enters lung and large intestine channels, and has the effects of clearing away heat and toxic materials, relieving sore throat and relieving pain. The compendium of materia Medica is collected and written in the book of drug Property examination: "detoxification". It is suitable for throat with acute arthralgia and erosion of mouth. Rhizoma Belamcandae is added to assist radix tinosporae in strengthening the effects of clearing heat, removing toxicity and relieving sore throat. The blackberry lily is bitter in taste and cold in nature, enters lung channel, and has the effects of clearing away heat and toxic materials, relieving sore throat, eliminating phlegm, dissipating blood and reducing swelling. Compendium of materia Medica: belamcanda rhizome, rhizoma Belamcandae, is the key herb for treating pharyngitis and pharyngalgia. "Shen nong Ben Cao Jing: "cough with adverse rising of qi, sore throat, failure of message, stagnation of qi, adverse flow of pathogenic qi in the abdomen, and large fever due to food and drink. Boat-fruited sterculia seed, semen sterculiae lychnophorae, sweet in taste, cold in nature, enters lung meridian and can clear heat and moisten lung. The national Chinese herbal medicine compilation: "clearing lung heat and relieving sore throat", "this materia Medica: it is good at opening and ventilating lung qi, and purging skin and hair simultaneously, so wind pathogen closes without affecting cold to heat. Retention of energy and initial sound can treat acute urticaria, with refreshing and phlegm eliminating effects. Boat-fruited sterculia seed, semen Sterculiae Lychnophorae, combined with periostracum Cicadae, can dispel wind-heat, ventilate lung and relieve sore throat. The cicada slough is sweet in taste and cold in nature, enters lung and liver channels, and has the effects of dispelling wind and heat, relieving sore throat and relieving voice and spasm. Compendium of materia Medica: the main treatment of cicada is all wind-heat syndrome, and ancient people use them and later use slough. Mint is pungent in flavor and cool in nature, enters lung and liver meridians, and has the effects of dispelling wind and heat, relieving sore throat, soothing liver and promoting qi circulation. Compendium of materia Medica: mint, pungent in flavor and cool in flavor can disperse and clear and is used for dispelling wind and dissipating heat. It is used with Bo He to reinforce the action of dispelling wind and relieving exterior syndrome, while it can extinguish wind and stop convulsions, and Bo He soothes liver and moves qi to regulate qi movement. The compatibility of the radix scrophulariae can nourish yin, moisten dryness, clear heat and promote fluid production. Radix scrophulariae is sweet, bitter, salty and slightly cold in nature, enters lung, stomach and kidney channels, and has the effects of clearing heat and cooling blood, nourishing yin and lowering fire, and detoxifying and resolving masses. The book of materia Medica: xuan Shen is mainly due to yin nature and bitter taste in the flavor of warm diseases, it can be indicated for the syndrome of heat accumulation in zang-fu organs. "the West records of medical professions: xuan Shen … … can enter lung to clear lung heat, relieve toxicity and eliminate fire. Borneol is used as an adjuvant to clear heat and relieve pain, and assists other medicines to better exert curative effects. Borneol is pungent and bitter in flavor and slightly cold in nature, enters lung meridian, can treat swollen and sore throat, is pungent and dispersing and flees, is a powerful medicine for opening orifices. The stevia rebaudiana is added for harmonizing the taste, and the whole formula has the efficacies of dispelling wind and relieving exterior syndrome, clearing away heat and toxic material, and calming endogenous wind and relieving spasm.
Each drug was analyzed from a modern pharmacological study, specifically as follows:
radix tinosporae belongs to dried root mass of Tinospora cordifolia or Tinospora cordifolia of Menispermaceae. The chemical components of the medicament mainly comprise compounds such as alkaloid, terpenes, sterols and the like, and the medicament has the effects of resisting inflammation, easing pain, resisting bacteria and the like.
Semen Sterculiae Lychnophorae is dry mature seed of plant of genus Poncirus of family Sterculiaceae, also named as semen Ananadis Comosi, semen Scaphii Lychnophori, and semen Scaphii Lychnophori. The main bioactive component of the medicine is boat-fruited sterculia seed polysaccharide which has anti-inflammatory activity.
The blackberry lily belongs to dried tubers of perennial grass blackberry lily of Iridaceae, also called Wu Fan, Wu Pu and Scissors. The main active ingredients of the composition are triterpenes and flavonoids, and the composition has the effects of resisting inflammation, resisting virus and the like.
Radix scrophulariae is dried root of Scrophularia ningpoensis, scrophularia ningpoensis, rhizoma corydalis, and radix Et rhizoma Rhei. The main chemical components of the compound are iridoid, sterol and phenylpropanoid glycoside compounds, and the compound has the effects of resisting inflammation, relieving pain and the like.
Cicada slough belongs to molting shell of nymph of cicada family insect black locust which falls off during eclosion, also called cicada shell and cicada shell. Has spasmolytic, anti-infectious, and antioxidant effects.
Herba Menthae is dry aerial part of Mentha haplocalyx of Labiatae, and is also called Poncirus chinensis and SHENGYANG CAI. The main components of the composition comprise volatile oil, flavonoids, terpenoids, phenolic acids, amino acids and other compounds, and have antiinflammatory, antibacterial, antiviral and spasmolytic effects.
Borneol belongs to borneol resin processed products, or crystals obtained by cutting trunks and branches of borneol trees and distilling and cooling the cut trunks and branches of the borneol trees, and is also called borneol and prune slices. Has antibacterial and antiinflammatory effects, and can assist the drug to penetrate blood brain barrier.
Stevia rebaudiana Bertoni belongs to leaves of stevia rebaudiana Bertoni of genus Eupatorium of family Compositae. The sweetness of the diterpenoid component stevioside is 300 times that of cane sugar, and the stevioside has low calorie and high safety and can be used as a natural flavoring agent. The taste of the Chinese medicinal preparation is not acceptable by children, and the taste can be improved and the compliance of children patients can be enhanced after the stevia rebaudiana is added.
In conclusion, the active ingredients of the cicada spray can inhibit the infection of bacteria and viruses and has anti-inflammatory effect, and can relieve muscle spasm and inhibit twitch. Thus can be used to treat vocal tic movements caused by inflammation.
The invention has the following beneficial effects:
the cicada spray throat agent can assist in treating the vocal tic disorder of children (external wind-induced tic syndrome), improve the vocal tic symptom and the traditional Chinese medicine syndrome, is convenient for children patients to carry and use, has high safety, and provides a new idea for clinically treating the children's tic disorder.
Drawings
FIG. 1 is a chart comparing YGTSS scores at different time points;
FIG. 2 is a comparison graph of vocal twitch integrals at different time points;
FIG. 3 is a comparison chart of the integral of the syndrome of traditional Chinese medicine at different time points.
Detailed Description
The present invention is further illustrated by the following examples, which are not intended to limit the scope of the invention.
1 clinical data
1.1 sources of cases
The clinical observation case is from the infant who is diagnosed in the pediatric clinic of the first subsidiary hospital of Tianjin Chinese medicine university from 3/1/2019 to 12/31/2019, and the infant with tic disorder who meets the standard and signs an informed consent form is selected as a research object.
1.2 diagnostic criteria
1.2.1 Western diagnostic standards
Reference is made to the American handbook of diagnosis and statistics of mental disorders, fifth edition (DSM-5) Standard. Classified as transient tic disorders, persistent (chronic) motor or vocalizing tic disorders, Tourette's syndrome.
Transient tic disorder:
(1) single or multiple locomotor and/or vocal twitches;
(2) the disease course is less than 1 year after twitch occurs;
(3) onset before 18 years of age;
(4) twitching does not occur due to the action of certain substances (e.g., cocaine) or other diseases (e.g., huntington's disease or post-viral encephalitis);
(5) not meeting the diagnostic criteria of persistent (chronic) motor or vocal tic and Tourette syndrome.
Persistent (chronic) motor or phonic tic disorder:
(1) single or multiple motor or vocal tics continue to exist in the course of the disease, but not both motor and vocal tics occur simultaneously;
(2) the frequency of twitch can be changed, increased or decreased, but the course of disease lasts at least 1 year;
(3) onset before 18 years of age;
(4) twitching does not occur due to the action of certain substances (e.g., cocaine) or other diseases (e.g., huntington's disease or post-viral encephalitis);
(5) does not meet the diagnosis standard of Tourette syndrome.
Syndrome C Tourette
(1) Multiple motor tics and one or more vocal tics occur in the course of the disease, but are not required to occur within the same time period;
(2) the frequency of twitch can be changed, increased or decreased, but the course of disease lasts for more than 1 year;
(3) onset before 18 years of age;
(4) twitching does not occur due to the action of certain substances (e.g., cocaine) or other diseases (e.g., huntington's disease or post-viral encephalitis).
1.2.2 Chinese medicine diagnostic standards
The standard is formulated according to the tenth edition of the Chinese medicine pediatrics medical guideline release-pediatric disease book and 2016, edited by the professor of horse fusion, and specifically comprises the following steps:
(1) the onset age is mostly 2-15 years old;
(2) the primary clinical manifestations are twitching movements and/or involuntary vocalization symptoms, which may occur in one or more, but are not required to occur simultaneously in the course of the disease;
(3) the twitch symptom appears repeatedly, can have intensity change, is characterized by repetition, rapidness and no purpose, and can be controlled by will in a short time;
(4) tic symptoms cannot be attributed to other diseases.
1.3 inclusion criteria
(1) Those who meet the western diagnostic criteria for transient tic disorders with symptoms of vocalization or those who meet the western diagnostic criteria for persistent (chronic) vocalization tic disorders;
(2) children aged 4-18 years (including 4 years and 18 years);
(3) those with red pharynx;
(4) the sick children and the legal guardians agree with the informed consent and sign informed consent.
1.4 exclusion criteria
(1) Refractory tic disorder (TD patients who have no obvious curative effect and have no lasting disease after being treated for more than 1 year by drugs such as haloperidol, tiapride and the like);
(2) tourette's syndrome;
(3) those with no red pharynx;
(4) involuntary movements caused by non-tic disorder, such as Huntington's disease, rheumatic chorea, myoclonus, epilepsy, etc.;
(5) combined with serious organic diseases of heart, liver and kidney and mental disease children.
1.5 shedding criterion
(1) The compliance of the tested children patients is poor, and the children patients are not treated according to the prescribed treatment means, so that the curative effect is influenced;
(2) the infant patient to be tested has anaphylactic reaction or serious adverse event, and the patient is not suitable for continuing the test according to the judgment of a doctor;
(3) no matter what reason the infant is, the infant will be quitted by the initiative request and will not be continuously accepted by the clinical testers.
2 research methods
2.1 Collection of cases
Cases were collected according to inclusion and exclusion criteria, and general conditions were recorded, including: name, sex, age, course of disease, contact information, etc., recording twitch symptom and the taken traditional Chinese medicine decoction, and measuring YGTSS scale and traditional Chinese medicine syndrome scale.
2.2 grouping and Blind method
The cases to be collected were randomly divided into a test group and a control group, 30 cases in the test group and 30 cases in the control group, according to a random number table method. Because the throat spray of the test group and the throat spray of the control group have color difference, double blindness cannot be realized, and blindness is provided for a subject and a curative effect evaluator in order to ensure the accuracy of the result as much as possible.
2.3 treatment regimens
2.3.1 test group
In the experimental group, the cicada spray throat agent is combined with the traditional Chinese medicine decoction to dispel wind and relieve exterior syndrome, clear away heat and toxic material, extinguish wind and stop spasm.
Golden cicada throat spray: the components and the proportion thereof are as follows: the traditional Chinese medicine composition comprises 6g of tinospora root, 10g of sterculia lychnophora, 10g of blackberrylily rhizome, 10g of figwort root, 6g of cicada slough, 6g of mint, 2g of stevia rebaudiana and 0.1g of borneol.
Preparation: decocting the above Chinese medicinal materials in water for 25 min, and making into 1000ml liquid with crude drug concentration of 0.05 g/ml.
Specification: 50 ml/bottle.
The usage and dosage are as follows: spraying on the pharyngeal isthmus and the posterior pharyngeal wall for 4-6 years old, and spraying for 4 times; spraying 5 times at age of 7-12 years old; above 13 years old, 6 times a day.
2.3.2 control group
The control group was treated with placebo in combination with the Chinese medicinal decoction. The placebo component and the golden cicada throat spray agent have the crude drug concentration of 1/6 of the golden cicada throat spray agent.
Specification: 50 ml/bottle.
The usage and dosage are as follows: it is also suitable for cicada to spray throat.
The traditional Chinese medicine decoction pieces used in the clinical observation are all selected from the national medicine hall of the first subsidiary hospital of Tianjin traditional Chinese medicine university.
2.4 Observation index
2.4.1 Baseline index
Gender, age, course of disease, YGTSS total score before treatment, vocal tic score before treatment, Chinese medicine syndrome score before treatment and Chinese medicine decoction selection.
2.4.2 therapeutic index
(1) Yale integrated twitch severity scale (YGTSS) (see appendix 1 for details): the method mainly comprises three aspects. The first aspect is a exercise tic checklist, which mainly describes the past one week exercise tic performance of the infant, mainly according to the observation of parents, including simple exercise tics such as blinking, nose creasing, shoulder shrugging, etc., and complex exercise tics such as eyeball rotation, flexion, torsion, paroxysmal twitching, etc. The second aspect is a vocalization tic twitching check chart, which mainly describes the vocalization twitching condition of the infant in the past week according to the observation of parents, and also comprises simple vocalization twitching symptoms such as a throat clearing part and a whistling part and complex vocalization twitching symptoms such as a foul language, simulated speech and repeated speech. The third aspect is a quantitative table, which scores the movement or phonation twitch of the infant patient from six aspects, including times, frequency, intensity, complexity, interference and defect. The five aspects except the loss are respectively divided into 6 grades of 0-5, the higher the score is, the higher the grade is, the more serious the twitch degree is, and the total score of the exercise twitch and the phonation twitch is 25. The defects are comprehensively evaluated mainly from the aspects of self-esteem of the sick children and influence brought by families, social contact, learning and the like, and are divided into 6 grades of 0, 10, 20, 30, 40 and 50, and the higher the score is, the more serious the adverse effect of tic disorder on the sick children is.
And (3) calculating the fraction:
motion/phonation twitch integral-number fraction + frequency fraction + intensity fraction + complexity fraction + interference fraction
YGTSS Total score-exercise twitch integral + phonation twitch integral + defect score
According to the technical points of clinical research on treating infantile tic disorder by traditional Chinese medicines, the curative effect is evaluated according to the reduction rate.
The reduction rate calculation method comprises the following steps:
the YGTSS total score reduction rate ═ [ (pre-treatment YGTSS total score-post-treatment YGTSS total score)/pre-treatment YGTSS total score ] × 100%
The vocalization tics jerk score reduction rate ═ [ (pre-treatment vocalization jerk score-post-treatment vocalization jerk score)/pre-treatment vocalization jerk score ] × 100%
The evaluation standard of the curative effect is as follows:
clinical control: the YGTSS total score/phonation twitch integral reduction rate is not less than 95 percent;
secondly, effect is displayed: the YGTSS total score/phonation twitch integral reduction rate is more than or equal to 60% and less than 95%;
③ effective: the YGTSS total score/phonation twitch integral reduction rate is more than or equal to 30% and less than 60%;
fourthly, invalidation: YGTSS total score/voicing twitch integral reduction rate < 30%.
Total effective rate [ (number of clinical control cases + number of significant cases + number of effective cases)/number of total cases ] × 100%
(2) The traditional Chinese medicine syndrome score table (see appendix 2 for details): the medicine is formulated according to the technical guidelines for clinical experimental design and evaluation of new traditional Chinese medicine for treating child tic disorder and the curative effect is evaluated. The scale is mainly divided into two parts of main symptoms and accompanying symptoms. The chief complaints and the accompanying complaints are divided into 4 grades of normal, mild, moderate and severe, and the scores are 0, 1, 2 and 3 respectively.
The reduction rate calculation method comprises the following steps:
the traditional Chinese medicine syndrome integral subtraction ratio is [ (traditional Chinese medicine syndrome integral before treatment-traditional Chinese medicine syndrome integral after treatment)/traditional Chinese medicine syndrome integral before treatment ] × 100%
The evaluation standard of the curative effect is as follows:
clinical control: the traditional Chinese medicine syndrome integral reduction rate is more than or equal to 95 percent;
secondly, effect is displayed: the integral reduction rate of the traditional Chinese medicine syndrome is more than or equal to 70 percent and less than 95 percent;
③ effective: the integral reduction rate of the traditional Chinese medicine syndrome is more than or equal to 30 percent and less than 70 percent;
fourthly, invalidation: the integral reduction rate of the traditional Chinese medicine syndrome is less than 30%.
Total effective rate [ (number of clinical control cases + number of significant cases + number of effective cases)/number of total cases ] × 100%
2.4.3 safety evaluation index
Level 1: no adverse event occurs;
and 2, stage: mild adverse events occurred, but no treatment was required and the test could be completed;
and 3, level: moderate adverse events occur, and the test is completed after symptomatic treatment;
4, level: severe adverse events occurred and the test was discontinued.
2.5 statistical analysis
Data were statistically analyzed using SPSS Statistics 23 software. When the counting data is compared, a chi-square test, a continuity correction chi-square test or a Fisher exact probability method is selected according to the total sample amount and the theoretical frequency. When the measured data in the group are compared, if the data are normally distributed, a paired t test is selected, and if the data are distributed in a biased state, a paired sample rank sum test is selected; when the measurement data between groups are compared, if two groups of data are normally distributed and have uniform variance, a group t test is selected, and if any one of the two groups of data is distributed in a biased state or has non-uniform variance, two independent sample rank sum tests are selected. And when the repeated measurement data are compared, repeated measurement variance analysis is selected. When multiple groups are compared, analysis of variance is selected. Setting 0.05 as the test level, p <0.05 is statistically different.
3 results of the study
In the treatment process, 1 falling-off case caused by frequent cough of children patients is found in the test group, and 59 falling-off cases are found in the control group in total.
3.1 Baseline data comparison
3.1.1 gender comparison
The test group comprises 19 male students accounting for 65.52% and 10 female students accounting for 34.48%; the control group comprises 21 boys accounting for 70% and 9 girls accounting for 30%. The total number of cases is 59, 40 for boys and 67.80% for girls, 32.20 for girls and about 2:1 for both boys and girls. The two groups were compared for gender, and the differences were not statistically significant (p >0.05) and were comparable. (see Table 1)
TABLE 1 two gender comparisons (example)
Figure BDA0002722199640000101
3.1.2 age comparison
The age of the children patients in the test group is 4-14 years, and the average age is 8.21 +/-2.583 years; the age of the infant patients in the control group is between 5 and 15 years, and the average age is 9.10 +/-2.670 years. The two groups of ages are compared, and the difference is not statistically significant (p >0.05) and is comparable. (see Table 2)
Table 2 comparison of the ages of the two groups (age,
Figure BDA0002722199640000103
)
Figure BDA0002722199640000105
3.1.3 course of disease comparison
The disease course of the infant patients in the test group is between 5 and 36 months, and the average disease course is 15.31 +/-6.995 months; the disease course of the children patients in the control group is between 8 and 36 months, and the average disease course is 17.07 +/-5.675 months. The two groups of disease courses are compared, the difference is not statistically significant (p is greater than 0.05), and the disease courses are comparable. (see Table 3)
Table 3 two sets of disease courses were compared (month,
Figure BDA0002722199640000104
)
Figure BDA0002722199640000102
3.1.4 comparison of the pre-treatment YGTSS Total score and Vocal tics tic score
The average total score of YGTSS before treatment in the test group was 37.24 + -11.472 points, and the average score of vocalization tics before treatment was 13.24 + -3.842 points; the average total score of YGTSS before treatment in the control group was 37.93 + -12.692 points, and the average integral of vocalization tics before treatment was 12.47 + -2.862 points. The YGTSS total score and the vocal tic integral before the two groups of treatments are respectively compared, and the difference has no statistical significance (p is more than 0.05) and is comparable. (see tables 4-5)
Table 4 pre-treatment YGTSS summary score comparisons (scores,
Figure BDA0002722199640000114
)
Figure BDA0002722199640000111
table 5 pre-treatment vocal tic integral comparisons (points,
Figure BDA0002722199640000115
)
Figure BDA0002722199640000112
3.1.5 Chinese medicine syndrome integral comparison before treatment
The average integral of the traditional Chinese medicine syndromes in the test group before treatment is 9.90 +/-4.039 points; the mean integral of the traditional Chinese medicine syndrome in the control group before treatment is 10.10 +/-5.189 points. The integral of the syndrome of the traditional Chinese medicine in the two groups before treatment is compared, the difference has no statistical significance (p is more than 0.05), and the syndrome of the traditional Chinese medicine is comparable. (see Table 6)
Table 6 integral comparison of the syndrome of traditional Chinese medicine before treatment (score,
Figure BDA0002722199640000116
)
Figure BDA0002722199640000113
3.1.6 comparison of the Chinese medicinal decoction used for the treatment
The traditional Chinese medicine decoction used in the treatment of the experimental group is 14 cases of Yinqiao powder, 8 cases of Xifeng Zhihuai decoction, 5 cases of Chaigu Longmu decoction and 2 cases of phlegm removing decoction respectively; the traditional Chinese medicine decoction used in the treatment of the control group is respectively 12 cases of Yinqiao powder, 11 cases of Xifeng Zhitong decoction, 5 cases of Chaigu Longmu decoction and 2 cases of phlegm removing decoction.
Yinqiao powder: 15g of honeysuckle, 10g of fructus forsythiae, 10g of platycodon grandiflorum, 10g of fructus aurantii, 10g of semen raphani, 10g of schizonepeta spike, 10g of scutellaria baicalensis, 15g of rhizoma phragmitis and 6g of liquorice.
Stopping endogenous wind and stopping bleeding: 15g of gastrodia elata, 15g of uncaria, 15g of concha haliotidis, 10g of mulberry leaf, 10g of chrysanthemum, 10g of seed of feather cockscomb, 10g of biond magnolia flower, 6g of prepared rhizoma typhonii, 15g of dragon bone and 15g of oyster.
Decoction of radix bupleuri, cortex cinnamomi, longmu and oyster shell: 10g of radix bupleuri, 15g of raw dragon bone, 15g of raw oyster, 10g of codonopsis pilosula, 10g of scutellaria baicalensis, 15g of radix paeoniae alba, 10g of stiff silkworm, 3g of dried ginger, 3 Chinese dates, 6g of liquorice, 15g of calcined magnetite and 10g of rhizoma pinelliae preparata.
Washing phlegm soup: 15g of rhizoma acori graminei, 6g of arisaema cum bile, 10g of gastrodia elata, 10g of ligusticum wallichii, 10g of dried orange peel, 15g of poria cocos, 10g of notopterygium root, 10g of stiff silkworm, 10g of fructus aurantii, 6g of liquorice, 10g of codonopsis pilosula and 10g of rhizoma pinelliae preparata.
The Chinese medicinal decoction used in the treatment of the two groups has no statistical significance (p >0.05) and is comparable. (see Table 7)
TABLE 7 comparison of the Chinese medicinal decoction for treatment (example)
Figure BDA0002722199640000121
3.2 comparison of the scores of the two groups before and after 4 weeks of treatment
3.2.1 comparison of YGTSS Total score before and after 4 weeks of treatment
The average total score of YGTSS in the pre-treatment group was 37.24 + -11.472 points, the average total score of YGTSS in the post-treatment group was 24.24 + -10.453 points, and the average difference was 13.00 + -7.025 points; the average total score of YGTSS in the control group before treatment was 37.93 + -12.692 points, and the average total score of YGTSS in the control group after treatment was 33.23 + -14.166 points, with the average difference of 4.70 + -5.299. Comparing the YGTSS total score before and after treatment in the two groups respectively, wherein the difference has statistical significance (p is less than 0.05), which indicates that the YGTSS total score can be improved by the treatment methods of the test group and the control group; comparing the difference between the YGTSS total before and after treatment between the two groups, the difference was statistically significant (p <0.05), indicating that the test group was superior to the control group in improving YGTSS total.
(see Table 8)
Table 8 comparison of the total YGTSS scores before and after 4 weeks of treatment (score,
Figure BDA0002722199640000123
)
Figure BDA0002722199640000122
3.2.2 phonic tic score comparison before and after 4 weeks of treatment
The average volume of the vocal tic twitching of the test group before treatment is 13.24 +/-3.842 points, the average volume of the vocal tic twitching of the test group after treatment is 6.59 +/-3.571 points, and the average difference value is 6.66 +/-3.457 points; the average volume of the vocalization tics of the control group before treatment is 12.47 +/-2.862 points, the average volume of the vocalization tics of the control group after treatment is 9.70 +/-3.789 points, and the average difference is 2.77 +/-2.738 points. The vocal tic integral before and after treatment in the two groups are respectively compared, the difference has statistical significance (p is less than 0.05), and the results show that the treatment methods of the test group and the control group can improve the vocal tic integral; the difference between the score of vocal tic before and after treatment was compared between the two groups, and the difference was statistically significant (p <0.05), indicating that the test group was superior to the control group in terms of improving vocal tic score. (see Table 9)
Table 9 vocal tic score comparisons before and after 4 weeks of treatment (min,
Figure BDA0002722199640000133
)
Figure BDA0002722199640000131
3.2.3 integral comparison of Chinese medicine syndrome before and after 4 weeks of treatment
The average integral of the traditional Chinese medicine syndromes of the test group before treatment is 9.90 +/-4.039 points, the average integral of the traditional Chinese medicine syndromes of the test group after treatment is 4.03 +/-3.076 points, and the average difference is 5.86 +/-2.748 points; the average integral of the traditional Chinese medicine syndrome in the control group before treatment is 10.10 +/-5.189 points, the average integral of the traditional Chinese medicine syndrome in the control group after treatment is 6.70 +/-3.064 points, and the average difference is 3.40 +/-4.215. The traditional Chinese medicine syndrome integrals before and after treatment in the two groups are respectively compared, the differences have statistical significance (p is less than 0.05), and the treatment methods of the test group and the control group can improve the traditional Chinese medicine syndrome integrals; the difference of the traditional Chinese medicine syndrome integrals before and after treatment is compared between the two groups, the difference has statistical significance (p is less than 0.05), and the experimental group is superior to the control group in the aspect of improving the traditional Chinese medicine syndrome integrals. (see Table 10)
Table 10 integral comparison of the syndrome of traditional chinese medicine before and after 4 weeks of treatment (score,
Figure BDA0002722199640000134
)
Figure BDA0002722199640000132
3.3 clinical efficacy comparison of two groups after 4 weeks of treatment
3.3.1 curative effect comparison of two groups for treating tic disorder after 4 weeks
Evaluation of efficacy of tic disorder after 4 weeks of treatment: the clinical control of the test group is 2 cases, the effect is 1 case, the effect is 11 cases, the effect is 15 cases, and the total effective rate is 48.28%; the control group is clinically controlled to 1 case, 0 case with obvious effect, 4 cases with effect and 25 cases with no effect, and the total effective rate is 16.67 percent. The total effective rates of the two groups are compared, and the difference has statistical significance (p is less than 0.05), which shows that the curative effect of the test group is better than that of the control group in the aspect of improving the twitch symptom. (see Table 11)
TABLE 11 comparison of the efficacy of the YGTSS score improvement 4 weeks after treatment (example)
Figure BDA0002722199640000141
3.3.2 comparison of the efficacy of the two groups of drugs in phonic tic twitching after 4 weeks of treatment
The therapeutic effect of phonic tic twitching after 4 weeks of treatment was compared: the clinical control of the test group is 4, the obvious effect is 2, the effective is 18, the ineffective is 5, and the total effective rate is 82.76%; the clinical control group has 1 case, 1 case with obvious effect, 8 cases with effect and 20 cases with no effect, and the total effective rate is 33.33 percent. The total effective rates of the two groups are compared, the difference has statistical significance (p is less than 0.05), and the curative effect of the test group is better than that of the control group in the aspect of improving the phonation tic twitch. (see Table 12)
TABLE 12 comparison of the improvement in the efficacy of vocal tic score 4 weeks after treatment (example)
Figure BDA0002722199640000142
3.3.3 comparison of the curative effects of the two groups of the Chinese medicine syndromes after treating for 4 weeks
The evaluation of the curative effect of the traditional Chinese medicine syndrome after 4 weeks of treatment: 1 clinical control, 8 obvious effects, 18 effective cases and 2 ineffective cases in a test group, and the total effective rate is 93.10%; the clinical control of the control group comprises 0 cases, 2 cases with obvious effect, 15 cases with effect and 13 cases with no effect, and the total effective rate is 56.67 percent. The total effective rates of the two groups are compared, and the difference has statistical significance (p is less than 0.05), which shows that the curative effect of the test group is better than that of the control group in the aspect of improving the traditional Chinese medicine symptoms. (see Table 13)
TABLE 13 comparison of the Chinese medicine syndrome integrals with the improvement of the curative effects after 4 weeks of treatment (example)
Figure BDA0002722199640000143
3.4 comparison of the integrals at different times for the two groups of treatments
3.4.1 comparison of YGTSS Total scores at different times of treatment
The test group and the control group are subjected to repeated measurement analysis of variance, and the result is a multivariate test if the football-shaped test is not satisfied (i.e. p is less than 0.05). The time point factors p are all less than 0.05, which shows that the total scores of the two groups of YGTSS change along with the change of time; the time-to-group interaction p <0.05 indicated that the fluctuations in the total score of the two groups of YGTSS differed with time. Through simple effect analysis, the comparison of all time points of the test group is p <0.05, which shows that the YGTSS total score of each time point of the test group is different; the comparison of the YGTSS total score of the control group at 1 week after the treatment and before the treatment, the comparison of the control group at 2 weeks after the treatment and after 1 week after the treatment and the comparison of the control group at 4 weeks after the treatment and after 2 weeks after the treatment all show that the p is greater than 0.05, which indicates that the YGTSS total score of the control group at 1 week before the treatment and after 1 week after the treatment and at 2 weeks after the treatment and after 4 weeks after the treatment is not different, and the comparison at other time points shows that the YGTSS total score is. Comparison between the two groups, except for 4 weeks post-treatment, gave a p >0.05, indicating that there was a difference in the YGTSS score 4 weeks post-treatment in the two groups and no difference in comparison at other time points. (see tables 14-15, FIG. 1)
Table 14 total score comparisons of YGTSS at different times of treatment within the group (score,
Figure BDA0002722199640000153
)
Figure BDA0002722199640000151
note:■in comparison with the treatment before the same group of treatment,■p<0.05；▲in comparison with the treatment before the same group of treatment,▲p>0.05；▼compared with the same group after 1 week of treatment,▼p<0.05；◆compared with the same group after 1 week of treatment,◆p>0.05；●compared with the treatment group after 2 weeks,●p<0.05；★compared with the treatment of the same group for 2 weeks,★p>0.05。
table 15 group treatment-time YGTSS total score comparisons (score,
Figure BDA0002722199640000154
)
Figure BDA0002722199640000152
note:acompared with the two groups before the treatment,ap>0.05；bfor the two groups compared after 1 week of treatment,bp>0.05；cfor the two groups after 2 weeks of treatment,cp>0.05；dcompared with the two groups after 4 weeks of treatment,dp<0.05。
3.4.2 comparison of vocal twitch integrals at different times of treatment
The test group and the control group are subjected to repeated measurement analysis of variance, and the result is a multivariate test if the football-shaped test is not satisfied (i.e. p is less than 0.05). The time point factors p are all less than 0.05, which shows that the two groups of phonic twitch integrals change along with the change of time; the time and group interaction is p <0.05, which shows that the fluctuation of the vocal tic integral of the two groups is different along with the time factor. Through simple effect analysis, the comparison average p of each time point of the test group is less than 0.05, which shows that the phonation twitch integrals of each time point of the test group are different; except for comparison between the control group after 4 weeks of treatment and 2 weeks of treatment, the comparison at other time points is p <0.05, which shows that the vocal tic score after 2 weeks of treatment and 4 weeks of treatment are not different, and the vocal tic score at other time points is different. Compared between the two groups, except for comparison after 4 weeks of treatment, the p is more than 0.05, which indicates that the vocal tic score of the two groups is different after 4 weeks of treatment, and other time points have no difference in comparison. (see tables 16-17, FIG. 2)
Table 16 comparison of vocal tic integral at different times of treatment (score,
Figure BDA0002722199640000164
)
Figure BDA0002722199640000161
note:■in comparison with the treatment before the same group of treatment,■p<0.05；▼compared with the same group after 1 week of treatment,▼p<0.05；●compared with the treatment group after 2 weeks,●p<0.05；★compared with the treatment of the same group for 2 weeks,★p>0.05。
table 17 inter-group treatment different time vocal tic score comparisons (score,
Figure BDA0002722199640000163
)
Figure BDA0002722199640000162
note:acompared with the two groups before the treatment,ap>0.05；bfor the two groups compared after 1 week of treatment,bp>0.05；cfor the two groups after 2 weeks of treatment,cp>0.05；dcompared with the two groups after 4 weeks of treatment,dp<0.05。
3.4.3 integral comparison of TCM syndromes at different treatment times
The test group and the control group are subjected to repeated measurement analysis of variance, and the result is a multivariate test if the football-shaped test is not satisfied (i.e. p is less than 0.05). The time point factors p are all less than 0.05, which shows that the integral of the two groups of traditional Chinese medicine syndromes can change along with the change of time; the interaction between time and groups is p <0.05, which shows that the fluctuation of the integral of the syndrome of two groups of traditional Chinese medicine is different along with the time factor. Through simple effect analysis, the comparison of the test group and the control group at each time point is p <0.05, which shows that the traditional Chinese medicine syndrome integrals of each time point of the two groups are different. Compared between the two groups, p is greater than 0.05 before and after 1 week of treatment, and p is less than 0.05 after 2 weeks of treatment and after 4 weeks of treatment, which shows that the traditional Chinese medicine syndrome integrals of the two groups before and after 1 week of treatment are not different, and the traditional Chinese medicine syndrome integrals of the two groups after 2 weeks of treatment and after 4 weeks of treatment are different. (see tables 18-19, FIG. 3)
Table 18 the results of the traditional chinese medical syndrome integral comparisons (scores,
Figure BDA0002722199640000174
)
Figure BDA0002722199640000171
note:■in comparison with the treatment before the same group of treatment,■p<0.05；▼compared with the same group after 1 week of treatment,▼p<0.05；●compared with the treatment group after 2 weeks,●p<0.05。
table 19 group-to-group comparisons of the syndrome integrals of chinese medicine at different times of treatment (score,
Figure BDA0002722199640000175
)
Figure BDA0002722199640000172
note:acompared with the two groups before the treatment,ap>0.05；bfor the two groups compared after 1 week of treatment,bp>0.05；cfor the two groups after 2 weeks of treatment,cp<0.05；dcompared with the two groups after 4 weeks of treatment,dp<0.05。
3.5 the curative effects of different Chinese medicinal decoctions are compared
3.5.1 comparison of scores 4 weeks after treatment
3.5.1.1 comparison of YGTSS Total score after 4 weeks of treatment
The difference between the YGTSS total points before treatment of the different traditional Chinese medicine decoctions in the test group and the control group and the difference between the YGTSS difference values before and after treatment of the two groups have no statistical significance (p is more than 0.05), which indicates that the different traditional Chinese medicine decoctions in the observation have no obvious difference in the aspect of improving the YGTSS total points. (see tables 20-21)
TABLE 20 test groupsCompared with the YGTSS total score after the treatment of the traditional Chinese medicine decoction (score,
Figure BDA0002722199640000176
)
Figure BDA0002722199640000173
table 21 comparison of the total score of YGTSS after treatment with different herbal decoctions for the control group (score,
Figure BDA0002722199640000184
)
Figure BDA0002722199640000181
3.5.1.2 score comparison of vocal tic twitch after 4 weeks of treatment
The difference between the vocalization pumping integral before treatment of different traditional Chinese medicine decoctions in the test group and the control group and the difference between the vocalization pumping integral difference before treatment and after treatment of the two groups have no statistical significance (p is more than 0.05), which indicates that different traditional Chinese medicine decoctions in the observation have no obvious difference in the aspect of improving the vocalization pumping integral. (see tables 22-23)
Table 22 comparison of vocal twitch integrals after treatment with different herbal decoctions (score,
Figure BDA0002722199640000185
)
Figure BDA0002722199640000182
table 23 comparison of vocal twitch integrals after treatment with different herbal decoctions of the control group (score,
Figure BDA0002722199640000186
)
Figure BDA0002722199640000183
3.5.2 clinical efficacy comparison after 4 weeks of treatment
3.5.2.1 comparison of therapeutic effects on tic disorder after 4 weeks
The total effective rate of different traditional Chinese medicine decoction for treating tic disorder in the test group and the control group is compared, and the difference has no statistical significance (p is more than 0.05). (see tables 24-25)
TABLE 24 comparison of the therapeutic effects of different Chinese medicinal decoctions for tic disorder in test group
Figure BDA0002722199640000191
TABLE 25 comparison of the curative effects of different Chinese medicinal decoctions for control group on tic disorder
Figure BDA0002722199640000192
3.5.2.2 comparison of therapeutic effects of 4 weeks after treatment with phonic tic twitch
The total effective rate of different traditional Chinese medicine decoction treatments for the vocal tic twitching in the test group and the control group is compared, and the difference has no statistical significance (p is more than 0.05). (see tables 26-27)
TABLE 26 comparison of the therapeutic effects of different Chinese medicinal decoction in the test group on vocalization and twitching after treatment (example)
Figure BDA0002722199640000193
TABLE 27 comparison of the therapeutic effects of different Chinese medicinal decoction of control group on vocalization and twitching
Figure BDA0002722199640000201
3.6 Security comparison
In the treatment process, 1 patient suffers from frequent cough and drop in the test group, and the control group does not suffer any adverse reaction. The difference between the two groups of safety was not statistically significant (p > 0.05). (see Table 28)
TABLE 28 two sets of safety comparisons (example)
Figure BDA0002722199640000202

Claims (6)

1. A cicada throat spray is characterized in that: the main components and the parts by weight are as follows: 6-10 parts of radix tinosporae, 6-10 parts of boat-fruited sterculia seed, 6-10 parts of blackberrylily rhizome, 10-15 parts of radix scrophulariae, 3-6 parts of periostracum cicadae, 3-6 parts of mint and 0.1-0.5 part of borneol.
2. The cicada spray throat agent according to claim 1, which is characterized in that: the cicada spray throat agent also comprises 1-3 parts of stevia rebaudiana.
3. The preparation method of the cicada spray-throat agent according to claim 1 or 2, which is characterized by comprising the following steps: the method comprises the following steps: weighing the raw materials according to the mass parts, decocting the raw materials with water for 25 minutes, and preparing the mixture into liquid, wherein the concentration of the crude drug is 0.05 g/ml.
4. Use of a cicada spray throat preparation according to claim 1 or 2 in the preparation of a medicament for the adjuvant treatment of child tic disorders.
5. Use according to claim 4, characterized in that: the child tic disorder is vocal tic.
6. A composition for treating tic disorders in children, comprising: the composition comprises the cicada spray throat agent and traditional Chinese medicine decoction of claim 1 or 2; the Chinese medicinal decoction is YINQIAOSAN, XIFENGZHITONG decoction, CHAIGUILONGMU decoction or ZHITANG decoction.
CN202011091439.1A 2020-10-13 2020-10-13 Cicada throat spray and application thereof Pending CN112190635A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202011091439.1A CN112190635A (en) 2020-10-13 2020-10-13 Cicada throat spray and application thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202011091439.1A CN112190635A (en) 2020-10-13 2020-10-13 Cicada throat spray and application thereof

Publications (1)

Publication Number Publication Date
CN112190635A true CN112190635A (en) 2021-01-08

Family

ID=74008860

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202011091439.1A Pending CN112190635A (en) 2020-10-13 2020-10-13 Cicada throat spray and application thereof

Country Status (1)

Country Link
CN (1) CN112190635A (en)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104547527A (en) * 2015-01-06 2015-04-29 延安大学 Traditional Chinese medicine composition for treating sphagitis
CN104771699A (en) * 2015-04-22 2015-07-15 徐欣昌 Medicine for treating children tic disorder and preparation method of medicine

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104547527A (en) * 2015-01-06 2015-04-29 延安大学 Traditional Chinese medicine composition for treating sphagitis
CN104771699A (en) * 2015-04-22 2015-07-15 徐欣昌 Medicine for treating children tic disorder and preparation method of medicine

Non-Patent Citations (8)

* Cited by examiner, † Cited by third party
Title
于忠翠，等: "育肝息风汤治疗小儿抽动秽语综合征120例", 《中国中医急症》 *
张小洁: "基于三焦辨证理论运用小儿推拿结合中药治疗小儿多发性抽动症（上焦证）的临床研究", 《中国优秀硕士学位论文全文数据库》 *
张晓慧，马融，等: "马融教授运用银翘散治疗儿童抽动障碍风邪犯肺证30例临床观察", 《辽宁中医药大学学报》 *
徐三文，等: "《中国脑病秘方全书》", 31 August 2002, 科学技术文献出版社 *
时骏英: "咽扁冲剂治疗咽炎扁桃体腺炎102例观察", 《北京中医》 *
李琳，等: "针药并举治疗抽动-秽语综合征46例临床体会", 《中国中医药信息杂志》 *
李瑞仕，等: "中医辨证治疗小儿多发性抽动症研究近况", 《中医儿科杂志》 *
董朝，等: "非化脓性扁桃体咽炎的病原治疗", 《北京中医》 *

Similar Documents

Publication Publication Date Title
US8623424B2 (en) Traditional Chinese medicinal compositions for treating depression, formulation thereof, method for preparing the same thereof
CN103961614B (en) Chinese medicine composition for treating respiratory disease and its production and use
CN101085231A (en) Internal-applied traditional Chinese medicine composition for treating depression
CN113134057A (en) Compound traditional Chinese medicine preparation for treating hyperlipemia and preparation method thereof
CN105031445A (en) Chinese medicinal composition for treating pulmonary tuberculosis
CN104825960A (en) Traditional Chinese medicine for treating pulmonary tuberculosis and preparation method thereof
CN104547598A (en) Traditional Chinese medicine preparation for treating neurasthenia and preparation method thereof
CN112190635A (en) Cicada throat spray and application thereof
CN103768153B (en) Traditional Chinese medicine composition for treating air sacculitis of poultry and preparation method thereof
CN113499425A (en) Composition for treating viral influenza and preparation method thereof
CN101129806A (en) Orally taken traditional Chinese medicine composition for treating melancholia
CN116531457B (en) Traditional Chinese medicine composition for treating chronic pharyngitis and application thereof
CN109078086B (en) Traditional Chinese medicine for treating sperm DNA damage
CN104740210B (en) A kind of Chinese medicine and preparation method for the treatment of qi stagnation and blood stasis type craniocerebral trauma syndrome
CN114470046B (en) Traditional Chinese medicine formula for treating allergic asthma and application thereof
CN114470110B (en) Anti-rhinitis traditional Chinese medicine composition with pain relieving effect
CN109106842B (en) A medicine for stopping smoking and its preparation method
CN1283283C (en) Tendon-extending bone-penetrating spray of and its preparing method
CN104940763A (en) Traditional Chinese medicine preparation for treating primary pulmonary tuberculosis
CN104586974A (en) Traditional Chinese medicine for treating lung-heat cough
CN115554372A (en) Traditional Chinese medicine for treating primary fibromyalgia syndrome and preparation method and application thereof
CN104491187A (en) External use ointment capable of preventing radiation and preparation method thereof
CN104547865A (en) Application of traditional Chinese medicine preparation in preparing medicine for treating senile dementia
CN118021925A (en) Traditional Chinese medicine composition for treating intractable chronic cough
CN104162074A (en) Traditional Chinese medicinal composition for treating respiratory infectious diseases of animals, and preparation method thereof

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
RJ01 Rejection of invention patent application after publication
RJ01 Rejection of invention patent application after publication

Application publication date: 20210108