CN109568470A - Shenkangning capsules, which combine zinc gluconate oral administration solution, is improving the application in the symptoms such as kidney-yang deficiency person's frequent urination at night urinary incontinence urine urgency-frequency - Google Patents
Shenkangning capsules, which combine zinc gluconate oral administration solution, is improving the application in the symptoms such as kidney-yang deficiency person's frequent urination at night urinary incontinence urine urgency-frequency Download PDFInfo
- Publication number
- CN109568470A CN109568470A CN201910069669.9A CN201910069669A CN109568470A CN 109568470 A CN109568470 A CN 109568470A CN 201910069669 A CN201910069669 A CN 201910069669A CN 109568470 A CN109568470 A CN 109568470A
- Authority
- CN
- China
- Prior art keywords
- urination
- kidney
- frequent
- night
- urinary incontinence
- 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
Links
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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/481—Astragalus (milkvetch)
-
- 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
- A61K31/28—Compounds containing heavy metals
- A61K31/315—Zinc compounds
-
- 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
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/076—Poria
-
- 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
- A61K36/533—Leonurus (motherwort)
-
- 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
- A61K36/537—Salvia (sage)
-
- 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)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
- A61K36/714—Aconitum (monkshood)
-
- 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)
- A61K36/884—Alismataceae (Water-plantain family)
-
- 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)
- A61K36/894—Dioscoreaceae (Yam family)
- A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Mycology (AREA)
- Epidemiology (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Botany (AREA)
- Medical Informatics (AREA)
- Microbiology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Urology & Nephrology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses shenkangning capsules joint zinc gluconate oral administration solutions to improve the application in the symptoms such as kidney-yang deficiency person's frequent urination at night urinary incontinence urine urgency-frequency.The combination product is by following product form: shenkangning capsules and zinc gluconate oral administration solution.Product mix of the present invention is applied to clinical test, test patient is the kidney-yang deficiency patient with diseases such as frequent urination at night, frequent micturition, urgent urination, the urinary incontinences, and clinical test mode is random, Double-blind double-dummy, parallel control, multi-center clinical trial.Clinical test results show: the combination product is significantly improved the diseases such as kidney-yang deficiency patient frequent urination at night, frequent micturition, urgent urination, urinary incontinence tool, and improvement is better than single use shenkangning capsules, and good security.It is proposed of the invention provides a kind of new technological means to improve the symptoms such as frequent urination at night, the urinary incontinence, frequent micturition, urgent urination caused by syndrome of deficiency of kidney yang.
Description
Technical field
The present invention relates to a kind of combination product and its application, in particular to a kind of pair of Patients with Kidney-Yang Deficiency Syndrome frequent urination at night, urine lose
The symptoms such as taboo, frequent micturition, urgent urination have combination product and its application of improvement result.The combination product is clinical tests prove that kidney
The symptoms such as yang deficiency syndrome patient frequent urination at night, the urinary incontinence, frequent micturition, urgent urination have improvement result.The invention belongs to pharmaceutical technology fields.
Background technique
The multifactor body deficiency of yang of kidney-yang deficiency or the year high Yang-function insufficiency of kidneyzang or prolonged illness impairment of yang, it is dirty to involve in kidney, or too because of sexual intercourse
It crosses, with the passing of time undermines kidney yang.Shen controls bone, waist are house of kidney, and decline of kidney-YANG, waist and knee is lost supports in temperature, and sees that waist and knee acid is cold；Kidney occupy down
Coke, YANG QI deficiency, warm dereliction of duty, the limb cold therefore shape is trembled with fear, lower limb are more so；The deficiency of yang cannot inspire spirit, then see spiritlessness and weakness；Kidney department two
Just, the insufficiency of the kidney yang, temperatureization are powerless, then, it is seen that frequent urination, enuresis nocturna, loose watery stool or Diarrhoea.Many diseases show as kidney
Yang deficiency syndrome, the elderly are especially common.Benign prostatic hyperplasis, stress incontinence, 1~2 phase of chronic kidney disease (CKD), bladder
These common symptoms of over-activity disease.The disease that overactive bladder is made of symptoms such as frequent micturition, urgent urination, urge incontinences
It waits, these symptoms both can individually occur, and can also occur with any complex form；Stress incontinence refers to sneeze, cough, laugh
Or the abdominal pressures such as movement occur involuntary urine when increasing and leak out from urethral orifice.Frequent urination at night, the urinary incontinence, frequent micturition, urgent urination are clinical
One group of common lower urinary tract symptom, seriously affects the quality of life of people especially the elderly.
Shenkangning capsules, national drug standard Z20090980 are produced by Harbin Kuai Hao pharmaceutcal corporation, Ltd.By Radix Astragali, pellet
Ginseng, Poria cocos, rhizoma alismatis, motherwort, RADIX ACONITI LATERALIS PREPARATA, cynomorium songaricum, eight taste medicinal material of Chinese yam composition, the function with warm kidney QI invigorating lose for kidney qi
The soreness of waist caused by damaging, tired, chilly and enuresis nocturna increase.This product has listed for many years, is chiefly used in frequent urination at night caused by syndrome of deficiency of kidney yang, urine
The treatment of the symptoms such as incontinence, frequent micturition, urgent urination.
Zinc gluconate oral administration solution is mainly used for malnutrition, apositia, allotriophagy, oral cavity caused by treating zinc-deficiency
Ulcer, acne, upgrowth and development of children are slow etc..
In order to obtain better curative effect, present invention applicant once entrusted Harbin Schumann moral medical sci-tech development corporation, Ltd.
Shenkangning capsules joint zinc gluconate oral administration solution has been carried out to diseases such as kidney-yang deficiency patient frequent urination at night, the urinary incontinence, frequent micturition, urgent urinations
The random of shape improvement result, Double-blind double-dummy, parallel control, multi-center clinical trial.As a result, it has been found that shenkangning capsules joint Portugal
Grape saccharic acid zinc oral administration solution is significantly improved the symptoms such as Patients with Kidney-Yang Deficiency Syndrome frequent urination at night, the urinary incontinence, frequent micturition, urgent urination tool,
Wherein urgent urination improvement rate, tcm syndrome total score curative effect, tcm syndrome individual event sexual hypoesthesia disappearance rate be superior to single use kidney
Healthy and free from worry capsule, and good security.
Therefore, the invention proposes shenkangning capsules joint zinc gluconate oral administration solutions to improve caused by syndrome of deficiency of kidney yang
Application in the symptoms such as frequent urination at night, the urinary incontinence, frequent micturition, urgent urination, proposition of the invention enable shenkangning capsules to play more
Good curative effect provides a kind of new technology to improve the symptoms such as frequent urination at night, the urinary incontinence, frequent micturition, urgent urination caused by syndrome of deficiency of kidney yang
Means.
Summary of the invention
The purpose of the present invention is to provide shenkangning capsules joint zinc gluconate oral administration solutions to lead in improvement syndrome of deficiency of kidney yang
Application in the symptoms such as frequent urination at night, the urinary incontinence, frequent micturition, the urgent urination of cause.
In order to achieve the above object, present invention employs following technological means:
Firstly, the invention proposes the symptoms such as a kind of pair of Patients with Kidney-Yang Deficiency Syndrome frequent urination at night, the urinary incontinence, frequent micturition, urgent urination to have
The combination product of improvement result, by following product form: shenkangning capsules and zinc gluconate oral administration solution.
Wherein, it is preferred that the shenkangning capsules, national drug standard Z20090980, by Harbin good limited public affairs of medicine company fastly
Department's production.
Wherein, it is preferred that the zinc gluconate oral administration solution, national drug standard H20093614, by Harbin good medicine fastly
The production of industry Co., Ltd.
By product mix of the present invention be applied to clinical test, test patient be with frequent urination at night, frequent micturition, urgent urination,
The kidney-yang deficiency patient of the diseases such as the urinary incontinence, clinical test mode are random, Double-blind double-dummy, parallel control, multi-center clinical trial.
Clinical test results show: the combination product, which has the diseases such as kidney-yang deficiency patient frequent urination at night, frequent micturition, urgent urination, the urinary incontinence, obviously to be changed
Kind effect, wherein urgent urination improvement rate, tcm syndrome total score curative effect, tcm syndrome individual event sexual hypoesthesia disappearance rate be superior to it is single
Using shenkangning capsules, and good security.
Therefore, further, the invention also provides the combination product preparation to patient's frequent urination at night, the urinary incontinence,
The symptoms such as frequent micturition, urgent urination have the application in the drug of improvement result.
Wherein, it is preferred that the patient is Patients with Kidney-Yang Deficiency Syndrome.
Specific embodiment
It elaborates below to specific embodiment provided by the invention.Those skilled in the art are contemplated that
A variety of modifications and adaptations carried out, without changing the spirit or scope of the present invention.This modifications and adaptations are included in the present invention
In the range of.Following embodiments are not limit the invention in any way.
The symptoms such as embodiment 1 a kind of pair of Patients with Kidney-Yang Deficiency Syndrome frequent urination at night, the urinary incontinence, frequent micturition, urgent urination have improvement result
Combination product
Include:
1, shenkangning capsules, national drug standard Z20090980 are produced by Harbin Kuai Hao pharmaceutcal corporation, Ltd.
2, zinc gluconate oral administration solution, national drug standard H20093614 are produced by Harbin Kuai Hao pharmaceutcal corporation, Ltd.
This product is minerals class non-prescribed medicine, and every milliliter contains 3.5 milligrams of zinc gluconate, and auxiliary material is sucrose, saccharin sodium, citric acid
Deng.
1 shenkangning capsules of test example combine zinc gluconate oral administration solution to Patients with Kidney-Yang Deficiency Syndrome frequent urination at night, frequent micturition, urine
The symptoms such as urgency, the urinary incontinence have the clinical test of improvement result
1 experimental design
1.1 test general descriptions
This test is a Xiang Suiji, Double-blind double-dummy, parallel control, multicenter, optimal efficiency clinical test.With enuresis nocturna
Increase, the Patients with Kidney-Yang Deficiency Syndrome of the urinary incontinence, frequent micturition and symptoms of urgency be tested crowd (be related to disease have benign prostatic hyperplasis,
Stress incontinence, 1~2 phase of chronic kidney disease, overactive bladder), meet participate in this test subject will at random into
Enter test group (shenkangning capsules+zinc gluconate oral administration solution) and control group (shenkangning capsules), 118 patients of test group,
112 patients of control group.With the period be 8 weeks when medicining condition observed, by observation enuresis nocturna increase, the urinary incontinence, frequent micturition
With the improvement situation of the symptoms such as urgent urination, to understand the therapeutic scheme and kidney health of shenkangning capsules joint zinc gluconate oral administration solution
The curative effect advantage of Yiganning capsule single drug treatment.
The selection of 1.2 comparison medicines
According to purpose, this clinical test selects shenkangning capsules for comparison medicine.
The selection of 1.3 test endpoint targets
Shenkangning capsules have been listed using for many years, and the function with warm kidney QI invigorating is tired for the soreness of waist caused by kidney qi loss
Weary, chilly and enuresis nocturna increase.Clinical practice shows that the medicine is improving Patients with Kidney-Yang Deficiency Syndrome frequent urination at night, the urinary incontinence, frequent micturition, urgent urination
Etc. have a better effect in terms of symptoms, therefore, this test is using urination journal record subject urination, selection frequent urination at night disease
The disappearance rate shape of shape is as endpoint, while the urinary incontinence, frequent micturition, the improvement rate of symptoms of urgency and disappearance rate are compared in analysis, with
And the changing value of tcm syndrome curative effect, tcm syndrome disappearance rate (soreness and weakness of waist and knees, sexual hypoesthesia, aversion to cold and cold limbs etc.) etc., from
And many-sided evaluation combined treatment is with respect to the advantage of single therapy.
2 case selection standards
2.1 diagnostic criteria
2.1.1 Western medicine diagnostic criteria
Benign prostatic hyperplasis: with reference to 2017 chronology of Professional Committee, Chinese Association of Chinese and Western Medicine andrology " before benign
Column gland hyperplasia combination of Chinese tradiational and Western medicine practice guidelines (trial version) ".
The stress incontinence: " female stress of 2017 chronology of gynecotokology branch, Chinese Medical Association gynaecology's basin bottom group
Diagnosis of urinary incontinence and treatment guidelines (2017) "
Chronic kidney disease: with reference to the early discovery of Shanghai chronic kidney disease and standardization diagnosis and treatment and Demonstration Project Expert group 2017
" chronic kidney disease screening, diagnosis and the guideline of prevention and treatment " of chronology
Overactive bladder: " 2014AUA/SUFU guide: adult bladder over-activity disease (non-neurogenic) is referred to
Clinics and Practices "
2.1.2 kidney-yang deficiency CM syndrome differentiation criterion
" new Chinese medicine guideline of clinical investigations (tentative) " is published with reference to China Medical Science Press in 2002 and is tied
The major function for closing shenkangning capsules is formulated.
Kidney-yang deficiency:
Primary symptom: frequent urination at night, the urinary incontinence, soreness and weakness of waist and knees, sexual hypoesthesia, aversion to cold and cold limbs.
Minor symptom: frequent micturition, apathetic, edema of lower extremity, dynamic then shortness of breath, is sent out tooth withered and is shaken urgent urination.
Tongue vein: the light whitish tongue of tongue nature, slow and sunken pulse, ruler are powerless.
Diagnosis: frequent urination at night is indispensable, and other primary symptom >=1, minor symptom >=2 can make a definite diagnosis in conjunction with tongue vein.
2.2 inclusion criteria
1) meet benign prostatic hyperplasis, stress incontinence, chronic kidney disease (CKD) 1-2 phase, overactive bladder
Diagnostic criteria；
2) meet Chinese medicine syndrome of deficiency of kidney yang CM syndrome differentiation criterion；
3) there is the patient of nycturia shape (night urination >=2 time)；
4) age 18-75 years old, male or female；
5) voluntary tested, signed informed consent form.
2.3 exclusion criteria
1) the constituent allergy to shenkangning capsules, zinc gluconate oral administration solution or allergic constitution patient.
2) enter to be inscribed for group first 3 days and received drug therapy (containing traditional Chinese herbal decoction).
3) previously there are bladder, prostate or urethral trauma or operation medical history, trauma of spinal cord history, bladder and tumor of prostate disease
History, neurogenic bladder medical history, or have the patient of retention of urine medical history.
4) cold, fever person, or be associated with following with enuresis nocturna, the urinary incontinence, frequent micturition or the disease of urgent urination clinical manifestation: under
Urinary obstruction (vesical calculus or tumour), ankylurethria, urinary infection, neurogenic bladder, indirect inguinal hernia, uterus or rectum
Prolapsus bulging, central urination disorder, congestive heart failure, obstructive sleep apnea syndrome, diabetes, urine collapse
Primary polydipsia caused by disease, inappropriate water are drained etc..
5) patient of arrhythmia cordis.
6) 1.5 times of ALT, AST >=Upper Limit of Normal Value, Scr > Upper Limit of Normal Value.
7) vitals such as other severe cardiacs, liver, kidney, hemopoietic system and system primary disease are associated with.
8) it is associated with neural, mental disease and can not cooperate or be reluctant partner.
9) suspect or truly have alcohol, drug abuse history person.
10) according to the judgement of researcher, with reduce into group possibility or make into group complicate other situations.
11) there are fecundity in the gestational period, breast feeding women and do not take abundant contraceptives person.
12) patient of other clinical tests was participated in nearly 3 months.
3 test articles and therapeutic scheme
3.1 test article
Shenkangning capsules: 0.32g/, national drug standard: Z20090980
Zinc gluconate oral administration solution: 10ml/ branch, national drug standard: H20093614
Zinc gluconate oral administration solution simulant
3.2 administrated method
3.2.1 test group:
Shenkangning capsules: 5 tablets/time, 3 times/day.
Zinc gluconate oral administration solution: 2/time, 2 times/day.
3.2.2 control group:
Shenkangning capsules: 5 tablets/time, 3 times/day.
Zinc gluconate oral administration solution simulant: 2/time, 2 times/day.
3.2.3 the period is observed: 8 weeks.
4 therapeutic evaluatioies
4.1 curative effect indexs
Frequent urination at night symptom disappearance rate: after medication, nocturia scoring be 0 subject's percentage.
4.2 secondary efficacy indexs
4.2.1 the urinary incontinence, frequent micturition, symptoms of urgency improvement rate and disappearance rate
The urinary incontinence, frequent micturition, symptoms of urgency disappearance rate: after medication, nocturia scoring be 0 subject's percentage.
Incontinence improvement rate: according to the data of urination journal record, calculating continuous 7 days average urinary incontinence numbers,
Compare after medication compared with the slip before medication.
Frequency symptoms improvement rate: according to the data of urination journal record, continuous 7 days isuria numbers is calculated, are compared
Compared with the slip before medication after medication.
Symptoms of urgency improvement rate: according to the data of urination journal record, continuous 7 days average urgent urination numbers is calculated, are compared
Compared with the slip before medication after medication.
5. statistical analysis: carrying out data analysis using statistical software.
6. curative effect index statisticallys analyze
The analysis of 6.1 curative effect indicator-specific statistics
6.1.1 frequent urination at night symptom disappearance rate
Statistical result is as shown in table 1, table 2:
Frequent urination at night symptom disappearance rate situation (PPS) after 1 two groups of patient medications of table
Remarks: frequent urination at night symptom disappears: scoring before medication is not 0, the subject that symptom score is 0 after medication.
Frequent urination at night symptom disappearance rate comparable situation (PPS) after 2 two groups of patient medications of table
| Index | Check groups | Statistic | P value |
| Frequent urination at night disappearance rate | Test group vs. control group | 2.8021 | 0.0941 |
By table 1,2 statistical data of table it is found that test group frequent urination at night disappearance rate is higher than control group frequent urination at night after medication
Disappearance rate.
6.2 secondary efficacy indexs
6.2.1 the disappearance rate of the urinary incontinence, frequent micturition, urgent urination
Statistical result is as shown in table 3- table 6:
The urinary incontinence, frequent micturition, urgent urination disappearance rate situation (PPS) after 3 two groups of patient medications of table
Remarks: it is not 0 point of patient that the table, which is only counted and scored before medication,.Symptom disappears: scoring before medication is not 0, medication
The subject that symptom score is 0 afterwards.
4 two groups of urinary incontinence in patients with incomplete of table, frequent micturition, urgent urination disappearance rate comparable situation (PPS) two-by-two
| Index | Check groups | Statistic | P value |
| Urinary incontinence disappearance rate | Test group vs. control group | 0.1286 | 0.7199 |
| Frequent micturition disappearance rate | Test group vs. control group | 3.7266 | 0.0536 |
| Urgent urination disappearance rate | Test group vs. control group | 3.3059 | 0.0690 |
By table 3,4 statistical data of table it is found that test group urinary incontinence disappearance rate, frequent micturition disappearance rate, urgent urination after medication
Disappearance rate is above control group.
Each interview urinary incontinence of 5 two groups of patients of table, frequent micturition, the improvement rate of urgent urination (%) comparable situation (PPS)
Remarks: incontinence improves: according to urination journal record leakage of urine number, comparing medication forward backward averaging leakage of urine number
Reduction number；Frequency symptoms improve: the reduction number of night urination number before and after medication；Symptoms of urgency improves: according to urination
The sense of urgency number of journal record compares the reduction number of medication forward backward averaging urgent urination number.
Each interview urinary incontinence of 6 two groups of patients of table, frequent micturition, the improvement comparable situation (PPS) of urgent urination
| Index | Interview | Check groups | Statistic | P value |
| The urinary incontinence | Before medication-medication after | Test group vs. control group | -0.7017 | 0.7625 |
| Frequent micturition | Before medication-medication after | Test group vs. control group | -1.0393 | 0.5520 |
| Urgent urination | Before medication-medication after | Test group vs. control group | -2.6683 | 0.0208 |
By table 5,6 statistical data of table it is found that the urinary incontinence improvement rate of test group, frequent micturition improvement rate are high after medication
In control group, two groups compared to more not statistically significant；But the urgent urination improvement rate of test group is compared with the control group after medication
Difference has statistical significance.
6.3 tcm syndrome total score curative effects
Statistical result is as shown in table 7, table 8:
Each interview tcm syndrome total score curative effect situation (PPS) of 7 two groups of patients of table
Remarks: (recovery from illness: Chinese medicine syndrome integral is compared with decline >=95% before medication for tcm syndrome the standard of curative effect evaluation；It is effective: in
Syndrome integral is cured compared with decline >=70% before medication；Effective: Chinese medicine syndrome integral is compared with decline >=30% before medication；It is invalid: Syndrome in TCM
It waits integral to decline less than 30% or increase compared with before medication).
Each interview tcm syndrome total score curative effect comparable situation (PPS) of 8 two groups of patients of table
By table 7,8 statistical data of table it is found that the tcm syndrome total score curative effect of test group is higher than control group after medication,
Difference has statistical significance.
6.4 tcm syndrome individual event disappearance rate
Statistical result is as shown in table 9, table 10:
9 two groups of patient's tcm syndrome individual event rate situations (PPS) of table
Remarks: the patient that it is 0 that this table, which only counts and treats preceding scoring in every individual event symptom,.Individual event symptom disappears: before medication
Scoring is not 0, the subject that symptom score is 0 after medication.
Tcm syndrome individual event disappearance rate comparable situation (PPS) after 10 two groups of patient medications of table
After by medication known to table 9,10 statistical data of table, soreness and weakness of waist and knees, sexual hypoesthesia, aversion to cold and cold limbs, spirit are withered
It wastes, edema of lower extremity, dynamic then shortness of breath, send out withered tooth and shake the disappearance rate result of 7 tcm syndrome individual events and be above control group for test group；
Wherein after medication test group sexual hypoesthesia tcm syndrome individual event disappearance rate compared with the control group, difference have statistics
Meaning.
7. brief summary:
By table 1 to 10 clinical test of table 4 weeks and 8 weekly datas show shenkangning capsules combine zinc gluconate take orally it is molten
Liquid has improvement result to Patients with Kidney-Yang Deficiency Syndrome frequent urination at night, the urinary incontinence, frequent micturition, symptoms of urgency, begins within 4 weeks improvement, changes within 8 weeks
Kind effect is more significant.Wherein urgent urination improvement rate, tcm syndrome total score curative effect are better than the curative effect that shenkangning capsules are individually taken；Together
When, shenkangning capsules joint zinc gluconate oral administration solution also has the sexual hypoesthesia of Patients with Kidney-Yang Deficiency Syndrome tcm syndrome individual event
Obvious improvement result.
Claims (6)
1. the symptoms such as a kind of pair of Patients with Kidney-Yang Deficiency Syndrome frequent urination at night, the urinary incontinence, frequent micturition, urgent urination have the combination product of improvement result,
It is characterized in that, by following product form: shenkangning capsules and zinc gluconate oral administration solution.
2. combination product as described in claim 1, which is characterized in that by Harbin, good medicine company has the shenkangning capsules fastly
The production of limit company.
3. combination product as described in claim 1, which is characterized in that the zinc gluconate oral administration solution is fast by Harbin
Good pharmaceutcal corporation, Ltd's production.
4. combination product as described in any one of claims 1-3, which is characterized in that the combination product is through clinical test results table
It is bright, there is improvement to Patients with Kidney-Yang Deficiency Syndrome frequent urination at night, the urinary incontinence, frequent micturition, symptoms of urgency after taking 4 weeks, takes improvement after 8 weeks
It is more significant.Wherein urgent urination improvement rate, tcm syndrome total score curative effect, tcm syndrome individual event sexual hypoesthesia disappearance rate better than single
Use shenkangning capsules and good security.
5. the described in any item combination products of claim 1-4 are in preparation to diseases such as patient's frequent urination at night, the urinary incontinence, frequent micturition, urgent urinations
Shape has the application in the drug of improvement result.
6. application described in claim 5, which is characterized in that the patient is Patients with Kidney-Yang Deficiency Syndrome.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910069669.9A CN109568470A (en) | 2019-01-24 | 2019-01-24 | Shenkangning capsules, which combine zinc gluconate oral administration solution, is improving the application in the symptoms such as kidney-yang deficiency person's frequent urination at night urinary incontinence urine urgency-frequency |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910069669.9A CN109568470A (en) | 2019-01-24 | 2019-01-24 | Shenkangning capsules, which combine zinc gluconate oral administration solution, is improving the application in the symptoms such as kidney-yang deficiency person's frequent urination at night urinary incontinence urine urgency-frequency |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN109568470A true CN109568470A (en) | 2019-04-05 |
Family
ID=65917391
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201910069669.9A Pending CN109568470A (en) | 2019-01-24 | 2019-01-24 | Shenkangning capsules, which combine zinc gluconate oral administration solution, is improving the application in the symptoms such as kidney-yang deficiency person's frequent urination at night urinary incontinence urine urgency-frequency |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN109568470A (en) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101480480A (en) * | 2008-01-07 | 2009-07-15 | 南京万舜源生物科技有限公司 | Compound recipe with kidney-tonifying and yang-invigorating functions as well as preparation method and application |
| CN106617038A (en) * | 2017-01-22 | 2017-05-10 | 哈尔滨乐泰药业有限公司 | Health-care food composition for relieving male frequent urination and urinary incontinence as well as preparation method and application of health-care food composition |
-
2019
- 2019-01-24 CN CN201910069669.9A patent/CN109568470A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101480480A (en) * | 2008-01-07 | 2009-07-15 | 南京万舜源生物科技有限公司 | Compound recipe with kidney-tonifying and yang-invigorating functions as well as preparation method and application |
| CN106617038A (en) * | 2017-01-22 | 2017-05-10 | 哈尔滨乐泰药业有限公司 | Health-care food composition for relieving male frequent urination and urinary incontinence as well as preparation method and application of health-care food composition |
Non-Patent Citations (3)
| Title |
|---|
| 周柱亮 等: "《肾脏病实用药物手册》", 31 October 2010, 军事医学科学出版社 * |
| 张瑞 等: "《男科病的治疗与调养》", 31 July 2018, 海科学技术文献出版社 * |
| 胡海翔等: "肾虚证(肾阴虚、肾阳虚)血清中微量元素锌铜的变化及其意义", 《空军总医院学报》 * |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN103463539B (en) | A kind of medicine for the treatment of eczema and its production and use | |
| CN102743501B (en) | A kind of prescription for the treatment of qi-deficiency type uterine prolapse | |
| CN102205107A (en) | Chinese medicinal preparation for treating duodenal ulcer and preparation method thereof | |
| CN103705796B (en) | A kind of pharmaceutical composition for the treatment of diarrhoea and preparation method thereof | |
| CN103768357B (en) | A kind of Traditional Chinese medicine compound composition with treatment recurrent aphtha | |
| CN104548029A (en) | Pharmaceutical composition for treating epigastric pain | |
| CN111228367B (en) | Traditional Chinese medicine external lotion for treating infantile anaphylactoid purpura and preparation method thereof | |
| CN109568470A (en) | Shenkangning capsules, which combine zinc gluconate oral administration solution, is improving the application in the symptoms such as kidney-yang deficiency person's frequent urination at night urinary incontinence urine urgency-frequency | |
| CN101647943B (en) | Medicinal composition | |
| CN103432540B (en) | The five internal organs, which are adjusted, mends ball | |
| CN103919895B (en) | The Chinese medicinal liquor of a kind of the intestines and stomach coordinating, treatment constipation | |
| CN105435048A (en) | Traditional Chinese medicine for treatment of thyroid tumor | |
| CN107753921B (en) | Traditional Chinese medicine navel plaster for treating hyperemesis gravidarum | |
| CN105434739A (en) | Traditional Chinese medicine composition for treating chalazia and preparation method thereof | |
| CN101647935B (en) | Medicinal composition | |
| CN104784650A (en) | Pharmaceutical preparation for clinical nursing of gastric ulcer | |
| CN104689239A (en) | Traditional Chinese medicine composition for treating cholelithiasis and preparation method thereof | |
| CN109432364A (en) | The female Chinese medicine composition of ginseng stilbene benefit and the preparation method and application thereof for Recovery | |
| CN107080817A (en) | A kind of Novel gynecology-department a thousand pieces of gold oil of zedoary turmeric bolt | |
| CN109700917A (en) | Shenkangning capsules combine microelement vitamin preparation, pollen pumpkin preparation improves the application of the symptoms such as kidney-yang deficiency person's frequent urination at night | |
| CN101607060B (en) | Traditional Chinese medicine for treating urination incontinence | |
| CN105434808A (en) | Traditional Chinese medicine composition for treating hemorrhoids and preparation method thereof | |
| CN103463569A (en) | Traditional Chinese medicine preparation for treating duodenal ulcer | |
| CN104758346A (en) | Medicine for treating migraine, as well as preparation method and preparation of medicine | |
| CN104524249B (en) | A kind of Chinese medicinal capsule for treating urinary tract infections |
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 | ||
| CB02 | Change of applicant information | ||
| CB02 | Change of applicant information |
Address after: 150025 Zhuhai Road, Limin District, Hulan District, Heilongjiang, Harbin Applicant after: Letai Pharmaceutical Co.,Ltd. Address before: 150025 Zhuhai Road, Limin District, Hulan District, Heilongjiang, Harbin Applicant before: HARBIN KUAIHAO PHARMACEUTICAL Co.,Ltd. |
|
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20190405 |