CN115919989A - Traditional Chinese medicine composition for orthopedic perioperative qi deficiency and blood stasis patients and preparation method thereof - Google Patents

Traditional Chinese medicine composition for orthopedic perioperative qi deficiency and blood stasis patients and preparation method thereof Download PDF

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CN115919989A
CN115919989A CN202211474414.9A CN202211474414A CN115919989A CN 115919989 A CN115919989 A CN 115919989A CN 202211474414 A CN202211474414 A CN 202211474414A CN 115919989 A CN115919989 A CN 115919989A
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李黔春
李源力
吴青
蔚芃
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North Sichuan Medical College
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Abstract

The invention discloses a traditional Chinese medicine composition for orthopedic perioperative qi deficiency and blood stasis patients and a preparation method thereof, and relates to the technical field of traditional Chinese medicine compositions, wherein the traditional Chinese medicine composition comprises the following raw material components in parts by weight: 10g to 25 parts of cistanche, 10 to 25 parts of ginseng, 10 to 25 parts of astragalus, 10 to 25 parts of angelica, 10 to 25 parts of szechuan lovage rhizome, 10 to 25 parts of white paeony root, 10 to 25 parts of largehead atractylodes rhizome, 6 to 25 parts of baical skullcap root, 5 to 25 parts of cassia bark core, 10 to 25 parts of dried ginger, 2 to 25 parts of evodia, 10 to 25 parts of bletilla striata, 10 to 25 parts of officinal magnolia bark, 10 to 25 parts of himalayan teasel root, 2 to 25 parts of ground beeltle and 6 to 25 parts of honey-fried licorice root. The traditional Chinese medicine composition for the orthopedic perioperative qi deficiency and blood stasis patients can tonify qi and nourish blood, promote blood circulation and remove blood stasis so as to achieve the purposes of restoring healthy qi and accelerating recovery, and fully embodies the unique advantages of the combination of Chinese and western medicine and the complementation of advantages.

Description

Traditional Chinese medicine composition for orthopedic perioperative qi deficiency and blood stasis patients and preparation method thereof
Technical Field
The invention relates to the technical field of traditional Chinese medicine compositions, in particular to a traditional Chinese medicine composition for orthopedic perioperative qi deficiency and blood stasis patients and a preparation method thereof.
Background
Orthopedics perioperative patients, particularly severe trauma, spinal fusion surgery, hip and knee replacement patients, experience moderate to extreme post-operative pain and severe debilitating conditions in about 80% of patients. With the increasing aging of the population, the number of surgeries of orthopedic elderly patients is gradually increasing, leading to undesirable postoperative complications, weakness, prolonged recovery, and a substantial increase in the risk of chronic pain. Henrik Kehlet proposed a multi-modal perioperative management approach in 1997, gradually evolving into accelerated rehabilitation Surgery (ERAS). Aims to achieve the aims of reducing complications, improving satisfaction, shortening hospitalization time, restoring daily life and exercise more quickly and improving operation results through multi-mode optimization of patient paths based on evidence. The development of orthopedic ERAS is only in an initial stage, and iterative improvement schemes for further research and evidence acquisition are needed.
The concept of 'overall observation and treatment based on syndrome differentiation' in traditional Chinese medicine and the treatment methods of 'consolidating basis, reinforcing primordial qi, strengthening healthy qi to eliminate pathogenic factors, harmonizing yin and yang' and the like are just in accordance with the modern medical development direction of ERAS 'centering on patients'. The traditional Chinese medicine holds that a human body is a unified whole consisting of skin, flesh, muscles, bones, qi, blood, body fluid and viscera, wounds of an organism caused by an operation are similar to knife and sword wounds contacted by ancient people, and are the processes of 'breaking qi and damaging blood, and qi is taken off along with blood', so that the traditional Chinese medicine can guide early-stage syndrome differentiation treatment and accelerated rehabilitation after the operation by taking the reference of 'traumatology theory' and combining with modern medicine. The essentials and orders of the orthosomatic classes: after the reinforcing and reducing treatment, do it work on the principle that the limbs are damaged, qi and blood are impaired in the interior, the nutrient and defensive are not enough, the zang-fu organs are not harmonized, and the theory is not followed, and the deficiency and excess are examined? The first push of the first one is to supplement qi and nourish blood, activate blood and remove stasis.
For severe orthopedic trauma and degenerative diseases in the elderly, patients have kidney qi deficiency. The operation is accompanied by long-time anesthesia and blood loss during the operation, and the qi is lost with the blood, which easily causes deficiency of both qi and blood. The body can mobilize the body's vital qi to resist pathogens, i.e. stress reaction, in response to surgical trauma, and a large amount of ' qi ' is consumed and kidney qi is mobilized. Under the condition of kidney qi deficiency, most patients after operation show that qi deficiency is greater than blood deficiency, and qi deficiency fails to promote and consolidate blood, further resulting in blood stasis. Therefore, the syndrome of qi deficiency and blood stasis is the main postoperative syndrome of the patients, which is consistent with the clinical observation. The patients with qi deficiency and blood stasis syndrome after orthopedic surgery reach 70 percent. The weak state and the prolonged recovery period of the postoperative patient are closely related to qi deficiency and blood stasis. In order to improve the symptoms of qi deficiency and blood stasis after operation and promote postoperative recovery, the internally-supplemented cistanche deserticola prescription carried by "Liu Juan Gui Yi Fang" (jin. Liu Juan Zi) roll two is found to be in accordance with the treatment of qi deficiency, blood stasis and kidney qi deficiency after orthopedic operation.
At present, no traditional Chinese medicine composition which meets the requirement of accelerated recovery of patients with qi deficiency and blood stasis in the orthopedic perioperative period, has definite curative effect, is safe and practical, and can tonify qi, nourish blood, promote blood circulation and remove blood stasis so as to achieve the purpose of restoring healthy qi exists.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides a traditional Chinese medicine composition for orthopedic perioperative qi deficiency and blood stasis patients and a preparation method thereof. The traditional Chinese medicine composition for the orthopedic perioperative qi deficiency and blood stasis patients can tonify qi and nourish blood, promote blood circulation and remove blood stasis so as to achieve the purposes of restoring healthy qi and accelerating recovery, and fully embodies the unique advantages of the combination of Chinese and western medicine and the complementation of advantages.
The traditional Chinese medicine composition for the orthopedic perioperative qi deficiency and blood stasis patients comprises the following raw material components in parts by weight: 10g to 25 parts of cistanche, 10 to 25 parts of ginseng, 10 to 25 parts of astragalus, 10 to 25 parts of angelica, 10 to 25 parts of ligusticum wallichii, 10 to 25 parts of white paeony root, 10 to 25 parts of bighead atractylodes rhizome, 6 to 25 parts of scutellaria baicalensis, 5 to 25 parts of cassia bark core, 10 to 25 parts of dried ginger, 2 to 25 parts of fructus evodiae, 10 to 25 parts of bletilla striata, 10 to 25 parts of cortex magnoliae officinalis, 10 to 25 parts of teasel root, 2 to 25 parts of ground beetle and 6 to 25 parts of honey-fried licorice root.
Preferably, the traditional Chinese medicine composition comprises the following raw material components in parts by weight: 10 parts of cistanche, 10 parts of ginseng, 10 parts of astragalus membranaceus, 10 parts of angelica sinensis, 10 parts of ligusticum wallichii, 10 parts of radix paeoniae alba, 10 parts of bighead atractylodes rhizome, 10 parts of scutellaria baicalensis, 10 parts of cassia bark, 10 parts of dried ginger, 3 parts of fructus evodiae, 10 parts of bletilla striata, 10 parts of ginger magnolia officinalis, 10 parts of teasel root, 3 parts of ground beetle and 10 parts of honey-fried licorice root.
Preferably, the traditional Chinese medicine composition comprises the following raw material components in parts by weight: 10 parts of cistanche, 10 parts of ginseng, 10 parts of astragalus membranaceus, 10 parts of angelica sinensis, 10 parts of ligusticum wallichii, 10 parts of radix paeoniae alba, 10 parts of bighead atractylodes rhizome, 10 parts of scutellaria baicalensis, 10 parts of cassia bark, 10 parts of dried ginger, 10 parts of fructus evodiae, 10 parts of bletilla striata, 10 parts of ginger magnolia officinalis, 10 parts of teasel root, 3 parts of ground beetle and 10 parts of honey-fried licorice root.
The invention also aims to protect the preparation method of the traditional Chinese medicine composition for the orthopedic perioperative patients with qi deficiency and blood stasis.
Can be prepared into decoction by the following steps:
s101, adding water into raw material components, soaking, boiling with strong fire, decocting with slow fire, filtering to obtain first filter residue and first filtrate, adding water into the first filter residue, decocting for the second time, filtering to obtain second filter residue and second filtrate, adding water into the second filter residue, decocting for the third time, filtering to obtain third filtrate;
s102, mixing the primary filtrate, the secondary filtrate and the tertiary filtrate, and uniformly mixing to prepare the traditional Chinese medicine composition for the patients with qi deficiency and blood stasis in the orthopedic perioperative period.
Preferably, in step S101, the weight portion ratio of the raw material components to water is 1:5; the weight part ratio of the first filter residue to the water is 1:5; the weight part ratio of the second filter residue to the neutralizing water is 1:5.
preferably, in step S101, the soaking time is 30min, the slow fire decoction time is 20min, and the second decoction time and the third decoction time are both 30min.
Can be made into granule, and comprises the following steps:
s201, adding water into raw material components, soaking, boiling with strong fire, decocting with slow fire, filtering to obtain first filter residue and first filtrate, adding water into the first filter residue, decocting for the second time, filtering to obtain second filter residue and second filtrate, adding an ethanol solution with the volume concentration of 60% into the second filter residue, decocting for the third time, filtering to obtain third filtrate;
s202, combining the first filtrate, the second filtrate and the third filtrate, uniformly mixing, and concentrating under reduced pressure to obtain an extract;
s203, adding auxiliary materials into the extract to prepare granules;
the auxiliary materials are one or more of sucrose, starch, dextrin and sodium hydroxymethyl cellulose; the weight part ratio of the extract to the auxiliary materials is 1:7.
preferably, in step S201, the weight portion ratio of the raw material components to water is 1:5; the weight part ratio of the first filter residue to the water is 1:5; the weight part ratio of the second filter residue to the ethanol solution is 1:1.5.
preferably, in step S201, the soaking time is 60min, the slow fire decocting time is 30min, and the second decocting time and the third decocting time are both 30min; in step S202, the reduced pressure concentration is carried out at 80 ℃ until the relative concentration of the extract is 1.2.
Can also be made into small honeyed pills, and comprises the following steps:
s301, mixing the raw material components, crushing, and sieving by using a 100-mesh sieve to prepare mixed medicinal powder;
s302, adding honey into the mixed medicinal powder, and preparing into small honeyed pills;
the weight part ratio of the mixed medicinal powder to the honey is 1:1.2.
wherein, the mixed powder prepared in the step S301 can also be directly used as powder; or making into tablet, sugar-coated or film-coated, and making into tablet.
The invention has the beneficial effects that:
(1) The traditional Chinese medicine cistanche for the orthopedic perioperative qi deficiency and blood stasis patient is sweet, salty, sour and warm in nature and enters kidney and large intestine channels. Entering kidney meridian, it can tonify kidney yang and nourish essence and blood; entering the large intestine meridian, it can moisten dryness of intestine and relax bowels. Ben Cao Jing Shu (the book of materia Medica Prime and Dredging): cistanche deserticola, the essential herb for nourishing kidney and blood, sweet in flavor can remove heat and tonify middle energizer, acid can enter liver, salty in flavor can nourish kidney, kidney and liver are sufficient, essence and blood become abundant day by day, and long-term taking can lead to body weight being fat and healthy and light. Cistanche deserticola warms and nourishes essence and blood to activate yang qi, and tonifies yin and invigorates yang. The hair growth has the functions of qi and blood generation, blood circulation smoothing, five internal organs nourishing, marrow and muscle strengthening, muscle growing, waist and knee warming, yin and yang harmonization of the body and recovery of healthy qi. It is warm but not hot, tonify but not drastic, warm but not dry, slippery but not leak, so it is called as monarch drug of the recipe;
"Yi Zong Bie Shu" (a book of medical records): ginseng is sweet in flavor, slightly warm in nature, nontoxic, and enters lung and spleen meridians. It is the essential herb for tonifying qi and strengthening body because it excels in tonifying original qi and spleen and lung qi. Strong qi can promote blood circulation, so it can promote blood circulation. The ginseng is prepared from astragalus and liquorice, so that the effect of reinforcing primordial qi is further enhanced, the qi is sufficient, the spirit is calm, and the healthy qi is vigorous, so that the ginseng is a holy medicine for treating incised wound and trauma deficiency syndrome in the past generation. Chuan Xiong is pungent and warm in property, and enters liver, gallbladder and pericardium meridians. It is most suitable for treating pain due to blood stasis and qi stagnation, and also known as "qi in blood" by predecessors. Dang Gui is sweet, pungent and warm in flavor, and enters liver, heart and spleen meridians. It excels in tonifying blood and activating blood, moistening intestines to relieve constipation, and dispelling cold, so it is suitable for blood deficiency and blood stasis with cold syndrome, especially for constipation due to intestinal dryness, and is commonly used in surgical and traumatological fields to relieve swelling and cure wound. For various syndromes of blood deficiency, it is combined with Bai Shao and Chuan Xiong to promote blood circulation, remove blood stasis, nourish blood and harmonize blood. The six drugs assist the cistanche to strengthen qi and blood and strengthen body resistance to eliminate evil, and are used as ministerial drugs;
rou Gui is pungent and sweet in flavor and hot in nature. Enter kidney meridian, tonify kidney yang slowly to tonify fire and strengthen yang or induce fire to return to original origin, enter liver, heart and spleen meridians, warm and dredge channels and collaterals to activate blood and dissipate blood stasis. The cortex Cinnamomi is removed to obtain the core, which enters the heart, induces blood and sweat, suppuration, and holds the inside to treat superficial infection and acne, as in Shenghui Fang. Has stronger effects of promoting blood circulation, removing blood stasis and promoting wound or operation incision healing than cinnamon. Dried ginger can remove dampness, stimulate appetite, warm middle energizer, arrest vomiting, dredge heart and lung, break blood and remove blood stasis. Evodia fruit: pungent, bitter, hot; has little toxicity. Warm middle energizer, alleviate pain, regulate qi, check adverse rise of qi and arrest vomiting. The four ingredients warm the middle-jiao and stimulate the appetite, recover the spleen yang, consolidate the acquired constitution and promote the generation of qi and blood, and are adjuvant drugs. Baikal skullcap root, radix Scutellariae, with the main actions of clearing heat and stopping bleeding, is a necessary herb for blood stasis. The bletilla striata can astringe to stop bleeding, relieve swelling and promote tissue regeneration; hou Po can dispel the fullness of qi, move qi and purge fu organs. Teasel root: mainly treat incised wound, carbuncle, turning over and falling down, reuniting bones and muscles, tonifying deficiency, and benefiting strength after long-term use. Ground beetle: to break blood stasis and continue the muscles and bones. Is beneficial to the early healing and osteogenesis of patients with fracture, intervertebral fusion and the like, and also is an adjuvant drug;
licorice root, radix Glycyrrhizae can tonify qi, relieve spasm, and harmonize the effects of other drugs in the recipe, acting as a guiding drug.
(2) The traditional Chinese medicine composition for the orthopedic perioperative patients with qi deficiency and blood stasis provided by the invention considers the characteristics of qi deficiency and blood stasis syndrome caused by blood stasis due to kidney qi deficiency, postoperative qi deficiency greater than blood deficiency, and qi deficiency failing to promote and consolidate blood. The medicines are combined to tonify the kidney, consolidate the constitution, tonify qi and nourish blood, ensure that essence and blood are exuberant day by day, gradually promote qi and blood and promote blood circulation to promote postoperative rehabilitation of patients.
(3) The preparation method of the traditional Chinese medicine composition for the orthopedic perioperative qi deficiency and blood stasis patient has the advantages of easily available raw materials, simple operation, stable technology, excellent effect of the prepared traditional Chinese medicine composition and great popularization value.
Detailed Description
Hereinafter, embodiments of the present invention will be described in detail. The following examples are only for illustrating the technical solutions of the present invention more clearly, and therefore are only examples, and the protection scope of the present invention is not limited thereby.
It is to be noted that, unless otherwise specified, technical or scientific terms used herein shall have the ordinary meaning as understood by those skilled in the art to which the invention pertains.
Example 1
The embodiment provides a traditional Chinese medicine composition for orthopedic perioperative qi deficiency and blood stasis patients, which comprises the following raw material components in parts by weight: 10 parts of cistanche, 10 parts of ginseng, 10 parts of astragalus membranaceus, 10 parts of angelica sinensis, 10 parts of ligusticum wallichii, 10 parts of radix paeoniae alba, 10 parts of bighead atractylodes rhizome, 10 parts of scutellaria baicalensis, 10 parts of cassia bark, 10 parts of rhizoma zingiberis, 3 parts of fructus evodiae, 10 parts of bletilla striata, 10 parts of ginger magnolia officinalis, 10 parts of radix dipsaci, 3 parts of ground beetle and 10 parts of honey-fried licorice root.
The embodiment also provides a preparation method of the traditional Chinese medicine composition for the orthopedic perioperative qi deficiency and blood stasis patient, which comprises the following steps:
s101, adding water into raw material components, soaking, boiling with strong fire, decocting with slow fire, filtering to obtain first filter residue and first filtrate, adding water into the first filter residue, decocting for the second time, filtering to obtain second filter residue and second filtrate, adding water into the second filter residue, decocting for the third time, filtering to obtain third filtrate;
s102, combining the primary filtrate, the secondary filtrate and the tertiary filtrate, and uniformly mixing to prepare the traditional Chinese medicine composition for the orthopedic perioperative qi deficiency and blood stasis patients.
In the step S101, the weight portion ratio of the raw material components to the water is 1:5; the weight part ratio of the first filter residue to the water is 1:5; the weight part ratio of the second filter residue and the neutralizing water is 1:5.
in step S101, the soaking time is 30min, the slow fire decoction time is 20min, and the second decoction time and the third decoction time are both 30min.
The method for taking the traditional Chinese medicine composition for the orthopedic perioperative patients with qi deficiency and blood stasis, provided by the embodiment, comprises the following steps: 150mL each time, 3-4 times daily.
Example 2
The embodiment provides a traditional Chinese medicine composition for orthopedic perioperative qi deficiency and blood stasis patients, which comprises the following raw material components in parts by weight: 10 parts of cistanche, 10 parts of ginseng, 10 parts of astragalus membranaceus, 10 parts of angelica sinensis, 10 parts of ligusticum wallichii, 10 parts of radix paeoniae alba, 10 parts of bighead atractylodes rhizome, 10 parts of scutellaria baicalensis, 10 parts of cassia bark, 10 parts of dried ginger, 3 parts of fructus evodiae, 10 parts of bletilla striata, 10 parts of ginger magnolia officinalis, 10 parts of teasel root, 3 parts of ground beetle and 10 parts of honey-fried licorice root.
The embodiment also provides a preparation method of the traditional Chinese medicine composition for the orthopedic perioperative patients with qi deficiency and blood stasis, which comprises the following steps:
s201, adding water into raw material components, soaking, boiling with strong fire, decocting with slow fire, filtering to obtain first filter residue and first filtrate, adding water into the first filter residue, decocting for the second time, filtering to obtain second filter residue and second filtrate, adding an ethanol solution with the volume concentration of 60% into the second filter residue, decocting for the third time, filtering to obtain third filtrate;
s202, combining the primary filtrate, the secondary filtrate and the tertiary filtrate, uniformly mixing, and concentrating under reduced pressure to obtain an extract;
s203, adding auxiliary materials into the extract to prepare granules;
wherein, the auxiliary materials are 1:1:1 of sucrose, starch, dextrin and sodium hydroxymethyl cellulose; the weight portion ratio of the extract to the auxiliary materials is 1:7.
in step S201, the weight ratio of the raw material components to water is 1:5; the weight part ratio of the first filter residue to the water is 1:5; the weight part ratio of the second filter residue to the ethanol solution is 1:1.5;
in step S201, the soaking time is 60min, the slow fire decoction time is 30min, and the second decoction time and the third decoction time are both 30min;
in step S202, the extract is concentrated under reduced pressure at 80 ℃ until the relative concentration of the extract is 1.2.
The administration method of the traditional Chinese medicine composition for the orthopedic perioperative qi deficiency and blood stasis patient provided by the embodiment comprises the following steps: the composition is taken before three meals and before sleep after being mixed with fresh boiled water or warm wine (yellow wine or rice wine) 6g each time.
Example 3
The embodiment provides a traditional Chinese medicine composition for orthopedic perioperative qi deficiency and blood stasis patients, which comprises the following raw material components in parts by weight: 10 parts of cistanche, 10 parts of ginseng, 10 parts of astragalus membranaceus, 10 parts of angelica sinensis, 10 parts of ligusticum wallichii, 10 parts of radix paeoniae alba, 10 parts of bighead atractylodes rhizome, 10 parts of scutellaria baicalensis, 10 parts of cassia bark, 10 parts of dried ginger, 10 parts of fructus evodiae, 10 parts of bletilla striata, 10 parts of ginger magnolia officinalis, 10 parts of teasel root, 3 parts of ground beetle and 10 parts of honey-fried licorice root.
The embodiment also provides a preparation method of the traditional Chinese medicine composition for the orthopedic perioperative qi deficiency and blood stasis patient, which comprises the following steps:
s301, mixing the raw material components, crushing, and sieving with a 100-mesh sieve to obtain mixed medicinal powder;
s302, adding honey into the mixed medicinal powder, and preparing into small honeyed pills;
wherein the weight part ratio of the mixed medicinal powder to the honey is 1:1.2.
the administration method of the traditional Chinese medicine composition for the orthopedic perioperative qi deficiency and blood stasis patient provided by the embodiment comprises the following steps: the preparation is taken 8g each time, mixed with fresh boiled water or warm wine (yellow wine or rice wine), before three meals and before sleep.
Test examples
1. Test objects: the patients were lumbar degenerative disease patients treated by single-segment lumbar fusion in the department of academy of 3-month-old-from 2021, and finally 57 patients completed follow-up visits and data collection and were divided into test groups and control groups.
Of these, 29, 10 male and 19 female test groups were tested. Mean age (58.70 ± 12.79) years. The course of disease is 24 (3, 63) months.
The control group consisted of 28 individuals, 8 individuals and 20 individuals. Mean age (59.50 ± 8.99) years. The course of the disease is 30 (6, 66) months.
The two groups of general data are statistically calculated, have no significant difference and are comparable.
2. Diagnostic criteria
2.1 Western diagnostic standards
The included cases all accord with the operation pointer of the single-segment lumbar fusion, and the clinical diagnosis is that the lumbar intervertebral disc protrusion syndrome is combined with intervertebral instability, the degenerative lumbar spinal stenosis syndrome is combined with lumbar instability or the degenerative lumbar spondylolisthesis. The diagnosis standard of the lumbar intervertebral disc protrusion refers to the diagnosis standard adopted in diagnosis and treatment guidelines for the lumbar intervertebral disc protrusion and Chinese specialist consensus for diagnosis and treatment of the lumbar intervertebral disc protrusion; the diagnosis standard of the degenerative lumbar spinal stenosis refers to the proposal of World union of neurosurgery society (WFNS) on the diagnosis of lumbar spinal stenosis and the formulation of spinal surgery; the diagnosis standard of degenerative lower lumbar instability refers to the diagnosis standard adopted in orthopedics disease diagnosis standard and modern spinal surgery; diagnosis standard of degenerative lumbar spondylolisthesis: the diagnosis and treatment of the degenerative lumbar spondylolisthesis are made by referring to the diagnosis method adopted in the 2 nd edition of the NASS clinical guidelines and the modern spinal surgery.
2.2 Chinese medicine diagnostic Standard
The syndrome type diagnosis standard adopts the diagnosis standard of 'qi deficiency and blood stasis' formulated by the Chinese medicine industry standard ZY/T001.9-94 'the standard of curative effect of diagnosis of bone and trauma of traditional Chinese medicine'.
Qi deficiency and blood stasis: lusterless complexion, lassitude, low back pain, lingering pain, pain or numbness of the lower limbs. A purple and thin tongue coating and a wiry and tense pulse.
3. Inclusion criteria
(1) Patients with lumbar degenerative diseases treated by single-segment lumbar fusion in the department of academy of osteology in 3 months-2022 months in 2021;
(2) (1) degenerative lumbar spondylolisthesis with a spondylolisthesis ratio of < 30%; (2) lumbar intervertebral disc protrusion accompanied by lumbar instability; (3) lumbar spinal stenosis with segmental instability, or estimation of intervertebral stability affected after decompression of the spinal canal; (4) recurrence is accompanied with instability of segments after simple decompression operation under spinal endoscopy;
(3) Differentiation and typing are performed on the 1 st postoperative day to obtain qi deficiency and blood stasis syndrome;
(4) Before operation, the treatment is ineffective or aggravated by conservative treatment for more than 3 months;
(5) Patients who volunteered to participate in the trial and consented to endorse the relevant written consent.
4. Exclusion criteria
(1) Severe lumbar osteoporosis (T value < -2.5), or other bone metabolic diseases;
(2) Body Mass Index (BMI) is more than or equal to 30kg/m2;
(3) Patients with malignant tumors or active infections;
(4) Pregnant or lactating women;
(5) Autoimmune diseases or treatment of patients with systemic hormones;
(6) Human Immunodeficiency Virus (HIV) or hepatitis b or hepatitis c virus infected;
(7) Alcoholics or opioid or other drug dependence;
(8) Multi-segment lesions, or significant scoliosis (Cobb angle >20 °);
(9) The history of open lumbar surgery in the past;
(10) Recent (within three months) acceptance of other clinical studies or other procedures;
(11) Psychopsychological diseases, or serious medical diseases, etc. which are not suitable for lumbar interbody fusion;
(12) Allergic to the pharmaceutical ingredients used in the study.
5. Intervention measures
5.1 control group: the control group was treated with the current western standard accelerated recovery protocol of the department, which was made in reference to the ERAS institute 2021 recommendations for accelerated recovery during the perioperative period of lumbar fusion.
5.2 test group: the test group is added with the test composition for the orthopedic perioperative qi deficiency and blood stasis patients prepared in example 1 on the 1 st day after operation on the basis of the control group, 3 times a day with 150ml each time, and the test composition is distributed to the subjects for administration in the morning, the evening and 3 times for 14 days continuously.
6. Index for evaluating therapeutic effect
(1) The quantitative assessment of the qi deficiency and blood stasis syndrome is shown in Table 1. The table is adopted to carry out quantitative scoring on the qi deficiency and blood stasis syndrome of the patient.
TABLE 1 evaluation form of qi deficiency and blood stasis syndrome after lumbar fusion
Figure BDA0003959206850000101
Figure BDA0003959206850000111
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(2) Post-operative recovery quality score scale (QoR-40) score: the assistant investigator instructed the patient to perform a post-operative recovery quality self-score using a questionnaire comprising 40 previously validated questions (QoR-40).
(3) Inflammatory response index: c-reactive protein Concentration (CRP), neutrophil to lymphocyte ratio (NLR).
7. Test results
(1) Scoring of qi deficiency and blood stasis syndromes: on day 1 before and after the operation, the scores of the qi-deficiency and blood-stasis syndromes of the two groups have no statistical difference (P is more than 0.05), on day 14 after the operation, the scores of the qi-deficiency and blood-stasis syndromes of the test group and the control group are respectively 31.14 +/-5.74 and 34.41 +/-6.25, P =0.039 is less than 0.05, the difference has statistical significance, and the score of the qi-deficiency and blood-stasis syndromes of the test group is lower than that of the control group (the score of the qi-deficiency and blood-stasis syndromes ranges from 0 to 100, and the value is larger, and the qi-deficiency and blood-stasis syndromes are more serious).
(2) QoR-40: no statistical difference was found in QoR-40 scores between the two groups (P > 0.05) on day 1, pre-and post-surgery. The QoR-40 scores of the test group and the control group are 178.57 +/-7.45 and 172.93 +/-7.92 respectively, and P =0.006 is less than 0.05, the difference has statistical significance, and the QoR-40 score of the test group is higher than that of the control group (the QoR-40 score ranges from 40 to 200, and the larger the value is, the better the postoperative recovery quality of patients is).
(3) CRP: the CRP concentration of the test group and the CRP concentration of the control group are respectively 6.73 +/-3.54 and 9.86 +/-5.58 on the 14 th day after operation, the P =0.012 < 0.05, the difference has statistical significance, and the CRP concentration of the test group is lower than that of the control group.
(4) NLR: on the 14 th day after operation, the NLR of the test group and the control group are respectively 2.51 +/-0.79 and 3.10 +/-1.10, P =0.021 < 0.05, the difference has statistical significance, and the NLR of the test group is lower than that of the control group.
To sum up, the traditional Chinese medicine composition for the orthopedic perioperative patients with qi deficiency and blood stasis in the embodiment 1 has a favorable influence on the recovery quality of the early-stage patients (qi deficiency and blood stasis type) after lumbar fusion, can obviously reduce the score of qi deficiency and blood stasis syndrome, improve the QoR-40 score, and reduce the inflammatory reaction indexes such as CRP concentration and NLR value.
Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; such modifications and substitutions do not depart from the spirit and scope of the present invention, and they should be construed as being included in the following claims and description.

Claims (10)

1. The traditional Chinese medicine composition for the orthopedic perioperative qi deficiency and blood stasis patient is characterized in that: the traditional Chinese medicine composition comprises the following raw material components in parts by weight: 10g to 25 parts of cistanche, 10 to 25 parts of ginseng, 10 to 25 parts of astragalus, 10 to 25 parts of angelica, 10 to 25 parts of ligusticum wallichii, 10 to 25 parts of white paeony root, 10 to 25 parts of bighead atractylodes rhizome, 6 to 25 parts of scutellaria baicalensis, 5 to 25 parts of cassia bark core, 10 to 25 parts of dried ginger, 2 to 25 parts of fructus evodiae, 10 to 25 parts of bletilla striata, 10 to 25 parts of cortex magnoliae officinalis, 10 to 25 parts of teasel root, 2 to 25 parts of ground beetle and 6 to 25 parts of honey-fried licorice root.
2. The traditional Chinese medicine composition for the orthopedic perioperative qi deficiency and blood stasis patient according to claim 1, characterized in that: the traditional Chinese medicine composition comprises the following raw material components in parts by weight: 10 parts of cistanche, 10 parts of ginseng, 10 parts of astragalus membranaceus, 10 parts of angelica sinensis, 10 parts of ligusticum wallichii, 10 parts of radix paeoniae alba, 10 parts of bighead atractylodes rhizome, 10 parts of scutellaria baicalensis, 10 parts of cassia bark, 10 parts of dried ginger, 3 parts of fructus evodiae, 10 parts of bletilla striata, 10 parts of ginger magnolia officinalis, 10 parts of teasel root, 3 parts of ground beetle and 10 parts of honey-fried licorice root.
3. The traditional Chinese medicine composition for the orthopedic perioperative patients with qi deficiency and blood stasis as claimed in claim 1, which is characterized in that: the traditional Chinese medicine composition comprises the following raw material components in parts by weight: 10 parts of cistanche, 10 parts of ginseng, 10 parts of astragalus membranaceus, 10 parts of angelica sinensis, 10 parts of ligusticum wallichii, 10 parts of radix paeoniae alba, 10 parts of bighead atractylodes rhizome, 10 parts of scutellaria baicalensis, 10 parts of cassia bark, 10 parts of dried ginger, 10 parts of fructus evodiae, 10 parts of bletilla striata, 10 parts of ginger magnolia officinalis, 10 parts of teasel root, 3 parts of ground beetle and 10 parts of honey-fried licorice root.
4. The preparation method of the traditional Chinese medicine composition for the patients with qi deficiency and blood stasis in the orthopedic perioperative period as claimed in claim 1 or 2, is characterized in that: the preparation method comprises the following steps:
s101, adding water into the raw material components, soaking, boiling with strong fire, decocting with slow fire, filtering to obtain first filter residue and first filtrate, adding water into the first filter residue, decocting for the second time, filtering to obtain second filter residue and second filtrate, adding water into the second filter residue, decocting for the third time, filtering to obtain third filtrate;
s102, mixing the primary filtrate, the secondary filtrate and the tertiary filtrate, and uniformly mixing to prepare the traditional Chinese medicine composition for the patients with qi deficiency and blood stasis in the orthopedic perioperative period.
5. The preparation method of the traditional Chinese medicine composition for the patient with qi deficiency and blood stasis in the orthopedic perioperative period according to claim 4, is characterized in that: in the step S101, the weight part ratio of the raw material components to water is 1:5; the weight part ratio of the first filter residue to the water is 1:5; the weight part ratio of the second filter residue and the water is 1:5.
6. the preparation method of the traditional Chinese medicine composition for the patient with qi deficiency and blood stasis in the orthopedic perioperative period according to claim 4, is characterized in that: in the step S101, the soaking time is 30min, the slow fire decoction time is 20min, and the second decoction time and the third decoction time are both 30min.
7. The preparation method of the traditional Chinese medicine composition for the patients with qi deficiency and blood stasis in the orthopedic perioperative period as claimed in claim 1 or 2, is characterized in that: the preparation method comprises the following steps:
s201, adding water into raw material components, soaking, boiling with strong fire, decocting with slow fire, filtering to obtain first filter residue and first filtrate, adding water into the first filter residue, decocting for the second time, filtering to obtain second filter residue and second filtrate, adding an ethanol solution with the volume concentration of 60% into the second filter residue, decocting for the third time, filtering to obtain third filtrate;
s202, combining the first filtrate, the second filtrate and the third filtrate, uniformly mixing, and concentrating under reduced pressure to obtain an extract;
s203, adding auxiliary materials into the extract to prepare granules;
the auxiliary material is one or more of sucrose, starch, dextrin and sodium carboxymethyl cellulose.
8. The preparation method of the traditional Chinese medicine composition for the patient with qi deficiency and blood stasis in the orthopedic perioperative period according to claim 7, is characterized in that: in step S201, the weight ratio of the raw material components to water is 1:5; the weight part ratio of the first filter residue to the water is 1:5; the weight part ratio of the second filter residue to the ethanol solution is 1:1.5.
9. the preparation method of the traditional Chinese medicine composition for the orthopedic perioperative patients with qi deficiency and blood stasis, according to claim 7, is characterized in that: in step S201, the soaking time is 60min, the slow fire decoction time is 30min, and the second decoction and the third decoction time are both 30min; in step S202, the reduced pressure concentration is carried out at 80 ℃ until the relative concentration of the extract is 1.2.
10. The preparation method of the traditional Chinese medicine composition for the patients with qi deficiency and blood stasis in the orthopedic perioperative period as claimed in claim 1 or 3, is characterized in that: the preparation method comprises the following steps: s301, mixing the raw material components, crushing, and sieving with a 100-mesh sieve to obtain mixed medicinal powder; s302, adding honey into the mixed medicinal powder to prepare small honeyed pills; the weight part ratio of the mixed medicinal powder to the honey is 1:1.2.
CN202211474414.9A 2022-11-23 2022-11-23 Traditional Chinese medicine composition for orthopedic perioperative qi deficiency and blood stasis patients and preparation method thereof Pending CN115919989A (en)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110013518A (en) * 2018-11-09 2019-07-16 重庆涪陵李志沧中医骨伤医院有限公司 It is a kind of to mend true strength Chinese medicine composition and its preparation and application greatly

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110013518A (en) * 2018-11-09 2019-07-16 重庆涪陵李志沧中医骨伤医院有限公司 It is a kind of to mend true strength Chinese medicine composition and its preparation and application greatly

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
郑少伟;SHAIKH ATIK BADSHAH;王健;蒋晖;李敏;陈国奋;: "益气活血补肾法对腰椎间盘突出症术后恢复的影响", 南方医科大学学报, no. 01, pages 137 - 140 *

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