CN111603506A

CN111603506A - Application of stomach-regulating qi-supporting decoction in preparation of medicine for preventing and treating metabolic syndrome caused by olanzapine taken by schizophrenia patient

Info

Publication number: CN111603506A
Application number: CN202010622984.2A
Authority: CN
Inventors: 朱丽萍; 龙彬; 赵静; 张建明; 陆颖; 陈妍
Original assignee: Shanghai Mental Health Center (shanghai Psychological Counseling Training Center)
Current assignee: Shanghai Mental Health Center (shanghai Psychological Counseling Training Center)
Priority date: 2020-07-01
Filing date: 2020-07-01
Publication date: 2020-09-01

Abstract

The invention relates to application of stomach regulating and qi supporting decoction in preparing a medicine for preventing and treating metabolic syndrome caused by olanzapine taken by a patient with schizophrenia. The curative effect and the safety of the stomach-regulating qi-supporting decoction for treating metabolic syndrome caused by olanzapine taken by patients with schizophrenia are evaluated through clinical experiments, and the results show that compared with metformin, the stomach-regulating qi-supporting decoction can better improve the weight and waistline increase caused by olanzapine taken by patients with schizophrenia, reduce glycosylated hemoglobin and has fewer side reactions; the stomach-regulating qi-supporting decoction has a prevention effect on various index disorders of blood fat caused by olanzapine taking. The invention provides a new effective means for preventing and treating metabolic syndrome caused by olanzapine taken by patients with clinical schizophrenia.

Description

Application of stomach-regulating qi-supporting decoction in preparation of medicine for preventing and treating metabolic syndrome caused by olanzapine taken by schizophrenia patient

Technical Field

The invention relates to the field of traditional Chinese medicine compositions, in particular to application of stomach-regulating qi-supporting decoction in preparing a medicine for preventing and treating metabolic syndrome caused by olanzapine taken by a patient with schizophrenia.

Background

Antipsychotics are the primary treatment of schizophrenic patients, but most of them, especially the second generation antipsychotics, often cause weight gain, glycolipid metabolic disorders, etc., leading to the development of metabolic syndrome. About one third of schizophrenic patients have metabolic syndrome, accounting for 69% of chronic patients^[1]. The prevalence of obesity, type 2 diabetes and hypercholesterolemia in schizophrenic patients is estimated to be 3-5 times that of the general population^[2]. Compared to the general population, schizophrenic patients are twice as likely to be diagnosed with heart disease and die as the general population^[3]. The mortality gap between schizophrenic patients and the general population is expanding^[4]. Metabolic syndrome is an independent predictor of cardiovascular disease and a major public health problem requiring urgent countermeasures^[5]。

Psychologists recommend a healthy lifestyle for the metabolic syndrome caused by taking antipsychotic drugs. If lifestyle changes fail, the patient needs to receive a pharmaceutical intervention. It is contemplated to switch to antipsychotics which are less metabolically risky, but this may lead to repeated disease or other adverse effects of the drug. It is also contemplated that drugs (e.g., metformin, etc.) may be added to reduce the risk of weight gain and metabolic abnormalities caused by antipsychotics. It has been shown that metformin reverses the weight gain and metabolic disturbances associated with olanzapine treatment^[6]Meta-analysis also indicates that metformin can manage antipsychotic-associated metabolic disorders^[7]. However, metformin also has some adverse reactions which cannot be tolerated by patients, such as nausea, vomiting, diarrhea, abdominal pain, abdominal distension, dyspepsia, hypodynamia and the like. It has also been reported that metformin causes spermatozoaWorsening of mental symptoms^[8]. Therefore, scholars at home and abroad are still striving to explore other treatment means capable of improving metabolic syndrome.

The existing research shows that the Chinese herbal medicine has obvious effect on treating the metabolic syndrome caused by the antipsychotic drugs. For example, the phlegm-eliminating and lipid-lowering decoction can remarkably improve the clinical effect of metformin on treating obesity caused by antipsychotics, and the phlegm-eliminating and lipid-lowering decoction comprises the following components: poria cocos, white atractylodes rhizome, pinellia tuber, dried orange peel each 15g, oriental water plantain rhizome, cape jasmine fruit, coptis root each 10g, polygala root, curcuma root, finger citron, Sichuan reed each 12g, licorice root 10g^[9]. The weight-reducing and fat-reducing decoction is combined with the metformin hydrochloride enteric-coated tablet to treat obesity caused by antipsychotics, can effectively reduce the weight of a human body and has few adverse reactions, and the weight-reducing and fat-reducing decoction comprises the following medicinal components: 15g of ginger processed pinellia tuber, 12g of dried orange peel, 12g of bighead atractylodes rhizome, 10g of rhubarb, 12g of hawthorn, 12g of tuckahoe, 12g of rhizoma alismatis and 6g of liquorice tablets, and the following are added: os Draconis and Concha Ostreae for patients with delusions and severe insomnia; radix aucklandiae and rhizoma Zingiberis recens for treating abdominal distention and fullness; rhizoma Dioscoreae, radix astragali, and fructus evodiae can be added for patients with soreness of waist and knees and listlessness; for halitosis, food hunger, thirst, and constipation, Coptidis rhizoma may be added^[10]. The Liu Yu Tang can effectively improve the glycolipid metabolism of a patient suffering from metabolic syndrome of schizophrenia caused by olanzapine, effectively regulate the blood pressure of the patient and improve the mental symptoms of the patient, and the Liu Yu Tang comprises the following components: rhizoma Ligustici Chuanxiong, Poria, fructus Amomi 15g each, rhizoma Pinelliae, fructus Gardeniae, fructus Aurantii Immaturus, rhizoma Cyperi, rhizoma Atractylodis, pericarpium Citri Tangerinae, cortex Magnolia officinalis 12g each, and Glycyrrhrizae radix 6g^[11]. The metformin-combined self-made Shugandingzhi decoction can relieve the adverse effects of the increase of physical quality and the disturbance of glycolipid metabolism of patients with schizophrenia caused by olanzapine and is beneficial to improving the clinical curative effect, and the Shugandingzhi decoction comprises the following components: 15g of radix bupleuri, 30g of snakegourd fruit, 15g of cape jasmine fruit, 15g of immature bitter orange, 15g of white paeony root, 12g of radix curcumae, 10g of arisaema cum bile, 12g of ginger processed pinellia tuber, 10g of coptis chinensis, 10g of rhizoma acori graminei, 30g of raw dragon and oyster respectively, and 6g of honey-fried licorice root; radix et rhizoma Rhei and Natrii sulfas can be added for patients with constipation and abdominal distention and pain; cinnabaris and Succinum can be added for patients with severe insomnia; for those who are thirsty and drinking pleasure, ginger-processed pinellia tuber is removed, and trichosanthes root and rhizoma anemarrhenae are added; rhizoma Ligustici Chuanxiong and fructus Vitics Simplicifoliae can be added for patients with headache; gypsum Fibrosum can be added for patients with sweating and fever^[12]. The lipid glucose-eliminating granule for treating schizophrenia with metabolic syndrome has the effects of reducing blood sugar, reducing weight, reducing triglyceride and regulatingThe function of cholesterol and the control of hypertension, and the lipid sugar eliminating granule medicine comprises the following components: summer 1 bag, pericarpium Citri Tangerinae 1 bag, Poria 1 bag, Glycyrrhrizae radix 1 bag, bupleuri radix 1 bag, Saviae Miltiorrhizae radix 2 bag, radix Puerariae 2 bag, and Trichosanthis radix 2 bag^[13]。

The stomach-regulating Chengqi decoction in Zhang Zhongjing Shang Han Lun is a proved recipe used for thousands of years and has been widely used clinically. The stomach-regulating qi-supporting decoction comprises 9 g of rhubarb (peeled and washed by sake), 6g of liquorice (roasted) and 6g of mango, and has the functions of treating slow-descending heat accumulation, main yangming disease gastrointestinal dryness-heat, thirst and constipation, abdominal fullness and tenderness, yellow tongue coating and smooth and rapid pulse; in the formula, rhubarb is bitter and cold in taste, the fire-purging and knot-dredging function is taken as a monarch, the mango is salty and cold in taste, the hard lump is softened and the dryness is moistened as a minister, the liquorice is sweet and moderate, the qi is benefited and the stomach is nourished, the bitter of the yellow is slowly relieved, and the potency of the guiding drug is slowly released to act as an assistant. The dryness-heat is relieved and the stomach-qi is self-harmonized, so it is called as stomach-regulating and qi-supporting decoction.

At present, no report on the application of stomach-regulating qi-supporting decoction in preventing and treating metabolic syndrome caused by olanzapine taken by schizophrenia patients is found.

Disclosure of Invention

The invention provides an application of a traditional Chinese medicine composition in preparing a medicine for preventing and treating metabolic syndrome caused by olanzapine taken by a patient with schizophrenia aiming at the defects in the prior art, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 8-10 g of rhubarb, 5-7 g of liquorice and 5-7 g of mango.

As a preferred example, the weight parts of the raw materials are as follows: rhubarb horsetails 9 g, licorice root 6g, and mango juice 6 g.

As another preferred example, the dosage form of the drug is an oral dosage form.

More preferably, the oral dosage form is decoction, granules, tablets, capsules or mixture.

As another preferred example, the medicament further comprises a pharmaceutically acceptable carrier.

More preferably, the pharmaceutically acceptable carrier is selected from the group consisting of emulsifiers, excipients, fillers, binders, humectants, disintegrants, absorption enhancers, flavoring agents, coloring agents and co-solvents.

The invention has the advantages that:

1. the inventor believes that the atypical antipsychotic olanzapine causes dysfunction of the spleen and the stomach, causes dryness-heat in the stomach and the intestine, polyphagia, hunger, dry stool or constipation, red tongue with yellow and dry fur and forceful pulse. According to the syndrome differentiation and treatment of the traditional Chinese medicine, the excessive stomach heat causes the appetite to be enhanced, the excessive food intake amount and the accumulation of green fat to form the metabolic syndrome. Therefore, the stomach-regulating and qi-supporting decoction is used for treating the adverse reaction of the metabolic syndrome caused by olanzapine and carrying out related clinical research to evaluate the curative effect and safety of the olanzapine.

2. In clinical studies, the method: 72 patients were randomly assigned to the modified stomach Chengqi decoction group (study group) and the metformin group (control group) for 8 weeks. Blood pressure, body weight, body mass index, waist circumference, hip circumference, waist-to-hip ratio measurements were performed on the patients at baseline and at the end of weeks 4 and 8, while triglyceride, total cholesterol, high density lipoprotein, low density lipoprotein, apolipoprotein-a, apolipoprotein-B, fasting glucose, glycated hemoglobin were measured before and after treatment to assess the change in the adverse reactions of the metabolic syndrome in the patients. As a result: (1) repeated measures analysis of variance, main effects analysis: the time-major effect of waist circumference after intervention was statistically significant (P <0.05), individual effect analysis: the body weights of the study groups differed at different time points before and after treatment (P <0.01), while the body weights of the control groups did not differ before and after treatment (P > 0.05); the differences between the time points before and after waist circumference treatment in the study group were statistically significant (P <0.05), while no significant difference was observed between the time points before and after waist circumference treatment in the control group (P > 0.05). (2) The time-major effect of triglycerides after intervention was statistically significant (P <0.05) using repeated measures of anova. After the study group had a decrease in total cholesterol (P ═ 0.059), an increase in HDL, a decrease in LDL, and a decrease in apolipoprotein-B at each time point, but the differences were not statistically significant (P > 0.05). (3) After dry prognosis, the change before and after glycated hemoglobin treatment (baseline phase-8 weeks after treatment) between groups was statistically significant (Z-2.378, P0.017), and the change before and after fasting glucose treatment was not statistically significant (P > 0.05). (4) Analysis of repeated measures of variance, analysis of main effects: after intervention, the Chinese medicine syndrome scale score has statistical significance (P <0.05) for comparing the main effect among groups, and the time main effect has statistical significance (P < 0.001). The effect analysis alone shows that the difference between the study group and the control group before and after treatment in the aspect of Chinese medicine symptom scale score has statistical significance (P is less than 0.01). (5) After the dry prognosis, the two groups of patients have the adverse reactions of tremor, akathisia, hypoactivity, constipation, salivation, blurred vision, insomnia, abnormal electrocardiogram and the like, and the incidence rate of the adverse reactions of the treatment group in the aspects of dry mouth, nausea, vomiting and diarrhea is obviously reduced compared with that of the control group (P is less than 0.05). And (4) conclusion: compared with metformin, the stomach-regulating qi-supporting decoction can better improve the increase of body weight and waist circumference of a schizophrenic patient caused by olanzapine taking, reduce glycosylated hemoglobin and has fewer side effects. The stomach-regulating qi-supporting decoction has a prevention effect on various index disorders of blood fat caused by olanzapine taking.

3. In the early stage of research, clinical diagnosis and treatment experience shows that the stomach-regulating and qi-supporting decoction has a remarkably better prevention and treatment effect on metabolic syndrome caused by olanzapine taken by schizophrenia patients than other formulas.

4. The stomach-regulating qi-supporting decoction can prevent and treat metabolic syndrome caused by olanzapine taken by schizophrenia patients, and has early curative effect.

5. Compared with other formulas, the stomach-regulating qi-supporting decoction has the advantages of less medicinal ingredients, convenience in preparation and low cost.

Drawings

FIG. 1: the body weight and waist circumference before and after treatment in the two groups were compared.

Detailed Description

The following detailed description of the present invention will be made with reference to the accompanying drawings.

Example 1

Object and method

1. Object

Prospective continuous inclusion in the mental health center of Shanghai city from 8 months in 2018 to 2 months in 2020, and 72 cases of olanzapine occurring metabolic syndrome when the first-time or recurrent schizophrenia patient is in hospital. Patients were randomized into study and control groups, 38 in study and 34 in control, using simple randomization (random number table).

Grouping standard: (1) meets the ICD-10 schizophrenia diagnosis standard; (2) conforms to the type of excessive stomach heat in the internal science of traditional Chinese medicine: A. the main symptoms are: obesity, polyphagia, hunger, fatigue; B. the key points of dialectical analysis: thirst with water, red tongue with yellow and dry coating, and forceful pulse; C. with symptoms: dysphoria with feverish sensation in the stomach, dry stool and obstructed stool. (3) Meets the suggested diagnosis standard of the Chinese medical society related to the metabolic syndrome: 3 or all of the following 4 components, a. overweight and/or obese: BMI is more than or equal to 25.0 (kg/m)²) (ii) a B. Hyperglycemia: FPG is more than or equal to 6.1mmol/L (110mg/dl) and/or 2hPG is more than or equal to 7.8mmol/L (140mg/dl) and/or a person diagnosed as a diabetes treatment; C. hypertension: SBP/DBP is not less than 140/90mmHg and/or the hypertension is confirmed and treated; D. blood lipid disorders: fasting blood TG is more than or equal to 1.7mmol/L (150mg/dL) and/or fasting blood HDL-C<0.9mmol/L (35mg/dL) (male), 1.0mmol/L (19mg/dL) (female); (4) the olanzapine is taken by the patient, and the dosage reaches the lowest therapeutic dose of the medicine and is more than the lowest therapeutic dose; (5) the age is 18-60 years old.

Exclusion criteria: (1) with severe somatic diseases, brain organic diseases, craniocerebral trauma, etc.; (2) patients with combined acute infections; (3) patients with acute complications such as diabetic ketoacidosis, or other cardiovascular and cerebrovascular diseases (such as myocardial infarction, cerebral infarction, and cerebral hemorrhage); (4) serious primary liver and kidney diseases, psychosis patients, pregnant or lactating women and people allergic to the medicine; (5) blood pressure >160/95 mmHg; (6) patients who met the international classification for disease (ICD-10) for alcohol, drug dependence, and intellectual impairment diagnostic criteria were excluded.

The study was approved by the ethical committee of the mental health center of Shanghai (batch number: 2018-36). All subjects or their guardians had been informed of specific study protocols and signed informed consent prior to the study.

The patients who are interrupted after the study due to poor compliance, missed visits, obvious adverse drug reactions, intolerance, serious physical diseases and other non-drug reasons cannot adhere to the patients, the patients whose condition deterioration needs emergency treatment measures and the patients who do not strictly use the drugs according to the test scheme are eliminated.

2. Research medicine

The stomach-regulating qi-supporting decoction comprises 9 g of rhubarb (peeled off and washed by sake), 6g of liquorice (roasted) and 6g of aristolochia indica, and has the functions of relieving heat accumulation, mainly treating gastrointestinal dryness-heat, thirst and constipation, abdominal fullness and tenderness. The frying method comprises the following steps: the common decocting method of the traditional Chinese medicine is adopted, the traditional Chinese medicine of each plaster prescription is soaked in cold water for 120 minutes, boiled with big fire and decocted with small fire for 30 minutes. The second time of big fire decoction is carried out, and then the second time of big fire decoction is carried out for 20 minutes. Mixing the two decoctions, concentrating to 300ml, and packaging into two bags (150 ml each) for twice daily administration. The processing unit of the traditional Chinese medicine preparation is as follows: the traditional Chinese medicine decoction and the traditional Chinese medicine placebo are decocted by Shanghai Delaware Chinese medicine product Limited company. The preparation of the traditional Chinese medicine placebo is basically the same as the package, color, smell and taste of the traditional Chinese medicine treatment group, and is harmless. Metformin and metformin placebo used in this study were also substantially identical in package, color, odor and taste, as provided by shanghai yinyi balance pharmaceutical limited, lot no: 67181107, 67180301.

3. Research implementation method

Random, double-blind and prospective clinical trial research methods are adopted. Study group: taking stomach-regulating qi-supporting decoction 150ml each time, 2 times daily, taking 1 tablet of metformin placebo in noon and evening respectively, and packaging, color and shape are basically the same as those of metformin tablet; control group: the Chinese medicinal placebo is taken 150ml respectively in noon and evening, the package, color, shape, smell and taste are basically the same as stomach regulating and qi supporting soup, and the metformin tablet is taken 1 tablet (250 mg/tablet) respectively in noon and evening. During the treatment period, the treatment dosage of olanzapine is fixed, and the living style (including daily life, diet and exercise) of hospitalized patients is the same; the treatment observation period was 8 weeks. General data of all cases were collected at baseline, blood pressure, body weight, body mass index, waist circumference, hip circumference, waist-hip ratio, triglyceride, total cholesterol, high density lipoprotein, low density lipoprotein, apolipoprotein-A, apolipoprotein-B, fasting glucose, glycated hemoglobin were measured at baseline and at the end of weeks 4 and 8 to assess the changes in the adverse reactions of metabolic syndrome. At baseline, 8 weeks after enrollment, the side-response Scale (TESS) rating was performed. The scale was assessed by an attending physician with 5 years of experience and prior to performance consistent training was performed on the study protocol, and the scale assessor, respectively.

4. Assessment tool

And (3) observing contents by self-prepared traditional Chinese medicine syndrome scales: polyphagia, easy hunger, thirst, constipation, red tongue with yellow and dry coating, and forceful pulse. The scoring criteria are as follows: the severity was 4 points, the moderate was 3 points, the mild was 2 points, and none was 1 point. The PANSS scale consists of 30 items, namely a positive scale 7 item, a negative scale 7 item and a general psychopathology scale 16 item. The time frame of the assessment is typically all information in the previous week. The side-effect scale TESS is compiled by NIMH in the united states and is divided into three columns, namely the severity of symptoms, the relationship with drugs, the measures taken, etc.

5. Statistical method

Epidata was applied for all data entry and exported to SPSS 20 statistical software for further data analysis. Chi-square and t-test statistical analysis was performed on general demographic data at baseline for both groups of patients; at baseline, 4 th and 8 th weeks after group entry, the patient's body weight, Body Mass Index (BMI), waist circumference, hip circumference, waist-hip ratio, blood pressure and blood lipid were subjected to t-test and repeated measures of analysis of variance. The fasting blood glucose and glycated hemoglobin changes before and after treatment (baseline period-after treatment) were tested by independent sample t-test and non-parametric test (Mann-Whitney test), and chi-square test was used for incidence of adverse reactions between the two groups. Test level α is 0.05, double-sided test.

Second, result in

1. General data comparison

During the study, 1 study group was dropped, the next day of patient enrollment resulted from an automatic hospital discharge visit, and finally 71 study patients were included in the study. The difference in age, gender, age at first onset, course of disease and baseline PANSS scale score was not statistically significant (mean P >0.05) for both groups of patients, see table 1.

TABLE 1 comparison of two sets of clinical data

2. Comparison of body weight and body weight index between groups

Body weight, body mass index, waist circumference, hip circumference, waist-hip ratio were not different in the baseline phase compared between the two groups (P both > 0.05). Repeated measures analysis of variance, main effects analysis: the time-based effect of waist circumference after intervention is statistically significant (F ═ 4.039, P ═ 0.025), simple effect analysis: the body weights of the study group varied at different time points before and after treatment (F ═ 6.502 and P ═ 0.003), while the body weights of the control group did not vary before and after treatment (P > 0.05); the differences between the time points before and after waist circumference treatment in the study group were statistically significant (F: 4.916, P: 0.023), while no significant difference was observed between the time points before and after waist circumference treatment in the control group (P >0.05), see table 2 and fig. 1.

TABLE 2 comparison of body weight, body weight index and hip circumference

Represents P <0.01, represents P <0.05

3. Comparison of blood pressure and blood lipid between two groups

The comparison of blood pressure and blood fat between two groups in the baseline period has no obvious difference (P is both greater than 0.05). By repeated measurement analysis of variance, the time-major effect of triglyceride after intervention has statistical significance (F is 3.767, and P is 0.026), and the time-major effect, the interclass main effect and the interaction effect of systolic pressure, diastolic pressure and blood fat of other indexes have no statistical significance (P is more than 0.05). After the study group had a decrease in total cholesterol (P ═ 0.059), an increase in HDL, a decrease in LDL, and a decrease in apolipoprotein-B at each time point, but the differences were not statistically significant (P >0.05), as shown in table 3.

TABLE 3 comparison of blood pressure and blood lipid changes in two groups

Represents P <0.05

4. Comparison of blood glucose between groups

There was no difference between fasting blood glucose and glycated hemoglobin in baseline period (mean P >0.05), and the difference between glycated hemoglobin of study group before and after treatment did not fit normal distribution (single sample K-S test P <0.05), so using Mann-Whitney test, there was statistical significance for the difference between glycated hemoglobin of two groups before and after treatment (baseline period-8 weeks of treatment) (Z ═ 2.378, P ═ 0.017), and no statistical significance for the difference between fasting blood glucose before and after treatment (P >0.05), see table 4.

TABLE 4 comparison of fasting plasma glucose and glycated hemoglobin between groups

Note: a represents that the data is normally distributed so as to

Expressing; b represents a non-normal distribution of data, in [ M (P25, P75)]Expressing; represents P<0.05

5. Comparison of self-fitting Chinese medicine symptom scale scores before and after two groups of treatment

At baseline, no obvious difference is found in the Chinese medicine symptom scale scores between two groups (P >0.05), and the main effect analysis is carried out by repeated measurement analysis of variance: after intervention, the main effect among groups has statistical significance (F: 4.445, P: 0.039), and the time main effect has statistical significance (F: 24.565, P < 0.001). The effect analysis alone, the study and control groups had statistical significance for both pre-and post-treatment differences in the scores of the chinese syndrome scale (F-12.487, P-0.001; F-12.704, P-0.001), as shown in table 5.

TABLE 5 comparison of the two sets of Chinese medicine syndrome scales

Represents P <0.01, represents P <0.05

6. Comparison of two adverse groups

The patients in the two groups all have tremor, akathisia, hypokinesia, constipation, salivation, blurred vision, insomnia, and abnormal electrocardiogram, and the incidence of adverse reaction in the treatment group is obviously reduced compared with the control group (chi type)²＝4.810，P＝0.028；χ²5.853, P0.016) as shown in table 6.

TABLE 6 comparison of incidence of adverse reactions in two groups

Represents P <0.05, compared to control group.

Third, discuss

The study was conducted with the formula of stomach-regulating qi-supporting decoction and metformin for the treatment of metabolic syndrome caused by olanzapine. The results show that: less waist and weight loss (average P) after intervention of stomach regulating qi-flowing decoction<0.05), no obvious change is seen in the prognosis of metformin dry (mean P)>0.05). The stomach-regulating qi-supporting decoction is used for improving symptoms of patients with stomach heat hyperactivity, and has obviously reduced adverse reaction incidence rate in the aspects of dry mouth, nausea, vomiting and diarrhea (P) compared with metformin<0.05). The index of the glycosylated hemoglobin is reduced after the intervention of the stomach regulating qi-supporting decoction,the glycosylated hemoglobin slightly rises after metformin intervention, and the index change of the glycosylated hemoglobin is different between two groups before and after treatment (P is 0.017). After the prognosis of the stomach-regulating qi-supporting decoction, total cholesterol is in a descending trend, HDL is in an ascending trend, LDL is in a descending trend, and apolipoprotein-B is in a descending trend, but the difference is not statistically significant (all P)>0.05). Review previous studies found that Toby Pallinger [14 ]]Etc. 100 randomized controlled trials were included in the study, including 25952 patients. The median treatment period was 6 weeks during the observation period. The body mass index of the patients increased on average by 1.07kg/m after administration of olanzapine compared to placebo²LDL increased by 0.20mmol/L on average. Trino Baptista [15 ]]The studies of et al show that patients receiving olanzapine and clozapine treatment have higher abnormal waist circumference, abnormally elevated blood glucose levels, and an abnormal proportion of triglyceride and blood pressure levels higher than the general population. Therefore, the research result shows that the influence of olanzapine on the glycolipid metabolism of a schizophrenic patient for 8 weeks tends to improve various blood lipid indexes (total cholesterol, HDL, LDL and Apo-B) after the stomach-regulating and qi-supporting decoction is used for treating. The stomach regulating and qi supporting decoction is suggested to have a prevention effect on lipid metabolism disorder caused by olanzapine taking treatment.

The present study concluded that: compared with metformin, the stomach-regulating qi-supporting decoction can better improve the increase of body weight and waist circumference of a schizophrenic patient caused by olanzapine taking, reduce glycosylated hemoglobin and has fewer side effects. The stomach-regulating qi-supporting decoction has a prevention effect on various index disorders of blood fat caused by olanzapine taking.

Reference documents:

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[2]Mitchell AJ,Vancampfort D,Sweers K,van Winkel R,Yu W,De HertM.Prevalence of metabolic syndrome and metabolic abnormalities inschizophrenia and related disorders—a systematic review and meta-analysis.Schizophr Bull 2013；39:306–18.

[3]Correll CU,Solmi M,Veronese N,et al.Prevalence,incidence andmortality from cardiovascular disease in patients with pooled and specificsevere mental illness:a large-scale meta-analysis of 3211768patients and113383368 controls.World Psychiatry 2018；17:120.

[4]Saha S,Chant D,McGrath J.A systematic review of mortality inschizophrenia:is the differential mortality gap worsening over time？Arch GenPsychiatry 2007；64:1123–31.

[5]Antonio Gonzalez-Chávez,JoséAlejandro Chávez-Fernández,SandraElizondo-Argueta,et al.Metabolic Syndrome and Cardiovascular Disease:A HealthChallenge[J].Arch Med Res.2018 Nov；49(8):516-521.doi:10.1016/j.arcmed.2018.10.003.Epub 2018Oct 24.

[6]Chen CH,Chiu CC,Huang MC,Wu TH,Liu HC,Lu ML.Metformin formetabolic dysregulation in schizophrenic patients treated witholanzapine.Prog Neuro-psychopharmacol Biol Psychiatry 2008；32:925e31.

[7]Hasnain M,Fredrickson SK,Vieweg WV.Metformin for obesity andglucose dysregulation in patients with schizophrenia receiving antipsychoticdrugs.J Psychopharmacol 2011；25:715e21.

[8]Tixeira—Ribeiro R,Bouca J，Freitas D,et a1.Metform-in-inducedpsychosis:a case report[J].Eur Psychiatry,2015,30(S1):1859.

[9] the intervention effect of the traditional Chinese medicine phlegm-eliminating and lipid-lowering decoction on obesity caused by antipsychotics is observed [ J ] in Chinese traditional medicine science and technology, 2020,27(1):92-94.

[10] Zhao Jianhua, Chen Lin Qing, Zhang Jingxia, etc. the weight-reducing and fat-reducing soup has the effect of antagonizing mental disease caused obesity patient's body mass [ J ] Chinese medicine research 2020,33(3):22-24.

[11] An improvement effect of Yangling, Liuyu decoction on metabolic syndrome of olanzapine caused schizophrenia [ J ]. world traditional Chinese medicine, 2017.

[12] Zhang Shi Ying, Zhang Shuqin, the influence of metformin and traditional Chinese medicine on the increase of physical quality and the disturbance of glycolipid metabolism of patients with schizophrenia caused by olanzapine [ J ] the modern J of Chinese and Western medicine, 2016(25):3838.

[13] Li Yazhong, Liu Hai Jun, Yangjie, etc. 120 cases of curative effect observation of lipid diabetes granule for treating schizophrenia accompanied with metabolic syndrome [ J ] China journal of health psychology, 2013,21(10):1461-1462.

[14]Toby Pillinger,Robert A McCutcheon,Luke Vano,et al.ComparativeEffects of 18 Antipsychotics on Metabolic Function in Patients WithSchizophrenia,Predictors of Metabolic Dysregulation,and Association WithPsychopathology:A Systematic Review and Network Meta-Analysis[J].LancetPsychiatry.2020 Jan；7(1):64-77.doi:10.1016/S2215-0366(19)30416-X.Epub 2019Dec 17.

[15]Trino Baptista,Ana Serrano,Euderruh Uzcátegui,et al.The MetabolicSyndrome and Its Constituting Variables in Atypical Antipsychotic-TreatedSubjects:Comparison With Other Drug Treatments,Drug-Free PsychiatricPatients,First-Degree Relatives and the General Population in Venezuela[J].Schizophr Res.2011 Mar；126(1-3):93-102.doi:10.1016/j.schres.2010.10.014.Epub2010 Nov 10.

Attached:

chinese medicine symptom scale

Grading standard: the severity was 4 points, the moderate was 3 points, the mild was 2 points, and none was 1 point.

The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and additions can be made without departing from the method of the present invention, and these modifications and additions should also be regarded as the protection scope of the present invention.

Claims

1. The application of a traditional Chinese medicine composition in preparing a medicine for preventing and treating metabolic syndrome caused by olanzapine taken by a patient with schizophrenia is characterized in that the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 8-10 g of rhubarb, 5-7 g of liquorice and 5-7 g of mango.

2. The application of claim 1, wherein the raw material medicines are in parts by weight as follows: rhubarb horsetails 9 g, licorice root 6g, and mango juice 6 g.

3. Use according to claim 1 or 2, wherein the medicament is in an oral dosage form.

4. The use according to claim 3, wherein the oral dosage form is a decoction, a granule, a tablet, a capsule or a mixture.

5. The use according to claim 1 or 2, wherein the medicament further comprises a pharmaceutically acceptable carrier.

6. Use according to claim 5, wherein the pharmaceutically acceptable carrier is selected from the group consisting of emulsifiers, excipients, fillers, binders, humectants, disintegrants, absorption enhancers, flavourings, colourings and cosolvents.