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ObjectiveTo construct the evidence body for revision of safety information on package inserts of Chinese patent medicines in post-marketing by taking Xiaoke'an capsules as an example， so as to provide reference for the revision of instructions of Chinese patent medicines in post-marketing. MethodThe construction of the evidence body was guided by the theory of traditional Chinese medicine（TCM） and the Technical Guiding Principles for Revision of Safety Information Items in Instructions for TCMs After Marketing， and 8 categories and 25 specific items were taken as the main body of the evidence body， and information inclusion， integration， screening and improvement were carried out， then expert demonstrations were conducted， and finally modifications were made based on the opinions of the Center for Drug Evaluation to complete the revision of the safety information in the instructions of Xiaoke'an capsules. Result［Adverse reactions］ of Xiaoke'an capsules was revised to "monitoring data show that the following adverse reactions can be seen with this product：individual hypoglycemic reaction reports". ［Contraindications］ was revised to "contraindicated for those allergic to this product and its ingredients". ［Precautions］ was revised to "（1）pregnant women should use with caution， （2）elderly people should consult a physician， （3）people with spleen deficiency and dampness， spleen and stomach deficiency and cold， or those who eat less and have diarrhea should use with caution， （4）this product contains ginseng， should not be taken at the same time with TCM prescriptions or patent medicines containing veratrum and Wulingzhi， （5）pay attention to monitoring blood sugar during medication， （6）if any other discomfort occurs during medication， you should seek medical attention in time". The warning was revised to "use with caution by pregnant women， and pay attention to regular monitoring of blood sugar". ConclusionIn accordance with the content and process of the evidence body for the revision of safety information in the instructions， the revision of the safety information in the instructions of Xiaoke'an capsules has been completed， providing a strong basis for the rational and safe use of medication in the clinic.
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Objective:The purpose of this study was to explore the therapeutic effect of modified Xiaoke prescription on patients with Yin deficiency and heat excessive type 2 diabetes mellitus (T2DM), and its influence on TCM syndrome scores, pancreatic islet function and oxidative stress.Methods:Randomized controlled trial. Eighty patients with Yin deficiency and heat excessive T2DM treated in the hospital between January and July 2021 were selected, and divided into observation group (41 cases) and control group (39 cases) by random number table method. Patients in the control group were treated with conventional western medicine, and patients in the observation group were treated with modified Xiaoke Prescription on the basis of the control group. Both groups were treated for 1 month. TCM syndrome scores were performed before and after treatment. Fasting plasma glucose (FPG) and 2 hPG were measured by glucose oxidase method. Serum HbA1c, malondialdehyde (MDA), 8-hydroxy-2'-deoxyguanosine (8-OHdG) levels and SOD activity were measured by ELISA. The levels of low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and total cholesterol (TC) were detected by colorimetry.Results:The total effective rate of the observation group was 92.68% (38/41), and that of the control group was 76.92% (30/39). The difference between the two groups was statistically significant ( χ2=3.89, P=0.048). After treatment, the scores of tiredness and fatigue, thirst and appetite, overeating and hunger, redness of tongue and lack of saliva and total scores in the observation group were significantly lower than those in the control group ( t=4.46, 16.89, 13.37, 8.58, 8.38, P<0.01). After treatment, the levels of serum FPG [(7.31±0.90) mmol/L vs. (8.72±1.50) mmol/L, t=5.13], 2 hPG [(9.64±2.05) mmol/L vs. (12.85±1.20) mmol/L, t=8.49], HbA1c [(7.64±0.58)% vs. (8.11±1.35)%, t=2.04] in the observation group were significantly lower than those in the control group ( P<0.05); MDA [(3.96±1.00) mmol/L vs. (5.04±0.73) mmol/L, t=5.49], 8-OHdG [(203.41±30.70) ng/L vs. (234.50±59.00) ng/L, t=2.98] levels were significantly lower than those in the control group ( P<0.05); The activity of serum SOD [(48.64±5.05) mU/L vs. (41.75±3.58) mU/L, t=7.01] was significantly higher than that of the control group ( P<0.01); The serum LDL-C [(2.01±0.11) mmol/L vs. (2.56±0.25) mmol/L, t=12.84], TC [(4.75±0.20) mmol/L vs. (5.12±0.07) mmol/L, t=10.93] levels were significantly lower than those in the control group ( P<0.01); The serum HDL-C [(1.62±0.18) mmol/L vs. (1.24±0.42) mmol/L, t=5.31] level was significantly higher than that of the control group ( P<0.01). Conclusion:The modified Xiaoke Prescription can improve clinical symptoms, curative effect and pancreatic function, and relieve oxidative stress on the patients with T2DM.
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Objective: To systematically evaluate the clinical effect of Xiaoke Decoction in the treatment of type 2 diabetes. Methods: Chinese databases such as CNKI, Wanfang, Weipu Chinese Biomedical Journal Database, and Chinese Medical Biological Literature Database, PubMed, Cochrane Library, Embase, and Web of Science were searched for English language literature from their inception until November 2019. A Meta-analysis was performed using RevMan 5.3 and Stata 12.0. Results: Thirty-eight studies were included in this study, with a total of 3757 patients. It was found that adding Xiaoke Decoction could improve total efficiency. The Xiaoke Decoction groups surpassed the western medicine groups regarding improvement in total efficiency (OR = 3.49; 95% CI: 2.78–4.39, P < 0.00001). Adding Xiaoke Decoction could lower the fasting plasma glucose (FPG) level. The Xiaoke Decoction groups surpassed the western medicine groups regarding reduction in FPG levels (MD = −1.14; 95% CI: −1.36 to 0.92, P < 0.00001). Adding Xiaoke Decoction could lower the 2 h postprandial blood glucose (2hPG) level. The Xiaoke Decoction groups surpassed the western medicine groups regarding reduction in 2hPG (MD = −1.40; 95% CI: −1.61 to 1.19, P < 0.00001). Adding Xiaoke Decoction could lower glycated hemoglobin (HbA1c). The Xiaoke Decoction groups surpassed the western medicine groups regarding reduction in HbA1c (MD = −0.77; 95% CI: −0.95 to 0.58, P < 0.00001). It was found that adding Xiaoke Decoction could lower the traditional Chinese medicine (TCM) syndrome score. The TCM syndrome scores among patients in the Xiaoke Decoction group were lower than those among patients in the control group after treatment (MD = −4.90; 95% CI: −7.22 to 2.57, P < 0.0001). At the same time, we conducted a subgroup and sensitivity analysis of age and intervention duration on the heterogeneity of total efficiency, FPG, 2hPG, HbAlc, and TCM syndrome score outcome indicators. For detecting publication bias, an egger test was conducted. Conclusion: Compared with western medicine alone, Xiaoke Decoction has more advantages for the treatment of type 2 diabetes with respect to total efficiency, FPG, 2hPG, HbAlc, and TCM syndrome score.
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OBJECTIVE To e stablish the fingerprint of Qings hen tiaozhi xiaoke tablets （QTXT）and carry out the analysis of chemical pattern recognition ，and determine the contents of seven active components simultaneously. METHODS Using coptisine hydrochloride as reference ，the Similarity Evaluation System for Chromatographic Fingerprint of TCM （2012 edition）was utilized to establish the HPLC fingerprints of 13 batches of QTXT and analyze their similarity. The common peaks were confirmed by comparing with the chromatogram of the mixed control ；the attribution of the common peak was determined by comparing the chromatograms of the sample solutions of single decoction pieces and negative sample solutions ；using SPSS 22.0 and SIMCA 14.1 software，cluster analysis （CA），principal component analysis （PCA）and orthogonal partial least squares-discriminant analysis （OPLS-DA）were carried out ，and the markers affecting the quality of QTXT were screened ，using the variable importance in projection（VIP）value greater than 1 as the standard. Using coptisine hydrochloride as internal reference ，the contents of naringin ， hesperidin，neohesperidin，berberine hydrochloride ，palmatine hydrochloride and lovastatin were determined by quantitative analysis of multicomponents by single marker （QAMS），and then compared wi th the result s（except for coptisine hydrochloride ） of external standard method. RESULTS There were 17 Δ 基金项目：江苏省“双创团队”项目[No.（2018）2024号] ＊硕士研究生。研究方向：中药新药药学。E-mail：2769544062@ common peaks in 13 batches of QTXT ，and the similarity was qq.com 0.987-0.999. Seven chromatographic peaks were identified ， # 通信作者：副研究员，硕士生导师，博士。研究方向：中药药剂 namely naringin （peak 4）， hesperidin （peak 5）， 学。E-mail：tsliur411@sina.com neohesperidin（peak 6），coptisine hydrochloride （peak 8）， ·1204· China Pharmacy 2022Vol. 33 No. 10 中国药房 2022年第33卷第10期 palmatine hydrochloride （peak 9），berberine hydrochlo ride（peak 10），lovastatin（peak 14）. Peaks 7-10 were the exclusive peaks of Coptis chinensis ；peaks 3-6 and 11-13 were the exclusive peaks of bran-fried Fructus aurantii ；peak 14 was the exclusive peak of Monascus purpureus ；peak 1 was the common peak of C. chinensis and M. purpureus . Peak 2 and 15 were the common peak of bran-fried F. aurantii and M. purpureus ；peaks 16 and 17 were the common peaks of 6 traditional Chinese medicines. The results of CA showed that 13 batches of QTXT could be divided into three categories ，S2 was clustered into one category ，S1，S9，S10 were clustered into one category ，S3-S8 and S 11-S13 were clustered into one category. The results of PCA showed that accumulative variance contribution of the first three principal components was 85.120％. Compared with CA ，S1 was further distinguished from S9 and S 10 by PCA. OPLS-DA showed that 7 common peaks with VIP value greater than 1（from large to small ）were peak 10 （berberine hydrochloride ），peak 9（palmatine hydrochloride ），peak 5（hesperidin），peak 11 and peak 8（coptisine hydrochloride ）， peak 12 and peak 6（neohesperidin）. The contents of naringin ，hesperidin，neohesperidin，berberine hydrochloride ，palmatine hydrochloride and lovastatin measured by QAMS were 40.198-77.552，6.138-13.413，71.823-125.868，11.274-49.951，3.303- 5.367，1.821-3.185 mg/g，respectively. The contents of naringin ，hesperidin，neohesperidin，berberine hydrochloride ，coptisine hydrochloride，palmatine hydrochloride and lovastatin measured by external reference method were 41.454-79.976，6.404-13.993， 74.068-129.081，11.627-51.512，5.922-12.020，3.158-5.131 and 1.901-3.325 mg/g，respectively. The deviations of the two methods （except for coptisine hydrochloride ）were all less than 3.00％. CONCLUSIONS The established HPLC fingerprint and the method of QAMS are simple ，accurate and reproducible. Combined with chemical pattern recognition analysis ，it can be used for the quality evaluation of QTXT. Berberine hydrochloride ，palmatine hydrochloride and other components may be the markers affecting the quality of the drug.
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The quality evaluation of compound Chinese medicines is an important but challenging issue in this research field, which has been paid much controversial due to the constrained association with clinical efficacy. Developing a methodology for quality evaluation of compound Chinese medicines related to clinical efficacy is an important measure in research on Chinese material medica quality to ensure clinical effectiveness and safety. Therefore, based on the research concept that "originating from clinic-testing in experiment-returning to clinic", and taking Xiaoke prescription as an example, the characteristic information of metabolome, proteome and microbiome are discussed from the clinical aspect, and the integrated markers associated with clinical efficacy constructed with artificial intelligence technology. Taking the integrated markers as the link and indication are connecting the clinical and basic, the main pharmacodynamic substances and key targets of Xiaoke prescription that are related to clinical efficacy are explained. Clinical samples are used for validation. Based on the main pharmacodynamic substances and key targets, methods and key technologies for chemical and biological evaluation of the quality of Xiaoke prescription are established, providing a methodology for quality evaluation of compound Chinese medicines, including clinical efficacy response indicators (related to clinic), main pharmacodynamic substances (chemical evaluation), and key targets (biological evaluation), to provide new ideas and methods for improving the quality evaluation of compound Chinese medicines.
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Objective To investigate the effects of angelica lactone combined with Xiaoke pill on blood glucose regulation, renal protection and vascular endothelial growth factor signal pathway in diabetic nephropathy rats. Methods Totally 75 rats were randomly divided into control group, model group, Xiaoke pill group, angelica lactone group and angelica lactone combined with Xiaoke pill group, with 15 rats in each group. Except for the control group, the rest of the rats established diabetic nephropathy model. Rats in Xiaoke pill group, angelica lactone group and angelica lactone combined with Xiaoke pill group were given Xiaoke pill (0.8 g/kg), angelica lactone (20 mg/kg), Xiaoke pill (0.8 g/kg) combined with angelica lactone (20 mg/kg), respectively, once for 8 weeks. The levels of 24-hour urinary protein, fasting and postprandial blood glucose, glycosylated serum albumin and glycosylated hemoglobin, fasting insulin and insulin sensitivity index, serum creatinine (SCr) and urea nitrogen (BUN) were measured. The levels of insulin (INS) and glucose-6-phosphatase (G6Pase) mRNA in islet tissue were measured by Real-time PCR. Renal histopathological changes were detected by HE staining. The levels of vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor 2 (VEGFR2) in rat kidney were detected by Western blotting and immunohistochemistry. Results Compared with the model group, 24-hour urinary protein, fasting and postprandial blood glucose, glycosylated serum albumin and glycosylated hemoglobin, fasting insulin, SCr and BUN, VEGF and VEGFR2 protein levels and relative integral absorbance of kidney tissue in angelica lactone combined with Xiaoke pill group were significantly lower than those in model group(P<0.05). The insulin sensitivity index, the levels of INS and G6Pase mRNA in islet tissue were significantly increased (P < 0.05), and the renal histopathology of diabetic nephropathy rats was significantly improved. Conclusion Angelica lactone combined with Xiaoke pill can reduce blood glucose level, increase insulin sensitivity index, and its mechanism may be related to the regulation of VEGF signal pathway.
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Xiaoke Pills are Chinese and Western medicine compound preparations with effects of nourishing kidney and Yin,and supplementing Qi and promoting fluid. It is widely used in clinical treatment of type 2 diabetes( Qi and Yin deficiency syndrome),and continuously included in 2010,2013 and 2017 editions of Chinese prevention guide for type 2 diabetes. For the purpose of accurate positioning and rational use in clinic,it is necessary to further define the curative effect,indications,medication precautions and contraindications of Xiaoke Pills,in order to improve medication safety. This consensus was reached by reference of international clinical guidelines and expert consensus approach based on clinical evidence-based evidence,expert experience and standard specification. The evidence-based evaluation was oriented to clinical problems summarized by no less than 200 front-line clinical physicians in two rounds.GRADE system was adopted for quality classification and evaluation of the evidences,and then the nominal group method was used to form consensus recommendations or suggestions. This consensus defined the curative effect advantages,target users,dosage,administration method,contraindications and precautions of Xiaoke Pills,and provided valuable reference for the clinical use of the drug. Thisconsensus still needs to be updated and revised based on new clinical problems and evidence-based evidence in practical application in the future.
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Humans , Consensus , Diabetes Mellitus, Type 2/drug therapy , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , Yin DeficiencyABSTRACT
“Pungent flavor” is one content of the Chinese medicine five-flavor theory, and generally speaking, pungent herbs have the functions of “dispersing”, “moving qi” as well as “activating blood”, which possessed a larger proportion of clinical applications in traditional Chinese medicine (TCM). The relationship of pungent herbs with the treatment of Xiaoke syndrome was discussed based on TCM efficacy of pungent herbs and the understanding of Xiaoke syndrome in TCM theory in this article. The therapeutic significance and value of pungent herbs were summarized. Furthermore, some thoughts based on the current trend and direction of the Chinese medicine five-flavor theory were investigated to provide references for peer study.
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OBJECTIVE: To explore the synergistic molecular network mechanism of Chinese medicine ingredients and glibenclamide from Xiaoke pill for the treatment of diabetes mellitus. METHODS: After obtained diabetic-related genes of Xiaoke pill, STRING software was used to construct biomolecular network, DAVID software was used to identify KEGG pathways, Cytoscape software was used to construct the network for Xiaoke pill ingredients-key target-disease related pathway. RESULTS: The results showed that Xiaoke pill targeted 123 diabetic-related genes. Glibenclamide mainly affected pathways involved in type 2 diabetes, whereas Chinese medicine ingredients from Xiaoke pill was associated with inflammatory-related pathways such as TNF, Jak-STAT, NF-kB and cytokine pathway, islet β cell-related pathways such as PI3K/Akt, mTOR and MAPK pathway, AGE-RAGE and metabolic pathways. By combining Chinese medicine ingredients and glibenclamide, Xiaoke pill widely targeted diabetic-related pathways. CONCLUSION: It indicates that Xiaoke pill, a combination of traditional Chinese and Western medicine, can prevente diabetes and diabetic syndrome possibly by improving insulin resistance and protecting β cells and inhibiting inflammatory response.
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AIM To establish a quantitative analysis of multi-components by single-marker (QAMS) method for the simultaneous content determination of 3'-hydroxy puerarin,puerarin,3'-methoxy puerarin,neomangiferin,mangiferin,calycosin-7-O-β-D-glucoside,astragaloside Ⅳ and batatasin Ⅰ in Yuye Xiaoke Granules (Astragali Radix,Dioscoreae Rhizoma,Puerariae lobatae Radix,etc.).METHODS The analysis of methanol extract of this drug was performed on a 30℃ thermostatic Kromasil C1scolumn (4.6 mm ×250 mm,5 μm),with the mobile phase comprising of methanol-acetonitrile (1 ∶ 1) and 0.4％ glacial acetic acid flowing at 0.9 mL/min in a gradient elution manner,and the detection wavelengths were set at 210,250,254,274 nm.With astragaloside Ⅳ as an internal standard,the relative correction factors of the other seven constituents were calculated,after which the con tent determination was made.RESULTS Eight constituents showed good linear relationships within their own ranges (r ＞ 0.999 0),whose average recoveries were 97.06％-99.95％ with the RSDs of 0.54％-1.44％.The results obtained by QAMS approximated those obtained by external standard method.CONCLUSION This stable and reliable method can be used for the quality control of Yuye Xiaoke Granules.
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OBJECTIVE:To systematically evaluate therapeutic efficacy of Xiaoke formula in the treatment of type 2 diabetes mellitus (T2DM) with Qi and Yin deficiency,and to provide evidence-based reference in clinic. METHODS:Retrieved from PubMed,Embase,Cochrane Library,CBM and CNKI,randomized controlled trials(RCTs)about modified Xiaoke formula(trial group) with Qi and Yin deficiency versus Metformin tablet or insulin(control group) in the treatment of T2DM were included. After literature screening and data extraction,the qualities of included studies were evaluated by modified Jadad scoring scale. Meta-analysis was performed by using Rev Man 5.3 statistical software. RESULTS:Totally 18 RCTs were included,involving 2 065 patients. Meta-analysis showed that response rate of trial group [OR＝2.89,95%CI(2.16,3.86),P＜0.001] was significantly higher than that of control group,while fasting blood glucose [SMD＝－0.72,95%CI(－0.96,－0.47),P＜0.001],2 h postprandial blood glucose [SMD＝ －0.72,95%CI(－0.96,－0.47),P＜0.001],glycosylated hemoglobin [MD＝－0.65,95%CI (－0.88,－0.42),P＜0.001] and TCM syndrome score [MD＝－5.77,95%CI(－7.46,－4.08),P＜0.001] were significantly lower than control group. Totally 18 RCTs were included,involving 18 formula and 66 ingredients. The sum of use frequency of various medicinal materials was 218. Trichosanthes,Coptis chinensis,Ophiopogon japonicus and so on were used most frequently. CONCLUSIONS:Xiaoke formula shows significant therapeutic efficacy for T2DM with Qi and Yin deficiency,and reduces related index levels and TCM syndrome score effectively.
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Based on the database of "Dictionary of Traditional Chinese Medicine Prescriptions", high-frequency herbs of Xiaoke disease is mined by traditional Chinese medicine inheritance support system, and core herbs and combinations are discovered through association rules and cluster analysis. On this basis, based on the integrative pharmacology of traditional Chinese medicine to explore the herb-disease relationship, the "herb-compound-target" network is constructed and enriched for the analysis of key target gene functions, metabolic pathways, and their "core herb-target interactions". In order to explore the molecular mechanism of its prevention and treatment of diabetes, 341 diabetes prescriptions are collected, organized, and tapped in the Dictionary of Traditional Chinese Medicine Prescriptions. Herb frequency statistics show that Licorice was the most commonly used, followed by Ophiopogonis Radix, Poria, Ginseng Radix et Rhizoma, Coptidis Rhizoma, etc., the medicinal properties are mostly cold, warm and ping, and the medicinal taste tends to be pungent, bitter, and sour, and they were attributed to lung meridian, stomach meridian, spleen meridian, etc. Among them, the 17 herbs were closely related. Ginseng Radix et Rhizoma, Ophiopogonis Radix, Poria and Glycyrrhizae Radix et Rhizoma were the core Chinese herbs. Ophiopogonis Radix was the key node of Coptidis Rhizoma, Trichosanthis Radix and core Chinese medicine, and Ophiopogonis Radix was the key node for the connection between Coptidis Rhizoma and Trichosanthis Radix and the core Chinese herbs. Using integrated pharmacology platform analysis, 10 crucial core targets for the prevention and treatment of diabetes were obtained, including the known disease targets (PLCD1, PIK3R1, ENPP1), and potential herb targets(GNB1, ADCY1, AKT1, RAC1, PRKAA1, RHOA) , common target (GCK). There were seven similar targets in the 10 crucial core targets predicted with the combination of "Ophiopogonis Radix, Coptidis Rhizoma and Trichosanthis Radix", including PLCD1, PIK3R1, ENPP1, ADCY1, AKT1, PRKAA1, GCK. These genes were mainly located in the cytosol, plasma membrane, etc., involved in adenosine triphosphate binding, protein binding, platelet activation, etc., mainly involved in the endocrine system, signal transduction, chemokine signaling pathway, cancer pathway, and other metabolic pathways, and it is speculated that these genes were potentially associated with diabetes. In this study, Traditional Chinese Medicine Inheritance Support System and Integrative Pharmacology of Traditional Chinese Medicine are used to analyze the prescription law of Xiaoke prescription, and the correlation of "core herbs-functionary targets" is excavated, which provided the basis and reference for the screening and development of TCM prescriptions for the prevention and treatment of diabetes.
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Data Mining , Drug Prescriptions , Drugs, Chinese Herbal , Pharmacology , Medicine, Chinese Traditional , MeridiansABSTRACT
[Objective] Analyze the academic thought ofpurge stomach and tonify spleentreatment used by Professor SUN Zhi in acupuncture on type-2 diabetes mellitus during his clinical experience.[Method] According to new recognition of type-2 diabetes mellitus pathogenesis, study of acupuncture theory, clinical manipulation, conclude acupuncture point choices and needling methods ofpurge stomach and tonify spleentreatment, studying its characteristics. [Result] Type-2 diabetes mellitus belonging toXiaokecategory which features excessive discharge of urine and persistent thirst in Chinese medicine, but their pathogenesis is not the same, Professor SUN Zhi based on years of clinical observation found that patients with type-2 diabetes mellitus commonly manifested obese, polyorexia and accompanied by fatigue, summarized asstrong stomach and weak spleen. Tonify the deficiency and purge sthenia, using acupuncture manipulation, regulating spleen and stomach function, by reducing method of acupuncture Zhongwan, Zusanli and Neiting to inhibt stomach and control appetite, reinforcing method of acupuncture Sanyinjiao, Taibai, Pishu to enhance the transport of the spleen, meaning purging stomach and tonifying spleen. This treatment of type-2 diabetes mellitus in clinic achieved good results. [Conclusion]Purge stomach and tonify spleentreatment offers a new way of acupuncture to treat diabetes, deserving further exploration, popularization and application.
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Property and flavor theory of traditional Chinese medicine (TCM) is the core base for clinical treatment of diseases. However, few research about its chemical and biological characterization was performed. In this paper, network pharmacology was adopted to review patterns around the theory of TCM. "Xiaoke" prescription database, which combinations of herb medicines for diabetes therapy, was firstly built to explore prescription regularity and screen core paired-components. The prescription regularity and molecular mechanism of flavor composition were explored through the relationship of "drug-compound-target-pathway-function" by ChEMBL, CTD and KEGG datebase. As a result, the tastes of "Gan" (sweetish taste) and "Ku" (bitter taste) were the popular therapeutic flavor to regulate the disorder of glucose and lipid metabolisms. The mechanism of Xiaoke was summarized from representative traditional Chinese medicine partner "Zhimu-Huangbai" and "Huangqi-Gegen". The key components of "Gan", including saponins stimulated insulin secretion, improve insulin resistance and promote glucose utilization. The components of "Ku", including flavonoids and alkaloids regulate inflammatory cytokines, promoted the utilization of glucose, improve endocrine and metabolism through MAPK, PI3K-Akt, PPAR signal pathway. The TCM therapeutic mechanism about "Xiaoke" was preliminarily summarized to clear "heat" by anti-inflammation and immunoregulation, to regulate glucolipid metabolism for removing the satiation of digestion, and to improve the utilization of insulin and diabetes complications for endocrine adjusting. The results demonstrate that therapeutic principle of TCM for "Xiaoke" is comprehensive via multi pathway. This study provides a new research method and strategy for exploring the mechanism of TCM for diabetes therapy.
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Objective To observe the clinical effect of Xiaoke-Yuzu decoction on diabetic peripheral neuropathy (DPN). Methods A total of 100 DPN inpatients were recruited and randomly divided into the treatment and control groups. The two groups were both received basic therapy, while the treatment group additionally received Xiaoke-Yuzu decoction. Toronto clinical scores and Chinese medicine symptom scores of both groups were collected to evaluate the clinical effect before and after the therapy. Results The Toronto scores of treatment group were significantly lower than control group after treatment (symptoms score 1.50 ± 0.94 vs. 2.23 ± 1.01, reflection score 3.60 ± 1.77 vs. 4.27 ± 1.72, feeling test score 1.53 ± 0.63 vs. 2.10 ± 0.84,all P<0.05). Meanwhile, the Chinese medicine symptom scores of treatment group were also significantly lower than the control group (main symptom score 1.77 ± 1.17 vs. 3.17 ± 1.82, posterior symptom score 2.23 ± 1.59 vs. 4.27 ± 1.57, the tongue and pulse score 1.83 ± 0.65 vs. 2.47 ± 0.51, all P<0.05). Conclusion Xiaoke-Yuzu decoction plus basic therpy could improve the clinical symptoms of DPN patients.
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Diabetes is in the category ofin TCM, which is mainly discussed in light ofdeficiency. The conception vessel is the sea ofmeridians, acting on regulating the accumulation and irrigation ofand blood of twelve meridians and collaterals. The physiological function of the conception vessel is closely related to the pathogenesis of, its running course is highly coincident with the location ofand the symptoms ofare relevant with the indications of the conception vessel. Hence, harmonizingand blood of the conception vessel may be an effective approach to the prevention and treatment of.
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OBJECTIVE:To systematically review the efficacy and safety of Xiaoke pill versus glibenclamide in the treatment of type 2 diabetes mellitus,and provide evidence-based reference for clinical treatment. METHODS:Retrieved from Medline, PubMed,EMBase,Cochrane Library,CBM,CJFD,Wanfang Database and VIP Database,randomized controlled trials (RCT) about the Xiaoke pill(test group)versus glibenclamide(control group)in the treatment of type 2 diabetes mellitus were enrolled. Meta-analysis was performed by using Rev Man 5.2 software after document selection,data extract and quality assessment by Co-chrane systematical evaluation. RESULTS:A total of 15 RCT were included,involving 3 319 patients. Results of Meta-analysis showed the hemoglobin A1c (HbA1c) level [MD=-0.39,95%CI(-0.75,-0.02),P=0.04],fasting plasma glucose (FPG) level [MD=-0.70,95%CI(-1.27,-0.12),P=0.02],2 h PG[MD=-0.87,95%CI(-1.55,-0.20),P=0.01],incidence of thirst with desire for drinks [RR=3.35,95%CI(1.92,5.85),P<0.001],incidence of tiredness and debilitation[RR=5.74,95%CI(3.52, 9.36),P<0.001] and incidence of hypoglycemia [RR=0.67,95%CI(0.49,0.91),P=0.01] in test group were significantly lower than control group,the differences were statistically significant. CONCLUSIONS:Xiaoke pill has better efficacy and safety than glibenclamide in the treatment of type 2 diabetes mellitus,can obviously improve the HbA1c,FPG,2 h PG tevel and TCM symp-toms.
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Objective To investigate the effects of Xiaoke Wan on serum adiponectin levels in patients with type 2 diabetes metlitus. Methods A total of 60 2TDM patients with deficiency of both qi and yin syndrome were recruited into a control group and a treatment group randomly, 30 cases in each group. The treatment group was treated with Xiaoke Wan, and the control group was treated with glibenclamide. After 32 weeks, the changes of FPG, 2hPG, HbAIc, FINS, C-P, APN, HBCI,IRI and improvement of symptoms were compared between the two groups. Results Compared with glibenclamide, Xiaoke Wan can significantly improve the patients' symptoms, reduce the level of IRI (t=-1.590, P=-0.036), and increase serum APN (t=1.918, P=0.002). Conclusion Xiaoke Wan can significantly improve symptoms, reduce fasting blood glucose and 2 hour postprandial blood glucose, recover the secretion of adipouectin, decrease insulin resistance in 2TDM patients with deficiency of both qi and yin.
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[Objective] To study the clinical curative effect in treating 48 cases who suffered diabetes merging cerebral infarction with combined traditional Chinese medicine and western medicine.[Method]89 cases of enrolled patients were randomly divided into 2 groups:traditional Chinese medicine combined with western medicine group(48 cases group) and western medicine group(41 cases group).The 48 cases group was treated with traditional Chinese medicine combined with western medicine,while the 41 cases group was only treated with western medicine.The total curative rate was observed in both groups.[Result]The total curative rates were 89.58% and 68.29% in traditional Chinese medicine combined with western medicine group and western medicine group respectively.The therapeutic effect of traditional Chinese medicine combined with western medicine group was superior to that of western medicine group (P
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We summarized the researches of syndrome differentiation for type 2 diabetes mellitus (T2DM) in this article. According to the constitution feature of obesity and non-obesity and analysis of researches of different medical scholars, we put forward that the easy-suffering constitutions were the basis of the evolution and development of syndromes of T2DM, and the different inducements were the conditions of that courses. The persons whose constitutions were of qi-deficiency of spleen and kidney and excessive stomach often appeared a obese physique, and the people whose constitutions were of yin-deficiency of both the liver and kidney usually showed a non-obese shape. Affected chronically by the inducements, the evolution and development of the syndromes had its own rules respectively corresponding to the different constitutions as the diseases go on. Therefore, to integrate the constitution, disease stage and pathological change with specific zang-fu organs can better grasp its rules of syndrome differentiation.