| Objective :1.Using meta-analysis to evaluate the clinical efficacy and safety of clearing heat and removing dampness in the treatment of T2DM,and provide evidence-based medical evidence for clinical application.2.Using data mining technology to explore the rule of syndrome and treatment of T2DM treated by Wendan Decoction in the research group,and to provide experience for the treatment of T2DM in the future.Methods :The literature of randomized controlled trials of heat-clearing and dampness-removing therapy for T2DM published before December18,2022 was retrieved by hand and computer.The literature management software Note Express was used to screen the literature,and the data were extracted from the literature that was finally included in the meta-analysis.The quality of the literature was evaluated by the Cochrane risk bias assessment tool.Rev Man 5.4 software was used to analyze the total effective rate,fasting blood glucose,2-hour postprandial blood glucose,glycosylated hemoglobin,total cholesterol,triglyceride,low-density lipoprotein,and high-density lipoprotein.Meta-analysis was performed to evaluate the efficacy and safety of clearing heat and removing dampness in the treatment of T2DM.The research group collected 315 patients with T2DM treated with Wendan Decoction from December 2011 to December 2021.According to the template provided by the ’ Traditional Chinese Medicine Inheritance Computing Platform(V3.0)’ software,the patient ’s name,main symptoms,treatment methods,TCM syndrome types,tongue and pulse conditions,first diagnosis of traditional Chinese medicine prescriptions and other information are entered into the Excel table,and the data are uploaded and run.The ’ Traditional Chinese Medicine Inheritance Computing Platform(V3.0)’ software performs gender analysis,age analysis,tongue and pulse analysis,four-qi and five-flavor meridian tropism efficacy analysis,frequency analysis,association rule analysis and cluster analysis.Results :1.This meta-analysis included 30 articles in Chinese.A total of 3987 patients were included in this study,2092 in the treatment group and 1895 in the control group.The total clinical effective rate(OR = 3.64,95 % CI [ 2.63,5.04 ],P <0.00001)of Qingre Qushi combined with metformin or Qingre Qushi in the treatment of T2DM was better than that of metformin alone.The effect of clearing heat and removing dampness combined with metformin or clearing heat and removing dampness to reduce fasting blood glucose in T2DM MD =-0.80,95 % CI = [-1.07,-0.54 ](P < 0.00001)was better than that of metformin alone.Subgroup analysis showed :Huanglian Wendan Decoction group(MD=-0.93,95 % CI=[-1.38,-0.48 ](P < 0.0001);gegen Qinlian Decoction group MD=-0.93,95 % CI = [-1.81,-0.05 ](P = 0.04);MD =-0.79,95 % CI = [-1.04,-0.53 ](P <0.00001);MD =-0.82,95 % CI = [-1.20,-0.43 ](P < 0.0001).The effect of clearing heat and removing dampness combined with metformin or clearing heat and removing dampness on reducing 2h postprandial blood glucose MD =-1.69,95 % CI = [-2.23,-1.15 ](P <0.00001)was better than that of metformin alone.Subgroup analysis showed that : MD =-1.29,95 % CI = [-1.88,-0.70 ](P < 0.0001);gegen Qinlian Decoction group MD =-1.73,95 % CI = [-2.81,-0.66 ](P <0.002);MD =-2.24,95 % CI = [-3.22,-1.26 ](P < 0.00001).The effect of clearing heat and removing dampness combined with metformin or clearing heat and removing dampness on reducing glycosylated hemoglobin MD =-0.86,95 % CI = [-1.37,-0.36 ](P =0.0008)was better than that of metformin alone.Subgroup analysis showed : Huanglian Wendan Decoction group [ Z = 3.40,P = 0.0007 ],(MD =-0.68,95 % CI = [-1.08,-0.29 ]);radix Puerariae,Radix Scutellariae and Rhizoma Coptidis group MD =-1.58,95 % CI = [-2.65,-0.79 ](P < 0.00001);MD =-0.85,95 % CI = [-0.92,-0.79 ](P <0.00001);MD =-0.30,95 % CI = [-0.55,-0.05 ](P = 0.02);the main drug group MD = 0.14,95 % CI = [-0.04,0.32 ](P = 0.13).The effect of clearing heat and removing dampness combined with metformin or clearing heat and removing dampness on reducing T2DM total cholesterol MD =-0.37,95 % CI = [-0.53,-0.20 ](P < 0.001)was better than that of metformin alone.Subgroup analysis showed that : MD =-0.32,95 % CI = [-0.48,-0.15 ](P = 0.0001);MD =-0.40,95 % CI = [-0.56,-0.24 ](P < 0.00001);gegen and Qinlian group MD =-0.34,95 %CI = [-0.78,0.09 ](P = 0.12);MD =-0.37,95 % CI = [-1.21,-0.37 ](P= 0.0002).The effect of clearing heat and removing dampness combined with metformin or clearing heat and removing dampness on reducing T2DM triglyceride MD =-0.47,95 % CI = [-0.75,-0.19 ](P = 0.001)was better than that of metformin alone.Subgroup analysis showed that MD =-0.49,95 % CI = [-1.09,0.10 ](P = 0.11)in Huanglian Wendan Decoction group,MD =-0.35,95 % CI = [-0.53,-0.18 ](P < 0.0001)after removing Li Dongfeng 2020 and Li Weiran 2019.MD =-0.63,95 % CI =[-1.18,-0.08 ](P = 0.03);gegen and Qinlian ] MD =-0.31,95 % CI =[-0.59,-0.04 ](P = 0.03);MD =-0.74,95 % CI = [-0.98,-0.50 ](P <0.00001).The effect of clearing heat and removing dampness combined with metformin or clearing heat and removing dampness on improving low density lipoprotein MD = 0.28,95 % CI = [-0.48,-0.08 ](P = 0.007)was better than that of metformin alone.Subgroup analysis showed that :Wendan Decoction group MD =-0.11,95 % CI = [-0.35,0.13 ](P =0.36),MD =-0.24,95 % CI = [-0.40,-0.08 ](P = 0.004);gegen and Qinlian group MD =-0.44,95 % CI = [-0.74,-0.13 ](P = 0.005);MD =-0.24,95 % CI = [-0.64,-0.16 ](P = 0.24)in modified Lianpu decoction group and MD =-0.28,95 % CI = [-0.48,-0.08 ](P = 0.007)in Sanren decoction group.The effect of clearing heat and removing dampness combined with metformin or clearing heat and removing dampness on reducing T2DM high-density lipoprotein MD = 0.09,95 % CI = [ 0.00,0.17 ](P = 0.04)was better than that of metformin alone.The subgroup analysis showed that : MD = 0.06,95 % CI = [-0.07,0.19 ](P = 0.38);gegen and Qinlian group MD = 0.14,95 % CI = [-0.02,0.30 ](P = 0.08);MD = 0.05,95 %CI = [-0.06,0.16 ](P = 0.37)in Jiawei Lianpu Decoction group,MD =-0.03,95 % CI = [-0.12,0.06 ](P = 0.51)in Sanren Decoction group.2.Study on the rule of syndrome differentiation and treatment of T2DM treated with Wendan Decoction and other prescriptions A total of315 patients with T2DM were collected,including 190 males(60.31 %)and 125 females(39.69 %).The top three age groups were 50 to 59 years old,40 to 49 years old and 60 to 69 years old,accounting for 33.97 %,28.89 % and 14.29 % respectively.Tongue image analysis showed that the frequency of red tongue and yellow greasy fur was 231 and 146,respectively.Pulse analysis showed that the frequency of pulse sinking,pulse string and pulse slip were 210,153 and 36,respectively.Four-qi analysis showed that cold drugs,warm drugs and mild drugs were used more frequently,which were 3336,2120,1206 respectively.Five flavor analysis showed that bitter medicine,sweet medicine and pungent medicine were used more frequently,which were 3752,3656 and 2397 respectively.The analysis of meridian tropism showed that the highest frequency of spleen,stomach and lung meridians was 3828,3237 and 3233 respectively.The frequency analysis of efficacy showed that the frequency of clearing heat,tonifying deficiency,relieving exterior syndrome and calming liver and calming wind was the highest,which was 1452,1403,874 and 673 respectively.Drug frequency analysis showed that there were 38 kinds of drugs used more than 20 times.The analysis of the frequency of symptoms showed that the frequency of symptoms of loose stool,chest tightness,dry mouth,dizziness and abdominal distension was the highest,108,51,47,42 and 32 respectively.The frequency analysis of TCM syndromes showed that the frequency of phlegm-heat syndrome with blood stasis,phlegm-heat syndrome,spleen deficiency and stomach stagnation syndrome,intestinal damp-heat syndrome and qi-yin deficiency syndrome with dampness was the highest,which was 90,78,16,14 and 12 respectively.The frequency analysis of therapeutic principles and methods showed that the frequency of clearing heat and resolving phlegm,promoting blood circulation and removing blood stasis,drying dampness and invigorating spleen,promoting qi and resolving phlegm,benefiting qi,nourishing yin and clearing heat were the highest,which were 173,101,37,33 and 24 respectively.In the analysis of association rules,the support degree was 308 and the confidence degree was 0.99.The core drugs were Pinellia ternata,tangerine peel,Poria cocos,licorice,Atractylodes macrocephala,Fructus aurantii immaturus and bamboo shavings.In the analysis of prescription composition rules,the ’ clustering number ’ was set to 5 by k-means algorithm,and five core drug combinations were obtained,which were group 1 : Fructus Aurantii Immaturus,Pinelliae Rhizoma,Poria Cocos,Atractylodes Macrocephala Koidz,Zhuru,Pericarpium Citri Reticulatae;group 2 : Angelica,Pinellia,Ginger,Poria,Ophiopogon,Atractylodes;group 3 : Pinellia,Poria,Citrus aurantium,tangerine peel,licorice,Atractylodes;group 4 : Pinellia,Poria,tangerine peel,licorice,Atractylodes,ginger;group 5 : Moutan Cortex,Pinelliae Rhizoma,Ginger,Poria,Rehmanniae Radix,Paeoniae Alba.Conclusion :The total effective rate of clearing heat and removing dampness or combined with metformin in the treatment of T2DM is better than that of metformin alone;in terms of improving fasting blood glucose,2h postprandial blood glucose,and glycated hemoglobin,Qingre Qushi or combined with metformin is better than metformin alone in reducing blood glucose;in terms of improving total cholesterol,triglycerides,and highdensity lipoprotein,the effect of clearing heat and removing dampness or combined with metformin is better than that of metformin alone;in improving the level of low density lipoprotein,clearing heat and removing dampness or combined with metformin is better than metformin alone.The TCM syndromes of Wendan Decoction in the treatment of T2DM are mainly phlegm-heat syndrome and stasis,phlegm-heat syndrome,spleen deficiency and stomach stagnation syndrome,and intestinal dampheat syndrome.The main treatment methods are clearing heat and resolving phlegm,promoting blood circulation and removing blood stasis,drying dampness and invigorating spleen,promoting qi and resolving phlegm.The categories of traditional Chinese medicine are mainly heatclearing,tonifying deficiency,relieving exterior syndrome,calming liver and calming wind,regulating qi and promoting diuresis.The medicinal properties of traditional Chinese medicine are mainly cold,warm and flat,and the taste is mainly bitter,sweet and pungent.The drugs are mostly spleen,stomach and lung.The core drugs are : Pinelliae Rhizoma,Pericarpium Citri Reticulatae,Poria Cocos,Glycyrrhizae Radix et Rhizoma,Aurantii Fructus Immaturus,Zhuru,Baizhu. |
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