半夏泻心汤治疗2型糖尿病寒热错杂证的随机对照临床研究  

Type 2 Diabetes Mellitus of Cold and Heat in Complexity Syndrome Treated with Banxia Xiexin Decoction:a Randomized Controlled Trial

作　　者：谈钰濛 胡骏 赵晖[1,2] 倪青 TAN Yumeng;HU Jun;ZHAO Hui;NI Qing(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing,100700;China Center for Evidence-Based Traditional Chinese Medicine;Guang’anmen Hospital, China Academy of Chinese Medical Sciences)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]中国中医药循证医学中心 [3]中国中医科学院广安门医院

出　　处：《中医杂志》2022年第14期1343-1349,共7页Journal of Traditional Chinese Medicine

基　　金：中国中医科学院基本科研业务费项目(ZZ14-FL-011)。

摘　　要：目的 观察半夏泻心汤治疗2型糖尿病寒热错杂证的临床疗效及安全性,并探讨可能的作用机制。方法 82例2型糖尿病寒热错杂证患者采用随机对照试验分为治疗组和对照组各41例,治疗组给予半夏泻心汤配方颗粒,每日1剂,分2次温服;对照组给予格列美脲片口服,每日1 mg。治疗12周后比较两组患者治疗前后中医证候积分、不同时间(餐前及餐后0.5 h、1 h、2 h、3 h)血清胰高血糖素样肽-1 (GLP-1)水平并计算餐后3小时GLP-1曲线下面积[GLP-1(0-3 h)-AUC],治疗前后检测糖化血红蛋白(HbA1c)、进行口服葡萄糖耐量试验(OGTT,检测餐前和餐后0.5 h、1 h、2 h、3 h血糖水平),并计算OGTT 3小时血糖曲线下面积[OGTT(0-3 h)-AUC],检测胃肠激素[包括胃泌素(Gas)、胃动素(MLT)、生长抑素(SS)]、血脂[包括胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)]、体重指数(BMI)。治疗后判定中医证候疗效和血糖疗效,并进行安全性评价。结果 最终治疗组和对照组各36例完成试验。治疗组中医证候疗效总有效率为77.78%,血糖疗效总有效率为50.00%,对照组分别为44.44%和66.67%,治疗组中医证候疗效总有效率显著高于对照组(P<0.01),而血糖疗效差异无统计学意义(P>0.05)。与本组治疗前比较,治疗组治疗后GLP-1(0-3 h)-AUC、HDL-C、SS水平及各时间点GLP-1水平均升高,中医证候积分、HbA1c、餐后1 h血糖、餐后2 h血糖、TC、LDL-C、BMI、Gas及MLT水平均显著下降(P<0.05)。与对照组治疗后比较,治疗组治疗后中医证候积分、Gas、MTL、BMI、LDL-C水平降低,GLP-1(0-3 h)-AUC、餐前血糖、餐后0.5 h血糖、餐后1h血糖、OGTT(0-3 h)-AUC水平显著升高(P<0.05)。两组患者安全性指标均未见明显异常,且无严重不良事件发生。结论 半夏泻心汤可显著改善2型糖尿病寒热错杂证患者中医证候,安全有效,其机制可能是通过促进血清GLP-1的分泌ObjectiveTo observe the clinical effect and safety of Banxia Xiexin Decoction(半夏泻心汤)in treating type 2 diabetes mellitus(T2DM)and to explore the possible mechanism.Methods with cold and heat in complexity syndrome were randomly divided into treatment group(Banxia Xiexin Decoction prepared granules,one dose,twice a day)and control group(oral glimepiride tablets,1mg per day),with 41 cases in each group.After 12 weeks of treatment,traditional Chinese medicine(TCM)syndrome scores,and levels of glucagon-like peptide-1(GLP-1)before meals and 0.5 h,1 h,2 h and 3 h after meals were compared between the two groups before and after treatment,and the area under the curve of GLP-1 from 0 to 3 h after the meal(GLP-1(0-3 h)-AUC)was calculated.The glycated hemoglobin(HbA1c)was tested before and after treatment.The oral glucose tolerance test(OGTT)was used to test the blood glucose levels before the meal and 0.5 h,1 h,2 h,and 3 h after the meal,and the area under the curve of glucose from 0 to 3 h after the meal(OGTT(0-3 h)-AUC)was calculated to test the gastrointestinal hormones including gastrin(Gas),motilin(MLT),somatostatin(SS),blood lipids including cholesterol(TC),triglycerides(TG),low-density lipoprotein cholesterol(LDL-C),high-density lipoprotein cholesterol(HDL-C),and body mass index(BMI)in two groups before and after treatment.The effects regarding TCM syndromes and blood glucose were determined,and the safety was evaluated.ResultsFinally,thirty-six cases in each group completed the trial.The total effective rate regarding TCM syndromes in the treatment group was 77.78%,significantly higher than 44.44% in the control group(P0.05).After treatment,the levels of GlP-1(0-3 h)-AUC,HDL-C,SS and GLP-1 at each time point in the treatment group significantly increased,while the TCM syndrome score and the levels of HbA1c,glucose(1h and 2 h after the meal),TC,LDL-C,BMI,Gas and MLT were significantly reduced(P<0.05).Compared to those in the control group,the TCM syndrome score and the levels of Gas,MTL,BMI and LDL-C in t

关 键 词：2型糖尿病 半夏泻心汤 寒热错杂证 胰高血糖素样肽-1 胃肠激素 血糖 血脂 

分 类 号：R259[医药卫生—中西医结合]