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

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,调节胃肠激素,纠正脂代谢来发挥降糖作用。

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 the treatment group significantly decreased after treatment,while the levels of GlP-1(0-3 h)-AUC,glucose(before the meal and 0.5 h,1 h after the meal),and OGTT(0-3 h)-AUC significantly increased(P<0.05).There were no abnormalities of the safety indicators in both groups,and no serious adverse events occurred.Conclusion Banxia Xiexin Decoctioncan improve the TCM syndromes of T2DM patients with cold and heat in complexity syndrome,and is safe.It can reduce blood glucose possibly by promoting the secretion of serum GLP-1,regulating gastrointestinal hormones,and correcting lipid metabolism.