大柴胡汤加减方对2型糖尿病肝胃郁热证胰岛β细胞功能影响的临床观察

Efficacy of the Dachaihu decoction on pancreatic β-cell function of type 2 diabetes with liver and stomach stagnated-heat syndrome

目的:通过大柴胡汤加减方治疗初发2型糖尿病肝胃郁热证患者,观察胰岛β细胞相关指标的变化,为中医药治疗2型糖尿病提供客观指标及证据。方法:选取门诊及入院初发2型糖尿病患者72例,治疗组36例,对照组36例。对照组脱落2例,实际完成34例,治疗组脱落3例,实际完成33例。治疗组给予基础治疗联合大柴胡汤加减方,对照组给予基础治疗联合二甲双胍缓释片,观察用药前后空腹血糖、餐后2小时血糖、糖化血红蛋白、空腹胰岛素、胰岛素敏感指数、胰岛素抵抗指数、胰岛素分泌指数、三酰甘油、总胆固醇、低密度脂蛋白胆固醇及高密度脂蛋白胆固醇、中医证候评分等指标的变化。结果:治疗后两组患者空腹血糖、餐后2小时血糖、糖化血红蛋白水平均显著低于治疗前(P <0.05);组间治疗后比较,差异无统计学意义(P> 0.05);组内比较,对照组胰岛素抵抗指数、胰岛素敏感指数显著改善(P <0.01),治疗组胰岛素抵抗指数、胰岛素敏感指数显著改善(P <0.05),治疗组胰岛素分泌指数显著升高(P <0.05),对照组胰岛素分泌指数无显著改善(P> 0.05);组间治疗后比较,治疗组胰岛素分泌指数改善好于对照组(P <0.05),对照组胰岛素抵抗指数、胰岛素敏感指数改善好于治疗组(P <0.05)。治疗组三酰甘油水平显著下降(P <0.05)、高密度脂蛋白胆固醇水平升高(P <0.05),对照组总胆固醇、低密度脂蛋白胆固醇水平下降(P <0.05);治疗后比较,治疗组三酰甘油、高密度脂蛋白胆固醇水平改善好于对照组(P <0.05),对照组总胆固醇、低密度脂蛋白胆固醇的改善情况好于治疗组。组内比较,治疗组中医证候积分改善(P <0.01),对照组中医证候积分的差异无统计学意义(P> 0.05)。两组不良反应的差异无统计学意义。结论:大柴胡汤加减方能降低空腹血糖、餐后2小时血糖、糖化血红蛋白、三酰甘油,升高高密度脂蛋白胆固醇,降糖作用与二甲双胍相当,其降糖机制与增加胰岛素分泌指数功能,改善胰岛素抵抗指数、胰岛素敏感指数有关。

Objective:To observe the changes ofβ-cell related indexes of newly diagnosed type 2 diabetic patients with liver and stomach stagnated-heat syndrome with the Dachaihu decoction(大柴胡汤),so as to provide objective indexes and evidence for the treatment of type 2 diabetes in TCM.Methods:In this study,72 cases were randomly divided into two groups:the treatment group(36 cases)and the control group(36 cases).In the control group,2 cases fell off,34 cases were actually completed.In the control group,3 cases fell off,33 cases were actually completed.The treatment group was given basic treatment plus the Dachaihu decoction;and the control group was given basic treatment plus metformin sustained release tablets.Results:GLU,2 hPBG and HbA1c levels in the two groups after treatment were significantly lower than before treatment(P<0.05).There was no difference between the two groups after treatment(P>0.05).HOMA-IR and insulin secretion index were significantly improved in the control group after treatment(P<0.01),HOMA-IR and insulin secretion index in the treatment group were improved in the treatment group(P<0.05),HOMA-βwas significantly increased in the treatment group(P<0.05).There was no improvement in HOMA-βin the control group(P>0.05).After treatment,the improvement of HOMA-βin the treatment group was better than the control group(P<0.05);the improvement of HOMA-IR and insulin secretion index in the control group was better than the treatment group(P<0.05).TG was decreased in the treatment group(P<0.05),HDL-C was elevated(P<0.05),TC and LDL-C levels were decreased in the control group(P<0.05).The improvement of TG and HDL-C in the treatment group was better than the control group(P<0.05).The improvement of TC and LDL-C in the control group was better than the treatment group(P<0.05).TCM syndrome score was improved in the treatment group(P<0.01).There was no statistically significant difference in the scores of TCM syndromes in the control group(P>0.05).There was no significant difference in adverse reactions between the two groups.Conclusion:Through the preliminary clinical study,the Dachaihu decoction can reduce the levels of GLU,2 hPBG,HbA1c,and TG,and increase the level of HDL-L.Its hypoglycemic effect is similar to metformin sustained release tablets.Its hypoglycemic mechanism was related to the increase of HOMA-βfunction and the improvement of HOMA-IR and insulin secretion index.