六味地黄软胶囊治疗消渴病(2型糖尿病)肾阴虚证的临床研究

Clinical Studies of Liuwei Dihuang Soft Capsule on Treating Kidney Yin Deficiency Syndrome of Type 2 Diabetes

目的:客观评价上市后药物六味地黄软胶囊干预消渴病(2型糖尿病)肾阴虚证中医证候的疗效。方法:采取随机、双盲、阳性药物及安慰剂对照的三臂临床试验设计,试验组:六味地黄软胶囊(0.38g/粒,3粒/次)+左归丸模拟剂(9g/次),1日2次(早晚各1次);阳性对照组:六味地黄软胶囊模拟剂(3粒/次)+左归丸(9g/次),1日2次(早晚各1次);安慰剂对照组:六味地黄软胶囊模拟剂(3粒/次)+左归丸模拟剂(9g/次),1日2次(早晚各1次);3组均于餐前口服。疗程为56天。结果:本试验共筛选140例受试者,随机入组130例,脱落2例,剔除2例,纳入FAS分析及PP分析病例数一致均为126例(其中试验组62例,阳性对照组32例,安慰剂对照组32例)。结果表明,3组用药后中医证候疗效等级比较差异有统计学差异(P<0.05);血糖控制疗效差异无统计学意义(P>0.05)。结论:六味地黄软胶囊能够明显改善消渴病(2型糖尿病)肾阴虚证的中医证候。

Objective： To objectively evaluate the efficacy of post-marketing drug Liuwei Dihuang Soft Capsule on interve- ning Kidney Yin Deficiency Syndrome of type 2diabetes. Methods ： A randomized, double-blind, positive drug and placebo con- trolled, three-arm clinical trial design, trial group： Liuwei Dihuang Soft Capsule （0. 38g per pill, 3pills per time） and the simulated drug of Zuogui Pill （9g per time） twice a day （morning and evening） ; the positive control group： The simulated a- gent of Liuwei Dihuang Soft Capsule （3pills per time） and the simulated agent of Zuogui Pill （9g per time）, twice a day （ morning and evening） ; placebo control group ： The simulated agent of Liu Wei Di Huang soft capsule （ 3pills per time） and the simulation agent of Zuogui Pill （9g per time） twice a day （morning and evening） ; three groups were in the fasting oral, treat- ment course was 56days. Results： q31is study screened a total of 140subjects were randomized into the group of 130cases, two shed, two excluded, the number of eases included in the FAS analysis and PP analysis were consistent with 126eases （test group was 62cases, the positive control group was 32cases, the placebo control group was 32cases）. The results showed that after the treatment, the curative effects of TCM syndromes in three groups were statistically different （P〈0. 05 ） ; efficacy in blood glu- cose control was not statistically significant difference （P〉0. 05）. Conclusion ： Liuwei Dihuang Soft Capsule can improve Kidney Yin Deficiency Syndrome of type 2diabetes significantly.