六味地黄软胶囊治疗糖尿病(肾阴虚证)的多中心临床研究

Multi-center Clinical Research on Liuwei Dihuang Soft Capsule Treat Diabetes(Kidney Yin Deficiency Syndrome)

目的:观察六味地黄软胶囊治疗糖尿病(肾阴虚证)的临床疗效。方法:236例糖尿病患者采用分层区组随机、双盲双模拟、阳性药和安慰剂平行对照、多中心临床试验方法。试验分3组,试验组:118例,口服六味地黄软胶囊(3粒/次)+左归丸模拟药(9 g/次),2次/日,早晚各1次;对照组1为60例,口服六味地黄软胶囊模拟药(3粒/次)+左归丸(9 g/次),2次/日,早晚各1次;对照组2为58例,口服六味地黄软胶囊模拟药(3粒/次)+左归丸模拟药(9 g/次),2次/日,早晚各1次。3组疗程均为8周。结果:3组病人用药后疾病中医证候疗效等级的比较差异有统计学意义(P<0.001);血糖控制疗效效果相似,差异无统计学意义;治疗后大部分主要临床症状的改善情况,3组间比较差异有统计学意义(P<0.05)。3组治疗后均有部分病例实验室检查出现异常有临床意义的改变,临床医生判断"改变与试验药物无关"。结论:六味地黄软胶囊治疗糖尿病(肾阴虚证)疗效确切,临床应用安全。

Objective：Observation Liuwei Dihuang soft capsule treat diabetes（kidney Yin deficiency syndrome） clinical curative effect.Method：Two hundred and thirty-six cases by stratified area group diabetes patients randomized,double-blind simulation,positive drug and placebo parallel control,multicenter clinical test method.Test points three groups,4.75%more： 118 cases of,oral Liuwei Dihuang soft capsule（3 grain/times） ＋ left to pill simulation medicine（9 g/times）,2 times per day,the morning 1 times;0 case： oral group 1∶6 Liuwei Dihuang soft capsule simulation medicine（3 grain/times） ＋ left to pill（9 g/times）,2 times per day,the morning 1 times;All cases of control group,oral Liuwei Dihuang soft capsule simulation medicine（3 grain/times） ＋ left to pill simulation medicine（9 g/times）,2 times per day,the morning 1 times.All three groups of course of 8 weeks.Result：Three groups of patients after disease medication syndromes curative effect levels of comparative differences have statistically significant（P 0.001）.Blood sugar control efficacy effect similar,difference was statistically significant.After treatment,the most major clinical symptoms improved situation between three groups was statistically significant comparative differences.Three groups were some cases after treatment laboratory appears unusual clinically meaningful change,clinical doctors think′change and test drug is not a matter of.Conclusion：The three groups of patients after treatment efficacy of disease syndromes difference between the level of statistical significance（P0.001）;effect of glycemic control similar effect,the difference was not statistically significant;clinical symptoms after treatment,most of the major improvements in three differences between groups was statistically significant.Three groups after treatment in some cases laboratory tests are clinically significant abnormal changes in clinical doctors to determine ＇change has nothing to do with the test drugs.