糖末宁颗粒治疗糖尿病性周围神经病变(气虚络阻证)432例临床研究

Effect of Tangmoning Granule in Treating Diabetic Peripheral Neuropathy with Qi-deficiency and Collateral Stagnation Syndrome:An Observation of 432 Cases

目的评价糖末宁颗粒治疗糖尿病性周围神经病变(气虚络阻证)的安全性和有效性。方法采用随机、阳性药平行对照、多中心临床试验方法,试验组口服糖末宁颗粒,对照组口服弥可保片,8周为1个疗程。结果糖末宁颗粒对糖尿病性周围神经病变的肌电图疗效的显效率为60.06%,总有效率为68.47%;中医证候疗效的显效率为23.12%,总有效率为90.99%。以15%为非劣效标准,对糖末宁组的肌电图疗效及中医证候疗效进行非劣效性检验,非劣效性检验合格。结论糖末宁颗粒能改善糖尿病性周围神经病变气虚络阻证的病情,同时安全性良好。

Objective To observe the efficacy and safety of Tangmoning Granule （TMG） in treating diabetic peripheral neuropathy with Qi - deficiency and collateral stagnation syndrome. Methods A randomized, positive drug parallel controled, multi -center clinical trial was adopted. The tested group was treated with TMG orally and the control group received Mikebao tablet orally. Treatment course of each group was 8 weeks. Results The marked effective rate and total effective rate on electromyogram was 60. 06 % and 68.47 % respectively in the tested group, and those on TCM Syndrome were 23.12 % and 90.99 % respectively. Non - inferiority test with the criterion of 15 % was conducted on the efficacy of electromyogram and TCM Syndrome, and the result showed statistical significant. Conclusion TMG has good efficacy and safety in treating diabetic peripheral neuropathy with Qi - deficiency and collateral stagnation syndrom.