灵异胶囊防治早期糖尿病性周围神经病变临床研究

目的观察灵异胶囊治疗早期糖尿病性周围神经病变的临床有效性和安全性。方法采用多中心、随机、盲法对照的方法,将206例患者分为治疗组（n=107）和对照组（n=99）。对照组给予降血糖、降血压基础治疗及弥可保口服,治疗组给予基础治疗及灵异胶囊口服,两组均治疗8周。采用简化McGill疼痛量表进行疼痛综合评定、神经电生理检测。结果治疗组总有效率为82.24%,对照组为76.77%,差异无统计学意义（P〉0.05）。治疗组疼痛综合评分下降,且低于对照组（P〈0.05）。两组均未有不良事件发生。结论灵异胶囊能有效改善糖尿病性周围神经病变症状。

Effects of ＂Lingyi Capsule＂ on Early Diabetic Peripheral Neuropathy： A Randomized Controlled Multi-center Double-Blind Clinical Trial

Objective To evaluate the efficacy and safety of＂Lingyi Capsule＂on patients with diabetic peripheral neuropathy.Methods 206 patients were included in a randomized controlled multi-center double-blind clinical trial.These participants were randomized into two groups;treatment group in which 107 cases were treated with＂Linyi Capsule＂and control group in which 99 cases were treated with Methylcobalamin;both groups accepted the treatments to control the blood glucose and blood pressure as much as possible.The short-form pain questionnaire and nerve conduction velocity were assessed.Results The total effective rate was 82.24%in treatment group,76.77%in control group（P〉0.05）.The effect in alleviating the pain was better in treatment group than in the control group（P〈0.05）.No severe side-effect was observed during clinical trial.Conclusion＂Linyi Capsule＂is effective and safe in improving diabetic peripheral neuropathy.