前列地尔注射液治疗下肢动脉硬化闭塞症的临床研究

Clinical study on alprostadil injection for limb arterial stenosis

目的:以前列地尔注射液(商品名:凯时,北京泰德制药有限公司生产)为阳性对照药物,评价上海福达制药有限公司生产的前列地尔注射液治疗下肢动脉硬化闭塞症的疗效与安全性。方法:全国8家医院采用随机、双盲、阳性药平行对照研究,观察试验组(前列地尔,114例)、对照组(凯时,110例)在综合疗效、间歇性跛行、静息痛、踝肱指数值的改善以及不良事件发生情况。结果:试验组总有效率为87.50%,对照组为85.45%。两组不良事件的发生率、严重程度以及与药物的相关性之间的比较,差异均无统计学意义(P>0.05)。结论:前列地尔与凯时治疗下肢动脉硬化症的有效性与安全性无差异。

Objective：To determine the efficacy and safety of prostaglandin E1,Liple injection for treatment of patients with arteriosclerosis obliterans（ASO）.Methods：The results of treatment were evaluated by comparison of Liple with another similar product＂Kaishi＂.A randomized,double-blind,positive-controlled parallel control study was designed to treat patients with ASO in 8 hospitals and patients were divided two groups,one for observation with 114 patients and the other for control with 110 patients.The comprehensive efficacy and the improvement in claudication,rest pain and ABI value were observed.Results：Total effective rate was 87.50%in observation group compared with 85.45%in control group.There was no difference in efficacy and safety between two groups.Conclusions：Both injections were safe and effective,could relieve pain and improve the walking capacity of patients without intolerable adverse effects.