前列地尔注射液治疗下肢动脉硬化闭塞症的临床研究..doc

前列地尔注射液治疗下肢动脉硬化闭塞症的临床研究 摘 要 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。 关键词 前列腺素el 下肢动脉硬化闭塞症 药物治疗 clinical study on alprostadil injection for limb arterial stenosis huang xiao-zhong1，zhang ji-wei1，guo da-qiao2，li jian-xin3， chen zhong4，jin bi5，zheng qi6，huang jian-hua7，han ping8 （1. department of vascular surgery，renji hospital of shanghai affiliated to school of medicine，shanghai jiao tong university，shanghai，200001；2. department of vascular surgery，zhongshan hospital of shanghai affiliated to school of medicine，fudan university，shanghai，200032；3. department of vascular surgery， xuanwu hospital of beijing affiliated to the capital medical university，beijing，100053；4. department of vascular surgery，anzhen hospital of beijin affiliated to the capital medical university，beijing，100029；5. department of vascular surgery，xiehe hospital of wuhan affiliated to tongji medicine school，huazhong university of science and technology，wuhan，430074；6. department of general surgery，shanghai sixth people’ s hospital of shanghai，shanghai，200233；7. department of general surgery，xiangya hospital of changsha affiliated to the zhongnan university，changsha，410008；8. department of general surgery， shengjing hospital of shenyang affiliated to the chinese medical university，shenyang，110004） abstract 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