摘要
目的本试验旨在观察种市售前列地尔注射液在治疗下肢慢性动脉闭塞症的等效性和安全性。方法采用随机盲法、阳性药平行对照、多中心临床研究。试验组使用A药,对照组使用已上市B药。疗程均为14d。结果本试验共有7家医院参与,随机入组217例受试者。对照组入选110人,试验组107人。主要疗效指标中踝肱比值,全分析集(fullanalysisset,FAS)人群组内比较两组治疗14d后踝肱比值均较基线时有所提高,且有统计学意义。组间比较:治疗14d后对照组提高0.09;试验组提高0.08,两组间无统计学意义,符合方案集(per-protocolset,PPS)人群结果趋势和FAS一致。两组治疗14d后静息痛均较基线时有所下降,且有统计学意义,组间比较无统计学差异,PPS人群结果趋势和FAS一致。最大无痛行走距离在两组间无统计学意义,PPS结果和FAS一致。全部不良事件发生率对照组为34.86%;试验组为30.84%。相关不良事件对照组6.42%;试验组为8.41%。差别无统计学意义。结论临床验证表明,2种前列地尔注射液在治疗慢性下肢缺血性疾病的过程中,表现出相同的疗效和安全性。
OBJECTIVE To compare the equivalence and safety between reference preparation and test preparation of alprostadil injection in patients with chronic lower extremity arterial occlusive disease. METHODS It was a random, blind, multicentre and control clinical pharmaceutical trial. All subjects were divided into two groups and each of group. The test and reference preparations of alprostadil injection by different companies were given via same administration route. RESULTS 7 hospitals in China and 217 volunteers were involved in the study. 110 patients received the reference preparation and 107 received test preparation. The ABI of both groups increased significantly after 14 days of treatment and the rest pain decreased. There was not significant different between two groups. The adverse drug reaction rate of reference preparation was 34.86% and the other was 30.84%. No significant different was found between two groups on adverse drug reaction. CONCLUSION The test preparation showed the same effect and safety in patients with peripheral artery occlusive disease as the reference preparation.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2009年第17期1350-1353,共4页
Chinese Pharmaceutical Journal
关键词
前列地尔注射液
慢性下肢缺血性疾病
alprostadil injection
chronic lower extremity ischemic disease
