两种前列地尔注射液治疗糖尿病下肢动脉闭塞症的等效性和安全性比较研究

Evaluate of the Equivalence and Safety of Two Dosage Form of Alprostadil Injection in Patients with Diabetic Lower Extremity Arterial Occlusive Disease by a Clinical Multi-Centre Trial

目的:观察2种前列地尔注射液在治疗糖尿病下肢动脉闭塞症(糖尿病足)的等效性和安全性。方法:采用随机双盲、阳性药平行对照、多中心临床研究。试验组使用前列地尔脂微球注射液,对照组使用前列地尔注射液。疗程均为14 d。结果:随机入组235例受试者。对照组入选117人,试验组118人。主要疗效指标中踝肱比值,全分析数据集(full analysis set,FAS)人群组内比较:两组治疗14 d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14 d后对照组提高0.09;试验组提高0.10,两组间无统计学意义,符合方案数据集(per-protocol set,PPS)人群结果趋势和FAS一致。两组治疗14 d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19.33%;试验组为17.65%。相关不良事件对照组10.08%;试验组为8.4%;差别无统计学意义。结论:2种前列地尔注射液在治疗慢性下肢动脉闭塞性疾病的过程中,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 (LEAOD). Methods: It was a random, blind, multicentre and controlled clinical pharmaceutical trial. All subjects were divided into two groups and each of group. The test and reference preparations of alprostadil injections by different companies were given via the same administration route. Results: Eight hospitals in China and 235 volunteers were involved in the study, and 117 patients received the reference preparation and 118 received the test preparation. The ankle brachial index of both groups increased significantly after 14 days of treatment and the rest pain decreased, while there was no significant difference between the two groups. The adverse drug reaction rate of the reference preparation was 19.33% and that of the test was 17.65%, no significant difference was found between the two groups on adverse drug reaction. Conclusion: The test preparation showed the same effect and safety in patients with diabetic LEAOD as the reference preparation.