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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 observe the equivalence and safety of two kinds of alprostadil injection in the treatment of diabetic lower extremity arterial occlusive disease (diabetic foot). Methods: Randomized double-blind, positive drug parallel control, multicenter clinical study. The test group used alprostadil microspheres injection, the control group used alprostadil injection. The course of treatment was 14 days. Results: 235 subjects were randomly enrolled. The control group of 117 selected, the experimental group of 118 people. The main efficacy indicators in the ankle and brachial ratio, full analysis set (FAS) within the group of patients: the 14th day after treatment, the ankle-brachial ratio was increased from baseline, and statistically significant. Comparison between groups: The control group increased by 0.09 after 14 days of treatment; the experimental group increased by 0.10, and there was no significant difference between the two groups. The trend of the results in accordance with the per-protocol set (PPS) was consistent with FAS. Resting pain in both groups after 14 days of treatment was lower than that at baseline, and there was statistical significance. There was no significant difference between the two groups. The trend of PPS population was consistent with that of FAS. The maximum painless walking distance was not statistically significant between the two groups, PPS results were consistent with FAS. The incidence of all adverse events in the control group was 19.33%; the experimental group was 17.65%. The related adverse events were 10.08% in the control group; 8.4% in the experimental group; the difference was not statistically significant. Conclusion: The two kinds of alprostadil injection in the treatment of chronic lower extremity arterial occlusive disease process, showed the same efficacy and safety.