摘要
目的:评价前列地尔脂微球载体制剂治疗急性缺血性卒中的疗效及安全性。方法:发病1周内的76例急性脑梗死患者随机分为试验组和对照组,每组各38例。试验组接受前列地尔脂微球载体制剂治疗,对照组接受低分子右旋糖苷加丹参注射液治疗。疗程14 d。主要疗效评价指标为d 21的躯体日常生活活动能力Barthel指数(BI),BI>95分定义为良好预后。次要疗效评价指标为d 21欧洲卒中神经功能评分(ESS)。安全性评价指标为血小板聚集率、凝血时间、纤维蛋白原、D-Dimer、血脂和不良反应。结果:试验组和对照组预后良好率分别为26.3%与2.6%(P=0.007)。试验组和对照组ESS改善的总有效率为47.37%与21.05%(P=0.016)。治疗期间血小板聚集功能下降明显,试验组比对照组下降明显(P<0.05)。试验组与对照组不良反应发生率分别为7.89%与5.26%(P>0.05)。结论:前列地尔脂微球载体制剂治疗急性脑梗死安全性好,有一定疗效。
Objective： To evaluate the efficacy and safety of liposomal prostaglandin E1（Lipo-PGE1） for the treatment of ischemic stroke.Methods： The patients with ischemic stroke within 7 days were randomized into 2 groups.They were treated with Lipo-PGE1 daily or with Dextran 40 and Danshen injection daily（control）.The primary end point was disability at 21 days,dichotomized as a favorable outcome（a score of 100 or 95 on the Barthel Index） or an unfavorable outcome（a score of 0 to 90 on the Barthel Index）.The secondary end point was the improvement of the European Stroke Scale.Safety end points included platelet aggregation,clotting time,fibrinogen,D-Dimer,lipid and other adverse events.Results： We enrolled a total of 78 patients in the study and randomly assigned 38 to Lipo-PGE1 group and 38 to control group.More patients had a favorable outcome in Lipo-PGE1 group than in control group（26.3% vs 2.6%;P=0.007）.In the analysis of the European Stroke Scale,the outcome was also improved after Lipo-PGE1 as compared that after control treatment（47.37% vs 21.05%;P=0.016）.The platelet aggregation was suppressed when the patients was treated with Lipo-PGE1.The adverse events did not differ significantly between Lipo-PGE1 group and control group（7.89% and 5.26%;P=0.671）.There was no significant difference in the rate of other safety end points.Conclusion： Lipo-PGE1 can significantly improve clinical outcomes in our patients with acute ischemic stroke;it is safe in the patients.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2011年第20期1993-1997,共5页
Chinese Journal of New Drugs
关键词
缺血性卒中
前列地尔
脂微球
血小板聚集
ischemic stroke
prostaglandin E1
liposomal
platelet aggregation
