纳络酮治疗急性脑梗死的多中心、随机、双盲、对照研究

目的观察盐酸纳络酮对急性脑梗死的临床疗效及安全性。方法将8家医院150例急性脑梗死患者随机分为对照组、纳络酮治疗1组和纳络酮治疗2组,并进行多中心、随机、双盲、对照研究;各组用药前后均进行神经功能缺损评分,治疗30d和3个月分别进行Barthel指数评分,并观察药物副作用。结果对于脑梗死患者急性期神经功能缺损的改善,纳络酮治疗组均优于对照组,尤以治疗2组为明显(P<0.005),而且无明显副作用;3组间治疗30d和3个月的Barthel指数比较均无显著性差异。结论纳络酮有助于脑梗死的急性期治疗,改善临床症状,而且安全性较高。

Effects of naloxone hydrochloride on the acute ischemic stroke: a multi-center, randomized, doubel-blind, placebo-control trial

Objective To assess the efficacy and safety of naloxone hydrochloride in the treatment of acute ischemic stroke.Methods In this multi-center,randomized,double-blind,placebo-control study,all 150 acute ischemia patients from 8 centers were randomized into three groups:naloxone 1 group,naloxone 2 group and the control group.The national rating scale score(NRSS)was used at both baseline and the end of 10 days.At the end of 30 days and 3 months,we respectively used the scale of Barthel to assess the ability of daily living.Safety issues including vital signs were measured during the study.Results There was a significant difference between the treatment groups and the control group in NRSS.The clinical improvement in the naloxone 2 group was more significant(P< 0.005).No side effect was found.But the scale of Barthel of the three groups at the end of both 30 days and 3 months showed no significant difference.Conclusion Naloxone hydrochloride may be an effective and safe treatment for acute ischemic stroke in acute period.