复方中风醒脑口服液干预急性脑出血治疗时间窗的临床研究

Clinical study on the therapeutic time window of acute intracerebral hemorrhage treated with herbal composition of Zhongfengxingnao taken orally

目的研究急性脑出血(AICH)可能存在的治疗时间窗及中药复方中风醒脑口服液(ZFXN)的干预作用。方法按照接受治疗时间,分层合并分析1988～2003年两个设计良好的随机对照临床试验资料共368例急性脑出血患者,分为治疗组(181例)及对照组(187例)。治疗组服用中药复方中风醒脑口服液,30ml/次,1次/6h,口服或鼻饲;对照组使用中药安慰剂。选用患者发病0～6h,6～24h,24～48h及48～72h4个时间段,疗效评价终点选用治疗后30、60、90d的病死率、神经功能缺失评分(NIHSS)、格拉斯哥量表(GOS)评分及Barthel指数(BI)。结果在0～72h的时间窗内,ZFXN可以降低AICH患者30、60d的病死率,改善90d的生活能力。在48～72h的时间窗内,ZFXN可以降低AICH患者60d病死率,改善90d生活能力。不同的治疗时间窗对治疗的结局无显著影响(P>0.05)。结论①在设计AICH临床方案时,72h是可以接受的时间窗。②ZFXN在48～72h的时间窗内,可以降低AICH患者60d病死率,改善90d生活能力。

Objective To explore the possibly existed therapeutic time window of acute intracerebral hemorrhage (AICH)treated with Zhongfengxingnao(ZFXN)taken orally. Methods From 1988~2003, 368 case with acute intracerebral hemorrhage were divided into treatment and placebo control groups. sub-groups were divided according to the time from onset to the initial treatment into 0~6 h, 6~24 h, 24~48 h, and 48~72 h groups. The therapeutic effect was evaluated according to the Glasgow Coma Scale (GCS), National Institute of Health Stroke Scale (NIHSS). mortality rate, Glasgow Outcome Scale (GOS)and Barthel Index (BI). Results In the time window from 0~72 h, ZFXN can reduce the mortality rate at 30 and 60 d, improve the BI at 90 d. In the time window from 48~72 h, ZFXN can ruduce the mortality rate at 60 d, improve the BI at 90 d. Conclusion ①72 h is the acceptable therapeutic time window for ZFXN treatment. ②ZFXN can reduce the mortality rate at 60 d and improve the BI at 90 d.