摘要
目的系统评价丁苯酞制剂治疗急性缺血性卒中的疗效和安全性。方法通过计算机检索、手工检索及向药厂索取资料,全面收集丁苯酞制剂治疗急性缺血性卒中的随机对照试验(RCT),按Cochrane协作网系统评价的方法进行评价。结果共纳入21个试验(2123例患者),包括2个安慰剂对照试验和19个非安慰剂对照试验。10个采用CSS评估神经功能缺损试验(958例)的Meta分析结果显示,丁苯酞组神经功能改善优于对照组[MD=2.30,95% CI(1.57,3.03)];6个采用NIHSS评估神经功能缺损试验(590例)的Meta分析结果亦显示,丁苯酞组神经功能改善优于对照组[MD=2.06,95%CI(0.65,3.46)]。共13个试验报道了药品不良事件,主要是肝功能异常(ALT异常1.4%～17.5%、AST异常1.9%～8.82%)和胃肠道不适(1.7%～8%),无严重不良事件发生。试验结束时均无死亡。21个试验均未采用病死率或依赖率作为结局指标,未进行生存质量评价。结论本系统评价结果提示丁苯酞软胶囊能有效改善急性缺血性卒中患者的神经功能缺损,且不良反应少,未见严重不良反应。丁苯酞降低缺血性卒中远期死亡和残疾的效果还需要进一步研究。
Objectives To assess the efficacy and safety of dl-3-butylphthalide for patients with acute ischemic stroke.Methods We collected randomized controlled trials,which compared dl-3-butylphthalide agents with placebo or open control in patients with acute ischaemic stroke,by searching the electronic bibliographic databases,scanning references listed in articles and handsearching journals.Meta-analysis was conducted based on the methods recommended by the Cochrane Collaboration.Results Twenty-one trials involving 2 123 patients were included,of which 2 were placebo-controlled and 19 were open-label controlled.Meta-analysis of 10 trials（n=958）,in which neurological de cits were assessed by CSS,suggested that there were significant differences favoring butylphthalide in the mean change of neurological deficits＇ score during the treatment period [MD=2.30,95% CI（1.57,3.03）].Meta-analysis of 6 trials（n=590）,in which neurological de cits were assessed by NIHSS,also favored butylphthalide [MD=2.06,95%CI（0.65,3.46）].Adverse events（AEs） were reported in 13 trials.Gastrointestinal discomfort（1.7%～8%） and abnormal liver function including abnormal ALT（1.4%～17.5%） and abnormal AST（1.9%～8.82%） were the two most common AEs.However,no severe adverse events（SAEs） were reported.Numbers of dead and dependent patients at the end of followup（at least three months） were not reported in the 21 included trials.Quality of life was not assessed in any of the trials.Conclusion Dl-3-butylphthalide can improve the neurological function after acute ischemic stroke and appears to be safe.However,further study is needed to confirm its effiects for lowering rates of death and dependency.
出处
《中国循证医学杂志》
CSCD
2010年第2期189-195,共7页
Chinese Journal of Evidence-based Medicine
关键词
丁苯酞
脑梗死
META分析
系统评价
随机对照试验
D1-3-butylphthalide
Acute ischemic stroke
Meta-analysis
Systematic review
Randomized controlled trial
