CAJ | 학술논문

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(2 123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.
목적 계통평개정분태제제치료급성결혈성졸중적료효화안전성.방법 통과계산궤검색、수공검색급향약엄색취자료,전면수집정분태제제치료급성결혈성졸중적수궤대조시험(RCT),안Cochrane협작망계통평개적방법진행평개.결과 공납입21개시험(2 123례환자),포괄2개안위제대조시험화19개비안위제대조시험.10개채용CSS평고신경공능결손시험(958례)적Meta분석결과현시,정분태조신경공능개선우우대조조[MD=2.30,95%CI(1.57,3.03)];6개채용NIHSS평고신경공능결손시험(590례)적Meta분석결과역현시,정분태조신경공능개선우우대조조[MD=2.06,95%CI(0.65,3.46)].공13개시험보도료약품불량사건,주요시간공능이상(ALT이상1.4%～17.5%、AST이상1.9%～8.82%)화위장도불괄(1.7%～8%),무엄중불량사건발생.시험결속시균무사망.21개시험균미채용병사솔혹의뢰솔작위결국지표,미진행생존질량평개.결론 본계통평개결과제시정분태연효낭능유효개선급성결혈성졸중환자적신경공능결손,차불량반응소,미견엄중불량반응.정분태강저결혈성졸중원기사망화잔질적효과환수요진일보연구.
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 deficits 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 deficits 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 D1-3-butylphthalide can improve the neurological function after acute ischemic stroke and appears to be safe.However,further study is needed to confirm its effects for lowering rates of death and dependency.