尤瑞克林治疗急性缺血性脑卒中随机对照试验的系统评价  

Efficacy and Safety of Human Urinary Kallidinogenase Injection for Acute Ischemic Stroke:A Systematic Review

作　　者：张灿飞[1] 陶文丹[1] 刘鸣[1] 王德任[1] 

机构地区：[1]四川大学华西医院神经内科,成都610041

出　　处：《中国循证医学杂志》2012年第5期570-576,共7页Chinese Journal of Evidence-based Medicine

摘　　要：目的系统评价注射用尤瑞克林治疗急性缺血性脑卒中的疗效及安全性。方法采用Cochrane系统评价方法,通过电子检索、手工检索以及向药厂索要相关资料,全面收集尤瑞克林治疗急性缺血性脑卒中的中英文随机对照试验(RCT),检索时限截至2010年10月。由两名评价者独立评价并交叉核对纳入研究质量后,对同质研究采用RevMan 5.0.2软件进行Meta分析。结果共纳入24个RCT,2433例患者,其中2个为多中心、安慰剂对照试验,22个为非安慰剂对照试验。2个试验(459例)报告了随访3个月的死亡或依赖情况,尤瑞克林组死亡或依赖率较对照组下降[RR=0.69,95%CI(0.55,0.86)]。20个试验(2117例)报告了治疗结束时(7～21天)的改善率,Meta分析结果显示尤瑞克林组神经功能缺损评分有效率明显高于对照组,其差异有统计学意义[RR=1.56,95%CI(1.44,1.70),P<0.00001]。共15个研究报告了不良反应,一过性血压下降是主要不良反应(1.5%～5.1%);3个研究报告7例非致死性脑出血,尤瑞克林组6例(1.2%),对照组1例(0.4%),两组间差异无统计学意义[RR=1.82,95%CI(0.34,9.61),P=0.48]。2个研究报告了治疗期内发生3例死亡,尤瑞克林组2例(0.4%),对照组1例(1.1%),两组差异无统计学意义[RR=0.6,95%CI(0.09,3.92),P=0.60]。无研究报告生存质量。结论现有临床研究提示,注射用尤瑞克林能改善急性缺血性脑卒中患者神经功能缺损,有改善远期功能结局的趋势,但少数患者用药期间有一过性血压下降。受纳入研究质量限制,以上结论有待开展更多高质量随机对照试验予以验证。Objective To assess the efficacy and safety of human urinary kallidinogenase injection（HUK） in treating patients with acute ischemic stroke.Methods Through adopting Cochrane systematic review methods,the relevant materials were retrieved by electronically and manually searching databases and claimed from pharmaceutical factories,so as to collect the randomized controlled trials（RCTs） about HUK for the patients with acute ischemic stroke,which were searched by the end of October 2010.The quality of each trial was assessed by two reviewers independently,and meta-analysis was conducted by using RevMan 5.0.2 software.Results Twenty-four trials involving 2433 patients were included,of which 2 were multi-center placebo controlled trials,and the other 22 were all non-placebo trials.Only 2 trials（459 cases） reported the death or dependence at the end of 3-month follow-up.In those trials,HUK reduced death or dependency comparing to the control group（RR=0.69,95%CI 0.55 to 0.86）.Twenty trials（2117 patients） reported the proportion of patients with marked neurological improvement after finishing the 7 to 21 days treatment.Meta-analysis showed the HUK group had more neurological improvement than the control group,with significant differences（RR=1.56,95%CI 1.44 to 1.70）.Fifteen trials reported adverse events,of which the transient hypotension was commonly seen（1.5%-5.1%）.Non-fatal intracerebral hemorrhage was detected in 7 patients in 3 trials,but the difference between the HUK group（6 patients,1.2%） and the control group（1 patient,0.4%） was not significant（RR=1.82,95%CI 0.34 to 9.61）.Deaths occurred in both HUK group（2 patients,0.4%） and the control group（1 patient,1.1%） in 2 trials,without significant differences（RR=0.6,95%CI 0.09 to 3.92）.No trial assessed quality of life.Conclusion Available evidence suggests that HUK injection reduces neurological impairment after acute ischemic stroke and improves long-term outcomes,though a few patients suffer from transient hypotensio

关 键 词：尤瑞克林 人尿激肽原酶 急性缺血性脑卒中 随机对照试验 系统评价 

分 类 号：R743.3[医药卫生—神经病学与精神病学]