中国人群予以不同剂量阿替普酶治疗急性缺血性脑卒中的Meta-分析

Meta-analysis of different doses of alteplase in treatment of acute ischemic stroke in Chinese population

目的系统评价中国人群分别予以标准剂量(0.9 mg/kg)和低剂量(0.6 mg/kg)阿替普酶治疗急性缺血性脑卒中的临床疗效和安全性,为临床提供循证医学证据。方法计算机检索EMbase、PubMed、中国生物医学文献数据库(CBM)、中国学术期刊全文数据库(CNKI)、维普中文科技期刊数据库(VIP)和万方数据库,收集急性缺血性脑卒中患者分别采用标准剂量和低剂量阿替普酶静脉溶栓的随机对照研究(RCT),检索时限均为建库—2018年3月,提取数据后采用RevMan 5.2软件进行Meta-分析。结果共纳入16个RCTs,1 745例患者。Meta-分析结果显示:标准剂量组在总有效率(RR=0.95,95%CI=0.92～0.99,P=0.01)、降低NIHSS评分(SMD=0.27,95%CI=0.14～0.40,P<0.001)、提高预后良好率(RR=0.85,95%CI=0.78～0.92,P=0.000 2)和降低脑出血率(RR=0.59,95%CI=0.38～0.92,P=0.02)方面均优于低剂量组,差异均有统计学意义(P<0.05),但是病死率(RR=1.23,95%CI=0.84～1.80,P=0.28)差异无统计学意义。结论现有证据表明,标准剂量阿替普酶静脉溶栓具有更好的临床疗效,但可能增加溶栓后脑出血的风险,临床医务人员应予以重点关注。

Objective To evaluate the clinical efficacy and safety of alteplase with standard dose(0.9 mg/kg)and low dose(0.6 mg/kg)in the treatment of acute ischemic stroke in Chinese patients,and provide the dvidence-based medical evidence for the clinic.Methods Randomized controlled trial(RCT)of standard dose and low dose of alteplase in the treatment of acute ischemic stroke in Chinese patients were searched from PubMed,EMbase,CBM,CNKI,VIP and WanFang Database by computer,data were collected from inception to March 2018.After extracting data,Meta-analysis was conducted by RevMan 5.2 software.Results A total of 16 RCTs and 1 745 patients were included.Meta-analysis showed that standard dose group were better than low dose group in improvomg total efficiency(RR=0.95,95%CI=0.92-0.99,P=0.01),reducing NIHSS score(SMD=0.27,95%CI=0.14-0.40,P<0.001),improving the rate of good prognosis(RR=0.85,95%CI=0.78-0.92,P=0.000 2),and reducing the incidence of cerebral hemorrhage(RR=0.59,95%CI=0.38-0.92,P=0.02),the differences were all statistically significant(P<0.05),but there was no statistically significant difference in mortality rate(RR=1.23,95%CI=0.84-1.80,P=0.28).Conclusion The results of this study shows that,alteplase with standard dose intravenous thrombolysis has better clinical efficacy,but may increase the risk of intracerebral hemorrhage after thrombolysis.Clinical medical personnel should pay attention to it.