人血白蛋白治疗急性缺血性脑卒中疗效及安全性系统评价

摘要

Objective To evaluate efficacy and safety of human serum albumin in the treatment of acute ischemic stroke.Methods Retrieved from PubMed, Web of Science, The Cochrane Library, Clinical Trials, CNKI and Wanfang database.Randomized controlled trials (RCTS) about human serum albumin in acute ischemic stroke were collected.The quality of RCTs was evaluated by Cochrane System Evaluator Manual 5.1.0.The 14-day NIHSS score, 14-day and 90-day efficiencyand the incidence of adverse reactionswere analyzed by Meta-analysis with Rev Man 5. 3 statistical software.Results A total of 8 RCTs were includedwith 1946 patients.The National Institutes of Health Stroke Scale at 14 days (MD =-2. 74, 95％ CI-3. 89-0. 16, Z = 4. 7, P＜0. 000 01) and response rate at 14 days (OR = 2. 73, 95％ CI 1. 77-4. 22, Z = 4. 55, P ＜ 0. 000 01) in trial group were significantly better than control group, but there was no statistical difference in the response rate at 90 days (OR = 1. 85, 95％ CI 0. 76-4. 6, Z = 1. 36, P = 0. 18).The incidence of Pulmonary edema/Congestive heart failure within 48h (OR = 6. 43, 95％ CI 4. 83-30. 84, Z = 6. 27, P＜0. 000 01) in trial group was significantly higher than control group.Conclusion The effectiveness of HSA in the treatment of acute ischemic stroke needs more clinical trialsbased on NIHSS scores, time of HSA administration, and dose of HSA; the major adverse effect of human serum albumin is pulmonary edema/congestive heart failure.%目的 系统评价人血白蛋白(human serum albumin,HSA)治疗急性缺血性脑卒中的疗效及安全性.方法 计算机检索PubMed、Web of Science、The Cochrane Library、Clinical Trials、CNKI及万方数据库,收集HSA治疗急性缺血性脑卒中的随机对照试验,提取资料并采用Cochrane系统评价员手册5.1.0进行质量评价后,采用Rev Man5.3系统软件对14 d美国国立卫生研究院卒中量表(NIHSS)评分、14 d和90 d有效率以及不良反应发生率等指标进行Meta分析.结果 共纳入8项RCT,共1 946例患者.试验组14 d NIHSS评分(MD=-2.74,95％CI-3.89～-0.16,Z=4.7,P＜0.000 01)、14 d有效率优于对照组(OR=2.73,95％CI 1.77～4.22,Z=4.55,P＜0.000 01),而2组90 d有效率差异无统计学意义(OR=1.85,95％CI 0.76～4.6,Z=1.36,P=0.18).试验组48 h肺水肿或充血性心力衰竭发生率高于对照组(OR=6.43,95％CI 4.83～30.84,Z=6.27,P＜0.000 01).结论HSA治疗急性缺血性脑卒中的整体有效性需要根据NIHSS评分、HSA给药时机以及HSA剂量等进行随机对照试验进一步证实,不良反应主要表现为肺水肿或充血性心力衰竭.