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目的 评价人血白蛋白治疗肝硬化腹水的疗效与安全性. 方法 以“cirrhosis”、“ascites”、“albumin”、“randomized controlled trials”和“肝硬化”、“腹水”、“人血白蛋白”、“随机对照试验”为检索词,检索Cochrane图书馆、PubMed、EMBase、Web of Science、中国生物医学文献数据库、中国知网、维普数据库和万方数据库,收集用人血白蛋白治疗肝硬化腹水的随机对照试验并全文发表的论文.根据纳入标准对文献进行筛选和评估,采用RevMan 5.2软件进行统计分析,计算相对危险度(RR)和95％置信区间(CI).试验组静脉滴注人血白蛋白,对照组静脉滴注等容积0.9％氯化钠注射液或人工胶体液(如羟乙基淀粉、葡聚糖、聚明胶肽等)或不用药.比较试验组与对照组的疗效与安全性. 结果 共检索到相关文献688篇,筛选后最终纳入13篇,英文11篇,中文2篇,共1 152例患者.Meta分析结果显示,试验组低钠血症发生率(7.67％)低于对照组(14.66％),差异有统计学意义(RR =0.60,95％CI:0.41 ～0.88,P=0.008);试验组和对照组腹水消退率(91.67％比88.44％)、肾损伤发生率(5.12％比6.93％)、感染发生率(5.04％比4.93％)、肝性脑病发生率(5.90％比5.00％)、消化道出血发生率(2.57％比2.73％)、高钾血症发生率(1.09％比6.45％)、再住院率(52.15％比61.82％)、因腹水再住院率(38.68％比41.85％)、住院病死率(3.80％比4.54％)、总病死率(21.40％比24.83％)差异均无统计学意义(均P＞0.05).试验组与对照组不良反应发生率(3.13％比3.05％)差异无统计学意义(P=0.97). 结论 目前的研究未证明使用人血白蛋白与人工胶体液或晶体液治疗肝硬化腹水的疗效及安全性有明显差异.“,”Objective To evaluate the efficacy and safety of human serum albumin in treatment of patients with ascites due to cirrhosis.Methods Cochrane Library,PubMed,EMBase,Web of Science,CBM,CNKI,VIP,Wanfang Database were searched by using keywords “ascites”,“albumin”,“cirrhosis” and “randomized controlled trials”.The full text papers of randomized controlled trials (RCT) about human albumin treatment in patients with ascites due to cirrhosis were collected.The articles were selected and evaluated according to the inclusion criteria.The related information was statistically analyzed with RevMan 5.2 software,the relative risk (RR) and 95％ confidence intervals (CI) were calculated.The patients in experimental group received Ⅳ infusion of human serum albumin.The patients in control group received isotonic 0.9％ sodium chloride injection or artificial colloid (such as hetastarch,dextran,polygeline etc.) or no drugs.The efficacy and safety were compared between the 2 groups.Results A total of 688 related articles were searched and 13 RCT were enrolled into the study finally.There were 11 articles in English and 2 in Chinese.A total of 1 152 patients were entered in the study.The results of Meta-analysis showed that the incidence of hyponatremia in the experimental group (7.67％) was lower than that in the control group (14.66％),the difference was statistically significant(RR =0.60,95％ CI:0.41 ～ 0.88,P =0.008).The differences of the ascites regression rates (91.67％ vs.88.44％),the incidences of renal injury (5.12％ vs.6.93％),the incidences of infection (5.04％ vs.4.93％),the incidences of hepatic encephalopathy (5.90％ vs.5.00％),the incidences of hemorrhage of digestive tract (2.57％ vs.2.73％),the incidences of hyperpotassemia (1.09％ vs.6.45％),the rehospitalization rates (52.15％ vs.61.82％),the rehospitalization rates due to ascites (38.68％ vs.41.85％),the hospital mortality (3.80％ vs.4.54％),and the total mortality rates (21.40％ vs.24.83％) between the experimental group and the control group were not statistically significant (all P ＞ 0.05).The difference of incidence of adverse reactions between the experimental group and the control group (3.13％ vs.3.05％) was not statistically significant (P =0.97).Conclusion The present study can not demonstrate the obvious differences in curative effect and safety between the therapies of Ⅳ infusion of human serum albumin and artifical colloid or chloride in treatment of patients with ascites due to cirrhosis.