目的:系统评价重组改构人肿瘤坏死因子(rmhTNF)对比顺铂胸腔灌注治疗恶性胸腔积液的疗效和安全性.方法:计算机检索PubMed、Cochrane图书馆、Web of Science、中国期刊全文数据库、万方数据库、中国科技期刊数据库、中国医学生物文献数据库,纳入rmhTNF(试验组)对比顺铂(对照组)胸腔灌注治疗恶性胸腔积液的随机对照试验(RCT),提取资料并按照Cochrane系统评价员手册5.3.0评价质量后,采用Rev Man 5.3统计软件对数据进行Meta分析.结果:共纳入7项RCT,合计478例患者.Meta分析结果显示,试验组患者临床总有效率[RR=1.43,95%CI(1.27,1.62),P<0.001]显著高于对照组,差异有统计学意义;试验组患者胃肠道反应[RR=1.15,95%CI(0.73,1.80),P=0.55]、胸痛[RR=1.12,95%CI(0.73,1.73),P=0.60]、发热[RR=0.62, 95%CI(0.35,1.08),P=0.09]、骨髓抑制[OR=0.94,95%CI(0.57,1.54),P=0.79]发生率与对照组比较,差异均无统计学意义.结论:rmhTNF胸腔灌注治疗恶性胸腔积液疗效显著优于顺铂,胃肠道反应、胸痛、发热、骨髓抑制等毒副反应的发生率与顺铂相当.%OBJECTIVE:To systematically evaluate therapeutic efficacy and safety of recombinant mutant human tumor necrosis factor(rmhTNF)versus pleural perfusion of cisplatin in the treatment of malignant pleural effusions,and to provide evidence-based reference in clinic. METHODS:Retrieved from PubMed,Cochrane Library,Web of Science,CJFD,Wanfang database,VIP and CBM,RCTs about rmhTNF(trial group)vs. cisplatin(control group)in the treatment of malignant pleural effusions were included. Meta-analysis was conducted by using Rev Man 5.3 statistical software after quality evaluation and data extraction with Cochrane system evaluator manual 5.3.0. RESULTS:A total of 7 RCTs were included,involving 478 patients. Meta-analysis showed that clinical total response rate of trial group [RR=1.43,95%CI(1.27,1.62),P<0.001] was significantly higher than that of control group,with statistical significance. There was no statistical significance in the incidence of gastrointestinal reaction[RR=1.15,95%CI(0.73,1.80),P=0.55],chest pain[RR=1.12,95%CI(0.73,1.73),P=0.60],fever[RR=0.62,95%CI(0.35,1.08),P=0.09] and myelosuppression[OR=0.94,95%CI(0.57,1.54),P=0.79] between trial group and control group. CONCLUSIONS:Pleural perfusion of rmhTNF is significantly better than cisplatin in the treatment of malignant pleural effusions. The incidences of gastrointestinal reaction,chest pain,fever and myelosuppression induced by rmhTNF were similar to those induced by cisplatin.
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