Objective To provide important reference for clinical rational drug use and scientific decision based on the systematic review of efficacy and safety of elemene injection combining with routine chemotherapy drugs in treating malignant serous effusions.Methods Papers and data of randomized controlled clinical trials (RCT) of elemene injection combining with routine chemotherapy drugs for malignant serous effusions published from Jan.1996 to Feb.2017 were retrieved by computer from the following databases:WanFang Data Knowledge Service Platform,China National Knowledge Infrastructure and Full-text database of Chinese Sci & Tech Journals.The quality of materials was under assessment of Juni evaluation standards and Cochrane system evaluation method.Revman 5.0 software was used for Meta analysis and funnel analysis was used to evaluate publication bias.Results Seven hundred and thirty papers were searched preliminarily and 22 RCTs (1288 subjects) were bring to meta-analysis.In which overall response rate (RR=1.42,95％ CI:1.25-1.60;P＜ 0.01) and quality of life improvement rate (RR =2.08,95％ CI:1.76-2.47;P＜ 0.01) of combining group (elemene combining with chemotherapy) were significantly better than control group (only chemotherapy).Compared with control group,the incidence of gastrointestinal reactions,myelosuppression and hepatic and renal impairment in combining group were obviously decreased,however,the incidcnce of fever reaction increased markedly.There was no significant difference of chest pain rate between the two groups (29.79％ vs.22.27％) after intrapleural therapy (RR =1.37,95％CI:0.96-1.96;P=0.08).The Juni quality evaluation standard showed that the RCT quality evaluation was only in B and C and the GRADE system's evidence quality was intermediate.Funnel analysis did not show any publication bias.Conclusion Elemene injection combining with chemotherapy drugs may have significant synergies effect.It is a good therapy choice for malignant serous effusions with the better safe as well as efficacy,improving the life quality and tolerability of the patients However,in view of the limitation of scientific research level at that time,the quality of original literatures included in this research are a little bit lower.Therefore the large-scale and high quality clinical researches including RCT or real world study (RWS) should be carried out to acquire further strong and more high evidence to support conclusion of this Meta analysis.%目的 系统评价榄香烯乳注射液联合常规化疗药物治疗恶性浆膜腔积液的有效性和安全性,为临床合理用药及科学决策提供重要的参考依据.方法 通过计算机检索万方数据知识服务平台、维普中文科技期刊数据库(VIP)和中国知网(CNKI),收集1996年1月至2017年2月间发表的有关榄香烯乳注射液联合常规化疗药物治疗恶性浆膜腔积液的临床随机对照试验(RCT),按照Juni 4条质量评价标准和Cochrane系统评价方法,纳入符合要求的RCT,并对其数据进行质量评价,采用RevMan 5.0版统计软件进行Meta分析,以漏斗图分析发表偏倚情况.结果 初步检索相关研究文献730篇,共纳入符合纳入标准的RCT 22项,合计1288例患者.Meta分析结果显示,榄香烯乳联合常规化疗组(联合组)患者的总有效率(RR=1.42,95％CI:1.25～1.60,P＜0.01)和生活质量改善率(RR=2.08,95％CI:1.76～2.47,P＜0.01)均显著高于单纯化疗组(对照组);联合组的胃肠道反应、骨髓抑制和肝肾功能损害的发生率均显著低于对照组,但是发热的发生率明显升高,而胸腔内给药后两组胸痛发生率分别为29.79％和22.27％,差异无统计学意义(RR=1.37,95％CI:0.96～ 1.96,P=0.08).Juni质量评价标准显示,纳入的RCT质量评价仅为B级或C级,GRADE系统证据质量评价均为中级;但漏斗图显示纳入的RCT无明显发表偏倚.结论 榄香烯乳注射液联合常规化疗药物治疗恶性浆膜腔积液,能够显著地协同增效,具有较好的临床疗效,且减轻了大剂量单药灌注化疗引发的胃肠道反应、肝肾功能损伤及骨髓抑制等不良反应,同时可以提高患者的生活质量,安全性和耐受性好,因此,可以作为临床上治疗恶性浆膜腔积液的一种优选方案.但是,鉴于受到当时医学科学发展和研究水平的局限性,纳入的RCT质量不高,本Meta分析的结论尚需进一步证明,建议开展大样本的、高质量的RCT和/或真实世界研究(RWS),以获得更充分的、高级别的循证医学证据加以支持.
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