目的:系统评价榄香烯治疗恶性腹水疗效与安全性,为临床提供循证参考。方法:检索CNKI、万方数据库、维普数据库、CBM、PubMed、Web of science,查找榄香烯治疗用于恶性腹水的随机对照临床试验(RCT),对符合纳入标准的研究进行资料提取,采按纳入排除标准选择文献、提取数据、评价文献质量,采用Rev Man 5.3统计软件进行Meta分析。结果:共纳入7项RCT,合计339例患者;Meta分析结果有效性显示,试验组患者的近期有效率[OR=1.78,95%CI(1.07,2.95),P<0.01]显著高于单纯化疗组;安全性显示试验组患者的骨髓抑制发生率[OR=0.05,95%CI(0.01,0.20),P<0.01]和胃肠道反应发生率[OR=0.05,95%CI(0.02,0.12),P<0.01]均低于对照组水平,但是发热发生率高于对照组发生率[OR=3.97,95%CI(1.82,8.67),P<0.01],且局部疼痛反应发生率与对照组未见差异[OR=3.03,95%CI(0.71,12.96),P<0.05]。结论:榄香烯治疗恶性腹水具有较好疗效,同时还可以降低化疗引起的胃肠道不良反应和骨髓抑制的毒副作用,但榄香烯有导致发热的风险,应结合患者的具体情况使用。
Objective:To provide an evidence-based reference for clinic by systematically evaluating the curative effect and safety of elemene for malignant ascites.Methods:Searched databases as CNKI,Wanfang Database,VIP Database,CBM,PubMed and web of science,for randomized controlled trials(RCT)of elemene for malignant ascites and extracted data of studies accorded with the inclusion criteria.Selected literature,extracted data and evaluated quality of literature according to the inclusive and exclusive criteria.The meta-analysis was conducted via RevMan 5.3 statistical software.Results:Seven pieces of RCT literature were included,339 cases of patients in total.The effectiveness of the meta-analysis results showed that the short term effective rate of patients in the experiment group[OR=1.78,95%CI(1.07,2.95),P<0.01]was significantly higher than that in the chemotherapy group.Safety showed that the myelosuppression incidence[OR=0.05,95%CI(0.01,0.20),P<0.01],and the gastrointestinal reaction rate[OR=0.05,95%CI(0.02,0.12),P<0.01]of patients in the experiment group were lower than those in the control group,while the fever incidence was higher than that in the control group[OR=3.97,95%CI(1.82,8.67),P<0.01]and no significant difference was found in the comparison of the local pain reaction incidence between the experiment group and the control group[OR=3.03, 95%CI(0.71, 12.96),P<0.05].Conclusion:Elemene has significant effect in treating malignant ascites,which also can reduce adverse reactions of gastrointestinal caused by chemotherapy and reduce toxic and side effects of myelosuppression.However,elemene has the risk of causing fever so it should be used according to the specific condition of patients.