中药静脉制剂胸腔内注射治疗恶性胸腔积液的Meta分析

目的系统评价中药静脉制剂胸腔内灌注对恶性胸腔积液患者的临床疗效、生活质量、毒副反应的影响。方法检索Pubmed、中文生物医学文献数据库、中文科技期刊数据库等数据库,同时手检相关文献,以随机对照试验为研究对象,采用RevMan5.0软件进行Meta分析,采用优势比作为效应合并指标。结果至2009年12月,共纳入19个研究945例患者,中药静脉制剂组483例,单纯使用化疗药物462例。Meta分析显示中药静脉制剂胸腔内注射治疗恶性胸腔积液近期有效率更高(OR=1.79,95%CI1.33～2.41,P0.05)。10个研究比较了生活质量,显示中药静脉制剂组生活质量改善率更高(OR=3.98,95%CI2.63～6.02,P0.05)。19个研究比较了毒副反应,显示中药静脉制剂方案比单纯化疗方案在消化道反应、骨髓抑制、肝肾功能损害及脱发方面发生率更低。结论中药静脉制剂方案较单纯使用化疗药更有效,并能提高患者生存质量、减少毒副反应。鉴于纳入的研究质量较低,有必要进行更多设计严谨的多中心、随机对照试验。

Meta-Analysis of TCM injection In the treatment of malignant pleural effusion.

Objective To evaluate the effect,QOL and adverse reaction of TCM injection in the treatment of malignant pleural effusion. Methods We searched all the randomized controlled trials（RCTs） form Pubmed, Chinese Biomedical Database （CMB） by key words,We also hand-searched relevant joumals.Mate-analysis was conducted combining the odd ratios of the individual studies.RevMan5.0 was used in the analysis.Tesults 19 RCTs including 945 patienes were included for efficacy analysis.It was found that the efficacy rate in TCM group was significantly higher than that in control group（OR=1.79, 95%CI 1.33-2.41, P〈0.05）.10 RCTs showed that TCM group had significant efficacy compared with simple control group in quality of life（OR=3.98, 95%CI 2.63-6.02, P〈0.05）.19 RCTs were included for safety analysis,it was found that the rates of gastrointestinal upset and hypodynamia in TCM group were significantly lower than those in control group.Conclusion TCM might be beneficial in treatment of malignant pleural effusion,but its efficacy and safety need to be confirmed with high-quality randomized controlled trials.