参芪扶正注射液对恶性肿瘤增效减毒作用的系统评价  

Systematic Review on Efficacy Enhancing and Toxicity Reducing Functions of Shenqifuzheng Injection in Patients with Malignant Tumors

作　　者：张硕[1] 张莉[1] 商洪才[1,2] 

机构地区：[1]天津中医药大学循证医学中心,天津300193 [2]天津中医药大学中医药研究院

出　　处：《中国执业药师》2012年第12期17-24,共8页China Licensed Pharmacist

基　　金：教育部新世纪优秀人才计划(NCET-09-0900)

摘　　要：目的:评价参芪扶正注射液联合放疗或化疗治疗恶性肿瘤的增效减毒作用。方法:计算机检索万方数据库、中国学术期刊全文数据库(CNKI)、中文科技期刊数据库(VIP)、中国生物医学文献服务系统(SinoMed),全面搜集参芪扶正注射液治疗恶性肿瘤的随机对照试验(RCTs),按照Cochrane协作网推荐的方法评价纳入研究的方法学质量并提取有效数据,应用RevMan5软件对符合要求文献进行汇总分析。结果:符合纳入标准的文献共16篇,共计1539例,其研究质量均为C级。Meta分析结果显示:相比于常规放疗、化疗,参芪扶正注射液联合放疗、化疗能提高放疗、化疗的近期疗效[优势比(OR)=2.11,95%可信区间(CI)为(1.71,2.60),P<0.00001]、改善生活质量[OR=3.07,95%C(I2.15,4.39),P<0.0001]、减轻骨髓抑制(白细胞降低)[OR=0.33,95%C(I0.24,0.47),P<0.00001]、血红蛋白减少[OR=0.35,95%C(I0.22,0.57),P<0.00001]、血小板减少[OR=0.48,95%C(I0.31,0.73),P=0.0007])、降低毒副反应(恶心呕吐)的发生率[OR=0.21,95%C(I0.13,0.34),P<0.00001],差异有统计学意义。结论:恶性肿瘤患者放疗、化疗过程中应用参芪扶正注射液能起到良好的增效减毒作用,但本研究纳入的RCTs均属低质量文献,且漏斗图分析显示左右不对称,提示存在发表偏倚,本文结论有待高质量临床研究进一步证实。Objective： To assess the efficacy enhancing and toxicity reducing functions of shenqifuzheng injection in chemotherapy or radiotherapy of the patients with malignant tumors. Methods： The clinical data of randomized controlled trials （RCTs） in the treatment of malignant tumors with shenqifuzheng injection were searched fi＇om Wanfang database, CNKI, VII＇ and SinoMed. The quality of inclusion criteria according to the Cochrane Collaboration＇s recommended method was assessed and the effective data extracted. RevMan5 software was used to summarize and analyze the effective literature. Results： There were 16 papers meeting the inclusion criteria and 1 539 cases in all, but the quality of which was all C grade. The meta analysis indicated that shenqifuzheng injection combining chemotherapy or radiotherapy improved the therapeutic effects compared to the routine radiotherapy or chemotherapy [OR = 2.11, 95%CI （ 1.71,2.60）, P 〈 0.000 01] and the qual- ity of life [OR = 3.07, 95%CI （2.15, 4.39）, P 〈 0.000 1 ], decreased the inhibition of marrow （WBC decreasing [OR=0.33,95%CI （0.24, 0.47） ,P〈 0.000 01], llb reducing [OR = 0.35,95%CI （0.22,0.57）, P 〈 0.000 01], PLT reducing [OR = 0.48,95%CI （0.31,0.73 ）, P = 0.000 7] ）, and reduced the rate of toxicity and side-effects （nausea or vomiting [OR = 0.21, 95%CI （0.13,0.34）, P〈 0.000 01]）. The difference had a statistical significance. Conclusion： It was proved that the efficacy can be enhanced and toxicity reduced when shenqifuzheng injection was used in the process of chemotherapy or radio- therapy in patients with malignant tumors. However, the RCTs enrolled in this research were all of low quality and the left-right asymmetry presented in the funnel plot, suggesting that publication bias may exist. The conclusion made in this paper needs to be further confirmed by high quality RCTs.

关 键 词：参芪扶正注射液 肿瘤 增效减毒 系统评价 

分 类 号：R734.2[医药卫生—肿瘤]