参芪扶正注射液辅助治疗胃癌患者系统评价

Adjuvant Treatment of Gastric Cancer Patients with Shenqi Fuzheng Injection:A Systematic Review

目的 :评价参芪扶正注射液对晚期胃癌及胃癌术后患者的临床疗效。方法 :计算机检索Cochrane图书馆、PUBMED、EMBASE、中国期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)和万方数据库(Wanfang Data)中有关参芪扶正注射液辅助治疗胃癌患者的随机对照试验,并手工检索相关文献。检索时限均为从建库至2012年12月。由3位研究者按Cochrane Reviewers'Handbook 4.2.2推荐的方法评价纳入研究的质量和资料提取,对符合质量标准的RCT用RevMan 5.1软件进行Meta分析。结果 :共纳入10个RCT。其中8个RCT结果显示,联合化疗方案治疗可以明显改善临床症状{RR=1.37,95%CI:[(1.04),(1.79)],P=0.02};6项研究结果显示:联合化疗方案对患者的生活质量能明显提高{RR=1.40,95%CI:[(1.26)-(1.57)],P<0.00001};5项研究显示,联合化疗可以提高患者免疫力{WMD=4.23,95%CI:[(3.71),(4.76)],P<0.00001},但尚不能说明可以减少胃肠道反应。结论 :晚期胃癌患者及胃癌术后患者化疗时联合参芪扶正注射液可以改善临床症状,减少骨髓抑制,同时对提高患者免疫功能有一定的效果。但鉴于纳入研究较少,样本量小,且质量不高,各研究评价方法变异性较大,并且存在评价时间的不同,故仍需开展大样本、多中心、方法科学和规范的高质量RCT,以求进一步验证参芪扶正注射液对晚期胃癌及胃癌术后患者的临床疗效。

Objective：To assess the efficacy of Shenqi Fuzheng Injection in the adjuvant treatment of advanced gastric cancer patients and gastric cancer patients after radical operation. Methods： Cochrane library, PUBMED, EMBASE, CNKI, CBM and Wanfang Date were searched from the date of establishment of the databases to December 2012. Randomized controlled trials （ RCTs ） of Shenqi Fuzheng Injection in the adjuvant treatment of severe gastric cancer patients were included. A manual search of relevant journals and conference proceedings were performed too. Three independent researchers evaluated the quality of each, including study according to Cochrane Reviewers＇ Handbook 4.2.2 recommend standard and then the data was extracted. A Meta-analysis was then performed of eligible RCTs by RevMan 5.1 software. Result ： Ten RCTs were included. Eight of RCTs indicated that it had obvious improvement of clinical symptom with Shenqi Fuzheng Injection combined with FOLFOX4 chemotherapy （ RR=l.37,95%CI： [1.04, 1.79], P=0.02 ） ; Six studies indicated that the quality of life and weight/physical agility significantly improved by adjuvant treatment （RR=1.40,95%CI： [ （ 1.26 ）-（ 1.57 ）], P〈0.00001 ）. Five studies proved that combined chemotherapy could improve the patients immunity, and reduce bone marrow suppression （ WMD=4.23,95%CI ： [ （ 3.71 ）, （ 4.76 ） ], P〈0.00001 ） .Conclusion ： Shenqi Fuzheng Injection combined with FOLFOX4 chemotherapy in the adjuvant treatment of advanced gastric cancer patients and gastric cancer patients after radical operation could improve clinical symptoms, reduce bone marrow suppression and improve patients＇ immunity. Compared with other rehabilitative therapies, it is simper, of lower input costs, and of low operating costs. The clinicians should recommend it. Due to the limitations of the included studies, more large-sample and high-quality RCTs are required.