参芪扶正注射液联合经肝动脉化疗栓塞术治疗原发性肝癌效果与安全性的Meta分析

杨婉婷　侯恩存

[摘要] 目的 系統评价参芪扶正注射液联合经肝动脉化疗栓塞术（TACE）治疗原发性肝癌的效果与安全性。 方法 采用Cochrane协作网系统评价方法，计算机检索Cochrane图书馆临床对照试验资料库、Medline、Embase、PubMed、万方数据库、中文科技期刊全文数据库（CNKI）、中国期刊全文数据库（VIP）等，以“参芪扶正注射液”“肝癌”“介入”等为关键词查找自建库至2016年12月公开发表的研究参芪扶正注射液联合TACE治疗原发性肝癌的临床随机对照试验。由两名研究员按照纳入与排除标准选择文献，对筛选出的文献查找全文，经质量评价、资料提取，最终纳入文献后采用Review Manger 5.2软件对纳入的试验结果进行统计学分析。 结果 共纳入7个RCT研究，合计466例患者。Meta分析结果显示：相对于单纯TACE治疗原发性肝癌，参芪扶正注射液联合TACE治疗原发性肝癌的近期疗效（RR = 1.45，95%CI：1.01～2.07，P = 0.04）、生活质量（RR = 2.29，95%CI：1.65～3.17，P < 0.01）、CD4+/CD8+（MD = 0.28，95%CI：0.09～0.47，P = 0.003）有明显提高，并且白细胞下降（RR = 0.68，95%CI：0.56～0.83，P = 0.0001）及胃肠道反应发生率（RR = 0.69，95%CI：0.51～0.95，P = 0.02）更低。 结论 参芪扶正注射液可以提高TACE对原发性肝癌的疗效与安全性。

[关键词] 参芪扶正注射液；经肝动脉化疗栓塞术；原发性肝癌；Meta分析

[中图分类号] R735.7 [文献标识码] A [文章编号] 1673-7210（2017）07（a）-0110-04

[Abstract] Objective To systematically evaluate the efficacy and safety of Shenqi Fuzheng Injection combined with transcatheter arterial chemoembolization （TACE） in the treatment of primary liver cancer. Methods The method of systematic review from the Cochrane library was adopted and clinical controlled trials were retrieved by computer in the Cochrane library， Medline， Embase， PubMed， Wanfang database， Chinese science and technology journal full-text database retrieval （CNKI）， China journal full-text database （VIP）， etc. "Shenqi Fuzheng Injection"， "liver cancer" and "intervention" were used as the keywords to find clinical randomized controlled trials of Shenqi Fuzheng Injection combined with TACE in the treatment of primary liver cancer which were open published from the establishment of database to December 2016. The inclusion and exclusion criteria were used to select the literature by two researchers， the full texts were sought， through quality assessment of literatures and data extraction， finally， the literatures were analyzed statistically by Review Manger 5.2 software eventually. Results There were 7 RCT studies and a total of 466 patients were included. Meta-analysis results showed that compared with single TACE in the treatment of primary hepatocellular carcinoma， the efficiency （RR = 1.45， 95%CI： 1.01-2.07， P = 0.04）， the quality of life （RR = 2.29， 95%CI： 1.65-3.17， P < 0.01）， CD4+/CD8+ （MD = 0.28， 95%CI： 0.09-0.47， P = 0.003） of Shenqi Fuzheng Injection combined with TACE in the treatment of primary hepatocellular carcinoma were significantly improved， the decrease of white blood cells （RR = 0.68， 95%CI： 0.56-0.83， P = 0.0001） and the occurrence rate of gastrointestinal tract reaction （RR = 0.69， 95%CI： 0.51-0.95， P = 0.02） of which were also lower than TACE. Conclusion Shenqi Fuzheng Injection can improve the efficacy and safety of TACE in the treatment of primary liver cancer.

[Key words] Shenqi Fuzheng Injection； Transcatheter arterial chemoembolization； Primary liver cancer； Meta analysis

原发性肝癌简称肝癌，是临床常见的恶性肿瘤之一，在我国的病死率位于恶性肿瘤的前列，每年死于肝癌的患者约有数十万人[1]。如今，经肝动脉化疗栓塞术（TACE）被认为是非手术治疗原发性肝癌的首选治疗方法[2]。原发性肝癌在中医学中辨证为“肝积”“积聚”等，中医治疗提倡辨证论治[3]。近年来，临床广泛采用参芪扶正注射液联合TACE治疗原发性肝癌，但是这些临床试验结果并不完全一致，我们也未检索到相关研究系统评价两者的治疗效果。本文系统评价参芪扶正注射液联合TACE治疗原发性肝癌的临床效果与安全性，从而为临床合理应用提供依据。……