Department of Hepatology, Ruikang Hospital Affiliated to Guangxi Chinese Medicine University, Nanning, 530000, China.
Chin J Integr Med. 2019 Oct;25(10):785-790. doi: 10.1007/s11655-017-2426-8. Epub 2018 Jan 15.
To evaluate the effects of Aidi Injection (, AD) in combination with Western medical therapies (WMT) in patients with primary liver cancer (PLC).
Randomized controlled trials (RCTs) comparing AD plus WMT with WMT alone were retrieved from inception to March 2013 by retrieving the literature database thoroughly and systematically. The extracted data from included studies were analyzed and synthesized by Review Manager 5.2 software. The Cochrane risk of bias tool was used to assess the quality of included studies, and Begg's and Egger's tests were used to evaluate the potential presence of publication bias. The studies were divided into 7 separate subgroups in terms of quality of life (QOL), recent chemotherapy and the incidence of leukocyte reduction. The subgroup analysis was applied to assess the heterogeneity between included researches, and the sensitivity analysis was used to weigh the stability of studies.
Twenty-four RCTs were included in this study. Compared with WMT used alone, AD as additional intervention was more effective on improving QOL (P<0.01), increasing short-term efficacy (P<0.01), prolonging life (P<0.05 or P<0.01), relieving clinical symptoms (P<0.01), and reducing adverse events (e.g. reduce white blood cell counts, P=0.002; reduce in platelet counts, P<0.01). Subgroup analysis showed that the hepatic artery interventions with AD was superior in improving QOL (P<0.01) and enhancing short-term response rates (P=0.007) and reducing white blood cell counts (P=0.0004) than hepatic artery interventions alone (P<0.01). The chemoembolization plus AD or the chemotherapy plus AD were both better than chemoembolization or the chemotherapy alone in improving the QOL and short-term response rate (P<0.05 or P<0.01).
AD in combination with WMT improves QOL in patients with PLC. Considering the inherent limitations of the included studies, further well-designed, rigorously performed, high-quality, and double-blinded RCTs with large sample sizes are needed.
评价艾迪注射液( ,AD )联合西医治疗(WMT )原发性肝癌(PLC )的疗效。
通过全面、系统地检索文献数据库,检索了 2013 年 3 月前比较 AD 联合 WMT 与单纯 WMT 的随机对照试验( RCT )。使用 Review Manager 5.2 软件分析和综合纳入研究的数据。采用 Cochrane 偏倚风险工具评估纳入研究的质量,并采用 Begg 和 Egger 检验评估潜在的发表偏倚。根据生活质量(QOL )、近期化疗和白细胞减少发生率将研究分为 7 个独立亚组。亚组分析用于评估纳入研究之间的异质性,并进行敏感性分析以衡量研究的稳定性。
共纳入 24 项 RCT 。与单独使用 WMT 相比,AD 作为附加干预措施在改善 QOL 方面更为有效(P<0.01 ),提高近期疗效(P<0.01 ),延长生存期(P<0.05 或 P<0.01 ),缓解临床症状(P<0.01 ),减少不良反应(如减少白细胞计数,P=0.002 ;减少血小板计数,P<0.01 )。亚组分析显示,与单纯肝动脉介入相比,AD 肝动脉介入在改善 QOL (P<0.01 )和提高近期反应率(P=0.007 )和减少白细胞计数(P=0.0004 )方面更具优势(P<0.01 )。化疗栓塞联合 AD 或化疗联合 AD 均优于化疗栓塞或化疗单独治疗,在改善 QOL 和近期反应率方面(P<0.05 或 P<0.01 )。
AD 联合 WMT 可提高 PLC 患者的 QOL 。鉴于纳入研究的固有局限性,需要进一步开展设计良好、执行严格、质量高、双盲、大样本 RCT 。