The Therapeutic Efficacy and Safety of Compound Kushen Injection Combined with Transarterial Chemoembolization in Unresectable Hepatocellular Carcinoma: An Update Systematic Review and Meta-Analysis.
The Therapeutic Efficacy and Safety of Compound Kushen Injection Combined with Transarterial Chemoembolization in Unresectable Hepatocellular Carcinoma: An Update Systematic Review and Meta-Analysis.
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DOI：
10.3389/fphar.2016.00070
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发表时间：
2016
影响因子：
5.6
通讯作者：
Xiao XH
中科院分区：
文献类型：
--
作者：
Ma X;Li RS;Wang J;Huang YQ;Li PY;Wang J;Su HB;Wang RL;Zhang YM;Liu HH;Zhang CE;Ma ZJ;Wang JB;Zhao YL;Xiao XH
背景资料：复方苦参注射液（CKI）是经国家食品药品监督管理局批准用于治疗各类实体瘤的中成药。CKI联合肝动脉化疗栓塞（TACE）被认为可以提高不可切除的肝细胞癌（HCC）的治疗效果。我们报告了一项更新和扩展的荟萃分析，详细介绍了CKI联合TACE治疗的疗效和不良事件（AE）结局。材料与方法：检索2015年11月13日前的电子数据库，包括PubMed、Embase、科克伦图书馆、中国生物医学数据库（CBM）、万方、维普医药信息系统（VMIS）和中国知网（CNKI）。使用比值比（OR）估计肿瘤缓解（TR）、Karnofsky体能量表（KPS）改善、Child-Pugh（CP）改善、生存率（SR）和AE。还评估了发表偏倚和亚组分析。结果：纳入了18项研究，共1，338例符合荟萃分析标准的HCC患者。与单纯TACE相比，联合治疗的TR、KPS改善和CP改善显著增强（OR = 1.84，95%CI：[1.46，2.33]，P < 0.00001; OR = 2.37，95%CI：[1.76，3.18]，P < 0.00001; OR = 1.81，95%CI：[1.08，3.03]，P = 0.02）。联合治疗与1年和2年SR的改善相关，但与3年SR的改善无关（OR = 2.40; 95% CI：[1.59，3.62]，P < 0.0001; OR = 2.49，95% CI：[1.24，5.00]，P = 0.01; OR = 2.49，95% CI：[0.94，6.61]，P = 0.07）。安全性分析表明，与TACE单药治疗相比，联合治疗的AE（包括恶心/呕吐、发热、肝痛、转氨酶升高、胆红素升高和白细胞减少症）减少。结论：TACE和CKI联合治疗与不可切除HCC患者的TR、KPS和CP改善以及1年和2年SR改善相关。3年SR未改善。联合治疗导致AE减少。由于样本量小和研究局限性，应谨慎解释本研究的结果。
Background: Compound Kushen Injection (CKI) is a Chinese patent medicine approved by the China Food and Drug Administration for the treatment of various types of solid tumors. CKI, combined with transarterial chemoembolization (TACE), is believed to increase the therapeutic efficacy of unresectable hepatocellular carcinoma (HCC). We report an updated and extended meta-analysis with detailed outcomes of both the efficacy and adverse events (AEs) of CKI combined with TACE therapy. Materials and methods: Electronic databases, including PubMed, Embase, the Cochrane Library, the Chinese Biomedical Database (CBM), Wanfang, the VIP medicine information system (VMIS) and the China National Knowledge Infrastructure (CNKI), were examined for relevant articles before November 13, 2015. An odds ratio (OR) was used to estimate tumor response (TR), Karnofsky Performance Scale (KPS) improvement, Child-Pugh (CP) improvement, survival rate (SR) and AEs. A publication bias and a subgroup analysis were also assessed. Results: Eighteen studies, with a total of 1,338 HCC patients who met the criteria for the meta-analysis, were included. TR, KPS improvement and CP improvement were significantly enhanced for the combination therapy compared to TACE alone (OR = 1.84, 95% CI: [1.46, 2.33], P < 0.00001; OR = 2.37, 95% CI: [1.76, 3.18], P < 0.00001; OR = 1.81, 95% CI: [1.08, 3.03], P = 0.02, respectively). The combination therapy was associated with an improvement in 1-year and 2-year SRs but not an improved 3-year SR (OR = 2.40; 95% CI: [1.59, 3.62], P < 0.0001; OR = 2.49, 95% CI: [1.24, 5.00], P = 0.01; OR = 2.49, 95% CI: [0.94, 6.61], P = 0.07, respectively). A safety analysis indicated that AEs (including nausea/vomiting, fever, hepatalgia, increased transaminase, increased bilirubin and leukopenia) were reduced for the combination treatment compared to TACE alone. Conclusion: The combination treatment of TACE and CKI was associated with improved TR, KPS and CP improvement and improved 1- and 2-year SRs in patients with unresectable HCC. The 3-year SR was not improved. The combination therapy resulted in a reduction in AEs. The findings of this study should be interpreted with caution because of the small sample size and study limitations.