摘要
目的评价中药配合肝动脉栓塞化疗(TACE)与单纯TACE比较治疗原发性肝癌的有效性和安全性。方法采用Cochrane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、CBM、CNKI和VIP;同时手检相关期刊和会议论文集,纳入有关中药配合TACE治疗原发性肝癌的随机对照试验,质量评价按照Cochrane系统评价员手册4.2.2版推荐的质量评价标准评价纳入研究质量,并对同质研究进行Meta分析。结果共检索到符合纳入标准的中文文献37篇(2653例患者)。文献质量评价结果显示,除2篇研究质量为B级外,其余35篇均为C级。Meta分析结果显示,中药配合TACE治疗在生存期、近期化疗有效率(CR+PR)、生存质量、临床症状改善和防止不良反应发生(如防止白细胞下降)等方面均优于单纯TACE治疗。亚组分析发现:TACE次数<3的亚组在生存期和临床症状的改善方面优于TACE次数>3的亚组;而TACE次数>3的亚组在近期化疗有效率(CR+PR)与生存质量改善方面优于TACE次数<3的亚组,在防止不良反应发生如防止白细胞下降方面两组效果相似,可能与样本含量较少有关。结论中药配合TACE治疗原发性肝癌优于单纯TACE治疗;TACE次数<3的亚组在生存期、临床症状改善方面优于TACE次数>3的亚组。但由于纳入试验的方法学质量普遍较低,期待更多设计合理、严格执行的大样本随机双盲对照试验提供高质量的证据。
Objective To evaluate the effectiveness and safety of traditional Chinese medicine （TCM） plus transcatheter arterial chemoembolization （TACE） compared with TACE alone, in the treatment of unresectable hepatocellular carcinoma （HCC）. Methods The Cochrane Library, MEDLINE, EMBASE, CANCERLIT, CBM, CNKI and VIP were searched electronically. Relevant journals and conference proceedings were also handsearched. The quality of included studies was assessed according to the criteria recommended by the Cochrane Handbook for Systematic Reviews of Interventions, and meta-analyses were performed for homogeneous studies using The Cochrane Collaboration＇s RevMan 4.2.10 software. Subgroup analyses by frequency of TACE （〈3 or ≥3 times） were also performed. Results Thirty seven trials, all published in China, involving 2 653 partici pants were included. The quality of 2 studies was graded B （medium） and that of the other 35 was graded C （low）. Meta-analyses showed that TCM plus TACE, compared with TACE alone, could significantly improve survival, tumor response （complete and partial）, quality of life and clinical symptoms, and was also associated with a lower incidence of adverse reactions. Subgroup analyses indicated that, patients with less than three TACE had more significant improvement in survival and clinical symptoms, while patients with three or more TACE had more significant improvement in tumor response and quality of life. The incidence of adverse reactions was similar between these two different frequencies of TACE. Conclusions The treatment regimen of TCM plus TACE is superior to TACE alone in patients with unresectable HCC, As the existing data have a high risk of bias, the current evidence is insufficient to define the efficacy of the combination treatment, and further large-scale, high- qualit）, randomized controlled trials are needed.
出处
《中国循证医学杂志》
CSCD
2008年第1期21-31,共11页
Chinese Journal of Evidence-based Medicine
关键词
原发性肝癌
中医药
肝动脉栓塞化疗
随机对照试验
META分析
Unresectable hepatocellular carcinoma
Traditional Chinese Medicine
Transcatheter arterial chemoembol ization
Randomized controlled trial
Meta analysis
