金龙胶囊联合TACE治疗肝癌随机对照试验的系统评价  

Efficacy and Safety of Jinlong Capsule and Transcatheter Arterial Chemoembolization for Primary Hepatic Carcinoma: A Systematic Review

作　　者：马文华[1] 李娜[1] 邹长鹏[1] 郭英[1] 安永辉[1] 

机构地区：[1]河北医科大学第一医院肿瘤科,石家庄050000

出　　处：《世界科学技术-中医药现代化》2016年第4期692-698,共7页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

摘　　要：目的:评价金龙胶囊联合肝动脉栓塞化疗(TACE)与单独TACE对中晚期肝癌患者有效性、安全性。方法:电子检索Cochrane图书馆临床对照试验资料库(CCTR)、Pub Med(1994年?2015年2月)、中国生物医学文献数据库(CBM,1978年?2015年2月)、中文科技期刊全文数据库(CNKI,1994年?2015年2月)、Embase(1994年?2015年2月)。根据纳入排除标准筛选文献,按照Cochrane推荐的质量评价标准对纳入研究进行质量学评价。结果:共纳入10篇平行随机对照试验,1篇采用信封法,均未采用盲法。2篇报道了病历完成情况,未行意向性分析(ITT),其他文献未对病例完成情况进行说明,所有文献对有效率进行比较,结果有统计学意义[RR=1.30,95%CI(1.15,1.47)];患者的肝功能Child?pugh分级改善率有统计学意义[RR=1.37,95%CI(1.15,1.62)];生存质量评价结果示[RR=1.58,95%CI(1.20,2.07)];TACE联合金龙胶囊改善了患者的生存质量[MD=6.97,95%CI(4.41,9.52)];结果示6月、1年、2年生存期分别为[RR=1.10,95%CI(0.98,1.23)]、[RR=1.18,95%CI(0.99,1.41)]、[RR=1.31,95%CI(0.97,1.79)],无统计学意义,未能改善患者生存;联合组减轻了患者消化道反应[RR=0.54,95%CI(0.34,0.85)];白细胞下降率[RR=0.62,95%CI(0.29,1.35)],无统计学意义,联合组未改善白细胞下降率。结论:TACE联合金龙胶囊可以提高有效率,改善患者生活质量及肝功能。The aim of the study was to perform a meta-analysis to evaluate therapeutic efficacy and safety of Jinlong Capsule（JLC） and transcatheter arterial chemoembolization（TACE） in primary hepatic carcinoma. Published literatures were retrieved in Cochrane controlled trials register（CCTR）,Pubmed（1994 - Feb. 2015）, Chinese biomedical database（CBM, 1978 - Feb. 2015）, CNKI（1994 - Feb. 2015） and Embase（1994 - Feb. 2015）, and screened according to inclusive and exclusive criteria. Literature quality evaluation was performed relying on Cochrane Handbook version 5.0. As a result, included in the studies were ten randomized parallel controlled trials： all the studies were non-blind, one of them used envelope method; two studies described the completion of medical record yet missing the ITT analysis, while other literatures did not mention any medical record stage. Outcomes of efficacy rate were compared and presented significant differences among groups in the ten studies（Relative Risk（RR）, 1.30; 95% Confidence Interval（CI）, 1.15-1.47）. Hepatic function index, called Child-pugh grade, was improved after treatment（RR, 1.37; 95%CI, 1.15-1.62）. KPS scores, known as a kind of quality of life evaluation, showed that the RR value was 1.58 with the 95%CI ranging from 1.20 to 2.07. Combination therapy between JLG and TACE improved the quality of life significantly（MD, 6.97; 95%CI, 4.41-9.52）. Meta-analysis outcomes of six-month, one-year and five-year survival showed JLG’s failure in improving the survival rate（RR, 1.10; 95%CI, 0.98-1.23; RR, 1.18; 95%CI, 0.99-1.41; RR, 1.31; 95%CI, 0.97-1.79, respectively）. Digestive tract reaction was alleviated through JLG and TACE treatment（RR, 0.54; 95%CI, 0.34-0.85）. However, JLG and TACE treatment did not decrease bone marrow toxicity（RR, 0.62; 95%CI, 0.29-1.35）. In conclusion, JLG and TACE therapy increased the therapeutic efficacy, and improved the quality of life and hepatic function in primary hepatic carcinoma patients.

关 键 词：临床试验 金龙胶囊 原发性肝癌 肝动脉栓塞化疗 

分 类 号：R273[医药卫生—中西医结合]