中西药结合与单用西药治疗慢性乙型肝炎随机对照试验的系统评价研究方案  

Integrated Traditional Chinese Medicine with Western Medicine and Western Medicine alone for Chronic Hepatitis B:A Systematic Review Protocol of Random-Controlled Trials

作　　者：杨诗杰[1] 苏汝好[2] 吴泰相[3] 吴进军[2] 李强[4] 项岚[5] 蔡定彬[2] 王娜[1] 孙莉[1] 

机构地区：[1]广东医学院公共卫生学院,广东湛江524023 [2]广东医学院附属医院,广东湛江524001 [3]四川大学华西医院中国循证医学中心&临床流行病学教研室,四川成都610041 [4]广东省医学情报研究所,广州510180 [5]开封市医科所,河南开封475000

出　　处：《时珍国医国药》2007年第5期1104-1106,共3页Lishizhen Medicine and Materia Medica Research

基　　金：广东省科技攻关项目(No.A98040)

摘　　要：慢性乙型肝炎严重危害人类健康,但目前尚缺乏满意的治疗药物。西药治疗慢性乙型肝炎疗效不甚理想且费用高、副作用大,中西医结合治疗正受到越来越多的关注和研究。文章评价了中医药能否提高西药治疗慢性乙型肝炎的疗效,降低其不良反应。检索策略:1.电子检索:以中西医结合、中西药结合、中医药、中成药和慢性乙型肝炎等为主题词或自由词,检索中国期刊网,Medline、中国生物医学光盘数据库(CBM),Cochrane肝胆病组临床试验资料库等电子数据库。2.手工检索30种中医杂志及有关学术论文汇编,鉴定相关文献的参考文献作为补充检索。纳入标准:所有研究中西药结合与单用西药治疗慢性乙型肝炎的随机对照研究,其中中药必须是国家正式批准文号的或有省级制剂批准文号的药品,并且干预组与对照组西药相同。评价方法:参照Cochrane系统评价的要求,对选择纳入的临床试验进行方法学质量的评估,数据的提取和Meta分析。Background Chronic hepatitis B is a kind of infectious diseases which is severly threatening human health, but there is not efficacious medicines for healing yet at present. Curative effect of western medicine for it is not satisfied with more adverse reactions and costs. Integrated traditional Chinese medicine with western medicine for it is attracting more solicitude and research now. Objectives To assess whether traditional Chinese medicines can enhance western medicine＇s therapeutic effect and decrease its adverse reactions. Search strategy 1. Electronic Searches： We searched the electronic databases such as The Cochrane Hepato - Biliary Group Controlled Trials Register,Medline,CMB（ Chinese Biomedical Databases）,CNKI （Chinese National Knowledge Infrastructure） ,using ＂ integrated traditional and western medicine＂, ＂ traditional Chinese medicine＂, ＂ Chinese patent medicine and chronic hepatitis B＂ as mesh or free -word. 2. 30 kinds of journals and assembles about traditional Chinese medicine will be handsearched, the reference lists of papers will also be scanned and indentified for further trials. Inclusion criteria All the randomized - controlled trials which studied integrated traditional Chinese medicine with western medicine and western medicine alone for chronic hepatitis B will be included. And the traditional Chinese medicine must be approved and registered by FDA（ including the state or each the province） . The western medicine used in control group and intervention group must be identical. Method of the review According to the demand of Cochrane systematic review, selection of inclusion and exclusion, assessment of the methodological quality, data extraction will be conducted and meta analysis will also be applied if the trials included have sufficient quality and similarity.

关 键 词：中西药结合 慢性乙型肝炎 安全性 有效性 

分 类 号：R2-031[医药卫生—中西医结合]