CAJ | 학술논문

背景过敏性疾病自20世纪后叶迅速增加,其治疗药物随之上市.但大量临床研究并未明确药物治疗效果和经济学特性好坏,药物严重不良反应的出现给临床用药和国家基本药物遴选带来困难.目的运用卫生技术评估方法,评价阿司咪唑、氯雷他丁、西替利嗪和特非那定治疗过敏性鼻炎、荨麻疹的有效性,心脏不良反应和经济学特性.检索策略数据库包括Cochrane图书馆、Medline、Embase和中文生物医学数据库,安全性和经济学另检索相关数据库.选择标准中文或英文研究.1)有效性:四种抗变态反应药物中的两种或以上用于过敏性鼻炎和荨麻疹的系统评价/meta-分析和高质量随机对照试验;2)安全性:四种抗变态反应药物用于各种变态反应性疾病后出现心脏不良反应的各种级别的证据;3)经济学特性:四种抗变态反应药物中的两种或以上用于过敏性鼻炎、荨麻疹的成本-效果和成本效用的研究.评价方法设计质量评价和资料提取表.系统评价和随机对照试验分别使用QUOROMSTATEMENT和Jadad评价表评价研究质量.两名评价者独立选择文献、评价研究质量和提取原始资料,不同意见经讨论解决.数据分析Revman 4.1使用固定效应模型分析原始数据,敏感性分析解决研究间异质性,若仍有异质性使用随机效应模型.
배경과민성질병자20세기후협신속증가,기치료약물수지상시.단대량림상연구병미명학약물치료효과화경제학특성호배,약물엄중불량반응적출현급림상용약화국가기본약물린선대래곤난.목적운용위생기술평고방법,평개아사미서、록뢰타정、서체리진화특비나정치료과민성비염、담마진적유효성,심장불량반응화경제학특성.검색책략수거고포괄Cochrane도서관、Medline、Embase화중문생물의학수거고,안전성화경제학령검색상관수거고.선택표준중문혹영문연구.1)유효성:사충항변태반응약물중적량충혹이상용우과민성비염화담마진적계통평개/meta-분석화고질량수궤대조시험;2)안전성:사충항변태반응약물용우각충변태반응성질병후출현심장불량반응적각충급별적증거;3)경제학특성:사충항변태반응약물중적량충혹이상용우과민성비염、담마진적성본-효과화성본효용적연구.평개방법설계질량평개화자료제취표.계통평개화수궤대조시험분별사용QUOROMSTATEMENT화Jadad평개표평개연구질량.량명평개자독립선택문헌、평개연구질량화제취원시자료,불동의견경토론해결.수거분석Revman 4.1사용고정효응모형분석원시수거,민감성분석해결연구간이질성,약잉유이질성사용수궤효응모형.
Background In the latter of 20th century, a global growth in allergic diseases has been witnessed, accompanyingwith spring- out of therapeutic drugs. However, trials did not clarify the comparative effectiveness and pharmaceutical eco-nomics of these agents. Severe adverse drug effects have been reported increasingly in the last few years. These made it diffi-cult for clinical practice and selection of national essential drugs. Objective To assess astemizole, loratadine, cetirizine and tefe-nadine for allergic rhinitis (AR) and urticaria in terms of effectiveness, heart-related drug adverse effects and pharmaceuticaleconomics. Search strategy Cochrane Library, Medline, Embase and Chinese Biomedical Database will be searched. Addition-al database should be searched for safety and economic studies. Selection Criteria The publication languages are restrained toEnglish and Chinese. 1) Effectiveness: high-quality randomized controlled trials (RCTs) and systematic Reviews (SRs)/meta-analysis for AR and uritcaria are included, with comparisons restrained to among these four drugs; 2) Safety: a hierar-chy of evidences of these four drugs for allergic diseases are included. 3) Economical evaluation: cost-effectiveness and cost-utility assessment of these four drugs for AR and urticaria should be included. Methods of review data extraction sheet andquality appraisal table are separately designed. QUOROM STATEMENT and Jadad Scale are applied, respectively, to SRsand RCTs. Two reviewers independently select the studies, appraise the quality and extract the data. Any disagreement issolved by discussion. Data analysis Fixed effect model is first applied. Sensitivity analysis is employed to study the heterogene-ity between trials. Randomized effect model is alternatively used when compromised.