四种抗变态反应药物的卫生技术评估的研究方案

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：中或英研究。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QUOROM STATEMENT和Jadad评价表评价研究质量。两名评价独立选择献、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。

Four non-sedating antihistamines for allergic diseases: health technology assessment (protocol)

Background In the latter of 20th century, a global growth in allergic diseases has been witnessed, accompanying with spring-out of therapeutic drugs. However, trials did not clarify the comparative effectiveness and pharmaceutical economics of these agents. Severe adverse drug effects have been reported increasingly in the last few years. These made it difficult for clinical practice and selection of national essential drugs.Objective To assess astemizole, loratadine, cetirizine and tefenadine for allergic rhinitis (AR) and urticaria in terms of effectiveness, heart-related drug adverse effects and pharmaceutical economics. Search strategy Cochrane Library, Medline, Embase and Chinese Biomedical Database will be searched. Additional database should be searched for safety and economic studies. Selection Criteria The publication languages are restrained to English 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 hierarchy 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 and quality appraisal table are separately designed. QUOROM STATEMENT and Jadad Scale are applied, respectively, to SRs and RCTs. Two reviewers independently select the studies, appraise the quality and extract the data. Any disagreement is solved by discussion.Data analysis Fixed effect model is first applied. Sensitivity analysis is employed to study the heterogeneity between trials. Randomized effect model is alternatively used when compromised.