Objective This review compared clinical effectiveness, cardiac safety and economics of astemizole, loratadine, cetirizine and terfenadine to provide evidence for adjustment of Essential Drug List in China. Search strategy We searched Medline, Cochrane Library, Embase and Chinese Biomedical Database. Fourteen databases for drug safety and pharmaceutical economics were additionally searched. Selection Criteria Randomized controlled trials and systematic reviews, published in English and Chinese and comparing two or more of these four antihistamines for allergic rhinitis and urticaria were included for study of effectiveness. Non-randomized clinical trials were additionally included for economic evaluation. Cardiac safety studies of antihistamines for allergic diseases of any type were included. Quality Appraisal Jadad scale was primarily applied to randomized controlled trials. Allocation concealment and intention-to-treat analysis were also appraised. The QUOROM statement was applied to systematic reviews and meta-analysis. Data extraction and analyses For the study of effectiveness, composite data were primarily extracted and analyzed by fixed effect model. Sensitivity analysis was done to explore the heterogeneity. For the study of cardiac safety, cases of adverse drug reactions and death were summarized. Difference of occurrence rate in sex and age were analyzed if possible.Electrocardiography and clinical symptoms were summarized. Results No studies on economic evaluation were identified. 27 and 6 randomized controlled trials, including 3 227 participants, for allergic rhinitis and urticaria were identified. Cetirizine was superior to loratadine (n=709) in symptom score and onset of action, superior to terfenadine (n=645) in Quality of Life and superior to astemizole (n=498) in patient satisfaction and onset of action. 73 h-ADR cases were identified in astemizole, 27 cases in terfenadine, 1 case in loratadine and none in cetirizine. No deaths were identified. Combination of terfenadine plus grapefruit juice (n=l8), itraconazole (n=6), nefazodone (n=67), and loratadine administration concomitant with cemitidine (n=30) significantly prolonged QTc interval. Conclusions Cetirizine was superior to other three antihistamines in terms of clinical effectiveness and drug safety. Astemizole and terfenadine could cause significantly more cardiac-related adverse reactions than cetirizine and loratadine.
摘要:目的: 分析特非那定所致不良反应的临床特征、相关因素,为临床药物治疗中药品不良反应的防治提供参考依据。 方法 :检索1986～2008年国内文献源特非那定的不良反应资料,并加以分析研究。 结果 :34例不良反应报告中女性明显多于男性;不良反应以心血管系统损害最多(23例,占6766%),其次为皮肤及附件损害(5例,1470%);不良反应预后较好。 结论 :患者的性别、体质、合并用药等因素能影响不良反应的发生,对于引起心律失常不良反应临床应提高警惕,减少不良反应的发生。Abstract: Objective: To analyze the clinical features、correlation factors of ADRs caused by Terfenadine drugs and provide beneficial references for preventing and curing the ADRs. Methods :To collect and analyze the cases of ADRs caused by Terfenadine from medical journals of 19862008 Results :Women were more than men in 34 ADRs;cardiovascular system lesions accounted for 6766%,skin and its appendix lesions accounted for 1470%;ADRs prognosis well. Conclusion :The occurrence of ADRs caused by Terfenadine due to many factors such as sex、age and combination drug,ect. The ADRs caused by second generation antihistamine drugs must be reconstred.