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應的臨床特征、相關因素,為臨床藥物治療中藥品不良反應的防治提供參考依據。 方法 :檢索1986～2008年國內文獻源特非那定的不良反應資料,并加以分析研究。 結果 :34例不良反應報告中女性明顯多于男性;不良反應以心血管系統損害最多(23例,占6766%),其次為皮膚及附件損害(5例,1470%);不良反應預后較好。 結論 :患者的性別、體質、合并用藥等因素能影響不良反應的發生,對于引起心律失常不良反應臨床應提高警惕,減少不良反應的發生。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.