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:评价孟鲁司特用于过敏性鼻炎的临床疗效和安全性。方法:计算机检索PubMed、维普及CNKI数据库,手工收集有关孟鲁司特用于过敏性鼻炎治疗的临床研究,根据纳入和剔除标准汇集文献,采用Jadad量表进行纳入文献质量评价,对总体治疗有效性使用Revman4.2软件进行Meta分析。结果:疗效评价共纳入9个临床随机对照研究共650例。有效率孟鲁司特组高于对照组,异质性检验显示各亚组及其合并总有效率P值均大于0.1,I2lt;50%,采用固定效应模型计算。2周时孟鲁司特组和对照组无统计学差异(Pgt;0.1),但2月、3月时二组均有显著性统计学差异(Plt;0.000 01),三个亚组综合分析孟鲁司特组和对照组有显著性统计学差异(Plt;0.000 01),不良反应差异无统计学意义。结论:现有临床证据显示孟鲁司特较传统抗过敏药物对过敏性鼻炎的治疗有效,但由于纳入研究存在选择性偏倚和测量性偏倚的可能性,势必影响结果的论证强度。故期待更多高质量的随机双盲对照试验性研究,以提供更高质量的证据。Abstract: Objective: To evaluate montelukast for allergic rhinitis clinical efficacy and safety. Methods: We searched the PubMed,VIP and CNKI databases, manual collection of clinical study about allergic rhinitis treatment of montelukast, based on inclusion and exclusion criteria for pooling of literature, Jadad scale used for quality assessment of the literature. Then use Revman4.2 Meta analysis software to evaluate the overall effectiveness. Results: Nine RCT clinical study have been included, The results showed that montelukast group was higher than control group on efficient control, Heterogeneity test showed that the subgroup and its total effective rate is Pgt;01,I2lt;50%. Therefore, we adopted a fixed effects model. After 2 weeks montelukast group and the control group no significant difference (Pgt;0.1). But after 2,3 month the two groups were statistically significant differences(Plt;0.000 01). On a comprehensive analysis of the three subgroups, montelukast group and the control group statistically significant differences(Plt;0.000 01), adverse drug reactions was no significant difference. Conclusion: The available clinical evidence to show that montelukast for the treatment of allergic rhinitis and effective, However, due to the existence of selection and measurement bias, This may affect the outcome of the argument strength.Therefore look forward to more highquality randomized and doubleblind controlled trials to provide highquality evidence.