摘要:目的:評價孟魯司特用于過敏性鼻炎的臨床療效和安全性。方法:計算機檢索PubMed、維普及CNKI數據庫,手工收集有關孟魯司特用于過敏性鼻炎治療的臨床研究,根據納入和剔除標準匯集文獻,采用Jadad量表進行納入文獻質量評價,對總體治療有效性使用Revman4.2軟件進行Meta分析。結果:療效評價共納入9個臨床隨機對照研究共650例。有效率孟魯司特組高于對照組,異質性檢驗顯示各亞組及其合并總有效率P值均大于0.1,I2lt;50%,采用固定效應模型計算。2周時孟魯司特組和對照組無統計學差異(Pgt;0.1),但2月、3月時二組均有顯著性統計學差異(Plt;0.000 01),三個亞組綜合分析孟魯司特組和對照組有顯著性統計學差異(Plt;0.000 01),不良反應差異無統計學意義。結論:現有臨床證據顯示孟魯司特較傳統抗過敏藥物對過敏性鼻炎的治療有效,但由于納入研究存在選擇性偏倚和測量性偏倚的可能性,勢必影響結果的論證強度。故期待更多高質量的隨機雙盲對照試驗性研究,以提供更高質量的證據。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.
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.
