孟鲁司特钠联合盐酸氮卓斯汀治疗变应性鼻炎有效性和安全性的系统评价

Systematic Review of Efficacy and Safety of Montelukast Sodium Combined with Azelastine Hydrochloride in the Treatment of Allergic Rhinitis

目的:系统评价孟鲁司特钠联合盐酸氮卓斯汀治疗变应性鼻炎的有效性和安全性。方法:计算机检索PubMed、中国知网、the Cochrane Library、EMBase和万方数据库,纳入评价孟鲁司特钠联合盐酸氮卓斯汀治疗变应性鼻炎的随机对照试验(研究组患者使用孟鲁司特钠联合盐酸氮卓斯汀治疗,对照组患者单独使用盐酸氮卓斯汀,用法、用量不限),检索时间从建库至2021年3月。由2名研究人员提取资料、选取文献、并评价纳入文献的偏倚风险后,采用RevMan 5.4软件进行荟萃分析(Meta分析)。结果:共纳入13项随机对照试验研究,包括2659例患者(研究组患者1330例,对照组患者1329例)。Meta分析结果显示,有效性方面,研究组患者的总有效率(OR=6.25,95%CI=4.52~8.65,P<0.00001)、显效率(OR=2.36,95%CI=1.85~3.01,P<0.00001)和复发率(OR=0.30,95%CI=0.14~0.65,P=0.002)均显著优于对照组,差异均有统计学意义;安全性方面,两组患者不良反应发生率的差异无统计学意义(OR=1.19,95%CI=0.52~2.71,P=0.69>0.05)。结论:现有证据表明,孟鲁司特钠联合盐酸氮卓斯汀治疗变应性鼻炎安全、有效,较单独使用盐酸氮卓斯汀有显著优势。因选取的研究数量和质量的限制,上述结论有待今后更多高质量随机对照试验予以验证。

OBJECTIVE:To systematically evaluate the efficacy and safety of montelukast sodium combined with azelastine hydrochloride in the treatment of allergic rhinitis.METHODS:PubMed,CNKI,the Cochrane Library,EMBase and Wanfang database were retrieved to collect the randomized controlled trial of montelukast sodium combined with azelastine hydrochloride in the treatment of allergic rhinitis(the study group was treated with montelukast sodium combined with azelastine hydrochloride,while the control group received azelastine hydrochloride alone,without limitation of usage and dosage).The retrieval time was from the establishment of the database to Mar.2021.Meta-analysis was performed by using RevMan 5.4 software after data extraction by two researchers,selection of literature,and evaluation of risk of bias in the included literature.RESULTS:Totally 13 randomized controlled trials were collected,including 2659 patients(1330 patients in the study group and 1329 patients in the control group).Meta-analysis showed that in terms of effectiveness,the total effective rate(OR=6.25,95%CI=4.52-8.65,P<0.00001),significant effective rate(OR=2.36,95%CI=1.85-3.01,P<0.00001)and recurrence rate(OR=0.30,95%CI=0.14-0.65,P=0.002)in the study group were significantly better than those in the control group,and the differences were statistically significant.There was no significant difference in the incidence of adverse drug reactions between two groups(OR=1.19,95%CI=0.52-2.71,P=0.69>0.05).CONCLUSIONS:Available evidence suggests that montelukast sodium in combination with azelastine hydrochloride is safe and effective in the treatment of allergic rhinitis,with significant advantages over the use of azelastine hydrochloride alone.Due to the limited number and quality of selected literature,the above conclusions need to be verified by more high-quality randomized controlled trials in the future.