Safety and efficacy of omalizumab for the treatment of allergic rhinitis: Meta-analysis of randomized clinical trials
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摘要: 目的:分析奥马珠单抗针对变应性鼻炎患者的疗效和安全性,为临床治疗变应性鼻炎提供循证医学证据。方法:检索Pubmed、Medline、Cochrane、Embase等数据库,同时手工检索相关会议论文集、出版物及会议摘要等。检索年限自建库至2014年8月。检索词汇包括:变应性鼻炎、奥马珠单抗、疗效、安全性和随机对照试验,无语言限制。然后按照纳入和排除标准对文献进行筛选及质量评估,运用RevMan5.3统计学软件(Cochrane协作网站提供)对所提取的数据进行Meta分析。结果:共纳入9例随机对照实验。均为英文文献,纳入人数1 764例,实验组859例,对照组905例。Meta分析结果表明,应用奥马珠单抗治疗的实验组相比较应用安慰剂的对照组,在改善患者症状评分上差异有统计学意义(P<0.05),安全性差异无统计学意义(P<0.05),其WMD值和95%CI分别为总鼻炎症状评分(0.04,-0.10~0.19),流涕(-0.32,-0.44~-0.21),鼻塞(-0.33,-0.38~-0.27),鼻痒(-0.08,-0.25~0.09),喷嚏(-0.24,-0.27~-0.21),非鼻部症状(0.30,0.04~0.55)。结论:奥马珠单抗与安慰剂相比,能明显改善变应性鼻炎患者的症状,疗效较好,安全性良好。Abstract: Objective: To assess the efficacy and safety of omalizumab in patients with allergic rhinitis(AR) in a meta-analysis of clinical trial results, and provide evidence for the clinical treatment of AR.Method: Pubmed, Medline, Cochrane and Embase were searched through August 2014 using the terms 'allergic rhinitis, omalizumab, efficacy, safety, and randomized controlled trial(RCT)'without language restriction. Relevant reviews, publications, and abstracts of meetings were also retrieved. RevMan5.3 software was used for meta-analysis after data extraction.Result: Nine RCTs were included(n=1764).Of the 1764 participants,859 patients were treated by omalizumab and the other 905 received a placebo.The meta-analysis revealed that patients treated with omalizumab had significantly reduced total and individual symptoms scorescompared with the placebo group(P<0.05). And there was no significantly differences in adverse events between placebo and omalizumab(P<0.05).The WMD rate and 95%CI were as follows:total nasal symptom scores(0.04,-0.10 to 0.19), rhinorrhea (-0.32, -0.44 to -0.21), nasal stuffiness(-0.33,-0.38 to -0.27), nasal itching (-0.08,-0.25 to 0.09), and sneezing(-0.24, -0.27 to -0.21), and non-nasal symptoms scores(0.30,0.04 to 0.55).Conclusion: Compared to the placebo,omalizumab can effectively and safely reduce symptoms scores of patients with AR.
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Key words:
- omalizumab /
- rhinitis, allergic /
- Meta-analysis
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