奥马佐单抗治疗过敏性支气管哮喘疗效与安全性的系统评价

Effectiveness and Safety of Omalizumab in Treating Allergy Bronchial Asthma: A Systematic Review

目的系统评价奥马佐单抗治疗过敏性支气管哮喘的疗效及安全性。方法计算机检索MEDLINE、EMbase、e Cochrane Library、CBM、CNKI、VIP和WanFang Data等数据库,收集奥马佐单抗治疗过敏性支气管哮喘的随机对照试验(RCT),检索时限均为从建库至2013年4月,并追溯纳入研究的参考文献和手工检索相关会议资料。由两位研究者按照纳入与排除标准独立筛选文献、提取资料和评价质量后,采用RevMan 5.1软件进行Meta分析。结果共纳入了13个RCT,4 195例患者。Meta分析结果显示:①试验组与对照组比较,治疗期间发生哮喘急性加重率降低[RR=0.71,95%CI(0.65,0.77),P<0.000 01];而哮喘全球疗效评估(GETE)达优/良的患者比例更高[RR=1.61,95%CI(1.32,1.97),P<0.000 01];更多的患者可在治疗期和之后的24周随访期达吸入性糖皮质激素(ICS)减量大于50%[分别为RR=1.40,95%CI(1.29,1.52)和RR=1.69,95%CI(1.41,2.03)];哮喘相关生存质量(AQLQ)总分提高0.5分和1.5分的患者比例也均明显增高。②两组间总不良反应发生率相似[RR=1.01,95%CI(0.98,1.04)],且严重不良反应发生率也无差异[RR=0.94,95CI(0.68,1.28)]。③对于能否减少急救药物的使用和肺功能的改善,可能有一定作用,但目前观察到的效果不明显。结论奥马佐单抗在哮喘治疗中可降低哮喘急性加重率和ICS的使用,提高疗效评估和生活质量,且有较好的安全性。

Objective To systematically evaluate the effectiveness and safety of omalizumab in treating allergic bronchial asthma. Methods The randomized controlled trials （RCTs） about omalizumab in treating allergic bronchial asthma were searched in databases such as MEDILINE, EMbase, The Cochrane Library, CBM, CNKI, VIP and WanFang Data from inception to April 2013. The references of included studies and relevant conference proceedings were also re- trieved manually. Two reviewers independently screened the literature according to the inclusion and exclusion criteria, extracted the data, and assessed the quality, and then RevMan 5.1 software was used for meta-analysis. Results A total of 13 RCTs involving 4 195 patients were included. The results of meta-analysis showed that： a） Compared with the con- trol group, the trial group revealed lower acute exacerbation of asthma during treatment （RR=0.71, 95%CI 0.65 to 0.77, P〈0.000 01）, and higher rate of patients achieved best/better results in Global Evaluation of Treatment Effectiveness （GETE） （RR=1.61, 95%CI 1.32 to 1.97, P〈0.000 01）. More patients could reduce the inhaled cortisteroid （ICS） by 50% during both treatment （RR=1.40, 95%CI 1.29 to 1.52） and 24-week follow-up period （RR=1.69, 95%CI 1.41 to 2.03）. And it also increased the ratio of patients whose Asthma Quality Of Life Questionnaire （AQLQ） score got improved by 0.5 and 1.5 socres, b） There were no significant differences in the incidence of overall adverse events （RR=1.01, 95%CI 0.98 to 1.04） and severe adverse events （RR=0.94, 95CI 0.68 to 1.28）. c） There might be the effects of omalzumab in improving lung function and reducing rescue medication use, but they were not obviously observed in the studies. Conclusion In the treatment of asthma, omalizumab can decrease the acute exacerbation of asthma and ICS use, and it is safer to improve the therapeutic effects and quality of life.