奥马珠单抗治疗难治性哮喘疗效与安全性的Meta分析

摘要

Objective To evaluate the efficacy and safety of omalizumab treatment in refractory asthma patients, a systemic review was performed.Methods Randomized trials of omalizumab treatment in asthma refractory patients should be double blinded.The study subjects were defined as refractory asthmatic patients. Computer searching included Cochrane Central Register of Controlled Trials, PubMed, CBM, CNKI, and Wanfang database.Data were combined and analyzed with RevMan 5.0.24. Results 12 trials (4987 participants) met the selection criteria. Omalizumab-treated patients showed a decreased risk of asthma exacerbations at the end of the stable (RR=0.64,95% CI 0.53-0.78, P<0.000 01) and adjustable-steroid phases (RR=0.57, 95% CI 0.48-0.68, P<0.000 01).At the end of the steroid-reduction phase, patients taking omalizumab were more likely to be able to withdraw from corticosteroids completely (RR=1.8, 95%CI 1.42-2.28, P<0.000 01) and reduce their corticosteroid dose by 50% (RR=1.35, 95% CI 1.26-1.46, P<0.000 01) compared with those taking placebo. Patients taking omalizumab did not increase the frequency of any adverse effects (RR=0.99, 95% CI 0.96, 1.02, P=0.63)and serious adverse effects (RR=0.82, 95%CI 0.64, 1.04, P=0.11)compared with the patients taking placebo. However, injection site reactions were more frequent in the omalizumab patients(RR=1.45, 95% CI 1.05, 2.02, P=0.003). Conclusions Data indicate that the efficacy of add-on omalizumab in patients with refractory asthma is accompanied by an acceptable safety profile.%目的：系统评价奥马珠单抗治疗难治性哮喘的疗效与安全性。方法通过检索 PubMed、Cochrane、CBM、CNKI以及万方数据库，纳入奥马珠单抗治疗难治性哮喘的随机双盲对照试验，研究对象为难治性哮喘患者。使用Revman 5.0.24软件对数据进行Meta分析，评价奥马珠单抗的疗效及安全性。结果本研究共纳入12项临床对照试验（n=4987）。与安慰剂组相比，奥马珠单抗组在激素量恒定期（RR=0.64,95%CI 0.53～0.78，P<0.00001）及激素减量期（RR=0.57，95%CI 0.48～0.68，P<0.00001）均可减少哮喘急性发作风险。在激素减量期，奥马珠单抗组完全停用激素的人数（RR=1.8，95%CI 1.42～2.28， P<0.00001）及激素减量>50%的人数（RR=1.35，95%CI 1.26～1.46，P<0.00001）均较安慰剂组为多。奥马珠单抗使用安全，除注射部位不良反应（RR=1.45，95%CI 1.05,2.02，P=0.003）外，总的不良反应（RR=0.99，95%CI 0.96,1.02，P=0.63）及严重不良反应（RR=0.82，95%CI 0.64,1.04，P=0.11）并未增加。结论对于难治性哮喘，在常规治疗的基础上加用奥马珠单抗治疗，可提高疗效，且安全性高。