CAJ | 학술논문

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。
목적：계통평개오마주단항치료난치성효천적료효여안전성。방법통과검색 PubMed、Cochrane、CBM、CNKI이급만방수거고，납입오마주단항치료난치성효천적수궤쌍맹대조시험，연구대상위난치성효천환자。사용Revman 5.0.24연건대수거진행Meta분석，평개오마주단항적료효급안전성。결과본연구공납입12항림상대조시험（n=4987）。여안위제조상비，오마주단항조재격소량항정기（RR=0.64,95%CI 0.53～0.78，P<0.00001）급격소감량기（RR=0.57，95%CI 0.48～0.68，P<0.00001）균가감소효천급성발작풍험。재격소감량기，오마주단항조완전정용격소적인수（RR=1.8，95%CI 1.42～2.28， P<0.00001）급격소감량>50%적인수（RR=1.35，95%CI 1.26～1.46，P<0.00001）균교안위제조위다。오마주단항사용안전，제주사부위불량반응（RR=1.45，95%CI 1.05,2.02，P=0.003）외，총적불량반응（RR=0.99，95%CI 0.96,1.02，P=0.63）급엄중불량반응（RR=0.82，95%CI 0.64,1.04，P=0.11）병미증가。결론대우난치성효천，재상규치료적기출상가용오마주단항치료，가제고료효，차안전성고。
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.