Padullés Zamora Núria, Comas Sugrañes Dolors, Méndez Cabaleiro Nadia, Figueras Suriol Anna, Jodar Masanes Ramon
Farm Hosp. 2013 Sep-Oct;37(5):399-405. doi: 10.7399/FH.2013.37.5.728.
To assess the efficacy and safety profile of omalizumab treatment. The conditions under which omalizumab was prescribed agreed with those in Xolair® drug information: age > 12 years old, severe uncontrolled asthma, FEV1 < 80%, IgE 30-700 UI/ml and positive test results for perennial allergens.
Asthmatic patients treated with omalizumab between January 2010 and July 2011 were evaluated retrospectively. Age, sex, weight, IgE level, concomitant asthma medications, change in FEV1, emergency department visits, hospitalizations, asthma exacerbations and corticosteroids bursts were recorded before and after omalizumab initiation. A 1.5- year period was chosen.
A total of 22 patients were included. The mean weight of subjects was 73 Kg (range, 51-102). Mean IgE was 203 UI/ml (range, 30-992) and mean FEV1 60% (range, 30-93%) at baseline. Adverse events were observed in 4 patients. There were no significant changes in FEV1 values after omalizumab treatment but omalizumab was associated with a reduction in concomitant asthma medications use in 14 patients and improvements in global asthma control in 12.
In these patients add-on therapy with omalizumab reduced asthma exacerbations and emergency visits or hospitalizations. Only 55% of patients significantly improved global asthma control and no significant changes in FEV1 were observed.
评估奥马珠单抗治疗的疗效和安全性。奥马珠单抗的处方条件与Xolair®药品说明书一致:年龄>12岁、重度未控制哮喘、第一秒用力呼气容积(FEV1)<80%、免疫球蛋白E(IgE)30 - 700 UI/ml且常年变应原检测结果为阳性。
对2010年1月至2011年7月接受奥马珠单抗治疗的哮喘患者进行回顾性评估。记录奥马珠单抗治疗前和治疗后的年龄、性别、体重、IgE水平、哮喘合并用药情况、FEV1变化、急诊就诊次数、住院次数、哮喘急性发作次数及糖皮质激素冲击治疗情况。选取1.5年的时间段。
共纳入22例患者。受试者平均体重为73千克(范围51 - 102千克)。基线时平均IgE为203 UI/ml(范围30 - 992),平均FEV1为60%(范围30 - 93%)。4例患者观察到不良事件。奥马珠单抗治疗后FEV1值无显著变化,但14例患者的哮喘合并用药量减少,12例患者的整体哮喘控制情况改善。
在这些患者中,奥马珠单抗辅助治疗减少了哮喘急性发作以及急诊就诊或住院次数。仅55%的患者整体哮喘控制情况显著改善,且未观察到FEV1有显著变化。