奥玛珠单抗减少重度过敏性哮喘患者皮质类固醇的使用:来自以色列的现实生活经验
2012/01/31
摘要
目的:奥玛珠单抗是第一个重组人源化单克隆免疫球蛋白E抗体,针对治疗过敏性哮喘而开发。2003年,奥玛珠单抗被FDA批准用于治疗。由于哮喘症状的异质性,因此,除对照试验之外,其他试验中研究奥玛珠单抗的疗效显得尤为重要。本研究旨在以色列现实生活中,评价奥玛珠单抗作为过敏性哮喘辅助治疗的疗效。
方法:本试验为基于患者病历和计算机数据(药物使用、急诊就诊和住院)的回顾性研究。
结果:共有33名受试者入选,包括18名男性、15名女性,平均年龄为50.0 ± 12.2岁(范围25~79岁)。这些患者因为严重过敏性哮喘而采用奥玛珠单抗治疗至少16周。在开始奥玛珠单抗治疗后,采用口服或注射皮质类固醇激素治疗哮喘的患者人数下降(P分别为<0.003和0.03),口服皮质类固醇的中位剂量也下降(P<0.02)。急诊就诊次数从原来的每人每年0.526次下降至0.246次(p <0.05)。未见奥玛珠单抗治疗的副作用。
结论:奥玛珠单抗作为过敏性哮喘的辅助治疗,能降低皮质类固醇激素的使用,改善哮喘控制,表现为哮喘相关急诊就诊次数下降。本研究支持对照和非对照研究结果,即奥玛珠单抗治疗过敏性哮喘具有较好的疗效和安全性,特别是对于严重哮喘患者疗效较好。现实生活研究对于发现那些能从奥玛珠单抗治疗中获益的患者具有重要作用。
(林江涛 审校)
J Asthma. 2011 Dec 7. [Epub ahead of print]
Omalizumab Reduces Corticosteroid Use in Patients with Severe Allergic Asthma: Real-Life Experience in Israel.
Rottem M.
Source
Division of Allergy Asthma and Clinical Immunology, Emek Medical Center , Afula, Israel.
Abstract
OBJECTIVE:Approved by the FDA in 2003, omalizumab is the first recombinant humanized monoclonal anti-immunoglobulin E antibody developed for the treatment of allergic asthma. Due to the heterogeneity of asthma symptoms, investigation of the efficacy of omalizumab in patients outside controlled trials is particularly important. The purpose of the current study was to evaluate the efficacy of omalizumab as an add-on treatment for allergic asthma in a real-life setting in Israel.
METHODS:This was a retrospective study based on patient records and computerized database for drug dispensing, emergency room visits, and hospital admissions.
RESULTS:The sample comprised 33 individuals (18 men, 15 women; mean age 50.0 ± 12.2, range 25-79) who were treated with omalizumab for severe allergic asthma for a duration of at least 16 weeks. After the initiation of omalizumab therapy, the number of patients who used oral or injected corticosteroids decreased (p < .003, .03, respectively), as did the median dosage of oral corticosteroids (p < .02). Visits to the emergency room decreased from an incidence of 0.526 visits per person-year to an incidence of 0.246 per person-year (p < .05). No adverse reactions to omalizumab were observed.
CONCLUSION:Omalizumab as an add-on therapy reduced the use of corticosteroids and improved the control of asthma, as evidenced by reduced asthma-related emergency room visits. This study supports both controlled and uncontrolled studies that have demonstrated the efficacy and safety of omalizumab, and particularly those that demonstrated effectiveness among severe asthma patients. "Real-life" studies are important to identify patients who will most benefit from omalizumab therapy.
J Asthma. 2011 Dec 7. [Epub ahead of print]
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