哮喘联盟

   摘要
   目的：数个临床研究已证实奥马珠单抗可有效治疗严重过敏性哮喘，但疗程相对较短（4-12个月）。只有很少的数据涉及奥马珠单抗的长期应用。我们有意评估严重过敏性哮喘患者长期应用奥马珠单抗的临床和功能有效性。
   方法：治疗前、治疗4个月、12个月、36个月后分别记录患者状况，对奥马珠单抗的有效性作出评价。26例严重过敏性哮喘患者（男性/女性：21/5）入组，均为根据经2006版GINA的 4级治疗无效的患者。疗效评价包括呼气量测定、哮喘控制试验(ACT)评估哮喘控制程度、全身应用糖皮质激素(sGCS)、急诊就诊、住院治疗严重大发作。另外，分别在治疗前、4个月、36个月后用生活质量问卷评价生活质量。
   结果：患者平均年龄47.6±13.9岁，过敏性哮喘病程22.7±10.1年。血清总IgE 322.0±178.1 IU/mL。奥马珠单抗中位治疗周期为40.81±8.2个月。每一个时间点的FEV1与基线相比均显著提高。以ACT评价的哮喘控制程度治疗后显著提高。36个月后，我们发现哮喘急性发作、急诊就诊、住院、sGCS 和SABA使用均明显减少。治疗持续4个月后AQLQ(S)评分提高1.5分以上者的比例为80.7%，持续36个月后达到96.1%。
   结论：本研究显示奥马珠单抗长期治疗持续至3年，耐受性良好，可显著改善症状和肺功能。因此，可推荐应答者接受奥马珠单抗长期治疗。
 

（刘国梁 审校）
J Asthma. 2013 Apr 4. [Epub ahead of print]

 

Assessment of Long-term Omalizumab Treatment in Patients with Severe Allergic Asthma.
 

Ozgür ES, Ozge C, Ilvan A, Nayci SA.
 

Abstract
OBJECTIVE: Several clinical studies have demonstrated omalizumab effectiveness in patients with severe allergic asthma but the treatment period has always been relatively short (4-12 months). Only a few data is present for long-term omalizumab therapy. We aimed to assess the long-term clinical and functional effectiveness of omalizumab treatment in severe allergic asthmatic patients.
METHODS: Medical records describing the patients' status starting before treatment and also having been registered at the end of 4th, 12th and 36th months from the commencement of treatment and at the last visit where the patient was evaluated were used for omalizumab effectiveness assessments. Twenty-six patients (female/male: 21/5) with severe allergic asthma, uncontrolled despite GINA 2006 Step 4 therapy, were included in the study. Effectiveness outcomes included spirometry measurements, level of asthma control measured by asthma control test (ACT), systemic glucocorticosteroid (sGCS) use, emergency room (ER) visits and hospitalizations for severe exacerbations. In addition, quality of life was assessed using the quality of life questionnaire AQLQ(S) before and 4 and 36 months after treatment.
RESULTS: The mean age was 47.6±13.9 and duration of allergic asthma 22.7±10.1 years. Serum total IgE levels were 322.0±178.1 IU/mL. Mean duration of omalizumab treatment was 40.81±8.2 months. FEV1 improved significantly at all control points versus baseline (p<0.05). The level of asthma control as evaluated by ACT improved significantly after treatment (p<0.05). We determined significantly reduced numbers of exacerbation, emergency visits, hospitalizations, sGCS and SABA use by the end of 36 months (p<0.05). The proportion of patients with improvements larger than 1.5 points in AQLQ(S) total score was 80.7% at the 4th month and 96.1% at the 36th month of treatment.
CONCLUSIONS: This study showed that long-term therapy with omalizumab for up to 3 years was well tolerated with significant improvement both in symptoms and lung functions. Accordingly, long-term omalizumab treatment may be recommended for responders.

J Asthma. 2013 Apr 4. [Epub ahead of print]