Alfarroba S, Videira W, Galvão-Lucas C, Carvalho F, Bárbara C
Serviço de Pneumologia, Hospital Pulido Valente, Lisboa, Portugal.
Serviço de Pneumologia, Hospital Pulido Valente, Lisboa, Portugal.
Rev Port Pneumol. 2014 Mar-Apr;20(2):78-83. doi: 10.1016/j.rppneu.2013.07.006. Epub 2014 Feb 10.
It is widely recognized that asthma control is not always possible in patients with very severe asthma despite available treatment. The aim of this study was to evaluate the efficacy of Omalizumab on asthma control as an add-on therapy in patients from the "Severe Asthma Outpatient Clinic" of Pulido Valente Hospital in Lisbon, Portugal.
A retrospective study was conducted to assess asthma control by the ACT score and by GINA classification, frequency and severity of exacerbations, medication use and pulmonary function in patients treated with Omalizumab. Clinical information was collected from medical records from the start of treatment and at 6, 12 and 24 month follow-up.
26 patients started treatment with Omalizumab, all (100%) were classified by GINA with uncontrolled asthma prior to treatment. Mean ACT score was 11.5. All patients had treatment with fixed-dose ICS and LABA and 34.6% also had an anti-cholinergic inhaler. 42.3% of patients were also treated with oral glucocorticosteroids for control. Patients reported an average of 1.8 moderate and 3.1 severe exacerbations/year. Statistical differences were found at 6 month follow-up in most end-points: GINA score improved: 60.9% of patients with partially controlled asthma and only 39.1% with uncontrolled asthma (Wilcoxon 0.00); ACT score improved to 19.52 (Wilcoxon 0.00); mean FEV1 improved to 76.7% (Wilcoxon 0.025); the proportion of patients requiring oral glucocorticosteroid therapy reduced to 17.4% (Wilcoxon 0.014); and the number of moderate and severe exacerbations also decreased to 1.04 and 1.83 respectively (Wilcoxon 0.007; Wilcoxon 0.002 respectively).
The current analysis shows evidence that omalizumab is successful in improving asthma control as an add-on therapy GINA step 5 treatment.
人们普遍认识到，尽管有可用的治疗方法，但对于非常严重的哮喘患者，哮喘控制并非总是能够实现。本研究的目的是评估奥马珠单抗作为附加疗法对葡萄牙里斯本普利多·瓦伦特医院“重度哮喘门诊”患者哮喘控制的疗效。
进行了一项回顾性研究，通过ACT评分、GINA分类、加重发作的频率和严重程度、药物使用情况以及接受奥马珠单抗治疗患者的肺功能来评估哮喘控制情况。从治疗开始以及在6个月、12个月和24个月随访时从病历中收集临床信息。
26例患者开始使用奥马珠单抗治疗，所有患者（100%）在治疗前根据GINA分类为哮喘未得到控制。ACT平均评分为11.5。所有患者均接受了固定剂量的吸入性糖皮质激素（ICS）和长效β2受体激动剂（LABA）治疗，34.6%的患者还使用了抗胆碱能吸入器。42.3%的患者也接受口服糖皮质激素治疗以控制病情。患者报告平均每年有1.8次中度发作和3.1次重度发作。在6个月随访时，大多数终点指标均发现有统计学差异：GINA评分改善：60.9%的患者哮喘部分得到控制，只有39.1%的患者哮喘未得到控制（威尔科克森检验，P = 0.00）；ACT评分提高到19.52（威尔科克森检验，P = 0.00）；平均第一秒用力呼气容积（FEV1）提高到76.7%（威尔科克森检验，P = 0.025）；需要口服糖皮质激素治疗的患者比例降至17.4%（威尔科克森检验，P = 0.014）；中度和重度发作次数也分别降至1.04次和1.83次（威尔科克森检验，分别为P = 0.007；P = 0.002）。
目前的分析表明，奥马珠单抗作为附加疗法在GINA第5步治疗中成功改善了哮喘控制情况。
