Lin Jiangtao, Wang Zaiyi, Qiu Chen, Wang Zhen, Jiang Shanping, Tang Huaping, Wang Xuefen, Qiu Zhongmin, He Yong, Zhao Jianping, Shi Guochao, Sun Shenghua, Wang Limin, Chen Lin, Wang Jue, Mao Annhua
Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China.
Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Xinjiang Medical University, Xinjiang, China.
J Thorac Dis. 2020 Nov;12(11):6573-6585. doi: 10.21037/jtd-20-1989.
Evidence of treatment against cough variant asthma (CVA) is insufficient for the clinical practice in China. We aimed at evaluating the real-world effectiveness of montelukast (MONT) alone or in combination with low-dose inhaled corticosteroids (ICS) and low-dose ICS plus long-acting beta-2-agonists (LABA) for Chinese CVA patients in a multicentre, prospective, cohort study.
Adult patients diagnosed with CVA defined as chronic cough >8 weeks with a positive bronchial provocation test and normal chest X-ray findings were enrolled at respiratory clinics. Study treatment followed routine clinical practice. The investigators initiated MONT by 10 mg/day alone or in combination with a low-dose ICS +/- LABA and followed up treatment outcomes for 4 weeks. The primary outcome measure was the change in cough score (CS) from baseline.
The study enrolled 247 patients (MONT =146, MONT + ICS =38, MONT + ICS/LABA =63). In the primary analysis, the mean change (95% CI) in CS at the end of the study was -1.2 (-1.6, -0.9), -0.9 (-1.5, -0.4), and -1.3 (-1.7, -0.8) in the three groups, respectively. MONT monotherapy had a satisfactory rate of weekly asthma control at the end of the study (83.5%, 95% CI: 75.1%, 89.4%) in the per-protocol analysis. Rates of weekly asthma control were similar in two MONT-based combination regimens (83.9%, 81.4%). Short-acting beta-2-agonist (SABA) user (≥2 times per week) was 16.8% in the MONT group.
The real-world effectiveness of MONT alone or in combination with ICS or ICS and LABA was acceptable for CVA short-term control.
在中国的临床实践中，针对咳嗽变异性哮喘（CVA）的治疗证据不足。我们旨在通过一项多中心、前瞻性队列研究，评估孟鲁司特（MONT）单药治疗或联合低剂量吸入性糖皮质激素（ICS）以及低剂量ICS加长效β2受体激动剂（LABA）对中国CVA患者的真实世界疗效。
在呼吸科门诊招募被诊断为CVA的成年患者，其定义为慢性咳嗽>8周，支气管激发试验阳性且胸部X线检查结果正常。研究治疗遵循常规临床实践。研究者开始使用10mg/天的MONT单药治疗，或联合低剂量ICS +/- LABA，并对治疗结果进行4周的随访。主要结局指标是咳嗽评分（CS）相对于基线的变化。
该研究共纳入247例患者（MONT组 =146例，MONT + ICS组 =38例，MONT + ICS/LABA组 =63例）。在初步分析中，三组患者在研究结束时CS的平均变化（95%CI）分别为-1.2（-1.6，-0.9）、-0.9（-1.5，-0.4）和-1.3（-1.7，-0.8）。在意向性分析中，MONT单药治疗在研究结束时的每周哮喘控制满意率为83.5%（95%CI：75.1%，89.4%）。两种基于MONT的联合治疗方案的每周哮喘控制率相似（83.9%，81.4%）。MONT组中短效β2受体激动剂（SABA）使用者（每周≥2次）为16.8%。
MONT单药治疗或联合ICS或ICS与LABA对CVA的短期控制的真实世界疗效是可以接受的。
