目的:慢性阻塞性肺疾病(COPD)是主要的公共卫生问题。COPD的恶化导致健康状况不佳和频繁发作的全身和气道炎症增加。免疫调节药物已引起广泛关注,因为它们可以降低COPD加重的发生率。本综述旨在评价奈米拉西布治疗COPD患者的疗效和安全性。
方法:医学数据库,包括Cochrane图书馆,EMBASE,和PubMed,从开始到2023年6月进行了查询,以确定关于Nemiralisib在COPD患者中疗效的随机对照试验(RCT)。本系统评价是根据系统评价和荟萃分析指南的首选报告项目进行的。Cochrane协作工具用于评估纳入随机对照试验的偏倚风险。两位作者独立进行文献筛选和数据提取。从纳入的研究中提取了关键信息,列表,并使用数据提取表进行比较。此外,关键特征,质量,潜在偏差,并对纳入研究的终点结局进行总结.当研究结果具有足够可比性时,进行荟萃分析,所需数据可供提取。
结果:最初,确定了48个参考文献,导致纳入四项试验。在圣乔治呼吸问卷评分中,尼拉利布组和安慰剂组之间没有发现显著差异,改良医学研究理事会呼吸困难量表评分,COPD评估测试评分,下一次治疗恶化的时间,达到恶化恢复的患者比例,到恶化恢复的时间,和抢救药物的使用。相反,结果表明,在COPD急性加重期间,奈米拉利布可能会降低口服糖皮质激素的使用.同时,Nemiralisib对恶化率的疗效,以及与肺功能相关的几个参数,包括1秒用力呼气量,比气道电导,特定成像气道壁厚,在功能性残余容量时测量的远端特定成像气道体积,特异性成像气道阻力,低衰减分数,和肺下区域的内部气流大叶分布,是矛盾的。归因于纳入的RCT数量有限,提取的数据不足,进行全面的荟萃分析是不可行的.
结论:由于数据不足,本系统综述未能就Nemiralisib在COPD患者中的疗效做出任何明确的陈述.在安全方面,Nemiralisib通常耐受性良好。需要进一步的试验来探索这种药物的功效。
OBJECTIVE: Chronic obstructive pulmonary disease (COPD) is a major public health concern.
Exacerbation of COPD leads to poor health and frequent episodes of increased systemic and airway inflammation. Immunomodulatory drugs have garnered extensive attention because they may reduce the rate of COPD
exacerbation. This review aimed to evaluate the efficacy and safety of nemiralisib in COPD patients.
METHODS: Medical databases, including the Cochrane Library, EMBASE, and PubMed, were queried from inception to June 2023 to identify randomized controlled trials (RCTs) on the efficacy of nemiralisib in COPD patients. This systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The Cochrane Collaboration tool was used to assess the risk of bias of the included RCTs. Two authors independently conducted literature screening and data extraction. Key information from the included studies was extracted, tabulated, and compared using a data extraction table. Moreover, the key characteristics, quality, potential bias, and endpoint outcomes of the included studies were summarized. A meta-analysis was conducted when the study outcomes were sufficiently comparable, and the required data were available for extraction.
RESULTS: Initially, 48 references were identified, leading to the inclusion of four trials. No significant difference was found between the nemiralisib and placebo groups in St George\'s Respiratory Questionnaire score, modified Medical Research Council Dyspnea Scale score, COPD Assessment Test score, time to next on-treatment
exacerbation, proportion of patients achieving
exacerbation recovery, time to
exacerbation recovery, and rescue medication use. Contrastingly, the results demonstrated that nemiralisib may lower oral corticosteroid use during acute exacerbation of COPD. Meanwhile, the efficacy of nemiralisib on the
exacerbation rate, as well as several parameters associated with lung function, including forced expiratory volume in 1 second, specific airway conductance, specific imaging airway wall thickness, distal specific imaging airway volume measured at functional residual capacity, specific imaging airway resistance, low attenuation score, and internal airflow lobar distribution in the lower pulmonary region, were conflicting. Attributed to the limited number of included RCTs and insufficient extracted data, it was not feasible to conduct a comprehensive meta-analysis.
CONCLUSIONS: Because of insufficient data, this systematic review could not make any definitive statement regarding the efficacy of nemiralisib in COPD patients. In terms of safety, nemiralisib was generally well tolerated. Further trials are required to explore the efficacy of this drug.