Tyson M Walters, Marcus C H Leong, Sydney B Montesi, Christopher J Ryerson, Yet H Khor
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引用次数: 0
Abstract
Background: Comorbidities can affect drug tolerability and health outcomes in patients with fibrotic interstitial lung disease. This systematic review and meta-analysis evaluated the types and prevalence of comorbidities amongst participants in pharmaceutical randomised controlled trials (RCTs) of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).
Methods: Ovid Medline, Embase and CENTRAL databases were searched to identify phase II and III pharmaceutical RCTs of IPF or PPF. Reporting of comorbidities was evaluated, with meta-analyses being performed for the prevalence of different conditions.
Results: 34 articles were included, with 23 unique trials for IPF and one for PPF. A mean of 14 (range 1-44) comorbidities per study was reported in the IPF RCTs, with 11 being reported in the PPF RCT. Common comorbidities in the IPF RCT cohorts were systemic hypertension (pooled prevalence 45%, 95% CI 39-50%), hyperlipidaemia (38%, 95% CI 27-49%), gastro-oesophageal reflux disease (45%, 95% CI 36-54%), ischaemic heart disease (18%, 95% CI 13-42%) and diabetes mellitus (16%, 95% CI 13-20%). The PPF trial cohort had similar types and prevalence of comorbidities to those reported in the IPF trial cohorts.
Conclusions: Reporting of comorbidities varied across previous IPF RCTs, with limited data available for PPF. Prevalence of comorbidities reported in the IPF and PPF trial cohorts appear to be lower than those reported in prospective patient registries. There is a need for careful consideration of trial eligibility criteria with detailed reporting of comorbidities in future pharmaceutical RCTs to better understand the applicability of trial findings to real-world patients.
背景：合并症可影响纤维化间质性肺疾病患者的药物耐受性和健康结局。本系统综述和荟萃分析评估了特发性肺纤维化（IPF）和进行性肺纤维化（PPF）药物随机对照试验（RCTs）参与者中合并症的类型和患病率。方法：检索Ovid Medline、Embase和CENTRAL数据库，筛选IPF或PPF的II期和III期药物随机对照试验。对合并症的报告进行了评估，并对不同疾病的患病率进行了荟萃分析。结果：纳入34篇文章，其中23篇是针对IPF的独特试验，1篇是针对PPF的。在IPF随机对照试验中，平均每项研究报告了14例（范围1-44例）合并症，PPF随机对照试验报告了11例。IPF RCT队列中常见的合并症是全身性高血压（总患病率45%，95% CI 39-50%）、高脂血症（38%,95% CI 27-49%）、胃食管反流病（45%,95% CI 36-54%）、缺血性心脏病（18%,95% CI 13-42%）和糖尿病（16%,95% CI 13-20%）。PPF试验队列与IPF试验队列报告的合并症的类型和患病率相似。结论：在之前的IPF随机对照试验中，合并症的报告各不相同，可获得的PPF数据有限。IPF和PPF试验队列中报告的合并症患病率似乎低于前瞻性患者登记中报告的患病率。在未来的药物随机对照试验中，有必要仔细考虑试验资格标准，并详细报告合并症，以更好地了解试验结果对现实世界患者的适用性。
期刊介绍：
The European Respiratory Review (ERR) is an open-access journal published by the European Respiratory Society (ERS), serving as a vital resource for respiratory professionals by delivering updates on medicine, science, and surgery in the field. ERR features state-of-the-art review articles, editorials, correspondence, and summaries of recent research findings and studies covering a wide range of topics including COPD, asthma, pulmonary hypertension, interstitial lung disease, lung cancer, tuberculosis, and pulmonary infections. Articles are published continuously and compiled into quarterly issues within a single annual volume.
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