Dept of Clinical Pharmacy, St Antonius Hospital, Nieuwegein, The Netherlands
Dept of Clinical Pharmacy, St Antonius Hospital, Nieuwegein, The Netherlands.
Eur Respir Rev. 2020 Jan 29;29(155). doi: 10.1183/16000617.0057-2019. Print 2020 Mar 31.
Many sarcoidosis patients experience a reduction in health-related quality of life (HRQoL) and a majority of patients report fatigue. Historically, drug trials in sarcoidosis have focused on changes in chest radiographs, lung function parameters and biomarkers, while HRQoL and fatigue have not been the main outcomes examined. We performed a systematic review of the literature to evaluate the existing evidence on the effects of pharmacological interventions on HRQoL and fatigue outcomes.
The systematic search was performed in Medline and Embase and yielded 15 records covering seven randomised controlled trials and seven single-arm open label studies, which were included in a qualitative synthesis (the results of one study were included in two publications). 12 studies evaluated immunosuppressive and/or immunomodulatory therapies and two studies evaluated stimulants.
Nine out of the 14 studies observed positive treatment effects from the interventions on HRQoL and/or fatigue, exceeding the minimal important difference. The risk of bias was generally high with only three studies rated as having a low risk of bias. The results suggest a potential for improvement in HRQoL and/or fatigue in patients with active disease who are either untreated or treated but not yet fully stabilised or therapy refractory.
More randomised, double-blind and placebo-controlled trials are needed to expand the evidence base on these important outcome parameters.
许多类肉瘤病患者的健康相关生活质量（HRQoL）下降，大多数患者报告疲劳。从历史上看，类肉瘤病的药物试验集中在胸部 X 光片、肺功能参数和生物标志物的变化上，而 HRQoL 和疲劳并不是主要的检查结果。我们对文献进行了系统回顾，以评估现有关于药物干预对 HRQoL 和疲劳结果影响的证据。
在 Medline 和 Embase 中进行了系统搜索，共获得了 15 份记录，涵盖了 7 项随机对照试验和 7 项单臂开放标签研究，这些研究被纳入定性综合分析（一项研究的结果被纳入了两份出版物）。12 项研究评估了免疫抑制和/或免疫调节疗法，两项研究评估了兴奋剂。
14 项研究中有 9 项观察到干预措施对 HRQoL 和/或疲劳有积极的治疗效果，超过了最小重要差异。偏倚风险通常较高，只有 3 项研究被评为低偏倚风险。结果表明，对于活动性疾病且未经治疗或治疗但尚未完全稳定或治疗抵抗的患者，HRQoL 和/或疲劳可能会有所改善。
需要更多的随机、双盲和安慰剂对照试验来扩大这些重要结局参数的证据基础。
