Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India
Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
Eur Respir J. 2023 Sep 9;62(3). doi: 10.1183/13993003.00198-2023. Print 2023 Sep.
Current guidelines recommend 20-40 mg·day of oral prednisolone for treating pulmonary sarcoidosis. Whether the higher dose (40 mg·day) can improve outcomes remains unknown.
We conducted an investigator-initiated, single-centre, open-label, parallel-group, randomised controlled trial (ClinicalTrials.gov identifier NCT03265405). Consecutive subjects with pulmonary sarcoidosis were randomised (1:1) to receive either high-dose (40 mg·day initial dose) or low-dose (20 mg·day initial dose) oral prednisolone, tapered over 6 months. The primary outcome was the frequency of relapse or treatment failure at 18 months from randomisation. Key secondary outcomes included the time to relapse or treatment failure, overall response, change in forced vital capacity (FVC, in litres) at 6 and 18 months, treatment-related adverse effects and health-related quality of life (HRQoL) scores using the Sarcoidosis Health Questionnaire and Fatigue Assessment Scale.
We included 86 subjects (43 in each group). 42 and 43 subjects completed treatment in the high-dose and low-dose groups, respectively, while 37 (86.0%) and 41 (95.3%), respectively, completed the 18-month follow-up. 20 (46.5%) subjects had relapse or treatment failure in the high-dose group and 19 (44.2%) in the low-dose group (p=0.75). The mean time to relapse/treatment failure was similar between the groups (high-dose 307 days low-dose 269 days, p=0.27). The overall response, the changes in FVC at 6 and 18 months and the incidence of adverse effects were also similar. Changes in HRQoL scores did not differ between the study groups.
High-dose prednisolone was not superior to a lower dose in improving outcomes or the HRQoL in sarcoidosis and was associated with similar adverse effects.
目前的指南建议使用 20-40mg·天的口服泼尼松龙治疗肺结节病。更高剂量（40mg·天）是否能改善结局尚不清楚。
我们进行了一项由研究者发起的、单中心、开放性、平行组、随机对照试验（ClinicalTrials.gov 标识符 NCT03265405）。连续入组的肺结节病患者按 1:1 随机分为高剂量（初始剂量 40mg·天）或低剂量（初始剂量 20mg·天）口服泼尼松龙组，6 个月内逐渐减量。主要结局为从随机分组后 18 个月时的复发或治疗失败频率。主要次要结局包括复发或治疗失败的时间、总体反应、6 个月和 18 个月时用力肺活量（FVC，以升计）的变化、治疗相关不良事件和健康相关生活质量（HRQoL）评分，使用结节病健康问卷和疲劳评估量表。
我们纳入了 86 例患者（每组 43 例）。高剂量组和低剂量组分别有 42 例和 43 例完成治疗，分别有 37 例（86.0%）和 41 例（95.3%）完成 18 个月随访。高剂量组有 20 例（46.5%）和低剂量组有 19 例（44.2%）发生复发或治疗失败（p=0.75）。两组间复发/治疗失败的平均时间相似（高剂量组 307 天 低剂量组 269 天，p=0.27）。总体反应、6 个月和 18 个月时 FVC 的变化以及不良反应的发生率也相似。两组间 HRQoL 评分的变化无差异。
高剂量泼尼松龙在改善结局或结节病患者的 HRQoL 方面并不优于低剂量，且与相似的不良反应相关。
