Division of Internal Medicine, McMaster University, Canada; Michael G. Degroote School of Medicine, McMaster University, Canada.
Michael G. Degroote School of Medicine, McMaster University, Canada.
Pulm Pharmacol Ther. 2022 Jun;73-74:102128. doi: 10.1016/j.pupt.2022.102128. Epub 2022 Apr 20.
Patients with idiopathic pulmonary fibrosis have a poor overall prognosis and there are few evidence-based drug therapies that reduce mortality.
We aimed to perform a systematic review and meta-analysis to assess whether sildenafil reduces mortality, disease progression and adverse side effects.
We reviewed randomized controlled studies (RCTs) from MEDLINE, Cochrane registry of clinical trials, and EMBASE. Our outcomes of interest included mortality, change in FVC, acute exacerbations and hospitalizations and adverse drug effects leading to discontinuation. We used an inverse variance fixed effects meta-analysis method to calculate pooled relative risk (RR) and mean difference (MD).
A total of 4 studies were included in the systematic review. Sildenafil probably reduces mortality when compared to placebo or to standard care, [RR 0.73 (95% CI 0.51 to 1.04); moderate certainty]. Pooled estimates showed sildenafil may not alter the rate of change of FVC [MD 0.61% (95% CI -0.29 to 1.52)], or DLCO [MD 0.97% (95% CI 0.04 to 1.90)] (both low certainty). Pooled estimated showed sildenafil may not reduce the number of hospitalizations or acute exacerbations, [RR 1.10 (95% CI 0.61 to 1.98); low certainty]. There is probably no difference in drug discontinuation due to adverse effects when comparing sildenafil to the control group, [RR 0.79 (95% CI 0.56, 1.10); moderate certainty].
Sildenafil probably reduces all-cause mortality in IPF patients. More studies need to be done to confirm the magnitude and reliability of the point estimate.
特发性肺纤维化患者的总体预后较差,目前仅有少数基于证据的药物疗法可以降低死亡率。
我们旨在进行系统评价和荟萃分析,以评估西地那非是否可以降低死亡率、疾病进展和不良反应。
我们检索了 MEDLINE、Cochrane 临床试验注册库和 EMBASE 中的随机对照研究(RCT)。我们感兴趣的结局包括死亡率、FVC 变化、急性加重和住院以及导致停药的药物不良反应。我们使用逆方差固定效应荟萃分析方法计算汇总相对风险(RR)和平均差(MD)。
共有 4 项研究纳入了系统评价。与安慰剂或标准治疗相比,西地那非可能降低死亡率,[RR 0.73(95%CI 0.51 至 1.04);中等确定性]。汇总估计表明,西地那非可能不会改变 FVC 的变化率[MD 0.61%(95%CI -0.29 至 1.52)]或 DLCO[MD 0.97%(95%CI 0.04 至 1.90)](均为低确定性)。汇总估计表明,西地那非可能不会减少住院或急性加重的次数,[RR 1.10(95%CI 0.61 至 1.98);低确定性]。与对照组相比,西地那非因不良反应导致停药的可能性可能没有差异,[RR 0.79(95%CI 0.56 至 1.10);中等确定性]。
西地那非可能降低特发性肺纤维化患者的全因死亡率。需要进一步开展研究以确认该点估计的幅度和可靠性。