Skandamis Aristeidis, Kani Chara, Markantonis Sophia L, Souliotis Kyriakos
Pharmacy Department, National and Kapodistrian University of Athens, Athens, Greece.
Faculty of Social and Political Sciences, University of Peloponnese, Corinth, Greece.
J Drug Assess. 2019 Apr 12;8(1):55-61. doi: 10.1080/21556660.2019.1597726. eCollection 2019.
Clinical practice guidelines for the treatment of idiopathic pulmonary fibrosis (IPF) currently recommend pirfenidone and nintedanib. However, there is a lack of evidence from head-to-head comparisons. To perform a systematic review and network meta-analysis (NMA) to access the efficacy and tolerability of two new treatments for IPF, pirfenidone and nintedanib. : Randomized controlled trials (RCTs) selection (CENTRAL, MEDLINE, Embase), data extraction, risk of bias analysis, and GRADE assessment were carried out by two authors separately. Direct estimates were calculated using standard pairwise meta-analysis. A Bayesian mixed treatment comparison approach for NMA estimates, with 95% confidence intervals (CI), was used to compare the treatments, calculating odds ratios (OR) and number needed to treat (NNTB) or harm (NNTH). The NMA on 10 randomized controlled trials showed that each drug had a positive effect on percentage of forced vital capacity (FVC) decline ≥ 10% (pirfenidone OR = 0.54 [95% CI = 0.37-0.80], NNTB = 9 [95% CI = 7-22]; nintedanib OR = 0.59 [95% CI = 0.41-0.84], NNTB = 9 [95% CI = 6-23]), but no significant differences were noted when comparing pirfenidone and nintedanib with respect to acute exacerbations, mortality, and serious adverse events (FVC decline OR = 0.91 [95% CI = 0.45-2.03]) or dropouts (OR = 0.75 [95% CI = 0.33-1.27]). Nintedanib showed an effect on dropouts, OR = 1.61 (1.13-2.28) and NNTH = 14 (8-61). Based on RCTs of 12 month duration in patients with IPF, a positive effect on FVC decline was noted for both treatments and on dropouts for nintedanib, but no significant differences were noted between treatments.
特发性肺纤维化（IPF）治疗的临床实践指南目前推荐使用吡非尼酮和尼达尼布。然而，缺乏来自直接对比的证据。为了进行一项系统评价和网状Meta分析（NMA），以评估IPF的两种新治疗方法（吡非尼酮和尼达尼布）的疗效和耐受性。由两位作者分别进行随机对照试验（RCT）的选择（CENTRAL、MEDLINE、Embase）、数据提取、偏倚风险分析和GRADE评估。使用标准的成对Meta分析计算直接估计值。采用贝叶斯混合治疗比较方法进行NMA估计，并给出95%置信区间（CI），以比较各种治疗方法，计算比值比（OR）和治疗所需人数（NNTB）或伤害所需人数（NNTH）。对10项随机对照试验的NMA显示，每种药物对用力肺活量（FVC）下降≥10%的百分比均有积极作用（吡非尼酮OR = 0.54 [95% CI = 0.37 - 0.80]，NNTB = 9 [95% CI = 7 - 22]；尼达尼布OR = 0.59 [95% CI = 0.41 - 0.84]，NNTB = 9 [95% CI = 6 - 23]），但在比较吡非尼酮和尼达尼布在急性加重、死亡率和严重不良事件方面（FVC下降OR = 0.91 [95% CI = 0.45 - 2.03]）或退出率方面（OR = 0.75 [95% CI = 0.33 - 1.27]）未发现显著差异。尼达尼布对退出率有影响，OR = 1.61（1.13 - 2.28），NNTH = 14（8 - 61）。基于对IPF患者进行的为期12个月的RCT，两种治疗方法对FVC下降均有积极作用，尼达尼布对退出率有影响，但各治疗方法之间未发现显著差异。
