吡非尼酮治疗肺纤维化的疗效与安全性meta分析

Efficacy and safety of pirfenidone for pulmonary fibrosis: A meta-analysis

目的:系统评估吡非尼酮应用于肺纤维化患者的有效性和安全性。方法:在中英文数据库检索1999年1月至2015年12月发表的吡非尼酮治疗肺纤维化患者的随机对照研究。筛选符合标准的文献,对文献进行质量评价,提取数据进行meta分析。结果:与安慰剂组相比,吡非尼酮组肺活量及用力肺活量(FVC)较基线下降减少,且对于特发性肺纤维化(IPF)患者吡非尼酮组FVC减少≥10%、6 min步行距离缩短≥50米、全因死亡及IPF相关死亡的相对风险均显著降低,无进展生存明显增加。吡非尼酮组胃肠道、皮肤、神经系统相关不良发生率较对照组增加。结论:吡非尼酮能够延缓轻中度肺纤维化患者病情进展。大多数患者对吡非尼酮耐受良好,常见胃肠道、皮肤相关轻度不良反应。

] Objective： To systematic review the efficacy and safety of pirfenidone in patient with pulmonary fibrosis. Methods： We search systematically for randomized controlled trials which compared pirfenidone with control therapies in pulmonary fibrosis patient published between January 1999 and December 2015. We selected the citations that met all eligibility criteria and assessed the quality of the included studies. The extracted data were analyzed using RevMan 5.3. Results： Pirfenidone, as compared with placebo, reduced decline in VC and predicted FVC% from baseline, and significantly reduced the risk of FVC decline ≥ 10%, 6 MWD decrease ≥ 50m, all- cause mortality and IPF-related mortality in IPF patient. Above all, pirfenidone improved progression-free survival. The incidence rates of relevant adverse reactions in gastrointestinal, skin and nervous system increased in pirfenidone group Compared to those of control group. Conclusion： Pirfenidone can delay the disease progress in patients with mild to moderate pulmonary fibrosis. Pirfenidone was generally well tolerated, and the gastrointestinal and skin-related mild adverse events were more common.