目的：系统评价吡非尼酮治疗特发性肺纤维化的疗效与安全性，以为临床提供循证参考。方法：计算机检索Cochrane 图

书馆、PubMed、EMBase、中国期刊全文数据库、中国生物医学文献数据库、中文科技期刊数据库和万方数据库，收集吡非尼酮（试

验组）对比安慰剂（对照组）治疗特发性肺纤维化疗效与安全性的随机对照试验（RCT），对符合纳入标准的临床研究进行资料提

取，并采用改良的Jadad 量表进行质量评价，采用Rev Man 5.1.7 统计软件进行Meta 分析。结果：共纳入4 项RCT，合计1 153 例患

者。Meta分析结果显示，试验组患者的肺活量降低程度[WMD＝0.39，95％CI（0.16，0.61），P＜0.001]、用力肺活量占预计值百分比

下降值[RR＝0.68，95％CI（0.53，0.87），P＝0.002]均低于对照组，差异均有统计学意义；两组患者最低血氧饱和度比较差异无统计

学意义[WMD＝0.53，95％CI（－0.78，1.84），P＝0.43]，但亚组分析结果显示，使用1 200 mg/d 吡非尼酮对患者最低血氧饱和度下

降的缓解作用优于对照组，差异有统计学意义[WMD＝1.72，95％CI（1.33，2.10），P＜0.001]，而使用1 800 mg/d 时则两组差异无统

计学意义；两组患者不良反应发生率比较差异无统计学意义[RR＝1.70，95％CI（0.46，6.31），P＝0.43]，但试验组患者的光敏反应发

生率显著高于对照组，差异有统计学意义[RR＝9.35，95％CI（4.23，20.67），P＜0.001]。结论：吡非尼酮治疗特发性肺纤维化的疗效

较好，但使用过程中应注意光敏反应的发生。

OBJECTIVE：To systematically review the efficacy and safety of pirfenidone in the treatment of idiopathic pulmonary

fibrosis（IPF），and provide evidence-based reference for clinical treatment. METHODS：Retrieved from Cochrane Library，

PubMed，EMBase，CJFD，CBM，VIP Database and Wanfang Database，randomized controlled trials（RCT）about the efficacy

and safety of pirfenidone（test group）versus placebo（control group）in the treatment of IPF were collected，and Meta-analysis

was performed by using Rev Man 5.1.7 software after data extracting and quality evaluating by modified Jadad. RESULTS：Totally

4 RCTs were enrolled，involving 1 153 patients. Results of Meta-analysis showed the decrease value of lung capacity [WMD＝

0.39，95％CI（0.16，0.61）， P＜0.001] and decrease value of the percentage of forced vital capacity to expected value [RR＝0.68，

95％CI（0.53，0.87），P＝0.002] in test group were lower than control group，there was significant difference between 2 groups；

there was no significant difference in the lowest oxygen saturation [WMD＝0.53，95％ CI（－ 0.78，1.84），P＝0.43] between 2

groups，however，the results of subgroup analysis showed the remission degree of 1 200 mg/d PFD for the decrease of lowest oxygen

saturation was superior to placebo group，there was significant difference between 2 groups [WMD＝1.72，95％CI（1.33，2.10），

P＜0.001]，but therewas no significant difference between the remission degree of 1800 mg/d and placebo ；and there was no significant

difference in the incidence of adverse reactions between 2 groups [RR＝1.70，95％CI（0.46，6.31），P＝0.43]，but the incidence

of photosensitivity veactions in test group was significantly higher than that of control group，there was significant difference [RR＝

9.35，95％CI（4.23，20.67），P＜0.001]. CONCLUSIONS：The efficacy of pirfenidone in the treatment of IPF is good，but the incidence

of photosensitivity reactions should be noticed.