吡非尼酮治疗特发性肺纤维化疗效与安全性的系统评价

发布时间：2018-12-30 19:39

【摘要】：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、Pub Med、EMBase、相关期刊论文、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),P0.001]、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),P0.001],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),P0.001]。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。
[Abstract]:Objective: to evaluate the efficacy and safety of pifenidone in the treatment of idiopathic pulmonary fibrosis. Methods: Cochrane library, Pub Med,EMBase, full text database, Chinese biomedical literature database, Chinese sci-tech journal database and Wanfang database were searched by computer. A randomized controlled trial (RCT),) of pifenidone (trial group) versus placebo (control group) for the efficacy and safety of idiopathic pulmonary fibrosis was conducted to extract data from clinical trials that met the inclusion criteria. The modified Jadad scale was used to evaluate the quality and the Rev Man 5.1.7 statistical software was used for Meta analysis. Results: a total of 1 153 patients with 4 items of RCT, were included. The results of Meta analysis showed that the patients in the trial group had reduced vital capacity [WMD=0.39,95%CI (0.160.61), P0.001]. The percentage of forced vital capacity to predicted value [RR=0.68,95%CI (0.53 卤0.87), P0. 002] was lower than that of control group, and the difference was statistically significant. There was no significant difference in minimum oxygen saturation between the two groups [WMD=0.53,95%CI (-0.781.84), P < 0.43], but subgroup analysis showed that, The remission effect of 1 200 mg/d pifenidone on the decrease of minimum oxygen saturation in patients was better than that in the control group, and the difference was statistically significant [WMD=1.72,95%CI (1.33 卤2.10), P0.001]. At 1 800 mg/d, there was no significant difference between the two groups. There was no significant difference in the incidence of adverse reactions between the two groups [RR=1.70,95%CI (0.46 卤6.31), P < 0.43], but the incidence of Guang Min reaction in the trial group was significantly higher than that in the control group. The difference was statistically significant [RR=9.35,95%CI (4.23 卤20.67), P 0.001]. Conclusion: pifenidone is effective in the treatment of idiopathic pulmonary fibrosis, but the reaction of Guang Min should be paid attention to.
【作者单位】：重庆医科大学附属第一医院药学部;
【分类号】：R563.9

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