吡非尼酮和尼达尼布治疗特发性肺纤维化的间接Meta分析

王佳; 李舒悦; 曲素欣; 王皓; 葛卫红

doi:10.6039/j.issn.1001-0408.2022.23.16

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吡非尼酮和尼达尼布治疗特发性肺纤维化的间接Meta分析

循证药学 | 更新时间：2023-02-22

- 吡非尼酮和尼达尼布治疗特发性肺纤维化的间接Meta分析
- Indirect meta-analysis of pirfenidone and nintedanib in the treatment of idiopathic pulmonary fibrosis
- 中国药房 2022年33卷第23期页码：2901-2907
- 作者机构：
  
  1.青岛大学附属青岛妇女儿童医院药学部，山东青岛　266011
  2.山西省肿瘤医院药学部，太原　030000
  3.南京大学医学院附属鼓楼医院药学部，南京　210008
- 作者简介：
  
  药师，硕士。研究方向：合理用药。电话：0532-68661380。E-mail：wangjia212@126.com
  主任药师，硕士。研究方向：医院药学。电话：025-83304616。E-mail：geyaoxue@163.com
- 基金信息：
  
  江苏省精益化用药-石药专项科研基金资助项目(JY202042)
- DOI：10.6039/j.issn.1001-0408.2022.23.16
  中图分类号： R974
- 纸质出版日期：2022-12-15，
  
  收稿日期：2022-05-22，
  
  修回日期：2022-09-20，
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王佳,李舒悦,曲素欣等.吡非尼酮和尼达尼布治疗特发性肺纤维化的间接Meta分析 ^Δ[J].中国药房,2022,33(23):2901-2907.

WANG Jia,LI Shuyue,QU Suxin,et al.Indirect meta-analysis of pirfenidone and nintedanib in the treatment of idiopathic pulmonary fibrosis[J].ZHONGGUO YAOFANG,2022,33(23):2901-2907.
王佳,李舒悦,曲素欣等.吡非尼酮和尼达尼布治疗特发性肺纤维化的间接Meta分析 ^Δ[J].中国药房,2022,33(23):2901-2907. DOI： 10.6039/j.issn.1001-0408.2022.23.16.

WANG Jia,LI Shuyue,QU Suxin,et al.Indirect meta-analysis of pirfenidone and nintedanib in the treatment of idiopathic pulmonary fibrosis[J].ZHONGGUO YAOFANG,2022,33(23):2901-2907. DOI： 10.6039/j.issn.1001-0408.2022.23.16.

摘要

目的

系统评价吡非尼酮和尼达尼布治疗特发性肺纤维化的临床有效性和安全性。

方法

在中国知网、万方、维普网、PubMed、Cochrane library等数据库对吡非尼酮和尼达尼布治疗特发性肺纤维化的中英文公开发表的随机对照研究进行检索，检索时间为2000年1月—2021年12月。用间接Meta分析的方法对已有研究进行合并，系统评价两种药物治疗特发性肺纤维化的有效性和安全性。

结果

共纳入15项随机对照研究，其中吡非尼酮试验组1 026例、对照组845例，尼达尼布试验组1 864例、对照组1 848例，两对照组均为安慰剂。间接Meta分析结果显示，在病情急性加重率、用力肺活量比基线下降≥10%或绝对值下降≥0.2 L发生率这两项疗效评价指标方面，两药表现相似（间接分析结果均

＞0.01，差异无统计学意义）；在病情进展率方面，尼达尼布150 mg（bid）优于吡非尼酮800 mg（tid）（RR＝1.66，95%CI为1.06～2.63）。安全性方面，尼达尼布150 mg（bid）的腹泻发生率高于吡非尼酮800 mg（tid）（RR＝0.42，95%CI为0.33～0.53）。

结论

尼达尼布与吡非尼酮相比，在控制疾病进展方面略占优势，但不良反应发生率也同时增加。

Abstract

OBJECTIVE

To systematically evaluate the clinical efficacy and safety of pirfenidone and nintedanib in the treatment of idiopathic pulmonary fibrosis.

METHODS

Randomised controlled trials on pirfenidone and nintedanib in the treatment of idiopathic pulmonary fibrosis which were publicly published in Chinese and English were searched from CNKI， Wanfang， VIP， PubMed， Cochrane library and other databases. The search time was set from January 2000 to December 2021. The existing studies were combined with indirect meta-analysis to systematically evaluate the efficacy and safety of the two drugs in the treatment of idiopathic pulmonary fibrosis.

RESULTS

A total of 15 randomized controlled trials were included， involving 1 026 cases in trial group of pirfenidone and 845 cases in control group of pirfenidone， 1 846 cases in trial group of nintedanib and 1 848 cases in control group of nintedanib. Both control groups were placebo. The results of indirect meta-analysis showed that the two drugs were similar in the evaluation indicators of therapeutic efficacy as acute exacerbation rate， the incidence of forced vital capacity （FVC）% decrease ≥10% from baseline or the incidence of absolute value decrease ≥0.2 L （

values of indirect analysis results were all ＞0.01， and the difference was not statistically significant）； but in terms of disease progression rate， nintedanib 150 mg （bid） was superior to pirfenidone 800 mg （tid）（RR＝1.66， 95%CI＝1.06-2.63）； in terms of safety， the incidence of diarrhea induced by nintedanib 150 mg （bid） was higher than pirfenidone 800 mg （tid）（RR＝0.42， 95%CI＝0.33-0.53）.

CONCLUSIONS

Compared with pirfenidone， nintedanib has slightly superior efficacy in terms of disease progression control， but the incidence of adverse reactions is also increased.

关键词

吡非尼酮尼达尼布特发性肺纤维化疗效安全性间接Meta分析

Keywords

nintedanibidiopathic pulmonary fibrosisefficacysafetyindirect meta-analysis

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