吡非尼酮和尼达尼布治疗特发性肺纤维化的间接Meta分析
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篇名: 吡非尼酮和尼达尼布治疗特发性肺纤维化的间接Meta分析
TITLE: Indirect meta-analysis of pirfenidone and nintedanib in the treatment of idiopathic pulmonary fibrosis
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、Cochranelibrary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1026例、对照组845例,尼达尼布试验组1864例、对照组1848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≥0.2L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P>0.01,差异无统计学意义);在病情进展率方面,尼达尼布150mg(bid)优于吡非尼酮800mg(tid)(RR=1.66,95%CI为1.06~2.63)。安全性方面,尼达尼布150mg(bid)的腹泻发生率高于吡非尼酮800mg(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 (P 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.
期刊: 2022年第33卷第23期
作者: 王佳,李舒悦,曲素欣,王皓,葛卫红
AUTHORS: WANG Jia,LI Shuyue,QU Suxin,WANG Hao,GE Weihong
关键字: 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: pirfenidone; nintedanib; idiopathic pulmonary fibrosis; efficacy; safety; indirect meta-analysis
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