尼达尼布治疗特发性肺纤维化有效性和安全性系统评价

A Systematic Review of the Effectiveness and Safety of Nidanib in the Treatment of Idiopathic Pulmonary Fibrosis

目的系统评价尼达尼布治疗特发性肺纤维化(IPF)的有效性与安全性。方法在The Cochrane Library、Embase、Medline等外文数据库及中国知网、万方等中文数据库进行文献检索,检索时间为建库至2019年1月。筛选文献条件为尼达尼布治疗特发性肺纤维化的随机对照试验(RCT),由两位研究人员独立进行文献筛选、数据提取和研究偏倚风险评价,使用RevMan5.3软件进行分析。结果共纳入4个随机对照研究,共计患者1249例。Meta分析结果显示:两组用力肺活量(FVC)下降超过10%的患者例数、圣乔治呼吸问卷(SGRQ)评分中的改善患者症状和活动能力差异有统计学意义(P<0.05),试验组优于对照组;在不良反应方面,虽然试验组在所有不良反应发生率及消化系统不良反应发生率上高于对照组,但是此类不良反应大多轻度、可逆,而在IPF进展、鼻咽炎、心脏功能紊乱方面和对照组差异无统计学意义(P>0.05)。结论尼达尼布治疗特发性肺纤维化疗效较好且耐受性较好。但由于纳入研究数量较少,该结论尚需大样本、高质量RCT进一步论证。

Objective To systematically evaluate the efficacy and safety of nidanib in the treatment of idiopathic pulmonary fibrosis( IPF).Methods Literature search was conducted in foreign databases( The Cochrane Library,Embase,Medline and Chinese databases) and Chinese databases( China national knowledge internet and Wanfang).The search time was from the time of databases establishment to January 2019.The literature screening conditions were randomized controlled trials( RCT) of nidanib in the treatment of idiopathic pulmonary fibrosis.Literature screening,data extraction and risk assessment of research bias were independently conducted by two researchers. Rev Man5. 3 software was used to analyze. Results A total of 4 randomized controlled studies were included,with 1249 patients. Meta-analysis results showed that: There were statistically significant differences in the number of patients whose force vital capacity( FVC) decreased by more than 10% and the improvement of symptoms and mobility in the St.George’s Respiratory Questionnaire( SGRQ) score( P<0. 05),and test group was better than control group.In terms of adverse reactions,although test group was higher than control group in the incidence of all adverse reactions and digestive system adverse reactions.However,most of these adverse reactions were mild and reversible,and there was no significant difference in IPF progression,nasopharyngitis,and cardiac dysfunction from control group( P>0. 05).Conclusion Nidanib would be effective and well tolerated in the treatment of IPF.However,due to the small number of studies included,this conclusion needs further demonstration with large samples and high-quality RCTs.