尼达尼布治疗特发性肺纤维化疗效的荟萃分析
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摘要
目的:系统评价尼达尼布治疗特发性肺纤维化(IPF)的疗效。方法:计算机检索PubMed,EMbase,The Cochrane Library,CNKI,VIP和WanFang Data数据库,搜集尼达尼布治疗IPF的随机对照试验(RCT)。由2位研究者独立进行文献筛选、资料的提取及纳入研究的偏倚风险,采用RevMan 5. 3软件进行Meta分析。结果:共纳入符合标准的4项RCTs,共计1 539例患者。Meta分析结果表明,与安慰剂相比,尼达尼布治疗IPF患者的用力肺活量(FVC)基线改变差异有统计学意义[WMD=3. 18,95%CI (2. 96,3. 41),P <0. 000 01]; FVC年递减率差异有统计学意义[WMD=91. 06,95%CI (75. 67,106. 45),P <0. 000 01];血氧饱和度(SpO2)差异有统计学意义[WMD=0. 28,95%(0. 26,0. 30),P <0. 000 01];一氧化碳的弥散量(DLCO)差异有统计学意义[WMD=0. 125,95%CI (0. 02,0. 21),P=0. 01];圣乔治呼吸问卷(SGRQ)评分差异有统计学意义[WMD=-2. 86,95%CI (-3. 053,-2. 67),P <0. 000 01]; IPF急性加重率差异有统计学意义[WMD=0. 66,95%CI (0. 48,0. 93),P=0. 02]。结论:尼达尼布治疗IPF,可改善患者肺功能和生活质量,延缓病情进展。
Objective: To estimate the effectiveness of nintedanib in the treatment of idiopathic pulmonary fibrosis( IPF). Methods: The randomized controlled trials( RCTs) of nintedanib treatment in patients with IPF were searched from PubMed,EMbase,The Cochrane Library,CNKI,VIP and Wanfang data base by Computer.Literature screening,data extraction,and risk of bias included in the study were assessed by two reviewers,and followed by Meta-analyses using Review Manage 5. 3 software. Results: Four RCTs which met the standards involving1 539 patients were included. The Meta-analysis showed compared with placebo,baseline change in FVC of nintedanib in patients with IPF [WMD = 3. 18,95%( 2. 96,3. 41),P < 0. 000 01]; FVC annual decline rate[WMD = 91. 06,95% CI( 75. 67,106. 45),P < 0. 000 01]; SpO2[WMD = 0. 28,95% CI( 0. 26,0. 30),P <0. 000 01]; DLCO [WMD = 0. 125,95% CI( 0. 02,0. 21),P = 0. 01]; SGRQ score [WMD =-2. 86,95% CI(-3. 053,-2. 67),P < 0. 000 01]; risk of an acute IPF exacerbation [WMD = 0. 66,95% CI( 0. 48,0. 93),P = 0. 02]. Conclusion: Nintedanib treatment for IPF can significantly improve the lung functional symptoms and quality of life,and slow the progression of the disease.
Objective: To estimate the effectiveness of nintedanib in the treatment of idiopathic pulmonary fibrosis( IPF). Methods: The randomized controlled trials( RCTs) of nintedanib treatment in patients with IPF were searched from PubMed,EMbase,The Cochrane Library,CNKI,VIP and Wanfang data base by Computer.Literature screening,data extraction,and risk of bias included in the study were assessed by two reviewers,and followed by Meta-analyses using Review Manage 5. 3 software. Results: Four RCTs which met the standards involving1 539 patients were included. The Meta-analysis showed compared with placebo,baseline change in FVC of nintedanib in patients with IPF [WMD = 3. 18,95%( 2. 96,3. 41),P < 0. 000 01]; FVC annual decline rate[WMD = 91. 06,95% CI( 75. 67,106. 45),P < 0. 000 01]; SpO2[WMD = 0. 28,95% CI( 0. 26,0. 30),P <0. 000 01]; DLCO [WMD = 0. 125,95% CI( 0. 02,0. 21),P = 0. 01]; SGRQ score [WMD =-2. 86,95% CI(-3. 053,-2. 67),P < 0. 000 01]; risk of an acute IPF exacerbation [WMD = 0. 66,95% CI( 0. 48,0. 93),P = 0. 02]. Conclusion: Nintedanib treatment for IPF can significantly improve the lung functional symptoms and quality of life,and slow the progression of the disease.
引文
[1] RAGHU G,ROCHWERG B,ZHANG Y,et al. An official ATS/ERS/JRS/ALAT clinical practice guideline:treatment of idiopathic pulmonary fibrosis. An update of the 2011 clinical practice guideline[J]. Crit Care Med,2015,192(5):644-653.
[2]孙锦涛,徐兴祥.特发性肺纤维化发病机制及药物治疗的研究进展[J].中华肺部疾病杂志:电子版,2015,8(2):82-87.
[3]邢洁,张洁.治疗特发性肺纤维化新药尼达尼布的研究进展[J].中国药房,2015(29):4174-4176.
[4]杨厚宇,梁宗安.尼达尼布治疗特发性肺间质纤维化的研究进展[J].西部医学,2017,29(4):578-581.
[5]耿艳艳,周植星,胡倩倩,等.特发性肺纤维化治疗靶点及药物研究进展[J].中国新药杂志,2015,24(1):46-51.
[6] ROTH G J,BINDER R,COLBATZKY F,et al. Nintedanib:from discovery to the clinic[J]. J Med Chem,2015,58(3):1053-1063.
[7] HARARI S,CAMINATI A. Idiopathic pulmonary fibrosis:from clinical trials to real-life experiences[J]. Eur Respir Rev,2015,24(137):420-427.
[8]杜毅.治疗特发性肺纤维化药物的药理研究及临床应用进展[J].天津药学,2015,27(2):60-64.
[9] RECK M. Nintedanib:examining the development and mechanism of action of a novel triple angiokinase inhibitor[J]. Expert Rev Anticancer Ther,2015,15(5):579-594.
[10]魏娜,李桂霞,毕宇鑫.特发性肺纤维化治疗新药—尼达尼布[J].沈阳药科大学学报,2015,(12):997-1000.
[11]白凡. FDA批准吡非尼酮和尼达尼布用于治疗特发性肺纤维化[J].药品评价,2014,10(20):31.
[12]范碧君,蒋捍东. 2015版特发性肺纤维化治疗指南解读[J].世界临床药物,2016,37(7):453-456.
[13]中华医学会呼吸病学分会间质性肺疾病学组.特发性肺纤维化诊断和治疗中国专家共识[J].中华结核和呼吸杂志,2016,39(6):427-432.
[14] CORTE T,BONELLA F,CRESTANI B,et al. Safety,tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis[J]. Respir Res,2015,16(1):116-125.
[15] OGURA T,TANIGUCHI H,AZUMA A,et al. Safety and pharmacokinetics of nintedanib and pirfenidone in idiopathic pulmonary fibrosis[J]. Eur Respir J,2015,45(5):1382-1392.
[16] RICHELDI L,ROLAND M,GANOSH R,et al. Efficacy and safety of nintedanib in idiopathic pulmonay fibrosis[J]. N Engl J Med,2014,370(22):2071-2082.
[17] RICHELDI L,COSTABELl U,SELMAN M,et al. Efficacy of a tyrosine kinase inhibitor in idiopathic pulmonary fibrosis[J]. N Engl J Med,2011,365(12):1079-1087.
[18] COLLARD HR,BRADFORD WZ,COTTIN V,et al. A new era in idiopathic pulmonary fibrosis:considerations for future clinical trials[J]. Eur Respir J,2015,46(1):243-249.
[19] COLLARD HR,YOW E,RICHELDI L,et al. Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials[J]. Respir Res,2013,14(1):73-79.
[20]杨厚宇,梁宗安.尼达尼布治疗特发性肺间质纤维化安全性Meta分析[J].医学综述,2017,23(17):3503-3510.
[2]孙锦涛,徐兴祥.特发性肺纤维化发病机制及药物治疗的研究进展[J].中华肺部疾病杂志:电子版,2015,8(2):82-87.
[3]邢洁,张洁.治疗特发性肺纤维化新药尼达尼布的研究进展[J].中国药房,2015(29):4174-4176.
[4]杨厚宇,梁宗安.尼达尼布治疗特发性肺间质纤维化的研究进展[J].西部医学,2017,29(4):578-581.
[5]耿艳艳,周植星,胡倩倩,等.特发性肺纤维化治疗靶点及药物研究进展[J].中国新药杂志,2015,24(1):46-51.
[6] ROTH G J,BINDER R,COLBATZKY F,et al. Nintedanib:from discovery to the clinic[J]. J Med Chem,2015,58(3):1053-1063.
[7] HARARI S,CAMINATI A. Idiopathic pulmonary fibrosis:from clinical trials to real-life experiences[J]. Eur Respir Rev,2015,24(137):420-427.
[8]杜毅.治疗特发性肺纤维化药物的药理研究及临床应用进展[J].天津药学,2015,27(2):60-64.
[9] RECK M. Nintedanib:examining the development and mechanism of action of a novel triple angiokinase inhibitor[J]. Expert Rev Anticancer Ther,2015,15(5):579-594.
[10]魏娜,李桂霞,毕宇鑫.特发性肺纤维化治疗新药—尼达尼布[J].沈阳药科大学学报,2015,(12):997-1000.
[11]白凡. FDA批准吡非尼酮和尼达尼布用于治疗特发性肺纤维化[J].药品评价,2014,10(20):31.
[12]范碧君,蒋捍东. 2015版特发性肺纤维化治疗指南解读[J].世界临床药物,2016,37(7):453-456.
[13]中华医学会呼吸病学分会间质性肺疾病学组.特发性肺纤维化诊断和治疗中国专家共识[J].中华结核和呼吸杂志,2016,39(6):427-432.
[14] CORTE T,BONELLA F,CRESTANI B,et al. Safety,tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis[J]. Respir Res,2015,16(1):116-125.
[15] OGURA T,TANIGUCHI H,AZUMA A,et al. Safety and pharmacokinetics of nintedanib and pirfenidone in idiopathic pulmonary fibrosis[J]. Eur Respir J,2015,45(5):1382-1392.
[16] RICHELDI L,ROLAND M,GANOSH R,et al. Efficacy and safety of nintedanib in idiopathic pulmonay fibrosis[J]. N Engl J Med,2014,370(22):2071-2082.
[17] RICHELDI L,COSTABELl U,SELMAN M,et al. Efficacy of a tyrosine kinase inhibitor in idiopathic pulmonary fibrosis[J]. N Engl J Med,2011,365(12):1079-1087.
[18] COLLARD HR,BRADFORD WZ,COTTIN V,et al. A new era in idiopathic pulmonary fibrosis:considerations for future clinical trials[J]. Eur Respir J,2015,46(1):243-249.
[19] COLLARD HR,YOW E,RICHELDI L,et al. Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials[J]. Respir Res,2013,14(1):73-79.
[20]杨厚宇,梁宗安.尼达尼布治疗特发性肺间质纤维化安全性Meta分析[J].医学综述,2017,23(17):3503-3510.