摘要
目的评估乌美溴铵/维兰特罗在真实世界临床实践中应用于中国患者的安全性。方法采用前瞻性、多中心、单臂、观察性研究,在2020年12月14日至2022年1月30日,从中国的14家研究中心纳入在真实世界临床实践中接受乌美溴铵/维兰特罗治疗的患者,共随访24周。研究主要结局为随访期内不良事件和严重不良事件的发生率。结果共纳入887例患者,年龄为(67.5±9.6)岁,其中男性689例(77.7%)。大多数患者(98.1%)有慢性阻塞性肺疾病史。468例患者(52.8%)报告了合并药物。在所有纳入的患者中,59例(6.7%)报告了不良事件,21例(2.4%)报告了严重不良事件,其中9例报告了致死性严重不良事件,10例报告了非致死性严重不良事件,2例同时报告了非致死性和致死性严重不良事件。所有严重不良事件,包括致死性事件,经研究者判定均与乌美溴铵/维兰特罗无关。6例(0.7%)发生药物不良反应,其严重程度均为轻度。3例(0.3%)患者报告的不良事件属于重要已确定或潜在风险,经研究者判定均与乌美溴铵/维兰特罗无关。结论乌美溴铵/维兰特罗在真实世界临床实践中应用于中国患者具有良好的安全性,未观察到与该药相关的新的安全性信号。
Objective To evaluate the safety of umeclidinium/vilanterol in Chinese participants in a real-world setting.Methods This was a 24-week,prospective,multicenter,single-arm,observational study that enrolled participants treated with umeclidinium/vilanterol in real-world settings from 14 sites in China from 14 December 2020 to 30 January 2022.The primary outcomes were the incidence of adverse events(AEs)and serious adverse events(SAEs)at week 24.Results A total of 887 participants on umeclidinium/vilanterol were enrolled.The mean(±SD)age of these participants was 67.5(±9.6)years,with more men(77.7%)enrolled.The majority of the participants(98.1%)had been diagnosed with chronic obstructive pulmonary disease,and 67.6%of them reported comorbidities.More than half of the participants(52.8%)were taking concomitant medication in addition to the study treatment.AEs were reported in 59(6.7%)participants and were predominantly mild to moderate in severity.SAEs were reported in 21(2.4%)participants,including 9 fatal SAEs,10 reported non-fatal SAEs,and 2 reported both non-fatal and fatal SAEs.None of the SAEs,including the fatal events,were considered by the investigators to be related to umeclidinium/vilanterol.Adverse drug reactions(ADRs)were reported in 6(0.7%)participants with 4 preferred terms(PTs),all of which were considered mild in severity.Of these PTs,2 were known ADRs of umeclidinium/vilanterol.Three participants(0.3%)reported AEs that were part of serious identified/potential hazards,all of which were considered by the investigators to be unrelated to umeclidinium/vilanterol.Conclusion The results of this study showed that umeclidinium/vilanterol was well tolerated in Chinese participants in a real-world setting and no new drug-related safety signals were observed.
作者
牟向东
李小明
何小鹏
贾立华
关英慧
安福成
陈丽萍
贾琦
肖爱莲
张黎川
肖志华
王玉梅
关巍
刘田田
苏麟
Mu Xiangdong;Li Xiaoming;He Xiaopeng;Jia Lihua;Guan Yinghui;An Fucheng;Chen Liping;Jia Qi;Xiao Ailian;Zhang Lichuan;Xiao Zhihua;Wang Yumei;Guan Wei;Liu Tiantian;Su Lin(Department of Respiratory and Critical Care Medicine,Beijing Tsinghua Changgung Hospital of Tsinghua University,Beijing 102218,China;Department of Respiratory Medicine,Beijing Yanhua Hospital,Beijing 102599,China;Department of Respiratory and Critical Care Medicine,Xianyang Central Hospital,Xianyang 712000,China;Department of Pharmacy,Peking University International Hospital,Beijing 102206,China;Department of Respiratory and Critical Care Medicine,DepartmentⅡ,the First Bethune Hospital of Jilin University,Jilin 130031,China;Department of Respiratory and Critical Care Medicine,Beijing Mentougou District Hospital,Beijing 102399,China;Department of Respiratory and Critical Care Medicine,the Second Affiliated Hospital of Shenyang Medical College,Shenyang 110000,China;Department of Respiratory Medicine,Beijing Longfu Hospital,Beijing 100010,China;Department of Respiratory and Critical Care Medicine,General Hospital of Taigang Affiliated to Shanxi Medical University,Taiyuan 030008,China;Department of Respiratory and Critical Care Medicine,Affiliated Zhongshan Hospital of Dalian University,Dalian 116000,China;Department of Respiratory and Critical Care Medicine,the Third People′s Hospital of Datong,Datong 037046,China;Department of Respiratory Medicine,Hospital of Southern University of Science and Technology,Shenzhen 518000,China;Department of Respiratory and Critical Care Medicine,Shenzhen Bao′an Central Hospital,Shenzhen 518000,China;GSK(Shanghai)R&D CO.,LTD.,Shanghai 201203,China)
出处
《中华结核和呼吸杂志》
CAS
CSCD
北大核心
2024年第7期632-637,共6页
Chinese Journal of Tuberculosis and Respiratory Diseases