经口吸入制剂临床试验健康受试者筛选失败原因分析  

Analysis of reasons for screening failure of healthy subjects in clinical trials of orally inhaled drug products

作　　者：刘敏 孔祥 章叶 顾逸飞 项雪梅 贺晴 黄凯 LIU Min;KONG Xiang;ZHANG Ye;GU Yifei;XIANG Xuemei;HE Qing;HUANG Kai(Drug Clinical Trial Institution,Affiliated Wuxi People's Hospital of Nanjing Medical University,Wuxi 214023,Jiangsu,China;Department of Endocrinology,The First Aflliated Hospital of Wannan Medical College,Yijishan Hospital,Wuhu 241001,Anhui,China;Wuxi Clinical Medical School of Nanjing Medical University,Wuxi 214023,Jiangsu,China)

机构地区：[1]南京医科大学附属无锡人民医院药物临床试验机构,江苏无锡214023 [2]皖南医学院第一附属医院弋矶山医院内分泌科,安徽芜湖241001 [3]南京医科大学无锡临床医学院,江苏无锡214023

出　　处：《中国临床药理学与治疗学》2023年第7期758-766,共9页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：国家自然科学基金项目(81600645)。

摘　　要：目的:探讨经口吸入制剂(OIDPs)临床试验健康受试者筛选失败的原因。方法:收集1432例健康受试者参与OIDPs临床试验的筛选情况,归纳分析受试者筛选失败的原因、筛选失败率的性别差异以及和年龄的相关性。结果:OIDPs临床试验筛选失败率为72.4%,有随年龄增长而升高的趋势,女性略高于男性。除生命体征异常(17.3%)、实验室检查异常(16.5%)和撤回知情(7.6%)等常见筛选失败原因外,静脉条件差(13.9%)、烟检阳性(12.6%)和吸入培训考核失败(7.1%)也成为影响OIDPs筛选成功率的三大主要原因。生命体征异常和静脉条件差分别是男性和女性受试者筛选失败的首要原因。结论:充分的知情、有效的沟通、选择理解能力强的年轻受试者和提高研究人员的培训能力,有助于提高筛选成功率。AIM:To explore the reasons for screening failure of healthy subjects in clinical trials of orally inhaled drug products(OIDPs).METHODS:Screening data of 1432 healthy subjects who participated in clinical trials of OIDPs were collected.The main reasons for the screening failure,gender differences in screening failure rate and the correlation between age and screening failure rate were summarized and analyzed.RESULTS:The screening failure rate was 72.4%and increased with age.The failure rate was slightly higher in females than in males.Besides abnormal vital signs(17.3%),abnormal laboratory test results(16.5%)and withdrawal of consent(7.6%),poor venous condition(13.9%),positive for cigarette test results(12.6%)and failure in inhalation training(7.1%)were also the other three main reasons affecting the screening success rate.Abnormal vital signs and poor venous conditions were the primary screening failure reasons for males and females,respectively.CONCLUSION:The screening success rate could be improved by informing fully and communicating effectively,selecting young subjects with strong understanding abilities,and enhancing the training skills of investigators.

关 键 词：经口吸入制剂 健康受试者 筛选失败 原因分析 

分 类 号：R969[医药卫生—药理学]