3016例基于主动监测的润燥止痒胶囊真实世界安全性医院集中监测研究  

Study on Real World Safety of Runzao Zhiyang Capsules in 3016 Cases Under Intensive Hospital Monitoring Based on Active Monitoring

作　　者：王馥丽 刘福梅[1] 贾忠武 李广瑞[2] 谢雁鸣[1,2] 王连心[1,2] WANG Fuli;LIU Fumei;JIA Zhongwu;LI Guangrui;XIE Yanming;WANG Lianxin(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Wangjing Hospital of China Academy of Chinese Medical Sciences,Beijing 100102,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]中国中医科学院望京医院,北京100102

出　　处：《中国中医药图书情报杂志》2024年第5期269-273,共5页Chinese Journal of Library and Information Science for Traditional Chinese Medicine

基　　金：国家重点研发计划(2022YFC3502004)。

摘　　要：目的评估润燥止痒胶囊上市后临床使用安全性,对药物潜在危险因素进行及时监测,以了解润燥止痒胶囊真实世界用药情况、不良反应发生率、临床特征,探索不良反应发生的影响因素。方法采取前瞻性、多中心、大样本、持续性集中监测,用药2周末现场随访、4周末±3 d复查、6~8周末电话随访。采取3个层次的质控措施,利用EDC电子监测平台监测数据,并利用SAS9.4及R语言对资料进行处理。结果共纳入21家医院3016例患者的安全性监测,发生不良事件87例,与润燥止痒胶囊有关药品不良反应16例,发生率为0.53%,属偶见范围;各项不良反应均属罕见范围。分析影响因素发现,枸地氯雷他定片、男性、复方甘草酸苷片等10个变量影响较为显著。结论润燥止痒胶囊在临床使用中不良反应发生率低,安全性良好,合并使用枸地氯雷他定片、复方甘草酸苷片等药物应特别注意安全风险。Objective To evaluate the clinical safety of the use of Runzao Zhiyang Capsules after the market;To monitor the potential risk factors of drugs in time to understand the medication,incidence and clinical characteristics of adverse reactions of Runzao Zhiyang Capsules in real world;To explore the influencing factors of the occurrence of adverse reactions.Methods Prospective,multi-center,large sample,continuous hospital wide,and registered centralized monitoring was performed.Patients receiving medication were followed up on-site for 2 weekends,followed up for±3 days at 4 weekends,and followed up by phone for 6-8 weekends.This study adopted three levels of quality control measures,using EDC electronic monitoring platform to monitor the data,and using SAS 9.4 and R language to process the data.Results A total of 3016 patients from 21 hospitals were included in the safety monitoring,and 87 adverse events occurred.There were 16 adverse reactions related to Runzao Zhiyang Capsules,with an incidence rate of 0.53%,which was within the occasional range;all adverse reactions were within the rare range.Analysis of influencing factors revealed that 10 variables,including cloloratadine tablets,male,and compound glycyrrhizin tablets,had a significant impact.Conclusion Runzao Zhiyang Capsules have a low incidence of adverse reactions and good safety in clinical use.Special attention should be paid to safety risks when used in combination with drugs such as cloloratadine tablets and compound glycyrrhizin tablets.

关 键 词：润燥止痒胶囊 真实世界研究 医院集中监测 安全性 不良反应 

分 类 号：R242[医药卫生—中医临床基础]