Yu Jinxia, Li Ming, Xue Hui, Liu Yitao, Fan Lijun, Zou Jianjun, Du Wei
Department of Epidemiology and Biostatistics, School of Public Health, Southeast University, Nanjing, China.
College of Life Science and Technology, China Pharmaceutical University, Nanjing, China.
Int J Risk Saf Med. 2025 Jul 18:9246479251360682. doi: 10.1177/09246479251360682.
BackgroundThe safety of sedative-hypnotic drugs represents an underrecognized and crucial public health concern, despite their widespread use.ObjectiveThe objective of this study was to investigate the characteristics and trends of adverse drug reactions (ADRs) to sedative-hypnotics in China.MethodData were extracted from the spontaneous reporting system (SRS) for ADR surveillance in Jiangsu Province. Sedative-hypnotic drugs for ADRs were coded using the Anatomical Therapeutic Chemical classification system. We used the Chinese modification of the International Classification of Diseases, Tenth Revision, to group primary diseases, and the Medical Dictionary for Regulatory Activities to classify the manifestation of ADRs. We analysed the characteristics of ADR reports, including demographic and sedative-hypnotics information, ADR involvement of system organs and clinical manifestations, and cost of ADRs. Joinpoint regression was employed to estimate age-adjusted ADR rates stratified by sex from 2011 to 2019, and the percentage change annualized estimator was used to evaluate trends over time.ResultsA total of 899 reports of ADRs to sedative-hypnotics were found, with 440 (49.1%) males and 459 (50.9%) females. Regarding ADRs to sedative-hypnotics, neurological disorders (310 cases, 34.5%) were the most common. An estimated cost savings of RMB 6031.98-54,287.82 (USD 826.38-7437.43) could be realised if 10%-90% of the ADRs in this study were reduced. The age-adjusted ADRs reporting rates increased significantly from 0.06 to 0.18 per 100,000 population during 2011-2019, representing an annual increase of 14.5% (95% confidence interval 9.4-19.9%; -value < 0.001). There was a gender difference, with an age-adjusted ADRs annual increase of 14.0% (95% confidence interval 6.6%-21.9%; -value 0.002) for males and 14.8% (95% confidence interval 7.5%-22.6%; -value 0.002) for females.ConclusionsReports of sedative-hypnotic ADRs were on the rise during the study period, and there was a gender difference. More rational policies and systems are needed to promote the safe use of sedative-hypnotic drugs.
背景
尽管镇静催眠药物被广泛使用，但其安全性仍是一个未得到充分认识且至关重要的公共卫生问题。
目的
本研究旨在调查中国镇静催眠药物不良反应（ADR）的特征和趋势。
方法
数据从江苏省药品不良反应监测自发报告系统（SRS）中提取。使用解剖学治疗学化学分类系统对引起ADR的镇静催眠药物进行编码。我们采用《疾病和有关健康问题的国际统计分类》第十次修订本的中文修订版对原发性疾病进行分组，并使用监管活动医学词典对ADR的表现进行分类。我们分析了ADR报告的特征，包括人口统计学和镇静催眠药物信息、系统器官的ADR累及情况和临床表现，以及ADR的成本。采用Joinpoint回归法估计2011年至2019年按性别分层的年龄调整后的ADR发生率，并使用年化百分比变化估计器评估随时间的趋势。
结果
共发现899例镇静催眠药物ADR报告，其中男性440例（49.1%），女性459例（50.9%）。关于镇静催眠药物的ADR，神经系统疾病（310例，34.5%）最为常见。如果本研究中10%-90%的ADR得以减少，估计可节省人民币6031.98-54287.82元（826.38-7437.43美元）。2011年至2019年期间，年龄调整后的ADR报告率从每10万人0.06显著增至0.18，年增长率为14.5%（95%置信区间9.4%-19.9%；P值<0.001）。存在性别差异，男性年龄调整后的ADR年增长率为14.0%（95%置信区间6.6%-21.9%；P值0.002），女性为14.8%（95%置信区间7.5%-22.6%；P值0.002）。
结论
在研究期间，镇静催眠药物ADR报告呈上升趋势，且存在性别差异。需要更合理的政策和制度来促进镇静催眠药物的安全使用。
