目的 挖掘和分析美国不良事件报告系统（FARES）数据库中盐酸可乐定缓释片治疗注意力缺陷多动障碍的安全警戒信号，为临床安全用药提供借鉴。方法 以“clonidine”或“clonidine hydrochloride”为首要怀疑对象，提取2004年第1季度—2023年第3季度FARES数据库中适应证为“attention deficit hyperactivity disorder”的相关不良事件（ADE）报告，采用报告比值比法（ROR）、比例报告比值比法（PRR）及贝叶斯置信度递进神经网络法（BCPNN）进行信号挖掘及检测分析。结果 检索到以可乐定或盐酸可乐定为主要怀疑对象且适应证为注意力缺陷多动障碍对应的ADE报告有136例，累及8个系统，36个安全警戒信号，其中以神经系统、心血管系统及呼吸系统ADE为主，常见镇静、嗜睡、窦性心动过缓、低血压、戒断性高血压、呼吸抑制、呼吸暂停等，另检测出说明书未提及的QT间期延长、全身强直性阵挛发作、自杀行为、超体质量等ADE信号。结论 临床使用盐酸可乐定缓释片时需做好用药监测，尤其心率和血压。当患儿出现精神系统症状或生长发育异常时也需积极排除是否与此药相关，做好安全合理用药。

Objective To mine and analyze the safety warning signals of Clonidine Hydrochloride Sustained-Release Tablets in treatment of attention deficit hyperactivity disorder in the FAERS database, and provide reference for clinical safety medication. Methods “clonidine” or “clonidine hydrochloride” is targeted as the primary suspect, and extracted adverse event reports related to “attention deficit hyperactivity disorder” in the FAERS database from first quarter 2004 to third quarter 2023, using the report odds ratio method (ROR), proportional reporting ratio (PRR), while bayesian confidence progressive neural network (BCPNN) were used for signal detection analysis. Results There were 136 ADE reports with clonidine or clonidine hydrochloride as the main suspected object and the indication corresponding to attention deficit hyperactivity disorder, involving 8 systems and 36 safety warning signals, including the nervous system, cardiovascular system and respiratory system. The main ADE are common sedation, drowsiness, sinus bradycardia, hypotension, withdrawal hypertension, respiratory depression, apnea, etc. In addition, prolongation of QT interval and generalized tonic convulsions not mentioned in the instruction manual were detected, including suicidal behavior, overweight and other ADE signals. Conclusion When using Clonidine Hydrochloride Sustained-Release Tablets clinically, it is necessary to monitor the medication, especially the heart rate and blood pressure. In children with behavioral disorders or brain development, it is also necessary to consider the relationship with this drug, and make a safe and rational use of the drug.

R971