目的 挖掘和分析美國(guó)不良事件報(bào)告系統(tǒng)（FARES）數(shù)據(jù)庫(kù)中鹽酸可樂(lè)定緩釋片治療注意力缺陷多動(dòng)障礙的安全警戒信號(hào)，為臨床安全用藥提供借鑒。方法 以“clonidine”或“clonidine hydrochloride”為首要懷疑對(duì)象，提取2004年第1季度—2023年第3季度FARES數(shù)據(jù)庫(kù)中適應(yīng)證為“attention deficit hyperactivity disorder”的相關(guān)不良事件（ADE）報(bào)告，采用報(bào)告比值比法（ROR）、比例報(bào)告比值比法（PRR）及貝葉斯置信度遞進(jìn)神經(jīng)網(wǎng)絡(luò)法（BCPNN）進(jìn)行信號(hào)挖掘及檢測(cè)分析。結(jié)果 檢索到以可樂(lè)定或鹽酸可樂(lè)定為主要懷疑對(duì)象且適應(yīng)證為注意力缺陷多動(dòng)障礙對(duì)應(yīng)的ADE報(bào)告有136例，累及8個(gè)系統(tǒng)，36個(gè)安全警戒信號(hào)，其中以神經(jīng)系統(tǒng)、心血管系統(tǒng)及呼吸系統(tǒng)ADE為主，常見(jiàn)鎮(zhèn)靜、嗜睡、竇性心動(dòng)過(guò)緩、低血壓、戒斷性高血壓、呼吸抑制、呼吸暫停等，另檢測(cè)出說(shuō)明書未提及的QT間期延長(zhǎng)、全身強(qiáng)直性陣攣發(fā)作、自殺行為、超體質(zhì)量等ADE信號(hào)。結(jié)論 臨床使用鹽酸可樂(lè)定緩釋片時(shí)需做好用藥監(jiān)測(cè)，尤其心率和血壓。當(dāng)患兒出現(xiàn)精神系統(tǒng)癥狀或生長(zhǎng)發(fā)育異常時(shí)也需積極排除是否與此藥相關(guān)，做好安全合理用藥。

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