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| 189 例儿童青少年非典型抗精神病药物不良反应报告分析 |
| 戴彪1,梁俊1,曹银1,孙艳红1,高文凡1,赵莹莲1,马真笑2 |
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| (1. 安徽医科大学附属心理医院,合肥市第四人民医院,安徽
省精神卫生中心精神药理研究室,安徽省精神心理疾病临床医学研究中心,合肥 230022;2. 皖南医学院,安徽芜湖 241002) |
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| 摘要: |
| 目的:探讨儿童青少年使用非典型抗精神病药物的不良反应(ADR)特点及规律,为临床安全用药提供依据。方法:回顾
性分析2019-2024 年合肥市第四人民医院上报至国家药品不良反应监测系统的189 例儿童青少年使用非典型抗精神病药物的
药品不良反应报告,对性别、年龄、ADR 发生时间、累及系统/ 器官、药物分布、药物剂量、联合用药以及转归情况进行统计分析。
结果:189 例ADR 报告中,以男性(52. 91%)和青少年(>13~17 岁,82. 01%)为主,52. 38%的ADR 发生于用药后1~10 天。主要
累及神经系统(48. 95%)、消化系统(23. 16%)和心血管系统(18. 94%);锥体外系反应(39. 16%)、窦性心动过速(16. 84%)及肝
功能异常(10. 00%)为典型表现;阿立哌唑(31. 22%) 发生ADR 占比最高。患者日平均剂量(11. 12±6. 23) mg,高剂量组( >
10 mg)ADR 发生率与低剂量组比较差异有统计学意义( P<0. 05)。联合用药比例高达84. 13%,ADR 严重程度以一般ADR
(92. 06%)为主,大多数ADR 经减停药物和对症处理痊愈或好转。结论:儿童青少年使用非典型抗精神病药物治疗,应密切关
注用药初期药物反应,优先选择低剂量单药治疗,警惕不良发应发生风险。 |
| 关键词: 儿童青少年 非典型抗精神病药物 药品不良反应 联合用药 用药安全 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2025.12.013 |
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| 基金项目:国家临床重点专科;安徽省临床重点专科;合肥市第七周期重点(培育)专科资助。 |
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| Analysis on 189 Reports of Adverse Drug Reactions Induced by Atypical Antipsychotic Drugs in Childrenand Adolescents |
| Dai Biao1, Liang Jun1, Cao Yin1, Sun Yanhong1, Gao Wenfan1, Zhao Yinglian1, Ma Zhenxiao2 |
| (1. Affiliated
Psychological Hospital of Anhui Medical University, Hefei Fourth People ’ s Hospital, Anhui Provincial Mental Health Center
Psychopharmacology Research Laboratory, Clinical Medical Research Center of Mental and Psychological Diseases in Anhui Province, Hefei
230022, China; 2. Wannan Medical College, Anhui Wuhu 241002, China) |
| Abstract: |
| Objective: To probe into the characteristics and patterns of adverse drug reactions (ADR) induced by atypical antipsychotic
drugs in children and adolescents, and to provide basis for safe clinical medication. Methods: Retrospective analysis was performed on
189 reports of ADR induced by atypical antipsychotic drugs in children and adolescent submitted to the National Drug Adverse Reaction
Monitoring System by Hefei Fourth People’s Hospital from 2019 to 2024. Statistical analysis was performed on gender, age, time of
ADR occurrence, involved systems/ organs, drug distribution, drug dosage, combined medication, and outcome. Results: Among the
189 ADR reports, the majority were male (52. 91%) and teenagers (aged from >13 to 17 years, 82. 01%), 52. 38% of the ADR
occurred within 1 to 10 d after administration. Neuropsychiatric complications emerged as the most prevalent systemic involvement
(48. 95%), followed by gastrointestinal (23. 16%) and cardiovascular manifestations ( 18. 94%). Characteristic ADR included
extrapyramidal reactions (39. 16%), sinus tachycardia (16. 84%), and hepatic function abnormalities (10. 00%). Aripiprazole
(31. 22%) had the highest proportion of ADR occurrences. Dose-response analysis revealed significant differences in ADR incidence
between high-dose group (>10 mg) and low-dose group (P<0. 05), with a mean daily exposure of (11. 12±6. 23) mg. The proportion
of combined medication was 84. 13%. The severity of ADR was mainly general (92. 06%). Most ADR were cured or improved after
drug withdrawal and symptomatic treatment. Conclusion: For children and adolescents with atypical antipsychotic drugs, close attention
should be paid to the drug reactions during the initial stage of treatment. Low-dose monotherapy should be preferred, and the risk of
ADR should be vigilantly monitored. |
| Key words: children and adolescents atypical antipsychotics drugs adverse drug reactions combined medication medication safety |
