目的 了解孟鲁司特致神经精神不良反应发生的相关规律、特点，寻找风险因素，为临床安全用药提供参考。方法 在新乡医学院第一附属医院中国医院药物警戒系统（CHPS v2.0）的药品评价系统中，通过医嘱检索、病历检索这两个检索维度，检索2019年1月-2020年2月使用孟鲁司特过程中发生"兴奋""焦虑""抑郁""迷失方向或混乱""注意力不集中""噩梦""幻觉""失眠""震颤""烦躁""易怒""梦游""自杀""强迫症""不安""口吃""肌肉不自主运动"等神经精神症状的病例；同时检索万方数字化期刊全文库、中国学术期刊（网络版）、中文科技期刊全文数据库（维普）中孟鲁司特相关神经精神不良反应报道，合并文献病例与院内病例，回顾性统计分析患者性别、年龄、原患疾病、用药剂量、合用用药、不良反应表现、发生时间、严重程度、治疗和转归等项目。结果 收集院内病例15例，文献检索获得病例12例，合计入选病例27例。关联性评价结果显示，"可能有关"4例（14.8%），"很可能"有23例（85.2%）；院内病例统计神经精神不良反应发生率0.33%；40~65岁年龄段不良事件发生率最高；13例不良反应无使用孟鲁司特的用药指征；未发现给药剂量与不良反应发生的相关性；不良反应表现为焦虑、噩梦、烦躁/激动/言语多、攻击性强较多，也可见遗尿、头痛头胀、肢体麻木等；发生时间多在用药后7 d以内，最快的0.5 h，也有延至数周后的可能；停药后绝大多数可以恢复正常且恢复较快。结论 孟鲁司特可能导致神经精神不良反应，临床应用时需严格把握用药指征，加强用药监护，在儿童患者的临床应用中应更加引起关注，一旦发生不良反应要立即停止使用，特别是在服药开始后一周内要加强临床观察。相关神经精神不良反应停药后多数可以恢复。

Objective To understand the relevant rules and characteristics of neuropsychiatric adverse reactions induced by montelukast, and to search for risk factors, and provide references for safe drug usage. Methods In the pharmacovigilance system (CHPS v2.0) drug evaluation system of First Affiliated Hospital of Xinxiang Medical College, the cases occurred in the process of "excited", "anxiety", "depression", "lost or chaos", "concentration" and "the nightmare" and "illusion", "insomnia", "vibration", "upset", "angry", "sleepwalking", "suicide", "obsessive compulsive disorder", "anxiety", "stuttering", and "involuntary muscles nerve cases" of using montelukast through the doctor's advice retrieval and case retrieving these two dimensions were retrieved from January2019 to February 2020. At the same time, the neuropsychiatric adverse reactions related to montelulast in Wangfang Database, Chinese Academic Journal (online), Chinese Science and Technology Journal Full-text Database (VIP) were searched. The literature cases were combined with the hospital cases. The patients' gender, age, original disease, dosage, combination of drugs, adverse reactions, occurrence time, severity, treatment, and outcome were analyzed retrospectively. Results 15 Cases in hospital were collected, and 12 cases were obtained by literature retrieval, and 27 cases were included in total. The results of correlation evaluation showed that 4 cases were "probably related" (14.8%), and 23 cases were "probably related" (85.2%). The incidence of adverse reactions in hospital cases was 0.33%. The incidence of adverse events was highest in the 40-65 ages old group. There were 13 cases of adverse reactions without indications of montelukast. No correlation was found between dose and adverse reactions. Adverse reactions include anxiety, nightmares, irritability/agitation/verbal hyperactivity, and more aggression, as well as enuresis, headache, head distension, and limb numbness. The time of occurrence was mostly within 7 d after the use of the drug, and the fastest was half an hour, but also may be delayed to several weeks later. Most of them can return to normal and recover quickly after stopping the drug. Conclusion Montelukast may cause neuropsychiatric adverse reactions, therefore clinical application should strictly grasp the indications of drug use and strengthen the monitoring of drug use. In the clinical application of children patients should be more attention, once the occurrence of adverse reactions the use should be immediately stopped, especially within a week after the start of drug use to strengthen the clinical observation. Related neuropsychiatric adverse reactions can be recovered after drug withdrawal.

R971

河南省医学科技攻关计划项目（201702129）