目的 了解孟魯司特致神經(jīng)精神不良反應發(fā)生的相關規(guī)律、特點，尋找風險因素，為臨床安全用藥提供參考。方法 在新鄉(xiāng)醫(yī)學院第一附屬醫(yī)院中國醫(yī)院藥物警戒系統(tǒng)（CHPS v2.0）的藥品評價系統(tǒng)中，通過醫(yī)囑檢索、病歷檢索這兩個檢索維度，檢索2019年1月-2020年2月使用孟魯司特過程中發(fā)生"興奮""焦慮""抑郁""迷失方向或混亂""注意力不集中""噩夢""幻覺""失眠""震顫""煩躁""易怒""夢游""自殺""強迫癥""不安""口吃""肌肉不自主運動"等神經(jīng)精神癥狀的病例；同時檢索萬方數(shù)字化期刊全文庫、中國學術期刊（網(wǎng)絡版）、中文科技期刊全文數(shù)據(jù)庫（維普）中孟魯司特相關神經(jīng)精神不良反應報道，合并文獻病例與院內(nèi)病例，回顧性統(tǒng)計分析患者性別、年齡、原患疾病、用藥劑量、合用用藥、不良反應表現(xiàn)、發(fā)生時間、嚴重程度、治療和轉歸等項目。結果 收集院內(nèi)病例15例，文獻檢索獲得病例12例，合計入選病例27例。關聯(lián)性評價結果顯示，"可能有關"4例（14.8%），"很可能"有23例（85.2%）；院內(nèi)病例統(tǒng)計神經(jīng)精神不良反應發(fā)生率0.33%；40~65歲年齡段不良事件發(fā)生率最高；13例不良反應無使用孟魯司特的用藥指征；未發(fā)現(xiàn)給藥劑量與不良反應發(fā)生的相關性；不良反應表現(xiàn)為焦慮、噩夢、煩躁/激動/言語多、攻擊性強較多，也可見遺尿、頭痛頭脹、肢體麻木等；發(fā)生時間多在用藥后7 d以內(nèi)，最快的0.5 h，也有延至數(shù)周后的可能；停藥后絕大多數(shù)可以恢復正常且恢復較快。結論 孟魯司特可能導致神經(jīng)精神不良反應，臨床應用時需嚴格把握用藥指征，加強用藥監(jiān)護，在兒童患者的臨床應用中應更加引起關注，一旦發(fā)生不良反應要立即停止使用，特別是在服藥開始后一周內(nèi)要加強臨床觀察。相關神經(jīng)精神不良反應停藥后多數(shù)可以恢復。

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

河南省醫(yī)學科技攻關計劃項目（201702129）