目的 了解孟魯司特致神經(jīng)精神不良反應(yīng)發(fā)生的相關(guān)規(guī)律、特點(diǎn)，尋找風(fēng)險(xiǎn)因素，為臨床安全用藥提供參考。方法 在新鄉(xiāng)醫(yī)學(xué)院第一附屬醫(yī)院中國(guó)醫(yī)院藥物警戒系統(tǒng)（CHPS v2.0）的藥品評(píng)價(jià)系統(tǒng)中，通過醫(yī)囑檢索、病歷檢索這兩個(gè)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(mèng)""幻覺""失眠""震顫""煩躁""易怒""夢(mèng)游""自殺""強(qiáng)迫癥""不安""口吃""肌肉不自主運(yùn)動(dòng)"等神經(jīng)精神癥狀的病例；同時(shí)檢索萬方數(shù)字化期刊全文庫(kù)、中國(guó)學(xué)術(shù)期刊（網(wǎng)絡(luò)版）、中文科技期刊全文數(shù)據(jù)庫(kù)（維普）中孟魯司特相關(guān)神經(jīng)精神不良反應(yīng)報(bào)道，合并文獻(xiàn)病例與院內(nèi)病例，回顧性統(tǒng)計(jì)分析患者性別、年齡、原患疾病、用藥劑量、合用用藥、不良反應(yīng)表現(xiàn)、發(fā)生時(shí)間、嚴(yán)重程度、治療和轉(zhuǎn)歸等項(xiàng)目。結(jié)果 收集院內(nèi)病例15例，文獻(xiàn)檢索獲得病例12例，合計(jì)入選病例27例。關(guān)聯(lián)性評(píng)價(jià)結(jié)果顯示，"可能有關(guān)"4例（14.8%），"很可能"有23例（85.2%）；院內(nèi)病例統(tǒng)計(jì)神經(jīng)精神不良反應(yīng)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(yīng)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(yīng)發(fā)生的相關(guān)性；不良反應(yīng)表現(xiàn)為焦慮、噩夢(mèng)、煩躁/激動(dòng)/言語(yǔ)多、攻擊性強(qiáng)較多，也可見遺尿、頭痛頭脹、肢體麻木等；發(fā)生時(shí)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(fù)正常且恢復(fù)較快。結(jié)論 孟魯司特可能導(dǎo)致神經(jīng)精神不良反應(yīng)，臨床應(yīng)用時(shí)需嚴(yán)格把握用藥指征，加強(qiáng)用藥監(jiān)護(hù)，在兒童患者的臨床應(yīng)用中應(yīng)更加引起關(guān)注，一旦發(fā)生不良反應(yīng)要立即停止使用，特別是在服藥開始后一周內(nèi)要加強(qiáng)臨床觀察。相關(guān)神經(jīng)精神不良反應(yīng)停藥后多數(shù)可以恢復(fù)。

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(xué)科技攻關(guān)計(jì)劃項(xiàng)目（201702129）