CAJ | 학술논문

目的：了解我国儿童患者中孟鲁司特钠所致精神系统不良反应（ PAE）的临床特点，为临床合理用药提供参考。方法对1010年1月至1013年11月在华中科技大学附属同济医院过敏反应科就诊并服用孟鲁司特钠的门诊患儿进行随访，收集服药后出现PAE患儿的临床资料，就患儿的疾病诊断、合并用药情况、不良反应具体表现、不良反应出现时间、不良反应程度以及停药后症状消失时间等进行汇总分析。结果共收集到符合入选标准的患儿1481例，男性1015例，女性466例；年龄3~17岁，其中3~6岁者613例，7~11岁603例，13~17岁155例；过敏性哮喘780例，过敏性鼻炎701例。1481例患儿中17例服药后出现PAE，发生率为1.15%。男性患儿PAE发生率为1.18%（13/1015），女性患儿为0.86%（4/466）；3~6岁患儿PAE发生率为1.61%（10/613），7~11岁患儿为0.83%（5/603），13~17岁患儿为0.78%（1/155）；过敏性哮喘患儿 PAE 发生率为1.15%（9/780），过敏性鼻炎患儿为1.14%（8/701）；不同性别、年龄段和疾病间PAE发生率差异无统计学意义（均P﹥0.05）。17例发生PAE患儿中睡眠障碍者9例（噩梦7例，失眠1例），行为异常5例（攻击性强4例，多动1例），焦虑1例，噩梦合并多动1例。不良反应呈轻度者14例，中度者3例。PAE发生在服药后1周内者15例，1周及3个月者各1例。17例患儿均在停用孟鲁司特钠后1周内恢复正常。结论儿童患者服用孟鲁司特钠后出现的PAE以睡眠障碍尤其是噩梦较为多见。不良反应程度多较轻微，停药后恢复快。
목적：료해아국인동환자중맹로사특납소치정신계통불량반응（ PAE）적림상특점，위림상합리용약제공삼고。방법대1010년1월지1013년11월재화중과기대학부속동제의원과민반응과취진병복용맹로사특납적문진환인진행수방，수집복약후출현PAE환인적림상자료，취환인적질병진단、합병용약정황、불량반응구체표현、불량반응출현시간、불량반응정도이급정약후증상소실시간등진행회총분석。결과공수집도부합입선표준적환인1481례，남성1015례，녀성466례；년령3~17세，기중3~6세자613례，7~11세603례，13~17세155례；과민성효천780례，과민성비염701례。1481례환인중17례복약후출현PAE，발생솔위1.15%。남성환인PAE발생솔위1.18%（13/1015），녀성환인위0.86%（4/466）；3~6세환인PAE발생솔위1.61%（10/613），7~11세환인위0.83%（5/603），13~17세환인위0.78%（1/155）；과민성효천환인 PAE 발생솔위1.15%（9/780），과민성비염환인위1.14%（8/701）；불동성별、년령단화질병간PAE발생솔차이무통계학의의（균P﹥0.05）。17례발생PAE환인중수면장애자9례（악몽7례，실면1례），행위이상5례（공격성강4례，다동1례），초필1례，악몽합병다동1례。불량반응정경도자14례，중도자3례。PAE발생재복약후1주내자15례，1주급3개월자각1례。17례환인균재정용맹로사특납후1주내회복정상。결론인동환자복용맹로사특납후출현적PAE이수면장애우기시악몽교위다견。불량반응정도다교경미，정약후회복쾌。
Objective To understand the clinical characteristics of psychiatric adverse effects ( PAE)caused by montelukast sodium and provide reference for clinical rational drug use. Methods The children who received montelukast sodium treatment in the department of allergy in Tongji Hospital from 1010 to 1013 were followed up and their data were collected. The diagnosis,situation of drug combination,the clinical manifestations,time of onset,and severity of the PAE,and the time to symptoms disappearing after drug discontinuation were analyzed. Results The data of 1 481 children who met inclusion criteria were collected. Of them,1 015 children were male and 466 were female. Their ages ranged from 3 to 17 years. Of the 1 481 patients,613 children' s ages were 3-6 years,603 were 7-11 years,and 155 were 13-17 years. Among them,780 cases were diagnosed as allergic asthma and 701 cases allergic rhinitis. A total of 17 children developed PAE after treatment with montelukast sodium and the incidence rate was 1. 15%( 17/1 481). The incidence rate of PAE in male sodium and female children was 1. 18(13/1 015)and 0. 86%(4/466),respectively. The incidence rate of PAE among 3-6 year-old children,7-11 year-old children,and 13-17 year-old children were 1. 61%(10/613),0. 83%(5/603),and 0. 78%(1/155),respectively. The incidence rate of PAE in children with allergic asthma and allergic rhinitis were 1. 15%(9/780)and 1. 14%(8/701),respectively. There were no significant differences in the incidence rates of PAE among different gender,ages,and diseases( all P ﹥ 0. 05 ). Among the 17 children who developed PAE,9 children developed sleep disorders ( 7 nightmare and 1 insomnia ), 5 children developed behavior disorders (4 aggressiveness,1 hyperactivity),1 children developed unspecified anxiety,and 1 developed nightmares combined with hyperactivity. The PAE were mild in 14 patients and moderate in 3 patients. There were 15 patients whose PAE occurred within 1 week after montelukast sodium treatment and 1 patient whose PAE occurred within 1 week and 3 months. All the 17 patients recovered within 1 week after montelukast sodium discontinuation. Conclusions The PAE occurred in children after montelukast sodium treatment is mainly sleep disorders,especially nightmare. Most of PAE are mild and the children recover soon after drug withdrawal.