摘要
背景：在儿童和青少年哮喘中，尚无明确证据证明孟鲁司特治疗与某些不良结局相关。
目的：本研究旨在调查3-17岁的CYP哮喘患者在开始使用孟鲁司特作为吸入糖皮质激素（ICS）辅助治疗后1年内神经精神疾病的发生率。
方法：本研究为倾向评分匹配的队列研究，采用2015年至2019年期间在美国TriNetX Analytics Network患者数据库中的电子病历记录。神经精神诊断采用国际疾病统计分类（第十版，临床修订版）（ICD-10-CM）代码进行识别。本研究评估了风险比（RR）、绝对风险增加值（ARI）及伤害所需数量（NNH）的95%可信区间（95%CI）。
结果：本研究共纳入107384名CYP哮喘患者，平均年龄（标准差，SD）为8.7（4.0）岁。其中，93461（87%）名患者为轻至中度哮喘，62 301（58%）名为男性，53 485（50%）名为白人，33 107（31%）名为黑人/非裔美国人。孟鲁司特与神经精神疾病的发生率正相关：每1000名服用孟鲁司特者中有71人发生神经精神疾病，每1000名未服用孟鲁司特者中有54人发生神经精神疾病；RR 为1.32（95%CI为1.25至1.39）；ARI为每百人1.71（95%CI为1.44至1.98）；1年NNH为58人（95%CI为51至69）。孟鲁司特组的最高超额风险是睡眠障碍（RR为1.63（95%CI为1.50至1.77）；ARI为每百人1.17（95%置信区间1.00至1.33）；NNH为85人（95%CI为75至100））。此外，服用孟鲁司特与焦虑症（RR为1.16（95%CI为1.08至1.24））和情绪障碍（RR为1.15（95%CI为1.05至1.29））的发病率正相关。
结论：在接受ICS治疗的CYP哮喘患者中，与未应用孟鲁司特的患者相比，接受孟鲁司特辅助治疗的患者神经精神疾病发生率更高。
Neuropsychiatric diagnoses after montelukast initiation in paediatric patients with asthma
Paljarvi T, Forton JT, Thompson C, Luciano S, Herttua K, Fazel S.
Abstract
BACKGROUND:The evidence base on montelukast-associated adverse outcomes is inconclusive in children and young persons (CYP) with asthma.
OBJECTIVES:We aimed to investigate 1-year incidence of neuropsychiatric diagnoses after initiation of montelukast as an adjunct therapy to inhaled corticosteroids (ICSs) in CYP aged 3-17 years with asthma.
METHODS:This propensity score matched cohort study was conducted using electronic health records between 2015 and 2019 in the TriNetX Analytics Network patient repository in the USA. Neuropsychiatric diagnoses were identified using the International Statistical Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes. We estimated risk ratios (RRs), absolute risk increase (ARI) and number needed to harm (NNH) with 95% CIs.
RESULTS:The mean age (SD) at index prescription in the 107 384 CYP with asthma was 8.7 (4.0) years (93 461 (87%) mild to moderate asthma; 62 301 (58%) male; 53 485 (50%) white; 33 107 (31%) black/African American). Montelukast was associated with excess incidence of any neuropsychiatric outcome (71 per 1000 persons with montelukast and 54 per 1000 persons with no montelukast; RR 1.32 (95% CI 1.25 to 1.39); ARI per 100 persons, 1.71 (95% CI 1.44 to 1.98); 1-year NNH, 58 patients (95% CI 51 to 69)). The highest excess risk in the montelukast group was for sleep disorders (RR 1.63 (95% CI 1.50 to 1.77); ARI per 100 persons 1.17 (95% CI 1.00 to 1.33); NNH, 85 patients (95% CI 75 to 100)). Montelukast use was also associated with excess incidence of anxiety disorders (RR 1.16 (95% CI 1.08 to 1.24)) and mood disorders (RR 1.16 (95% CI 1.05 to 1.29)).
CONCLUSION: In CYP with asthma who were treated with ICSs, adjunct treatment with montelukast was associated with a higher incidence of neuropsychiatric outcomes compared with those who were not exposed to montelukast.
背景：在儿童和青少年哮喘中，尚无明确证据证明孟鲁司特治疗与某些不良结局相关。
目的：本研究旨在调查3-17岁的CYP哮喘患者在开始使用孟鲁司特作为吸入糖皮质激素（ICS）辅助治疗后1年内神经精神疾病的发生率。
方法：本研究为倾向评分匹配的队列研究，采用2015年至2019年期间在美国TriNetX Analytics Network患者数据库中的电子病历记录。神经精神诊断采用国际疾病统计分类（第十版，临床修订版）（ICD-10-CM）代码进行识别。本研究评估了风险比（RR）、绝对风险增加值（ARI）及伤害所需数量（NNH）的95%可信区间（95%CI）。
结果：本研究共纳入107384名CYP哮喘患者，平均年龄（标准差，SD）为8.7（4.0）岁。其中，93461（87%）名患者为轻至中度哮喘，62 301（58%）名为男性，53 485（50%）名为白人，33 107（31%）名为黑人/非裔美国人。孟鲁司特与神经精神疾病的发生率正相关：每1000名服用孟鲁司特者中有71人发生神经精神疾病，每1000名未服用孟鲁司特者中有54人发生神经精神疾病；RR 为1.32（95%CI为1.25至1.39）；ARI为每百人1.71（95%CI为1.44至1.98）；1年NNH为58人（95%CI为51至69）。孟鲁司特组的最高超额风险是睡眠障碍（RR为1.63（95%CI为1.50至1.77）；ARI为每百人1.17（95%置信区间1.00至1.33）；NNH为85人（95%CI为75至100））。此外，服用孟鲁司特与焦虑症（RR为1.16（95%CI为1.08至1.24））和情绪障碍（RR为1.15（95%CI为1.05至1.29））的发病率正相关。
结论：在接受ICS治疗的CYP哮喘患者中，与未应用孟鲁司特的患者相比，接受孟鲁司特辅助治疗的患者神经精神疾病发生率更高。
(中日友好医院呼吸与危重症医学科 张婧媛 摘译 林江涛 审校)
(Thorax. 2024 Nov 22:thorax-2024-221590. doi: 10.1136/thorax-2024-221590.)
(Thorax. 2024 Nov 22:thorax-2024-221590. doi: 10.1136/thorax-2024-221590.)
Neuropsychiatric diagnoses after montelukast initiation in paediatric patients with asthma
Paljarvi T, Forton JT, Thompson C, Luciano S, Herttua K, Fazel S.
Abstract
BACKGROUND:The evidence base on montelukast-associated adverse outcomes is inconclusive in children and young persons (CYP) with asthma.
OBJECTIVES:We aimed to investigate 1-year incidence of neuropsychiatric diagnoses after initiation of montelukast as an adjunct therapy to inhaled corticosteroids (ICSs) in CYP aged 3-17 years with asthma.
METHODS:This propensity score matched cohort study was conducted using electronic health records between 2015 and 2019 in the TriNetX Analytics Network patient repository in the USA. Neuropsychiatric diagnoses were identified using the International Statistical Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes. We estimated risk ratios (RRs), absolute risk increase (ARI) and number needed to harm (NNH) with 95% CIs.
RESULTS:The mean age (SD) at index prescription in the 107 384 CYP with asthma was 8.7 (4.0) years (93 461 (87%) mild to moderate asthma; 62 301 (58%) male; 53 485 (50%) white; 33 107 (31%) black/African American). Montelukast was associated with excess incidence of any neuropsychiatric outcome (71 per 1000 persons with montelukast and 54 per 1000 persons with no montelukast; RR 1.32 (95% CI 1.25 to 1.39); ARI per 100 persons, 1.71 (95% CI 1.44 to 1.98); 1-year NNH, 58 patients (95% CI 51 to 69)). The highest excess risk in the montelukast group was for sleep disorders (RR 1.63 (95% CI 1.50 to 1.77); ARI per 100 persons 1.17 (95% CI 1.00 to 1.33); NNH, 85 patients (95% CI 75 to 100)). Montelukast use was also associated with excess incidence of anxiety disorders (RR 1.16 (95% CI 1.08 to 1.24)) and mood disorders (RR 1.16 (95% CI 1.05 to 1.29)).
CONCLUSION: In CYP with asthma who were treated with ICSs, adjunct treatment with montelukast was associated with a higher incidence of neuropsychiatric outcomes compared with those who were not exposed to montelukast.
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