Sun L, Gong Y R, Chen Q, Zhang T, Li G M, Liu H M, Yang C H, Qian L L, Li Y F, Yao W, Xu H
Department of Rheumatology, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai 201102, China.
Department of Ophthalmology, Eye & ENT Hospital of Fudan University, Shanghai 200031, China.
Zhonghua Er Ke Za Zhi. 2021 Feb 2;59(2):107-112. doi: 10.3760/cma.j.cn112140-20200622-00656.
To analyze the disease spectrum among children who were using hydroxychloroquine (HCQ), and evaluate the drug's safety and compliance. From January 2008 to December 2019, children from Children's Hospital of Fudan University who used HCQ were selected as subjects, the disease spectrum of HCQ was analyzed, and the drug safety and compliance were evaluated for the patients who were followed up for more than 6 months. Demographic information, diagnosis, initial dose, time of continuous use, cumulative dosage and related adverse reactions report, project and the results of eye test were collected. A total of 528 cases used HCQ during the 12 years, with 156 male cases and 372 female cases, and age at initial medication was (10.5±3.2) years. Among them, 514 cases (97.3%) had rheumatic disease, 5 had pulmonary interstitial lesions and 9 had other system diseases. The top three of the rheumatic diseases were systemic lupus erythematosus (SLE) in 316 cases (316/514,61.5%), juvenile idiopathic arthritis in 69 cases (69/514,13.4%), and juvenile dermatomyositis in 56 cases (56/514,10.9%). During the same period, 397 cases were diagnosed with SLE, and the utilization rate was 79.6% (316/397), which was the highest compared with other diseases and increased year by year. Pulmonary interstitial lesions included 4 cases with SFTPC gene defect related interstitial lung disease. Of the 528 ceses who were treated with HCQ, 397 cases were included for evaluating HCQ's safety and compliance, the initial dose was (4.2±1.0) mg/kg, duration was 29.6 (14.9, 48.8) months, the longest usage time was 127 months, the largest cumulative dosage was 566.8 g. The continuous usage duration (=-3.191, =0.001) of SLE was significantly higher than those of other diseases, as well as cumulative dosage (=-5.355, =0.001). All cases received comprehensive eye exams before medication, 354 cases (354/397, 89.2%) were followed up in the ophthalmological department, and 65.5% (232/354) of them could be reviewed regularly at least 1 time per year. One case suffered from severe skin adverse reactions when the drug was used for 32.7 months, and no other serious adverse reactions were reported. HCQ related retinopathy was not seen during the follow-up period. There were 5 cases stopped HCQ on their own. HCQ was widely used in rheumatic disease in children, especially in those with SLE. It was safe for long-time usage in children, and the medication compliance and the ophthalmic follow-up was good.
分析使用羟氯喹(HCQ)的儿童的疾病谱,并评估该药物的安全性和依从性。选取2008年1月至2019年12月在复旦大学附属儿科医院使用HCQ的儿童作为研究对象,分析HCQ的疾病谱,并对随访6个月以上的患者进行药物安全性和依从性评估。收集人口统计学信息、诊断、初始剂量、连续使用时间、累积剂量及相关不良反应报告、眼部检查项目及结果。12年间共有528例使用HCQ,其中男性156例,女性372例,初始用药年龄为(10.5±3.2)岁。其中,514例(97.3%)患有风湿性疾病,5例有肺间质病变,9例有其他系统疾病。风湿性疾病中前三位分别为系统性红斑狼疮(SLE)316例(316/514,61.5%)、幼年特发性关节炎69例(69/514,13.4%)、幼年皮肌炎56例(56/514,10.9%)。同期,397例被诊断为SLE,使用率为79.6%(316/397),高于其他疾病且逐年上升。肺间质病变中包括4例SFTPC基因缺陷相关间质性肺病。在528例接受HCQ治疗的患者中,397例纳入评估HCQ安全性和依从性,初始剂量为(4.2±1.0)mg/kg,疗程为29.6(14.9,48.8)个月,最长用药时间为127个月,最大累积剂量为566.8g。SLE的连续使用时间(=-3.191,=0.001)及累积剂量(=-5.355,=0.001)显著高于其他疾病。所有病例用药前均接受全面眼部检查,354例(354/397,89.2%)在眼科随访,其中65.5%(232/354)每年至少能定期复查1次。1例在用药32.7个月时出现严重皮肤不良反应,未报告其他严重不良反应。随访期间未发现HCQ相关视网膜病变。有5例自行停用HCQ。HCQ在儿童风湿性疾病中广泛应用,尤其在SLE患儿中。儿童长期使用安全,用药依从性及眼科随访情况良好。