Simons F E
Section of Allergy and Clinical Immunology, Department of Pediatrics and Child Health, University of Manitoba, Winnipeg, Canada.
J Allergy Clin Immunol. 1999 Aug;104(2 Pt 1):433-40. doi: 10.1016/s0091-6749(99)70389-1.
In very young children, H(1 )-receptor antagonists have not been adequately studied, although they are widely used and assumed to be safe.
Our objective was to test the hypothesis that cetirizine would be as safe as placebo for long-term use in this population.
In the prospective, double-blind, parallel-group, 18-month-long Early Treatment of the Atopic Child (ETAC) study, 817 children with atopic dermatitis who were 12 to 24 months old at study entry were randomized to receive either cetirizine 0.25 mg/kg or placebo twice daily. Safety was assessed by using the reports of all adverse events, diary cards, physical examinations, developmental assessments, electrocardiograms, blood hematology and chemistry tests, and urinalyses.
The population evaluated for safety consisted of 399 children receiving cetirizine and 396 children receiving placebo. Drop-outs and serious events, including hospitalizations, occurred infrequently and were less common in the children receiving cetirizine than in those children receiving placebo, although the differences were not statistically significant. Most reported symptoms and events were mild and were attributed to intercurrent respiratory or gastrointestinal infections, exacerbations of allergic disorders, or age-related concerns rather than to medication-related adverse effects. There were no clinically relevant differences between the groups for neurologic or cardiovascular symptoms or events, growth, behavioral or developmental assessments, laboratory test results, or electrocardiograms, and no child receiving cetirizine therapy had prolongation of the QTc interval.
The safety of cetirizine has been confirmed in this prospective study, the largest and longest randomized, double-blind, placebo-controlled safety investigation of any H(1 )-antagonist ever conducted in children and the longest prospective safety study of any H(1 )-antagonist ever conducted in any age group.
尽管H(1)受体拮抗剂在幼儿中广泛使用且被认为是安全的，但对其研究尚不充分。
我们的目的是检验西替利嗪在该人群中长期使用与安慰剂一样安全的假设。
在为期18个月的前瞻性、双盲、平行组“特应性儿童早期治疗（ETAC）”研究中，817名入组时年龄为12至24个月的特应性皮炎患儿被随机分为两组，分别每日两次接受0.25mg/kg西替利嗪或安慰剂治疗。通过收集所有不良事件报告、日记卡、体格检查、发育评估、心电图、血液学和化学检测以及尿液分析来评估安全性。
纳入安全性评估的人群包括399名接受西替利嗪治疗的儿童和396名接受安慰剂治疗的儿童。退出研究和严重事件（包括住院）发生率较低，接受西替利嗪治疗的儿童比接受安慰剂治疗的儿童更少见，尽管差异无统计学意义。大多数报告的症状和事件为轻度，归因于并发的呼吸道或胃肠道感染、过敏性疾病加重或与年龄相关的问题，而非药物相关的不良反应。两组在神经或心血管症状或事件、生长、行为或发育评估、实验室检测结果或心电图方面无临床相关差异，接受西替利嗪治疗的儿童均无QTc间期延长。
在这项前瞻性研究中证实了西替利嗪的安全性，这是在儿童中进行的规模最大、时间最长的关于任何H(1)拮抗剂的随机、双盲、安慰剂对照安全性研究，也是在任何年龄组中进行的关于任何H(1)拮抗剂的最长的前瞻性安全性研究。
