Long-term evaluation of the impact of the h1-receptor antagonist cetirizine on the behavioral, cognitive, and psychomotor development of very young children with atopic dermatitis.

The impact of the prolonged use of cetirizine at high dose (0.25 mg/kg twice a day over 18 mo) on behavior and cognitive ability was examined in a double-blind, randomized, placebo-controlled trial (ETAC-Early Treatment of the Atopic Child) designed to establish whether it was possible to prevent young children (1-2 y old at study entry) with atopic dermatitis from developing asthma. Well-validated and standardized measures of behavior (Behavior Screening Questionnaire) and cognition (McCarthy Scales of Children's Abilities) were used. In addition, the ages of attainment of psychomotor milestones were established. These measures were taken between an average of 32 and 53 mo of age, both during the study treatment with cetirizine or placebo and after the study treatment had been discontinued. The Behavior Screening Questionnaire was completed at least once on approximately 300 children in each group and on approximately 200 children on five occasions. The McCarthy Scales of Children's Abilities were administered to approximately 100 in each group at three different times. There were no significant differences between the cetirizine and placebo groups on either of the behavior and cognition measures or in psychomotor milestones during or after the study treatment. These findings suggest that there are no adverse effects on behavior or learning processes associated with the prolonged use of cetirizine in young children with atopic dermatitis.

H1受体拮抗剂西替立嗪对低龄特应性皮炎患儿行为、认知和精神运动发育影响的长期评估北京翻译公司

通过双盲、随机化及安慰剂对照（ETAC-特应性疾病患儿的早期治疗）的试验检测长期大剂量（0.25毫克/千克，2/日，连续使用18个月以上）使用西替立嗪对行为和认知能力的影响，旨在确定该药是否可预防低龄（进入本试验时为1-2岁）特应性皮炎患儿发生哮喘。使用经过很好验证和标准化的测量结果评估患儿行为（《行为筛查表》）和认知（《麦卡锡儿童智能量表》）能力。此外，还确定了到达精神运动里程碑的年龄。 这些测量结果平均在患儿32至53个月之间采集，在使用西替立嗪或安慰剂治疗期间以及终止研究性治疗之后均采集相关数据。在每个组中约有300名患儿至少完成一次行为筛查表调查，约200名患儿完成五次。每组中约100名患儿在三个不同的时间点完成麦卡锡儿童智能量表的调查。西替立嗪和安慰剂组的行为和认知测量结果以及研究性治疗期间或之后的精神运动的里程碑方面均无显著差异。这些结果提示，低龄特应性皮炎患儿长期使用西替立嗪并未发生行为或学习过程相关的不良反应俄语口译。