Volovitz B, Varsano I, Cumella J C, Jaber L
Department of Pediatrics, Tel-Aviv University Sackler School of Medicine, Beilinson Medical Center, Petach-Tikva, Israel.
J Allergy Clin Immunol. 1988 Mar;81(3):526-30.
Thirty children (aged 1 to 3 years) with mild to moderate asthma were entered into a 28-week double-blind, crossover study comparing the prophylactic effect of ketotifen and placebo. A patient daily diary card was used to document symptoms and concomitant medications taken during a 2-week baseline and subsequent 12-week drug/placebo period. This was followed by a 2-week washout and 12 more weeks of drug/placebo in a crossover design. Physician assessment was performed at the beginning, at the end of each period, and at 4-week intervals throughout the drug study. No significant difference was observed between ketotifen treatment and placebo treatment in any of the study parameters that were tested. A decrease in concomitant medication usage during the first treatment period with ketotifen was observed. The principle side effect of ketotifen therapy observed in this age group was weight gain. In contrast to studies in adults, no sedation was noted.
30名年龄在1至3岁之间的轻度至中度哮喘患儿进入了一项为期28周的双盲交叉研究，比较酮替芬和安慰剂的预防效果。使用患者每日日记卡记录在2周基线期及随后12周药物/安慰剂期出现的症状和同时服用的药物。之后是2周的洗脱期，然后以交叉设计再进行12周的药物/安慰剂治疗。在研究开始时、每个阶段结束时以及整个药物研究期间每隔4周进行一次医生评估。在所测试的任何研究参数中，酮替芬治疗与安慰剂治疗之间均未观察到显著差异。在第一个使用酮替芬的治疗期内，观察到同时用药的使用有所减少。在该年龄组中观察到的酮替芬治疗的主要副作用是体重增加。与成人研究不同，未观察到镇静作用。
