van Asperen P P, McKay K O, Mellis C M, Loh R K, Harth S C, Thong Y H, Harris M, Robertson I F, Gibbeson M, Rhodes L
Department of Respiratory Medicine, Children's Hospital, Camperdown, New South Wales, Australia.
J Paediatr Child Health. 1992 Dec;28(6):442-6. doi: 10.1111/j.1440-1754.1992.tb02714.x.
The efficacy of Ketotifen was examined in the treatment of 113 infants between 6 and 36 months of age presenting with a history of cough and/or wheeze in a multicentre randomized placebo-controlled double-blind study. A 4 week no-medication baseline phase preceded the 16 week treatment phase in which infants took 2.5 mL twice daily of either placebo or Ketotifen (0.5 mg) syrup; this was followed by a 4 week wash-out phase. Diary card evaluation was performed by the parent or guardian for the duration of the study and recorded wheeze and cough twice daily as well as medication used. The percentage of symptom-free days decreased significantly in both groups (P < 0.005) with placebo-treated infants experiencing significantly more symptom-free days compared with the Ketotifen group (P < 0.01), although this difference was never more than 10% in any 4 week treatment period. Symptom severity scores and use of beta-agonist medication were also less in the placebo-treated infants but did not reach statistical significance. This study was unable to show a therapeutic advantage of Ketotifen over placebo in this group of infants with chronic cough and/or wheeze and the apparent statistical advantage of placebo is not a clinically relevant finding.
在一项多中心随机安慰剂对照双盲研究中，对113名6至36个月有咳嗽和/或喘息病史的婴儿进行了酮替芬治疗效果的研究。在为期16周的治疗阶段之前有4周的无药物基线期，在此期间婴儿每日两次服用2.5 mL安慰剂或酮替芬（0.5 mg）糖浆；随后是4周的洗脱期。在研究期间由父母或监护人进行日记卡评估，每天记录两次喘息和咳嗽情况以及使用的药物。两组的无症状天数百分比均显著下降（P < 0.005），与酮替芬组相比，接受安慰剂治疗的婴儿无症状天数显著更多（P < 0.01），尽管在任何4周治疗期内这种差异从未超过10%。接受安慰剂治疗的婴儿症状严重程度评分和β受体激动剂药物的使用也较少，但未达到统计学意义。本研究未能显示酮替芬在这组患有慢性咳嗽和/或喘息的婴儿中比安慰剂具有治疗优势，安慰剂明显的统计学优势并非具有临床意义的发现。
