Kabra S K, Pandey R M, Singh R, Seth V
Department of Pediatrics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi.
Ann Allergy Asthma Immunol. 2000 Jul;85(1):46-52. doi: 10.1016/S1081-1206(10)62433-7.
The prophylactic agent ketotifen has been studied in mild-to-moderate asthma. Various trials showed benefit from 10 to 12 weeks of therapy, but no trial in children with followup beyond 12 weeks of the drug is available.
We studied the efficacy of ketotifen, 1 mg twice a day, orally as a prophylactic drug in children with asthma.
The double-blind, placebo-controlled trial studied 120 asthmatic children of either sex between the ages of 5 to 15 years at a tertiary care hospital. After an observation period of 4 weeks, children were randomly assigned to receive either ketotifen, 1 mg twice a day, or placebo for 6 months. Antiasthma drugs were continued as required. Main outcome measures included average duration for regular antiasthma drugs, average symptom scores, symptom free days, peak expiratory flow rate, FEV1, and need for emergency room visits.
Of the 120 children enrolled, 13 could not complete the trial. Thus 58 children remained in the treatment group and 49 were in the placebo group. Both groups were comparable in their baseline characteristics. The average number of days that required antiasthma drugs were significantly less in the treatment group: salbutamol (27+/-4.7 versus 37+/-3.5 P < .05), theophylline (37+/-4.7 versus 51+/-4.8 P < .05), oral steroids (2+/-0.4 versus 5+/-1.6 P < .05), and inhalation steroids (18+/-2.7 versus 16+/-10.8 P < .05). The average symptom scores and symptom free days for cough, wheeze, and breathlessness also favored the ketotifen group. Emergency room visits were also significantly lower in the ketotifen group (20 versus 10 P < .05). Statistically significant improvement in all the above parameters were observed after 14 weeks of therapy. The mean PEFR, FEV1 and side effects of medications were comparable between the two groups.
Ketotifen, 1 mg twice a day, is an effective prophylaxis for asthma in children between 5 to 15 years. Significant clinical improvement is evident after 14 weeks of therapy.
预防性药物酮替芬已在轻至中度哮喘中进行了研究。各种试验表明，10至12周的治疗有益，但尚无对使用该药物超过12周的儿童进行随访的试验。
我们研究了每天口服两次、每次1毫克的酮替芬作为哮喘儿童预防性药物的疗效。
这项双盲、安慰剂对照试验在一家三级护理医院对120名年龄在5至15岁之间的男女哮喘儿童进行了研究。经过4周的观察期后，儿童被随机分配接受每天两次、每次1毫克的酮替芬或安慰剂治疗6个月。根据需要继续使用抗哮喘药物。主要结局指标包括常规抗哮喘药物的平均使用时长、平均症状评分、无症状天数、呼气峰值流速、第一秒用力呼气容积（FEV1）以及急诊就诊需求。
在登记的120名儿童中，13名无法完成试验。因此，治疗组有58名儿童，安慰剂组有49名儿童。两组的基线特征具有可比性。治疗组需要使用抗哮喘药物的平均天数显著更少：沙丁胺醇（27±4.7天对37±3.5天，P<.05）、茶碱（37±4.7天对51±4.8天，P<.05）、口服类固醇（2±0.4天对5±1.6天，P<.05）以及吸入性类固醇（18±2.7天对16±10.8天，P<.05）。咳嗽、喘息和呼吸急促的平均症状评分和无症状天数也有利于酮替芬组。酮替芬组的急诊就诊次数也显著更低（20次对10次，P<.05）。治疗14周后，上述所有参数均出现了统计学上的显著改善。两组之间的平均呼气峰值流速、第一秒用力呼气容积以及药物副作用具有可比性。
每天两次、每次1毫克的酮替芬是5至15岁儿童哮喘的有效预防药物。治疗14周后，临床改善显著。
