Varsano I, Volovitz B, Soferman R, Tal A, Schlessinger M, Rotchild M, Tabachnik E
Department of Pediatrics, Hasharon Hospital, Petach Tikva, Israel.
Pediatr Allergy Immunol. 1993 Feb;4(1):45-50. doi: 10.1111/j.1399-3038.1993.tb00065.x.
One hundred and seven chronically wheezing infants, aged 6 months to 3 years, completed a double-blind placebo controlled multicenter study. After a two-week baseline period the patients were randomized into two groups receiving twice daily either ketotifen or placebo for a period of 12 weeks. The ketotifen dosage was 0.5 mg for children younger than one year and 1 mg for the older. During the 12-week treatment period the patients from the two groups demonstrated gradual improvement of the disease severity parameters, as compared with the baseline period. The amelioration was more marked in the ketotifen treated patients and during the 0-4, and 4-8 weeks of treatment a significant decrease was achieved in the percentage of days with a cough (p < 0.04) and in the number of wheezing episodes (p = 0.02). Moreover, a 50% reduction of the days and nights with cough and in the number of wheezing episodes occurred earlier in the ketotifen than in the placebo treated patients, i.e. after 1.2 vs 4.6; 4.4 vs 8.6 and 5.2 vs 7.2 weeks, respectively. It should be stressed that the amelioration of the asthmatic morbidity in the ketotifen group was achieved with a significantly reduced need for the concomitant use of bronchodilators. The principal side effects observed were weight gain and transient sedation. It is concluded that ketotifen may be effective in the amelioration of asthma associated symptomatology and acceleration in the natural tendency for improvement in chronic wheezing infants.
107名年龄在6个月至3岁之间的慢性喘息婴儿完成了一项双盲安慰剂对照多中心研究。在为期两周的基线期后，患者被随机分为两组，每天两次接受酮替芬或安慰剂治疗，为期12周。1岁以下儿童的酮替芬剂量为0.5毫克，1岁以上儿童为1毫克。在12周的治疗期内，与基线期相比，两组患者的疾病严重程度参数都有逐渐改善。酮替芬治疗的患者改善更为明显，在治疗的0 - 4周和4 - 8周，咳嗽天数百分比（p < 0.04）和喘息发作次数（p = 0.02）显著下降。此外，酮替芬治疗组咳嗽的白天和夜晚天数以及喘息发作次数减少50%的时间比安慰剂治疗组更早，分别为1.2周对4.6周；4.4周对8.6周和5.2周对7.2周。应该强调的是，酮替芬组哮喘发病率的改善是在显著减少支气管扩张剂联合使用需求的情况下实现的。观察到的主要副作用是体重增加和短暂的镇静作用。结论是，酮替芬可能有效地改善哮喘相关症状，并加速慢性喘息婴儿自然改善的趋势。
