Radielovic P, Morley J, Hansel T T, Medici T C
Clinical Research Department, Sandoz Pharma Ltd., Basel, Switzerland.
J Asthma. 1995;32(2):105-15. doi: 10.3109/02770909509083231.
This international, multicenter clinical trial was designed to compare the efficacy and safety of two different formulations of ketotifen: Zaditen SRO and Zaditen Standard Form. In a randomized double-blind study over a 12-week treatment period, 3 parallel groups of asthmatic subjects received Zaditen SRO (2 mg once daily), Zaditen SRO (4 mg once daily), or Zaditen Standard Form (1 mg twice daily). Asthmatic subjects (362 evaluable cases, aged 6-29 years) kept daily records of clinical symptoms, use of concomitant medication, and peak flow recordings and were examined at 2-week intervals up to the end of the study. Zaditen SRO 4 mg administered once a day at night showed a statistically significant faster onset of action and was more clinically effective than Zaditen Standard Form. The Zaditen SRO 4-mg and 2-mg formulations were at least as well tolerated as the standard form, with somnolence occurring equally after both formulations. In conclusion, Zaditen SRO (4 mg once daily) was found to be equally safe and more effective in the prophylactic treatment of mild and moderate bronchial asthma than Zaditen Standard Form (1 mg twice daily).
这项国际多中心临床试验旨在比较两种不同剂型的酮替芬（Zaditen SRO和Zaditen标准剂型）的疗效和安全性。在一项为期12周的随机双盲研究中，3组平行的哮喘患者分别接受Zaditen SRO（每日1次，每次2毫克）、Zaditen SRO（每日1次，每次4毫克）或Zaditen标准剂型（每日2次，每次1毫克）治疗。哮喘患者（362例可评估病例，年龄6至29岁）每天记录临床症状、伴随用药情况和峰值流量记录，并在研究结束前每2周进行一次检查。每晚服用一次4毫克的Zaditen SRO起效在统计学上明显更快，且在临床上比Zaditen标准剂型更有效。4毫克和2毫克的Zaditen SRO剂型的耐受性至少与标准剂型相同，两种剂型后嗜睡发生率相同。总之，发现Zaditen SRO（每日1次，每次4毫克）在轻度和中度支气管哮喘的预防性治疗中与Zaditen标准剂型（每日2次，每次1毫克）同样安全且更有效。
