White M P, MacDonald T H, Garg R A
Department of Paediatrics, Royal Hospital for Sick Children, Yorkhill, Glasgow, UK.
J Int Med Res. 1988 Mar-Apr;16(2):107-13. doi: 10.1177/030006058801600205.
A double-blind placebo-controlled trial was carried out to assess the efficacy of ketotifen in the pre-school asthmatic. The trial period consisted of a 1-month run-in period followed by a 4-month treatment period. Symptom scores for asthma, rhinitis, eczema and, where possible, twice daily peak flow measurements (24 cases) were recorded on diary cards by the parents. All concomitant medication used in addition to the trial drug was noted. The only medication not allowed was disodium cromoglycate. A total of 37 children, 23 boys and 14 girls, mean age 4.1 years (range 1.3-5.9 years) completed the trial. They comprised 19 given ketotifen and 18 given placebo. All were atopic and had allergic rhinitis and 15 had eczema. Ketotifen dosage was 1 mg twice daily in the under 5-year-olds (23 cases) and 2 mg twice daily in the remainder. On analysing the results no significant benefit could be demonstrated for giving ketotifen in this group of patients.
开展了一项双盲安慰剂对照试验，以评估酮替芬对学龄前哮喘患者的疗效。试验期包括1个月的导入期，随后是4个月的治疗期。父母在日记卡上记录哮喘、鼻炎、湿疹的症状评分，并尽可能记录每日两次的最高呼气流量测量值（24例）。记录了除试验药物外使用的所有伴随药物。唯一不允许使用的药物是色甘酸钠。共有37名儿童完成了试验，其中23名男孩和14名女孩，平均年龄4.1岁（范围1.3 - 5.9岁）。他们中19人服用酮替芬，18人服用安慰剂。所有儿童均为特应性体质，患有过敏性鼻炎，15人患有湿疹。5岁以下儿童（23例）的酮替芬剂量为每日两次，每次1毫克，其余儿童为每日两次，每次2毫克。分析结果显示，在这组患者中使用酮替芬未显示出显著益处。
