Osterballe O, Lykkegaard Nielsen E A
Allergy. 1979 Apr 2;34(2):125-9. doi: 10.1111/j.1398-9995.1979.tb01373.x.
Twenty-two children with perennial extrinsic allergic asthma participated in a double-blinded, controlled, cross-over study of Ketotifen syrup during a 2 x 6-week period. The placebo was identical with the active drug in taste, colour, and consistency. The dosage level was, on weight basis, a little higher than the standard dosage for adults. The double-blinded investigation was supplemented with a 1 2-week open study of the tolerance for Ketotifen. This study also involved 22 patients, 12 new ones, and 10 from the double-blind study. The study showed Ketotifen to have no effect on changes in lung function (peak flow), on reduction in frequency of asthmatic attacks, or on consumption of additional medicine. The tolerance for Ketotifen was good, but physicians are advised to watch for increases in weight and decreases in blood pressure during tests on children which involve higher dosage levels.
22名患有常年性外源性过敏性哮喘的儿童参与了一项为期2×6周的酮替芬糖浆双盲、对照、交叉研究。安慰剂在味道、颜色和稠度方面与活性药物相同。按体重计算,剂量水平略高于成人标准剂量。双盲研究辅以一项为期12周的酮替芬耐受性开放研究。该研究也涉及22名患者,其中12名是新患者,10名来自双盲研究。研究表明,酮替芬对肺功能变化(峰值流量)、哮喘发作频率降低或额外药物消耗均无影响。酮替芬的耐受性良好,但建议医生在涉及较高剂量水平的儿童测试中留意体重增加和血压下降情况。