Tinkelman D G, Moss B A, Bukantz S C, Sheffer A L, Dobken J H, Chodosh S, Cohen B M, Rosenthal R R, Rappaport I, Buckley C E
J Allergy Clin Immunol. 1985 Sep;76(3):487-97. doi: 10.1016/0091-6749(85)90732-8.
Three hundred seventy-four patients with asthma were entered into a year-long, double-blind, double-placebo controlled study comparing the prophylactic effect of ketotifen (229 patients), theophylline (73 patients), and placebo (72 patients). The ketotifen group was larger to allow the accumulation of additional long-term safety data. The primary measure of therapeutic effect was a decrease in concomitant medication without a significant increase in symptomatology or a decrement in pulmonary functions. A patient daily diary was used to document symptoms (cough, shortness of breath, and wheeze) and concomitant medications taken during the 2-week baseline and the subsequent 12 monthly periods. After 2 months of study-drug therapy, the ketotifen patients had a greater decrease in both concomitant medication and symptomatology than either of the other groups. This delay in the onset of therapeutic activity has been observed in other studies and is characteristic of this compound. The principal side effect observed with ketotifen is initial sedation, which was found to be self-limiting and of little concern to the patient after the first month.
374名哮喘患者参与了一项为期一年的双盲、双安慰剂对照研究，该研究比较了酮替芬（229例患者）、茶碱（73例患者）和安慰剂（72例患者）的预防效果。酮替芬组样本量更大，以便积累更多长期安全性数据。治疗效果的主要衡量指标是伴随用药量减少，同时症状无显著增加或肺功能无下降。使用患者每日日记记录在2周基线期及随后12个月度期间出现的症状（咳嗽、呼吸急促和喘息）以及服用的伴随药物。经过2个月的研究药物治疗后，酮替芬组患者的伴随用药量和症状减少程度均大于其他两组。在其他研究中也观察到了这种治疗活性起效延迟的情况，这是该化合物的特点。酮替芬观察到的主要副作用是初始镇静作用，发现这种作用具有自限性，在第一个月后患者对此几乎无需担忧。
