Aguilar A J
Acta Ophthalmol Scand Suppl. 2000(230):52-5. doi: 10.1034/j.1600-0420.2000.078s230052.x.
To compare the clinical efficacy and tolerance of 0.1% olopatadine hydrochloride (OHC) versus 0.05% ketotifen fumarate (KF) in the management of allergic conjunctivitis.
Eighty adult patients with a history of allergy (allergic conjunctivitis, hay fever, asthmatic bronchitis and dermatitis) that were showing allergic conjunctivitis signs and symptoms (itching, hyperemia, mucous discharge and tearing) at the time of inclusion in this study were evaluated. Patients were divided in two groups, A and B. Group A patients were treated with OHC and group B patients were treated with KF. Both groups received one drop in the affected eye every 12 hrs. The start time of this study was the first patient visit, in which the medication was instilled for the first time. Both groups of patients were evaluated 30 min, 48 hr., 7 days and 14 days later. Local tolerance of each medication was evaluated.
Clinical improvement of the signs and symptoms of allergic conjunctivitis occurred in 42.5% to 62.5% of the patients in Group A when assessed 30 min following the first topical ocular dose of olopatadine. However, mucous discharge was not affected. Forty-eight (48) hrs. after the first instillation, improvements in 57.5% to 75% of the patients were shown in every evaluated parameter. After 7 days of treatment, positive clinical results were observed in 80% to 87.5% of the treated patients. Except for the patients that were dismissed from the study before the seventh day of treatment due to the absence of therapeutic response (4/40), all patients satisfactorily completed the therapeutic plan by the seventh day. No intolerance reactions were observed in patients of this group. In Group B patients (KF), clinical improvement of the signs and symptoms measured in the study was shown in 20.0% to 47.5% 30 min after instillation. As observed with olopatadine, no improvement in the number of patients showing mucous discharge was noted at the 30-min time point. At 48 hr. after the first instillation, 27.5% to 48% of patients showed improvement in every evaluated parameter. After 7 days of treatment, improvement was observed in 60% to 75% of patients. On Day 14, positive responses were observed in 67.5% to 75% of patients. Seventeen and one-half percent of the patients were dismissed from the study before the seventh day of treatment due to the absence of a therapeutic response. Approximately 23% of the patients had mild reactions of intolerance (stinging) which was not a cause to discontinue the treatment.
Olopatadine hydrochloride controlled allergic conjunctivitis symptoms and signs more rapidly and to a greater extent than ketotifen fumarate. Fewer cases of treatment failure were noted with OHC, and no local intolerance reactions were observed, while KF triggered mild reactions (stinging) in 23% of patients.
比较0.1%盐酸奥洛他定（OHC）与0.05%富马酸酮替芬（KF）治疗过敏性结膜炎的临床疗效和耐受性。
对80例有过敏史（过敏性结膜炎、花粉症、哮喘性支气管炎和皮炎）且在纳入本研究时出现过敏性结膜炎体征和症状（瘙痒、充血、黏液分泌物和流泪）的成年患者进行评估。患者分为A组和B组。A组患者接受OHC治疗，B组患者接受KF治疗。两组均每12小时在患眼滴入一滴。本研究的开始时间为首次患者就诊，即首次滴入药物之时。两组患者在30分钟、48小时、7天和14天后进行评估。评估每种药物的局部耐受性。
在首次局部眼部滴入奥洛他定后30分钟评估时，A组42.5%至62.5%的患者过敏性结膜炎的体征和症状出现临床改善。然而，黏液分泌物未受影响。首次滴入后48小时，每个评估参数在57.5%至75%的患者中显示有改善。治疗7天后，80%至87.5%的治疗患者观察到阳性临床结果。除因无治疗反应在治疗第7天前退出研究的患者（4/40）外，所有患者在第7天均令人满意地完成了治疗方案。该组患者未观察到不耐受反应。在B组患者（KF）中，滴入后30分钟研究中测量的体征和症状的临床改善在20.0%至47.5%的患者中显示。与奥洛他定观察到的情况一样，在30分钟时间点显示有黏液分泌物的患者数量没有改善。首次滴入后48小时，27.5%至48%的患者每个评估参数显示有改善。治疗7天后，60%至75%的患者有改善。在第14天，67.5%至75%的患者观察到阳性反应。17.5%的患者因无治疗反应在治疗第7天前退出研究。约23%的患者有轻度不耐受反应（刺痛），但这并非停药原因。
盐酸奥洛他定比富马酸酮替芬更迅速、更有效地控制过敏性结膜炎的症状和体征。OHC治疗失败的病例较少，且未观察到局部不耐受反应，而KF在23%的患者中引发轻度反应（刺痛）。
