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目的:验证国产溴莫尼定滴眼液治疗原发性开角型青光眼和高眼压症的治疗价值。方法:对139例原发性开角型青光眼及高眼压症病人进行为期6 wk的多中心、随机、双盲、阳性对照研究,试验组滴用国产制剂,对照组滴用进口制剂,均早、晚各1次,于治疗前,治疗后2,4,6 wk,随访眼压的变化,并做眼部检查、视野检查,观察生命体征和不良反应。结果:试验组入选70例(70只眼),对照组入选69例(69只眼),完成试验的分别为60例(60只眼)和61例(61只眼)。6 wk后试验组眼压下降(1.0±s0.5)kPa,降眼压的有效率(眼压下降>10%)为98%;对照组下降(0.9±0.4)kPa,有效率为100%。2组比较差异无显著意义。部分病人出现眼烧灼感、眼刺痛、口干、疲劳等不适症状,除试验组2例病人因此中止试验外,其余均能良好耐受。结论:国产溴莫尼定滴眼液对于控制原发性开角型青光眼和高眼压症的眼压是有效和安全的,效果与进口制剂相当。
Objective: To verify the value of domestic brimonidine eye drops in the treatment of primary open angle glaucoma and ocular hypertension. Methods: A total of 139 patients with primary open-angle glaucoma and ocular hypertension underwent a multi-center, randomized, double-blind, positive control study for 6 weeks. The experimental group dripped with the domestic preparation and the control group with the imported preparation, both Morning and evening 1, before treatment, 2,4,6 wk after treatment, follow-up intraocular pressure changes, and do eye examination, visual field examination, observation of vital signs and adverse reactions. RESULTS: Seventy patients (70 eyes) were enrolled in the study group and 69 (69 eyes) were enrolled in the control group. Sixty eyes (60 eyes) and 61 eyes (61 eyes) completed the trial. After 6 weeks, the intraocular pressure of the experimental group decreased (1.0 ± s 0.5) kPa and the intraocular pressure (IOP decreased more than 10%) was 98%. In the control group decreased 0.9 ± 0.4 kPa, the effective rate was 100% . There was no significant difference between the two groups. Some patients showed eye burning, eye irritation, dry mouth, fatigue and other symptoms, in addition to the experimental group of 2 patients so stop the test, the rest are well tolerated. Conclusion: The domestic brimonidine eye drops are effective and safe for controlling intraocular pressure of primary open-angle glaucoma and ocular hypertension with the same effect as imported preparations.