国产与进口溴莫尼定滴眼液的多中心临床对照试验139例

A clinical multicenter comparative study of domestic and imported brimonidine in139 patients

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。

AIM： To investigate the therapeutic value of domestic brimonidine in treating patients with primary open angle glaucoma （POAG） or ocular hypertension （OHT）. METHODS ： A muhicentric, randominzed, double blind, parallel group controlled study was undertaken for 139 patients with POAG or OHT being treated for 6 wk. Brimonidine made domestically was applied twice a day in the experiment group and same for the brimonidine imported in the control group. Intraocular pressure （ IOP ）, visual acuity, blood pressure, pulse, ocular symptom and sign and adverse reactions were observed before and 2,4,6 wk after the treatment. RESULTS： There were 70 patients in the experiment group and 69 in the control group separately, among which 60 and 61 patients finished the study respectively. The daily IOP reduction in the experiment group was （ 1.0 ± s 0.5 ） kPa with the effective rate （ IOP decrease 〉 10 % ） of 98 % and the IOP reduction in the control group was （0.9 ± 0.4） kPa with the effective rate of 100 % after 6 wk treatment of domestic brimonidine and imported brimonidine respectively. There was no significant difference between the two groups. Some patients suffered from discomforts such as sense of burn, tingle, thirst and so on. Two patients in the experiment group quited the study for such discomforts but the others could tolerate well. CONCLUSION： Brimonidine made domestically is effective and safe in reducing IOP of POAG and OHT, possessing equivalent efficacy with brimonidine imported.