摘要
目的 验证latanoprost对青光眼的治疗价值。方法 对 12 8例原发性开角型青光眼和高眼压症患者进行为期 12周的多中心、开放式、临床随机对照研究 ,观察其降眼压疗效和不良反应。分别应用 0 0 0 5 %latanoprost每日滴眼 1次及 0 5 %噻吗心安每日滴眼 2次。随访时间为治疗前、治疗后 2、6及 12周 ,测量眼压并观察记录局部、全身不良反应。结果 共入选 12 8例 (latanoprost组 6 3例 ,噻吗心安组 6 5例 ) ,其中 117例 (latanoprost组 6 0例 ,噻吗心安组 5 7例 )做有效性评估。latanoprost组平均眼压下降值为 (7 5± 0 3)mmHg(1mmHg=0 133kPa) (32 % ,t=2 2 73,P <0 0 0 0 1) ;噻吗心安组为 (6 1± 0 3)mmHg (2 6 % ,t=17 94,P <0 0 0 0 1)。两组之差 1 4mmHg (F =9 5 4,P =0 0 0 2 6 )。噻吗心安组 2例因眼压控制不良退出研究 ,latanoprost组无因眼压控制不良而退出者。latanoprost组 3例有眼部异物感 ,1例睫毛变黑、变长 ,未发现其他与药物有关的眼部和全身不良反应。结论latanoprost的降眼压疗效优于噻吗心安 。
Objective To evaluate the therapeutic value of latanoprost on glaucoma Methods In an open label fashion, multicenter, randomized control clinical trial, the efficacy and adverse drug reactions of topical application of 0 005% latanoprost once daily were compared with that of 0 5% timolol twice daily for 12 weeks in patients with open angle glaucoma or ocular hypertension Results The study included 128 patients (63 patients in latanoprost group and 65 patients in timolol group) and 117 patients remained at the end of the study (60 cases in latanoprost group and 57 cases in timolol group) Comparing 12 weeks with baseline diurnal intraocular pressure (IOP), the IOP reduction (mean±standard deviation) in latanoprost group was (7 5±0 3) mm Hg (1 mm Hg =0 133 kPa) (32%, t =22.73, P <0 000 1) greater than the reduction in timolol group (6 1±0 3) mm Hg (26%, t =17.94, P <0 000 1), the difference between the two groups being significant ( F =9.54, P =0 002 6) Two patients treated with timolol and none treated with latanoprost were withdrawn from the study because of inadequate IOP control; 3 patients with latanoprost had foreign body sensation In latanoprost group, there was one patient whose eyelashes became darker and longer at the last visit (the 12th week) No ocular and systemic adverse events related to the two drugs were found Conclusion It is demonstrated that 0 005% latanoprost topically applied once daily is well tolerated and more effective in reducing IOP than 0 5% timolol topically applied twice daily Thus, latanoprost has the potential to be a new first line antiglaucoma drug
出处
《中华眼科杂志》
CSCD
北大核心
2000年第4期285-288,共4页
Chinese Journal of Ophthalmology