J Glaucoma. 1995 Feb;4(1):6-10.
The purpose of this study was to examine the long-term efficacy and safety of dorzolamide (a topical carbonic anhydrase inhibitor, previously known as MK-507) as an ocular hypotensive agent.
This open-labeled, multicenter, 52-week trial enrolled patients with primary open-angle glaucoma or ocular hypertension. One percent dorzolamide hydrochloride was instilled in both eyes of each patient every 8 h. On the 1st day of the study, intraocular pressure (IOP) was measured with a Gold-mann applanation tonometer at 8:30 and 10:30 a.m. Patients were examined at least every 4 weeks. During each clinic visit, dorzolamide was given at 12:30 a.m., and IOP was determined 8 h later. After IOP measurements, dorzolamide was administered again. Further IOP readings were taken 2 h later at 10:30 a.m. Patients were monitored closely by testing for visual acuity, anterior segment, and by continuously evaluating symptoms.
Ninety-eight patients entered the study and 81 patients (82.7%) completed the study according to the protocol. Three patients had to be withdrawn because of untoward reactions; two experienced ocular discomfort and one developed palpitation. Four patients required additional ocular hypotensive medication for further IOP reduction. One patient was excluded from the analysis because the patient was younger than age 20, which violated the protocol. Dorzolamide significantly reduced IOP by 12.9-17.5% at 8 h after administration and by 16.7-24.1% at 2 h after administration. The IOP decrease was consistent throughout the 52-week trial without waning or potentiation. Our results indicate that dorzolamide may be a safe and effective ocular hypotensive agent.
本研究旨在考察多佐胺（一种局部碳酸酐酶抑制剂，以前称为 MK-507）作为眼降压药的长期疗效和安全性。
这是一项开放性、多中心、52 周的试验，纳入了原发性开角型青光眼或高眼压症患者。每位患者的双眼每 8 小时滴注 1%盐酸多佐胺。研究的第 1 天，在 8：30 和 10：30 测量双眼的眼压（IOP），使用 Gold-mann 压平眼压计。患者至少每 4 周检查一次。每次就诊时，于 12：30 给予多佐胺，并在 8 小时后测量 IOP。测量 IOP 后再次给予多佐胺，2 小时后在 10：30 再次测量 IOP。通过测试视力、眼前节和持续评估症状密切监测患者。
98 例患者进入研究，81 例（82.7%）按方案完成研究。由于不良反应，3 例患者不得不退出研究；2 例出现眼部不适，1 例出现心悸。4 例患者需要额外的眼降压药物以进一步降低眼压。1 例患者因违反方案（患者年龄小于 20 岁）而被排除在分析之外。多佐胺在给药后 8 小时可显著降低 IOP12.9-17.5%，在给药后 2 小时可降低 IOP16.7-24.1%。整个 52 周试验中 IOP 下降情况一致，没有减弱或增强。我们的结果表明，多佐胺可能是一种安全有效的眼降压药。
