Strahlman E, Tipping R, Vogel R
Department of Clinical Research, Merck Research Laboratories, West Point, Pa., USA.
Arch Ophthalmol. 1995 Aug;113(8):1009-16. doi: 10.1001/archopht.1995.01100080061030.
To investigate the safety profile and efficacy of 2.0% dorzolamide hydrochloride, when administered three times daily for up to 1 year, compared with that of 0.5% timolol maleate and 0.5% betaxolol hydrochloride, each administered twice daily. In addition, the effect of adding dorzolamide to the regimen of patients with inadequate ocular hypotensive efficacy while they were receiving one of the two beta-adrenoceptor antagonists and the effect of adding timolol to the regimen of patients receiving dorzolamide were also evaluated.
A double-masked, randomized, parallel comparison.
Multinational study at 34 international sites.
Five hundred twenty-three patients with open-angle glaucoma or ocular hypertension, 17 to 85 years of age. Patients currently using ocular hypotensive medications were required to undergo a washout.
Two percent dorzolamide three times a day, 0.5% timolol (Timoptic, Merck, Whitehouse Station, NJ) twice daily, and 0.5% betaxolol solution (Betoptic, Alcon, Fort Worth, Tex) twice daily.
At 1 year, the mean percent reduction in intraocular pressure at peak of 2% dorzolamide, 0.5% timolol, and 0.5% betaxolol was approximately 23%, 25%, and 21%, respectively. At afternoon trough, the mean percent reduction in intraocular pressure was 17%, 20%, and 15% for dorzolamide, timolol, and betaxolol, respectively.
The ocular hypotensive efficacy of 2.0% dorzolamide, given three times a day, is comparable with that of 0.5% betaxolol, given twice daily, for up to 1 year. In addition, long-term use of dorzolamide was not associated with clinically meaningful electrolyte disturbances or systemic side effects commonly observed with the use of oral carbonic anhydrase inhibitors.
研究2.0%盐酸多佐胺每日给药三次、持续给药长达1年时的安全性和疗效，并与0.5%马来酸噻吗洛尔和0.5%盐酸倍他洛尔每日给药两次的情况进行比较。此外，还评估了在接受两种β-肾上腺素能拮抗剂之一但眼压降低效果不佳的患者治疗方案中添加多佐胺的效果，以及在接受多佐胺治疗的患者治疗方案中添加噻吗洛尔的效果。
双盲、随机、平行对照研究。
在34个国际地点进行的多国研究。
523例年龄在17至85岁之间的开角型青光眼或高眼压症患者。目前正在使用降眼压药物的患者需要经过洗脱期。
2%多佐胺每日三次，0.5%噻吗洛尔（噻吗心安，默克公司，新泽西州怀特豪斯站）每日两次，以及0.5%倍他洛尔溶液（贝特舒，爱尔康公司，得克萨斯州沃思堡）每日两次。
1年后，2%多佐胺、0.5%噻吗洛尔和0.5%倍他洛尔眼压峰值时的平均降低百分比分别约为23%、25%和21%。下午谷值时，多佐胺、噻吗洛尔和倍他洛尔的眼压平均降低百分比分别为17%、20%和15%。
每日给药三次的2.0%多佐胺的降眼压疗效与每日给药两次的0.5%倍他洛尔相当，长达1年。此外，长期使用多佐胺与临床上有意义的电解质紊乱或口服碳酸酐酶抑制剂常见的全身副作用无关。
