Clineschmidt C M, Williams R D, Snyder E, Adamsons I A
Department of Clinical Research, Merck Research Laboratories, West Point, Pennsylvania 19486, USA.
Ophthalmology. 1999 Dec;106(12 Suppl):17-24.
To compare the dorzolamide-timolol fixed combination twice daily to its components, timolol maleate and dorzolamide hydrochloride, given in their usual monotherapy regimens in patients whose intraocular pressure (IOP) was not controlled on timolol twice daily alone.
Parallel, randomized, double-masked, and active-controlled study.
Enrolled were 253 patients from 22 sites throughout the United States.
After a 3-week run-in of timolol (TIMOPTIC; Merck & Co., Inc., Whitehouse Station, NJ) twice daily, eligible patients received either the combination (COSOPT; Merck & Co., Inc., Whitehouse Station, NJ) twice daily (plus placebo to ensure masking), timolol twice daily (plus placebo to ensure masking), or dorzolamide (TRUSOPT; Merck & Co. Inc., Whitehouse Station, NJ) three times daily for 3 months.
Intraocular pressure taken at hours 0 (trough) and 2 (peak) after week 2 and months 1, 2, and 3 was compared to baseline within each treatment group and between the combination and each component group. The safety profile of the combination was compared to each component.
The combination was numerically superior at all study timepoints and was statistically superior at all timepoints except for month 2, hour 0 for timolol, and month 2, hour 2 for dorzolamide. The safety profile of the combination reflected those of its two components. The number of patients reporting ocular or local adverse experiences was greater for the combination (45%) and dorzolamide (45%) than for timolol (27%), with burning and/or stinging eye being the most frequently reported.
The dorzolamide-timolol combination provides additional IOP lowering compared to either of its individual components and generally is well-tolerated.
在仅使用噻吗洛尔每日两次眼压（IOP）仍未得到控制的患者中，比较多佐胺-噻吗洛尔固定复方制剂每日两次给药与其成分马来酸噻吗洛尔和盐酸多佐胺按常规单一疗法给药的效果。
平行、随机、双盲、活性对照研究。
招募了来自美国各地22个地点的253名患者。
在每日两次使用噻吗洛尔（噻吗心安；默克公司，新泽西州怀特豪斯站）进行为期3周的导入期后，符合条件的患者接受每日两次复方制剂（Cosopt；默克公司，新泽西州怀特豪斯站）（加用安慰剂以确保设盲）、每日两次噻吗洛尔（加用安慰剂以确保设盲）或每日三次多佐胺（Trusopt；默克公司，新泽西州怀特豪斯站），为期3个月。
比较第2周、第1个月、第2个月和第3个月时0小时（谷值）和2小时（峰值）的眼压与各治疗组内的基线水平以及复方制剂组与各成分组之间的眼压。将复方制剂的安全性与各成分进行比较。
在所有研究时间点，复方制剂在数值上均更优，除第2个月、噻吗洛尔0小时以及第2个月、多佐胺2小时外，在所有时间点在统计学上均更优。复方制剂的安全性反映了其两种成分的安全性。报告眼部或局部不良事件的患者数量，复方制剂组（45%）和多佐胺组（45%）多于噻吗洛尔组（27%），最常报告的是眼部烧灼感和/或刺痛感。
与单独使用其任何一种成分相比，多佐胺-噻吗洛尔复方制剂能进一步降低眼压，且总体耐受性良好。
