Fechtner Robert D, Airaksinen P Juhani, Getson Albert J, Lines Christopher R, Adamsons Ingrid A
Glaucoma Division, New Jersey Medical School, UMDNJ, Newark, NJ 07101-1709, USA.
Acta Ophthalmol Scand. 2004 Feb;82(1):42-8. doi: 10.1046/j.1600-0420.2004.0205.x.
To compare the efficacy of the fixed dorzolamide 2%/timolol 0.5% combination (COSOPT) versus latanoprost 0.005% (XALATAN).
Two 3-month, parallel group, randomized, observer-masked and patient-masked, multicentre, clinical trials were performed in patients with ocular hypertension or open-angle glaucoma. Study 1 (n=256) was conducted in the United States and Study 2 (n=288) was conducted in Europe/Israel. Patients could be included whether or not they were currently taking ocular hypotensive therapy, and regardless of the effectiveness of any previous therapy. Patients were washed out from their usual ocular hypotensive medications and then those with a baseline intraocular pressure (IOP) >/= 24 mmHg were randomized to either the dorzolamide/timolol combination eye drops twice daily or latanoprost eye drops once daily in both eyes. Efficacy was assessed by daytime diurnal IOP (the mean of measurements made at 0800, 1000, 1400 and 1600 h).
At baseline, the mean daytime diurnal IOP was 26.1 mmHg in the dorzolamide/timolol combination group versus 25.6 mmHg in the latanoprost group in Study 1, and 25.3 mmHg in the dorzolamide/timolol combination group versus 24.7 mmHg in the latanoprost group in Study 2. After 3 months, the mean daytime diurnal IOP was 18.9 mmHg for the dorzolamide/timolol combination versus 18.4 mmHg for latanoprost in Study 1, and 17.4 mmHg for the dorzolamide/timolol combination versus 17.5 for latanoprost in Study 2. The difference between treatments in mean IOP change at 3 months was -0.04 mmHg [95% confidence interval (CI) -0.85, 0.77] in Study 1, and -0.57 mmHg (95% CI -1.31, 0.16) in Study 2. The probability that the true difference lay between -1.5 and 1.5 mmHg, the predefined bounds for equivalence, was >0.950 in both studies. Both treatments were well tolerated over 3 months, although ocular stinging occurred more frequently with the dorzolamide/timolol combination.
The dorzolamide/timolol combination and latanoprost were equally effective at lowering IOP.
比较2%多佐胺/0.5%噻吗洛尔固定复方制剂（Cosopt）与0.005%拉坦前列素（Xalatan）的疗效。
对高眼压症或开角型青光眼患者进行了两项为期3个月的平行组、随机、观察者设盲和患者设盲的多中心临床试验。研究1（n = 256）在美国进行，研究2（n = 288）在欧洲/以色列进行。无论患者目前是否正在接受降眼压治疗，也无论既往任何治疗的效果如何，均可纳入研究。患者停用其常用的降眼压药物，然后将基线眼压（IOP）≥24 mmHg的患者随机分为每日双眼滴用多佐胺/噻吗洛尔复方滴眼液两次或每日双眼滴用一次拉坦前列素滴眼液。通过日间眼压（08:00、10:00、14:00和16:00测量值的平均值）评估疗效。
在研究1中，基线时多佐胺/噻吗洛尔复方组的日间平均眼压为26.1 mmHg，拉坦前列素组为25.6 mmHg；在研究2中，多佐胺/噻吗洛尔复方组为25.3 mmHg，拉坦前列素组为24.7 mmHg。3个月后，在研究1中，多佐胺/噻吗洛尔复方组的日间平均眼压为18.9 mmHg，拉坦前列素组为18.4 mmHg；在研究2中，多佐胺/噻吗洛尔复方组为17.4 mmHg，拉坦前列素组为17.5 mmHg。在研究1中，3个月时治疗组间平均眼压变化的差异为 -0.04 mmHg [95%置信区间（CI）-0.85, 0.77]；在研究2中为 -0.57 mmHg（95% CI -1.31, 0.16）。两项研究中，真实差异落在预先定义的等效界限 -1.5至1.5 mmHg之间的概率均>0.950。两种治疗在3个月内耐受性均良好，尽管多佐胺/噻吗洛尔复方制剂引起眼部刺痛的情况更频繁。
多佐胺/噻吗洛尔复方制剂和拉坦前列素在降低眼压方面同样有效。
