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曲伏前列素/噻吗洛尔固定复方制剂与多佐胺/噻吗洛尔在原发性开角型青光眼和高眼压症患者中的疗效与安全性比较。

Comparison of the efficacy and safety of fixed combination travoprost/timolol and dorzolamide/ timolol in patients with primary open-angle glaucoma and ocular hypertension.

作者信息

Babić Nikola, Andreić Veljko, Miljković Aleksandar, Grković Desanka, Jovanović Predrag

机构信息

Eye Clinic, Clinical Center of Vojvodina, Novi Sad, Serbia.

出版信息

Srp Arh Celok Lek. 2013 Jul-Aug;141(7-8):441-6. doi: 10.2298/sarh1308441b.

DOI:10.2298/sarh1308441b
PMID:24073548
Abstract

INTRODUCTION

Combining two medications in one bottle may improve compliance by reducing the time required to administer drops and the frequency of the total number of medication bottles.

OBJECTIVE

To compare the efficacy of reduced intraocular pressure (IOP) and safety of fixed combination travoprost 0.004%/timolol 0.5% vs. fixed combination dorzolamide 2%/timolol 0.5% in patients with primary open-angle glaucoma or ocular hypertension.

METHODS

Prospective randomized clinical study included 60 patients divided into 2 groups. Follow-up was done at day 14 and 45 and month 3. IOP measurements were taken at each follow-up examination at 8 am, 10 am and 4 pm.

RESULTS

Both fixed combinations reduced IOP significantly compared to initial values at all follow-ups (p < 0.001). Mean pooled IOP at all visits and time points was slightly lower in the travoprost/timolol group compared with the dorzolamide/timolol group (16.13 mmHg vs. 16.15 mmHg). Mean IOP reduction from baseline ranged from -7.46 mmHg to -9.92 mmHg in the travoprost/timolol group and from -6.93 mmHg to -8.93 mmHg for the dorzolamide/timolol group. Mean (+/- standard error of the mean) reduction in diurnal LOP from baseline to 3rd month was 8.96 +/- 2.79 in the travoprost/timolol group versus 8.07 +/- 2.91 in patients receiving dorzolamide/timolol fixed combination (p = 0.196). The most frequent treatment-related adverse events were conjunctival hyperemia in the travoprost/timolol group, and dry eye and foreign body sensation in the dorzolamide/timolol group.

CONCLUSION

Travoprost/timolol fixed combination was slightly more effective than dorzolamide/timolol fixed combination in reducing mean diurnal IOP. Travoprost/timolol group resulted in an IOP reduction for up to 1.07 mmHg higher than dorzolamide/timolol group. Both fixed combinations were well tolerated and safe.

摘要

引言

将两种药物装在一个瓶子里,可能会减少滴眼所需时间以及药瓶总数的使用频率,从而提高用药依从性。

目的

比较0.004%曲伏前列素/0.5%噻吗洛尔固定复方制剂与2%多佐胺/0.5%噻吗洛尔固定复方制剂对原发性开角型青光眼或高眼压症患者降低眼压的疗效及安全性。

方法

前瞻性随机临床研究纳入60例患者,分为2组。在第14天、第45天和第3个月进行随访。每次随访检查均于上午8点、10点和下午4点测量眼压。

结果

与所有随访时的初始值相比,两种固定复方制剂均显著降低了眼压(p<0.001)。曲伏前列素/噻吗洛尔组在所有访视和时间点的平均合并眼压略低于多佐胺/噻吗洛尔组(16.13 mmHg对16.15 mmHg)。曲伏前列素/噻吗洛尔组眼压从基线水平的平均降低幅度为-7.46 mmHg至-9.92 mmHg,多佐胺/噻吗洛尔组为-6.93 mmHg至-8.93 mmHg。曲伏前列素/噻吗洛尔组从基线到第3个月日间眼压的平均(±平均标准误)降低值为8.96±2.79,接受多佐胺/噻吗洛尔固定复方制剂的患者为8.07±2.91(p = 0.196)。最常见的与治疗相关的不良事件是曲伏前列素/噻吗洛尔组的结膜充血,以及多佐胺/噻吗洛尔组的干眼和异物感。

结论

曲伏前列素/噻吗洛尔固定复方制剂在降低日间平均眼压方面比多佐胺/噻吗洛尔固定复方制剂略更有效。曲伏前列素/噻吗洛尔组的眼压降低幅度比多佐胺/噻吗洛尔组高出1.07 mmHg。两种固定复方制剂耐受性良好且安全。

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