阿可乐定与噻吗洛尔治疗慢性开角型青光眼的比较。一项为期三个月的研究。

Comparison of apraclonidine and timolol in chronic open-angle glaucoma. A three-month study.

作者信息

Nagasubramanian S, Hitchings R A, Demailly P, Chuniaud M, Pannarale M R, Pecori-Giraldi J, Stodtmeister R, Parsons D G

机构信息

Moorfields Eye Hospital, London, England.

出版信息

Ophthalmology. 1993 Sep;100(9):1318-23. doi: 10.1016/s0161-6420(13)31818-1.

DOI:10.1016/s0161-6420(13)31818-1

PMID:8371918

Abstract

PURPOSE

To compare the safety and efficacy of apraclonidine ophthalmic solution 0.25% and 0.5% (both given 3 times daily) to timolol maleate (0.5%) given twice daily, in primary open-angle glaucoma or ocular hypertension.

METHODS

This study was a 90-day prospective, multicenter, double-masked, randomized, parallel group trial. Intraocular pressure (IOP) measurements were made between 8:00 and 10:00 AM before the morning dose (i.e., up to 12 hours after the evening dose of glaucoma medication) and at 4:00 PM (i.e., 8 hours after the morning dose of glaucoma medication). Patients with off-therapy IOP of greater than 22 mmHg and less than 35 mmHg were entered into the study and were assessed 14, 30, and 90 days after treatment.

RESULTS

Sixty-nine patients were enrolled; there were no significant demographic differences among the three study groups. All three treatments significantly reduced IOP over 90 days (P < 0.011). For apraclonidine 0.5%, IOP reductions from 25.8 +/- 3.2 mmHg (pretreatment) to 20.4 +/- 4.00 mmHg (day 90) were observed; for apraclonidine 0.25%, from 25.7 +/- 3.05 mmHg (pretreatment) to 22.1 +/- 4.24 mmHg (day 90); and for timolol 0.5% from 26.1 +/- 3.79 mmHg to 21.1 +/- 5.91 mmHg (day 90). The 90-day period of therapy was completed by 12 patients treated with apraclonidine 0.5%, 21 patients treated with apraclonidine 0.25%, and 23 patients treated with timolol 0.5%. There were no serious adverse events. Fourteen of 22 patients (0.5% apraclonidine) and 21 of 23 patients (0.25% apraclonidine) tolerated the drug well; ocular allergy developed in the remaining patients treated with apraclonidine, which resolved upon discontinuation.

CONCLUSIONS

Apraclonidine effectively lowers IOP associated with open-angle glaucoma or ocular hypertension; these pilot results will need to be confirmed by a larger pivotal study. Long-term therapy for some patients may be inhibited by ocular allergy for which there was a higher incidence to the 0.5% apraclonidine solution than to the 0.25% solution in this study. Apraclonidine may be of value as an additional therapy for open-angle glaucoma in selected patients.

摘要

目的

比较0.25%和0.5%阿可乐定滴眼液（均每日给药3次）与0.5%马来酸噻吗洛尔滴眼液（每日给药2次）治疗原发性开角型青光眼或高眼压症的安全性和有效性。

方法

本研究为一项为期90天的前瞻性、多中心、双盲、随机、平行组试验。在上午给药前（即青光眼药物晚间给药后长达12小时）的8:00至10:00以及下午4:00（即青光眼药物上午给药后8小时）测量眼压。治疗前眼压高于22 mmHg且低于35 mmHg的患者纳入研究，并在治疗后14天、30天和90天进行评估。

结果

共纳入69例患者；三个研究组在人口统计学方面无显著差异。所有三种治疗在90天内均显著降低了眼压（P < 0.011）。对于0.5%阿可乐定，眼压从25.8±3.2 mmHg（治疗前）降至20.4±4.00 mmHg（第90天）；对于0.25%阿可乐定，眼压从25.7±3.05 mmHg（治疗前）降至22.1±4.24 mmHg（第90天）；对于0.5%噻吗洛尔，眼压从26.1±3.79 mmHg降至21.1±5.91 mmHg（第90天）。接受0.5%阿可乐定治疗的12例患者、接受0.25%阿可乐定治疗的21例患者和接受0.5%噻吗洛尔治疗的23例患者完成了90天的治疗疗程。未发生严重不良事件。22例接受0.5%阿可乐定治疗的患者中有14例、23例接受0.25%阿可乐定治疗的患者中有21例对药物耐受性良好；其余接受阿可乐定治疗的患者出现眼部过敏，停药后症状缓解。