盐酸阿可乐定联合最大耐受药物治疗青光眼的短期疗效。阿可乐定最大耐受药物治疗研究组。

Short-term efficacy of apraclonidine hydrochloride added to maximum-tolerated medical therapy for glaucoma. Apraclonidine Maximum-Tolerated Medical Therapy Study Group.

作者信息

Robin A L, Ritch R, Shin D H, Smythe B, Mundorf T, Lehmann R P

机构信息

Department of Ophthalmology, Johns Hopkins University, Baltimore, Maryland, USA.

出版信息

Am J Ophthalmol. 1995 Oct;120(4):423-32. doi: 10.1016/s0002-9394(14)72655-8.

DOI:10.1016/s0002-9394(14)72655-8

PMID:7573299

Abstract

PURPOSE

We determined whether the addition of topical apraclonidine hydrochloride to eyes that are receiving maximal medical therapy but still have inadequate intraocular pressure control and that are scheduled to undergo surgery could adequately decrease intraocular pressure, postponing the need for further intervention.

METHODS

We performed a prospective, 90-day, multicentered, placebo-controlled, double-masked parallel study. We enrolled one eye each of 174 glaucoma patients with inadequate intraocular pressure control who were on maximally tolerated medical therapy. We continued to administer maximum medical therapy for glaucoma. Study medications were either apraclonidine hydrochloride 0.5% or placebo (apraclonidine's vehicle). Patients were instructed to take the study medication every eight hours. We measured intraocular pressure, change in intraocular pressure from baseline, and the number of eyes requiring surgery after the addition of study medication.

RESULTS

Fifty-two (60%) of 86 patients treated with apraclonidine maintained adequate intraocular pressure control throughout the study and avoided surgery, compared with 28 (32%) of 88 patients treated with placebo (P < .001). Apraclonidine treatment resulted in significantly more patients attaining an additional 20% reduction or more in intraocular pressure from baseline and an intraocular pressure less than or equal to 20 mm Hg (P < .05). The most common ocular complication was conjunctival hyperemia (11 of 86 patients, 12.8%). The most frequent nonocular problem was dry mouth (four patients, 4.7%).

CONCLUSION

Apraclonidine appeared to be safe in all eyes and efficacious in some eyes. It significantly lowered intraocular pressure when used in combination with maximally tolerated medical therapy, which delayed or prevented further glaucoma surgery for at least 90 days in 52 (60%) of 86 treated patients.

摘要

目的

我们确定对于接受最大剂量药物治疗但眼压控制仍不理想且计划接受手术的眼睛，添加局部用盐酸阿可乐定是否能充分降低眼压，从而推迟进一步干预的必要性。

方法

我们进行了一项为期90天的前瞻性、多中心、安慰剂对照、双盲平行研究。我们纳入了174例眼压控制不佳且正在接受最大耐受药物治疗的青光眼患者的单眼。我们继续给予青光眼最大剂量的药物治疗。研究药物为0.5%盐酸阿可乐定或安慰剂（阿可乐定的赋形剂）。患者被指示每8小时服用一次研究药物。我们测量了眼压、眼压相对于基线的变化以及添加研究药物后需要手术的眼睛数量。

结果

在整个研究过程中，86例接受阿可乐定治疗的患者中有52例（60%）维持了足够的眼压控制并避免了手术，而88例接受安慰剂治疗的患者中有28例（32%）做到了这一点（P <.001）。阿可乐定治疗使更多患者的眼压相对于基线额外降低了20%或更多，且眼压小于或等于20 mmHg（P <.05）。最常见的眼部并发症是结膜充血（86例患者中有11例，12.8%）。最常见的非眼部问题是口干（4例患者，4.7%）。