Camras C B, Alm A, Watson P, Stjernschantz J
Department of Ophthalmology, University of Nebraska Medical Center, Omaha 68198-5540, USA.
Ophthalmology. 1996 Nov;103(11):1916-24. doi: 10.1016/s0161-6420(96)30407-7.
To determine efficacy and safety of latanoprost, a prostaglandin analog for glaucoma, during 1 year of treatment.
After baseline measurements, 0.005% latanoprost was topically applied once daily for 12 months in patients from Scandinavia, the United Kingdom, and the United States who had elevated intraocular pressure (IOP). Diagnoses included ocular hypertension, chronic open-angle glaucoma, exfoliation syndrome, and pigment dispersion syndrome. Treatment was masked for the first 6 months and open-label during the second 6 months.
Of the 272 patients initially enrolled, withdrawals were due to inadequate IOP control (1%), increased iris pigmentation (5%), other ocular problems (3%), systemic medical problems (3%), and nonmedical reasons (14%). Latanoprost significantly (P < 0.0001) reduced diumal IOP from 25.3 +/- 3.0 mmHg (mean +/- standard deviation) at baseline to 17.4 +/- 2.7 mmHg (32% reduction) at 12 months in the 198 patients who completed 1 year of treatment. The IOP reduction was maintained at a consistent level throughout the 12 months without evidence of drift, and was not affected by sex, age, race, or eye color. Overall, latanoprost caused a possible or definite increase in iris pigmentation in 12% of the 272 patients, all of whom had multicolored irides at baseline. One half of these patients with increased pigmentation withdrew before completing 1 year of therapy. Visual field, optic disc cupping, visual acuity, refractive error, conjunctival hyperemia, aqueous flare, anterior chamber cellular response, lens examination, blood pressure, heart rate, blood tests, and urinalysis were not appreciably altered.
Latanoprost safely and effectively reduces IOP for 1 year in patients of diverse nationalities, providing further evidence for its usefulness in chronic glaucoma therapy.
确定前列腺素类似物拉坦前列素治疗青光眼1年的疗效和安全性。
在进行基线测量后，来自斯堪的纳维亚、英国和美国的眼压升高患者，每天局部应用0.005%拉坦前列素，持续12个月。诊断包括高眼压症、慢性开角型青光眼、剥脱综合征和色素播散综合征。治疗在最初6个月为盲法，后6个月为开放标签。
最初入组的272例患者中，退出治疗的原因包括眼压控制不佳（1%）、虹膜色素沉着增加（5%）、其他眼部问题（3%）、全身性内科问题（3%）和非医疗原因（14%）。在完成1年治疗的198例患者中，拉坦前列素使日间眼压从基线时的25.3±3.0 mmHg（均值±标准差）显著（P<0.0001）降至12个月时的17.4±2.7 mmHg（降低32%）。眼压降低在整个12个月中维持在稳定水平，无漂移迹象，且不受性别、年龄、种族或眼睛颜色影响。总体而言，拉坦前列素在272例患者中有12%导致虹膜色素沉着可能或肯定增加，所有这些患者基线时虹膜均为多色。这些色素沉着增加的患者中有一半在完成1年治疗前退出。视野、视盘杯状凹陷、视力、屈光不正、结膜充血、房水闪光、前房细胞反应、晶状体检查、血压、心率、血液检查和尿液分析均无明显改变。
拉坦前列素可安全有效地降低不同国籍患者的眼压达1年，为其在慢性青光眼治疗中的有效性提供了进一步证据。
