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拉坦前列素与噻吗洛尔治疗高眼压症和青光眼患者的比较:在美国进行的一项为期6个月的双盲、多中心试验。美国拉坦前列素研究组

Comparison of latanoprost and timolol in patients with ocular hypertension and glaucoma: a six-month masked, multicenter trial in the United States. The United States Latanoprost Study Group.

作者信息

Camras C B

机构信息

Ophthalmology, University of Nebraska Medical Center, Omaha, USA.

出版信息

Ophthalmology. 1996 Jan;103(1):138-47. doi: 10.1016/s0161-6420(96)30749-5.

Abstract

PURPOSE

Latanoprost, a new prostaglandin analogue, was compared with timolol for ocular hypotensive efficacy and side effects.

METHODS

In a multicenter, randomized, double-masked, parallel group study, 268 patients with ocular hypertension or early primary open-angle glaucoma received either 0.005% latanoprost once daily or 0.5% timolol twice daily for 6 months. All except ten patients from each group successfully completed the study.

RESULTS

Intraocular pressure (IOP) was significantly (P<0.001) reduced and maintained by both medications without evidence of a long-term drift over 6 months. Comparing 6-month with baseline diurnal IOP values, the IOP reduction (mean +/- standard deviation) achieved with latanoprost (-6.7 +/- 3.4 mmHg) was significantly (P<0.001) greater than that produced with timolol (4.9 +/- 2.9 mmHg). Four patients treated with timolol and none treated with latanoprost were withdrawn from the study because of inadequate IOP control. Pulse rate was significantly reduced with timolol, but not with latanoprost. Slightly more conjunctival hyperemia appeared in latanoprost-treated compared with timolol-treated eyes. Fewer subjective side effects occurred in latanoprost-treated eyes. Both eyes of a patient with a characteristic, concentric iris heterochromia (darker centrally) at baseline showed a definite, photographically documented increase in pigmentation during latanoprost treatment, making the irides uniformly darker. Three additional patients treated with latanoprost were suspects for this color change. Otherwise, no significant difference between treatment groups occurred visual acuity, slit-lamp examination, blood pressure, and laboratory values.

CONCLUSION

Latanoprost has the potential for becoming a new first-line treatment for glaucoma.

摘要

目的

比较新型前列腺素类似物拉坦前列素与噻吗洛尔的降眼压疗效及副作用。

方法

在一项多中心、随机、双盲、平行组研究中,268例高眼压或早期原发性开角型青光眼患者,分别接受每日一次0.005%拉坦前列素或每日两次0.5%噻吗洛尔治疗,为期6个月。每组除10例患者外均成功完成研究。

结果

两种药物均能显著降低眼压(P<0.001)并维持眼压稳定,在6个月内无长期眼压漂移迹象。比较6个月时与基线的日眼压值发现,拉坦前列素降低的眼压(均值±标准差)为(-6.7±3.4 mmHg),显著高于噻吗洛尔(4.9±2.9 mmHg)(P<0.001)。因眼压控制不佳,4例接受噻吗洛尔治疗的患者退出研究,而接受拉坦前列素治疗的患者无一人退出。噻吗洛尔能显著降低脉搏率,而拉坦前列素无此作用。与噻吗洛尔治疗的眼睛相比,拉坦前列素治疗的眼睛出现的结膜充血略多。拉坦前列素治疗的眼睛出现的主观副作用较少。一名基线时虹膜呈现特征性同心性异色(中央较深)的患者,在拉坦前列素治疗期间,双眼色素沉着明显增加,照片记录显示虹膜颜色均匀变深。另外3例接受拉坦前列素治疗的患者也怀疑有这种颜色变化。除此之外,治疗组在视力、裂隙灯检查、血压和实验室检查值方面无显著差异。

结论

拉坦前列素有可能成为青光眼的一种新的一线治疗药物。

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