Mishima H K, Masuda K, Kitazawa Y, Azuma I, Araie M
Department of Ophthalmology, Hiroshima University, Japan.
Arch Ophthalmol. 1996 Aug;114(8):929-32. doi: 10.1001/archopht.1996.01100140137004.
To evaluate the intraocular pressure (IOP)-reducing effect and the side effects of latanoprost (PhXA41), a new phenyl-substituted prostaglandin F2 alpha-isopropyl ester analogue, in patients with elevated IOP, using timolol maleate as the reference drug.
A total of 184 patients with primary open-angle glaucoma or ocular hypertension at 35 medical centers participated in this randomized double-masked study. The patients were randomized to receive either 0.005% latanoprost once daily or 0.5% timolol maleate twice daily, for a period of 12 weeks. Intraocular pressure was measured 24 hours after the administration of timolol, at 2, 4, 8, and 12 weeks of treatment.
Latanoprost reduced IOP at the end of 12 weeks by 6.2 +/- 2.7 mm Hg (mean +/- SD) (26.8%), while timolol reduced IOP by 4.4 +/- 2.3 mm Hg (19.9%). At all visits latanoprost reduced IOP significantly more than timolol did. The main ocular side effects observed in both groups were conjunctival hyperemia and smarting. The main systemic side effect was a reduced pulse rate, which occurred in patients treated with timolol.
The results of this study demonstrated that 0.005% latanoprost taken once daily is well tolerated and more effective in reducing IOP than 0.5% timolol taken twice daily. Thus, latanoprost may become an important choice for the medical treatment of glaucoma.
以马来酸噻吗洛尔作为参比药物,评估新型苯基取代的前列腺素F2α异丙酯类似物拉坦前列素(PhXA41)对眼压升高患者的降眼压效果及副作用。
35个医学中心的184例原发性开角型青光眼或高眼压症患者参与了这项随机双盲研究。患者被随机分为两组,一组每天一次使用0.005%拉坦前列素,另一组每天两次使用0.5%马来酸噻吗洛尔,为期12周。在使用噻吗洛尔24小时后以及治疗的第2、4、8和12周测量眼压。
12周结束时,拉坦前列素使眼压降低了6.2±2.7 mmHg(平均值±标准差)(26.8%),而噻吗洛尔使眼压降低了4.4±2.3 mmHg(19.9%)。在所有访视中,拉坦前列素降低眼压的幅度均显著大于噻吗洛尔。两组观察到的主要眼部副作用为结膜充血和刺痛。主要的全身副作用是脉搏率降低,发生在使用噻吗洛尔治疗的患者中。
本研究结果表明,每天一次使用0.005%拉坦前列素耐受性良好,且在降低眼压方面比每天两次使用0.5%噻吗洛尔更有效。因此,拉坦前列素可能成为青光眼药物治疗的重要选择。