Robin A L
School of Hygiene and Public Health, Johns Hopkins University, Baltimore, USA.
Trans Am Ophthalmol Soc. 1996;94:89-101; discussion 101-3.
To evaluate the ocular hypotensive efficacy and safety of a fixed combination of betaxolol (0.25%) and pilocarpine (1.75%).
Three multicenter, double-masked, parallel trials were completed in patients with primary open-angle glaucoma or ocular hypertension of 3 months' treatment duration. Studies 1 and 2 were three-arm comparisons of betaxolol, pilocarpine, and a fixed combination, each used 3 times daily. Study 3 was a two-arm study of the fixed combination with and without a surfactant, used twice daily. In all studies, there was a 1-month runin period with betaxolol 0.25% suspension given twice daily. There were 182 patients in Study 1, 186 patients in Study 2, and 166 patients in Study 3.
In all 3 studies, approximately 10% to 15% of patients treated with pilocarpine or the combination therapy were terminated from further participation because of typical pilocarpine side effects (eg, blurred vision, headache). In studies 1 and 2, there was a mean reduction in intraocular pressure from a betaxolol baseline of approximately 3 to 4 mmHg. Patients continuing on betaxolol alone or randomly assigned to pilocarpine alone experienced a mean reduction of 1 to 2 mm Hg. Overall, the combination was approximately 2 mmHg more effective than either betaxolol or pilocarpine alone. In Study 3, the two betaxolol combinations had equivalent efficacy.
In patients requiring more than one ocular hypotensive agent, the combination of betaxolol and pilocarpine in a single formulation appears to be an effective and relatively safe agent. The use of this combination agent promises the potential for enhanced patient convenience.
评估倍他洛尔（0.25%）与毛果芸香碱（1.75%）固定复方制剂的降眼压疗效及安全性。
完成了三项多中心、双盲、平行试验，研究对象为原发性开角型青光眼或高眼压症患者，治疗周期为3个月。研究1和研究2为三臂比较试验，分别使用倍他洛尔、毛果芸香碱和固定复方制剂，均每日用药3次。研究3为双臂试验，比较含与不含表面活性剂的固定复方制剂，每日用药2次。在所有研究中，均有为期1个月的导入期，给予0.25%倍他洛尔混悬液，每日用药2次。研究1有182例患者，研究2有186例患者，研究3有166例患者。
在所有3项研究中，约10%至15%接受毛果芸香碱或联合治疗的患者因典型的毛果芸香碱副作用（如视力模糊、头痛）而终止进一步参与研究。在研究1和研究2中，倍他洛尔基线眼压平均降低约3至4 mmHg。继续单独使用倍他洛尔或随机分配至单独使用毛果芸香碱的患者眼压平均降低1至2 mmHg。总体而言，联合用药比单独使用倍他洛尔或毛果芸香碱的疗效约高2 mmHg。在研究3中，两种含倍他洛尔的复方制剂疗效相当。
对于需要多种降眼压药物的患者，单一剂型的倍他洛尔与毛果芸香碱复方制剂似乎是一种有效且相对安全的药物。使用这种复方制剂有望提高患者的便利性。
