Johnson L N, Gould T J, Krohel G B
Neuro-Ophthalmology Unit, Mason Institute of Ophthalmology, University of Missouri-Columbia 65212, USA.
Am J Ophthalmol. 1996 Jan;121(1):77-83. doi: 10.1016/s0002-9394(14)70536-7.
We conducted a pilot clinical trial to determine the efficacy of levodopa in promoting visual recovery in eyes with nonarteritic anterior ischemic optic neuropathy of greater than six months' duration.
This prospective, randomized, double-masked, placebo-controlled clinical trial involved 20 subjects with nonarteritic anterior ischemic optic neuropathy of 30 months' mean duration. Subjects were randomly assigned to receive either low-dose levodopa and carbidopa or a placebo for three weeks. At 12 weeks after the baseline visit, the levodopa group then was provided a higher, conventional dose of levodopa and carbidopa for three more weeks. Change in visual function was monitored at four, 12, 16, and 24 weeks after the baseline visit.
At 12 weeks after the baseline visit, the levodopa group experienced a significant (P = .016) mean difference in improvement of visual acuity of 5.9 letters from the placebo group. At 24 weeks after the baseline visit, a significant treatment effect (P = .036) for visual acuity was still evident; the levodopa group had a mean gain in improvement of 7.5 letters difference from baseline from the placebo group. Three subjects in the levodopa group experienced a doubling of the visual angle as denoted by a gain of at least 15 letters. Significant improvement was not observed for color vision (P = .82) or mean deviation of visual field loss (P = .82).
The study found significant improvement of visual acuity among subjects receiving levodopa and carbidopa despite long-standing visual loss from nonarteritic anterior ischemic neuropathy. Confirmation of our results is awaited from larger population studies and with a longer follow-up time interval regarding the efficacy of levodopa in reversing visual loss in this disease.
我们进行了一项试点临床试验,以确定左旋多巴对病程超过6个月的非动脉炎性前部缺血性视神经病变患者促进视力恢复的疗效。
这项前瞻性、随机、双盲、安慰剂对照的临床试验纳入了20名平均病程为30个月的非动脉炎性前部缺血性视神经病变患者。受试者被随机分配接受低剂量左旋多巴和卡比多巴或安慰剂,为期3周。在基线访视后12周,左旋多巴组再接受更高剂量的常规左旋多巴和卡比多巴,为期3周。在基线访视后的第4、12、16和24周监测视觉功能变化。
在基线访视后12周,左旋多巴组与安慰剂组相比,视力改善的平均差异显著(P = .016),为5.9个字母。在基线访视后24周,视力的显著治疗效果(P = .036)仍然明显;左旋多巴组与安慰剂组相比,从基线开始的平均改善增益为7.5个字母差异。左旋多巴组有3名受试者的视角翻倍,表现为至少提高15个字母。未观察到色觉(P = .82)或视野缺损平均偏差(P = .82)有显著改善。
该研究发现,尽管非动脉炎性前部缺血性神经病变导致长期视力丧失,但接受左旋多巴和卡比多巴治疗的受试者视力有显著改善。关于左旋多巴在这种疾病中逆转视力丧失的疗效,尚需更大规模的人群研究和更长的随访时间间隔来证实我们的结果。