Effect of Nilvadipine on Central Visual Field in Retinitis Pigmentosa: A 30-Month Clinical Trial
Effect of Nilvadipine on Central Visual Field in Retinitis Pigmentosa: A 30-Month Clinical Trial
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DOI：
10.1159/000320500
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发表时间：
2011-01-01
期刊：
影响因子：
2.6
通讯作者：
Metoki, Tomomi
中科院分区：
文献类型：
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作者：
Nakazawa, Mitsuru;Ohguro, Hiroshi;Metoki, Tomomi
目的：观察尼伐地平对视网膜色素变性（RP）患者中心视野缺损进展的影响。设计：前瞻性、随机、非盲、单中心试验。研究方法：RP患者随机分为治疗组和对照组，治疗组口服尼伐地平4 mg/d，6 - 30个月，对照组口服生育酚烟酸酯300 mg/d，海伦宁15 mg/d或不服药。使用Humphrey视野分析仪的10-2 SITA快速程序评估RP的进展，并比较组间从平均偏差（MD斜率）的时间过程计算的回归系数。结果：治疗组19例，对照组14例完成了≥ 30个月的随访。治疗组的平均（+/-标准差）观察持续时间为48.8 +/- 11.8个月（中位数48个月，范围30-66个月），对照组为49.2 +/- 18.1个月（中位数48个月，范围30-90个月）（p = 0.94）。治疗组最初30个月平均MD值的平均（+/-平均值标准误，SEM）回归系数为-0.35 +/- 0.17 dB/年，对照组为-0.75 +/- 0.06 dB/年（p < 0.01）。总观察期内，治疗组的平均（+/-SEM）MD斜率为-0.49 +/- 0.17 dB/年，对照组为-0.89 +/- 0.16 dB/年（平均值+/- SEM，p = 0.042）。结论：尼伐地平4 mg/天显著延缓RP患者中心视野缺损的进展。版权所有（C）2010 S. Karger AG，巴塞尔
Purpose: To assess the effects of nilvadipine on the progression of central visual field defect in retinitis pigmentosa (RP). Design: Prospective, randomized, nonmasked, single-center trial. Methods: Patients with RP were randomly divided into a treated group receiving oral nilvadipine at 4 mg/day for 6 30 months and a control group receiving tocopherol nicotinate at 300 mg/day, helenien at 15 mg/day or no medication for the same periods. Progression of RP was evaluated using the 10-2 SITA Fast Program of the Humphrey Visual Field Analyzer, and regression coefficients calculated from the time courses of mean deviation (MD slope) were compared between groups. Results: Nineteen patients in the treated group and 14 patients in the control group completed the follow-up for >= 30 months. The mean (+/- standard deviation) duration of observation was 48.8 +/- 11.8 months (median 48 months, range 30-66 months) for the treated group and 49.2 +/- 18.1 months (median 48 months, range 30-90 months) for the control group (p = 0.94). Mean (+/-standard error of the mean, SEM) regression coefficients of the averaged MD values for the initial 30 months were -0.35 +/- 0.17 dB/year in the treated group and -0.75 +/- 0.06 dB/year in the control group (p < 0.01). Mean (+/-SEM) MD slopes for total observational periods were -0.49 +/- 0.17 dB/year in the treated group and -0.89 +/- 0.16 dB/year in the control group (mean +/- SEM, p = 0.042). Conclusion: Nilvadipine at 4 mg/day significantly retarded progression of central visual field defects in RP in this small patient series. Copyright (C) 2010 S. Karger AG, Basel