Berson E L, Rosner B, Sandberg M A, Hayes K C, Nicholson B W, Weigel-DiFranco C, Willett W
Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School, Massachusetts Eye and Ear Infirmary, Boston 02114.
Arch Ophthalmol. 1993 Jun;111(6):761-72. doi: 10.1001/archopht.1993.01090060049022.
To determine whether supplements of vitamin A or vitamin E alone or in combination affect the course of retinitis pigmentosa.
Randomized, controlled, double-masked trial with 2 x 2 factorial design and duration of 4 to 6 years. Electroretinograms, visual field area, and visual acuity were measured annually.
Clinical research facility.
601 patients aged 18 through 49 years with retinitis pigmentosa meeting preset eligibility criteria. Ninety-five percent of the patients completed the study. There were no adverse reactions.
Patients were assigned to one of four treatment groups receiving 15,000 IU/d of vitamin A, 15,000 IU/d of vitamin A plus 400 IU/d of vitamin E, trace amounts of both vitamins, or 400 IU/d of vitamin E.
Cone electroretinogram amplitude.
The two groups receiving 15,000 IU/d of vitamin A had on average a slower rate of decline of retinal function than the two groups not receiving this dosage (P = .01). Among 354 patients with higher initial amplitudes, the two groups receiving 15,000 IU/d of vitamin A were 32% less likely to have a decline in amplitude of 50% or more from baseline in a given year than those not receiving this dosage (P = .01), while the two groups receiving 400 IU/d of vitamin E were 42% more likely to have a decline in amplitude of 50% or more from baseline than those not receiving this dosage (P = .03). While not statistically significant, similar trends were observed for rates of decline of visual field area. Visual acuity declined about 1 letter per year in all groups.
These results support a beneficial effect of 15,000 IU/d of vitamin A and suggest an adverse effect of 400 IU/d of vitamin E on the course of retinitis pigmentosa.
确定单独补充维生素A或维生素E或两者联合补充是否会影响色素性视网膜炎的病程。
采用2×2析因设计的随机、对照、双盲试验，为期4至6年。每年测量视网膜电图、视野面积和视力。
临床研究机构。
601例年龄在18至49岁之间符合预设入选标准的色素性视网膜炎患者。95%的患者完成了研究。未出现不良反应。
患者被分配到四个治疗组之一，分别接受15000国际单位/天的维生素A、15000国际单位/天的维生素A加400国际单位/天的维生素E、两种维生素的微量补充剂或400国际单位/天的维生素E。
视锥细胞视网膜电图振幅。
接受15000国际单位/天维生素A的两组患者视网膜功能平均下降速度比未接受该剂量的两组患者慢（P = 0.01）。在354例初始振幅较高的患者中，接受15000国际单位/天维生素A的两组患者在某一年中振幅从基线下降50%或更多的可能性比未接受该剂量的患者低32%（P = 0.01），而接受400国际单位/天维生素E的两组患者振幅从基线下降50%或更多的可能性比未接受该剂量的患者高42%（P = 0.03）。虽然视野面积下降率的趋势不具有统计学意义，但也观察到了类似趋势。所有组的视力每年下降约1行。
这些结果支持15000国际单位/天的维生素A具有有益作用，并提示400国际单位/天的维生素E对色素性视网膜炎病程有不良影响。
