A RANDOMIZED, CONTROLLED TRIAL OF CORTICOSTEROIDS IN THE TREATMENT OF ACUTE OPTIC NEURITIS
A RANDOMIZED, CONTROLLED TRIAL OF CORTICOSTEROIDS IN THE TREATMENT OF ACUTE OPTIC NEURITIS
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DOI：
10.1056/nejm199202273260901
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发表时间：
1992-02-27
影响因子：
158.5
通讯作者：
ATWELL, CW
中科院分区：
文献类型：
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作者：
BECK, RW;CLEARY, PA;ATWELL, CW
研究背景和方法。使用皮质类固醇治疗视神经炎是有争议的。在15个临床中心，我们随机将457例急性视神经炎患者分为三组：口服泼尼松1 mg/kg/天，静脉注射甲基强的松龙1 g/天，然后口服泼尼松1 mg/kg/天，或口服安慰剂14天。在6个月的随访期内对患者进行视功能评估。与安慰剂组相比，静脉注射甲基强的松龙组的视觉功能恢复更快；在视野缺陷逆转方面尤其如此(P=0.0001)。虽然两组之间的差异随着时间的推移而缩小，但在6个月时，静脉注射甲基强的松龙组的视野(P=0.054)、对比敏感度(P=0.026)和色觉(P=0.033)仍略有改善，但视力没有改善(P=0.66)。此外，与安慰剂组相比，口服强的松组的双眼视神经炎的新发现率更高(口服强的松组的相对风险为1.79，95%可信区间为1.08-2.95)，而静脉注射甲基强的松龙组则不是。静脉注射甲基强的松龙后口服强的松可加速视神经炎引起的视力丧失的恢复，并在6个月后导致略好的视力。在这项研究中，单用口服强的松是一种无效的治疗方法，并增加了新的视神经炎发作的风险。
Background and Methods. The use of corticosteroids to treat optic neuritis is controversial. At 15 clinical centers, we randomly assigned 457 patients with acute optic neuritis to receive oral prednisone (1 mg per kilogram of body weight per day) for 14 days; intravenous methylprednisolone (1 g per day) for 3 days, followed by oral prednisone (1 mg per kilogram per day) for 11 days; or oral placebo for 14 days. Visual function was assessed over a six-month follow-up period.Results. Visual function recovered faster in the group receiving intravenous methylprednisolone than in the placebo group; this was particularly true for the reversal of visual-field defects (P = 0.0001). Although the differences between the groups decreased with time, at six months the group that received intravenous methylprednisolone still had slightly better visual fields (P = 0.054), contrast sensitivity (P = 0.026), and color vision (P = 0.033) but not better visual acuity (P = 0.66).The outcome in the oral-prednisone group did not differ from that in the placebo group. In addition, the rate of new episodes of optic neuritis in either eye was higher in the group receiving oral prednisone, but not the group receiving intravenous methylprednisolone, than in the placebo group (relative risk for oral prednisone vs. placebo, 1.79; 95 percent confidence interval, 1.08 to 2.95).Conclusions. Intravenous methylprednisolone followed by oral prednisone speeds the recovery of visual loss due to optic neuritis and results in slightly better vision at six months. Oral prednisone alone, as prescribed in this study, is an ineffective treatment and increases the risk of new episodes of optic neuritis.