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日本评估甲基强的松龙冲击治疗特发性视神经炎的多中心临床试验。视神经炎治疗试验多中心合作研究组(ONMRG)。

Multicenter clinical trial for evaluating methylprednisolone pulse treatment of idiopathic optic neuritis in Japan. Optic Neuritis Treatment Trial Multicenter Cooperative Research Group (ONMRG).

作者信息

Wakakura M, Mashimo K, Oono S, Matsui Y, Tabuchi A, Kani K, Shikishima K, Kawai K, Nakao Y, Tazawa Y, Kiyosawa M, Abe H, Ohba N, Yago K, Maeda S, Sugita M, Ishikawa S

机构信息

Department of Ophthalmology, Kitasato University School of Medicine, Sagamihara, Japan.

出版信息

Jpn J Ophthalmol. 1999 Mar-Apr;43(2):133-8. doi: 10.1016/s0021-5155(98)00071-9.

DOI:10.1016/s0021-5155(98)00071-9
PMID:10340796
Abstract

BACKGROUND

A randomized, controlled clinical trial was conducted in 1991 to compare an intravenous megadose of methylprednisolone with a control drug (mecobalamin) for treating acute idiopathic optic neuritis.

CASES

Sixty-six cases from 22 clinical centers throughout Japan were examined to evaluate the treatment on visual function parameters, such as visual acuity, visual field, color vision, contrast sensitivity, and critical flicker frequency.

OBSERVATIONS

The methylprednisolone pulse treatment group showed faster recovery of visual function, particularly the visual acuity at 1 week (P<.05), Humphrey field analyzer mean deviation at 3 weeks (P<.05), and color vision at 1 week (P<.05). Recovery of contrast sensitivity at several different spatial frequencies was significant in the pulse treatment group at 1 (P<.01), 2 (P<.05), and 4 weeks (P<.05) after the start of treatment. Visual function test results at 12 weeks and 1 year were essentially the same in the two treatment groups. Side effects appeared more frequently in the pulse treatment group than in the control (P<.05).

CONCLUSIONS

Pulse treatment does not appear effective for idiopathic optic neuritis even though visual function in the pulse treatment group of this trial recovered more quickly during the initial phase compared to the controls. More effective and specific treatment should be established for optic neuritis.

摘要

背景

1991年进行了一项随机对照临床试验,比较静脉注射大剂量甲基泼尼松龙与对照药物(甲钴胺)治疗急性特发性视神经炎的效果。

病例

对来自日本全国22个临床中心的66例患者进行了检查,以评估治疗对视力、视野、色觉、对比敏感度和临界闪烁频率等视觉功能参数的影响。

观察结果

甲基泼尼松龙脉冲治疗组的视觉功能恢复更快,尤其是1周时的视力(P<0.05)、3周时的 Humphrey 视野分析仪平均偏差(P<0.05)和1周时的色觉(P<0.05)。治疗开始后1周(P<0.01)、2周(P<0.05)和4周(P<0.05)时,脉冲治疗组在几个不同空间频率下的对比敏感度恢复显著。两个治疗组在12周和1年时的视觉功能测试结果基本相同。脉冲治疗组的副作用出现频率高于对照组(P<0.05)。

结论

尽管本试验中脉冲治疗组的视觉功能在初始阶段比对照组恢复得更快,但脉冲治疗对特发性视神经炎似乎无效。应针对视神经炎建立更有效和特异的治疗方法。

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