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Ⅳ型免疫球蛋白治疗急性视神经炎的双盲、随机研究 被引量:1

A double-blind, randomized trial of IV immunoglobulin treatment in acute optic neuritis
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摘要 Objective: To investigate if IV immunoglobulin (IVIG)treatment in the acute ph ase of optic neuritis (ON) could improve visual outcome and reduce MRI disease a ctivity 6 months after onset of ON. Methods: Sixty-eight patients with ON were randomized within 4 weeks from onset of symptoms. Thirty-four pa tients were randomized to IVIG 0.4 g/kg body wt, and 34 patients were randomized to placebo. Infusions were given at days 0, 1, 2, 30, and 60. Contrast sensitiv ity, visual acuity, and color vision were measured at baseline and after 1 week, 1 month, and 6 months. Pattern reversal visual evoked potential studies and gad olinium-enhanced MRI were performed at baseline and after 1 and 6 months. Clini cal relapses during follow-up were recorded. Results: There was no difference i n the primary outcome, contrast sensitivity after 6 months, between patients ran domized to treatment with IVIG or placebo. In addition, there was no significant difference in the secondary outcome measures, improvement in the visual functio n measures and MRI, at any time during follow-up. At baseline, a significantly higher number of patients in the IVIG group had one or more enhancing lesions on MRI and IVIG-treated patients had a significantly higher number of enhancing l esions on MRI than patients treated with placebo. No difference was found in num ber of patients with one or more enhancing lesions or number of enhancing lesion s in subsequent scans between treatment groups. Number of relapses was equal in the two treatment groups during follow-up. Conclusions: There was no effect of IV immunoglobulin (IVIG) on long-term visual function following acute optic neu ritis, nor was there an effect of IVIG treatment in reducing latency on visual e voked potentials and thus preserving function of axons of the optic nerve. Objective: To investigate if IV immunoglobulin (IVIG)treatment in the acute ph ase of optic neuritis (ON) could improve visual outcome and reduce MRI disease a ctivity 6 months after onset of ON. Methods: Sixty-eight patients with ON were randomized within 4 weeks from onset of symptoms. Thirty-four pa tients were randomized to IVIG 0.4 g/kg body wt, and 34 patients were randomized to placebo. Infusions were given at days 0, 1, 2, 30, and 60. Contrast sensitiv ity, visual acuity, and color vision were measured at baseline and after 1 week, 1 month, and 6 months. Pattern reversal visual evoked potential studies and gad olinium-enhanced MRI were performed at baseline and after 1 and 6 months. Clini cal relapses during follow-up were recorded. Results: There was no difference i n the primary outcome, contrast sensitivity after 6 months, between patients ran domized to treatment with IVIG or placebo. In addition, there was no significant difference in the secondary outcome measures, improvement in the visual functio n measures and MRI, at any time during follow-up. At baseline, a significantly higher number of patients in the IVIG group had one or more enhancing lesions on MRI and IVIG-treated patients had a significantly higher number of enhancing l esions on MRI than patients treated with placebo. No difference was found in num ber of patients with one or more enhancing lesions or number of enhancing lesion s in subsequent scans between treatment groups. Number of relapses was equal in the two treatment groups during follow-up. Conclusions: There was no effect of IV immunoglobulin (IVIG) on long-term visual function following acute optic neu ritis, nor was there an effect of IVIG treatment in reducing latency on visual e voked potentials and thus preserving function of axons of the optic nerve.
出处 《世界核心医学期刊文摘(眼科学分册)》 2005年第8期5-6,共2页 Digest of the World Core Medical Journals:Ophthalmology
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