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免疫抑制治疗多发性硬化症的双盲对照试验:最终报告

Double-blind controlled trial of immunosuppression in the treatment of multiple sclerosis: final report.

作者信息

Mertin J, Rudge P, Kremer M, Healey M J, Knight S C, Compston A, Batchelor J R, Thompson E J, Halliday A M, Denman M, Medawar P B

出版信息

Lancet. 1982 Aug 14;2(8294):351-4. doi: 10.1016/s0140-6736(82)90547-5.

DOI:10.1016/s0140-6736(82)90547-5
PMID:6124759
Abstract

In a double-blind controlled trial 43 patients with relapsing-remitting multiple sclerosis were treated either with anti-lymphocyte globulin, prednisolone, and azathioprine, or with placebo preparations. Treatment began with a combination of the three medicaments but after 1 month was continued for another 14 months with azathioprine (3 mg/kg dialy) only. There was a marginally beneficial effect of immunosuppression on the overall relapse rate and clinical progression. However, there were significant effects on in-vitro lymphocyte function and in the visual evoked potentials in favour of the group receiving suppressive treatment. Placebo-treated patients of the HLA A3 tissue type had significantly more relapses than placebo-treated patients who were not of type HLA A3. Nevertheless, HLA-A3-positive patients treated with immunosuppression had significantly fewer relapses than A3-positive placebo-treated patients.

摘要

在一项双盲对照试验中,43例复发缓解型多发性硬化症患者接受抗淋巴细胞球蛋白、泼尼松龙和硫唑嘌呤治疗,或接受安慰剂制剂治疗。治疗开始时使用这三种药物的组合,但1个月后仅继续使用硫唑嘌呤(每日3mg/kg)治疗另外14个月。免疫抑制对总体复发率和临床进展有轻微有益作用。然而,对体外淋巴细胞功能和视觉诱发电位有显著影响,有利于接受抑制治疗的组。HLA A3组织类型的安慰剂治疗患者比非HLA A3类型的安慰剂治疗患者有更多的复发。然而,接受免疫抑制治疗的HLA - A3阳性患者比接受安慰剂治疗的A3阳性患者复发明显更少。

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Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD003982. doi: 10.1002/14651858.CD003982.pub2.
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Problems with UK government's risk sharing scheme for assessing drugs for multiple sclerosis.英国政府用于评估治疗多发性硬化症药物的风险分担计划存在的问题。
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