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一项关于蜂蛰疗法治疗多发性硬化症的随机交叉研究。

A randomized crossover study of bee sting therapy for multiple sclerosis.

作者信息

Wesselius T, Heersema D J, Mostert J P, Heerings M, Admiraal-Behloul F, Talebian A, van Buchem M A, De Keyser J

机构信息

Department of Neurology, University Medical Center Groningen, Groningen, The Netherlands.

出版信息

Neurology. 2005 Dec 13;65(11):1764-8. doi: 10.1212/01.wnl.0000184442.02551.4b. Epub 2005 Oct 12.

DOI:10.1212/01.wnl.0000184442.02551.4b
PMID:16221950
Abstract

BACKGROUND

Bee sting therapy is increasingly used to treat patients with multiple sclerosis (MS) in the belief that it can stabilize or ameliorate the disease. However, there are no clinical studies to justify its use.

METHODS

In a randomized, crossover study, we assigned 26 patients with relapsing-remitting or relapsing secondary progressive MS to 24 weeks of medically supervised bee sting therapy or 24 weeks of no treatment. Live bees (up to a maximum of 20) were used to administer bee venom three times per week. The primary outcome was the cumulative number of new gadolinium-enhancing lesions on T1-weighted MRI of the brain. Secondary outcomes were lesion load on T2*-weighted MRI, relapse rate, disability (Expanded Disability Status Scale, Multiple Sclerosis Functional Composite, Guy's Neurologic Disability Scale), fatigue (Abbreviated Fatigue Questionnaire, Fatigue Impact Scale), and health-related quality of life (Medical Outcomes Study 36-Item Short Form General Health Survey).

RESULTS

During bee sting therapy, there was no significant reduction in the cumulative number of new gadolinium-enhancing lesions. The T2*-weighted lesion load further progressed, and there was no significant reduction in relapse rate. There was no improvement of disability, fatigue, and quality of life. Bee sting therapy was well tolerated, and there were no serious adverse events.

CONCLUSIONS

In this trial, treatment with bee venom in patients with relapsing multiple sclerosis did not reduce disease activity, disability, or fatigue and did not improve quality of life.

摘要

背景

蜂蜇疗法越来越多地用于治疗多发性硬化症(MS)患者,人们认为它可以稳定或改善病情。然而,尚无临床研究证明其有效性。

方法

在一项随机交叉研究中,我们将26例复发缓解型或继发进展型复发型MS患者分为两组,分别接受为期24周的医学监督下的蜂蜇疗法或24周的不治疗。使用活蜂(最多20只)每周进行3次蜂毒注射。主要结局是脑部T1加权MRI上新出现的钆增强病灶的累积数量。次要结局包括T2 *加权MRI上的病灶负荷、复发率、残疾程度(扩展残疾状态量表、多发性硬化功能综合评分、盖伊神经残疾量表)、疲劳程度(疲劳简易问卷、疲劳影响量表)以及健康相关生活质量(医学结局研究36项简短形式一般健康调查)。

结果

在蜂蜇治疗期间,新出现的钆增强病灶的累积数量没有显著减少。T2 *加权病灶负荷进一步进展,复发率也没有显著降低。残疾程度、疲劳程度和生活质量均未改善。蜂蜇疗法耐受性良好,未出现严重不良事件。

结论

在本试验中,复发型多发性硬化症患者接受蜂毒治疗并未降低疾病活动度、残疾程度或疲劳程度,也未改善生活质量。

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