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原始研究:吉兰-巴雷综合征预后不良的第二次 IVIg 治疗:非随机 ISID 研究。

Original research: Second IVIg course in Guillain-Barré syndrome with poor prognosis: the non-randomised ISID study.

机构信息

Department of Neurology, Erasmus MC, Rotterdam, The Netherlands.

Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA.

出版信息

J Neurol Neurosurg Psychiatry. 2020 Feb;91(2):113-121. doi: 10.1136/jnnp-2019-321496. Epub 2019 Oct 5.

Abstract

OBJECTIVE

To compare disease course in patients with Guillain-Barré syndrome (GBS) with a poor prognosis who were treated with one or with two intravenous immunoglobulin (IVIg) courses.

METHODS

From the International GBS Outcome Study, we selected patients whose modified Erasmus GBS Outcome Score at week 1 predicted a poor prognosis. We compared those treated with one IVIg course to those treated with two IVIg courses. The primary endpoint, the GBS disability scale at 4 weeks, was assessed with multivariable ordinal regression.

RESULTS

Of 237 eligible patients, 199 patients received a single IVIg course. Twenty patients received an 'early' second IVIg course (1-2 weeks after start of the first IVIg course) and 18 patients a 'late' second IVIg course (2-4 weeks after start of IVIg). At baseline and 1 week, those receiving two IVIg courses were more disabled than those receiving one course. Compared with the one course group, the adjusted OR for a better GBS disability score at 4 weeks was 0.70 (95%CI 0.16 to 3.04) for the early group and 0.66 (95%CI 0.18 to 2.50) for the late group. The secondary endpoints were not in favour of a second IVIg course.

CONCLUSIONS

This observational study did not show better outcomes after a second IVIg course in GBS with poor prognosis. The study was limited by small numbers and baseline imbalances. Lack of improvement was likely an incentive to start a second IVIg course. A prospective randomised trial is needed to evaluate whether a second IVIg course improves outcome in GBS.

摘要

目的

比较预后不良的吉兰-巴雷综合征(GBS)患者接受单剂和双剂静脉注射免疫球蛋白(IVIg)治疗的疾病进程。

方法

我们从国际吉兰-巴雷综合征结局研究中选择了改良 Erasmus GBS 结局评分在第 1 周预测预后不良的患者。我们比较了接受单剂 IVIg 治疗的患者与接受双剂 IVIg 治疗的患者。主要终点为第 4 周的吉兰-巴雷综合征残疾量表评分,采用多变量有序回归进行评估。

结果

在 237 例符合条件的患者中,199 例患者接受了单剂 IVIg 治疗。20 例患者接受了“早期”第二剂 IVIg 治疗(在第一剂 IVIg 治疗开始后 1-2 周),18 例患者接受了“晚期”第二剂 IVIg 治疗(在 IVIg 治疗开始后 2-4 周)。基线和第 1 周时,接受双剂 IVIg 治疗的患者比接受单剂 IVIg 治疗的患者残疾程度更严重。与单剂 IVIg 治疗组相比,早期组和晚期组第 4 周吉兰-巴雷综合征残疾评分改善的调整 OR 分别为 0.70(95%CI 0.16 至 3.04)和 0.66(95%CI 0.18 至 2.50)。次要终点不利于第二剂 IVIg 治疗。

结论

本观察性研究并未显示预后不良的吉兰-巴雷综合征患者接受第二剂 IVIg 治疗后有更好的结局。该研究受到样本量小和基线不平衡的限制。缺乏改善可能是开始第二剂 IVIg 治疗的动力。需要进行前瞻性随机试验来评估第二剂 IVIg 治疗是否能改善吉兰-巴雷综合征的结局。

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