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Original research: Second IVIg course in Guillain-Barré syndrome with poor prognosis: the non-randomised ISID study.
Journal of Neurology, Neurosurgery, and Psychiatry ( IF 8.7 ) Pub Date : 2019-10-05 , DOI: 10.1136/jnnp-2019-321496
Christine Verboon 1 , Bianca van den Berg 1 , David R Cornblath 2 , Esmee Venema 1, 3 , Kenneth C Gorson 4 , Michael P Lunn 5 , Hester Lingsma 3 , Peter Van den Bergh 6 , Thomas Harbo 7 , Kathleen Bateman 8 , Yann Pereon 9 , Søren H Sindrup 10 , Susumu Kusunoki 11 , James Miller 12 , Zhahirul Islam 13 , Hans-Peter Hartung 14 , Govindsinh Chavada 15 , Bart C Jacobs 1, 16 , Richard A C Hughes 17 , Pieter A van Doorn 18 ,
Affiliation  

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.

中文翻译:

原始研究:吉兰-巴雷综合征的第二次IVIg病程预后不良:ISID非随机研究。

目的比较预后较差的吉兰-巴雷综合征(GBS)患者接受一或两次静脉免疫球蛋白(IVIg)治疗的病程。方法从国际GBS结果研究中,我们选择了在第1周时改良的Erasmus GBS结果得分预后较差的患者。我们将接受一门IVIg课程的患者与接受两门IVIg课程的患者进行了比较。主要终点是4周时的GBS残疾量表,采用多变量序数回归进行评估。结果在237名合格患者中,有199名患者接受了一次IVIg疗程。20名患者接受了“早期”第二次IVIg疗程(第一次IVIg疗程开始后1-2周),18例患者接受了“晚期”第二次IVIg疗程(IVIg开始开始后2-4周)。在基线和1周时,接受两门IVIg课程的人比接受一门课程的人更加残疾。与一个疗程组相比,早期组的校正后OR为4周时更好的GBS残疾评分为0.70(95%CI 0.16至3.04),晚期组为0.66(95%CI 0.18至2.50)。次要终点并不赞成第二次IVIg课程。结论这项观察性研究未在预后较差的GBS进行第二次IVIg疗程后未显示出更好的结果。该研究受到少量和基线失衡的限制。缺乏改进很可能是开始第二次IVIg课程的动力。需要一项前瞻性随机试验来评估第二次IVIg疗程是否可以改善GBS结局。早期组的调整后OR为4周时更好的GBS残疾评分为0.70(95%CI 0.16至3.04),晚期组为0.66(95%CI 0.18至2.50)。次要终点并不赞成第二次IVIg课程。结论这项观察性研究未在预后较差的GBS进行第二次IVIg疗程后未显示出更好的结果。该研究受到少量和基线失衡的限制。缺乏改进很可能是开始第二次IVIg课程的动力。需要一项前瞻性随机试验来评估第二次IVIg疗程是否可以改善GBS的结局。早期组的调整后OR为4周时更好的GBS残疾评分为0.70(95%CI 0.16至3.04),晚期组为0.66(95%CI 0.18至2.50)。次要终点不赞成第二次IVIg课程。结论这项观察性研究未在预后较差的GBS进行第二次IVIg疗程后未显示出更好的结果。该研究受到少量和基线失衡的限制。缺乏改进很可能是开始第二次IVIg课程的动力。需要一项前瞻性随机试验来评估第二次IVIg疗程是否可以改善GBS的结局。结论这项观察性研究未在预后较差的GBS进行第二次IVIg疗程后未显示出更好的结果。该研究受到少量和基线失衡的限制。缺乏改进很可能是开始第二次IVIg课程的动力。需要一项前瞻性随机试验来评估第二次IVIg疗程是否可以改善GBS的结局。结论这项观察性研究未在预后较差的GBS进行第二次IVIg疗程后未显示出更好的结果。该研究受到少量和基线失衡的限制。缺乏改进很可能是开始第二次IVIg课程的动力。需要一项前瞻性随机试验来评估第二次IVIg疗程是否可以改善GBS结局。
更新日期:2020-01-10
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