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台湾一项为期 4 年的临床孤立综合征向多发性硬化转化的前瞻性观察研究(MS NEO 研究)。

A prospective, observational study on conversion of clinically isolated syndrome to multiple sclerosis during 4-year period (MS NEO study) in Taiwan.

机构信息

Department of Neurology, Chang Gung Memorial Hospital-Linkou Medical Center, Chang Gung University College of Medicine, Taoyuan, Taiwan, R.O.C.

Division of Nephrology, Department of Internal Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan, R.O.C.

出版信息

PLoS One. 2019 Jul 15;14(7):e0202453. doi: 10.1371/journal.pone.0202453. eCollection 2019.

Abstract

IMPORTANCE

CIS to MS conversion rates vary depending on population cohorts, initial manifestations, and durations of follow-up.

OBJECTIVE

To investigate conversion rate of patients from CIS to MS and the prognostic significance of demographic and clinical variables in Taiwanese population.

DESIGN

Nationwide, prospective, multi-centric, observational study from November 2008 to November 2014 with 4 years follow-up.

SETTING

Multi-centre setting at 5 institutions in Taiwan.

PARTICIPANTS

152 patients having single clinical event potentially suggestive of MS in last 2 years were enrolled as consecutive sample. 33 patients were lost to follow-up and 16 patients did not complete the study.103 patients completed the study.

INTERVENTION(S) (FOR CLINICAL TRIALS) OR EXPOSURE(S) (FOR OBSERVATIONAL STUDIES): Natural progression from first episode of CIS to MS or NMO was observed.

MAIN OUTCOME(S) AND MEASURE(S): Variables analysed were 'proportion of patients converting to MS or NMO after first episode of CIS', 'duration between first episode of neurological event and diagnosis of MS', 'status of anti-AQP4 IgG' and 'length of longest contiguous spinal cord lesion in MS patients'. Association between baseline characteristics and progression to MS from CIS was analyzed using multiple logistic regression. Multivariate time dependent effect of baseline characteristics on progression to MS was plotted.

RESULTS

14.5% patients with CIS converted to MS after 1.1 ± 1.0 years with greater predisposition (18.8%) in those having syndromes referable to the cerebral hemispheres. Conversion rate from ON to MS was 9.7%. 90.9% patients had mild disease course. 46.7% patients had abnormal MRIs at baseline, with 0.6±0.5 contrast enhanced lesions. 'Below normal BMI' and 'MRI lesion load (≥ 4 lesions)' were identified as risk indicators for the development of MS. Amongst the patients who developed NMO as diagnosed by modern criteria, 80% were positive for anti-AQP4 IgG antibody.

CONCLUSIONS AND RELEVANCE

'Below normal BMI' and 'number of demyelinating lesions (≥4)' are significant predictors of conversion from CIS to MS. A low conversion rate to MS in Taiwanese CIS patients and majority of them having a mild course and minimal disability suggest the roles of geographic, genetic and ethnic factors.

TRIAL REGISTRATION

Non-trial observational study.

摘要

重要性

CIS 向 MS 的转化率因人群队列、初始表现和随访时间长短而异。

目的

研究台湾人群中 CIS 患者向 MS 转化的转化率以及人口统计学和临床变量的预后意义。

设计

2008 年 11 月至 2014 年 11 月进行的全国性、前瞻性、多中心、观察性研究,随访 4 年。

地点

台湾 5 家机构的多中心。

参与者

纳入 152 名在过去 2 年内有单一临床事件(可能提示 MS)的连续样本患者。33 名患者失访,16 名患者未完成研究。103 名患者完成了研究。

干预措施(临床试验)或暴露情况(观察性研究):观察从 CIS 首次发作到 MS 或 NMO 的自然进展。

主要结果和测量

分析的变量包括“CIS 首次发作后转化为 MS 或 NMO 的患者比例”、“首次神经事件与 MS 诊断之间的时间”、“抗 AQP4 IgG 状态”和“MS 患者最长连续脊髓病变长度”。使用多变量逻辑回归分析基线特征与 CIS 向 MS 进展的相关性。绘制基线特征对 MS 进展的多变量时间依赖性影响。

结果

14.5%的 CIS 患者在 1.1±1.0 年后转化为 MS,大脑半球综合征患者的倾向更大(18.8%)。ON 向 MS 的转化率为 9.7%。90.9%的患者病情较轻。基线时 46.7%的患者 MRI 异常,有 0.6±0.5 个对比增强病变。“体重指数低于正常值”和“MRI 病变负荷(≥4 个病变)”被确定为发展为 MS 的危险因素。根据现代标准诊断为 NMO 的患者中,80%抗 AQP4 IgG 抗体阳性。

结论和相关性

“体重指数低于正常值”和“脱髓鞘病变数量(≥4 个)”是从 CIS 向 MS 转化的重要预测指标。台湾 CIS 患者向 MS 的转化率较低,且多数患者病情较轻,残疾程度较轻,提示地理、遗传和种族因素的作用。

试验注册

非试验观察性研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/70f6/6629056/b3a2b2284d9a/pone.0202453.g001.jpg

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