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CIDP 患者握力计:一种反应灵敏的工具,可快速测量 IVIG 的效果——ICE 研究。

Vigorimeter grip strength in CIDP: a responsive tool that rapidly measures the effect of IVIG--the ICE study.

机构信息

Department of Neurology, Maastricht University Medical Centre, Maastricht, The Netherlands.

出版信息

Eur J Neurol. 2013 May;20(5):748-55. doi: 10.1111/j.1468-1331.2012.03851.x. Epub 2012 Aug 14.

Abstract

BACKGROUND AND PURPOSE

In a recent trial in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), the ICE study, grip strength measurement captured significantly more improvement in patients receiving immune globulin (IGIV-C) intravenously than in those receiving placebo.

METHODS

We conducted a systematic analysis to determine the sensitivity of grip strength as an indicator of meaningful clinical changes in CIDP.

RESULTS

A randomized double-blind trial was undertaken in 117 CIDP patients who received IGIV-C or placebo every 3 weeks for up to 24 weeks. Grip strength and inflammatory neuropathy cause and treatment (INCAT) disability scores were assessed at each visit, and the responsiveness of each scale was compared. A minimum clinically important difference cut-off value for grip strength (>8 kPa) and INCAT score (>1 point) was applied to assess the proportion of responders to IGIV-C versus placebo. This analysis showed that grip strength demonstrated significant improvement earlier (as early as day 16) than the INCAT disability scale in patients receiving IGIV-C compared with placebo. A significantly higher proportion of improvers were seen in the IGIV-C group (37.5%-50.9%) than in the placebo group (21.1%-25.9%) for grip strength at day 16, week 3, week 6 and the end of the first period. Also, grip strength showed within the first 6 weeks in the placebo group significantly more patients with a clinically meaningful deterioration (>8 kPa), compared with the INCAT (>1-point deterioration) findings.

CONCLUSIONS

Grip strength can be considered a sensitive tool for assessing clinically relevant changes in patients with CIDP. Its use in daily practice is suggested.

摘要

背景与目的

在最近一项针对慢性炎症性脱髓鞘性多发性神经病(CIDP)患者的试验(ICE 研究)中,与接受安慰剂的患者相比,接受静脉注射免疫球蛋白(IGIV-C)的患者握力测量值的改善更为显著。

方法

我们进行了一项系统分析,以确定握力作为 CIDP 有意义的临床变化的指标的敏感性。

结果

对 117 例 CIDP 患者进行了一项随机、双盲试验,这些患者每 3 周接受一次 IGIV-C 或安慰剂治疗,最长 24 周。每次就诊时评估握力和炎症性神经病病因和治疗(INCAT)残疾评分,并比较每个量表的反应性。应用握力(>8kPa)和 INCAT 评分(>1 分)的最小临床重要差异截断值来评估 IGIV-C 与安慰剂相比对响应者的比例。该分析表明,与安慰剂相比,接受 IGIV-C 的患者握力比 INCAT 残疾量表更早(最早在第 16 天)显示出显著改善。IGIV-C 组的改善者比例(37.5%-50.9%)显著高于安慰剂组(21.1%-25.9%),在第 16 天、第 3 周、第 6 周和第一阶段结束时。此外,在第 6 周内,安慰剂组中握力显著更多的患者出现有临床意义的恶化(>8kPa),而 INCAT(>1 分恶化)的结果则不同。

结论

握力可被视为评估 CIDP 患者临床相关变化的敏感工具。建议在日常实践中使用它。

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