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用于下肢痉挛的A型肉毒毒素:德尔菲专家小组方法的指导意见

OnabotulinumtoxinA for Lower Limb Spasticity: Guidance From a Delphi Panel Approach.

作者信息

Esquenazi Alberto, Alfaro Abraham, Ayyoub Ziyad, Charles David, Dashtipour Khashayar, Graham Glenn D, McGuire John R, Odderson Ib R, Patel Atul T, Simpson David M

机构信息

MossRehab Gait and Motion Analysis Laboratory, MossRehab Gait and Motion Analysis Laboratory, 60 Township Line Rd, Elkins Park, PA 19027(∗).

Spasticity and Dystonia Clinic, Bacharach Institute for Rehabilitation, Pomona, NJ(†).

出版信息

PM R. 2017 Oct;9(10):960-968. doi: 10.1016/j.pmrj.2017.02.014. Epub 2017 Mar 7.

Abstract

BACKGROUND

OnabotulinumtoxinA is approved for the treatment of upper and lower limb spasticity in adults. Guidance on common postures and onabotulinumtoxinA injection paradigms for upper limb spasticity has been developed via a Delphi Panel; however, similar guidance for lower limb spasticity has not been established.

OBJECTIVE

To define a clinically recommended treatment paradigm for the use of onabotulinumtoxinA for each common posture among patients with poststroke lower limb spasticity (PSLLS) and to identify the most common PSLLS aggregate postures.

DESIGN

Clinical experts provided insight regarding onabotulinumtoxinA treatment for PSLLS using an adaptation of the Delphi consensus process.

SETTING

Delphi panel.

PARTICIPANTS

Ten expert clinicians in neurology and physical medicine and rehabilitation who treat PSLLS.

METHODS

A minimum of 2 rounds of anonymous voting occurred for each recommendation until consensus was reached (≥66% agreement). The first round was conducted via a survey; the second round was an in-person meeting.

MAIN OUTCOME MEASUREMENTS

Reached consensus on muscle selection for injection, overall and per-muscle dose of onabotulinumtoxinA, number of injection sites/muscle, onabotulinumtoxinA dilution, and use of localization techniques. The most common PSLLS postures were reviewed. Recommendations were tailored toward injectors with less experience.

RESULTS

Consensus was reached on targeted subsets of muscles for each posture. Doses ranged from 20 to 150 U for individual muscles and 50 to 300 U for limb postures. OnabotulinumtoxinA dilution 50 U/mL (2:1 ratio) was considered most appropriate but varied based on muscles selected (range, 2:1-4:1). Experts agreed that localization techniques for muscle identification during injection for all postures would be useful. For suboptimal response to injection, all panel members would increase the dose, and the majority (89%) would increase the number of treated muscles. The panel identified 3 common aggregating lower limb postures: (1) equinovarus foot and flexed toes; (2) extended knee and plantar flexed foot/ankle; and (3) plantar flexed foot/ankle and flexed toes. The recommended starting doses for each aggregate posture were 400 U, 400 U, and 300 U, respectively.

CONCLUSION

The modified Delphi panel process provided consensus on common muscles and corresponding onabotulinumtoxinA treatment paradigms for postures associated with PSLLS that can be used for guidance in optimizing care delivery.

LEVEL OF EVIDENCE

V.

摘要

背景

A型肉毒毒素已被批准用于治疗成人的上肢和下肢痉挛。通过德尔菲小组制定了关于上肢痉挛的常见姿势和A型肉毒毒素注射方案的指南;然而,尚未建立针对下肢痉挛的类似指南。

目的

为中风后下肢痉挛(PSLLS)患者的每种常见姿势确定使用A型肉毒毒素的临床推荐治疗方案,并确定最常见的PSLLS综合姿势。

设计

临床专家通过改编德尔菲共识程序,提供了关于PSLLS的A型肉毒毒素治疗的见解。

设置

德尔菲小组。

参与者

10名治疗PSLLS的神经科、物理医学与康复领域的专家临床医生。

方法

对每项建议进行至少两轮匿名投票,直至达成共识(≥66%的同意率)。第一轮通过调查进行;第二轮是面对面会议。

主要观察指标

就注射的肌肉选择、A型肉毒毒素的总体剂量和每块肌肉的剂量、每个肌肉的注射部位数量、A型肉毒毒素的稀释度以及定位技术的使用达成共识。回顾了最常见的PSLLS姿势。建议针对经验较少的注射者进行调整。

结果

就每种姿势的目标肌肉亚组达成了共识。单个肌肉的剂量范围为20至150单位,肢体姿势的剂量范围为50至300单位。50单位/毫升(2:1比例)的A型肉毒毒素稀释度被认为最合适,但根据所选肌肉的不同而有所变化(范围为2:1至4:1)。专家们一致认为,在所有姿势的注射过程中用于识别肌肉的定位技术将很有用。对于注射反应欠佳的情况,所有小组成员都会增加剂量,大多数人(89%)会增加治疗的肌肉数量。该小组确定了3种常见的下肢综合姿势:(1)马蹄内翻足和屈曲脚趾;(2)伸直膝关节和跖屈足/踝关节;(3)跖屈足/踝关节和屈曲脚趾。每种综合姿势的推荐起始剂量分别为400单位、400单位和300单位。

结论

改良的德尔菲小组程序就与PSLLS相关姿势的常见肌肉和相应的A型肉毒毒素治疗方案达成了共识,可用于指导优化护理服务。

证据水平

V级。

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