鞘内巴氯芬试验在装置植入前：连续给药 12 年的经验。

Intrathecal Baclofen Trial Before Device Implantation: 12-Year Experience With Continuous Administration.

机构信息

Department of Neurology, Hochzirl Hospital, Zirl, Austria.

出版信息

Arch Phys Med Rehabil. 2019 May;100(5):837-843. doi: 10.1016/j.apmr.2018.09.124. Epub 2018 Oct 26.

DOI:10.1016/j.apmr.2018.09.124

PMID:31030729

Abstract

OBJECTIVE

To report our experience using continuous intrathecal baclofen (ITB) administration prior to a possible ITB device implantation.

DESIGN

Retrospective open label study. Mean duration of follow-up 64 months.

SETTING

Primary-care and referral center, ambulatory and hospitalized care.

PARTICIPANTS

Patients (N=116) undergoing continuous ITB trials between 2006 and 2017.

INTERVENTIONS

Continuous application of baclofen via a temporary intrathecal catheter connected to an external pump.

MAIN OUTCOME MEASURES

Assessment of the modified Ashworth Scale and range of movement prior versus end of ITB trial. According to the Barthel Index, definition of high-level patients (60-100 scoring points) and low-level patients (0-55 scoring points). Calculation of the Rivermead Mobility Index in high-level patients prior versus end of ITB trial. Evaluation of occurring adverse events.

RESULTS

A total of 119 ITB trials were performed in 116 patients (78 men, mean age 41±16), 113 patients completed the trials (31 of 113 high level, 82 of 113 low level). The median modified Ashworth scale improved from 4 (interquartile range [IQR] 3-4) to 2 (IQR 1-2; P≤.001), the range of movement from 2 (IQR 1-3) to 3 (IQR 3-3; P≤.001). The Rivermead Mobility Index increased from 9 (IQR 6-12) to 10 (IQR 7-12.5; P=.004) in high-level patients. Eighty-eight out of 113 patients (78%) were appropriate candidates for ITB device surgery, 75 of 88 (85%) proceeded to an implantation. A total of 69 adverse events occurred in 57 of 119 trials (48%), 37 of 69 (54%) were drug related, 32 of 69 (46%) were procedure related, and 42 of 69 (61%) were minor. The ITB device was implanted in 69 of 75 patients (92%) at last follow-up.

CONCLUSIONS

Continuous administration of ITB is an effective and useful alternative to ITB bolus application during ITB screening period. Half of the patients experienced adverse events; the majority were minor events.

摘要

目的

报告我们在可能进行鞘内巴氯芬（ITB）装置植入之前使用连续 ITB 给药的经验。

设计

回顾性开放标签研究。中位随访时间为 64 个月。

设置

初级保健和转诊中心，门诊和住院治疗。

参与者

2006 年至 2017 年间接受连续 ITB 试验的患者（N=116）。

干预措施

通过临时鞘内导管向外部泵连续应用巴氯芬。

主要观察指标

在 ITB 试验之前和结束时，评估改良 Ashworth 量表和活动范围。根据巴氏指数，定义高水平患者（60-100 分）和低水平患者（0-55 分）。在 ITB 试验之前和结束时，计算高水平患者的 Rivermead 移动指数。评估发生的不良事件。

结果

在 116 例患者中进行了 119 次 ITB 试验（78 例男性，平均年龄 41±16 岁），113 例患者完成了试验（31 例为高水平，113 例为低水平）。改良 Ashworth 量表中位数从 4（四分位距 [IQR] 3-4）改善至 2（IQR 1-2；P≤.001），活动范围从 2（IQR 1-3）改善至 3（IQR 3-3；P≤.001）。在高水平患者中，Rivermead 移动指数从 9（IQR 6-12）增加至 10（IQR 7-12.5；P=.004）。113 例患者中有 88 例（78%）是 ITB 装置手术的合适候选者，88 例中有 75 例（85%）进行了植入。在 119 次试验中，共发生 69 例不良事件（58%），57 例患者（48%），其中 37 例（54%）与药物相关，69 例（46%）与操作相关，42 例（61%）为轻微不良事件。最后一次随访时，在 75 例患者中有 69 例（92%）植入了 ITB 装置。