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一项前瞻性随机双盲先导研究,旨在检查肉毒杆菌毒素 A 注射与利多卡因/地塞米松注射对残肢痛和幻肢痛的影响:初步报告。

A prospective randomized double-blinded pilot study to examine the effect of botulinum toxin type A injection versus Lidocaine/Depomedrol injection on residual and phantom limb pain: initial report.

机构信息

Department of Physical Medicine and Rehabilitation, Medical College of Wisconsin, Milwaukee, WI 53226, USA.

出版信息

Clin J Pain. 2012 Feb;28(2):108-12. doi: 10.1097/AJP.0b013e3182264fe9.

DOI:10.1097/AJP.0b013e3182264fe9
PMID:21750460
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3845354/
Abstract

OBJECTIVE

Botulinum toxin type A (Botox) injection has been used to manage pain. However, it remains to be proved whether Botox injection is effective to relieve residual limb pain (RLP) and phantom limb pain (PLP).

DESIGN

Randomized, double-blinded pilot study.

SETTING

Medical College and an outpatient clinic in Department of Physical Medicine and Rehabilitation.

PARTICIPANTS

Amputees (n=14) with intractable RLP and/or PLP who failed in the conventional treatments.

INTERVENTIONS

Study amputees were randomized to receive 1 Botox injection versus the combination of Lidocaine and Depomedrol injection. Each patient was evaluated at baseline and every month after the injection for 6 months.

MAIN OUTCOME MEASURE

The changes of RLP and PLP as recorded by VAS, and the changes of the pressure pain tolerance as determined by a pressure algometer.

RESULTS

All patients completed the protocol treatment without acute side effects, and monthly assessments of RLP, PLP, and pain tolerance after the treatment. The time trend in the outcomes was modeled as an immediate change owing to the treatment followed by a linear tread afterward. Repeated measures were incorporated using mixed effects modeling. We found that both Botox and Lidocaine/Depomedrol injections resulted in immediate improvements of RLP (Botox: P=0.002; Lidocaine/Depomedrol: P=0.06) and pain tolerance (Botox: P=0.01; Lidocaine/Depomedrol: P=0.07). The treatment effect lasted for 6 months in both groups. The patients who received Botox injection had higher starting pain than those who received Lidocaine/Depomedrol injection (P=0.07). However, there were no statistical differences in RLP and pain tolerance between these 2 groups. In addition, no improvement of PLP was observed after Botox or Lidocaine/Depomedrol injection.

CONCLUSIONS

Both Botox and Lidocaine/Depomedrol injections resulted in immediate improvement of RLP (not PLP) and pain tolerance, which lasted for 6 months in amputees who failed in conventional treatments.

摘要

目的

肉毒杆菌毒素 A (肉毒杆菌)注射已被用于治疗疼痛。然而,肉毒杆菌注射是否能有效缓解残肢痛(RLP)和幻肢痛(PLP)仍有待证实。

设计

随机、双盲试点研究。

地点

医学院和康复医学系的门诊。

参与者

接受常规治疗失败的难治性 RLP 和/或 PLP 截肢者。

干预措施

研究性截肢者随机接受 1 次肉毒杆菌注射或利多卡因和地塞米松注射的联合治疗。每位患者在基线时和注射后每月评估一次,共 6 个月。

主要观察指标

VAS 记录的 RLP 和 PLP 的变化,压力测痛仪测定的压力痛觉耐受度的变化。

结果

所有患者均完成了方案治疗,无急性副作用,治疗后每月评估 RLP、PLP 和疼痛耐受度。结果的时间趋势被建模为治疗引起的即时变化,随后是线性趋势。使用混合效应模型纳入重复测量。我们发现肉毒杆菌和利多卡因/地塞米松注射均能立即改善 RLP(肉毒杆菌:P=0.002;利多卡因/地塞米松:P=0.06)和疼痛耐受度(肉毒杆菌:P=0.01;利多卡因/地塞米松:P=0.07)。两组的治疗效果均持续 6 个月。接受肉毒杆菌注射的患者起始疼痛高于接受利多卡因/地塞米松注射的患者(P=0.07)。然而,两组间 RLP 和疼痛耐受度无统计学差异。此外,肉毒杆菌或利多卡因/地塞米松注射后 PLP 无改善。

结论

在接受常规治疗失败的截肢者中,肉毒杆菌和利多卡因/地塞米松注射均能立即改善 RLP(而非 PLP)和疼痛耐受度,持续 6 个月。

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