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颈部清扫术后肉毒杆菌毒素A治疗神经性疼痛:一项剂量探索性研究。

Botulinum toxin A for neuropathic pain after neck dissection: a dose-finding study.

作者信息

Wittekindt Claus, Liu Wei-Chi, Preuss Simon F, Guntinas-Lichius Orlando

机构信息

Department of Otorhinolaryngology, School of Medicine, Cologne, Germany.

出版信息

Laryngoscope. 2006 Jul;116(7):1168-71. doi: 10.1097/01.mlg.0000217797.05523.75.

Abstract

OBJECTIVES

Botulinum toxin type A (BtxA) has been reported to be feasible in chronic neuropathic pain after neck dissection. The impact of the dose on the outcome has not been investigated yet.

STUDY DESIGN

Twenty-three patients with neuropathic pain after neck dissection were selected for an open and prospective phase II trial.

METHODS

In the low-dose group (n=13), a concentration of 10 mouse units (MU)/0.1 mL saline and in the high-dose-group (n=10), a concentration of 20 MU/0.1 mL saline were injected subcutaneously. Pain and quality of life were assessed at day 0 and day 28, respectively, by visual analog scales (VAS) and European Organization for Research and Treatment of Cancer (EORTC) quality-of-life core and EORTC quality-of-life head and neck module questionnaires.

RESULTS

Patients in the low-dose group showed a significant pain reduction (VAS) from 4.3 at day 0 to 3.0 at day 28 (P<.05). The mean pain VAS values in the high-dose group did not improve significantly. No serious adverse events were observed. There were trends toward improvement in quality of life in the low-dose group.

CONCLUSIONS

BtxA in a low concentration seems to be a useful therapeutic option in chronic neuropathic pain of the neck and shoulder after neck dissection.

摘要

目的

据报道,A型肉毒毒素(BtxA)对于颈清扫术后慢性神经性疼痛是可行的。但尚未研究剂量对结果的影响。

研究设计

选择23例颈清扫术后神经性疼痛患者进行开放的前瞻性II期试验。

方法

低剂量组(n = 13)皮下注射浓度为10鼠单位(MU)/0.1 mL生理盐水,高剂量组(n = 10)皮下注射浓度为20 MU/0.1 mL生理盐水。分别在第0天和第28天通过视觉模拟量表(VAS)以及欧洲癌症研究与治疗组织(EORTC)生活质量核心问卷和EORTC生活质量头颈模块问卷评估疼痛和生活质量。

结果

低剂量组患者疼痛明显减轻(VAS),从第0天的4.3降至第28天的3.0(P<0.05)。高剂量组的平均疼痛VAS值未显著改善。未观察到严重不良事件。低剂量组生活质量有改善趋势。

结论

低浓度的BtxA似乎是颈清扫术后颈肩部慢性神经性疼痛的一种有用治疗选择。

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