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8%辣椒素贴剂对腰骶部疼痛患者生活质量的有效性和影响:一项开放标签研究。

Effectiveness and Impact of Capsaicin 8% Patch on Quality of Life in Patients with Lumbosacral Pain: An Open-label Study.

作者信息

Zis Panagiotis, Bernali Nikolitsa, Argira Erifili, Siafaka Ioanna, Vadalouka Athina

机构信息

Evangelismos General Hospital, Athens, Greece.

出版信息

Pain Physician. 2016 Sep-Oct;19(7):E1049-53.

PMID:27676676
Abstract

BACKGROUND

Capsaicin 8% patch (Qutenza™) is mainly used to treat postherpetic neuralgia and HIV-associated neuropathy. Evidence of the efficacy of Qutenza in other forms of neuropathic pain is lacking.

OBJECTIVE

To evaluate the analgesic effect and the impact on quality of life after a single application of the capsaicin 8% cutaneous patch in patients with lumbosacral pain.

STUDY DESIGN

Prospective open-label study of capsaicin 8% patch in patients with lumbosacral pain.

SETTING

Outpatient Pain and Palliative Care Center.

METHODS

All recruited patients were evaluated prior to capsaicin 8% patch administration and were followed-up at 2 weeks, at 8 weeks, and at 12 weeks post administration. Visual analog scale (VAS) was used to record pain intensity and EQ-5D was used to assess the quality of life of the participants.

RESULTS

Ninety patients met our inclusion criteria (54.4% men, mean age 59.1 ± 9.2 years). At baseline the mean VAS score of the participants was 7.6 ± 0.7. A statistically significant reduction of the VAS score between baseline and week 2 (mean VAS score 5.6 ± 1.1, P < 0.001) was observed. The therapeutic effect further continued between week 2 and week 8 (mean VAS score 3.2 ± 1.2, P < 0.001) and between week 8 and at endpoint at week 12 (mean VAS score 2.6 ± 1.1, P < 0.001).Between baseline and weeks 2, 8, and 12 (end-point) a significant improvement in all 5 dimensions of EQ-5D (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) was observed (P < 0.001).

LIMITATIONS

As it is an open-label study, a prospective randomized placebo-controlled study should be designed to confirm the effectiveness of capsaicin 8% patch in patients with lumbosacral pain.

CONCLUSIONS

Administration of the capsaicin 8% patch resulted in a significant relief of neuropathic pain and a significant improvement of the quality of life of patients with lumbosacral neuropathic pain.

KEY WORDS

Lumbosacral pain, peripheral pain, Qutenza, neuropathic pain, capsaicin, patch, quality of life, effectiveness.

摘要

背景

8%辣椒素贴剂(Qutenza™)主要用于治疗带状疱疹后神经痛和HIV相关性神经病变。目前缺乏Qutenza对其他形式神经病理性疼痛疗效的证据。

目的

评估8%辣椒素皮肤贴剂单次应用于腰骶部疼痛患者后的镇痛效果及其对生活质量的影响。

研究设计

关于8%辣椒素贴剂治疗腰骶部疼痛患者的前瞻性开放标签研究。

研究地点

门诊疼痛与姑息治疗中心。

方法

所有招募的患者在给予8%辣椒素贴剂前均接受评估,并在给药后2周、8周和12周进行随访。采用视觉模拟评分法(VAS)记录疼痛强度,采用EQ-5D评估参与者的生活质量。

结果

90例患者符合纳入标准(男性占54.4%,平均年龄59.1±9.2岁)。基线时参与者的平均VAS评分为7.6±0.7。观察到基线至第2周时VAS评分有统计学意义的降低(平均VAS评分5.6±1.1,P<0.001)。治疗效果在第2周和第8周之间(平均VAS评分3.2±1.2,P<0.001)以及第8周和第12周终点之间(平均VAS评分2.6±1.1,P<0.001)持续存在。在基线至第2周、第8周和第12周(终点)期间,观察到EQ-5D的所有5个维度(活动能力、自我护理、日常活动、疼痛/不适和焦虑/抑郁)均有显著改善(P<0.001)。

局限性

由于本研究为开放标签研究,应设计前瞻性随机安慰剂对照研究以证实8%辣椒素贴剂对腰骶部疼痛患者的有效性。

结论

8%辣椒素贴剂的应用可显著缓解神经病理性疼痛,并显著改善腰骶部神经病理性疼痛患者的生活质量。

关键词

腰骶部疼痛;外周性疼痛;Qutenza;神经病理性疼痛;辣椒素;贴剂;生活质量;有效性

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