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盐酸曲马多缓释片治疗伴有或不伴有神经病理性成分的中重度慢性颈痛。

Tapentadol prolonged release for managing moderate to severe chronic neck pain with or without a neuropathic component.

机构信息

Department of Medical and Surgical Sciences and Biotechnologies, Unit Anaesthesiology, Intensive Care Medicine and Pain Therapy, Sapienza University of Rome, Latina, Italy.

NEMA Research, Inc., Naples, FL, USA.

出版信息

Curr Med Res Opin. 2020 Apr;36(4):651-659. doi: 10.1080/03007995.2020.1722083. Epub 2020 Feb 6.

DOI:10.1080/03007995.2020.1722083
PMID:31983248
Abstract

Despite the high prevalence of neck pain, few studies have addressed the pharmacological treatment of this condition. We evaluated the effectiveness of tapentadol prolonged-release (PR) in patients with or without a neuropathic pain component, with a focus on functional movements, disability and Quality of Life (QoL). Observational, retrospective study. Ninety-four adult patients with severe neck pain not responsive to opioid step III treatment. The primary endpoint was  ≥ 30% improvement of pain intensity at 4 weeks (W4). Several secondary outcomes were evaluated, including neck disability index (NDI), range of motion (ROM), and QoL. Patients received tapentadol PR at the starting dose of 100 mg/day. Dose titration was allowed in 50 mg increments, up to 500 mg daily. At W4, the primary endpoint of ≥30% improvement of pain was reported in 70% ( = 35; 95% confidence interval [CI]: 55-82%) of patients with a neuropathic pain component and in 69% ( = 20; 95% CI: 49-85%) of those without a neuropathic component. The percentage of patients reporting a neuropathic pain component significantly decreased from baseline (64.2%) to W4 (27.8%). NDI significantly improved in both groups at W12. ROM significantly improved in all three planes of motion ( < .01), with no difference between the two groups. Interference of pain with sleep and QoL also improved. The reduction in pain provided by tapentadol is associated with functional recovery, which may in turn be linked to an improvement in QoL.

摘要

尽管颈部疼痛的患病率很高,但很少有研究涉及这种疾病的药物治疗。我们评估了曲马多控释片(PR)在有或没有神经病理性疼痛成分的患者中的疗效,重点关注功能运动、残疾和生活质量(QoL)。观察性、回顾性研究。94 名患有严重颈部疼痛且对阿片类药物 III 步治疗无反应的成年患者。主要终点是在 4 周(W4)时疼痛强度改善≥30%。评估了几个次要结局,包括颈部残疾指数(NDI)、活动范围(ROM)和 QoL。患者接受曲马多 PR 起始剂量为 100mg/天。允许以 50mg 的增量进行剂量滴定,每日最高剂量为 500mg。在 W4 时,有神经病理性疼痛成分的患者中有 70%( = 35;95%置信区间[CI]:55-82%)和无神经病理性成分的患者中有 69%( = 20;95% CI:49-85%)报告疼痛改善≥30%,达到主要终点。报告有神经病理性疼痛成分的患者比例从基线(64.2%)显著下降到 W4(27.8%)。两组患者在 W12 时的 NDI 均显著改善。所有三个运动平面的 ROM 均显著改善( < .01),两组之间无差异。疼痛对睡眠和 QoL 的干扰也得到改善。曲马多减轻的疼痛与功能恢复相关,而功能恢复可能与 QoL 的改善相关。

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