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曲马多治疗癌症神经病理性疼痛患者:一项前瞻性开放性研究。

Tapentadol in neuropathic pain cancer patients: a prospective open label study.

机构信息

Neuro-Oncology Unit, "Regina Elena" National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.

Biostatistic Unit-Scientific Direction, "Regina Elena" National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.

出版信息

Neurol Sci. 2017 Oct;38(10):1747-1752. doi: 10.1007/s10072-017-3035-1. Epub 2017 Jul 11.

Abstract

Many chemotherapy treatments induce peripheral neuropathy (CIPN). These patients often experience neuropathic pain (NP) that reduces the quality of life. The aim of this prospective, open label study was to evaluate the efficacy and tolerability of tapentadol (TP) in patients affected by CIPN. CIPN were consecutively enrolled in a prospective open label study at the Neuro-Oncology Unit of the Regina Elena National Cancer Institute in Rome. During the titration phase, each patient initially received doses of TP 50 mg twice a day. All patients underwent pain intensity (NRS) and DN4. For evaluation of quality of life, patients underwent EORTC QLQ-C30 and EORTC QLQ-CIPN2 QLQ-CIPN20. We enrolled 31 patients, 19 were females with a median age of 60 years. After 3 months of treatment with TP, 22 patients completed the statistical package for social sciences (SPSS). Nineteen patients out of 22 showed a response to treatment (86%). We also observed that TP reduced the NRS and DN4 values from baseline to the last visit in a significant way (p < 0.001, respectively). Seven patients (22.5%) discontinued the TP therapy after the first week of occurrence of side effects. Furthermore, we observed that TP improved also the global health status measured by EORT QLQ-C30. TP is well tolerated and efficacy in the treatment of NP. The important reduction of neuropathic pain, the improvement in NRS and QoL scores after therapy with TP makes it a candidate in the management of patients suffering from neuropathic pain of CIPN also as a first line of therapy.

摘要

许多化疗药物会引起周围神经病变(CIPN)。这些患者常经历神经病理性疼痛(NP),降低生活质量。本前瞻性、开放标签研究旨在评估曲马多(TP)治疗 CIPN 患者的疗效和耐受性。CIPN 患者连续入组于罗马 Regina Elena 国家癌症研究所神经肿瘤科的前瞻性开放标签研究。在滴定阶段,每位患者最初接受 TP 50mg,每日两次。所有患者均接受疼痛强度(NRS)和 DN4 评估。为评估生活质量,患者进行 EORTC QLQ-C30 和 EORTC QLQ-CIPN2 评估。我们共纳入 31 例患者,其中 19 例女性,中位年龄 60 岁。TP 治疗 3 个月后,22 例患者完成了统计软件包(SPSS)分析。22 例患者中有 19 例(86%)对治疗有反应。我们还观察到,TP 治疗显著降低了 NRS 和 DN4 评分(p<0.001)。7 例患者(22.5%)在出现副作用的第一周后停止了 TP 治疗。此外,我们还观察到,TP 还改善了 EORT QLQ-C30 评估的整体健康状况。TP 耐受性良好,治疗 NP 有效。神经病理性疼痛显著减轻,NRS 和 QoL 评分在 TP 治疗后改善,使其成为 CIPN 神经病理性疼痛患者管理的候选药物,也可作为一线治疗。

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