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首页> 外文期刊>European review for medical and pharmacological sciences. >Efficacy of tapentadol prolonged release for pre- and post-operative low back pain: a prospective observational study
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Efficacy of tapentadol prolonged release for pre- and post-operative low back pain: a prospective observational study

机译:他喷他多缓释对术前和术后腰痛的疗效:一项前瞻性观察研究

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OBJECTIVE: Low back pain (LBP) is a highly prevalent chronic pain condition with a neuropathic component of pain that limits the benefits of classical opioids. Tapentadol is an innovative drug for the treatment of chronic severe pain, with a dual mechanism of action combining μ-opioid receptors agonism and noradrenaline re-uptake inhibition (NRI). Its efficacy is equal to that of strong opioids, with a better tolerability profile and a consequently lower risk of treatment discontinuation. The aim of this study was to evaluate the analgesic efficacy and tolerability of tapentadol prolonged release (PR) vs. other analgesics in patients with moderate-to-severe neuropathic low back pain, before and after back surgery. PATIENTS AND METHODS: The primary endpoints of the study were the rate of response to treatment, measured as ≥30% reduction in pain intensity on the Numeric Rating Scale (NRS), and tapentadol PR efficacy for pain relief. The secondary endpoints were the improvements of the neuropathic component of pain and of sleep quality. RESULTS: A total of 40 patients were enrolled in the study, receiving either tapentadol PR (n=21, 52.5%) or other analgesics (n=19, 47.5%), both before and after surgery. The rate of response to treatment was statistically in favor of tapentadol PR (p0.01). The reduction in pain intensity was statistically significant in the group treated with tapentadol PR, both before and after surgery (p0.01), with a complete resolution of pain 90 days after surgery. The quality of sleep after surgery improved more in patients treated with tapentadol PR than in the comparator group (p0.01), with 100% of the patients reporting a “good” sleep quality 2 months after surgery. CONCLUSIONS: Tapentadol PR was well tolerated by all patients, and its efficacy for pain relief was also confirmed in our small group of “real-life” patients with chronic, severe low back pain. Overall, the tolerability of this treatment may help to improve patients’ quality of life, which is frequently compromised because of pain and its related comorbidities.
机译:目的:下腰痛(LBP)是一种高度流行的慢性疼痛病,具有神经性疼痛,限制了传统阿片类药物的益处。他喷他多是一种用于治疗慢性严重疼痛的创新药物,其双重作用机制结合了μ阿片受体激动作用和去甲肾上腺素再摄取抑制(NRI)。它的功效与强效阿片类药物相同,具有更好的耐受性,因此中断治疗的风险更低。这项研究的目的是评估中度至重度神经性下腰痛患者术后前后他喷他多缓释(PR)与其他镇痛药的镇痛效果和耐受性。患者与方法:研究的主要终点是对治疗的反应率,在数字评分量表(NRS)上测得疼痛强度降低≥30%,以及他喷他多PR缓解疼痛的功效。次要终点是疼痛和睡眠质量的神经性成分的改善。结果:共有40名患者参加了这项研究,在手术前后均接受他喷他多PR(n = 21,52.5%)或其他镇痛药(n = 19,47.5%)。从统计学上看,对他喷他多PR的治疗反应率有统计学意义(p <0.01)。在手术前后,使用他喷他多PR治疗的组中疼痛强度的减少在统计学上具有统计学意义(p <0.01),并且在手术后90天完全缓解了疼痛。他喷他多PR治疗的患者术后的睡眠质量比对照组的患者改善了更多(p <0.01),其中100%的患者术后2个月的睡眠质量良好。结论:他喷他多PR对所有患者均具有良好的耐受性,并且在我们的一小部分“真实生活”慢性,严重下腰痛患者中也证实了他喷他多的镇痛效果。总体而言,这种治疗方法的耐受性可能有助于改善患者的生活质量,由于疼痛及其相关合并症,这种生活质量常常受到损害。

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