Cánovas-Martínez Luz, Carceller-Ruiz José J, Díaz-Parada Pilar, Illodo-Miramontes Gustavo, Freire-Vila Enrique, De la Iglesia-López Aurora, Iglesias Belén García, López-Ulloa Beatriz, Domínguez-Suárez Enrique, Camba-Rodríguez Alberto
Pain Unit, Anesthesiology Department, Complexo Hospitalario Universitario de Ourense, c/ Ramón Puga Noguerol 52-54, 32005, Orense, Spain,
Clin Drug Investig. 2015 Mar;35(3):169-77. doi: 10.1007/s40261-015-0268-8.
Despite its prevalence and impact, breakthrough pain (BTP) in chronic non-cancer pain with neuropathic component, has not been well studied and is sometimes unrecognized and often undertreated. We evaluated the efficacy of sublingual fentanyl tablet (SLF) for the treatment of BTP in opioid-tolerant patients with chronic musculoskeletal pain with neuropathic component in terms of relief of pain intensity and assessed whether hypothetical pain relief impacts on quality of life (QoL).
A multicenter, prospective, open-label study was conducted over a 30-day period. Efficacy was evaluated using a visual analogue scale (VAS) and time to onset of action of SLF. The incidence of dependence was assessed by the Leeds Dependence Questionnaire (LDQ). Changes in QoL were evaluated using the Brief Pain Questionnaire (BPI) and the EuroQol (EQ-5D). Adverse events (AE) were recorded throughout.
106 patients were enrolled and 105 completed the study. The average pain reduction across the study was -3.30 points [95 % confidence interval (CI) 2.9-3.7; P < 0.0001]. Pain intensity improvement from baseline was statistically significant at first assessment and all subsequent assessments (P < 0.0001). The most common AEs included nausea (33.87 %), constipation (33.06 %), somnolence (19.35 %) and vomiting (6.45 %). No significant differences were observed on LDQ (P = 0.71). QoL as measured by BPI showed statistically significant improvement in all four severity items and all interference items (P < 0.0001) and a significant improvement in the percentage of pain relief reported by patients (P < 0.0001). EQ-5D results showed a trend towards improvement. Mean self-rate health status, as measured by the EQ VAS scale increased significantly (P < 0.0001).
SLF provides significant reductions in BTP intensity. The results of the BPI and EQ-5D assessments indicate that pain relief is associated with improvement of functioning and enhancement of QoL.
尽管突破性疼痛（BTP）在伴有神经病理性成分的慢性非癌性疼痛中普遍存在且影响较大，但尚未得到充分研究，有时未被识别，且常常治疗不足。我们评估了舌下含服芬太尼片（SLF）对伴有神经病理性成分的慢性肌肉骨骼疼痛的阿片耐受患者治疗BTP的疗效，包括疼痛强度缓解情况，并评估了假设的疼痛缓解对生活质量（QoL）的影响。
进行了一项为期30天的多中心、前瞻性、开放标签研究。使用视觉模拟量表（VAS）和SLF起效时间评估疗效。通过利兹依赖性问卷（LDQ）评估依赖性发生率。使用简明疼痛问卷（BPI）和欧洲生活质量量表（EQ-5D）评估QoL的变化。全程记录不良事件（AE）。
106例患者入组，105例完成研究。整个研究期间平均疼痛减轻-3.30分[95%置信区间（CI）2.9 - 3.7；P < 0.0001]。首次评估及所有后续评估时，与基线相比疼痛强度改善具有统计学意义（P < 0.0001）。最常见的AE包括恶心（33.87%）、便秘（33.06%）、嗜睡（19.35%）和呕吐（6.45%）。LDQ未观察到显著差异（P = 0.71）。BPI测量的QoL在所有四个严重程度项目和所有干扰项目上均显示出统计学显著改善（P < 0.0001），患者报告的疼痛缓解百分比也有显著改善（P < 0.0001）。EQ-5D结果显示有改善趋势。EQ VAS量表测量的平均自我评估健康状况显著提高（P < 0.0001）。
SLF可显著降低BTP强度。BPI和EQ-5D评估结果表明，疼痛缓解与功能改善和QoL提高相关。
