1 Sun Yat-Sen Memorial Hospital; Sun Yat-Sen University, Guangzhou, People's Republic of China.
2 Zengcheng District People's Hospital of Guangzhou, Guangzhou, People's Republic of China.
J Clin Oncol. 2019 Jan 10;37(2):135-143. doi: 10.1200/JCO.18.00896. Epub 2018 Nov 20.
Neuropathic pain is an unavoidable treatment-related adverse event among patients with head and neck cancer who are undergoing radiotherapy. We aimed to test the efficacy and safety of pregabalin versus placebo in the treatment of radiotherapy-related neuropathic pain.
This randomized, double-blind, placebo-controlled trial was conducted in four centers in China. Eligible patients with a mean pain intensity score of 4 or more on an 11-point numeric rating scale were randomly assigned to receive either active treatment with a flexible dose of pregabalin or placebo for 16 weeks. The primary efficacy outcome was pain reduction measured on the numeric rating scale.
There were 128 patients who received treatment as randomly assigned. Pain intensity reduction was 2.44 in the pregabalin arm and 1.58 in the placebo arm at week 16, yielding an adjusted mean difference of 0.87 (95% CI, 0.30 to 1.44; P = .003). In the pregabalin arm, 38 patients (59.4%) achieved at least 30% pain relief versus 21 (32.8%) in the placebo arm ( P = .006). Nineteen patients (29.7%) in the pregabalin group and five (7.8%) in the placebo group achieved 50% or greater pain relief ( P = .003). Total scores on the Profile of Mood States-Short Form, pain severity and functional interference of Brief Pain Inventory-Short Form, as well as the physiology and psychology domain of the WHO Quality of Life-BREF all were reduced significantly at week 16 in patients who received pregabalin compared with those who received placebo. There was no significant difference ( P = .29) in the incidence of experiencing at least one adverse event in the pregabalin arm (n = 35; 54.7%) versus the placebo arm (n = 29; 45.3%).
Patients treated with pregabalin with radiotherapy-related neuropathic pain had greater pain alleviation, better mood states, and higher quality of life compared with patients in the placebo group, with a good tolerability.
神经性疼痛是头颈部癌症患者接受放疗时不可避免的治疗相关不良反应。本研究旨在检验普瑞巴林治疗放疗相关性神经性疼痛的疗效和安全性。
本随机、双盲、安慰剂对照试验在中国的 4 个中心进行。纳入标准为疼痛强度评分均值≥4 分（11 分制数字评分量表）的患者，随机分为普瑞巴林治疗组（灵活剂量）或安慰剂组，治疗 16 周。主要疗效终点为数字评分量表上的疼痛缓解程度。
128 例患者接受了随机分组治疗。治疗 16 周后，普瑞巴林组和安慰剂组的疼痛强度分别降低了 2.44 和 1.58 分，调整后平均差值为 0.87 分（95%CI：0.30 至 1.44；P =.003）。普瑞巴林组中 38 例（59.4%）患者疼痛缓解至少 30%，而安慰剂组中 21 例（32.8%）患者达到这一标准（P =.006）。普瑞巴林组中有 19 例（29.7%）患者疼痛缓解 50%或以上，安慰剂组中有 5 例（7.8%）患者达到这一标准（P =.003）。治疗 16 周后，与安慰剂组相比，普瑞巴林组患者的简明心境量表总分、疼痛严重程度和简明疼痛量表功能干扰评分、WHO 生存质量测定量表简表的生理和心理领域评分均显著降低。普瑞巴林组和安慰剂组的不良事件总发生率分别为 54.7%（n = 35）和 45.3%（n = 29），两组间差异无统计学意义（P =.29）。
与安慰剂组相比，接受普瑞巴林治疗的放疗相关性神经性疼痛患者疼痛缓解更明显，情绪状态更好，生活质量更高，且耐受性良好。
