目的 评估普瑞巴林治疗放射性臂丛神经痛的疗效及安全性.方法 将45例确诊放射性臂丛神经损伤伴单侧或双侧中度以上疼痛的患者,根据用药情况分成治疗组(普瑞巴林+神经营养药物)和对照组(神经营养药物).普瑞巴林治疗方案为口服,150 ~ 600 mg/d,疗程12周.用视觉模拟评分法(VAS)和神经病理性疼痛症状量表(NPSI)对疗效进行评估,以应答率(与基线相比,疼痛量表减分率达到30% ~ 50%的患者比例)作为主要疗效终点.结果 治疗组应答率(36.4%)高于对照组(9.1%),差异有统计学意义(χ^2=4.98,P<0.05).治疗组神经病理性疼痛症状量表(NPSI)、患者总体变化印象(PGIC),及睡眠评分均较对照组低,差异有统计学意义(t=-6.62、-5.65、-6.16,P<0.05),治疗组与对照组HADS-A比较,差异无统计学意义(P>0.05).结论 普瑞巴林联合常规神经营养药物治疗对放射性臂丛神经损伤疼痛症状有较好的疗效,并能改善患者各种性质的疼痛、患者总体变化印象及睡眠障碍等,入组患者能够较好地耐受普瑞巴林,无严重的不良反应事件发生.
Objective To evaluate the efficacy of pregabalin on painful radiation-induced brachial plexus injury.Methods A total of forty-five patients with painful radiation-induced brachial plexus injury were assigned to treatment group with pregabalin 150-600 mg/d combined with conventional therapy, and to control group with conventional treatment for 12 weeks.The visual analogue scale (VAS) and neuropathic pain symptom inventory (NPSI) were evaluated.The response rate (proportion of subjects with at least a 30% to 50% reduction in visual analogue scale) was evaluated as the primary endpoint.Results The response rate of the pregabalin group(36.4%) was significantly higher than that of the control group (9.1%) (χ^2 =4.98, P 〈 0.05).Although hospital anxiety and depression level, clinical global impression of change, and clinical global impression of change (CGIC) did not differ significantly between pregabalin group and control group (P 〉 0.05), improvements in neuropathic pain symptom inventory (NPSI), patient global impression of change (PGIC) and the sleep interference score(t =-6.62,-5.65,-6.16, P 〈 0.05)suggested some utility in the management of radiation-induced brachial plexus.Conclusions Pregabalin treatment combined with conventional treatment exerts efficacy on patients with painful radiation-induced brachial plexus and patients are well tolerated.