普瑞巴林与吗啡联合应用对癌性神经病理性疼痛的治疗效果

Assessment of pregabalin combined with morphine in patients with neuropathic cancer pain

目的研究普瑞巴林与吗啡联合用于癌性神经病理性疼痛治疗的疗效及安全性。方法采用交叉设计的研究方法,将30例癌性神经病理性疼痛患者随机分为普瑞巴林-安慰剂(PGB-PL)组和安慰剂-普瑞巴林(PL-PGB)组,每组15例,分别接受两个阶段的治疗,PGB-PL组先接受普瑞巴林+吗啡的治疗,再接受安慰剂+吗啡的治疗;PL-PGB组的治疗顺序相反。分别记录两种治疗方案用药前及用药后的吗啡日用量、MOS睡眠量表(MOS-SS)评分和便秘评估量表(CAS)评分。记录硫酸吗啡缓释片及盐酸吗啡片日用量;记录每天的疼痛评分。观察患者的头晕、口干、嗜睡等不良反应。结果普瑞巴林与安慰剂相比能显著减少癌性神经病理性疼痛患者吗啡的使用剂量(P<0.01);改善MOS-SS评分表中入睡障碍、睡眠时长、睡眠问题指数(P<0.01)和睡眠充裕度(P<0.05)等项目的评分,缓解患者的便秘(P<0.05)。结论普瑞巴林与吗啡联合用于癌性神经病理性疼痛的治疗安全有效,效果优于单纯吗啡治疗。

Objective To evaluate the efficacy and safety of pregabalin combined with morphine in the treatment of neuropathic cancer pain. Methods A total of 30 cancer patients with severe neuropathic cancer pain were enrolled in the study and randomly divided into two groups （n=15）： group pregabalin-placebo （PGB-PL） and group placebo-pregabalin （PL-PGB）. Each group received two treatments of two different sequences. In the first phase, patients of group PGB-PL were treated with pregabalin and morphine followed by a second phase treated with placebo and morphine in combination. The treatment sequences of group PL-PGB were just the opposite. The dosage of morphine, medical outcomes study sleep scale （MOS-SS）, constipation assessment scale （CAS）, and the adverse reactions were compared during the study. Results The dosage of morphine decreased significantly in the pregabalin compared to the placebo（P〈0. 01）. Pregabalin provided significantly sleep improvement in sleep disturbance, sleep quantity, sleep problems index（P〈0. 01） and sleep adequacy（P〈0.05）, and also induced CAS reduction significantly compared with placebo（P〈0.05）. Conclusion Pregabalin can treat neuropathic cancer pain effectively and safely. It can enhance the efficacy of morphine and reduce the adverse reactions.