Mech-Sense, Department of Gastroenterology, Aalborg Hospital, Aarhus University Hospital, Aalborg, Denmark.
Gastroenterology. 2011 Aug;141(2):536-43. doi: 10.1053/j.gastro.2011.04.003. Epub 2011 Apr 14.
BACKGROUND & AIMS: Pain is a disabling symptom for patients with chronic pancreatitis (CP) and difficult to treat. Evidence from basic science and human studies indicates that pain processing by the central nervous system is abnormal and resembles that observed in patients with neuropathic pain disorders. We investigated whether agents used to treat patients with neuropathic pain are effective in CP.
We conducted a randomized, double-blind, placebo-controlled trial to evaluate the effects of the gabapentoid pregabalin as an adjuvant analgesic. We measured pain relief, health status, quality of life, and tolerability in 64 patients with pain from CP; they were randomly assigned to groups given increasing doses of pregabalin or placebo (control) for 3 consecutive weeks. The primary end point was pain relief, based on a visual analogue scale documented by a pain diary. Secondary end points included Patients' Global Impression of Change (PGIC) score, changes in physical and functional scales, pain character, quality of life, and tolerability.
Pregabalin, compared with placebo, caused more effective pain relief after 3 weeks of treatment (36% vs 24%; mean difference, 12%; 95% confidence interval, 22%-2%; P = .02). The percentage of patients with much or very much improved health status (PGIC score) at the end of the study was higher in the pregabalin than the control group (44% vs 21%; P = .048). Changes in physical and functional scales, pain character, quality of life, and number of serious adverse events were comparable between groups.
In a placebo-controlled trial, pregabalin is an effective adjuvant therapy for pain in patients with CP.
疼痛是慢性胰腺炎(CP)患者的一种致残症状,且难以治疗。基础科学和人体研究的证据表明,中枢神经系统的疼痛处理异常,类似于观察到的神经性疼痛障碍患者。我们研究了用于治疗神经性疼痛患者的药物是否对 CP 有效。
我们进行了一项随机、双盲、安慰剂对照试验,以评估加巴喷丁类似物普瑞巴林作为辅助镇痛剂的效果。我们评估了 64 例 CP 疼痛患者的镇痛效果、健康状况、生活质量和耐受性;他们被随机分为普瑞巴林递增剂量组或安慰剂(对照组),连续 3 周给药。主要终点是基于疼痛日记记录的视觉模拟量表的疼痛缓解。次要终点包括患者总体印象变化(PGIC)评分、身体和功能量表变化、疼痛特征、生活质量和耐受性。
与安慰剂相比,普瑞巴林治疗 3 周后能更有效地缓解疼痛(36%对 24%;平均差异 12%;95%置信区间 22%-2%;P =.02)。研究结束时,普瑞巴林组比对照组有更多的患者健康状况(PGIC 评分)明显或非常明显改善(44%对 21%;P =.048)。两组之间身体和功能量表、疼痛特征、生活质量和严重不良事件的变化无差异。
在安慰剂对照试验中,普瑞巴林是 CP 患者疼痛的有效辅助治疗药物。