Gatti Antonio, Sabato Alessandro Fabrizio, Occhioni Roberto, Colini Baldeschi Gianni, Reale Carlo
Dipartimento AFA Servizio di Anestesia e Terapia del Dolore, Ospedale Tor Vergata, Viale Oxford 81, Rome, Italy.
Eur Neurol. 2009;61(3):129-37. doi: 10.1159/000186502. Epub 2008 Dec 18.
The aim of our study was to compare the efficacy, safety, and quality of life of combination therapy with controlled-release (CR) oxycodone plus pregabalin versus monotherapy with either CR oxycodone or pregabalin in patients with neuropathic pain.
Patients with moderate to severe neuropathic pain, despite the use of various pharmacologic treatments prior to study entry, were enrolled (n = 409) and treated with CR oxycodone plus pregabalin (n = 169), CR oxycodone (n = 106), and pregabalin (n = 134). Pain intensity was rated on an 11-point numerical rating scale (NRS).
The combination of CR oxycodone plus pregabalin and CR oxycodone monotherapy were both more effective for alleviating neuropathic pain than pregabalin monotherapy (reduction in NRS value: 80, 76, and 46%, respectively; p </= 0.003). Significantly greater improvements from baseline in quality of life were reported with combination therapy than with monotherapy (p = 0.0009). At the end of treatment, the majority (91.2%) of patients receiving CR oxycodone plus pregabalin found that the treatment had been 'effective' or 'very effective'. Combination therapy also allowed a dose reduction of both agents (22% for CR oxycodone and 51% for pregabalin) compared with the dosages of the respective monotherapies. Combination therapy had a superior safety profile compared with pregabalin monotherapy.
The combination of CR oxycodone plus pregabalin may represent a valuable addition to the existing pharmacotherapy for neuropathic pain and warrants further investigation.
我们研究的目的是比较控释羟考酮加普瑞巴林联合治疗与单独使用控释羟考酮或普瑞巴林单药治疗对神经性疼痛患者的疗效、安全性及生活质量。
纳入尽管在研究入组前使用了各种药物治疗但仍患有中度至重度神经性疼痛的患者（n = 409），并分别用控释羟考酮加普瑞巴林（n = 169）、控释羟考酮（n = 106）和普瑞巴林（n = 134）进行治疗。疼痛强度采用11点数字评定量表（NRS）进行评分。
控释羟考酮加普瑞巴林联合治疗和控释羟考酮单药治疗在减轻神经性疼痛方面均比普瑞巴林单药治疗更有效（NRS值降低分别为80%、76%和46%；p≤0.003）。联合治疗组报告的生活质量较基线的改善显著大于单药治疗组（p = 0.0009）。治疗结束时，接受控释羟考酮加普瑞巴林治疗的大多数患者（91.2%）认为治疗“有效”或“非常有效”。与各自单药治疗的剂量相比，联合治疗还使两种药物的剂量均有所降低（控释羟考酮降低22%，普瑞巴林降低51%）。与普瑞巴林单药治疗相比，联合治疗具有更好的安全性。
控释羟考酮加普瑞巴林联合治疗可能是现有神经性疼痛药物治疗的一个有价值的补充，值得进一步研究。
