Prescrire Int. 2005 Dec;14(80):203-6.
(1) The first-line treatment for partial epilepsy is carbamazepine monotherapy; gabapentin monotherapy is an alternative, given its lower risk of drug-drug interactions. (2) The standard treatment for neuropathic pain associated with diabetes or post-herpetic neuralgia is a tricyclic antidepressant, with gabapentin as an alternative. Few drugs are available in this setting, and their efficacy is often modest. (3) Pregabalin is a GABA analogue closely related to gabapentin. Both drugs are marketed by Pfizer. Pregabalin has been approved for use in two indications: refractory partial epilepsy and neuropathic pain. (4) In patients with partial epilepsy inadequately controlled by a combination of two or possibly three antiepileptics, three placebo-controlled double-blind trials lasting 12 weeks suggest that adjunctive pregabalin treatment, at a dose of 600 mg/day divided in two or three doses, at least halves the frequency of seizures in 50% of patients. Pregabalin has not been compared with other second-line antiepileptics. (5) In neuropathic pain, there are 12 double-blind placebo-controlled trials involving patients with diabetes or post-herpetic neuralgia. Depending on the trial, between one-third and one-half of patients treated with pregabalin at a dose of 600 mg/day given in two or three doses had at least a 50% reduction in their pain score. In the only trial that included a group treated with amitriptyline (75 mg/day), the latter was significantly more effective than placebo, while pregabalin was not. (6) There are no comparative trials of pregabalin after amitriptyline and gabapentin failure. (7) The adverse effects profile of pregabalin is similar to that of gabapentin, and includes mainly neuropsychological reactions (dizziness and drowsiness). (8) Pregabalin, like gabapentin, can lead to weight gain and peripheral oedema especially in elderly patients. (9) Cases of visual field restriction have been reported with pregabalin in clinical trials. Animal studies suggest a possible risk of haemangiosarcoma, although no human cases have yet been described. (10) Pregabalin, like gabapentin, is eliminated unchanged in urine, implying a limited risk of interactions involving cytochrome P450, and suggesting that the dose should be reduced in patients with even moderate renal failure (creatinine clearance below 60 ml/min). (11) In practice, pregabalin offers nothing new for patients with partial epilepsy, for whom several other antiepileptics are available. The few available treatments for neuropathic pain have limited efficacy, and pregabalin may therefore be tried when both tricyclics and gabapentin fail. However, it is in no way certain that pregabalin is effective in such patients, and comparative trials are lacking.
(1) 部分性癫痫的一线治疗是卡马西平单药治疗；加巴喷丁单药治疗是一种替代方案，因其药物相互作用风险较低。(2) 糖尿病相关性神经病理性疼痛或带状疱疹后神经痛的标准治疗是三环类抗抑郁药，加巴喷丁作为替代药物。在这种情况下可用的药物很少，且其疗效通常一般。(3) 普瑞巴林是一种与加巴喷丁密切相关的GABA类似物。这两种药物均由辉瑞公司销售。普瑞巴林已被批准用于两种适应证：难治性部分性癫痫和神经病理性疼痛。(4) 在使用两种或可能三种抗癫痫药联合治疗仍控制不佳的部分性癫痫患者中，三项为期12周的安慰剂对照双盲试验表明，辅助使用普瑞巴林治疗，剂量为600mg/天，分两次或三次服用，至少使50%的患者癫痫发作频率减半。普瑞巴林尚未与其他二线抗癫痫药进行比较。(5) 在神经病理性疼痛方面，有12项针对糖尿病或带状疱疹后神经痛患者的双盲安慰剂对照试验。根据试验情况，接受普瑞巴林治疗的患者中，三分之一至二分之一的患者，剂量为600mg/天，分两次或三次服用，其疼痛评分至少降低了50%。在唯一一项纳入了阿米替林治疗组（75mg/天）的试验中，后者比安慰剂显著更有效，而普瑞巴林则不然。(6) 没有关于普瑞巴林在阿米替林和加巴喷丁治疗失败后的对比试验。(7) 普瑞巴林的不良反应谱与加巴喷丁相似，主要包括神经心理反应（头晕和嗜睡）。(8) 普瑞巴林与加巴喷丁一样，尤其在老年患者中可导致体重增加和外周水肿。(9) 在临床试验中已报告普瑞巴林导致视野受限的病例。动物研究提示有血管肉瘤的潜在风险，尽管尚未有人类病例的描述。(10) 普瑞巴林与加巴喷丁一样，经尿液原形排泄，这意味着涉及细胞色素P450的相互作用风险有限，提示即使是中度肾功能衰竭（肌酐清除率低于60ml/分钟）的患者也应减少剂量。(11) 在实际应用中，普瑞巴林对于部分性癫痫患者并无新意，因为有几种其他抗癫痫药可供选择。神经病理性疼痛的可用治疗方法疗效有限，因此当三环类药物和加巴喷丁治疗失败时可尝试使用普瑞巴林。然而，普瑞巴林在此类患者中是否有效尚无定论，且缺乏对比试验。
