摘要： 目的   观察抗癫药物加巴喷丁治疗神经病理性疼痛的临床疗效及安全性。方法   采用前瞻性随机对照研究方法观察神经病理性疼痛患者对加巴喷丁的临床治疗效果，根据视觉模拟评分（VAS）评价患者治疗前后疼痛改善程度，记录药物不良反应发生率。结果   83 例患者完成试验，1 例脱落。与治疗前相比，加巴喷丁组患者治疗后第1、2、4 和8 周末VAS 评分显著减少（均P = 0.001），且自治疗第2 周末开始各测量时间点VAS 评分均低于卡马西平组（P = 0.011，0.001，0.001）。治疗第8 周末加巴喷丁组患者治疗有效率为87.50%（35/40），高于卡马西平组的67.44%（29/43；χ2 = 4.723，P = 0.030）。两组患者治疗过程中药物不良反应发生率差异无统计学意义（Z = 0.324，P = 0.373），实验室检查未出现具有临床意义的异常变化。结论   加巴喷丁治疗神经病理性疼痛安全、可靠，值得临床推广应用。

关键词: 抗惊厥药, 卡马西平, 神经痛, 药物疗法, 随机对照试验

Abstract: Objective To explore the efficacy and safety of gabapentin, an anticonvulsant, in the treatment of neuropathic pain (NP). Methods Eighty-four patients with NP were randomly allocated into 2 groups, group A (gabapentin, n = 44) and group B (carbamazepine, n = 40). The patients in group A were given gabapentin 300 mg orally only one time on the first day, twice on the second day, and started from the third day, 3 times per day until the first weekend. Since then, the dose can be gradually adjusted according to the degree of pain relief and adverse drug reactions, but the maximum dose was not more than 2400 mg/d, 3 times daily. The dose, which can relieve or eliminate pain and symptoms would be used as a maintenance dose for 8 weeks until the end of the trial. The patients in group B received carbamazepine 100 mg orally twice a day on the first day, and 3 times on the second day, continuously until the first weekend. Since then, the dose can be gradually adjusted according to the degree of pain relief and adverse drug reactions, but the maximum dose can not be given more than 800 mg/d, 3 times orally. The dose, which can relieve or eliminate pain and symptoms would also be maintained for 8 weeks until the end of the trial. Quantification of the pain severity was determined by using Visual Analog Scale (VAS) at the beginning of the study and 1, 2, 4 and 8 weeks after treatment. In the meanwhile, blood and urine routine examination, and liver and renal function tests were performed both before and after treatment. In addition, adverse drug reactions were also observed. Results Eighty-three patients accomplished the clinical trial. The results of VAS in group A at 1, 2, 4 and 8 weeks after therapy were all significantly decreased (P = 0.001, for all). From the second weekend of the therapy, the scores of VAS at every time point in group A were all lower than those in group B, respectively (P = 0.011, 0.001, 0.001). After 8 weeks treatment, the effective rate of gabapentin (87.50%, 35/40) was significantly higher than that of carbamazepine (67.44%, 29/43; χ2 = 4.723, P = 0.030). The ratio of adverse effects in 2 groups were not significantly different (Z = 0.324, P = 0.373), and there were no abnormal changes in blood and urine routine examination, and liver and renal function tests. Conclusion Gabapentin is safe and effective to treat NP. It is worthy of clinical application.

Key words: Anticonvulsants, Carbamazepine, Neuralgia, Drug therapy, Randomized controlled trial