加巴喷丁治疗血液透析患者顽固性尿毒症皮肤瘙痒的临床研究

Clinical study of gabapentin in the treatment of refractory uremic pruritus in hemodialysis patients

目的 观察加巴喷丁（gabapentin）治疗顽固性尿毒症性皮肤瘙痒的有效性和安全性.方法 采用随机对照研究,选择顽固性皮肤瘙痒的维持性血液透析（MHD）患者,随机分为试验组25例和对照组24例.试验组患者每周3次透析后晚间口服加巴喷丁100～300mg;对照组每天口服氯雷他定10 mg.12周后根据视觉模拟评分、瘙痒VAG评分和改良Duo氏瘙痒评分进行疗效评价,同时观察不良反应.结果 试验组患者经治疗后皮肤瘙痒症状明显改善.瘙痒分布范围减小,发作频率降低,睡眠明显改善,VAS评分（1.46±1.38比8.71±1.17,P＜0.01）、VAG评分（2.92±1.63比8.29±0.68,P＜0.01）和改良Duo氏瘙痒评分（11.33±3.99比30.75±4.87,P＜0.01）均较治疗前显著下降.对照组患者经治疗后瘙痒症状部分缓解,但疗效与试验组差异有统计学意义（P＜0.01）.服用加巴喷丁患者中,36%出现嗜睡、头晕,而症状均在1周内减轻或消失,没有患者因此中断治疗;未观察到严重不良反应.结论 短期服用加巴喷丁能够安全和有效地治疗部分MHD患者的顽固性皮肤瘙痒.长期疗效及安全性仍需大样本和长期研究.

Objective To assess the safety and efficacy of gabapentin in treatment of refractory uremic pruritus in maintenance hemodialysis （MHD）patients. Methods A randomized controlled trial was performed.Forty-nine MHD patients with severe pruritus were randomly divided into treatment group（gabapentin 100-300 mg at dialysis day before sleep）and the control group（loratadine 10 mg daily）.The efficacy was assessed by visual analogue score,pruritus score and improved Duo＇s VAG Score after 12-week treatment,and the side effect was also observed to assess the safety. Results After treatment,the frequency,degree and area of pruritus in 25 patients of treatment group were significantly reduced,and VAS score（1.46±1.38vs 8.71±1.17,P〈0.01）,VAG score（2.92±1.63 vs 8.29±0.68,P〈0.01）and the improved Duo＇s pruritus score（11.33±3.99 vs 30.75±4.87,P〈0.01）decreased significantly compared with that of prior treatment.The symptoms of 24 patients in control group were improved partly,which were not as good as those in treatment group（P〈0.01）.The side effects of gabapentin were drowsiness and dizziness,but most symptoms were relieved or disappeared within 1 week and no patient interrupted therapy.No serious adverse events were observed. Conclusion Gabapentin is safe and effective for refractory uremic pruritus,but long-term efficacy and safety requires larger sample and long-term observation.