神经妥乐平治疗维持性血液透析患者不宁腿综合征的有效性及安全性

Efficacy and safety of neurotropin in treatment of restless legs syndrome in patients undergoing maintenance hemodiaiysis

目的探讨神经妥乐平（牛痘疫苗接种家兔炎症皮肤提取物）治疗维持性血液透析患者不宁腿综合征和睡眠障碍的有效性和安全性。方法采用随机、双盲和安慰剂对照的方法，符合入选标准的68例患者被随机分为对照组（34例）和治疗组（34例）。所有入组患者均接受充分透析治疗，治疗组患者每次透析结束前缓慢推注7．2单位（2支）神经妥乐平注射液，8周后停止使用。对照组患者在充分透析基础上无针对不宁腿综合征的治疗，研究持续16周。每周监测两组患者血生化指标，应用国际不宁腿综合征研究评价量表和匹茨堡睡眠质量指数量表评估患者不安腿症状和睡眠质量的改善情况。结果68例患者均完成本研究。与基线值比较，两组患者各随访点不宁腿综合征评分均有下降，治疗组不宁腿综合征评分下降更显著，对照组和治疗组间差异有统计学意义（均P〈0．01）。与基线值比较，治疗组患者在主观睡眠、入睡时间、睡眠时间、睡眠效率、睡眠紊乱、助眠药物、日间功能和总分等项目的评分均明显下降，组间比较差异有统计学意义（均P〈0．01）。研究过程中未发现神经妥乐平相关不良反应。结论神经妥乐平可改善维持性血液透析患者不宁腿综合征症状和睡眠障碍，且安全性较好，但停药后症状可再次出现。

Objective To investigate the efficacy and safety of neurotropin in the treatment of restless legs syndrome and sleep disorder in patients with maintenance hemodialysis. Methods Sixty eight patients who met the inclusion criteria were randomly assigned to control group （n=34） and treatment group （n=34）. The trial lasted for 16 weeks, and all patients undergone thorough dialysis. 7.2 units （2 branches） neurotropin were slowly injected to the patients in the treatment group at the end of each hemodialysis and they were stopped after 8 weeks. The patients in the control group had no treatment for restless leg syndrome on the basis of adequate dialysis. All patients were assessed regularly as regards their biochemical indexes, restless legs syndrome rating scale and Pittsburgh sleep quality index. Results All the patients completed the experiment, and restless legs syndrome scores were decreased in two groups. Compared with the baseline, the restless legs syndrome scores decreased significantly in patients treated with neurotropin, and the differences between two groups were significant （P 〈 0.01）. In the Pittsburgh sleep quality index scores, the patients in the treatment group decreased in all scores and the difference was statistically significant （P 〈 0.01）. Conclusions Neurotropin can relieve the symptoms of restless legs syndrome and sleep disturbance in patients on maintenance hemodialysis and is safe, but symptoms may occur again after withdrawal.