加巴喷丁联合普拉克索治疗不宁腿综合征的临床研究

Clinical observation of gabapentin combined with pramipexole in the treatment of restless legs syndrome

目的观察加巴喷丁联合普拉克索治疗不宁腿综合征的临床效果,为临床治疗此类疾病提供一种可行的治疗方法。方法26例诊断为RLS的患者随机分为2组:单用普拉克索治疗组(A组)和加巴喷丁联合普拉克索治疗组(B组),每组13例。A组给予普拉克索口服,最终剂量为0.25 mg/d;B组除给予相同剂量的普拉克索外,给予加巴喷丁口服,剂量为600 mg/d。均连续用药12周,记录两组患者治疗前(T_0)、治疗后2周(T_2)、6周(T_6)、12周(T_(12))的IRLS(不宁腿严重程度量表)、PSQI(匹兹堡睡眠质量指数)、AIS(阿森斯失眠量表)、VAS(疼痛视觉模拟评分),以此来评估疗效并记录两组治疗的不良反应。结果治疗后各观察时间点,两组患者IRLS、AIS、PSQI、VAS评分较治疗前均有不同程度的下降,差异有统计学意义(P<0.01)。在治疗后2周,B组各项治疗效果优于A组(P<0.05)。在治疗后6周及12周,B组在改善IRLS、PSQI上仍然明显优于A组(P<0.05)。A组、B组的药物不良反应发生率分别为23.1%(3/13)和38.5%(5/13),差异无统计学意义。A组最常见的不良反应为头痛、恶心,B组最常见的不良反应除头痛、恶心外,还有头晕、口干。结论加巴喷丁联合普拉克索治疗不宁腿综合征的临床疗效较单用普拉克索疗效好,且安全性较高,耐受性较好,未见严重不良反应的发生。

Objective To observe the clinical effect of gabapentin and pramipexole orally taken on patients with restless legs syndrome,in order to provide a feasible treatment method for this kind of disease.Methods 26 patients with restless legs syndrome were divided into two groups randomly.Group A was treated with pramipexole and group B was orally administered gabapentin and pramipexole,13 cases in each group.The dosage of pramipexole in patients of two groups were both 0.25 mg daily.In addition,g roup B was given gabapentin 600 mg once a day orally before sleep.The periods of treatment were both 12 weeks.The IRLS（International Restless Legs Syndrome Study Group rating scale）,PSQI（Pittsburgh Sleep Quality Index）,AIS（Athens Insomnia Scale）and VAS（Visual Analogue Scale/Score）were recorded before treatment（T_0）and at 2 weeks（T_2）,6weeks（T_6）,12 weeks（T_（12））after treatment,in order to evaluate the clinical effect.The adverse reactions in the course of treatment were both recorded.Results The IRLS,PSQI,AIS and VAS scores of the two groups decreased at T_2,T_6 and T_（12）（P〈0.01）.The clinical efficacy of group B was statistically different from group A at T_2 in IRLS,PSQI,AIS and VAS scores（P〈0.05）.There were significant differences between the two groups in IRLS and PSQI at T_6 and T_（12）.The incidence of adverse drug reactions was 23.1%（3/13）and 38.5%（5/13）,respectively.No significant difference of overall adverse reactions existed.The most common adverse reactions of group A included headache and nausea,while dizziness and dry mouth were the common adverse reactions of group B besides headache and nausea.Conclusion The combination of gabapentin with pramipexole is effective and safe for the patients with restless legs syndrome.