摘要
目的:评价普拉克索治疗原发性不安腿综合征(RLS)的临床疗效和安全性。方法:本研究采用随机平行对照临床试验的研究设计方案,将80例原发性RLS受试者随机分为试验组和对照组,每组各40例。试验组的受试者给予普拉克索治疗,对照组的受试者给予美多巴治疗,共治疗8周。疗效的评定采用国际不安腿综合征评估量表(IRLS),匹兹堡睡眠质量指数(PSQI)和汉密尔顿抑郁量表(HAMD)。同时,密切观察并记录普拉克索治疗的不良反应,评价其安全性。两组受试者分别于治疗前,治疗8周结束后和随访3个月进行疗效评估,以及治疗后评估其安全性。结果:治疗前,两组受试者IRLS,PSQI和HAMD评分比较,差异无统计学意义(P>0.05)。治疗后,两组受试者的IRLS,PSQI和HAMD评分均显著降低,与同组治疗前比较,差异显著,有统计学意义(P<0.01)。治疗后,与对照组比较,试验组原发性RLS受试者的IRLS,PSQI和HAMD评分均显著低于对照组。二者比较,差异有统计学意义(P<0.05)。但两组不良反应比较,差异无统计学意义(P>0.05)。结论:普拉克索不仅能有效缓解原发性不安腿综合征的临床症状,还可以有效改善这些患者的睡眠和焦虑。该药物的不良反应较小,患者可以耐受。
Objective： To assess the efficacy and safety of Pramipexole for treating primary restless legs syndrome（PRLS）. Methods： This study was designed as a randomized parallel-controlled trial. Eighty PRLS patients were randomly divided into the intervention group（40 subjects） and the control group（40 subjects）. The patients in the control group received Madopar tablet, while the subjects in the intervention group received Pramipexole. The outcomes included IRLS, PSQI and HAMD scales as well as the adverse events. The outcome measurements were conducted before treatment, after treatment and 3-month follow-up. Results： After treatment, the scales of IRLS, PSQI and HAMD were reduced significantly compared with those before treatment in both groups（P〈0.01）. In addition, the scales of IRLS, PSQI and HAMD were also reduced significantly in the intervention group compared with those of the control group（P〈0.05）. However, the adverse events were similar between both groups（P〉0.05）. Conclusion： Pramipexole can effectively treat PRLS. In addition, the patients can tolerate its adverse events.
作者
马利
王娟娟
薛涛
MA Li WANG Juan-juan XUE Tao(Department of neurology, The Affiliated Hospital of Yanan University, Yanan, 716000, China)
出处
《临床药物治疗杂志》
2017年第3期25-28,共4页
Clinical Medication Journal
