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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 evaluate the clinical efficacy and safety of pramipexole in the treatment of primary disturbed leg syndrome (RLS). Methods: In this study, a randomized controlled clinical trial design was used. Eighty patients with primary RLS were randomly divided into experimental and control groups, 40 in each. Subjects in the test group received pramipexole, while those in the control group received metoprolol for a total of 8 weeks. The efficacy was assessed using the IRLS, Pittsburgh Sleep Quality Index (PSQI) and Hamilton Depression Rating Scale (HAMD). At the same time, closely observe and record the adverse reactions of pramipexole treatment, evaluate its safety. The two groups of subjects were evaluated before treatment, after 8 weeks of treatment and after 3 months of follow-up respectively, and their safety was evaluated after treatment. Results: Before treatment, there was no significant difference in IRLS, PSQI and HAMD scores between the two groups (P> 0.05). After treatment, the scores of IRLS, PSQI and HAMD in both groups were significantly lower than those in the same group before treatment, with significant difference (P <0.01). After treatment, the IRLS, PSQI and HAMD scores of the primary RLS subjects in the experimental group were significantly lower than those in the control group. The difference between the two groups was statistically significant (P <0.05). However, there was no significant difference in adverse reactions between the two groups (P> 0.05). Conclusion: Pramipexole not only can effectively alleviate the clinical symptoms of primary disturbed leg syndrome, but also can effectively improve their sleep and anxiety. The adverse drug reaction is small, the patient can tolerate.