Wang Tiantian, Ying Miaofa, Zhao Rui, Zhu Danyan, Zhang Lisan
Department of Pharmacy, Xiasha Campus, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, No. 368 Rd Xiasha, Zhejiang Province, 310016, Hangzhou, China.
Institute of Pharmacology and Toxicology, College of Pharmaceutical Science, Zhejiang University, No. 866 Rd Yuhangtang, Zhejiang Province, 310058, Hangzhou, China.
Sleep Breath. 2022 Mar;26(1):373-380. doi: 10.1007/s11325-021-02353-9. Epub 2021 Apr 16.
Augmentation is a major complication of long-term pramipexole treatment of restless legs syndrome (RLS). However, there have been no studies on augmentation in Chinese patients with RLS. We therefore investigated the clinical characteristics of augmentation in RLS patients treated with pramipexole in a real-world Chinese setting.
This study was an observational, retrospective assessment of 103 patients with RLS, who had been continuously treated with pramipexole for at least one month between January 2016 and December 2018 in a tertiary hospital in East China. Demographic data and disease and drug treatment information were collected from electronic medical records and telephone interviews to analyze the rate and clinical features of augmentation. Augmentation was confirmed by Max Planck Institute criteria. Comparisons were made between patients with and without augmentation.
Fifteen patients (15%) were classified as having augmentation. Compared to RLS patients without augmentation, more patients with augmentation switched from other dopaminergic drugs (P<0.05) and had a longer duration of RLS symptoms before pramipexole treatment (P<0.05). In addition, patients with augmentation had a longer duration (P<0.05) and higher dosage (P<0.05) of pramipexole than those without augmentation. Augmentation was possibly associated with pramipexole tolerance (P<0.01).
The augmentation rate of the Chinese RLS patients in our study was 15%. Augmentation may be associated with switching from other dopaminergic drugs, long disease duration before pramipexole use, the dose and duration of pramipexole, and tolerance to pramipexole.
症状加重是不安腿综合征（RLS）长期使用普拉克索治疗的主要并发症。然而，尚未有关于中国RLS患者症状加重情况的研究。因此，我们在真实世界的中国环境中调查了接受普拉克索治疗的RLS患者症状加重的临床特征。
本研究是一项对103例RLS患者的观察性回顾性评估，这些患者于2016年1月至2018年12月在中国东部一家三级医院连续接受普拉克索治疗至少1个月。从电子病历和电话访谈中收集人口统计学数据以及疾病和药物治疗信息，以分析症状加重的发生率和临床特征。症状加重根据马克斯·普朗克研究所的标准确定。对有症状加重和无症状加重的患者进行比较。
15例患者（15%）被归类为症状加重。与无症状加重的RLS患者相比，症状加重的患者中更多人从其他多巴胺能药物转换而来（P<0.05），并且在使用普拉克索治疗前RLS症状持续时间更长（P<0.05）。此外，症状加重的患者使用普拉克索的持续时间更长（P<0.05），剂量更高（P<0.05）。症状加重可能与对普拉克索的耐受性有关（P<0.01）。
我们研究中的中国RLS患者症状加重率为15%。症状加重可能与从其他多巴胺能药物转换、使用普拉克索前疾病持续时间长、普拉克索的剂量和持续时间以及对普拉克索的耐受性有关。
