Ondo William, Romanyshyn Jonathan, Vuong Kevin Dat, Lai Dejian
Department of Neurology, Baylor College of Medicine, 6550 Fannin, Houston, TX 77030, USA.
Arch Neurol. 2004 Sep;61(9):1393-7. doi: 10.1001/archneur.61.9.1393.
Controlled clinical trials robustly demonstrate the short-term efficacy of dopamine agonists (DA) for restless legs syndrome (RLS), but little is known about the long-term efficacy and long-term adverse events. Augmentation-an increase in the duration, intensity, and anatomy of RLS symptoms-is commonly associated with dopaminergic treatments; however, risk factors for this troubling scenario have not been formally evaluated.
To evaluate the long-term efficacy and tolerability of DA for RLS and to evaluate factors that could predict the occurrence of augmentation.
We queried all subjects seen from 1996 to 2003 and followed up those initiated on any DA by the Baylor College of Medicine Movement Disorders Clinic, Houston, Tex. Patients with Parkinson disease, uremia, or medications that could affect RLS were excluded. Demographics, efficacy, dosing, adverse events, and augmentation were tracked across time. Statistical modeling was used to evaluate for factors that could predict augmentation.
After eliminating all patients with RLS who had factors that could affect DA dosing or the accuracy of data, we observed 83 subjects with at least 6 months' use of DA (mean +/- SD, 39.2 +/- 20.9 months). Efficacy was maintained across time but at the expense of moderate but significant increases in doses (P<.01). Adverse events were frequent but usually mild and seldom resulted in discontinuation. Augmentation was frequent (48% of subjects) but usually modest, and it was predicted by a positive family history for RLS and especially the lack of any neuropathy on electromyographic or nerve conduction velocity tests.
Dopamine agonists continued to effectively treat RLS without long-term adverse events but often required adjustments across time. The higher rate of augmentation in familial and nonneuropathic RLS should be considered when initiating therapy.
对照临床试验有力地证明了多巴胺激动剂（DA）治疗不宁腿综合征（RLS）的短期疗效，但对其长期疗效和长期不良事件知之甚少。症状加重——RLS症状在持续时间、强度和范围上的增加——通常与多巴胺能治疗相关；然而，这一令人困扰情况的危险因素尚未得到正式评估。
评估DA治疗RLS的长期疗效和耐受性，并评估可预测症状加重发生的因素。
我们查询了1996年至2003年期间就诊的所有受试者，并对德克萨斯州休斯顿贝勒医学院运动障碍诊所开始使用任何DA的患者进行了随访。排除患有帕金森病、尿毒症或可能影响RLS的药物的患者。对人口统计学、疗效、剂量、不良事件和症状加重情况进行长期跟踪。采用统计建模来评估可预测症状加重的因素。
在排除所有患有可能影响DA剂量或数据准确性因素的RLS患者后，我们观察了83名至少使用DA 6个月的受试者（平均±标准差，39.2±20.9个月）。疗效随时间维持，但代价是剂量适度但显著增加（P<0.01）。不良事件频繁，但通常较轻，很少导致停药。症状加重很常见（48%的受试者），但通常程度较轻，并且通过RLS的阳性家族史，尤其是肌电图或神经传导速度测试中无任何神经病变可预测。
多巴胺激动剂继续有效治疗RLS且无长期不良事件，但通常需要随时间进行调整。开始治疗时应考虑家族性和非神经病变性RLS中较高的症状加重率。
