Department of Neurology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China; Department of Neurology, Yancheng City First People's Hospital, Yancheng, Jiangsu 224005, China.
Department of Neurology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.
Parkinsonism Relat Disord. 2019 Jan;58:70-73. doi: 10.1016/j.parkreldis.2018.08.022. Epub 2018 Aug 30.
Many patients with Parkinson's disease (PD) suffer from sialorrhea. Sialorrhea is often treated with anticholinergics and botulinum toxin, but some adverse effects have limited the use of these treatments. Dihydroergotoxine mesylate is an α-adrenergic blocking agents as well as some affinities to the dopaminergic and serotonin (5-HT) receptors. In the current study, we examine the safety and efficacy of dihydroergotoxine mesylate in PD patients.
This study consisted of 2 phases. The intervention was 2.5-mg oral dihydroergotoxine mesylate twice daily in both phases. The first phase is a three-week open-label single-arm trial (n = 10). The second phase was a six-week randomized controlled trials with a crossover design (n = 20). Efficacy was assessed using the United Parkinson's Disease Rating Scale (UPDRS) sialorrhrea subscore and Sialorrhea Clinical Scale for PD (SCS-PD).
In the first phase, the UPDRS sialorrhea score was 3.5 ± 0.53 vs. 1.9 ± 0.57 prior to and after the treatment (P = 0.004). The SCS-PD score decreased from 15.8 ± 2.78 to 9.9 ± 3.00 after the treatment (P = 0.005). The response rate (defined by at least 30% reduction in SCS-PD score) was 60%. In the second phase of crossover trial, the UPDRS sialorrhea score was 3.00 ± 0.56 in placebo weeks vs. 2.00 ± 0.65 on dihydroergotoxine in dihydroergotoxine weeks (P = 0.001). The SCS-PD was 12.50 ± 2.84 and 9.25 ± 2.86 versus, respectively (P < 0.001). The response rate was 10% and 55%, respectively (P = 0.003). There were no significant adverse effects.
Dihydroergotoxine mesylate is safe and effective for sialorrhea in PD patients.
许多帕金森病（PD）患者患有流涎症。流涎症通常采用抗胆碱能药物和肉毒毒素治疗，但这些治疗方法存在一些不良反应，限制了其应用。甲磺酸二氢麦角碱是一种 α-肾上腺素能阻断剂，对多巴胺能和 5-羟色胺（5-HT）受体也有一定亲和力。在本研究中，我们研究了甲磺酸二氢麦角碱治疗 PD 患者的安全性和疗效。
该研究包括 2 个阶段。干预措施为 2.5mg 甲磺酸二氢麦角碱口服，每日 2 次，在两个阶段均使用。第一阶段是为期 3 周的开放标签单臂试验（n=10）。第二阶段是为期 6 周的随机对照交叉试验（n=20）。采用帕金森病统一评定量表（UPDRS）流涎亚量表和帕金森病流涎临床量表（SCS-PD）评估疗效。
第一阶段，治疗前和治疗后 UPDRS 流涎评分分别为 3.5±0.53 和 1.9±0.57（P=0.004）。SCS-PD 评分从 15.8±2.78 降至治疗后的 9.9±3.00（P=0.005）。应答率（定义为 SCS-PD 评分至少降低 30%）为 60%。在交叉试验的第二阶段，安慰剂周的 UPDRS 流涎评分为 3.00±0.56，甲磺酸二氢麦角碱周的评分则为 2.00±0.65（P=0.001）。SCS-PD 分别为 12.50±2.84 和 9.25±2.86（P＜0.001）。应答率分别为 10%和 55%（P=0.003）。无明显不良反应。
甲磺酸二氢麦角碱治疗 PD 患者的流涎症安全有效。
