Mov Disord : 皮下注射左旋多巴新药,治疗帕金森,效果如何

2021-09-21 Freeman MedSci原创

ND0612的皮下注射左旋多巴/卡比多巴连续输液总体上是安全的

ND0612(NeuroDerm Ltd, Rehovot, Israel)是一种研究性的皮下(SC)给药系统,提供微创、连续输注液体左旋多巴/卡比多巴,用于治疗出现运动波动的帕金森病(PD)患者。

以前的研究表明,ND0612可提供稳定的血浆左旋多巴浓度,明显减少每日停药时间,并增加动作启动时间,而无明显运动障碍。

奥地利 Medical University Innsbruck 的Werner Poewe等人,探究了ND0612在12个月的治疗中的长期安全性和耐受性,特别是关注输液部位反应(ISRs),这些反应通常与SC给药有关。

他们纳入了214名入组患者,其中(24小时SC输注:n = 90;16小时SC输注:n = 124),120人(56%)完成了12个月的治疗。

研究中止的主要原因是同意撤销(19.6%)和不良事件(17.3%)。

经过方案修订和再培训,中止率从49%降至29%。

对于使用左旋多巴/卡比多巴治疗的PD患者来说,系统安全性是典型的。

大多数患者出现了输液部位的反应,特别是结节(30.8%)和血肿(25.2%),这些反应大多被判定为轻度至中度,只有10.3%的参与者导致停药。

这个研究的重要意义在于:ND0612的皮下注射左旋多巴/卡比多巴连续输液总体上是安全的,SC给药的典型输液部位反应是主要的不良事件。

 

原文出处:
Poewe W, Stocchi F, Arkadir D, et al. Subcutaneous Levodopa Infusion for Parkinson’s Disease: 1 ‐Year Data from the Open‐Label BeyoND Study. Mov Disord. Published online September 8, 2021:mds.28758. doi:10.1002/mds.28758

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    2021-12-08 cmsvly
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