分期双侧聚焦超声苍白球丘脑束切断术治疗帕金森病:疗效与安全性警示
一项单臂试验结果显示,药物难治性运动并发症的晚期帕金森病患者在分期双侧聚焦超声苍白球丘脑束切断术后,第二侧治疗仅带来停药状态下运动评分较单侧平台期改善19%的有限获益。
要点
- 双侧第二侧治疗后停药期运动获益有限,仅较单侧改善19%。
- 1例患者出现重度持续性构音不能,需警惕双侧对称毁损风险。
核心结论
- 分期双侧手术的第二侧获益有限,且伴随较高的持续性中重度不良事件风险,支持对此疗法需持谨慎态度。
研究设计与样本
- 本研究为一项单臂试验;双侧治疗组共纳入40例患者。
主要发现
- 第二侧治疗后,停药状态运动评分在单侧治疗达平台期的基础上进一步改善19%。
- 1例持续性重度不良事件表现为完全性构音不能。
局限性
- 原文为通讯文章,未报告具体方法学与样本量计算等信息;双侧治疗获益有限但不良事件率较高。
以上解读依据论文摘要(全文未开放获取或许可不允许翻译转载)。
原文
On July 3, 2025, the US Food and Drug Administration approved staged, bilateral focused ultrasound pallidothalamic tractotomy for advanced Parkinson's disease with medication-refractory motor complications, on the basis of results from a then-unpublished single-arm trial.1 We cautioned then that a symmetrical lesioning procedure was being licensed ahead of its evidence.2 The results presented by Arif Dalvi and colleagues1 support that caution was warranted: modest gains in off-medication motor scores after treatment of the second side (a 19% improvement over the plateau reached after unilateral treatment) were accompanied by persistent moderate or severe adverse events at 12 months in ten (25%) of the 40 bilaterally treated patients, one of whom had severe persistent anarthria.
引用
- The Lancet Neurology:[Correspondence] Staged bilateral focused ultrasound pallidothalamic tractotomy for Parkinson's disease
供执业医师工作参考,不替代临床判断;数值与分级以指南原文为准。