注射用daxibotulinumtoxinA用于颈部肌张力障碍管理的实践考虑。
完整摘要 · 中文译文
背景：注射用DaxibotulinumtoxinA（DAXI）已获批用于治疗成人颈部肌张力障碍（CD），是首个采用新型定制工程化肽段配制的肉毒神经毒素（BoNT）。 目的：基于早期使用者的真实世界经验，为将DAXI纳入临床实践提供实用考量。 方法：相关观点和实用考量由一组在使用BoNT治疗CD方面具有丰富经验的医生提供，这些医生参与了DAXI早期体验项目。考量内容根据医生个人问卷回答起草，并通过个人及小组讨论最终确定。所有作者审阅并批准了最终的实用考量。 结果：在当前BoNT再治疗前出现症状重新显现或寻求更持久症状缓解的患者是DAXI的主要候选人群。对于从其他BoNT转换的患者，DAXI初始剂量可按其既往onabotulinumtoxinA等效剂量按比例确定，同时应认识到不同BoNT的单位不可互换，并在2-3个周期内滴定至适当的维持剂量。吞咽困难和肌无力不良事件发生率较低，为安全实施和剂量滴定提供了基础。 结论：早期真实世界经验提示，DAXI可较容易地在实践中实施。最佳个体化剂量可在2-3次治疗中确定，再治疗时间可根据症状重新显现来安排。与3期临床试验一致， DAXI 作用持续时间长、安全范围宽，可提供持久的症状缓解，对于在标准12周再治疗间隔内出现早期症状复现的患者，可能具有更大的灵活性。
完整摘要 · 英文原文
BACKGROUND: DaxibotulinumtoxinA (DAXI) for injection is approved for treatment of adults with cervical dystonia (CD) and is the first botulinum neurotoxin (BoNT) to be formulated with a novel, custom-engineered peptide. OBJECTIVES: To provide practical considerations for incorporating DAXI into clinical practice based on real-world experience from early adopters. METHODS: The perspectives and practical considerations were informed by a panel of physicians with extensive experience treating CD with BoNT who participated in a DAXI early-experience program. Considerations were drafted based on individual physician questionnaire responses and finalized through individual and group discussions. All authors reviewed and approved the final practical considerations. RESULTS: Patients experiencing symptom re-emergence before retreatment with their current BoNT or seeking longer-lasting symptom relief are the primary candidates for DAXI. For patients switching from other BoNTs, the initial DAXI dose can be proportional to their prior onabotulinumtoxinA-equivalent dose, recognizing that units of different BoNTs are not interchangeable, with titration to an appropriate maintenance dose over 2-3 cycles. The low rate of dysphagia and muscle weakness adverse events provides a foundation for safe implementation and dose titration. CONCLUSIONS: Early real-world experience suggests that DAXI can be readily implemented in practice. Optimal individual dosing is established in 2-3 treatments, and retreatments can be timed to address symptom re-emergence. Consistent with phase 3 clinical trials, DAXI demonstrates a long duration of action and wide safety margin, offering long-lasting symptom relief and potentially greater flexibility in patients who experience early symptom re-emergence within a standard 12-week retreatment interval.