A型肉毒毒素注射治疗面肌痉挛的剂量优化与长期疗效研究

Dose Optimization and Long-Term Efficacy of Botulinum Toxin Type A in Hemifacial Spasm

摘要: 目的：探讨不同剂量A型肉毒毒素(BoNT-A)对HFS患者的疗效、安全性及长期复发模式的影响。方法：前瞻性队列研究纳入201例原发性HFS患者，随机分为安慰剂对照组(注射生理盐水)、低剂量组(1.25 U/点，总剂量30 U)、标准剂量组(2.5 U/点，总剂量50 U)和高剂量组(5.0 U/点，总剂量80 U)，随访12个月，评估痉挛缓解率、疗效持续时间及不良反应。结果：标准剂量组总有效率最高(安慰剂对照组0% vs. 95.2% vs.低剂量组82.1% vs.高剂量组93.3%)，但高剂量组疗效持续时间显著延长(6.8 ± 1.2月vs.标准组4.5 ± 0.9月，P < 0.01)。长期随访显示，3次注射后复发间隔时间延长(Δ + 1.8月/次，P = 0.003)。结论：BoNT-A剂量与疗效持续时间呈正相关，但需权衡高剂量引发的面部僵硬风险。个性化剂量策略可优化长期管理。

Abstract: Objective: To explore the effects of different doses of Botulinum Toxin Type A (BoNT-A) on the therapeutic efficacy, safety, and long-term recurrence patterns in patients with Hemifacial Spasm (HFS). Methods: A prospective cohort study enrolled 201 patients with primary hemifacial spasm (HFS). Participants were randomly assigned to four groups: Placebo control group (normal saline injections), Low-dose group (1.25 U/site, total dose: 30 U), Standard-dose group (2.5 U/site, total dose: 50 U), High-dose group (5.0 U/site, total dose: 80 U). All patients were followed for 12 months to evaluate spasm relief rates, duration of efficacy, and adverse effects. Results: The standard-dose group demonstrated the highest overall response rate (95.2% vs. placebo control group: 0%, low-dose group: 82.1%, and high-dose group: 93.3%). However, the high-dose group exhibited a significantly prolonged duration of efficacy (6.8 ± 1.2 months vs. standard-dose group: 4.5 ± 0.9 months, P < 0.01). Long-term follow-up revealed extended recurrence intervals after three injections (Δ +1.8 months per injection, P = 0.003). Conclusion: The dose of BoNT-A is positively correlated with the duration of therapeutic effect. However, the risk of facial stiffness caused by high doses needs to be balanced. A personalized dosing strategy can optimize long-term management.