肉毒素穴位注射多维调控治疗偏头痛的随机对照试验:疗效验证与安全性评价

摘要:

目的:探讨肉毒素穴位注射多维调控与单纯枕神经阻滞治疗偏头痛的疗效和安全性。方法:前瞻性纳入2025年1月至2025年8月确诊的偏头痛患者52例，按1:1随机分为治疗组（肉毒素穴位注射+枕神经阻滞）和对照组（单纯枕神经阻滞）。治疗组接受肉毒素穴位注射（每穴2.5IU A型肉毒素）联合超声引导下枕神经阻滞；对照组接受超声引导下枕神经阻滞（0.5%利多卡因5ml+复方倍他米松1ml）。比较两组治疗前及治疗后1周、1月、2月、3月的NRS疼痛评分、头痛发作频率、ID-Migraine症状（恶心、畏光畏声）发生率、MIDAS评分、药物使用率及并发症。结果:两组患者基线资料无显著差异（P>0.05）。临床结局显示:治疗后1周两组NRS疼痛评分（2.5±1.7 vs 2.7±1.3）、头痛发作频率（2.0±1.2 vs 2.5±1.3天/周）及镇痛药物药物使用率无显著差异（P>0.05）；治疗后1-3月，治疗组NRS疼痛评分（1月:2.8±1.6 vs 3.7±1.5；2月:3.2±1.2 vs 5.6±1.9；3月:4.4±1.7 vs 6.4±1.3）、头痛发作频率（1月:2.1±1.6 vs 5.2±1.8；2月:2.4±1.5 vs 5.8±2.0；3月:3.4±1.9 vs 5.8±2.0天/周）、ID-Migraine症状发生率、MIDAS评分及镇痛药物药物使用率均显著低于对照组（P<0.05）。对照组治疗后2-3月头痛发作频率、恶心发生率及药物使用率与治疗前无差异（P>0.05）。安全性方面，治疗组出现2例暂时性眼睑下垂（3月内恢复）和2例穿刺点疼痛（2周内恢复），对照组1例穿刺点疼痛（2周内恢复），均无严重并发症。结论:肉毒素穴位注射多维调控治疗偏头痛的疗效优于单纯枕神经阻滞，较传统肉毒素注射使用更少的注射点数与剂量，为偏头痛治疗提供兼具长效性与安全性的优化方案。

Abstract:

Objective: To investigate the efficacy and safety of multi-dimensional regulation via botulinum toxin acupoint injection combined with occipital nerve block versus occipital nerve block alone for migraine. Methods: A total of 52 migraine patients diagnosed from January 2025 to August 2025 were prospectively enrolled and randomized (1:1) into the treatment group (botulinum toxin acupoint injection + occipital nerve block) and control group (occipital nerve block alone). The treatment group received botulinum toxin injection (2.5 IU per acupoint) at Jin" acupuncture points combined with ultrasound-guided occipital nerve block; the control group received ultrasound-guided occipital nerve block (0.5% lidocaine 5ml + compound betamethasone 1 ml). Outcomes including NRS pain score, headache frequency, ID-Migraine symptom rate, MIDAS score, the use of analgesics, and complications were compared at baseline and 1 week, 1 month, 2 months, and 3 months post-treatment. Results: Baseline data were comparable between groups (P>0.05). At 1 week post-treatment, no significant differences were observed in NRS score (2.5±1.7 vs 2.7±1.3), headache frequency (2.0±1.2 vs 2.5±1.3 days/week), or medication usage rate (P>0.05). From 1 to 3 months post-treatment, the treatment group showed significantly lower NRS scores (1 month: 2.8±1.6 vs 3.7±1.5; 2 months: 3.2±1.2 vs 5.6±1.9; 3 months: 4.4±1.7 vs 6.4±1.3), headache frequency (1 month: 2.1±1.6 vs 5.2±1.8; 2 months: 2.4±1.5 vs 5.8±2.0; 3 months: 3.4±1.9 vs 5.8±2.0 days/week), ID-Migraine symptom rate, MIDAS score , and medication usage rate compared to the control group (P<0.05). In the control group, headache frequency, nausea rate, and the use of analgesics at 2–3 months post-treatment did not differ from baseline (P>0.05). Safety: The treatment group had 2 cases of transient ptosis (recovered within 3 months) and 2 cases of puncture pain (recovered within 2 weeks); the control group had 1 case of puncture pain (recovered within 2 weeks). No severe complications occurred. Conclusion: Botulinum toxin acupoint injection with multi-dimensional regulation shows superior efficacy to occipital nerve block alone, with fewer injection points and lower dosage, providing a safe and long-lasting optimized strategy for migraine.