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外部联合枕神经和三叉神经刺激设备(eCOT-NS)治疗偏头痛的疗效与安全性：一项系统评价与荟萃分析
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Abstract:
背景：全球有超过10亿人患有偏头痛。外部联合枕神经和三叉神经神经刺激设备(eCOT-NS)正在开发作为偏头痛治疗手段。因此，我们进行了这项荟萃分析，以明确eCOT-NS设备的疗效和安全性。方法：两名研究者系统地检索了MEDLINE、ClinicalTrials.gov、EMBASE和Cochrane临床试验中央注册(CENTRAL)，寻找截至2024年10月25日已发表的相关文献。根据纳入标准筛选了符合条件的文章。采用风险比(RR)和95%置信区间(CI)评估结果。结果：共筛选出来自MEDLINE (n = 27)、EMBASE (n = 150)、Cochrane临床试验中央注册(CENTRAL) (n = 4)和ClinicalTrials.gov (n = 0)共181篇文章。eCOT-NS治疗组有16例(20.8%)患者报告发生不良事件(AEs)，而安慰剂组有12例(13.8%)患者报告发生不良事件。eCOT-NS治疗组与安慰剂组在1小时、2小时和24小时无痛患者比例上，与基线相比，均显示出显著差异(1小时：RR = 2.94，P = 0.015；2小时：RR = 3.10，P < 0.001；24小时：RR = 1.82，P = 0.001)；对于基线时有中度至重度偏头痛的患者，在1小时、2小时和24小时的无痛比例也有显著差异(1小时：RR = 3.45，P = 0.021；2小时：RR = 4.51，P < 0.001；24小时：RR = 1.72，P = 0.011)。结论：我们的荟萃分析表明，eCOT-NS设备对偏头痛患者具有良好的疗效和安全性。对于中度至重度偏头痛患者，治疗效果优于总体人群。
Background: Globally, more than 1 billion people are suffering from migraines. An external combined occipital and trigeminal neurostimulation (eCOT-NS) device is being developed as a treatment for migraine. Therefore, we conducted this meta-analysis to clarify the effectiveness and safety of the eCOT-NS device. Methods: Two investigators systematically searched the MEDLINE, Clinical Trials.gov, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) for relevant articles published up to October 25, 2024. Articles were included following the inclusion criteria. Risk ratios (RR) and 95% confidence intervals (CI) were used to evaluate the results. Results: A total of 181 articles from MEDLINE (n = 27), EMBASE (n = 150), the Cochrane Central Register of Controlled Trials (CENTRAL) (n = 4), and Clinical Trials.gov (n = 0) were identified. 16 (20.8%) patients at the eCOT-NS treatment group and 12 (13.8%) patients at the sham group were reported to have AEs. A significant difference was found separately in the 1 h, 2 h, and 24 h pain-free subjects versus baseline between the eCOT-NS treatment group and the sham group (RR = 2.94, P = 0.015; RR = 3.10, P < 0.001; RR = 1.82, P = 0.001) and 1 h, 2 h, and 24 h in those with moderate to severe migraine at baseline (RR = 3.45, P = 0.021; RR = 4.51, P < 0.001; RR = 1.72, P = 0.011). Conclusion: Our meta-analysis demonstrated that eCOT-NS device is of great effectiveness and safety for patients with migraine. And the treatment is better for patients with moderate to severe migraine than the overall population.
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