| 摘要: | 背景：非侵入性迷走神經刺激術近年來被認為是治療原發性頭痛的新神經調節療法。本研究旨在分析刺激迷走神經頸分支治療原發性頭痛的有效性和安全性。
方法：針對非侵入性迷走神經刺激術治療原發性頭痛的隨機對照試驗進行文獻回顧與統合分析。我們搜索了2019年1月29日以前登記在Medline、Embase和CENTRAL資料庫的文獻。所有結果均以隨機效應模型運算。主要指標為頭痛天數或發作次數減少、30分鐘內達到無痛狀態。次要指標為30分鐘內疼痛緩解、60分鐘內疼痛緩解、止痛藥物的使用、大於50%有效率、大於50%以上的頭痛緩解、不良事件和滿意度。
結果：收錄六個試驗共九百八十三名患者。非侵入性迷走神經刺激術和對照組比較在30分鐘內達到無痛狀態（odds ratio（OR）勝算比, 2.27; 95% confidence interval（CI）信賴區間, 1.16~4.44; p=0.02）、30分鐘內疼痛緩解（OR, 1.8; 95% CI, 1.17~2.78; p=0.007）、60分鐘內疼痛緩解（OR, 1.93; 95% CI, 1.2~3.1; p=0.006）、止痛藥物的使用（OR, 0.61; 95% CI, 0.41~0.92; p=0.02）、大於50%以上的頭痛緩解（OR, 2.15; 95% CI, 1.27~3.66; p=0.005）均達顯著意義。非侵入性迷走神經刺激術和對照組比較在頭痛天數或發作次數減少（standardized mean difference（SMD）標準均值差, -0.159; 95% CI, -0.357~0.04; p=0.117）、不良事件（OR, 1.084; 95% CI, 0.559~2.104; p=0.811）和滿意度（OR, 1.45; 95% CI, 0.97~2.17; p=0.07）均未達顯著意義。至於大於50%有效率（OR, 3.34; 95% CI, 0.83~13.33; p=0.09; I2=73%）則還無法下定論。
結論：刺激迷走神經頸分支可有效緩解急性原發性頭痛。
"Background: Non-invasive vagus nerve stimulation (nVNS) has been proposed as a new neuromodulation therapy to treat primary headache disorders. The purpose of this study was to analyze the effectiveness and safety of peripheral nerve stimulation of the cervical branch of the vagal nerve for primary headache disorders.
Methods: A systematic review and meta-analysis of the literature was carried out on randomized controlled trials of nVNS for treating headaches. We searched the Medline, Embase, and CENTRAL databases until January 29, 2019.A random-effects model was used to report all outcomes. The primary outcomes were a reduction in headache days or attacks and pain-free status within 30 min. Secondary outcomes were: the pain-relief status within 30 min, pain-relief status at 60 min, abortive medication use, ≥50% responder rate, pain-free status in ≥50% of treated attacks, adverse events, and satisfaction.
Results: In total, 983 patients were included from six trials. We found that nVNS was effective in achieving a pain-free status within 30 min (odds ratio (OR), 2.27; 95% confidence interval (CI), 1.16~4.44; p=0.02), pain-relief status within 30 min (OR, 1.8; 95% CI, 1.17~2.78; p=0.007), pain-relief status at 60 min (OR, 1.93; 95% CI, 1.2~3.1; p=0.006), a reduction in abortive medication use (OR, 0.61; 95% CI, 0.41~0.92; p=0.02), and pain-free status in ≥50% of treated attacks (OR, 2.15; 95% CI, 1.27~3.66; p=0.005) compared to sham-device treatment. There were no significant differences in decreased headache days (standardized mean difference (SMD), -0.159; 95% CI, -0.357~0.04; p=0.117), adverse events (OR, 1.084; 95% CI, 0.559~2.104; p=0.811), or satisfaction (OR, 1.45; 95% CI, 0.97~2.17; p=0.07) between nVNS and sham-device treatment. The ≥50% responder rate could not be determined (OR, 3.34; 95% CI, 0.83~13.33; p=0.09; I2=73%).
Conclusions: Cervical nVNS is effective for acute pain relief for migraine and cluster headache." |
