Maizels M, Geiger A M
Department of Family Practice, Southern California Permanente Medical Group, Woodland Hills, CA, USA.
Headache. 1999 Sep;39(8):543-51. doi: 10.1046/j.1526-4610.1999.3908543.x.
To study the efficacy of intranasal lidocaine for the treatment of migraine when administered by subjects in a nonclinic setting.
A 1-month, randomized, controlled, double-blind trial, followed by a 6-month open-label follow-up.
Ambulatory subjects treating themselves outside of a medical setting.
One hundred thirty-one adult subjects with migraine, diagnosed according to International Headache Society criteria, were enrolled in the study: 113 treated at least one headache in the controlled trial, and 74 treated at least one headache in the open-label phase. All subjects were members of the Kaiser Permanente Southern California Medical Care Program and were recruited at two urban medical centers.
Intranasal lidocaine 4% or saline placebo 0.5 mL was dropped into the nostril on the side of the headache, or bilaterally for bilateral headache, according to study protocol.
Trial: percent of headaches relieved to mild or none at 15 minutes and relapse of headache within 24 hours. Open-label: percent of headaches relieved to mild or none at 15 and 30 minutes and relapse within 24 hours.
In the controlled trial, headache was relieved within 15 minutes in 34 (35.8%) of 95 subjects treated with 4% intranasal lidocaine compared with 8 (7.4%) of 108 subjects receiving placebo (P < .001). Headaches relapsed in 7 (20.6%) of 34 subjects treated with 4% intranasal lidocaine compared to 0 of 8 placebo subjects (P = .312). In the open-label follow-up, headaches were relieved in 129 (41.2%) of 313 episodes within 15 minutes and in 141 (57.6%) of 245 episodes after 30 minutes. Headaches relapsed in 28 (19.9%) of 140. The response did not diminish over time: 32 (62.8%) of 51 first headaches were relieved at 30 minutes and 10 (71.4%) of 14 seventh headaches were relieved. Relapse occurred in 28 (20%) [corrected] of 129 headaches at a mean time (+/- SD) of 7.4 (+/- 6.6) hours.
Intranasal lidocaine 4% provides rapid relief of migraine symptoms. For those subjects who do respond, the effect does not diminish over 6-month follow-up.
研究在非临床环境中，受试者自行使用鼻内利多卡因治疗偏头痛的疗效。
为期1个月的随机对照双盲试验，随后进行6个月的开放标签随访。
在医疗机构外自行治疗的门诊受试者。
根据国际头痛协会标准诊断为偏头痛的131名成年受试者纳入研究：113名在对照试验中至少治疗过一次头痛，74名在开放标签阶段至少治疗过一次头痛。所有受试者均为南加州凯撒医疗保健计划的成员，在两个城市医疗中心招募。
根据研究方案，将4%的鼻内利多卡因或0.5 mL生理盐水安慰剂滴入头痛侧鼻孔，双侧头痛则双侧滴入。
试验阶段：15分钟时头痛缓解至轻度或完全缓解的百分比以及24小时内头痛复发情况。开放标签阶段：15分钟和30分钟时头痛缓解至轻度或完全缓解的百分比以及24小时内复发情况。
在对照试验中，95名接受4%鼻内利多卡因治疗的受试者中有34名（35.8%）在15分钟内头痛缓解，而108名接受安慰剂治疗的受试者中有8名（7.4%）头痛缓解（P <.001）。34名接受4%鼻内利多卡因治疗的受试者中有7名（20.6%）头痛复发，而8名接受安慰剂治疗的受试者中无头痛复发（P = 0.312）。在开放标签随访中，313次发作中有129次（41.2%）在15分钟内头痛缓解，245次发作中有141次（57.6%）在30分钟后头痛缓解。140次发作中有28次（19.9%）头痛复发。反应并未随时间减弱：51次首次头痛中有32次（62.8%）在30分钟时缓解，14次第七次头痛中有10次（71.4%）在30分钟时缓解。129次头痛中有28次（20%）[校正后]复发，平均时间（±标准差）为7.4（±6.6）小时。
4%的鼻内利多卡因可迅速缓解偏头痛症状。对于有反应的受试者，在6个月的随访中效果并未减弱。
