FDA批准首个偏头痛预防装置

美国食品药品管理局(FDA)已批准经皮电神经刺激装置Cefaly上市，该装置的设计目的是预防偏头痛的发生。

FDA器械与放射卫生中心器械评估办公室主任Christy Foreman在声明中指出，Cefaly是在美国上市的首个此类装置，它在预防偏头痛方面为患者们提供了药物以外的选择。“这也许能帮助那些无法耐受当前用于预防或治疗偏头痛的药物的患者。”



这种装置类似于一种具有未来主义风格的前额配饰，由电池供电，将作为处方器械用于年龄≥18岁的患者。该装置可产生电流，刺激三叉神经的分支，而后者与偏头痛有关。FDA指出，该装置的唯一用法是每日1次，每次20分钟。

该装置获得批准是基于一项纳入67例患者的随机对照试验和对2,300名使用者的满意度研究。略多于半数使用者声称满意。在这两项研究中均未出现严重不良事件。

这项纳入67例患者的研究显示，发生偏头痛的平均天数、每月偏头痛发作次数以及每月紧急服用抗偏头痛药物的次数，在接受该装置治疗的患者中均显著减少，而在使用安慰剂装置的患者中并未减少。

与此同时，在那项纳入2,300例患者的满意度研究中，最常见的患者不满是不喜欢该装置引起的感觉。使用者还报告称在治疗期间难以入睡，治疗后发生头痛。

在公司网站上，Cefaly套装标价约350美元。

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By: NASEEM S. MILLER, Internal Medicine News Digital Network

The Food and Drug Administration has authorized the marketing of Cefaly, a transcutaneous electrical nerve stimulation device that is designed for use before the onset of migraine headaches.

Cefaly would be first device of its kind in the United States, and it "provides an alternative to medication for migraine prevention," Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in a statement. "This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks."

The device, which resembles a futuristic tiara for the forehead, is battery powered and will be available via prescription for patients aged 18 years or older. It generates an electric current that stimulates branches of the trigeminal nerve, which has been associated with migraine headaches, and it should only be used once per day for 20 minutes, according to the FDA.

The device was approved based on a randomized, controlled trial of 67 patients, and a satisfaction study of 2,300 users, a little more than half of whom said they were satisfied. There were no serious adverse events in either study.

The 67-patient study showed that the mean number of migraine days, monthly migraine attacks, monthly headache days, and monthly acute antimigraine drug intake were significantly reduced among the patients who received the device, but not among those who were using the placebo device.

Meanwhile, in the 2,300-patient satisfaction study, the most common patient complaint was dislike of the feeling that the device generated. Users also reported sleepiness during the treatment session, and headache afterward.

The Cefaly kit sells for about $350 on the company’s website.