移植芯片治疗抑郁症

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时间: 2004-6-17 周四, 上午1:58    标题: Cyberonics' Device Safe for Depression – Experts


GAITHERSBURG, Md. (Reuters) - A Cyberonics device for epilepsy is safe enough to treat chronically depressed patients, despite concerns over how much relief it could provide, a U.S. Food and Drug Administration (news - web sites) panel of outside experts said on Tuesday.

While data showed some impact for those most severely depressed, the panelists said muddled results made it difficult to determine if the pacemaker-like implant or other factors were at work. But the device --called VNS Therapy -- was safe despite "some annoying side effects," said panel chair Kyra Becker, a neurologist at the University of Washington in Seattle.

The device, which is surgically implanted to deliver electrical pulses to the brain, is already cleared for epilepsy. The FDA usually, but not always, follows the advice of its outside experts. The panel's 5-2 recommendation is vital to expanding Cyberonics' sales potential. Analysts say the chronic depression market could be as much as 10 times larger than the one for epilepsy.

"It is their growth opportunity for the future. This market may take a little time to develop but it will ultimately be a very attractive market for devices," said analyst Jan Wald of A.G. Edwards, adding it was "unclear that it's going to be smooth sailing with the FDA." Some panel members suggested the company conduct double-blind, randomized placebo studies to gain clearer data.

Psychiatrist John Rush of University of Texas Southwestern in Dallas, who conducted some depression studies for Cyberonics, said researchers were "now in a position where that could be done." But such studies would yield little additional information and were not necessary, he said, adding they would deny chronically depressed patients immediate help.

Other panelists agreed the acute need to help those patients outweighed the data problems. At the meeting, a number of patients told the panel through hoarse voices -- one of the most common side effects - how the device had given them hope to live.

In one group of 342 patients studied, 68 percent suffered voice problems while another 29 percent reported coughing. Other reactions included breathing difficulties and heart problems, studies showed.

FDA staff also told the panel the number of suicides or attempted suicides were "enough to make us concerned." In the same 324 patients, 3.5 percent tried to kill themselves.

Despite the risks, the patients said they were desperate for help. "I had nothing to lose," said patient Carmen McGuffy, explaining why she sought the surgical option that is already approved for depression in Europe and Canada.

The FDA outside experts agreed but recommended several conditions along with the approval, including proper education for surgeons, psychiatrists and other doctors as well as a patient registry to collect more data.

Panel members also said the device should only be used for patients who did not respond to at least four other types of therapy.

Cyberonics CEO Robert Cummins said the company was "not surprised at the conditions," calling them "fair." (additional reporting by Bill Berkrot in New York)


   路透社报道，一位美国FDA的专家周二说，尽管到底能起多大的效果仍是值得关注的问题，一种用于治疗癫痫的电子设备已经被开发成可用于安全地治疗慢性抑郁症。
   虽然一些数据显示该设备对于严重抑郁症有帮助，但小组专家们说他们很难从复杂的结果判断出到底是这种移植还是其他因素在起主导作用。“尽管有一些副作用，但这种被称为VNS的治疗是安全的。” 小组主席、华盛顿大学神经学家Kyra Becker说。
   这种设备是通过外科移植的方法把电脉冲传输给大脑，其对于癫痫的治疗效果已经很清楚。FDA通常会征求外部专家的意见。小组中5-2的推荐结果对于推广这种Cyberonics品牌设备的销售前景。分析家认为慢性抑郁症的市场是癫痫市场的10倍。
  “这种设备的前景很好，这个市场仍要花一段时间去开拓，但最终这一市场将非常有吸引力，”分析员Jan Wald of A.G. Edwards说“但并不知道这种设备是否能够获得FDA的认证。” 一些专家组成员建议公司采用镇静剂的双盲随机研究以获得更清晰的数据。
    在达拉斯德州大学的精神病学家John Rush，作过Cyberonics用于治疗抑郁症的研究，说：“现在研究人员认为这种设备是可以用于治疗。”但是这些研究很少额外的信息且毫无必要，他说，他们会拒绝慢性抑郁病患者的紧急求助。
   其他专家同意对于这些病人的急性求助的重要性显然比研究数据更重要。
   在会议中，一些病人通过沙哑的声音—这是副作用之一--告诉专家这种设备给了他们生存的希望。
    在一组342个病人的研究中，有68%的病人有嗓声方面的问题，还有29%会咳嗽。其他反应包括：呼吸困难、心脏问题的研究也有显示。
    FDA的职员也告诉专家自杀或自杀企图的数量也大得另人关注。 在324个病人中，3.5%企图自杀。
    尽管存在风险，病人仍说他们竭尽全力求助。“我没有什么会失去的。”病人Carmen McGuffy说，解释她为什么会寻求这种外科手术来治抑郁症。这种手术在欧洲和加拿大已经获得批准。
    FDA外部专家同意给予这种设备的正式牌照，但附加若干条件，包括对手术医生，精神病学家和其他医生的正确教育，对病人的情况做记录以获得更多的数据。
    专家成员也说这种设备只适合那些已经用过至少四种治疗方法仍不见效的患者。Cyberonics的CEO Robert Cummins 说公司对这些附加条件并不吃惊，认为很公平。

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