慢性偏头痛定义中的15天阈值是合理和充分的-不改变ICHD - 3定义的五个理由

Laura Fischer-Schulte, A. May
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摘要

可能是因为这些药物未被批准用于治疗偶发性偏头痛(如肉毒杆菌毒素和某些国家的降钙素基因相关肽抗体)。改变ICHD的标准似乎是解决这个问题的可行办法。然而,当考虑使用已经获得美国食品和药物管理局批准的治疗方法的后果时,人们必须非常小心。如果一项临床试验应用了当前的ICHD标准来诊断发作性和CM,那么对CM患者组的益处意味着每个月有15天或更多头痛日的患者有益处,而对那些较少头痛日的患者没有益处,无论我们称之为偏头痛的亚型是什么。19如果我们选择改变命名法,将头痛天数大于等于8天的偏头痛称为慢性偏头痛,这仍然不能改变对头痛天数≥15天的患者已确立临床疗效的科学证据。只有在新的证据表明对另一亚组患者有效时,才能扩大特定药物的适应症。例如,最近的一项开放标签研究表明,肉毒杆菌毒素a对HFEM患者可能有效,这本身需要在适当的随机对照试验中得到证实。在治疗患有严重疼痛的病人时,人们经常面临很多绝望,而那些绝望的人会抓住一根稻草。作为负责任的医生,我们的行动必须以证据为基础。因此,我们绝不能让病人接受对他们的病情没有显示出有效的治疗,不管他们的病情被称为什么。我们确实赞赏将某些药物的适应症扩大到更多患者的呼吁。然而,解决方案不是简单地将HFEM纳入CM,而是在HFEM患者中进行适当的研究,并使用已证明对CM有效的药物。
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The 15‐day threshold in the definition of chronic migraine is reasonable and sufficient—Five reasons for not changing the ICHD‐3 definition
might be withheld from them because these medications are not approved for episodic migraine (such as botulinumtoxin and the same for calcitonin gene- related peptide antibodies in some coun -tries). Changing ICHD criteria might seem like a viable solution for this problem. When looking at the consequences for the use of already Food and Drug Administration– approved treatments one, however, must be very careful. If a clinical trial has applied the current ICHD criteria for episodic and CM, a benefit for the group of CM patients means that there is a benefit for patients with 15 or more headache days per month and not for those with less, regardless of what we call the subtype of migraine. 19 Should we choose to change the nomenclature and call migraine with eight or more headache days chronic, that still does not alter the sci entific evidence that the clinical efficacy has been established in patients with ≥15 headache days. Indication for a specific medica tion can only be broadened if new evidence may suggest efficacy in another subgroup of patients. For example, a recent open- label study suggests probable efficacy of onabotulinumtoxinA in pa tients with HFEM, 20 which itself needs to be confirmed in a proper randomized controlled trial. When treating patients with severe pain conditions one is often faced with a lot of despair and those in despair will clutch at a straw. As responsible physicians, our ac tions must be evidence based. Consequently, we must not subject patients to treatments that have not been shown to be effective in their condition regardless of what the condition is called. We do appreciate the call to broaden the indication of certain medi cations to a higher number of patients. The solution is however not to simply include HFEM into CM, but to do proper studies in HFEM patients with medications that have proven efficacy in CM.
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