Green Mark W, Rothrock John F
Icahn School of Medicine at Mt Sinai, New York, NY 10029, USA.
George Washington School of Medicine School, Washington, DC 20037, USA.
Toxicon. 2018 Jun 1;147:116-119. doi: 10.1016/j.toxicon.2018.03.011. Epub 2018 Mar 27.
In 2010 onabotulinumtoxinA (OnabotA) was approved by the United States Food and Drug Administration for the treatment of chronic migraine (CM). Data supporting approval were derived primarily from two parallel placebo-controlled trials, the PREEMPT studies. Many clinicians and research investigators critical of those data have recommended that the dosing/injection paradigm for treating CM be "customized" to the needs of the individual patient rather than administered in a uniform fashion conforming to the methodology utilized in the PREEMPT studies. In this paper the authors debate the issue of whether treatment of CM with OnabotA should be standardized versus customized.
2010年，美国食品药品监督管理局批准了A型肉毒杆菌毒素（OnabotA）用于治疗慢性偏头痛（CM）。支持该批准的数据主要来自两项平行的安慰剂对照试验，即PREEMPT研究。许多对这些数据持批评态度的临床医生和研究人员建议，治疗CM的给药/注射模式应根据个体患者的需求进行“定制”，而不是按照PREEMPT研究中使用的方法以统一方式给药。在本文中，作者们就使用OnabotA治疗CM应标准化还是定制化这一问题展开了辩论。
Zotero 插件