Counseling and School Psychology, University of Massachusetts Boston, Boston, Massachusetts, USA.
Clinical Psychology and Psychotherapy, Babes-Bolyai University, Cluj-Napoca, Romania.
BMJ Evid Based Med. 2019 Dec;24(6):231-238. doi: 10.1136/bmjebm-2019-111204. Epub 2019 Jul 18.
In November 2017, the Food and Drug Administration (FDA) approved a version of a second-generation antipsychotic, aripiprazole, embedded with a sensor (Abilify MyCite).
To systematically review the evidence supporting the FDA's approval of digital aripiprazole and how that evidence was disseminated in the scientific literature and news reports.
Prospective, double-blind, randomised controlled trials (RCTs), non-randomised and non-comparative studies were included if they focused on the use of digital aripiprazole. All scientific publications citing the trials were included if written in English. For the news reports, all languages were included if an English translation was available, and all records that were published after FDA approval were included.
In the primary evidence search, no RCT comparing digital aripiprazole with a non-digital formulation, other active comparators or placebo was found. Only three non-comparative uncontrolled cohorts were found. No study provided data on remission, quality of life or any efficacy outcome. Fourteen scientific papers were identified that cited the trials and 70 news stories met the inclusion criteria. Almost 80% (11/14) of the scientific papers and three-fourths (52/70) of the news stories conveyed an unsupported impression of benefit.
Regulatory approval for this first-ever digital drug was based on weak evidence, and there was no evidence of better adherence with the digital version of aripiprazole compared with the non-digital version. The possibilities afforded by this technology make room for a new type of evergreening (ie, patenting of older drugs with a sensor as a 'new invention'). Both the scientific literature and news reports conveyed an unsupported impression of benefit.
CRD42018089515.
2017 年 11 月，美国食品和药物管理局（FDA）批准了第二代抗精神病药阿立哌唑的一种版本，其中嵌入了一个传感器（Abilify MyCite）。
系统审查支持 FDA 批准数字阿立哌唑的证据，以及该证据如何在科学文献和新闻报道中传播。
如果研究重点是数字阿立哌唑的使用，则包括前瞻性、双盲、随机对照试验（RCT）、非随机和非对照研究。如果以英文撰写，则包括所有引用这些试验的科学出版物。对于新闻报道，如果有英文翻译，则包括所有语言，如果是 FDA 批准后发布的所有记录，则包括所有记录。
在主要证据搜索中，未发现比较数字阿立哌唑与非数字制剂、其他活性对照物或安慰剂的 RCT。仅发现三个非对照非对照队列。没有研究提供关于缓解、生活质量或任何疗效结果的数据。确定了 14 篇引用这些试验的科学论文和 70 篇符合纳入标准的新闻报道。近 80%（11/14）的科学论文和四分之三（52/70）的新闻报道传达了一种没有支持的获益印象。
首个数字药物的监管批准基于薄弱的证据，并且没有证据表明与非数字版本相比，数字阿立哌唑版本的依从性更好。这项技术提供的可能性为一种新型的常青化（即，对带有传感器的较老药物进行专利保护作为“新发明”）创造了空间。科学文献和新闻报道都传达了一种没有支持的获益印象。
CRD42018089515。
