鼓励非标签使用奎蒂亚平的研究:系统的元流行病学分析
Peter Grabitz1, Lana Saksone1, Susanne Gabriele Schorr1
1QUEST Center for Responsible Research, Berlin Institute of Health, Charité- Universitätsmedizin Berlin, Berlin, Germany.
Clinical trials (London, England)
|January 29, 2024
概括
小规模的研究表明抗精神病药物奎平 (Seroquel) 在非标签用途的有效性,但大型确认性试验往往滞后,导致潜在的无效处方.
科学领域:
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
- 基于证据的医学基于证据的医学.
背景情况:
- 小规模的研究经常测试未经批准 (非标签) 用途的药物疗效.
- 缺乏更大的,随机的,双盲试验,阻碍了药物价值的确认.
- 这可能导致非标签处方的治疗方法缺乏经过证明的临床益处.
研究的目的:
- 分析临床研究如何影响非标签处方的奎蒂阿平 (Seroquel).
- 评估早期疗效研究的后续情况,并进行强有力的确认性试验.
主要方法:
- 对EMBASE,MEDLINE,Cochrane CENTRAL和PsycINFO数据库进行系统的元流行病学分析.
- 包括对未经批准的适用性测试奎平的研究 (1995年5月至2022年5月).
- 评估了低水平证据出版和大型随机双盲试验之间的时间滞后.
主要成果:
- 176项研究在26个适应症中确定了提氨酸在26个适应症中的潜在疗效.
- 探索性研究在2000-2007年间迅速超过了确认性试验.
- 79%的适应症在初始阳性研究后5年内缺乏大型确认性试验.
- 临床指导方针建议在缺乏证据的情况下使用非标签用途.
结论:
- 许多小型研究表明,奎平对非标签用途的承诺.
- 这些发现往往没有得到大型随机试验的证实.
- 研究类型的不平衡可能会促进无效的非标签治疗.
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