失明就是看到:在随机对照试验中对盲人药物注射器自动注射器可行性的单中心研究
Vishal Aggarwal1, Jorg Taubel2, Ulrike Lorch1
1Clinical Research, Richmond Pharmacology Ltd, London, GBR.
Cureus
|September 29, 2023
概括
自动注射器系统 (A-INJ) 有效地保持随机对照试验 (RCT) 中的调查者盲目,通过提供无修改的活性和安慰剂注射物. 这项研究表明,与传统注射器相比,A-INJs可以提高失明的完整性.
科学领域:
- 临床研究 临床研究
- 制药科学 制药科学
- 医疗器械技术 医疗器械技术
背景情况:
- 在随机对照试验 (RCT) 中,对研究人员进行失明对于获得公正的结果至关重要.
- 由于注射粘度和外观的差异,在皮下 (SC) 和肌肉内 (IM) 药物 (IMP) 管理期间保持失明存在挑战.
- 目前确保失明的方法,例如改变安慰剂配方或使用没有失明的人员,都有局限性.
研究的目的:
- 评估自动注射器系统 (A-INJ) 在RCT期间保护研究员失明的有效性.
- 为了比较A-INJs与传统注射器 (CS) 在提供安慰剂和活性IMP的性能.
- 评估A-INJ使用对研究人员区分注射体的能力的影响.
主要方法:
- 一项单中心实验研究比较了A-INJ (Owen Mumford,Autoject 2) 与CS,用于1毫升IMP和安慰剂.
- 在A-INJ和CS组之间,用于安慰剂和IMP的注射输送百分比进行了比较.
- 八名研究医生评估了A-INJ连续注射到人体组织模拟物后的安全性和有效性,评估了他们分辨溶液的能力.
主要成果:
- 对安慰剂 (95.38% vs. 96.00%) 和IMP (94.715% vs. 94.74%),A-INJ和CS的平均注射输送是可比的,没有统计学意义.
- 使用A-INJs的研究人员无法区分安慰剂和活性IMP解决方案,报告没有关于解盲的担忧.
- 平均施用时间为8.5秒;A-INJs的音频提示被认为是潜在的挑战.
结论:
- 自动注射器系统 (A-INJ) 通过使未经改的活性和安慰剂注射剂能够被注入,从而显著提高了RCT中的调查员失明.
- A-INJs为传统注射器提供了可行的替代方案,消除了对安慰剂修改的需求,并改善了盲目的完整性.
- 虽然存在像音频线索这样的轻微挑战,但A-INJs在临床试验中为注射化合物提供了有希望的进步.
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