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非劣效性试验在急性疼痛研究中的应用:合理方法还是歧途?

Noninferiority trials in acute pain research: a valid approach or a slippery slope?

机构信息

Department of Anesthesia, McMaster University, Hamilton, ON, Canada.

Department of Anesthesiology and Pain Management, The University of Texas Southwestern Medical Center, Dallas, TX, USA.

出版信息

Br J Anaesth. 2024 May;132(5):1027-1032. doi: 10.1016/j.bja.2024.01.019. Epub 2024 Feb 22.

DOI:10.1016/j.bja.2024.01.019
PMID:38642963
Abstract

The conduct and reporting of studies with a noninferiority hypothesis is challenging because of the complexity involved in their design and interpretation. However, studies with a noninferiority design have increased in popularity. A recently published trial reported on the noninferiority of lidocaine infusion to epidural analgesia in major abdominal surgeries. Apart from needing a critical appraisal, this draws attention to improve our understanding of noninferiority study framework and its unique features. Given the increasing focus on using various analgesic adjuncts and multiple approaches to fascial plane blocks to avoid more definitive and standard approaches, it is imperative that particular attention is paid to appropriate execution and reporting of noninferiority studies.

摘要

具有非劣效性假设的研究的实施和报告具有挑战性,因为其设计和解释涉及到复杂性。然而,具有非劣效性设计的研究越来越受欢迎。最近发表的一项试验报告了利多卡因输注在大型腹部手术中的非劣效性,与硬膜外镇痛相比。除了需要批判性评价外,这也引起了人们对提高我们对非劣效性研究框架及其独特特征的理解的关注。鉴于越来越关注使用各种镇痛辅助手段和多种筋膜平面阻滞方法来避免更明确和标准的方法,因此必须特别注意非劣效性研究的正确执行和报告。

相似文献

1
Noninferiority trials in acute pain research: a valid approach or a slippery slope?非劣效性试验在急性疼痛研究中的应用:合理方法还是歧途?
Br J Anaesth. 2024 May;132(5):1027-1032. doi: 10.1016/j.bja.2024.01.019. Epub 2024 Feb 22.
2
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Therapeutic efficacy of intravenous lidocaine infusion compared with thoracic epidural analgesia in major abdominal surgery. Comment on Br J Anaesth 2023; 131: 947-54.静脉输注利多卡因与胸段硬膜外镇痛用于腹部大手术的疗效比较。对《英国麻醉学杂志》2023年;131卷:947 - 54页的评论
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引用本文的文献

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Optimizing Analgesia After Minimally Invasive Cardiac Surgery: A Randomized Non-Inferiority Trial Comparing Interpectoral Plane Block Plus Serratus Anterior Plane Block to Erector Spinae Plane Block.微创心脏手术后镇痛的优化:一项比较胸肌间平面阻滞联合前锯肌平面阻滞与竖脊肌平面阻滞的随机非劣效性试验。
J Clin Med. 2025 May 28;14(11):3786. doi: 10.3390/jcm14113786.
2
Pain management after abdominal surgery: requiem for epidural analgesia?腹部手术后的疼痛管理:硬膜外镇痛的挽歌?
Br J Surg. 2024 Nov 27;111(12). doi: 10.1093/bjs/znae299.