Lotus Clinical Research, Pasadena, CA, United States.
Pain. 2023 Feb 1;164(2):258-270. doi: 10.1097/j.pain.0000000000002736. Epub 2022 Aug 17.
To have a complete understanding of an experimental analgesic's efficacy in treating acute postoperative pain, it is necessary to understand its effect on both hard-tissue pain and soft-tissue pain. For this reason, regulatory bodies including the U.S. Food and Drug Administration and European EMA typically require drug developers to demonstrate efficacy in both hard-tissue and soft-tissue pain to grant a broad approval for an analgesic in acute postoperative pain. Hard-tissue models such as bunionectomy and molar extraction are well-validated and efficient with long histories in clinical trials, but until recently, a similarly well-standardized and fast-enrolling soft-tissue model was not available. Abdominoplasty was developed as an acute postoperative pain model and introduced to the clinical trial marketplace in 2014 to address the need for a viable soft-tissue model. Since then, at least 13 industry-sponsored studies, including multiple pivotal trials, have been conducted, providing a data set that can be used to interrogate the model's strengths and weaknesses. The authors outline the development history of abdominoplasty, discuss key clinical and design characteristics of the model, and review public data from abdominoplasty acute pain studies available to date. The data suggest that abdominoplasty is a well-validated soft-tissue surgical model that provides high-quality experimental outputs, enabling the efficacy of investigational analgesics in soft-tissue pain to be understood successfully.
要全面了解一种实验性镇痛药治疗急性术后疼痛的疗效，就必须了解其对硬组织疼痛和软组织疼痛的影响。出于这个原因，包括美国食品和药物管理局（FDA）和欧洲药品管理局（EMA）在内的监管机构通常要求药物开发商在硬组织和软组织疼痛方面都证明疗效，以批准一种镇痛药广泛用于急性术后疼痛。拇囊炎切除术和磨牙拔除等硬组织模型经过长期临床试验验证，效果良好且效率高，但直到最近，仍然缺乏一种同样标准化且快速入组的软组织模型。腹部整形术作为一种急性术后疼痛模型应运而生，并于 2014 年引入临床试验市场，以满足对可行的软组织模型的需求。自那时以来，至少进行了 13 项由行业赞助的研究，包括多项关键性试验，提供了可用于研究该模型优缺点的数据集。作者概述了腹部整形术的发展历史，讨论了该模型的关键临床和设计特征，并回顾了迄今为止可用于腹部整形急性疼痛研究的公开数据。这些数据表明，腹部整形术是一种经过充分验证的软组织手术模型，可提供高质量的实验结果，使人们能够成功了解研究性镇痛药在软组织疼痛方面的疗效。
