一项前性随机化剂量检测研究,用于在经过微创性结肠直肠手术后治疗术后止痛的内类药物
Patrice A Vinsard1,2, Josef Pleticha1, Emily E Sharpe1
1Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.
Mayo Clinic proceedings. Innovations, quality & outcomes
|March 21, 2025
概括
这项研究的目的是寻找结直肠外科手术后缓解疼痛的最佳剂量. 在90%的患者中 (ED90) 无法确定有效剂量,但为两种药物建立了ED50.
科学领域:
- 麻醉学 麻醉学
- 药理学 药理学是指药理学的学科.
- 结肠直肠手术 结肠直肠手术
背景情况:
- 手术后的疼痛管理对于在微创性结直肠手术后的患者康复至关重要.
- 静脉内止痛提供了有针对性的疼痛缓解,但对于特定药物如吗啡和摩的最佳剂量需要精确的确定.
- 结直肠外科手术中最少的侵入性技术需要有效和安全的术后疼痛控制策略.
研究的目的:
- 为了确定在接受微创性结直肠外科手术的患者手术后止痛的最佳剂量.
- 确定在90%的患者 (ED90) 中有效的剂量,以实现特定的疼痛和阿片类药物需求目标.
- 为了在这个患者群体中比较内吗啡与水利吗啡的疗效和安全性.
主要方法:
- 一个双盲临床剂量试验随机分配了80名患者,接受了内吗啡或摩.
- 剂量采用了顺序上下方法,带有偏见的硬币设计,以根据患者的结果调整后续剂量.
- 测量的主要结果是ED90,定义为疼痛分数≤4和术后阿片类药物使用≤15口服吗啡12小时等价值.
主要成果:
- 在研究的剂量范围内,无论是内吗啡还是摩的ED90都无法确定.
- 确定ED50为100mcg的吗啡和75mcg的水合吗啡.
- 虽然这两种药物都提供了类似的缓解疼痛,但增加摩的剂量与中度至严重的发病率更高相关 (P=.009).
结论:
- 在微创性结直肠外科手术患者的甲状腺内注射吗啡和摩的ED90无法确定.
- 成功确定了内吗啡和水利吗啡的ED50,提供了有价值的剂量信息.
- 没有报告任何严重的不良事件,这表明在这种情况下,测试的内药物具有一般安全的特征.
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