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在患有慢性疼痛的儿科患者中,对 gabapentin 和 tramadol 的剂量推理
Paul Healy1, Luka Verrest1, Mariagrazia Felisi2
1Clinical Pharmacology & Therapeutics Group, School of Pharmacy, University College London, London, UK.
Pharmacology research & perspectives
|October 7, 2023
概括
临床试验模拟优化了对儿科慢性疼痛的 gabapentin 和 tramadol 剂量. 确定了剂量策略,以确保儿童的安全和有效的全身暴露.
科学领域:
- 药理学 药理学是指药理学的学科.
- 儿科医学 儿科医学
- 临床试验设计 临床试验设计
背景情况:
- 加巴丁和特拉马多尔用于治疗儿科慢性疼痛的非标签药物,但它们的疗效和安全性在这个人群中尚不清楚.
- 对儿童进行慢性疼痛的随机临床试验具有挑战性.
研究的目的:
- 为未来的临床试验优化剂量和协议设计,研究儿科慢性疼痛患者的 gabapentin 和 tramadol.
- 描述儿科患者中 gabapentin 和特拉马多尔的药理动力学 (PK).
主要方法:
- 使用了药理动力学 (PK) 建模和临床试验模拟 (CTS).
- 系统性暴露 (AUC,Css) 引导剂量选择,假设成人和儿童之间的暴露-反应关系相似.
- 针对 gabapentin 的剂量,建立了两个重量级别.
主要成果:
- 确定了从5到63毫克/公斤的 gabapentin 剂量,目标暴露量相当于成人剂量.
- 2-5毫克/公斤的特拉马多尔剂量达到治疗度,但显示出高的个体间变异性.
- 模拟场景强调了剂量定位的必要性,以优化治疗范围,并考虑安全性.
结论:
- CTS是优化儿科药物研究设计的宝贵工具.
- 对 gabapentin (t.i.d.) 的推剂量策略 和特拉马多尔 (t.i.d.) 的使用. 建议用于儿科慢性疼痛患者.
- 需要进一步的研究来确认在这个人群中有效性和安全性.
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