Holt D W
Analytical Unit, St George's Hospital Medical School, London, UK.
Therapie. 2002 Mar-Apr;57(2):128-32.
The immunosuppressive drug sirolimus, recently licensed in Europe for use following kidney transplantation, was developed against a background in which it was common practice to use blood concentration measurements as a guide to therapy. This article sets out to document the use of blood concentration measurements in the assessment of the early and pivotal clinical trials of the drug and the attention that has been paid to the validation of analytical techniques used to measure the drug. It is concluded that, building on experience from the older drugs used for immunosuppression, data relating drug concentrations with efficacy outcomes have played a significant role in formulating guidelines on sirolimus dosing.
免疫抑制药物西罗莫司最近在欧洲获批用于肾移植后，它是在将血药浓度测量作为治疗指导的普遍做法的背景下研发出来的。本文旨在记录血药浓度测量在该药物早期关键临床试验评估中的应用，以及对用于测量该药物的分析技术验证所给予的关注。得出的结论是，基于用于免疫抑制的老药的经验，将药物浓度与疗效结果相关的数据在制定西罗莫司给药指南方面发挥了重要作用。
