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中国临床药理学与治疗学 ›› 2025, Vol. 30 ›› Issue (5): 608-621.doi: 10.12092/j.issn.1009-2501.2025.05.004

• 临床药理学 • 上一篇    下一篇

基于非房室模型的药代动力学参数计算SAS宏工具

张莉,娄冬华   

  1. 南京医科大学公共卫生学院,南京  211166,江苏
  • 收稿日期:2024-08-05 修回日期:2024-09-15 出版日期:2025-05-26 发布日期:2025-05-13
  • 通讯作者: 娄冬华,男,硕士,副教授,硕士生导师,研究方向:医学统计理论、方法与应用。 E-mail: loudonghua@vip.sina.com
  • 作者简介:张莉,女,硕士研究生在读,研究方向:临床试验数据分析研究。 E-mail: 1079186018@qq.com
  • 基金资助:
    国家自然科学基金(82473734)

SAS macro tool for pharmacokinetic parameter estimation based on non-compartmental models

ZHANG Li, LOU Donghua   

  1. School of Public Health, Nanjing Medical University, Nanjing 211166, Jiangsu, China
  • Received:2024-08-05 Revised:2024-09-15 Online:2025-05-26 Published:2025-05-13

摘要:

目的:通过开发SAS宏工具,以适用于不同给药方式和给药频率的非房室模型分析(NCA)药代动力学(PK)参数计算。方法:结合非房室模型分析PK参数计算原理,设计SAS宏程序结构并编制SAS宏程序,结合模拟实例演示宏程序的用法。结果:本研究基于非房室模型分析,通过SAS宏语言编程,实现单次和稳态完整PK参数的计算,并且支持血管外、静脉输注和静脉注射3种给药方式以及4种曲线下面积(AUC)算法。该方法通过与权威计算软件比较,在各种计算场景下的结果均高度一致,且首次可测量浓度之前的观测时间(Tlag)的计算结果更为准确。结论:%M_CREATE_PK_PARAMETERS宏是支持NCA PK完整参数计算的SAS宏,为PK参数的计算提供了一种准确、高效、灵活的解决方案,具备广泛的应用前景。

关键词: 非房室模型分析(NCA), SAS宏, PK参数

Abstract:

AIM: To develop a SAS macro tool for calculating pharmacokinetic (PK) parameters using non-compartmental analysis (NCA) that is applicable to various routes and frequencies of drug administration. METHODS: By incorporating the principles of NCA PK parameter calculations, the structure of the SAS macro program is designed and programmed. The usage of the macro program is demonstrated through simulated examples. RESULTS: Based on NCA, this study programmed a SAS macro using SAS macro language to calculate both single-dose and steady-state complete PK parameters. It supports three modes of drug administration: extravascular, intravenous infusion, and intravenous bolus injection, as well as four algorithms for calculating area under the curve (AUC). By comparing with authoritative calculation software, the results were found to be highly consistent across various calculation scenarios, with more accurate calculations for the time of first measurable concentration (Tlag). CONCLUSION: The %M_CREATE_PK_PARAMETERS macro is a SAS macro that supports comprehensive PK parameter calculations in NCA, providing an accurate, efficient, and flexible solution for PK parameter estimation with broad application prospects.

Key words: non-compartmental analysis (NCA), SAS macros, PK parameters

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