基于倾向性评分的不同疗程使用参麦注射液肝肾功能变化分析

Propensity score analysis of liver and kidney function changes when Shenmai is parenterally administered over extended period

参麦注射液因直接进入血液循环而不经胃肠道吸收,肝肾毒性尤当重点关注。"量-毒"关系与"时-毒"关系是探讨肝肾毒性的2个重点问题,笔者已对超剂量使用参麦注射液是否引起肝肾毒性(即"量-毒"问题)进行探讨,该文基于医院信息系统(hospital information system,HIS)提供的使用参麦注射液患者的数据信息,探讨不同疗程(临床连续使用超过14 d)对丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、肌苷(Cr)和尿素氮(Bun)等4个反应肝肾功能指标的影响,采用列联分析、Logistic回归及倾向性评分法(propensity score,PS)、倾向性评分的加权分析法(propensity score weighting,PSW)等分析方法,发现尚不能说明不同疗程对肝肾功能有明显影响。然而肝肾毒性监测是一个长期与重要的问题,尚需毒理学实验及临床前瞻性观察进一步探索。

Since parenterally administered Shenmai directly enters the bloodstream, avoiding gastrointestinal absorption, there are concerns as to its toxicity on the liver and kidneys. Previously, the risk of toxicity to the liver and kidneys through overdose has been discussed. This paper investigates changes in liver and kidney functions as indicated by ALT, AST, Cr and Bun, obtained from hospital information system （HIS） data, when it is administered over a longer than the recommended period of 14 days. Methods ap- plied include ： column joint analysis, logistic regression, propensity score and propensity score weighting. Results indicate that a longer course of administration does not have a significant effect on the function of liver and kidneys. However, continued monitoring of the toxicity to the liver and kidneys is a long-term and important issue; further exploration through toxicology experiments and prospective clinical research is required.