真实世界中注射用丹参多酚酸盐不同使用剂量对肝功能的影响

Real world study of affect on liver function of overdose of salvianolate extract injection

目的:了解临床使用不同剂量注射用丹参多酚酸盐对肝功能是否有影响。方法:以全国18家三级甲等医院的HIS为数据来源14 191例患者作为研究对象,患者2次理化指标测定期间内的最大单次给药剂量大于200 mg的为超出说明书推荐剂量组,其余为未超出说明书推荐剂量组。采用倾向性评分法对2组间影响因素进行平衡后,采用Logstic回归方法对2组患者的肝功能进行评价。结果:超出说明书推荐剂量使用注射用丹参多酚酸盐患者的AST,ALT发生异常的可能性大于未超出说明书推荐剂量的患者,但统计学无显著性差异。结论:根据目前数据未发现超出说明书推荐剂量使用注射用丹参多酚酸盐对肝功能产生影响,提示临床要按照说明书推荐剂量使用,注意监测肝功能。

Objective： To understand the affect on liver function of using salvianolate injection above the recommended dose. Method： Nationwide, research of hospital information system （HIS） data from 18 general hospitals comprising 14 191 patients was car- tied out. Two groups of patients were studied and their blood tests monitored before and after injections. One group received the recom- mended dose of 200 mg, the other exceeded it. To take into account group differences the propensity score method and logstic regres- sion was used alongside liver function. Result： When salvianolate injection was administered above the recommended dose patients were more likely to have abnormal AST and ALT levels. However, the difference between the groups was not statistically significant. Conclusion： According to our data the affect of exceeding the recommended dose of salvianolate injection on liver function is not signif- icant. However, monitoring of liver function should be carried out in clinic.