舒血宁注射液临床用药剂量对肝功能影响的临床实效研究  

Outcome research of Shuxuening injection different dosage impact on patient's liver function

作　　者：杨薇[1] 李霖[2] 谢雁鸣[1] 杨伟[2] 庄严[3] 

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]中国人民大学统计学院,北京100872 [3]中国人民解放军海军总医院,北京100048

出　　处：《中国中药杂志》2013年第18期3076-3083,共8页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2009ZX09502-030);国家自然科学基金青年基金项目(81202776);中国中医科学院第7批自主选题项目(Z0255);中国中医科学院客座研究员联合创新研究项目(ZZ070817)

摘　　要：中药注射剂临床安全性问题一直受到临床医生、患者与药品管理部门关注，但探讨其对肝功能损害的研究较少，该研究以舒血宁注射液为研究对象，回顾性分析全国20家三甲医院信息系统（hospitalinformationsystem，HIS）数据库中使用舒血宁注射液的用药患者信息，将超过说明书推荐剂量使用（21～50mL）舒血宁注射液作为观察组，将按照说明书推荐剂量（20mL以内）使用舒血宁注射液对照组，以2次谷丙转氨酶（ALT）、谷草转氨酶（AST）的变化作为结局评价指标，采用倾向性评分方法对2组患者性别、年龄、入院病情、住院总费用等共71个协变量进行平衡后，分析用药剂量对ALT，AST的影响。舒血宁注射液对ALT变化影响分析中，倾向性评分前经典Logistic回归分析中P为0．007，倾向性评分后P为0．254，组间无差异，使用舒血宁注射液单次用药剂量为2l一50mL时对ALT异常变化无显著影响；舒血宁注射液对AST变化影响分析中，倾向性评分前经典Logistic回归分析P为0．192，倾向性评分后P为0．568，组间无显著差异，提示使用舒血宁注射液单次用药剂量为21～50mL时对AST异常变化无显著影响。但是由于本研究为回顾性分析，存在大量已知及未知的混杂因素，而倾向性评分仅对已知混杂因素可以很好的控制，因此本研究结论仅作为舒血宁注射液临床使用参考。The safety of parenterally administered Chinese medicine has caught the attention of clinicians, patients and drug administration departments. However, there are few studies that have assessed liver function damage from these medications. This study retrospectively analyzed hospital information system （HIS） data, from 20 nationwide general hospitals, of patients who were trea- ted with parenterally administered Shuxuening. Patients that were given doses of 21-50 mL, which is above the recommended dose, ac- ted as the observation group. Those receiving the recommended dose of 〈 20 mL were the control group. Alanine aminotransferase （ALT） and aspartate aminotransferase （AST） were measured before and after parenteral administration of Shuxuening, changes after treatment were outcomes. Also recorded were： age, costs, length of hospitalization and the patients＇ condition on admission. Propensity score method was used to balance 71 confounding variables such as gender, age, mortality, and costs. The influence of dosage of ALT and AST can then be known. Analysis of the impact of parenterally administered Shuxuening on ALT, before logistic regression based on adjusted propensity score, then the P value is O. 007. However, after logistic regression based on adjusted propensity score method the P value became 0.254. Hence, no differences were found between the two groups; using parenterally administered Shuxuening at the higher dose of 21 to 50 mL had no significant effects on ALT compared with the normal dose. Similarly analysis of AST changes be- fore and after logistic regression based on adjusted propensity score method, P value changes from O. 192 to 0. 568. There were no differences between the two groups using parenterally administered Shuxuening; a dosage of 21 to 50 mL each time had no significant effects on AST. Nevertheless, this study is a retrospective analysis, whilst known confounding factors have been taken into account there may be unknown ones to include inanalysis. Logistic regression b

关 键 词：舒血宁注射液 用药剂量 肝功能 谷丙转氨酶 谷草转氨酶 倾向性评分 医院信息系统 实效研究 

分 类 号：R285[医药卫生—中药学]