中国中药杂志

2013, v.38(18) 3141-3149

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基于真实世界灯盏细辛注射液对脑梗死治疗结局影响的临床实效研究
Treatment outcomes of parenterally administered Dengzhan Xixin for treatment of cerebral infaction based on real world hospital injection system data

杨薇;李霖;谢雁鸣;庄严;杨伟;
YANG Wei;LI Lin;XIE Yan-ming;ZHUANG Yan;YANG Wei;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences;School of Statistics,Renmin University of China;The PLA Navy General Hospital;

摘要(Abstract):

脑梗死是灯盏细辛注射液适应症之一,为了解灯盏细辛注射液真实世界中对脑梗死患者治疗结局的影响,该研究选取全国20家三甲综合医院信息系统(hospital information system,HIS)数据作为数据来源,以使用灯盏细辛注射液的1 008例脑梗死患者作为观察组,未使用灯盏细辛注射液的1 504例脑梗死患者作为对照组,以脑梗死患者是否死亡作为治疗结局。通过分析发现,未控制混杂因素前,灯盏细辛注射液对脑梗死死亡率无显著影响,P为0.098 3;分别以年龄、性别、入院病情、单次用药剂量、用药疗程作为分层因素进行分层分析,发现以单次用药剂量、用药疗程作为分层因素分析时,灯盏细辛注射液对脑梗死死亡率有显著影响,P分别为0.029 3,0.030 9;采用经典Logistic回归分析灯盏细辛注射液对脑梗死治疗结局的影响,观察组与对照组无差异,采用generalized boosted models(GBM)倾向性评分(propensity score,PS)加权后的Logistic回归对数据库中年龄、性别等72个变量加以平衡后,观察组与对照组有显著差异(P<0.001)。基于现有数据及分析方法发现灯盏细辛注射液可降低脑梗死患者死亡率。但由于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能够进行很好的控制,因此该研究结论仅作为临床医师治疗脑梗死用药选择的参考。
Cerebral infarction is one of the indications for parenterally administered Dengzhan Xixin.This study aims to analyze treatment outcomes in patients with cerebral infarction of parenterally administered Dengzhan Xixin,in the real world.Data from 20 national hospitals' hospital injection system(HIS)databases were collected.1 008 cases of parenterally administered Dengzhan Xixin for the treatment of cerebral infarction were compared with 1 504 cases who did not receive Dengzhan Xixin who acted as the control group.Outcome was defined by mortality or survival following cerebral infarction.It was found that,before controlling for confounding factors,parenterally administered Dengzhan Xixin did not have a significant effect on mortality,P = 0.098 3.Stratified analysis taking into account,age,gender,condition on admission,dosage,and length of treatment found that parenterally administered Dengzhan Xixin had significant effects on cerebral infarction mortality when dosage and length of treatment course were stratification factors;P values were 0.029 3 and 0.030 9 respectively.When applying classic logistic regression to the analysis there was no difference between the observation group and control group,P =0.106.Generalized boosted models(GBM) and propensity score(PS) weighted Logistic regression,was then applied to balance 72 variables such as age and gender,this found that there were significant differences between the observation and control groups,P < 0.001.This study concludes that parenterally administered Dengzhan Xixin can reduce the mortality of cerebral infarction patients based on existing data.However,there are many known and unknown confounders in retrospectively analysis,and the propensity score can only control for known confounding factors.Therefore,these findings should be considered as a reference for treating cerebral infarction.

关键词(KeyWords): 灯盏细辛注射液;真实世界;医院信息系统;脑梗死;治疗结局;实效研究
parenterally administered Dengzhan Xixin;real world study;hospital information system;cerebral infarction;treatment outcomes;outcome research

Abstract:

Keywords:

基金项目(Foundation): 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联合创新研究项目(ZZ070817)

作者(Authors): 杨薇;李霖;谢雁鸣;庄严;杨伟;
YANG Wei;LI Lin;XIE Yan-ming;ZHUANG Yan;YANG Wei;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences;School of Statistics,Renmin University of China;The PLA Navy General Hospital;

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