[Impact analysis of shuxuetong injection on abnormal changes of ALT based on generalized boosted models propensity score weighting].
OBJECTIVE
To estimate treatment effects of Shuxuetong injection on abnormal changes on ALT index, that is, to explore whether the Shuxuetong injection harms liver function in clinical settings and to provide clinical guidance for its safe application.


METHODS
Clinical information of traditional Chinese medicine (TCM) injections is gathered from hospital information system (HIS) of eighteen general hospitals. This is a retrospective cohort study, using abnormal changes in ALT index as an outcome. A large number of confounding biases are taken into account through the generalized boosted models (GBM) and multiple logistic regression model (MLRM) to estimate the treatment effects of Shuxuetong injections on abnormal changes in ALT index and to explore possible influencing factors.


RESULTS
The advantages and process of application of GBM has been demonstrated with examples which eliminate the biases from most confounding variables between groups. This serves to modify the estimation of treatment effects of Shuxuetong injection on ALT index making the results more reliable.


CONCLUSIONS
Based on large scale clinical observational data from HIS database, significant effects of Shuxuetong injection on abnormal changes in ALT have not been found.
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China. yangyxq@ruc.edu.cn
Wei
W
Yang
Statistical Institute of Renmin University, Beijing 100872, China.
Dan-Hui
DH
Yi
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Yan-Ming
YM
Xie
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Wei
W
Yang
Statistical Institute of Renmin University, Beijing 100872, China.
Yi
Y
Dai
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Ying-Jie
YJ
Zhi
The PL4 Navy General Hospital, Beijing 100048, China.
Yan
Y
Zhuang
Statistical Institute of Renmin University, Beijing 100872, China.
Hu
H
Yang
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000410:Alanine Transaminase / Q000378:metabolism*; D002648:Child; D004358:Drug Therapy; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006751:Hospital Information Systems / Q000706:statistics & numerical data; D006801:Humans; D008099:Liver / Q000187:drug effects / Q000201:enzymology; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D064792:Pragmatic Clinical Trials as Topic; D057216:Propensity Score; D012189:Retrospective Studies; D055815:Young Adult
D004365:Drugs, Chinese Herbal; C532053:shuxuetong; D000410:Alanine Transaminase