[Data analysis of real world clinical changes in indexes of liver and kidney function to use of parenterally administered kudiezi at different doses and time periods].
This is a retrospective study based on a 18 hospital information system data warehouse. Records of 1 982 patients who used Kudiezi intravenous infusion (KDZ) were extracted from the data warehouse. All the patients were divided into two groups, one group of 1 707 patients used KDZ, < or = 14 days under the instruction, the other group of 275 patients used KDZ, > 14 days, off label use. Generalized boosted models (GBM) with propensity score were applied to compare the two groups on four indexes of liver and kidney functions, such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (Cr) and blood urea nitrogen (BUN). Seventy one confounders were identified and balanced by GBM. And another two logistic analysis methods were used to confirm the results from GBM. The results indicated that there were no significant difference on the four indexes except the AST (P < 0. 05) by all the three analyzing models. It is hard to conclude that ultra long, off label using Kudiezi intravenous infusion could influence the four indexed of liver and kidney from this data analysis. More conclusive evidence should be collected by further prospective study.
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China. okfrom2008@hotmail.com
Xing
X
Liao
School of Statistics, Renmin University of China, Beijing 100872, China.
Hui
H
Zhang
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
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Wei
W
Yang
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000410:Alanine Transaminase / Q000378:metabolism; D001219:Aspartate Aminotransferases / Q000378:metabolism; D001806:Blood Urea Nitrogen; D016022:Case-Control Studies; D003404:Creatinine / Q000097:blood; D004305:Dose-Response Relationship, Drug; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006751:Hospital Information Systems / Q000706:statistics & numerical data; D006801:Humans; D007263:Infusions, Parenteral; D007668:Kidney / Q000187:drug effects* / Q000378:metabolism / Q000503:physiopathology; D008099:Liver / Q000187:drug effects* / Q000201:enzymology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D064792:Pragmatic Clinical Trials as Topic; D057216:Propensity Score; D011446:Prospective Studies; D055815:Young Adult
D004365:Drugs, Chinese Herbal; D003404:Creatinine; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase