[Outcome research of shuxuening injection different dosage impact on patient's liver function].
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 treated with parenterally administered Shuxuening. Patients that were given doses of 21-50 mL, which is above the recommended dose, acted 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 0.007. 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 before and after logistic regression based on adjusted propensity score method, P value changes from 0.192 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 based on adjusted propensity score method can control known confounding factors very well. This research serves as an aid to the safe clinical use of parenterally administered Shuxuening.
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China. ywonline@163.com
Wei
W
Yang
School of Statistics, Renmin University of China, Beijing 100872, China.
Lin
L
Li
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Yan-Ming
YM
Xie
School of Statistics, Renmin University of China, Beijing 100872, China.
Wei
W
Yang
The PLA Navy General Hospital, Beijing 100048, China.
Yan
Y
Zhuang
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000410:Alanine Transaminase / Q000378:metabolism; D001219:Aspartate Aminotransferases / Q000378:metabolism; D016022:Case-Control Studies; 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; D008099:Liver / Q000187:drug effects* / Q000201:enzymology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D064792:Pragmatic Clinical Trials as Topic; D057216:Propensity Score; D012189:Retrospective Studies; D055815:Young Adult
D004365:Drugs, Chinese Herbal; C578963:shuxuening; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase