[Nested case control study to analyze suspected cases and their related factors of allargic reactions to parenterally administered dengzhan xixin].
To assess if adverse drug reactions (ADR)s to parenterally administered Dengzhan Xixin are allergic in origin. Hospital information system (HIS) data from 20 hospitals in China were used to carry out a nested case control design study. Included were patients who received dexamethasone for suspected allergic reactions after receiving parenterally administered Dengzhan Xixin. These were compared with non-allergic reaction people. Single factor logistic regression and multiple factor logistic regression were used to analyze data. Condition on admission, allergic history, dosage, disease status and drug combinations were taken into account in cases of suspected allergic reactions. After analysis we found that the condition on admission had a significant effect, P = 0.008 3, OR value = 5.642 on suspected cases of allergic reactions. Using vitamin B6 injection or ambroxol at the same time as parenterally administered Dengzhan Xixin were significant, P = 0.000 2 and 0.016 7, OR value = 9.545 and 3.194, risk factors in this group. Based on this current research, condition on admission as well as the concomitant use of vitamin B6 or ambroxol may be the risk factors in suspected cases of allergic reactions. However, further research for verification is required. This study can provide guidance for safe clinical practice in using parenterally administered. It can also provide a new method for the pharmcovigilance of parenterally administered Dengzhan Xixin.
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.
Hao
H
Cheng
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.
Hu
H
Yang
Navy General Hospital, Beijing 100048, China.
Yan
Y
Zhuang
D000328:Adult; D000368:Aged; D016022:Case-Control Studies; D004342:Drug Hypersensitivity / Q000209:etiology*; 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; D008297:Male; D008875:Middle Aged; D064792:Pragmatic Clinical Trials as Topic; D011446:Prospective Studies
D004365:Drugs, Chinese Herbal