Analysis suspected allergic factors to shenqi fuzheng injection based on prescription sequence analysis and nested case control study.
- Author:
Qing-Hua AI
;
Xian-Bin ZENG
;
Yan-Ming XIE
;
Wei YANG
- Publication Type:Journal Article
- MeSH:
Case-Control Studies;
Drugs, Chinese Herbal;
adverse effects;
Female;
Humans;
Male
- From:
China Journal of Chinese Materia Medica
2014;39(18):3563-3566
- CountryChina
- Language:Chinese
-
Abstract:
This study based on twenty 3A grade hospital information system (HIS) database in China, adopt toprescription sequence analysis (PSA) with nested case control study (NCCS) to analysis mainly suspected allergy factor of Shenqi Fuzheng injection (Shenqi Fuzheng). Study design according to start to stop using Shenqi Fuzheng whether using dexamethasone injection will crowd divided into cases group and control group, each case matched 4 controls were selected, two groups according to the ratio of the age and sex matched well. Square test, Fisher exact test, single factor and multiple factor logistic regression were used to analyze data Condition on admission, allergic history, dosage and drug combinations were taken into account in cases of suspected allergic reactions. After analysis in two subgroups we found that the single dose (P = 0.000 2) and the combined use of matrine (P < 0.000 1, OR = 14.312, confidence interval [8.184, 25.029]) had significant effects on the suspected allergic reaction. Study on the existing HIS data and the study method based on screening suspected risk factors for allergic reaction. This study can provide guidance for Shenqi Fuzheng injection safety using in clinical practice, and it can also provides new method for the clinical safety reevaluation of post-marketing Chinese medicine injection.
