title: Hepatitis B patients exhibiting mild alanine aminotransferase elevation: A comparative analysis of treatment with and without Bicyclol tablets.
abstract: The aim of the present study was to analyze the medicinal effect of Bicyclol tablets on patients with chronic hepatitis B (CHB) and concomitant mild alanine aminotransferase (ALT) elevation (40-80 IU/l). A retrospective cohort study, which included patients from the hospital information system (HIS; established by the Chinese Academy of Medical Sciences) viral hepatitis database comprised of 18 third-grade class A hospitals in China, was performed. Patients were divided into an exposed group (administered with Bicyclol tablets) and a non-exposed group (no administration of Bicyclol tablets). The CHB patients that exhibited mild ALT elevation provided the curative effect analysis data set, and the patients with viral hepatitis who underwent more than two creatinine/hemoglobin/leucocyte examinations served as the safety analysis data set. The factors influencing ALT normalization rate were analyzed and the safety of Bicyclol tablets was assessed. In total, 82 pairs of patients were included in the curative effect analysis, and single factor analysis revealed that the ALT normalization rate of the exposed group was statistically significantly higher than that of the non-exposed group (P=0.040) for patients with mild ALT elevation. After adjusting for patient age, gender, baseline ALT levels, state of illness upon admission, pattern of hospitalization, hospitalization days and drug combination, the odds ratio (95% confidence interval) of the ALT normalization rate of the exposed group was 2.156 (1.103-4.215) when compared with the non-exposed group. During treatment, the occurrence rates of creatinine/hemoglobin/leucocyte level abnormalities of the exposed group, which were included in the safety analysis were statistically significantly lower than those of the non-exposed group (P<0.05). These findings indicate that Bicyclol tablets improve the ALT normalization rate of CHB patients exhibiting mild ALT elevation.
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P.R. China.
authors.forename: Yin
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P.R. China.
authors.forename: Yanming
authors.initials: Y
authors.lastname: Xie
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P.R. China; Institute of Information on Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P.R. China.
authors.forename: Yiying
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: School of Statistics, Renmin University of China, Beijing 100872, P.R. China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Center of Computer Management, Navy General Hospital of PLA, Beijing 100048, P.R. China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Zhuang
keywords: Bicyclol; alanine aminotransferase; alanine aminotransferase normalization rate; chronic hepatitis B; curative effect; hospital information system