A novel analytical method to assess the effect of imipenem/cilastatin on liver function laboratory indexes in Chinese underage inpatients: Probability distribution curve

OBJECTIVES: The primary objective of this study was to establish a novel method to assess the effect of imipenem/cilastatin (IMP) on liver function laboratory indexes in Chinese underage inpatients (inpatients aged <18 year-old). METHODS: A retrospective study was conducted in 188 underage inpatients who received IMP in Xiangya Hospital from January 2016 to April 2018. Demographic data and clinical information of these inpatients were collected. As there was no reference interval of minors, the occurrence of abnormal liver function was estimated by that of adults, temporarily. A new concept (mean-variance induced by drug, MVID) was introduced to analyze the characteristics of total bilirubin (TBil), direct bilirubin (DBil), alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Effect of MVID of TBil, DBil, ALT and AST in different patients (aged<1 year old and aged ≥ 1 year old) were compared by Mann-Whitney U test. RESULTS: Estimating by reference intervals of adults, 57.4% underage inpatients (108/188) had abnormal liver function. According to the probability distribution curve of MVID, IMP can cause the increase of AST in 24% (0.62–0.38) Chinese underage inpatients, and the increase of ALT in 20% (0.60–0.40) Chinese underage inpatients. And liver protecting drugs can decrease MVID of ALT and AST. There were not statistically significant differences in MVID of TBil, DBil, ALT and AST in different patients (aged<1 year old and aged ≥ 1 year old); P value was 0.711, 0.734, 0.067 and 0.086, respectively. CONCLUSION: IMP can affect the liver function of 20–24% Chinese underage inpatients mainly by increasing the AST and ALT. IMP may induce hepatocellular injury, but not cholestasis. And liver protecting drugs can reverse the side effects caused by IMP. Age may not affect the effect of IMP on liver function.