Abstract
Objective Our aim was to analyze the influence of Yinzhihuang granules on serum liver enzymes in jaundice patients and to provide real-world evidence for the efficacy evaluation of Yinzhihuang granules in treating jaundice. Methods We constructed a data warehouse which integrates real-world electronic medical records from the hospital information system of multiple 3A hospitals in China and used a descriptive statistical method to analyze the changes in the serum liver enzymes of the jaundice patients treated with Yinzhihuang granules and then used Wilcoxon signed-rank to test the changes in the indicators caused by the treatment. Results After being treated with Yinzhihuang granules, the jaundice patients had a decrease in the average serum levels of total bilirubin, indirect bilirubin, aspartate aminotransferase, glutamyl transpeptidase, and alkaline phosphatase, and the differences were statistically significant (P < 0.05) but had no significant changes in the average serum levels of direct bilirubin and alanine aminotransferase (P > 0.05). Conclusion The data analysis on the real-world electronic medical records demonstrate that Yinzhihuang granules help to reduce jaundice patients' serum levels of total bilirubin, indirect bilirubin, aspartate aminotransferase, glutamyl transpeptidase, and alkaline phosphatase, but there is no evidence that Yinzhihuang granules help to reduce the jaundice patients' serum levels of direct bilirubin and alanine aminotransferase.
Highlights
Jaundice, the yellow staining of the skin, sclera, and mucous membrane caused by the elevation of bilirubin, is a common indicator of hepatobiliary diseases [1]
We extracted the data of 3610 jaundice patients who had been treated with Yinzhihuang granules and who met the jaundice diagnosis standard: serum total bilirubin (TBil) > 17.1 μmol/L [13]. eir laboratory test information was extracted and analyzed, including seven serum liver enzyme indicators: TBil, direct bilirubin (DBil), indirect bilirubin (IBil), ALT, AST, GGT, and alkaline phosphatase (ALP)
Inclusion and Exclusion Criteria. e jaundice patients from the hospital information system (HIS) database who met the following criteria were included in our study: (1) they were treated with Yinzhihuang granules; (2) their TBil values were greater than 17.1 μmol/L (1.0 mg/dl) for at least one test; (3) there were at least one detection of serum liver enzymes seven days before and seven days after the use of Yinzhihuang granules
Summary
Our aim was to analyze the influence of Yinzhihuang granules on serum liver enzymes in jaundice patients and to provide real-world evidence for the efficacy evaluation of Yinzhihuang granules in treating jaundice. We constructed a data warehouse which integrates real-world electronic medical records from the hospital information system of multiple 3A hospitals in China and used a descriptive statistical method to analyze the changes in the serum liver enzymes of the jaundice patients treated with Yinzhihuang granules and used Wilcoxon signed-rank to test the changes in the indicators caused by the treatment. E data analysis on the real-world electronic medical records demonstrate that Yinzhihuang granules help to reduce jaundice patients’ serum levels of total bilirubin, indirect bilirubin, aspartate aminotransferase, glutamyl transpeptidase, and alkaline phosphatase, but there is no evidence that Yinzhihuang granules help to reduce the jaundice patients’ serum levels of direct bilirubin and alanine aminotransferase Conclusion. e data analysis on the real-world electronic medical records demonstrate that Yinzhihuang granules help to reduce jaundice patients’ serum levels of total bilirubin, indirect bilirubin, aspartate aminotransferase, glutamyl transpeptidase, and alkaline phosphatase, but there is no evidence that Yinzhihuang granules help to reduce the jaundice patients’ serum levels of direct bilirubin and alanine aminotransferase
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