• 国家药监局综合司 国家卫生健康委办公厅
  • 国家药监局综合司 国家卫生健康委办公厅

[title missed]

Corresponding author: Zhu Xiaojing, fll861031@126.com
DOI: 10.12201/bmr.202412.00015
Statement: This article is a preprint and has not been peer-reviewed. It reports new research that has yet to be evaluated and so should not be used to guide clinical practice.
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    Abstract: Objective To explore the characteristics of patients with DILI, suspected drugs and outcomes, and to provide reference for the clinical standard use of drugs and reduce the adverse reactions of DILI. Methods 281 cases of DILI in a hospital from 2016 to 2023 were retrospectively analyzed. Results Among 281 patients with DILI, 164 were males and 117 were females. There were 83 general ADRs (29.54%) and 198 serious ADRs (70.46%). There was no significant difference between the two types of adverse reaction reports and the gender and age of patients. In terms of clinical manifestations, 190 patients (67.62%) had no clinical manifestations, 91 patients (32.38%) had clinical manifestations, mainly manifested as skin scleral yellow stain,fatigue, poor appetite and so on. From the clinical classification, there were 150 cases (53.38%) with hepatocyte injury, 79 cases (28.11%) with cholestasis, and 52 cases (18.51%) with mixed type. There were significant differences in RUCAM scale scores (very likely/probable) among the three groups. In terms of injury degree, 156 cases (55.52%) suffered mild liver injury, 121 cases (43.06%) suffered moderate liver injury, and 4 cases (1.42%) suffered severe liver injury. There were 164 cases(58.36%) of combined medication and 117cases(41.64%) of single medication. The disease types of patients include tumor, respiratory disease, tuberculosis infection, etc. There were 167 cases (59.43%) of underlying diseases, among which the top three underlying diseases were hypertension (54 cases), diabetes (41 cases) and hyperlipidemia (38 cases). Among the suspected drugs, the top three drugs are Chinese medicine, anti-tumor drugs and anti-tuberculosis drugs in order. There were significant differences between different types of suspected drugs and whether they were used in combination.Finally, 246 patients (87.54%) were effective after treatment, 35 patients (12.46%) were ineffective, and there were significant differences in clinical classification and outcome. Conclusion Chinese medicine, antitumor drugs and antituberculosis drugs are relatively easy to cause DILI. The type of liver cell damage, combination of drugs, types of diseases, and underlying diseases all affect the occurrence of DILI. These provide reference for clinical workers to use drugs safely and rationally.

    Key words: drug-induced liver damage; Chinese medicine; Antitumor drug; Antituberculosis drug

    Submit time: 4 December 2024

    Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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    1 2024-07-04

    bmr.202412.00015V1

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Zhu Xiaojing. [title missed]. 2024. biomedRxiv.202412.00015

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