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临床试验/ITMCTR2000003728
ITMCTR2000003728尚未招募1 期

The main characteristics and mechanism of liver injury caused by the combination of Chinese and Western drugs

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症

试验速览

阶段
1 期
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational study

入排标准

性别
All

入选标准

  • Prospective follow-up cohort of liver injury caused by tripterygium wilfordii preparation combined with different Western medicine:
  • (1) patients with rheumatoid arthritis (ra) basic diseases, one of the admission diagnosis of drug-induced liver injury or drug-induced liver disease or drug-induced hepatitis or drug-induced liver damage or drug cirrhosis or drug-induced liver failure or use other diagnostic terminology hints may be an various types of drug-induced liver injury patients, diagnostic criteria, meet above drug-induced liver injury and causation RUCAM score of 3 or more cases;
  • (2) No limitation on age and gender; sign informed consent.
  • Clinical study on DILI induced by immunocheckpoint inhibitor combined with Traditional Chinese medicine:
  • (1) basic diseases of liver cancer patients, the hospital diagnosis of drug-induced liver injury or drug-induced liver disease or drug-induced hepatitis or drug-induced liver damage or drug cirrhosis or drug-induced liver failure or use other diagnostic terminology hints may be an various types of drug-induced liver injury patients, diagnostic criteria, meet above drug-induced liver injury and causation RUCAM score of 3 or more cases;
  • (2) No limitation on age and gender; sign informed consent.

排除标准

  • Prospective follow-up cohort of liver injury caused by tripterygium wilfordii preparation combined with different Western medicine:
  • (1) The possibility of drug-induced liver injury has been clearly excluded at the time of discharge diagnosis of various types of liver injury;
  • (2) Patients with incomplete clinical key data, unable to make clinical judgment on DILI diagnosis or unable to use RUCAM scale for causal assessment;
  • (3) Liver damage caused by exposure to toxic chemicals;
  • (4) Patients with liver injury combined with other factors such as virus, immunity, alcohol, genetic metabolism, bile duct, blood vessel, etc.;
  • (5) Non-rheumatoid arthritis patients.
  • Clinical study on DILI induced by immunocheckpoint inhibitor combined with Traditional Chinese medicine:
  • (1) The possibility of drug-induced liver injury has been clearly excluded at the time of discharge diagnosis of various types of liver injury;
  • (2) Patients with incomplete clinical key data, unable to make clinical judgment on DILI diagnosis or unable to use RUCAM scale for causal assessment;
  • (3) Liver damage caused by exposure to toxic chemicals;
  • (4) Patients with liver injury combined with other factors such as virus, immunity, alcohol, genetic metabolism, bile duct, blood vessel, etc.;
  • (5) Non-liver cancer patients.

研究者

发起方
Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

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