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OBJECTIVE To conduct data mining on drugs causing liver failure in underage populations based on the FDA Adverse Event Reporting System （FAERS） database， so as to provide reference for clinical use of related drugs. METHODS The data on reported adverse drug event （ADE） of liver failure in this population （under 18 years old） from the first quarter of 2013 to the third quarter of 2022 were retrieved from the FAERS database for mining and analysis； they were divided into infants（≤1 year old）， young children（＞1-＜6 years old）， children（6-＜12 years old） and adolescents（12-＜18 years old） according to the age. The reporting odds ratio （ROR）， proportional reporting ratio and Bayesian confidence propagation neural network of the proportional imbalance method were used to screen ADE signals. RESULTS A total of 1 051 ADE reports of liver failure were collected from the underage population involving 60 drugs. The highest incidence was found in adolescents （410 cases， 39.01%）， followed by young children （297 cases， 28.26%）. The instructions of 14 drugs did not mention hepatobiliary system injury and liver failure risk， including 31 cases of levetiracetam （2.95%），18 cases of metronidazole （1.71%）， 16 cases of each of topiramate and methylprednisolone （1.52% each）， 12 cases of dexamethasone （1.14%）， 11 cases of tisagenlecleucel （1.05%）， 10 cases of each of ferrous sulfate， metformin and busulfan （0.95% each）， 9 cases of propofol （0.86%）， 8 cases of onasemnogene abeparvovec （0.76%）， 5 cases of each of diphenhydramine and omeprazole （0.48% each）， 4 cases of sebeliesterase α （0.38%）， totaling 165 cases， accounting for 15.70% of the total reported cases. Metformin was contrary to the known liver safety， and E-mail：libingchemical@163.com metronidazole and levetiracetam were new risk signals， which caused more serious clinical outcomes. CONCLUSIONS Fourteen new pharmacovigilance signals which cause liver failure in the underage population are found in this study； the liver function of patients should be closely monitored when using these drugs. Among those drugs， metformin neither undergoes liver metabolism nor has been reported in the relevant literature， and the liver-related ADE caused by metformin deserves further attention. The clinical outcomes caused by metronidazole and levetiracetam are relatively serious and need to be given sufficient attention.
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Objective:To investigate the current situation of damage compensation for subjects in drugs clinical trials.Methods: Retrospective analyzes was conducted on 70 drug clinical trail from January 2008 to December 2014 in our hospital , including protocols、informed consent and insurance .Results: It was written in most proto-cols that sponsor undertook damage compensation due to experimental drugs , however , lack of detailed rules .Dam-age compensation for subjects was missed in some informed consents .17 drugs clinical trials provided insurance , the rate of jointing insurance 24 .3%.In international trail , the rate of jointing insurance ( 100%) was higher than that in domestic trail (9.1%).As to domestic trail, the rate of jointing insurance increased gradually .There was no difference between insurance of different periods .In 17 insurance , 13 were clinical trial liability insurance , oth-ers were product and general liability insurance;5 provided insurance instruction , only insurance certificate or poli-cy in others;2 insurance applied foreign language .Conclusion:Through project access system , strengthening the ethical approval , strengthening quality management to prevent the damage occurred , participants damage happened after fully protect the health and rights and interests of the subjects , and actively promote clinical trial insurance to perfect our subjects′damage compensation mechanism , the protection of the rights of the subjects , and reduce the risk of clinical trials .
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Objective:To investigate the improvement in antibiotics use in our hospital by comparing the prophylactic application of antibiotics in type I incision before and after antimicrobial drug special rectification. Methods:The medical records of 100 hospital-ized patients undergoing I incision respectively from May to December in 2011 (before the rectification), from May to December in 2012 ( during the rectification) and from May to December in 2013 ( after the rectification) were withdrawn randomly. The prophylactic application of antibiotics was statistically and comparatively analyzed. Results: After the antimicrobial drug special rectification, the prophylactic application rate of antibiotics was reduced from 100% to 28%, and in 7 kinds of operations stressed by the National Health and Family Planning Commission ( inguinal hernia repair, thyroid disease, breast disease, arthroscopy, carotid endarterectomy, skull tumor resection and endovascular interventional diagnosis) , the prophylactic use rate of antimicrobial drugs was reduced to 11%. The variety choice of antibiotics in type I incision was more reasonable. The irrationality rate of medication time and course was de-creased obviously, and the accuracy of dosage and usage was improved significantly. The combination of antibiotics was also notably decreased. Conclusion:The antimicrobial drug special rectification is effective, which can significantly improve the prophylactic appli-cation rationality of antibiotics for type I incision in our hospital.