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?:abstract
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Objective: This study used data mining to conduct real-world research on adverse drug events (ADEs) after LPV/r was launched on the market, providing a reference for clinical identification and treatment of early ADEs Methods: MedDRA terminology in different levels of the reproductive system were selected, and all LPV/r-related ADE reports were extracted from the European Drug Adverse Event Reporting Database (Eudravigilance) Results: Until February 1, 2020, 3 753 reports of LPV/r-related ADEs were collected in Eudravigilance, with 5 833 drug-related adverse events In terms of gender composition, males (54 5%) are higher than females (37 5%), and the age is concentrated between 18~64 years (69 0%) The reporting population is mainly \'medical staff reporting\' (82 8%) The ADE reports are focused on the system classification, much involving the following systems: gastrointestinal system, hepatobiliary system, nervous system, nutritional metabolism system, and cardiovascular system, etc This research uses PT terminology to query each system report, showing that LPV/r-related ADEs invaded the gastrointestinal system and often manifested as diarrhea 205 (22 4%), vomiting 135 (14 7%), nausea124 (13 5%), and severe of pancreatitis 89 (9 7%) and gastrointestinal bleeding 57 (6 2%), etc Liver and gallbladder system mainly showed abnormal liver function 93 (14 7%), changes in liver function indicators and jaundice 67 (10 6%) Nervous system mainly involved symptoms of mild headache 199 (31 6%), dizziness 70 (11 1%) It is worth noting that LPV/r induced seizures 54 (8 6%) and peripheral neuropathy 33 (5 2%) Other severe system effects: 21 (3 3%) decrease in blood glucose, 163 (28 5%) hypotension, 50 (8 7%) increase in blood pressure, 10 (1 6%) hyperkalemia, 36 (6 3%) AV block, deep vein thrombosis 17 (3 0%), electrocardiogram QT interval prolongation 16 (2 8%), anemia 168 (37 3%), acute kidney injury 129 (32 3%), etc Conclusion: In the clinical use of LPV/r, we should be alert to gastrointestinal bleeding, seizures, hypotension, thrombosis, prolonged QT interval, acute serious adverse events such as kidney injury and severe liver injury, in addition to some mild adverse events such as diarrhea, rash, and headache, etc © 2020, Chinese Journal of New Drugs Co Ltd All right reserved
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