ADR Signal Mining of Paclitaxel for Injection （Albumin-bound Type ）Based on FDA Adverse Event Database / 中国药房

ABSTRACT

OBJECTIVE：To utilize ADR signal of Paclitaxel for injection （albumin-bound type ）by using FDA adverse event reporting system （FAERS），and to provide reference for rational use of drugs in the clinic. METHODS ：The reporting odds ratio （ROR）method was used for data mining of adverse events （AEs）related to Paclitaxel for injection （albumin-bound type ）reported by FDA public data program （Open-FDA）during Jan. 1st，2004-Dec. 31th，2019. The demographic characteristics ，constituents and signals of ADR were analyzed. RESULTS ：A total of 1 659 AEs were identified for Paclitaxel for injection （albumin-bound type）. The female （1 169 cases，70.5％）was more than the male （345 cases，20.8％）. The age was mainly 45-64 years old （519 cases，31.3％）. ADR signal mainly involved nerve system ，blood and lymphatic system ，gastrointestinal system ，hepatobiliary system，respiratory system ，thoracic and mediastinal system and general ADR. Twenty positive ADR signals which were not recorded in the drug instructions were found in the study ，mainly including leucopenia ，lymphopenia，macular edema ，abdominal pain，dysphagia，shivering，jaundice，liver failure ，cirrhosis，urinary tract infection ，purulent secretion ，decreased ejection fraction，hypocalcemia，hypokalemia，hyponatremia，bone pain ，facial paralysis ，mental state change ，epistaxis，atelectasis. Among them ，lymphopenia，macular edema and mental state changes were not recorded in the drug instructions ，while others were the specific manifestations of ADR recorded in the drug instructions. CONCLUSIONS ：In the clinical application of Paclitaxel for injection（albumin-bound type ），in addition to ADR mentioned in the drug instructions ，great importance should be closely paid to neurotoxicity，lymphocyte changes ，regular eye monitoring 2021MSXM041） and mental state monitoring ，so as to avoid drug withdrawal or organ injury induced by ADR.