Mining and analysis of adverse drug events signals of nilotinib based on FDA adverse event database / 中国药房

OBJECTIVE To provide a reference for safe drug use in clinic. METHODS ADE reports related to nilotinib from the first quarter of 2007 to the fourth quarter of 2022 were collected from the US FDA adverse event reporting system database. The reporting odds ratio （ROR） and proportional reporting ratio （PRR） of disproportionality measures were used to mine potential ADE signals，which were compared with drug instruction and related case report， and were screened and analyzed according to the designated medical events （DME） list formulated by the European Medicines Agency. RESULTS Totally 23 332 cases of ADE with nilotinib as the primary suspected drug were reported. A total of 359 positive signals were obtained，involving 24 system organ classes （SOC），mainly concentrated in various examinations，heart organ diseases，vascular and lymphatic diseases，all kinds of nervous system diseases，etc. Among them，ADEs such as vertebral artery stenosis，coronary artery stenosis，arterial disease，liver infection and the second primary malignant tumor were not mentioned in the instructions. Seven DMEs were detected，of which bone marrow failure，pulmonary hypertension and deafness were not mentioned in the drug instruction. CONCLUSIONS The common ADE signals of nilotinib excavated in this study are consistent with the instructions. In clinical use，special attention should be paid to DME not mentioned in the instructions such as bone marrow failure，pulmonary hypertension and deafness； cardiac function， blood glucose and blood lipid indexes should be monitored closely.

Data-mining of Adverse Drug Events Signals for Tocilizumab Based on US FAERS Database / 中国药房

OBJECTIVE：To provide reference for clinical safe and rational drug use by mining adverse drug events （ADE） signals for tocilizumab. METHODS ：Data of ADE reports related to tocilizumab in the first quarter of 2015 to second quarter of 2020 were collected from US FDA adverse event reporting system. After data standardization ，the proportional imbalance method was used for ADE signal mining. RESULTS ：A total of 163 718 ADE reports were extracted ，in which tocilizumab was primary suspected drug ，involving 26 674 patients. In 26 674 patients，the proportion of female （73.69％）was higher than that of male （19.04％），and the age was mainly 60-74 years old （21.19％）. Among the 163 718 ADE reports ，the main reporting countries were the United States （70.15％），Canada（15.95％），Japan（3.33％），Australia（3.05％）and Brazil （1.43％）；consumers （31.35％）and doctors （24.94％）were the main reporting staff. A total of 747 ADE signals for tocilizumab were obtained ， commonly rheumatoid arthritis ，joint pain and pain ；and the signals as the increase of disability assessment scale score ，the decrease of disability assessment scale score ，abnormal diastolic blood pressure and abnormal systolic blood pressure were strong. A total of 33 kinds of ADE signals were found ，which were not recorded in the instructions of tocilizumab ，and mainly abnormal laboratory indicators such as decreased oxygen saturation ，decreased blood pressure and abnormal heart rate. ADE mainly involved 27 system organs ，including musculoskeletal and connective tissue ，various reactions of systemic diseases and drug delivery site ， various examinations. CONCLUSIONS ：In addition to the ADE mentioned in the drug instructions ，when using tocilizumab in clinic，attention should also be paid close to blood oxygen saturation ，blood pressure ，blood routine indexes and other laboratory indicators，and intervention measures should be taken early when ADE occurs ，so as to ensure the safety and effectiveness of drug use.