1.Signal mining and analysis of adverse drug reactions for polatuzumab vedotin based on FAERS database
Zaiwei SONG ; Xinya LI ; Peng MEN ; Dan JIANG ; Fei DONG ; Rongsheng ZHAO ; Jun YANG
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(7):752-761
		                        		
		                        			
		                        			AIM:To evaluate and analyze the post-marketing adverse drug reaction(ADR)signals of polatuzumab vedotin,so as to provide reference for clinical safety management.METHODS:Using the FDA adverse drug event reporting system(FAERS)database and OpenVigil data platform,the ADR reports of polatuzumab vedotin were collect-ed from June 10,2019(FDA approval for market-ing)to the March 31,2023.The ADR signals were detected by using the reporting odds ratio(ROR)and proportional reporting ratio(PRR)in the pro-portional imbalance method.To increase the threshold and obtain stronger and more frequently occurring ADRs,a second screening of signals was performed.RESULTS:A total of 2 408 ADR reports related to polatuzumab vedotin were collected,and 83 ADR signals were detected after secondary screening.26 ADR signals were not mentioned in the drug instructions such as abnormal spinal mag-netic resonance imaging,increased bone resorp-tion,osteolysis,decreased aspartate aminotransfer-ase,decreased alanine aminotransferase,hypofibri-nogenemia,and pulmonary embolism.The system organ classes with a high signal counts or cumula-tive number of cases included infections and inva-sive diseases(24 signals,632 cases),various exami-nations(17 signals,675 cases),blood and lymphat-ic system diseases(11 signals,734 cases),various nervous system diseases(7 signals,153 cases),im-mune system diseases(3 signals,95 cases),system-ic diseases and various reactions at the site of ad-ministration(2 signals,145 cases),and systemic dis-eases and various reactions at the site of adminis-tration(2 signals,87 cases),etc.CONCLUSION:In addition to the common ADRs suggested by the in-structions,this study identified new ADR risk sig-nals for polatuzumab vedotin.In the clinical appli-cation of polatuzumab vedotin,in addition to the ADR mentioned in the instructions such as infec-tions,myelosuppression,peripheral neuropathies,infusion-related reactions,and abnormal liver func-tion,attention should also be paid to the risk sig-nals not mentioned such as abnormal spinal mag-netic resonance imaging,and increased bone re-sorption.
		                        		
		                        		
		                        		
		                        	
2.MR imaging of neurosyphilis (report of 2 cases)
Xiaoyi WANG ; Weihua LIAO ; Xinya JIANG ; Dengming CHEN
Chinese Journal of Radiology 2001;0(04):-
		                        		
		                        			
		                        			Objective  To enhance the understanding of MR imaging  in neurosyphilis   Methods   One case   of syphilitic gumma with positive treponemal antibody test in the serum was confirmed pathologically after operation, and the other case with positive treponemal antibody test in the cerebrospinal fluid (CBF) was cured by medical therapy   Both patients were examined by MRI   Results  Syphilitic gumma has some characteristic MRI findings   The roundish areas of low signal or mixed low and iso   signal intensity were revealed on T  1WI with the diameter ranged from 2  0 cm to 2  5 cm   The lesions were located at the cortex or infra  cortex surrounded by obvious edema   The lesions showed high signal or mixed signal made up of iso  , high, and low signals on T  2WI   Gd  DTPA enhanced T  1WI demonstrated irregular circular enhancement on the edge of the lesions and abnormal neighboring meningeal enhancement, and the border of the lesions was angulated with neighboring meninges by obtuse angle   Conclusion  The final diagnosis of neurosyphilis should depend on laboratory examination or histopathologic examination, but neuroimaging suspicion is paramount to early detection and diagnosis of neurosyphilis
		                        		
		                        		
		                        		
		                        	
            
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