Objective To explore the risk signals of niraparib and provide references for rational and safe clinical medication.Methods Niraparib-related adverse drug events(ADEs)reports from Q1 2017 to Q2 2023 were extracted from the US FDA Adverse Event Reporting System(FAERS)database.Risk signals were identified using the reporting odds ratio(ROR),proportional reporting ratio(PRR),Bayesian confidence propagation neural network(BCPNN),and multi-item gamma Poisson shrinker(MGPS)methods.The Risk signals were described and classified by preferred system organ classes(SOCs)and preferred terms(PTs)from the Medical Dictionary for Regulatory Activities(MedDRA)version 26.1,and the occurrence of niraparib-related ADEs was also analyzed.Results A total of 16,961 ADE reports with niraparib as the primary suspected drug were extracted.Through screening and analysis,32 PTs were identified involving 11 SOCs,which were largely consistent with the information in the drug label.However,suspicious signals not mentioned in the label,including neuropathy peripheral,decreased red blood cell count,reduced hematocrit,dehydration,and hot flashes,require further attention.The median occurrence time was 22 days(IQR 2-98 days),and the Weibull distribution test indicated an early failure-type curve.Conclusion When using niraparib,particularly in early stages of treatment,it is essential to monitor not only the ADEs mentioned in the drug instructions,such as decreased platelet count,nausea and fatigue,but also to pay close attention to the ADEs not included in the instructions,such as peripheral neuropathy and decreased red blood cell count,which exhibit strong signal values,to ensure patient medication safety.

Objective:To analyze the different clinicopathological features of intrahepatic cholangiocarcinoma with and without viral hepatitis.Methods:The clinicopathological data of 79 intrahepatic cholangiocarcinoma cases from Mar 2012 to Sep 2018 at Henan Provincial People's Hospital were retrospectively analyzed.Results:Twenty-five of the 79 patients with intrahepatic cholangiocarcinoma were accompanied by viral hepatitis. Those with viral hepatitis had a lower mean age at onset than those without [(53±11) years vs. (60±11) years, P=0.011], higher proportion of male patients (80% vs. 52%, P=0.017), higher AFP positive rate (40% vs. 19%, P=0.041), lower CA19-9 positive rate (48% vs. 72%, P=0.036), tend to occur in the right liver lobe (76% vs. 44%, P=0.009), a lower rate of bile duct invasion (16% vs. 41%, P=0.03), and were more likely to be mass type (mass type proportion 96% vs. 72%, P=0.032). Conclusions:Viral hepatitis is common in intrahepatic cholangiocarcinoma. Intrahepatic cholangiocarcinoma with and without viral hepatitis differ in clinicopathology. Intrahepatic cholangiocarcinoma with viral hepatitis is more likely to have the characteristics of hepatocellular carcinoma, while intrahepatic cholangiocarcinoma without viral hepatitis is more likely to have the characteristics of cholangiocarcinoma.