Signal mining and analysis for adverse events of avatrombopag based on FAERS / 陆军军医大学学报

Objective To mine the adverse drug events(ADE)signal of avatrombopag,an effective drug for thrombocytopenia treatment,based on real world data in order to provide reference for its clinical safety application.Methods The OpenVigil2.1 pharmacovigilance platform was used to obtain the ADE report data of avatrombopag from May 2018 to March 2023 in the database of FDA adverse event reporting system(FAERS).The ADE signals were classified and described by the system organ class(SOC)and preferred term(PT)of the ADE terminology set in the Medical Dictionary for Regulatory Activities(MedDRA),and reporting odds ratio(ROR)and UK Medicines and Healthcare Products Regulatory Agency(MHRA)comprehensive standard were used to detect the positive ADE signals.Results A total of 1 879 ADE reports related to avatrombopag were obtained,24 SOCs were involved,and 28 positive ADE signals were detected at PT level.Among these signals,the strongest ones were renal vein thrombosis,portal vein thrombosis and graft versus host disease,while the reports accounting for the largest numbers were headache,fatigue and asthenia.There were 8 ADE signals discovered newly,that is,seasonal allergy,back disorder,musculoskeletal discomfort,flatulence,hypersomnia,rash macular,emotional disorder,and rhinorrhoea.Conclusion For clinical use of avatrombopag,clinicians should not only concern the risk of thrombosis,but also pay close attention to ADE signals such as seasonal allergy,back disorder,musculoskeletal discomfort,flatulence,hypersomnia,rash macular,emotional disorder,and rhinorrhoea that are not documented in the instructions.

Mining and analysis of acalabrutinib-induced ADE risk signals based on FDA adverse event reporting system / 中国药房

OBJECTIVE To provide reference for the clinically safe application of acalabrutinib by mining and analyzing the risk signals of adverse drug events （ADE）. METHODS The acalabrutinib-induced ADE reports were extracted from the U.S. FDA adverse event reporting system using the OpenVigil 2.1 platform from November 1， 2017 to March 31， 2023. The reporting odds ratio （ROR） method and composite criteria method from the Medicines and Healthcare Products Regulatory Agency （MHRA） were used for detection of ADE signals. RESULTS There were 7 869 ADE reports of acalabrutinib as the primary suspect drug and 142 ADE positive signals were detected from them， involving 20 system organ classes， which was generally consistent with the ADE recorded in the drug instruction of acalabrutinib， mainly involving general disorders and administration site conditions， various inspection， blood and lymphatic system disorders， various neurological disorders and cardiac disorders. In addition， this study identified several new potential ADE signals that were not mentioned in the drug instruction， including sudden cardiac death， pulmonary toxicity， tumor lysis syndrome， pleural effusion， dyspepsia， gastroesophageal reflux disease， bone pain， decreased blood pressure， and abnormal blood sodium， etc. CONCLUSIONS When using acalabrutinib， in addition to paying attention to the ADE recorded in its instructions， the risk of serious ADE that may lead to death， such as sudden cardiac death and pulmonary toxicity， should also be evaluated to avoid or reduce the occurrence of ADE as much as possible.

Effects of Typhae pollen Decoction on Isolated Uterine Smooth Muscle Contraction of Rats at Postconceptu-al Stage / 中国药房

OBJECTIVE:To study the effect of Typhae pollen decoction on isolated uterine smooth muscle(USM)contraction of rats at postconceptual stage. METHODS:16 Wistar rats at postconceptual stage were selected and USM strips were isolated. T. pollen decoction 0(blank control),2,4,8 and 12 mg(medicinal material)/ml were added respectively;the effects of T. pollen de-coction on USM strips contraction were observed,and mean tension,duration of contraction and frequency were measured and re-corded. The effects of T. pollen decoction on USM strips contraction were investigated after pretreatment of prostaglandin synthase inhibitor indometacin(1×10-7 mol/ml)and calcium channel blocker verapamil(1×10-7 mol/ml);USM tension,duration of contrac-tion and frequency were measured and recorded. RESULTS:Compared with blank control group,T. pollen decoction 4,8 and 12 mg(medicinal material)/ml could increase USM tension,duration of contraction and frequency(P<0.05);after added verapamil and indometacin,T. pollen decoction decreased USM tension,shortened duration of contraction and decreased frequency (P<0.05). CONCLUSIONS:T. pollen decoction can strengthen USM strips contraction,and the effect is inhibited by prostaglandin syn-thase inhibitor and calcium channel blocker.

Preparation and quality control of flurbiprofen orally disintegrating tablets / 第三军医大学学报

Objective To prepare the flurbiprofen orally disintegrating tablets and establish the procedures of controlling the quality.Methods Flurbiprofen orally disintegrating tablets was prepared by wet granulation and it content was determined by HPLC.Results The obtained tablets were fine in the shape and smooth in the surface.Their hardness was 2 kg,the disintegrating time was about 30 s.The linear correlation was in a range of 1.0-10.0 ?g/ml,r=0.999 9.The average recovery was 99.32%,RSD=1.09%(n=7).Conclusion Our methods of flurbiprofen orally disintegrating tablets are simple and feasible in preparation and quality control.