1.Signals mining and analysis of adverse drug events in minors using recombinant human growth hormone based on the FAERS database
Jiaxiao DONG ; Yilei WANG ; Xiuzheng LI ; Jie LI ; Yichun XU ; Xiaodong XU
Chinese Journal of Pharmacoepidemiology 2025;34(2):157-165
Objective To mine and analyze adverse drug events(ADEs)signals in minors using recombinant human growth hormone(rhGH),and to provide reference for clinically safe use of drugs.Methods Based on the the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,the data of ADE reports related to rhGH from the third quarter of 2014 to the second quarter of 2024 were retrieved.The ADE reports were standardized and categorized using the Medical Dictionary for Regulatory Activities(MedDRA).The reporting odds ratio(ROR)method and Bayesian confidence propagation neural network(BCPNN)method were employed to mine and analyze ADE signals between rhGH and individuals under 18 years of age.Results A total of 33,642 ADE reports related to the use of rhGH in minors were retrieved.After excluding signals unrelated to ADEs(product issues,social issues,etc.),358 ADE signals were ultimately identified,involving 21 system organ lasses(SOCs).The most frequently reported ADEs were general disorders and administration site reactions(3,621 cases),as well as various laboratory test abnormalities(3,259 cases).Notably,ADE signals related to cardiovascular system tests,psychiatric disorders,and reproductive system and breast disorders,such as decreased serum creatinine,elevated alkaline phosphatase,reduced red blood cell distribution width,crying,aggression,and hypogonadism,were not documented in the drug package insert.Conclusion When administering rhGH to minors,in addition to monitoring common ADEs such as changes in blood glucose levels and scoliosis,attention should also be given to potential ADEs,including alterations in hematological parameters,psychiatric issues,and reproductive system and breast disorders,to ensure medication safety.
2.Signals mining and analysis of adverse drug events in minors using recombinant human growth hormone based on the FAERS database
Jiaxiao DONG ; Yilei WANG ; Xiuzheng LI ; Jie LI ; Yichun XU ; Xiaodong XU
Chinese Journal of Pharmacoepidemiology 2025;34(2):157-165
Objective To mine and analyze adverse drug events(ADEs)signals in minors using recombinant human growth hormone(rhGH),and to provide reference for clinically safe use of drugs.Methods Based on the the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,the data of ADE reports related to rhGH from the third quarter of 2014 to the second quarter of 2024 were retrieved.The ADE reports were standardized and categorized using the Medical Dictionary for Regulatory Activities(MedDRA).The reporting odds ratio(ROR)method and Bayesian confidence propagation neural network(BCPNN)method were employed to mine and analyze ADE signals between rhGH and individuals under 18 years of age.Results A total of 33,642 ADE reports related to the use of rhGH in minors were retrieved.After excluding signals unrelated to ADEs(product issues,social issues,etc.),358 ADE signals were ultimately identified,involving 21 system organ lasses(SOCs).The most frequently reported ADEs were general disorders and administration site reactions(3,621 cases),as well as various laboratory test abnormalities(3,259 cases).Notably,ADE signals related to cardiovascular system tests,psychiatric disorders,and reproductive system and breast disorders,such as decreased serum creatinine,elevated alkaline phosphatase,reduced red blood cell distribution width,crying,aggression,and hypogonadism,were not documented in the drug package insert.Conclusion When administering rhGH to minors,in addition to monitoring common ADEs such as changes in blood glucose levels and scoliosis,attention should also be given to potential ADEs,including alterations in hematological parameters,psychiatric issues,and reproductive system and breast disorders,to ensure medication safety.
3.New advances in baicalein's antitumor effects and mechanisms
Jiaxiao DONG ; Yongsheng JIN ; Ying CAO
Journal of Pharmaceutical Practice 2021;39(1):9-12
Baicalein (BE) is an active ingredient derived from the root of Scutellaria baicalensis Georgi. It is a polyhydroxyflavonoid in structure and has many biological activities. Among them, the antitumor effects of baicalein have received widespread attention. It exerts anti-tumor effects by inducing tumor cell apoptosis and invasion, inhibiting tumor angiogenesis, and eliminating free radicals. This article reviews the most recent research works of baicalein in its anti-tumor effects and mechanisms. It is aimed to provide a theoretical basis for the search and development of potential new anti-tumor drugs.
4.Study on synthesis and antifungal activities of galloyl piperazine derivatives
Hanxuan WANG ; Jiaxiao DONG ; Ying MA ; Yue GAO ; Yongsheng JIN
Journal of Pharmaceutical Practice 2020;38(6):506-508
Objective To design, synthesize and measure antifungal activities of galloyl piperazine derivatives. Methods Trimethoxyl gallic acid was used as starting material, reacted with piperazine in the presence of PyBOP/DIEA to afford the intermediates. The target compounds were obtained through the reaction with corresponding acids after deprotection gave. The antifungal activities of the target compounds were evaluated by FLC-resistant Candida albican isolated according to the CLSI recommended method. Results 11 target compounds were synthesized and six of them showed more potent antifungal activities than gallic acid. Conclusion Galloyl piperazine derivatives could enhance antifungal activities. Galloyl moiety was an important pharmacophore, which could improve antifungal activities with the introduction of cinnamic acid and 2,3-dichlorobenzoic acid.
5.Research progress in sinomenine structural modification
Xiuzheng LI ; Qingjie ZHAO ; Jiaxiao DONG ; Yunyun JIANG ; Guangming YE
Journal of Pharmaceutical Practice 2018;36(3):204-209,214
Sinomenine is an alkaloid found in the climbing plant Sinomenium acutum.Structurally,it belongs to the iso-quinoline derivatives,which have various bioactivities.Clinically,it is used in the treatment for rheumatism,rheumatoid arthri-tis and arrhythmia,etc.Nevertheless,due to the need of large dose,photo and thermal instability,quick metabolism in vivo and highly allergic for some patients,scientists have committed to modify its structure to develop the highly effective and low toxic derivatives.In this paper,the recent advances in structural modification of sinomenine are reviewed.

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