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.Formulation and Explanation of the Standards for Hospital Pharmacy Research
Yan LI ; Shiting LIU ; Yilei LI ; Wei ZHANG ; Weiyi FENG ; Yalin DONG ; Rongsheng ZHAO ; Wan-sheng CHEN ; Houwen LIN ; Jin LU ; Boxin ZHAO ; Xin HUANG ; Jiancun ZHEN
Herald of Medicine 2025;44(5):716-719
Hospital pharmacy research is significant in enhancing the level of rational drug use,improving the quality of pharmacy services,and promoting the improvement of drug treatment effects.To guarantee the standardization of hospital pharmacy research,the compilation team of"Hospital Pharmacy Research Standards"adheres to the principles of scientificity,universality,guidance,and operability,combs through the key management contents from three aspects,namely,relevant national policy docu-ments,relevant domestic and international standards and norms,and literature analysis,combines with the actual working condition of hospital pharmacy research,and formulates the standards after several rounds of opinion collection and expert argumentation.This paper analyzes the key contents of the standard,including basic requirements,research process management,and research re-sults management,to provide guidance and reference for hospital pharmacy researchers to understand the standard in-depth and further improve the standardization of hospital pharmacy research.
3.Analysis of the Interaction Effect between the"New Talent Policy"and the Retention of Grassroot Health Personnel
Zhaoxu LI ; Lifeng WEI ; Yilei ZHAO
Chinese Hospital Management 2025;45(12):48-50
Objective To analyze the interaction effect between the new talent policy and the retention of healthcare personnel,and propose suggestions for improving talent administration.Methods Grassroot health personnel in 12 prefecture level cities in Zhejiang,Sichuan,and Henan Provinces were selected as the research subjects.Policy text analysis and multilevel linear models were used to analyze the interaction effect between talent policies and healthcare workforce retention.Results A total of 2 156 grassroots health personnel completed the survey.The completeness of policy tools had a significant positive impact on retention(coefficient=0.23,P<0.001),and the stability of institutional environment also showed a positive impact(coefficient=0.18,P=0.002);Meanwhile,the stability of the institutional environment positively moderated the relationship between occupational commitment and retention(interaction coefficient=0.12,P=0.003).lndividuals with high human capital were more susceptible to the influence of career development tools(coefficient=0.27,P<0.001),while those with low human capital relied more on basic security tools(coefficient=0.21,P<0.001).Conclusion The interactive effect between the new talent policy and the retention of grassroots health personnel was confirmed.The new talent policy should focus on improving the completeness of policy tools and the stability of the institutional environment.
4.A critical role for Phocaeicola vulgatus in negatively impacting metformin response in diabetes.
Manyun CHEN ; Yilei PENG ; Yuhui HU ; Zhiqiang KANG ; Ting CHEN ; Yulong ZHANG ; Xiaoping CHEN ; Qing LI ; Zuyi YUAN ; Yue WU ; Heng XU ; Gan ZHOU ; Tao LIU ; Honghao ZHOU ; Chunsu YUAN ; Weihua HUANG ; Wei ZHANG
Acta Pharmaceutica Sinica B 2025;15(5):2511-2528
Metformin has been demonstrated to attenuate hyperglycaemia by modulating the gut microbiota. However, the mechanisms through which the microbiome mediates metformin monotherapy failure (MMF) are unclear. Herein, in a prospective clinical cohort study of newly diagnosed type 2 diabetes mellitus (T2DM) patients treated with metformin monotherapy, metagenomic sequencing of faecal samples revealed that Phocaeicola vulgatus abundance was approximately 12 times higher in nonresponders than in responders. P. vulgatus rapidly hydrolysed taurine-conjugated bile acids, leading to ceramide accumulation and reversing the improvements in glucose intolerance conferred by metformin in high-fat diet-fed mice. Interestingly, C22:0 ceramide bound to mitochondrial fission factor to induce mitochondrial fragmentation and impair hepatic oxidative phosphorylation in P. vulgatus-colonized hyperglycaemic mice, which could be exacerbated by metformin. This work suggests that metformin may be unsuitable for P. vulgatus-rich T2DM patients and that clinicians should be aware of metformin toxicity to mitochondria. Suppressing P. vulgatus growth with cefaclor or improving mitochondrial function using adenosylcobalamin may represent simple, safe, effective therapeutic strategies for addressing MMF.
5.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.
6.Formulation and Explanation of the Standards for Hospital Pharmacy Research
Yan LI ; Shiting LIU ; Yilei LI ; Wei ZHANG ; Weiyi FENG ; Yalin DONG ; Rongsheng ZHAO ; Wan-sheng CHEN ; Houwen LIN ; Jin LU ; Boxin ZHAO ; Xin HUANG ; Jiancun ZHEN
Herald of Medicine 2025;44(5):716-719
Hospital pharmacy research is significant in enhancing the level of rational drug use,improving the quality of pharmacy services,and promoting the improvement of drug treatment effects.To guarantee the standardization of hospital pharmacy research,the compilation team of"Hospital Pharmacy Research Standards"adheres to the principles of scientificity,universality,guidance,and operability,combs through the key management contents from three aspects,namely,relevant national policy docu-ments,relevant domestic and international standards and norms,and literature analysis,combines with the actual working condition of hospital pharmacy research,and formulates the standards after several rounds of opinion collection and expert argumentation.This paper analyzes the key contents of the standard,including basic requirements,research process management,and research re-sults management,to provide guidance and reference for hospital pharmacy researchers to understand the standard in-depth and further improve the standardization of hospital pharmacy research.
7.Effect of aflatoxin B1 on replication of porcine delta coronavirus infection
Yifan FENG ; Qinghao LI ; Manxi WANG ; Yuqing TANG ; Ming LI ; Qian-qian GUO ; Juan SUN ; Yilei LI ; Xin JIN
Chinese Journal of Veterinary Science 2025;45(2):187-194
This study aims to investigate the effects of aflatoxin B1(AFB1)on the infection and replication of porcine delta coronavirus(PDCoV).Porcine small intestinal epithelial cells(IPEC-J2),porcine kidney cells(LLC-PK)and swine testis cells(ST)were used as models,and CCK-8 method was used to detect the safe mass concentration range of AFB1 on the three cell lines.Each cell line was divided into the blank control group,AFB1 treatment group,PDCoV treatment group and AFB1 and the PDCoV co-treatment group.The cells were treated with safe mass concentration of AFB1 for 12 h,and then treated with PDCoV for 20 h.Total RNA and total protein were extrac-ted from the cells.The effects of AFB1 on PDCoV infection and replication were detected by qPCR,Western blot and cell immunofluorescence tests.The results showed that compared with the PDCoV treatment group,the mRNA and N protein of viral S protein in the AFB1 and PDCoV co-treatment group were significantly increased(P<0.05),and a significantly higher fluorescence of PDCoV N protein is also visibly present in the co-treatment group,and there was a significant difference between the two groups.The results showed that AFB1 could promote the infection and replication of PDCoV.It provides important data that AFB1 can promote the infection replication of PDCoV and provides a new idea for the prevention and treatment of PDCoV.
8.Effect of aflatoxin B1 on replication of porcine delta coronavirus infection
Yifan FENG ; Qinghao LI ; Manxi WANG ; Yuqing TANG ; Ming LI ; Qian-qian GUO ; Juan SUN ; Yilei LI ; Xin JIN
Chinese Journal of Veterinary Science 2025;45(2):187-194
This study aims to investigate the effects of aflatoxin B1(AFB1)on the infection and replication of porcine delta coronavirus(PDCoV).Porcine small intestinal epithelial cells(IPEC-J2),porcine kidney cells(LLC-PK)and swine testis cells(ST)were used as models,and CCK-8 method was used to detect the safe mass concentration range of AFB1 on the three cell lines.Each cell line was divided into the blank control group,AFB1 treatment group,PDCoV treatment group and AFB1 and the PDCoV co-treatment group.The cells were treated with safe mass concentration of AFB1 for 12 h,and then treated with PDCoV for 20 h.Total RNA and total protein were extrac-ted from the cells.The effects of AFB1 on PDCoV infection and replication were detected by qPCR,Western blot and cell immunofluorescence tests.The results showed that compared with the PDCoV treatment group,the mRNA and N protein of viral S protein in the AFB1 and PDCoV co-treatment group were significantly increased(P<0.05),and a significantly higher fluorescence of PDCoV N protein is also visibly present in the co-treatment group,and there was a significant difference between the two groups.The results showed that AFB1 could promote the infection and replication of PDCoV.It provides important data that AFB1 can promote the infection replication of PDCoV and provides a new idea for the prevention and treatment of PDCoV.
9.Analysis of the Interaction Effect between the"New Talent Policy"and the Retention of Grassroot Health Personnel
Zhaoxu LI ; Lifeng WEI ; Yilei ZHAO
Chinese Hospital Management 2025;45(12):48-50
Objective To analyze the interaction effect between the new talent policy and the retention of healthcare personnel,and propose suggestions for improving talent administration.Methods Grassroot health personnel in 12 prefecture level cities in Zhejiang,Sichuan,and Henan Provinces were selected as the research subjects.Policy text analysis and multilevel linear models were used to analyze the interaction effect between talent policies and healthcare workforce retention.Results A total of 2 156 grassroots health personnel completed the survey.The completeness of policy tools had a significant positive impact on retention(coefficient=0.23,P<0.001),and the stability of institutional environment also showed a positive impact(coefficient=0.18,P=0.002);Meanwhile,the stability of the institutional environment positively moderated the relationship between occupational commitment and retention(interaction coefficient=0.12,P=0.003).lndividuals with high human capital were more susceptible to the influence of career development tools(coefficient=0.27,P<0.001),while those with low human capital relied more on basic security tools(coefficient=0.21,P<0.001).Conclusion The interactive effect between the new talent policy and the retention of grassroots health personnel was confirmed.The new talent policy should focus on improving the completeness of policy tools and the stability of the institutional environment.
10.Safety of early antiplatelet therapy for non-cardioembolic mild stroke patients with thrombocytopenia
Dongjuan XU ; Huan ZHOU ; Mengmeng HU ; Yilei SHEN ; Hongfei LI ; Lianyan WEI ; Jing XU ; Zhuangzhuang JIANG ; Xiaoli SHAO ; Zhenhua XI ; Songbin HE ; Min LOU ; Shaofa KE
Journal of Zhejiang University. Medical sciences 2024;53(2):175-183
Objective:To investigate the safety of early antiplatelet therapy for non-cardioembolic mild stroke patients with thrombocytopenia.Methods:Data of acute ischemic stroke patients with baseline National Institutes of Health Stroke Scale(NIHSS)score≤3 and a platelet count<100×109/L were obtained from a multicenter register.Those who required anticoagulation or had other contraindications to antiplatelet therapy were excluded.Short-term safety outcomes were in-hospital bleeding events,while the long-term safety outcome was a 1-year all-cause death.The short-term neurological outcomes were evaluated by modified Rankin scale(mRS)score at discharge.Results:A total of 1868 non-cardioembolic mild stroke patients with thrombocytopenia were enrolled.Multivariate regression analyses showed that mono-antiplatelet therapy significantly increased the proportion of mRS score of 0-1 at discharge(OR=1.657,95%CI:1.253-2.192,P<0.01)and did not increase the risk of intracranial hemorrhage(OR=2.359,95%CI:0.301-18.503,P>0.05),compared with those without antiplatelet therapy.However,dual-antiplatelet therapy did not bring more neurological benefits(OR=0.923,95%CI:0.690-1.234,P>0.05),but increased the risk of gastrointestinal bleeding(OR= 2.837,95%CI:1.311-6.136,P<0.01)compared with those with mono-antiplatelet therapy.For patients with platelet counts≤75×109/L and>90×109/L,antiplatelet therapy significantly improved neurological functional outcomes(both P<0.05).For those with platelet counts(>75-90)×109/L,antiplatelet therapy resulted in a significant improvement of 1-year survival(P<0.05).For patients even with concurrent coagulation abnormalities,mono-antiplatelet therapy did not increase the risk of various types of bleeding(all P>0.05)but improved neurological functional outcomes(all P<0.01).There was no significant difference in the occurrence of bleeding events,1-year all-cause mortality risk,and neurological functional outcomes between aspirin and clopidogrel(all P>0.05).Conclusions:For non-cardioembolic mild stroke patients with thrombocytopenia,antiplatelet therapy remains a reasonable choice.Mono-antiplatelet therapy has the same efficiency as dual-antiplatelet therapy in neurological outcome improvement with lower risk of gastrointestinal bleeding.

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