1.Signals mining and analysis of deucravacitinib adverse drug events based on FAERS database
Ye HU ; Qineng GONG ; Linlin ZHANG ; Aming WANG ; Wang QI ; Yang MIAO
Chinese Journal of Pharmacoepidemiology 2025;34(4):419-427
Objective To mine adverse drug event(ADE)signals of deucravacitinib,and to guide its rational clinical use.Methods ADE reports reported to the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database from the third quarter of 2022 to the third quarter of 2024 were collected,ADE reports with deucravacitinib as the primary suspect drug were selected for analysis.ADE signals were identified using reporting adds ratios method and Bayesian confidence propagation neural networks method.Results A total of 1,777 ADE reports were collected involving 3,258 ADEs.Sixty-two ADE signals were identified,spanning 14 system-organ classifications.The top five ADE signals based on the number of reported cases were acne,oral ulcers,folliculitis,urticaria,and oral pain.The top five ADE signals based on signal intensity were cystic acne,hepatitis A,acne vulgaris,pustular acne,and folliculitis.ADE signals such as pigmenturia,hepatitis A,and gingival swelling were not included in the drug instructions.The median duration of ADEs associated with deucravacitinib was 22 days,with 58.33%occurring within the first month of treatment.Women may have a higher risk of developing acne than men.Conclusions When using deutericolaxitinib,healthcare professionals should focus on skin and subcutaneous tissue disorders,gastrointestinal system disorders,and infections and infestations to monitor the occurrence of acne in female patients.The latent ADEs that are not mentioned in the instructions should be remained vigilant to ensure safe drug use.
2.Signals mining and analysis of deucravacitinib adverse drug events based on FAERS database
Ye HU ; Qineng GONG ; Linlin ZHANG ; Aming WANG ; Wang QI ; Yang MIAO
Chinese Journal of Pharmacoepidemiology 2025;34(4):419-427
Objective To mine adverse drug event(ADE)signals of deucravacitinib,and to guide its rational clinical use.Methods ADE reports reported to the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database from the third quarter of 2022 to the third quarter of 2024 were collected,ADE reports with deucravacitinib as the primary suspect drug were selected for analysis.ADE signals were identified using reporting adds ratios method and Bayesian confidence propagation neural networks method.Results A total of 1,777 ADE reports were collected involving 3,258 ADEs.Sixty-two ADE signals were identified,spanning 14 system-organ classifications.The top five ADE signals based on the number of reported cases were acne,oral ulcers,folliculitis,urticaria,and oral pain.The top five ADE signals based on signal intensity were cystic acne,hepatitis A,acne vulgaris,pustular acne,and folliculitis.ADE signals such as pigmenturia,hepatitis A,and gingival swelling were not included in the drug instructions.The median duration of ADEs associated with deucravacitinib was 22 days,with 58.33%occurring within the first month of treatment.Women may have a higher risk of developing acne than men.Conclusions When using deutericolaxitinib,healthcare professionals should focus on skin and subcutaneous tissue disorders,gastrointestinal system disorders,and infections and infestations to monitor the occurrence of acne in female patients.The latent ADEs that are not mentioned in the instructions should be remained vigilant to ensure safe drug use.
3.Single-leg Static Postural Balance in Individuals with or Without Unilateral Functional Ankle Instability
Qiuxia ZHANG ; Yicheng GU ; Yang ZHANG ; Guodong WANG ; Aming LU
Chinese Journal of Sports Medicine 2018;37(5):377-383
Objective To explore the static postural balance in individuals with or without functional ankle instability (FAI)by identifying and quantifying the spatial characteristics of center of pressure (COP),as well as rambling and trembling trajectory properties.Methods Twelve FAI patients was selected into the FAI group,while another 14 healthy students were chosen into the control group.The single-leg standing test with and without vision was conducted on the unstable side of the FAI group and the non-dominant side of the control group 3 trials with each trial lasting 30 s.The displacement of COP and the time and frequency domain of rambling and trembling were analyzed and compared between the two groups.Results There was no significant difference in the displacement of COP with opened eyes(P>0.05).The area and the anterior-posterior length of COP of the FAI group were larger than those of the control group with eyes closed (P<0.05).For the rambling and trembling trajectory,no significant differences were found in all the time domains between the two groups with eyes open or closed(P>0.05),except the mean sway amplitude(MSA)(P<0.05).Moreover,the mean square root and standard deviation of MSA of the FAI group were significantly bigger than the control group(P< 0.05).Significant differences were found in the MSA frequency between open and closed eyes(P>0.05),but not between the FAI and control groups(P<0.05).Conclusions The FAI patients are weaker than healthy people not only in the peripheral control,but also in the central control of the static postural balance.Therefore,injuries in the central neural system must also be considered when analyzing the reason for FAI.The imbalance of the FAI patients can be avoided by opening eyes.
4.Establishment and Application of Evaluation Criteria on Rational Use of Human Serum Albumin in Our Hospital
Ting ZHANG ; Hui WU ; Hailin BIAN ; Hongxia WANG ; Feng QI ; Xiao WEI ; Wang QI ; Aming WANG
China Pharmacy 2016;27(20):2752-2755
OBJECTIVE:To establish the Evaluation Criteria on Rational Use of Human Serum Albumin(HSA)in our hospi-tal,and to provide refereuce for rational use of HSA. METHODS:Referring to drug utilization evaluation(DUE)criteria of WHO and developed countries,based on the guideline of HSA use,Human Serum Albumin,Non-protein Colloid and Crystalloid Solu-tion Guidelines of USA University Hospital Consortium,Blood Products Prescription Evaluation Guideline of Beijing area,etc., Evaluation Criteria on Rational Use of HAS was established through experts discussion,and the use of HAS in 420 patients of our hospital were evaluated. RESULTS:The Evaluation Criteria on Rational Use of HSA mainly included indication,contraindication, usage and dosage,drug combination,incompatibility,etc. 414 patients (98.57%) detected serum albumin concentration before treatment;167 patients(39.76%)were in line with the indication;56 patients(13.33%)had contraindication in using HSA;352 patients(83.81%)met the criteria in usage and dosage,duration of treatment;there were 17 cases(4.05%)of unreasonable drug combination and 3 cases(0.71%)of incompatibility. CONCLUSIONS:The established criteria has strong practicability,and some problems and insufficiencies can be found in the clinical practice,is conducive to promote rational drug use in the clinic.

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