1.Analysis of adverse reaction reports on Xuesaitong (血塞通) preparations and mining of coagulation disorders/bleeding risk signals
Wenwen GAO ; Lubo GUO ; Yanjun XIE ; Qiuhong ZHANG ; Xia LI ; Yanhui YIN
Adverse Drug Reactions Journal 2025;27(8):479-485
Objective:To investigate the occurrence and characteristics of adverse reactions of Xuesaitong preparations, mine its coagulation disorders/bleeding risk signals, and provide references for its safe and rational use in clinic. Methods:The reports of adverse drug reactions (ADR) caused by Xuesaitong preparations from August 2003 to August 2023 in the database of Shandong Provincial Center of Adverse Drug Reaction Monitoring were collected. ADR were counted and classified using the system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities 26.1. Three methods, namely the reporting odds ratio (ROR), the proportional reporting ratio (PRR), and the comprehensive standard method of the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom, were used to detect the risk signals of coagulation disorders/bleeding in using Xuesaitong preparations. Results:A total of 17 015 reports of ADR related to Xuesaitong preparations were collected, involving 9 dosage forms, in which injection dosage form accounted for 95.50% (16 250/17 015). The median age of the patients was 62 years, 44.87% of the cases were 45-64 years and 42.90% of them were 65 years and above. There were 2 217 cases of severe ADR reports, accounting for 13.03% (2 217/17 015). A total of 18 SOCs were involved, the top 3 were skin and subcutaneous tissue diseases, systemic diseases and drug administration site reactions, and neurological diseases. A total of 54 PTs were not recorded in the instructions, among which 34 were severe. Ninety-three cases about coagulation disorders/bleeding (98 times) were reported, the top 3 PTs were hematuria [24.49% (24/98)], purpura [11.22% (11/98)], and epistaxis [10.20% (10/98)]. Seven dosage forms of Xuesaitong preparations were involved, the top 3 were Xuesaitong for injection (freeze-dried) (48 cases, accounting for 51.61%), Xuesaitong injection (29 cases, accounting for 31.18%), and Xuesaitong tablets (8 cases, accounting for 8.60%). Among 93 reports of coagulation disorders/bleeding, there were 23 severe cases, accounting for 24.73%, which was significantly higher than that in other reports (12.97%), and the difference was statistically significant ( P<0.001). Sixteen PTs about coagulation disorders/bleeding were not recorded in the instructions, among which 9 were severe. The proportion of cases with onset time longer than 7 days in ADRs about coagulation disorders/bleeding was higher than that in other ADRs [22.58%(21/93) vs. 7.43%(1 258/16 922), P<0.001]. The risk signals of coagulation disorders/bleeding were mined for Xuesaitong for injection (freeze-dried), Xuesaitong injection, Xuesaitong tablets, and Xuesaitong capsules, and the risk signal density of Xuesaitong tablets was the strongest. Conclusions:The ADRs of Xuesaitong preparations involve multiple systems and organs. Among them, Xuesaitong for injection (freeze-dried), Xuesaitong injection, Xuesaitong tablets, and Xuesaitong capsules have a strong association with coagulation disorders/bleeding risks, and the proportion of severe cases is relatively high. However, the relevant risk warning information is not included in the drug instructions of some manufacturers. Medication monitoring needs to be strengthened and timely intervention should be carried out in clinic.
2.Risk signal mining of adverse reactions to triazole antifungal drugs: a comparative study on domestic and foreign adverse drug reaction/event reports
Jinxia ZHAO ; Yanjun XIE ; Shen′ao JING ; Ying ZHANG ; Nannan SUN ; Xia LI ; Yi HAN
Adverse Drug Reactions Journal 2025;27(8):472-478
Objective:To detect adverse reaction risk signals of triazole antifungal agents and provide evidences for their safe use in clinic.Methods:Adverse reaction/event reports with fluconazole, itraconazole, voriconazole, posaconazole, or isavuconazonium as the primary suspect drug were collected from the data in National Adverse Drug Reaction Monitoring System of China reported by Shandong Province from January 2004 to June 2024 and the US Food and Drug Administration Adverse Event Reporting System (FAERS) database from the first quarter of 2004 to the second quarter of 2023. Adverse reaction/event terms were standardized using the preferred term (PT) and system organ class in Medical Dictionary for Regulatory Activities 24.0. Risk signals were detected using the reporting odds ratio (ROR) method and the Bayesian confidence propagation neural network (BCPNN) algorithm. A PT was defined as an adverse reaction risk signal if the number of reports was ≥3, the lower limit of the 95% confidence interval ( CI) for ROR was >2, and the lower limit of the 95% CI for the information component ( IC) was >0. Descriptive statistical analysis was performed. Results:A total of 3 988 reports with the above 5 antifungal drugs as the primary suspect drug were collected from data in National Adverse Drug Reaction Monitoring System of China reported by Shandong Province, 822 (20.6%) of which were serious cases. Voriconazole, fluconazole, itraconazole, posaconazole, and isavuconazonium was the primary suspect drug in 1 852, 1 395, 703, 27, and 11 cases among the 3 988 reports, and in 591 (31.9%), 149 (10.7%), 59 (8.4%), 18 (66.7%), and 5 (5/11) serious cases among the 822 serious case reports, respectively. A total of 20 066 reports with the above 5 drugs as the primary suspect drug were collected in FAERS database, 9 635 (48.0%) of which were serious cases. Voriconazole, fluconazole, itraconazole, posaconazole, and isavuconazonium was the primary suspect drug in 7 758, 6 180, 2 869, 1 796, and 1 463 cases among the 20 066 reports, and in 4 295 (55.4%), 2 806 (45.4%), 1 191 (41.5%), 828 (46.1%), and 515 (35.2%) serious cases among the 9 635 serious case reports, respectively. Based on the data reported by Shandong Province and in FAERS database, 18 and 207 risk signals of adverse reaction not mentioned in the labels were identified, respectively, and 5 of them were identified in both databases, including fluconazole-induced renal impairment and voriconazole-induced oliguria, delirium, psychiatric disorders, and rhabdomyolysis. In the data reported by Shandong Province and in FAERS database, 13 and 189 reports of muscle-related disorders (rhabdomyolysis, myopathy, and myositis) were identified respectively, involving voriconazole (in 8 and 62 cases), itraconazole (in 4 and 74 cases), and fluconazole (in 1 and 53 cases).Conclusions:Renal impairment induced by fluconazole and oliguria, delirium, psychiatric disorders, and rhabdomyolysis induced by voriconazole are risk signals of adverse reaction not mentioned in the labels for triazole antifungal agents. Voriconazole, itraconazole, and fluconazole may also cause muscle-related disorders, warranting vigilance in clinical practice.
3.Analysis of adverse reaction reports on Xuesaitong (血塞通) preparations and mining of coagulation disorders/bleeding risk signals
Wenwen GAO ; Lubo GUO ; Yanjun XIE ; Qiuhong ZHANG ; Xia LI ; Yanhui YIN
Adverse Drug Reactions Journal 2025;27(8):479-485
Objective:To investigate the occurrence and characteristics of adverse reactions of Xuesaitong preparations, mine its coagulation disorders/bleeding risk signals, and provide references for its safe and rational use in clinic. Methods:The reports of adverse drug reactions (ADR) caused by Xuesaitong preparations from August 2003 to August 2023 in the database of Shandong Provincial Center of Adverse Drug Reaction Monitoring were collected. ADR were counted and classified using the system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities 26.1. Three methods, namely the reporting odds ratio (ROR), the proportional reporting ratio (PRR), and the comprehensive standard method of the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom, were used to detect the risk signals of coagulation disorders/bleeding in using Xuesaitong preparations. Results:A total of 17 015 reports of ADR related to Xuesaitong preparations were collected, involving 9 dosage forms, in which injection dosage form accounted for 95.50% (16 250/17 015). The median age of the patients was 62 years, 44.87% of the cases were 45-64 years and 42.90% of them were 65 years and above. There were 2 217 cases of severe ADR reports, accounting for 13.03% (2 217/17 015). A total of 18 SOCs were involved, the top 3 were skin and subcutaneous tissue diseases, systemic diseases and drug administration site reactions, and neurological diseases. A total of 54 PTs were not recorded in the instructions, among which 34 were severe. Ninety-three cases about coagulation disorders/bleeding (98 times) were reported, the top 3 PTs were hematuria [24.49% (24/98)], purpura [11.22% (11/98)], and epistaxis [10.20% (10/98)]. Seven dosage forms of Xuesaitong preparations were involved, the top 3 were Xuesaitong for injection (freeze-dried) (48 cases, accounting for 51.61%), Xuesaitong injection (29 cases, accounting for 31.18%), and Xuesaitong tablets (8 cases, accounting for 8.60%). Among 93 reports of coagulation disorders/bleeding, there were 23 severe cases, accounting for 24.73%, which was significantly higher than that in other reports (12.97%), and the difference was statistically significant ( P<0.001). Sixteen PTs about coagulation disorders/bleeding were not recorded in the instructions, among which 9 were severe. The proportion of cases with onset time longer than 7 days in ADRs about coagulation disorders/bleeding was higher than that in other ADRs [22.58%(21/93) vs. 7.43%(1 258/16 922), P<0.001]. The risk signals of coagulation disorders/bleeding were mined for Xuesaitong for injection (freeze-dried), Xuesaitong injection, Xuesaitong tablets, and Xuesaitong capsules, and the risk signal density of Xuesaitong tablets was the strongest. Conclusions:The ADRs of Xuesaitong preparations involve multiple systems and organs. Among them, Xuesaitong for injection (freeze-dried), Xuesaitong injection, Xuesaitong tablets, and Xuesaitong capsules have a strong association with coagulation disorders/bleeding risks, and the proportion of severe cases is relatively high. However, the relevant risk warning information is not included in the drug instructions of some manufacturers. Medication monitoring needs to be strengthened and timely intervention should be carried out in clinic.
4.Risk signal mining of adverse reactions to triazole antifungal drugs: a comparative study on domestic and foreign adverse drug reaction/event reports
Jinxia ZHAO ; Yanjun XIE ; Shen′ao JING ; Ying ZHANG ; Nannan SUN ; Xia LI ; Yi HAN
Adverse Drug Reactions Journal 2025;27(8):472-478
Objective:To detect adverse reaction risk signals of triazole antifungal agents and provide evidences for their safe use in clinic.Methods:Adverse reaction/event reports with fluconazole, itraconazole, voriconazole, posaconazole, or isavuconazonium as the primary suspect drug were collected from the data in National Adverse Drug Reaction Monitoring System of China reported by Shandong Province from January 2004 to June 2024 and the US Food and Drug Administration Adverse Event Reporting System (FAERS) database from the first quarter of 2004 to the second quarter of 2023. Adverse reaction/event terms were standardized using the preferred term (PT) and system organ class in Medical Dictionary for Regulatory Activities 24.0. Risk signals were detected using the reporting odds ratio (ROR) method and the Bayesian confidence propagation neural network (BCPNN) algorithm. A PT was defined as an adverse reaction risk signal if the number of reports was ≥3, the lower limit of the 95% confidence interval ( CI) for ROR was >2, and the lower limit of the 95% CI for the information component ( IC) was >0. Descriptive statistical analysis was performed. Results:A total of 3 988 reports with the above 5 antifungal drugs as the primary suspect drug were collected from data in National Adverse Drug Reaction Monitoring System of China reported by Shandong Province, 822 (20.6%) of which were serious cases. Voriconazole, fluconazole, itraconazole, posaconazole, and isavuconazonium was the primary suspect drug in 1 852, 1 395, 703, 27, and 11 cases among the 3 988 reports, and in 591 (31.9%), 149 (10.7%), 59 (8.4%), 18 (66.7%), and 5 (5/11) serious cases among the 822 serious case reports, respectively. A total of 20 066 reports with the above 5 drugs as the primary suspect drug were collected in FAERS database, 9 635 (48.0%) of which were serious cases. Voriconazole, fluconazole, itraconazole, posaconazole, and isavuconazonium was the primary suspect drug in 7 758, 6 180, 2 869, 1 796, and 1 463 cases among the 20 066 reports, and in 4 295 (55.4%), 2 806 (45.4%), 1 191 (41.5%), 828 (46.1%), and 515 (35.2%) serious cases among the 9 635 serious case reports, respectively. Based on the data reported by Shandong Province and in FAERS database, 18 and 207 risk signals of adverse reaction not mentioned in the labels were identified, respectively, and 5 of them were identified in both databases, including fluconazole-induced renal impairment and voriconazole-induced oliguria, delirium, psychiatric disorders, and rhabdomyolysis. In the data reported by Shandong Province and in FAERS database, 13 and 189 reports of muscle-related disorders (rhabdomyolysis, myopathy, and myositis) were identified respectively, involving voriconazole (in 8 and 62 cases), itraconazole (in 4 and 74 cases), and fluconazole (in 1 and 53 cases).Conclusions:Renal impairment induced by fluconazole and oliguria, delirium, psychiatric disorders, and rhabdomyolysis induced by voriconazole are risk signals of adverse reaction not mentioned in the labels for triazole antifungal agents. Voriconazole, itraconazole, and fluconazole may also cause muscle-related disorders, warranting vigilance in clinical practice.
5.Construction and characterization of adjustable stiffness hydrogels based on gelatin methacryloyl
Yanjun FENG ; Xia LIU ; Haiyue JIANG
Chinese Journal of Plastic Surgery 2024;40(11):1149-1156
Objective:To construct adjustable stiffness hydrogels based on gelatin methacryloyl (GelMA), in order to better simulate the growth environment under physiological conditions.Methods:SYLGARD 184 silicone rubber was used to prepare adjustable stiffness hydrogels. The stiffness values of the adjustable stiffness hydrogels prepared with GelMA of different grafting rates (30%, 60%, 90%) at various concentrations (5%, 10%, 15%) were quantified using Young’s modulus. Based on the result, the optimal grafting rate GelMA was selected as the material for constructing the adjustable stiffness hydrogels. The relationship between the concentration (2%, 3%, 5%, 6%, 8%, 10%, 15%) of 90% grafting rate (GM90) and the stiffness after photopolymerization was determined by measuring the Young’s modulus of GelMA at different concentrations and fitting the data. Three groups of suitable concentrations were chosen to construct three different stiffness hydrogels. After soaking in phosphate-buffered saline for 48 hours, various samples underwent biomechanical measurements, internal pore structure observation, atomic force microscopy to measure parameters such as Young’s modulus, pore size and surface roughness. Rheological tests were carried out, curves were drawn according to the energy storage modulus and loss modulus, and shear frequencies of the intersection points of the two curves were observed at each concentration to evaluate the ability of hydrogel to maintain its morphology. Data analysis was performed using GraphPad Prism 8.0.2 software. Quantitative data were expressed as Mean±SD, and one-way ANOVA was used for comparison among multiple groups, and LSD method was used for pairwise comparison. Statistical significance was set at P<0.05. Results:Increasing the grafting rate and concentration of GelMA hydrogels effectively enhanced their stiffness. GelMA with a GM90 provided a broader range of stiffness, making it suitable for constructing the adjustable stiffness hydrogels. Fitting curves of GM90 concentrations and stiffness after photopolymerization showed that at concentrations of 2%, 6%, and 15%, GelMA could mimic the stiffness of various tissues of human. Therefore, these three concentrations were selected for subsequent experiments. The Young’s modulus of GM90 at concentrations of 15%, 6% and 2% were (98.43±7.71), (14.57±1.62), and (2.11±0.32) kPa, respectively, with statistically significant differences between each pair of groups ( P<0.01). The pore sizes were (41.32±3.51), (3.26±0.33), and (1.21±0.11) μm, respectively, showing significant differences between each pair of groups ( P<0.01). Surface roughness values were (48.15±2.65), (22.65±1.78), and (24.12±1.43) nm, respectively, with 15% concentration showing significantly higher roughness than the 2% and 6% concentrations ( P<0.01), while there was no significant difference between the 2% and 6% concentrations ( P>0.05). Rheological testing indicated that as the concentration decreased, the shear frequency at the crossover point of the storage modulus and loss modulus of GM90 hydrogels decreased, >100, 30 and 18 Hz, respectively. The result showed that the solid form of GM90 hydrogel with 15% concentration was more stable, while the hydrogel with 2% concentration had better fluidity. Conclusion:Adjusting the grafting rate and concentration can regulate the stiffness of GelMA hydrogels. GelMA hydrogels with a 90% grafting rate provide a wide range of stiffness, making them ideal materials for constructing hydrogels with adjustable stiffness. At concentrations of 2%, 6%, and 15%, GM90 exhibited different mechanical properties and internal structures.
6.Construction and characterization of adjustable stiffness hydrogels based on gelatin methacryloyl
Yanjun FENG ; Xia LIU ; Haiyue JIANG
Chinese Journal of Plastic Surgery 2024;40(11):1149-1156
Objective:To construct adjustable stiffness hydrogels based on gelatin methacryloyl (GelMA), in order to better simulate the growth environment under physiological conditions.Methods:SYLGARD 184 silicone rubber was used to prepare adjustable stiffness hydrogels. The stiffness values of the adjustable stiffness hydrogels prepared with GelMA of different grafting rates (30%, 60%, 90%) at various concentrations (5%, 10%, 15%) were quantified using Young’s modulus. Based on the result, the optimal grafting rate GelMA was selected as the material for constructing the adjustable stiffness hydrogels. The relationship between the concentration (2%, 3%, 5%, 6%, 8%, 10%, 15%) of 90% grafting rate (GM90) and the stiffness after photopolymerization was determined by measuring the Young’s modulus of GelMA at different concentrations and fitting the data. Three groups of suitable concentrations were chosen to construct three different stiffness hydrogels. After soaking in phosphate-buffered saline for 48 hours, various samples underwent biomechanical measurements, internal pore structure observation, atomic force microscopy to measure parameters such as Young’s modulus, pore size and surface roughness. Rheological tests were carried out, curves were drawn according to the energy storage modulus and loss modulus, and shear frequencies of the intersection points of the two curves were observed at each concentration to evaluate the ability of hydrogel to maintain its morphology. Data analysis was performed using GraphPad Prism 8.0.2 software. Quantitative data were expressed as Mean±SD, and one-way ANOVA was used for comparison among multiple groups, and LSD method was used for pairwise comparison. Statistical significance was set at P<0.05. Results:Increasing the grafting rate and concentration of GelMA hydrogels effectively enhanced their stiffness. GelMA with a GM90 provided a broader range of stiffness, making it suitable for constructing the adjustable stiffness hydrogels. Fitting curves of GM90 concentrations and stiffness after photopolymerization showed that at concentrations of 2%, 6%, and 15%, GelMA could mimic the stiffness of various tissues of human. Therefore, these three concentrations were selected for subsequent experiments. The Young’s modulus of GM90 at concentrations of 15%, 6% and 2% were (98.43±7.71), (14.57±1.62), and (2.11±0.32) kPa, respectively, with statistically significant differences between each pair of groups ( P<0.01). The pore sizes were (41.32±3.51), (3.26±0.33), and (1.21±0.11) μm, respectively, showing significant differences between each pair of groups ( P<0.01). Surface roughness values were (48.15±2.65), (22.65±1.78), and (24.12±1.43) nm, respectively, with 15% concentration showing significantly higher roughness than the 2% and 6% concentrations ( P<0.01), while there was no significant difference between the 2% and 6% concentrations ( P>0.05). Rheological testing indicated that as the concentration decreased, the shear frequency at the crossover point of the storage modulus and loss modulus of GM90 hydrogels decreased, >100, 30 and 18 Hz, respectively. The result showed that the solid form of GM90 hydrogel with 15% concentration was more stable, while the hydrogel with 2% concentration had better fluidity. Conclusion:Adjusting the grafting rate and concentration can regulate the stiffness of GelMA hydrogels. GelMA hydrogels with a 90% grafting rate provide a wide range of stiffness, making them ideal materials for constructing hydrogels with adjustable stiffness. At concentrations of 2%, 6%, and 15%, GM90 exhibited different mechanical properties and internal structures.
7.Signal mining of cardiotoxicity risk in arsenical for injection based on the database of Shandong Provincial Center of Adverse Drug Reaction Monitoring in China and the US FDA Adverse Event Reporting System database
Qiaoyan YI ; Yanjun XIE ; Yutong SHU ; Qiuhong ZHANG ; Yingmei QI ; Min LI ; Xia ZHAO ; Fengqin LIU ; Xia LI ; Yi HAN
Adverse Drug Reactions Journal 2024;26(3):133-137
Objective:To explore the adverse cardiac event risk signals in arsenical for injection, improve the clinical understanding of the cardiac toxicity of arsenical.Methods:The risk signals of adverse cardiac events associated with arsenical for injection were mined using 3 methods, including reporting odds ratio (ROR) method, proportional reporting ratio (PRR) method, and the Medicines and Healthcare Products Regulatory Agency (MHRA) comprehensive standard method based on data in Shandong Provincial Center of Adverse Drug Reaction Monitoring (Shandong data) in China from the first quarter of 2003 to the fourth quarter of 2022 and the data in US FDA Adverse Event Reporting System (FAERS) database from the fourth quarter of 2003 to the third quarter of 2023. The definition of risk signal in ROR and PRR method was the number of adverse event reports ≥3 and the lower limit of 95% confidence interval ( CI) of ROR and PRR >1. The definition of risk signals in MHRA comprehensive standard method was the number of adverse event reports ≥3, PRR>2, and χ2>4. Results:There were a total of 358 reports on arsenical for injection in Shandong data, of which 275 (76.8%) were related to arsenious acid and sodium chloride injection, and 83 (23.2%) were related to arsenic trioxide for injection. Among the 358 reports, adverse cardiac reactions were reported in 25 reports (7.0%), and severe cases accounted for 28.0% (7/25). There were a total of 1 294 reports on ATO in FAERS, and adverse cardiac events were reported in 418 reports (32.3%), of which severe cases accounted for 62.2% (260/418). The signal mining results form 275 reports on arsenious acid and sodium chloride injection in Shandong data showed that QT interval prolonged, chest tightness, cardiopalmus, and palpitations were risk signals. Among them, the signal strength of QT interval prolonged was the strongest. A total of 35 adverse cardiac event signals were mined in FAERS data, of which the signal strength of QT interval prolonged and long QT syndrome were the strongest. In addition, the strength of 6 arrhythmia signals (bradyarrhythmia, supraventricular premature contraction, ventricular premature contraction, torsade de pointes, ventricular tachycardia, and atrioventricular block) and 6 cardiac organic lesion signals (pericarditis, endocarditis, pericardial effusion, myocarditis, mitral regurgitation, and cardiac enlargement) also ranked high.Conclusions:Arsenical for injection is strongly associated with cardiotoxicity, and the proportion of severe cases is relatively high. The cardiotoxicity mainly affects the QT interval, and can also manifest as various types of arrhythmias and some cardiac organic lesions.
8.Signal mining of cardiotoxicity risk in arsenical for injection based on the database of Shandong Provincial Center of Adverse Drug Reaction Monitoring in China and the US FDA Adverse Event Reporting System database
Qiaoyan YI ; Yanjun XIE ; Yutong SHU ; Qiuhong ZHANG ; Yingmei QI ; Min LI ; Xia ZHAO ; Fengqin LIU ; Xia LI ; Yi HAN
Adverse Drug Reactions Journal 2024;26(3):133-137
Objective:To explore the adverse cardiac event risk signals in arsenical for injection, improve the clinical understanding of the cardiac toxicity of arsenical.Methods:The risk signals of adverse cardiac events associated with arsenical for injection were mined using 3 methods, including reporting odds ratio (ROR) method, proportional reporting ratio (PRR) method, and the Medicines and Healthcare Products Regulatory Agency (MHRA) comprehensive standard method based on data in Shandong Provincial Center of Adverse Drug Reaction Monitoring (Shandong data) in China from the first quarter of 2003 to the fourth quarter of 2022 and the data in US FDA Adverse Event Reporting System (FAERS) database from the fourth quarter of 2003 to the third quarter of 2023. The definition of risk signal in ROR and PRR method was the number of adverse event reports ≥3 and the lower limit of 95% confidence interval ( CI) of ROR and PRR >1. The definition of risk signals in MHRA comprehensive standard method was the number of adverse event reports ≥3, PRR>2, and χ2>4. Results:There were a total of 358 reports on arsenical for injection in Shandong data, of which 275 (76.8%) were related to arsenious acid and sodium chloride injection, and 83 (23.2%) were related to arsenic trioxide for injection. Among the 358 reports, adverse cardiac reactions were reported in 25 reports (7.0%), and severe cases accounted for 28.0% (7/25). There were a total of 1 294 reports on ATO in FAERS, and adverse cardiac events were reported in 418 reports (32.3%), of which severe cases accounted for 62.2% (260/418). The signal mining results form 275 reports on arsenious acid and sodium chloride injection in Shandong data showed that QT interval prolonged, chest tightness, cardiopalmus, and palpitations were risk signals. Among them, the signal strength of QT interval prolonged was the strongest. A total of 35 adverse cardiac event signals were mined in FAERS data, of which the signal strength of QT interval prolonged and long QT syndrome were the strongest. In addition, the strength of 6 arrhythmia signals (bradyarrhythmia, supraventricular premature contraction, ventricular premature contraction, torsade de pointes, ventricular tachycardia, and atrioventricular block) and 6 cardiac organic lesion signals (pericarditis, endocarditis, pericardial effusion, myocarditis, mitral regurgitation, and cardiac enlargement) also ranked high.Conclusions:Arsenical for injection is strongly associated with cardiotoxicity, and the proportion of severe cases is relatively high. The cardiotoxicity mainly affects the QT interval, and can also manifest as various types of arrhythmias and some cardiac organic lesions.
9. Expression and Clin ical Significance of B7-H5 in Ulcerative Colitis
Lu XIA ; Yanjun CHEN ; Yuqi CHEN ; Juntao LI ; Jiayu WANG ; Linqing SUN ; Jinghan ZHU ; Tongguo SHI ; Qinhua XI ; Rui LI ; Lu XIA ; Yanjun CHEN ; Yuqi CHEN ; Juntao LI ; Jiayu WANG ; Linqing SUN ; Jinghan ZHU ; Tongguo SHI ; Rui LI ; Lu XIA ; Yanjun CHEN ; Yuqi CHEN ; Juntao LI ; Jiayu WANG ; Linqing SUN ; Jinghan ZHU ; Tongguo SHI ; Rui LI ; Lu XIA ; Yanjun CHEN ; Yuqi CHEN ; Juntao LI ; Jiayu WANG ; Linqing SUN ; Jinghan ZHU ; Tongguo SHI ; Rui LI
Chinese Journal of Gastroenterology 2022;27(1):21-25
Background: The incidence of ulcerative colitis (UC) has gradually increased in China in recent years. The pathogenesis of UC is related to the dysfunction of immune system. B7-H5 is an important immune checkpoint molecule and is significant for the regulation of immune function. Ainis: To investigate the expression and clinical significance of B7-H5 in UC. Methods: A total of 65 UC tissue specimens were collected from Jan. 2010 to Dec. 2020 at the First Affiliated Hospital of Soochow University, and 5 healthy subjects were served as controls. Immunohistoehemistry and immunofluorescence were used to detect the expression of B7-H5, and its relationship with elinieopathologieal characteristics of UC patients was analyzed. Results: Expression of B7-H5 was significantly increased in UC patients than in controls (P < 0. 001). B7-H5 expression in UC patients was positively correlated with ESR and CRP (P < 0. 01), but not related to gender, age, extent of lesion, Mayo score and UCEIS score (P > 0. 05). Conclusions; The expression of B7-H5 in UC patients is significantly increased and is correlated with ESR and CRP, and can be used as a new marker for reflecting the severity of inflammation in UC patients.
10.Thevalueofdynamicenhanced MRIimaginginthedifferentialdiagnosis betweenbenignIPandIP malignanttransformation
Jingge YU ; Hao YAN ; Yanjun LIU ; Pengtao LIU ; Shuang XIA
Journal of Practical Radiology 2019;35(3):362-366
Objective ToinvestigatethevalueofDCEGMRIimagingindifferentiatingmalignanttransformationinvertedpapilloma (IP)frombenignIP.Methods 24casesofIPconfirmedbyoperationandpathologywerecollectedfromJanuary2012toJanuary 2018,including14caseswithbenignIPand10patientswithIP malignanttransformation.Thedynamicenhancementparametersof thetwogroups,theproductoftransferconstant(Ktrans),therefluxrateconstant(Kep),theextravascularextracellularspacevolume fraction (Ve)andthedifferenceoftheareaundertheinitialcurve(iAUC)wereanalyzed.Thesensitivityandspecificityofdifferent parametersintheidentificationofbenignIPandIP malignancytransformationwereevaluated.Results Thereweredifferencesno significantdifferenceinageandsexbetweenbenignIPgroupandIPmalignanttransformationgroup.Therewasasignificantdifference abouttheconvolutedcerebriformpatternbetweenthetwogroups(P=0.004).Therewasnosignificantdifferenceofstagingbetween thetwogroups(P=0.136).TheKtransvaluesofbenignIPgroupandIPmalignanttransformationgroupwere0.21±0.53 (min-1), 0.36±0.93 (min-1),andtherewasasignificantdifferencebetweenthetwogroups(P=0.000).TheiAUCvaluesofbenignIPgroupand IP malignanttransformationgroupwere29.05±5.45,41.14±9.47,respectively,andthedifferenceofiAUCbetweentwogroupswas statisticallysignificant(P=0.001).TherewasnosignificantdifferenceinKepandVebetweenbenignIPfromIPmalignanttransformation (P>0.05).Conclusion BenignIPhasatypicalconvolutedcerebriG formpatternandtheabsenceofitindicatesmalignanttransformation. Thestagingoflesioncan’tdifferentiatethebenignIPfromIP malignanttransformation.DCEGMRIexaminationisworthyinthe evaluationbenignIPandIP malignanttransformation,especiallyKtransandiAUCvalues.

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