1.New Recognition of the Tongue Characteristics of Blood Stasis Constitution:Purple Tongue and Tortuous Sublingual Vessel
Wanning ZHOU ; Junhan YANG ; Shiqi ZHANG ; Jishi WANG ; Xueshan QI ; Han WANG ; Xiaojing LI ; Yanyun ZHANG ; Xiangze LI ; Zhe ZHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(6):1758-1765
Objective Based on the general belief that the tongue characteristics of blood stasis constitution is"purple tongue,tortuous sublingual vessels",this study systematically summarized blood stasis tongue characteristics using artificial intelligence image processing combined with expert evaluation.Methods A physical questionnaire survey was conducted on 1275 college students,and 100 cases were randomly selected from the blood stasis constitution group and the mild constitution group.After collecting the tongue images,Unet,OpenCV,YOLOv5 and YOLOv8 algorithms combined with expert evaluation method were used to extract and analyze the tongue features of the two groups.By comparing the differences of tongue image characteristics between the blood stasis constitution group and the mild constitution group,the tongue characteristics of blood stasis constitution were systematically summarized.Results Compared with the mild constitution group,the proportion of light dark tongue and light purple tongue in the blood stasis constitution group was significantly higher(P<0.05).The I value,L value and a value of the tongue area 1 in the blood stasis constitution group were significantly larger(P<0.01,P<0.05).The S value and a value of area 2 and area 3 were significantly larger(P<0.05),and the I value,L value,a value and b value of area 5 were significantly smaller(P<0.01,P<0.05).Compared with the mild constitution group,the proportion of tooth marks tongue in the blood stasis constitution group was significantly higher(P<0.01),the proportion of cracked tongue in the blood stasis constitution group was significantly larger(P<0.05),and the number of tooth marks,crack area,relative height of crack and relative width of crack in the blood stasis constitution group were significantly larger(P<0.01,P<0.05).Compared with the mild constitution group,the I value,L value,a value and b value of tongue coating area 1 in the blood stasis constitution group were significantly larger(P<0.01,P<0.05),the I value,L value,S value,a value and b value of tongue coating area 2 were significantly larger(P<0.01,P<0.05),the I value,S value,a value and b value of tongue coating area 3 were significantly larger(P<0.01,P<0.05),the b value of tongue coating area 4 was significantly larger(P<0.05),the S value,a value and b value of tongue coating area 5 were significantly larger(P<0.01,P<0.05).The proportion of thick tongue coating and greasy tongue coating in the blood stasis group was significantly higher than that in the gentleness group(P<0.05).Compared with the mild constitution group,the proportion of tortuous,thickened and nodular sublingual collaterals in the blood stasis constitution group was significantly larger(P<0.01,P<0.05).The a value,I value,S value,b value and relative width of sublingual collaterals in the blood stasis constitution group were significantly larger(P<0.01,P<0.05).Conclusion On the basis of the general belief that the characteristics of blood stasis constitution tongue are dark purple tongue and dark purple sublingual collaterals/varicose veins/thickening,blood stasis constitution people also have new tongue characteristics,such as redder tips and edges,more teeth marks and fissures,thicker and greasier coatings,and yellow fur.These findings offer new insights for"to identify the constitution of traditional Chinese medicine and prevent diseases by observing the tongue manifestation".
2.Characterization and correction of astigmatism in children aged 6-12 years from urban and suburban counties of Xi'an city, Shaanxi Province, China
Junhan WEI ; Lu YE ; Qian YAO ; Rui LIU ; Guoyun ZHANG
International Eye Science 2025;25(5):831-838
AIM: To analyze the prevalence, severity, types, and correction of astigmatism in children, and provide scientific evidences for the prevention and treatment of refractive errors.METHODS: This cross-sectional study included 29 153 children aged 6-12 years from Xi'an and Lantian County, Shaanxi Province, China. Visual acuity and non-cycloplegic refraction were measured. Astigmatism was defined as an absolute cylindrical power ≥0.5 D in the right eye. Differences in astigmatism severity, type distribution, and refractive correction were analyzed across age, gender, and region.RESULTS:The prevalence of astigmatism increased with age, peaking at 11 years old(62.88%). Boys(57.10%)had a higher prevalence than girls(54.86%), and the municipal areas(58.29%)had a higher prevalence than county areas(51.75%). Mild astigmatism was the most common(63.82%), with moderate astigmatism increasing with age. The highest prevalence of high astigmatism was observed in 11-years-old children(9.68%). Compound myopic astigmatism(59.28%)and mixed astigmatism(25.16%)were the most frequent types. With increasing age, compound myopic astigmatism increased, while simple myopic, simple hyperopic, and compound hyperopic astigmatism decreased. Mixed astigmatism increased from ages 6 to 7, but declined from ages 7 to 12. For astigmatic axis types, with-the-rule astigmatism was the most prevalent(81.06%)and increased with age, peaking at 11 years(85.74%). Against-the-rule astigmatism showed a declining trend, while oblique astigmatism remained relatively stable. Distribution differences in astigmatism types and axes by gender and region were observed. Significant differences in astigmatism severity, types, and axis types across different ages, genders, and regions were observed(all P<0.05). The overall refractive correction rate for children with astigmatism was only 40.18%.CONCLUSION: The overall prevalence of astigmatism among children aged 6-12 years in Shaanxi Province was 56.02%, with higher prevalence observed in boys and in municipal areas. Age, gender, and region significantly influenced the prevalence of astigmatism. Notably, less than half of the children with astigmatism received refractive correction, highlighting the need for increased attention from parents and relevant authorities.
3.Research progress on correlation between non-high-density lipoprotein cholesterol and complications of type 2 diabetes mellitus
Junhan ZHANG ; Honghua WEN ; Zhixiong PAN ; Qun ZHU
Journal of Clinical Medicine in Practice 2025;29(17):133-137
Dyslipidemia is one of the common metabolic disorders in type 2 diabetes mellitus,often coexisting with insulin resistance and central obesity to form metabolic syndrome,significantly increasing the risk of macrovascular and microvascular complications in diabetic patients.Non-high-density lipoprotein cholesterol(non-HDL-C)refers to the sum of cholesterol contained in other lipopro-teins except high-density lipoprotein cholesterol(HDL-C).In recent years,the importance of non-HDL-C in the management of diabetic complications has garnered increasing attention,and it has been established as a major lipid-lowering target along with low-density lipoprotein cholesterol(LDL-C)in the latest expert consensus on lipid management for Chinese diabetic patients.Clinical studies have demonstrated that non-HDL-C is closely associated with residual cardiovascular risk and recurrent stroke risk in diabetic patients,as well as carotid plaque vulnerability and the development of peripher-al arterial disease.Additionally,non-HDL-C is also closely related to diabetic nephropathy and reti-nopathy in type 2 diabetes mellitus,and achieving long-term control of non-HDL-C levels can reduce the risk of chronic kidney disease.This article summarized the relationship between non-HDL-C and complications of type 2 diabetes mellitus and elucidated its significance as a future clinical therapeutic target.
4.Correlation between type 2 diabetes and hepatitis B virus infection
Wu LIU ; Tianshuo ZHAO ; Liguo YANG ; Genxia GAO ; Wenli MIAO ; Tongxia ZENG ; Yonglan CHEN ; Lina ZHANG ; Xiaoyan CHE ; Lihong WANG ; Junhan ZHANG ; Bingfeng HAN ; Fuqiang CUI
Chinese Journal of Epidemiology 2025;46(5):833-839
Objective:To analyze the latent prevalence of hepatitis B and type 2 diabetes and their correlation through an observational study.Methods:This study used a case-control design. The cases with diabetes were recruited through the diabetes management system and village doctors, while the controls without diabetes were screened from volunteers recruited by village health clinics. Capillary blood samples were collected from the study participants for the measurement of real-time blood glucose level, and venous blood samples were taken from them for the detections of HBV serological markers. Firth logistic regression model was used to fit the relationship between HBsAg positive status and diabetes status.Results:The study included 1 218 diabetes patients, 62 patients with impaired fasting glucose and 491 cases without diabetes. In the cases without diagnosis of diabetes, 11.15% had impaired fasting blood glucose and 4.43% had diabetes. Among those who reported no or unknown diagnosis of hepatitis B, 1.73% were positive for HBsAg, while 18.80% were positive for both HBV core antibody and surface antibody, indicating latent infection of hepatitis B virus. In the non-diabetes group, 0.81% reported hepatitis B history, and in the diabetes group, 2.76% reported hepatitis B history. After adjustment, the HBsAg positive rate was higher in the diabetes group ( OR=2.90, 95% CI: 1.21-6.91). Conclusions:Both diabetes and hepatitis B exhibited a high degree of latent prevalence. The HBsAg positive rate was significantly higher in those with diabetes than in those without diabetes, indicating a potential correlation. These findings highlighted the importance of strengthened screening and management of comorbidities.
5.Study on the immunogenicity and persistence of different types of hepatitis B vaccines in diabetic patients
Wu LIU ; Tianshuo ZHAO ; Liguo YANG ; Genxia GAO ; Wenli MIAO ; Xiaoyan CHE ; Lihong WANG ; Junhan ZHANG ; Fuqiang CUI
Chinese Journal of Epidemiology 2025;46(8):1409-1416
Objective:Exploration of the immunogenicity and persistence of three different immunization regimens of hepatitis B vaccines in diabetic patients.Methods:Participants with diabetes and non-diabetic individuals were recruited from study sites and assigned to different vaccination regimens: the diabetic group (①D60Yeast0-1: received 60 μg Saccharomyces cerevisiae-derived recombinant HBV vaccine on a 0-1-month schedule; ②D20Yeast0-1-6: received 20 μg Saccharomyces cerevisiae-derived recombinant HBV vaccine on a 0-1-6-month schedule; ③D20CHO0-1-6: received 20 μg Chinese hamster ovary (CHO) cell-derived recombinant HBV vaccine on a 0-1-6-month schedule) and the non-diabetic group (ND20Yeast0-1-6: non-diabetic individuals received 20 μg Saccharomyces cerevisiae-derived recombinant HBV vaccine on a 0-1-6-month schedule). Venous blood samples were collected at 1,12, and 48 months post-full vaccination to measure anti-HBs levels. Differences in immunogenicity between diabetic and non-diabetic groups, as well as among diabetic subgroups, were analyzed.Results:This study enrolled a total of 564 subjects. In the D20CHO0-1-6 group, the seroconversion rate decreased from 90.72% (95% CI: 84.84%-96.60%) at 1 month to 74.23% (95% CI: 65.37%-83.08%) at 48 months, and the antibody geometric mean concentration (GMC) decreased from 676.08 (95% CI: 389.05- 1 148.20) mIU/ml at 1 month to 33.11 (95% CI: 23.44-46.77) mIU/ml at 48 months. In the D20Yeast0-1-6 group, the seroconversion rate declined from 93.81% (95% CI: 89.29%-98.32%) at 1 month to 63.72% (95% CI: 54.71%-72.72%) at 48 months, with antibody GMC dropping from 630.96 (95% CI: 407.40-954.99) mIU/ml to 25.70 (95% CI: 17.78-38.02) mIU/ml over the same period. For the D60Yeast0-1 group, seroconversion rate fell from 82.03% (95% CI: 75.29%-88.77%) to 56.25% (95% CI: 47.54%-64.96%), and antibody GMC decreased from 81.28 (95% CI: 51.29-128.82) mIU/ml to 15.49 (95% CI: 11.75-20.89) mIU/ml between 1 and 48 months. The ND20Yeast0-1-6 group (non-diabetic control) exhibited a higher initial seroconversion rate of 97.56% (95% CI: 94.80%- 100.00%) at 1 month, but it still declined to 76.42% (95% CI: 68.82%-84.03%) at 48 months, with antibody GMC decreasing from 1 318.30 (95% CI: 912.01- 1 905.50) mIU/ml to 34.67 (95% CI: 25.12-47.86) mIU/ml. Multivariate analysis on factors influencing the GMC of antibodies revealed statistically significant differences in antibody GMC between the D20Yeast0-1-6 group and ND20Yeast0-1-6 group at 12 months (a OR=0.73, 95% CI: 0.58-0.93) and 48 months (a OR=0.79, 95% CI: 0.63-0.99) post-vaccination (all P<0.05). As for the diabetic population, when compared with the D20Yeast0-1-6 group, the D60Yeast0-1 group also showed statistically significant differences in antibody GMC at 12 months (a OR=0.57, 95% CI: 0.44-0.74) and 48 months (a OR=0.60, 95% CI: 0.47-0.76)(all P<0.05). Conclusions:The seroconversion rate and antibody GMC gradually decreased over time (1, 12, and 48 months) in the four groups. Diabetic patients showed poor immunogenicity and persistence to hepatitis B vaccines. The immunogenicity and persistence of hepatitis B vaccination in diabetic patients were associated with vaccine type, antigen dose, and vaccination regimen. The CHO cell-recombinant hepatitis B vaccine demonstrated better performance in terms of immunogenicity and persistence among the diabetic population.
6.Clinical safety of sodium-glucose cotransporter 2 inhibitors: a study based on adverse drug reaction monitoring data in Beijing from 2019 to 2024
Yue XIE ; Zhihui SONG ; Junhan LIU ; Huiying ZHAO ; Guojuan ZHANG ; Jiawei WANG
Adverse Drug Reactions Journal 2025;27(11):660-666
Objective:To analyze the characteristics of adverse reactions of sodium-glucose cotransporter 2 inhibitors (SGLT2i), and provide a basis for the rational clinical application.Methods:The adverse drug reaction (ADR) cases of SGLT2i reported by Beijing from January 1, 2019 to June 30, 2024 were collected through searching the National Adverse Drug Reaction Monitoring System of China. The Medical Dictionary for Regulatory Activities (MedDRA) terminology set was used to standardize the description of ADR, and the involving system organ class (SOC) and preferred term (PT) was extracted. Data of ADR were analyzed descriptively and statistically. Results:A total of 409 SGLT2i-related adverse reaction reports involving 409 patients were included. Among these patients, there were 232 females and 177 males; the median age was 62(52, 70) years, and 231 cases (56.48%) were under the age of 65 years; 5 types of SGLT2i (dapagliflozin, empagliflozin, canagliflozin, ertugliflozin, and henagliflozin proline) were involved, and reports of dapagliflozin was the most (279 cases, 68.22%). The primary indication for medication was diabetes (404 cases, 98.78%). The majority of ADRs did not reach the severe level (395 cases, 96.58%). The 14 cases (3.42%) of severe ADR were primarily about diabetic ketoacidosis (11 cases, 11/14), of which 7 cases presented with normal blood glucose levels and 5 cases occurred after medical stress events. The outcomes of patients were improvement in 241 cases (58.92%) and recovery in 127 cases (31.05%). In total, 476 ADR occurrences were recorded among the 409 patients, involving 82 PTs, 24 of which were not listed in the drug labels. The top 2 SOCs were the infections and infestations [26.26% (125/476)] and renal and urinary disorders [13.87% (66/476)]; the top 3 PTs were urinary tract infection [23.32% (111/476)], urinary ketone detection [6.51% (31/476)], and vulvovaginal pruritus [5.88% (28/476)]; the top 3 newly identified possible ADRs (PTs) were dizziness [2.31% (11/476)], palpitations [1.89% (9/476)], and decreased appetite [1.05% (5/476)].Conclusions:Based on the ADR monitoring data in Beijing in the past 5 and a half years, SGLT2i-associated adverse reactions primarily involved the infections and infestations, and renal and urinary disorders. ADRs identified in the study such as dizziness and palpitations are not documented in the drug labels, euglycaemic ketoacidosis accounts for a high proportion of severe reactions, and most of them occur after acute stress events.
7.Correlation between type 2 diabetes and hepatitis B virus infection
Wu LIU ; Tianshuo ZHAO ; Liguo YANG ; Genxia GAO ; Wenli MIAO ; Tongxia ZENG ; Yonglan CHEN ; Lina ZHANG ; Xiaoyan CHE ; Lihong WANG ; Junhan ZHANG ; Bingfeng HAN ; Fuqiang CUI
Chinese Journal of Epidemiology 2025;46(5):833-839
Objective:To analyze the latent prevalence of hepatitis B and type 2 diabetes and their correlation through an observational study.Methods:This study used a case-control design. The cases with diabetes were recruited through the diabetes management system and village doctors, while the controls without diabetes were screened from volunteers recruited by village health clinics. Capillary blood samples were collected from the study participants for the measurement of real-time blood glucose level, and venous blood samples were taken from them for the detections of HBV serological markers. Firth logistic regression model was used to fit the relationship between HBsAg positive status and diabetes status.Results:The study included 1 218 diabetes patients, 62 patients with impaired fasting glucose and 491 cases without diabetes. In the cases without diagnosis of diabetes, 11.15% had impaired fasting blood glucose and 4.43% had diabetes. Among those who reported no or unknown diagnosis of hepatitis B, 1.73% were positive for HBsAg, while 18.80% were positive for both HBV core antibody and surface antibody, indicating latent infection of hepatitis B virus. In the non-diabetes group, 0.81% reported hepatitis B history, and in the diabetes group, 2.76% reported hepatitis B history. After adjustment, the HBsAg positive rate was higher in the diabetes group ( OR=2.90, 95% CI: 1.21-6.91). Conclusions:Both diabetes and hepatitis B exhibited a high degree of latent prevalence. The HBsAg positive rate was significantly higher in those with diabetes than in those without diabetes, indicating a potential correlation. These findings highlighted the importance of strengthened screening and management of comorbidities.
8.Study on the immunogenicity and persistence of different types of hepatitis B vaccines in diabetic patients
Wu LIU ; Tianshuo ZHAO ; Liguo YANG ; Genxia GAO ; Wenli MIAO ; Xiaoyan CHE ; Lihong WANG ; Junhan ZHANG ; Fuqiang CUI
Chinese Journal of Epidemiology 2025;46(8):1409-1416
Objective:Exploration of the immunogenicity and persistence of three different immunization regimens of hepatitis B vaccines in diabetic patients.Methods:Participants with diabetes and non-diabetic individuals were recruited from study sites and assigned to different vaccination regimens: the diabetic group (①D60Yeast0-1: received 60 μg Saccharomyces cerevisiae-derived recombinant HBV vaccine on a 0-1-month schedule; ②D20Yeast0-1-6: received 20 μg Saccharomyces cerevisiae-derived recombinant HBV vaccine on a 0-1-6-month schedule; ③D20CHO0-1-6: received 20 μg Chinese hamster ovary (CHO) cell-derived recombinant HBV vaccine on a 0-1-6-month schedule) and the non-diabetic group (ND20Yeast0-1-6: non-diabetic individuals received 20 μg Saccharomyces cerevisiae-derived recombinant HBV vaccine on a 0-1-6-month schedule). Venous blood samples were collected at 1,12, and 48 months post-full vaccination to measure anti-HBs levels. Differences in immunogenicity between diabetic and non-diabetic groups, as well as among diabetic subgroups, were analyzed.Results:This study enrolled a total of 564 subjects. In the D20CHO0-1-6 group, the seroconversion rate decreased from 90.72% (95% CI: 84.84%-96.60%) at 1 month to 74.23% (95% CI: 65.37%-83.08%) at 48 months, and the antibody geometric mean concentration (GMC) decreased from 676.08 (95% CI: 389.05- 1 148.20) mIU/ml at 1 month to 33.11 (95% CI: 23.44-46.77) mIU/ml at 48 months. In the D20Yeast0-1-6 group, the seroconversion rate declined from 93.81% (95% CI: 89.29%-98.32%) at 1 month to 63.72% (95% CI: 54.71%-72.72%) at 48 months, with antibody GMC dropping from 630.96 (95% CI: 407.40-954.99) mIU/ml to 25.70 (95% CI: 17.78-38.02) mIU/ml over the same period. For the D60Yeast0-1 group, seroconversion rate fell from 82.03% (95% CI: 75.29%-88.77%) to 56.25% (95% CI: 47.54%-64.96%), and antibody GMC decreased from 81.28 (95% CI: 51.29-128.82) mIU/ml to 15.49 (95% CI: 11.75-20.89) mIU/ml between 1 and 48 months. The ND20Yeast0-1-6 group (non-diabetic control) exhibited a higher initial seroconversion rate of 97.56% (95% CI: 94.80%- 100.00%) at 1 month, but it still declined to 76.42% (95% CI: 68.82%-84.03%) at 48 months, with antibody GMC decreasing from 1 318.30 (95% CI: 912.01- 1 905.50) mIU/ml to 34.67 (95% CI: 25.12-47.86) mIU/ml. Multivariate analysis on factors influencing the GMC of antibodies revealed statistically significant differences in antibody GMC between the D20Yeast0-1-6 group and ND20Yeast0-1-6 group at 12 months (a OR=0.73, 95% CI: 0.58-0.93) and 48 months (a OR=0.79, 95% CI: 0.63-0.99) post-vaccination (all P<0.05). As for the diabetic population, when compared with the D20Yeast0-1-6 group, the D60Yeast0-1 group also showed statistically significant differences in antibody GMC at 12 months (a OR=0.57, 95% CI: 0.44-0.74) and 48 months (a OR=0.60, 95% CI: 0.47-0.76)(all P<0.05). Conclusions:The seroconversion rate and antibody GMC gradually decreased over time (1, 12, and 48 months) in the four groups. Diabetic patients showed poor immunogenicity and persistence to hepatitis B vaccines. The immunogenicity and persistence of hepatitis B vaccination in diabetic patients were associated with vaccine type, antigen dose, and vaccination regimen. The CHO cell-recombinant hepatitis B vaccine demonstrated better performance in terms of immunogenicity and persistence among the diabetic population.
9.New Recognition of the Tongue Characteristics of Blood Stasis Constitution:Purple Tongue and Tortuous Sublingual Vessel
Wanning ZHOU ; Junhan YANG ; Shiqi ZHANG ; Jishi WANG ; Xueshan QI ; Han WANG ; Xiaojing LI ; Yanyun ZHANG ; Xiangze LI ; Zhe ZHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(6):1758-1765
Objective Based on the general belief that the tongue characteristics of blood stasis constitution is"purple tongue,tortuous sublingual vessels",this study systematically summarized blood stasis tongue characteristics using artificial intelligence image processing combined with expert evaluation.Methods A physical questionnaire survey was conducted on 1275 college students,and 100 cases were randomly selected from the blood stasis constitution group and the mild constitution group.After collecting the tongue images,Unet,OpenCV,YOLOv5 and YOLOv8 algorithms combined with expert evaluation method were used to extract and analyze the tongue features of the two groups.By comparing the differences of tongue image characteristics between the blood stasis constitution group and the mild constitution group,the tongue characteristics of blood stasis constitution were systematically summarized.Results Compared with the mild constitution group,the proportion of light dark tongue and light purple tongue in the blood stasis constitution group was significantly higher(P<0.05).The I value,L value and a value of the tongue area 1 in the blood stasis constitution group were significantly larger(P<0.01,P<0.05).The S value and a value of area 2 and area 3 were significantly larger(P<0.05),and the I value,L value,a value and b value of area 5 were significantly smaller(P<0.01,P<0.05).Compared with the mild constitution group,the proportion of tooth marks tongue in the blood stasis constitution group was significantly higher(P<0.01),the proportion of cracked tongue in the blood stasis constitution group was significantly larger(P<0.05),and the number of tooth marks,crack area,relative height of crack and relative width of crack in the blood stasis constitution group were significantly larger(P<0.01,P<0.05).Compared with the mild constitution group,the I value,L value,a value and b value of tongue coating area 1 in the blood stasis constitution group were significantly larger(P<0.01,P<0.05),the I value,L value,S value,a value and b value of tongue coating area 2 were significantly larger(P<0.01,P<0.05),the I value,S value,a value and b value of tongue coating area 3 were significantly larger(P<0.01,P<0.05),the b value of tongue coating area 4 was significantly larger(P<0.05),the S value,a value and b value of tongue coating area 5 were significantly larger(P<0.01,P<0.05).The proportion of thick tongue coating and greasy tongue coating in the blood stasis group was significantly higher than that in the gentleness group(P<0.05).Compared with the mild constitution group,the proportion of tortuous,thickened and nodular sublingual collaterals in the blood stasis constitution group was significantly larger(P<0.01,P<0.05).The a value,I value,S value,b value and relative width of sublingual collaterals in the blood stasis constitution group were significantly larger(P<0.01,P<0.05).Conclusion On the basis of the general belief that the characteristics of blood stasis constitution tongue are dark purple tongue and dark purple sublingual collaterals/varicose veins/thickening,blood stasis constitution people also have new tongue characteristics,such as redder tips and edges,more teeth marks and fissures,thicker and greasier coatings,and yellow fur.These findings offer new insights for"to identify the constitution of traditional Chinese medicine and prevent diseases by observing the tongue manifestation".
10.Clinical safety of sodium-glucose cotransporter 2 inhibitors: a study based on adverse drug reaction monitoring data in Beijing from 2019 to 2024
Yue XIE ; Zhihui SONG ; Junhan LIU ; Huiying ZHAO ; Guojuan ZHANG ; Jiawei WANG
Adverse Drug Reactions Journal 2025;27(11):660-666
Objective:To analyze the characteristics of adverse reactions of sodium-glucose cotransporter 2 inhibitors (SGLT2i), and provide a basis for the rational clinical application.Methods:The adverse drug reaction (ADR) cases of SGLT2i reported by Beijing from January 1, 2019 to June 30, 2024 were collected through searching the National Adverse Drug Reaction Monitoring System of China. The Medical Dictionary for Regulatory Activities (MedDRA) terminology set was used to standardize the description of ADR, and the involving system organ class (SOC) and preferred term (PT) was extracted. Data of ADR were analyzed descriptively and statistically. Results:A total of 409 SGLT2i-related adverse reaction reports involving 409 patients were included. Among these patients, there were 232 females and 177 males; the median age was 62(52, 70) years, and 231 cases (56.48%) were under the age of 65 years; 5 types of SGLT2i (dapagliflozin, empagliflozin, canagliflozin, ertugliflozin, and henagliflozin proline) were involved, and reports of dapagliflozin was the most (279 cases, 68.22%). The primary indication for medication was diabetes (404 cases, 98.78%). The majority of ADRs did not reach the severe level (395 cases, 96.58%). The 14 cases (3.42%) of severe ADR were primarily about diabetic ketoacidosis (11 cases, 11/14), of which 7 cases presented with normal blood glucose levels and 5 cases occurred after medical stress events. The outcomes of patients were improvement in 241 cases (58.92%) and recovery in 127 cases (31.05%). In total, 476 ADR occurrences were recorded among the 409 patients, involving 82 PTs, 24 of which were not listed in the drug labels. The top 2 SOCs were the infections and infestations [26.26% (125/476)] and renal and urinary disorders [13.87% (66/476)]; the top 3 PTs were urinary tract infection [23.32% (111/476)], urinary ketone detection [6.51% (31/476)], and vulvovaginal pruritus [5.88% (28/476)]; the top 3 newly identified possible ADRs (PTs) were dizziness [2.31% (11/476)], palpitations [1.89% (9/476)], and decreased appetite [1.05% (5/476)].Conclusions:Based on the ADR monitoring data in Beijing in the past 5 and a half years, SGLT2i-associated adverse reactions primarily involved the infections and infestations, and renal and urinary disorders. ADRs identified in the study such as dizziness and palpitations are not documented in the drug labels, euglycaemic ketoacidosis accounts for a high proportion of severe reactions, and most of them occur after acute stress events.

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