1.Analysis of differences on contraindication information for children in domestic and foreign drug instructions
Pengxiang ZHOU ; Xinwen XU ; Xiaoling WANG ; Ruiling ZHAO ; Zhigang ZHAO
Adverse Drug Reactions Journal 2025;27(6):339-347
Objective:To explore the differences on contraindication information for children in domestic and foreign drug instructions, and provide reference for improving the relevant information in Chinese drug insert sheets.Methods:Chinese drug insert sheets of chemicals and biological products contained in the China Pharmacopoeia 2020 and those of the western medicines in the 2023 China′s Basic Medical Insurance, Work-related Injury Insurance and Childbirth Insurance Drug Catalog were collected; drugs that were marked as contraindication for children were selected and relevant contraindication information in the Chinese drug insert sheets was collected. Instructions of the above-mentioned drugs approved by the U.S. Food and Drug Administration (English labels) were also collected, and the information on pediatric medication was reviewed and compared with the Chinese drug insert sheets. Results:A total of 222 drugs were labeled as contraindication for children in the Chinese drug insert sheets, of which 149 were available for their English labels; 123 drugs (17.5%) were not labeled as contraindication for children in English labels, and 26 (82.5%) were labeled. The 123 drugs that were not labeled as contraindication for children in the English labels included the following conditions: 58 were labeled as contraindication for children of some age in the Chinese drug insert sheets but not in the English labels, and relevant medication information was provided; 40 were labeled as contraindication for children of some age group in the Chinese drug insert sheets but was described as the effectiveness and safety of the use for children have not yet been determined for this age group in the English labels; 13 were labeled as contraindication for children in the Chinese drug insert sheets, but the medication information on children in the English labels was not clear or missing; 12 were labeled as contraindicated for children in Chinese drug insert sheets but not in the English labels, only expressed as not yet determined or not recommended for use, etc., with inconsistent age group. Among the 26 drugs labeled as contraindication for children in both Chinese and English instructions, the contraindication age group were the same in above 2 instructions for 20 drugs, and were inconsistent for the other 6 drugs; reasons for contraindication were described in both the 2 instructions for 17 drugs (13 were consistent, 4 were inconsistent), only in English labels for 8 drugs, and only in Chinese drug insert sheets for 1 drug.Conclusions:Many drugs are labeled as contraindication for children in Chinese drug insert sheets, but reasons for contraindication are rarely explained. Differences in children′s age in contraindications exist for some drugs between the Chinese drug insert sheets and English labels. The information on contraindications for children in Chinese drug insert sheets still needs to be further improved.
2.Characteristics of first-time callers with suicidal ideation to psychological assistance hotline in Henan Province
Kunya LIU ; Xiaoniu LI ; Qingqing ZHANG ; Lei ZHANG ; Huiping CHENG ; Shiyun WANG ; Yunsheng HOU ; Ying XU ; Ruiling ZHANG
Chinese Mental Health Journal 2025;39(5):398-404
Objective:To examine the spatial and temporal distribution characteristics of first-time callers with suicidal ideation and risk factors related to suicidal ideation in a psychological assistance hotline in Henan Province.Methods:The computerised counselling operating system of the Henan Provincial Psychological Assis-tance Hotline was used to extract data from 31 401 callers who called the hotline between January 2020 and October 2023.A circular distribution and kernel density analysis were employed to investigate the spatial and temporal distri-bution of first-time callers with suicidal ideation.Binary logistic regression analysis was employed to investigate the risk factors for suicidal ideation.Results:A total of 5 494 first-time callers were included in the study,of whom 1 697(30.9%)reported suicidal ideation in the previous two weeks.The temporal distribution of suicidal ideation calls indicated a peak between 12:36 and 01:08.The weekly distribution further revealed that the majority of calls occurred on Fridays.In terms of spatial distribution,the primary hotspots for callers with suicidal ideation were clus-tered around Zhengzhou and Xinxiang.Meanwhile,the secondary hotspots exhibited a dispersed distribution across multiple centers within the province.Logistic regression analysis revealed that being under 20 years old(OR=11.85),being unemployed(OR=1.78),having psychological issues(OR=5.03),experiencing family relation-ship problems(OR=3.67),and facing economic hardships(OR=7.08)were risk factors for suicidal ideation.Conclusion:The time distribution of calls from individuals with suicidal ideation to the psychological as-sistance hotline in Henan Province exhibits a centralized trend,while the spatial distribution of calls demonstrates an imbalance.When receiving initial calls from individuals with suicidal ideation,particular attention should be paid to those aged 20 years old or younger,those who are unemployed,and those experiencing psychiatric,psychological,familial,and economic difficulties.
3.Characteristics of first-time callers with suicidal ideation to psychological assistance hotline in Henan Province
Kunya LIU ; Xiaoniu LI ; Qingqing ZHANG ; Lei ZHANG ; Huiping CHENG ; Shiyun WANG ; Yunsheng HOU ; Ying XU ; Ruiling ZHANG
Chinese Mental Health Journal 2025;39(5):398-404
Objective:To examine the spatial and temporal distribution characteristics of first-time callers with suicidal ideation and risk factors related to suicidal ideation in a psychological assistance hotline in Henan Province.Methods:The computerised counselling operating system of the Henan Provincial Psychological Assis-tance Hotline was used to extract data from 31 401 callers who called the hotline between January 2020 and October 2023.A circular distribution and kernel density analysis were employed to investigate the spatial and temporal distri-bution of first-time callers with suicidal ideation.Binary logistic regression analysis was employed to investigate the risk factors for suicidal ideation.Results:A total of 5 494 first-time callers were included in the study,of whom 1 697(30.9%)reported suicidal ideation in the previous two weeks.The temporal distribution of suicidal ideation calls indicated a peak between 12:36 and 01:08.The weekly distribution further revealed that the majority of calls occurred on Fridays.In terms of spatial distribution,the primary hotspots for callers with suicidal ideation were clus-tered around Zhengzhou and Xinxiang.Meanwhile,the secondary hotspots exhibited a dispersed distribution across multiple centers within the province.Logistic regression analysis revealed that being under 20 years old(OR=11.85),being unemployed(OR=1.78),having psychological issues(OR=5.03),experiencing family relation-ship problems(OR=3.67),and facing economic hardships(OR=7.08)were risk factors for suicidal ideation.Conclusion:The time distribution of calls from individuals with suicidal ideation to the psychological as-sistance hotline in Henan Province exhibits a centralized trend,while the spatial distribution of calls demonstrates an imbalance.When receiving initial calls from individuals with suicidal ideation,particular attention should be paid to those aged 20 years old or younger,those who are unemployed,and those experiencing psychiatric,psychological,familial,and economic difficulties.
4.Analysis of differences on contraindication information for children in domestic and foreign drug instructions
Pengxiang ZHOU ; Xinwen XU ; Xiaoling WANG ; Ruiling ZHAO ; Zhigang ZHAO
Adverse Drug Reactions Journal 2025;27(6):339-347
Objective:To explore the differences on contraindication information for children in domestic and foreign drug instructions, and provide reference for improving the relevant information in Chinese drug insert sheets.Methods:Chinese drug insert sheets of chemicals and biological products contained in the China Pharmacopoeia 2020 and those of the western medicines in the 2023 China′s Basic Medical Insurance, Work-related Injury Insurance and Childbirth Insurance Drug Catalog were collected; drugs that were marked as contraindication for children were selected and relevant contraindication information in the Chinese drug insert sheets was collected. Instructions of the above-mentioned drugs approved by the U.S. Food and Drug Administration (English labels) were also collected, and the information on pediatric medication was reviewed and compared with the Chinese drug insert sheets. Results:A total of 222 drugs were labeled as contraindication for children in the Chinese drug insert sheets, of which 149 were available for their English labels; 123 drugs (17.5%) were not labeled as contraindication for children in English labels, and 26 (82.5%) were labeled. The 123 drugs that were not labeled as contraindication for children in the English labels included the following conditions: 58 were labeled as contraindication for children of some age in the Chinese drug insert sheets but not in the English labels, and relevant medication information was provided; 40 were labeled as contraindication for children of some age group in the Chinese drug insert sheets but was described as the effectiveness and safety of the use for children have not yet been determined for this age group in the English labels; 13 were labeled as contraindication for children in the Chinese drug insert sheets, but the medication information on children in the English labels was not clear or missing; 12 were labeled as contraindicated for children in Chinese drug insert sheets but not in the English labels, only expressed as not yet determined or not recommended for use, etc., with inconsistent age group. Among the 26 drugs labeled as contraindication for children in both Chinese and English instructions, the contraindication age group were the same in above 2 instructions for 20 drugs, and were inconsistent for the other 6 drugs; reasons for contraindication were described in both the 2 instructions for 17 drugs (13 were consistent, 4 were inconsistent), only in English labels for 8 drugs, and only in Chinese drug insert sheets for 1 drug.Conclusions:Many drugs are labeled as contraindication for children in Chinese drug insert sheets, but reasons for contraindication are rarely explained. Differences in children′s age in contraindications exist for some drugs between the Chinese drug insert sheets and English labels. The information on contraindications for children in Chinese drug insert sheets still needs to be further improved.
5.A multicentre cross-sectional study on the correlation of female sexual dysfunction with sex hormones
Rui JU ; Xiangyan RUAN ; Yinmei DAI ; Yu YANG ; Xin XU ; Jiaojiao CHENG ; Yongtao BAI ; Yanhong SHI ; Xingzi YANG ; Yanhua SUN ; Ruiling LI ; Mueck Alfred O.
Chinese Journal of Reproduction and Contraception 2024;44(3):278-284
Objective:To explore the correlation between endogenous sex hormone factors and sexual function in Chinese women.Methods:A total of 711 women who met the criteria were investigated in the Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing Chaoyang District Maternal and Child Health Care Hospital, Beijing Chaoyang District Taiyanggong Community Health Service Centre from April 2020 to March 2021. Sociodemographic data (data split into two groups according to educational background: high school or above and lower high school; and three categories based on marital relationship: satisfied, average, and dissatisfied) and serum levels of sex hormones were collected. Female sexual dysfunction (FSD) was evaluated using the female sexual function index (FSFI). Participants were divided into three groups according to the Stages of Reproductive Aging Workshop (STRAW+10): reproductive stage group, menopausal transition stage group and postmenopausal stage group. Spearman rank correlation analysis and multiple linear regression analyses were performed to determine the correlation between characteristics and scores of FSFI.Results:The multivariate logistic regression analysis revealed that postmenopausal stage, secondary education level, neutral and dissatisfied marital relations were significantly negatively correlated with total FSFI score (all P<0.01). Secondary education level, neutral and dissatisfied marital relations were negatively associated with nearly all FSFI domains apart from pain score (all P<0.05); postmenopausal stage was negatively associated with lubrication, satisfaction and pain (all P<0.05). FSH was negatively associated with all FSFI domain scores (all P<0.05). There was a significantly positive correlation between estradiol and scores of FSFI dimensions other than orgasm and satisfaction (all P<0.05). Total testosterone positively affected the score of total FSFI and desire (all P<0.05); free testosterone was positively related to orgasm ( P<0.05). Conclusion:Estradiol and total testosterone serve as protective factors for female sexual function.
6.Survey and analysis of the shared decision-making concept and the influencing factors for depression in outpatient clinics of tertiary hospitals
Xilong CUI ; Xiaoping WANG ; Ning ZHANG ; Jianlin JI ; Xiufeng XU ; Daihui PENG ; Yuping NING ; Jie LI ; Guoqing JIANG ; Ruiling ZHANG ; Qiang WANG ; Zheng LU ; Cuixia AN
Chinese Journal of Psychiatry 2024;57(12):819-827
Objectives:To investigate the current willingness of depressive outpatients and their doctors in China to engage in shared decision-making (SDM), and to analyze the factors influencing this willingness.Methods:A questionnaire survey was conducted among doctors and patients with depression in 12 tertiary psychiatric hospitals and general hospitals by scanning two-dimensional code and filling in the questionnaire on the mobile terminal. The questionnaire covered patient demographics, emotional state scores, initial diagnosis and treatment, treatment expectations and concerns, symptom improvement needs, medication safety requirements, and diagnosis details (completed by the attending physician). Doctors provided basic information, current depression diagnosis and treatment status, and concerns regarding medications. Logistic regression analysis (univariate and multivariate) was used to identify factors influencing patients′ and doctors′ willingness to engage in SDM.Results:A total of 622 valid patient questionnaires and 45 valid physician questionnaires were collected. Both patients and doctors had a strong willingness to make shared decisions (80.39% (500/622) vs. 60.00% (27/45)). Multivariate binary logistic regression analysis showed that residential location (town versus rural areas: OR (95% CI)=1.895 (1.087-3.305)), acceptable monthly medical expenses (≥1 000-<2 000 CNY vs.<300 CNY: OR (95% CI)=0.194 (0.088-0.427);≥2 000 CNY vs.<300 CNY: OR (95% CI)=0.267 (0.094-0.754)), acceptance of online treatment and consultation (accept versus not accept: OR (95% CI)=3.196 (2.024-5.046)), and knowing about psychotherapy (yes versus no: OR (95% CI)=1.711 (1.003-2.921)) were the factors influencing the willingness of shared decision-making in patients (all P<0.05). For the doctors, the time spent on initial consultation was the factor influencing the willingness to engage in SDM ( OR (95% CI)=1.090 (1.004-1.184), P=0.040). Conclusions:Both depression patients and doctors in tertiary outpatient clinics in China show a strong willingness to engage in SDM, providing a solid foundation for clinical application. However, it is necessary to pay attention to the influence of residential location, acceptable monthly medical expenses, acceptance of online treatment and consultation, and knowledge of psychotherapy should be considered for patients, while the time spent on initial consultations should be considered for doctors.
7.A multicentre cross-sectional study on the correlation of female sexual dysfunction with sex hormones
Rui JU ; Xiangyan RUAN ; Yinmei DAI ; Yu YANG ; Xin XU ; Jiaojiao CHENG ; Yongtao BAI ; Yanhong SHI ; Xingzi YANG ; Yanhua SUN ; Ruiling LI ; Mueck Alfred O.
Chinese Journal of Reproduction and Contraception 2024;44(3):278-284
Objective:To explore the correlation between endogenous sex hormone factors and sexual function in Chinese women.Methods:A total of 711 women who met the criteria were investigated in the Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing Chaoyang District Maternal and Child Health Care Hospital, Beijing Chaoyang District Taiyanggong Community Health Service Centre from April 2020 to March 2021. Sociodemographic data (data split into two groups according to educational background: high school or above and lower high school; and three categories based on marital relationship: satisfied, average, and dissatisfied) and serum levels of sex hormones were collected. Female sexual dysfunction (FSD) was evaluated using the female sexual function index (FSFI). Participants were divided into three groups according to the Stages of Reproductive Aging Workshop (STRAW+10): reproductive stage group, menopausal transition stage group and postmenopausal stage group. Spearman rank correlation analysis and multiple linear regression analyses were performed to determine the correlation between characteristics and scores of FSFI.Results:The multivariate logistic regression analysis revealed that postmenopausal stage, secondary education level, neutral and dissatisfied marital relations were significantly negatively correlated with total FSFI score (all P<0.01). Secondary education level, neutral and dissatisfied marital relations were negatively associated with nearly all FSFI domains apart from pain score (all P<0.05); postmenopausal stage was negatively associated with lubrication, satisfaction and pain (all P<0.05). FSH was negatively associated with all FSFI domain scores (all P<0.05). There was a significantly positive correlation between estradiol and scores of FSFI dimensions other than orgasm and satisfaction (all P<0.05). Total testosterone positively affected the score of total FSFI and desire (all P<0.05); free testosterone was positively related to orgasm ( P<0.05). Conclusion:Estradiol and total testosterone serve as protective factors for female sexual function.
8.Survey and analysis of the shared decision-making concept and the influencing factors for depression in outpatient clinics of tertiary hospitals
Xilong CUI ; Xiaoping WANG ; Ning ZHANG ; Jianlin JI ; Xiufeng XU ; Daihui PENG ; Yuping NING ; Jie LI ; Guoqing JIANG ; Ruiling ZHANG ; Qiang WANG ; Zheng LU ; Cuixia AN
Chinese Journal of Psychiatry 2024;57(12):819-827
Objectives:To investigate the current willingness of depressive outpatients and their doctors in China to engage in shared decision-making (SDM), and to analyze the factors influencing this willingness.Methods:A questionnaire survey was conducted among doctors and patients with depression in 12 tertiary psychiatric hospitals and general hospitals by scanning two-dimensional code and filling in the questionnaire on the mobile terminal. The questionnaire covered patient demographics, emotional state scores, initial diagnosis and treatment, treatment expectations and concerns, symptom improvement needs, medication safety requirements, and diagnosis details (completed by the attending physician). Doctors provided basic information, current depression diagnosis and treatment status, and concerns regarding medications. Logistic regression analysis (univariate and multivariate) was used to identify factors influencing patients′ and doctors′ willingness to engage in SDM.Results:A total of 622 valid patient questionnaires and 45 valid physician questionnaires were collected. Both patients and doctors had a strong willingness to make shared decisions (80.39% (500/622) vs. 60.00% (27/45)). Multivariate binary logistic regression analysis showed that residential location (town versus rural areas: OR (95% CI)=1.895 (1.087-3.305)), acceptable monthly medical expenses (≥1 000-<2 000 CNY vs.<300 CNY: OR (95% CI)=0.194 (0.088-0.427);≥2 000 CNY vs.<300 CNY: OR (95% CI)=0.267 (0.094-0.754)), acceptance of online treatment and consultation (accept versus not accept: OR (95% CI)=3.196 (2.024-5.046)), and knowing about psychotherapy (yes versus no: OR (95% CI)=1.711 (1.003-2.921)) were the factors influencing the willingness of shared decision-making in patients (all P<0.05). For the doctors, the time spent on initial consultation was the factor influencing the willingness to engage in SDM ( OR (95% CI)=1.090 (1.004-1.184), P=0.040). Conclusions:Both depression patients and doctors in tertiary outpatient clinics in China show a strong willingness to engage in SDM, providing a solid foundation for clinical application. However, it is necessary to pay attention to the influence of residential location, acceptable monthly medical expenses, acceptance of online treatment and consultation, and knowledge of psychotherapy should be considered for patients, while the time spent on initial consultations should be considered for doctors.
9.Predictive value of visceral fat index and lipid accumulation product on metabolic associated fatty liver disease in the population without overweight/obesity
Hongyan WANG ; Yupeng LIU ; Hongmei FU ; Ruiling XU ; Chaoqi YAN
Chinese Journal of Health Management 2023;17(11):848-853
Objective:To investigate the value of visceral fat index (VAI) and lipid accumulation product (LAP) on predicting metabolic associated fatty liver disease (MAFLD) in the population without overweight/obesity.Methods:This study is a cross-sectional study. The physical examination data derived from International Physical Examination and Health Center of the Second Affiliated Hospital of Harbin Medical University from January to December 2021 were collected. According to the inclusion and exclusion criteria, a total of 4 304 subjects without overweight/obesity aged from 18-75 were included in this study. The subjects were divided into two groups with MAFLD or without MAFLD, according to the diagnostic criteria of MAFLD provided by The Asian Pacific Association for the Study of the liver clinical practice guidelines for the diagnosis and management of metabolic associated fatty liver disease. Comparison of the clinical parameters (blood pressure, lipid, glucose) and obesity measurement indexes (BMI, VAI, LAP) between the two groups was analyzed. All subjects were respectively divided into four groups according to BMI, VAI and LAP quartile, which were defined as A, B, C, D. The prevalence of MAFLD in the population without overweight/obesity in quartile area groups of different obesity measurement indexes was calculated. Spearman′s rank correlation was used to evaluate the correlation between BMI, LAP, VAI and MAFLD in the population without overweight/obesity, respectively. Meanwhile, receiver operating characteristics (ROC) curves were used to calculate area under the curve (AUC) and evaluate the accuracy of BMI, VAI and LAP on predicting for MAFLD in the population without overweight/obesity.Results:The prevalence of MAFLD in the population without overweight/obesity was 10.87%. In the population without overweight/obesity, the clinical data blood pressure, total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), triglyceride (TG) and fasting plasma glucose (FPG) in the group with MAFLD were significantly higher than those of the group without MAFLD (131/80 vs 113/70 mmHg, 5.29 vs 4.65 mmol/L, 3.21 vs 2.75 mmol/L, 1.87 vs 0.89 mmol/L, 5.60 vs 4.95 mmol/L; P<0.001), but high density lipoprotein cholesterol (HDL-C) of the group with MAFLD was significantly lower than that of the group without MAFLD (1.19 vs 1.49 mmol/L; P<0.001). The obesity measurement indexes (BMI, VAI, LAP) in the group with MAFLD were significantly higher than those of the group without MAFLD (22.10 vs 20.70 kg/m 2, 2.64 vs 1.00, 36.27 vs 12.48; all P<0.001). In the population without overweight/obesity, the prevalence of MAFLD was increased with the increase of BMI, VAI and LAP quartile area, and there was a linear correlation between MAFLD and obesity measurement indexes above. Spearman′s rank correlation analysis showed that correlation coefficient between obesity measurement indexes and MAFLD in the population without overweight/obesity was respectively LAP (0.427)>VAI (0.406)>BMI (0.282). ROC curve analysis showed that in the population without overweight/obesity, LAP had the highest accuracy on predicting MAFLD, with the AUC value of 0.896 (0.886-0.905), the optional cut-off value was 20.75, sensitivity and specificity was 85.9% and 79.0%, respectively. VAI (0.876) took the second place and BMI (0.761) located lastly. Conclusions:Both VAI and LAP have good prediction ability for MAFLD in the population without overweight/obesity. However, compared with VAI, LAP has higher accuracy on predicting MAFLD in the population without overweight/obesity.
10.Analysis of information related to child-prohibition in drug labels in China
Yu YANG ; Yayun HUANG ; Yunxia ZHANG ; Qianqian QIN ; Zhimin XUE ; Ruiling ZHAO ; Xinwen XU ; Xiaoling WANG
Adverse Drug Reactions Journal 2023;25(5):281-286
Objective:To analyze the information related to child-prohibition in drug labels in China.Methods:The existing drug labels for chemical drugs and biological products included in the China Pharmacopoeia 2020 (Ch. P) were collected through searching websites such as "Yaozhiwang" "Dingxiangyuan" and "Yimaitong", and information related to child-prohibition was extracted. The expression and existing problems of information about child-prohibition were analyzed.Results:A total of 1 741 and 149 chemical and biological products were included in the Ch.P, respectively, of which 411 (23.6%) and 6 (4.0%) products involved information of child-prohibition. Information of child-prohibition was expressed in 18 ways, such as "prohibited" "not recommended" and "try not to", etc. Issues of child-prohibition information in drug labels of the same drug from different manufacturers were inconsistent text descriptions, inconsistent age range, and incomplete information on whether there was benzyl alcohol; issues in the same drug label was different age ranges for child-prohibition in different chapters.Conclusions:There are inconsistencies and non-standard issues in information related to child-prohibition in the existing drug instructions in China. Drug manufacturers should conduct full lifecycle management of drug labels in accordance with the "Technical Guidelines for Writing Information on Children′s Medication in the Instructions of Chemical Drugs and Therapeutic Biological Products (trial)", and continuously standardize and improve the information of child-prohibition.

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