1.Analysis of the Structural Changes of Adverse Drug Reaction Reports in China
Yingni HUANG ; Guangxing MENG ; Yanxiang LI
Herald of Medicine 2025;44(6):982-988
Objective To explore the structural changes and potential improvement in the reporting system,and to provide reference for improving the efficiency of drug safety supervision.Methods Descriptive statistical analysis and structural analysis were used to analyze the source of adverse drug reaction(ADR)reports,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China from 2014 to 2023.Results The structural variation of the source of ADR report,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China were 20.00%,6.20%,27.20%,9.40%and 16.62%,respectively.Among them,patients aged 65 and over(VSV=13.20)had the largest change value and positive change;the source of drug business enterprises(VSV=-9.70),intravenous injection route(VSV=-6.51)and traditional Chinese medicine category(VSV=-4.70)showed negative changes.Conclusions It is necessary to improve the laws and regulations of the industry,enhance the ability of enterprises to implement the main responsibility,improve the public's awareness and participation awareness of ADR,strengthen the monitoring and guidance strategies of drug safety in specific age groups,improve the monitoring level of adverse reactions of traditional Chinese medicine,and strengthen the supervision of adverse reactions of intravenous injection.
2.Diagnostic Value of Coronary Slow Flow for Coronary Microvascular Dysfunction in Patients With Angina and Nonobstructive Coronary Arteries
Zhaoxue SHENG ; Yuhui HUANG ; Xingliang LI ; Jingyu WANG ; Qiang CHEN ; Wuqiang CHE ; Zhen ZHANG ; Xuecheng ZHAO ; Shuoyan AN ; Yanxiang GAO ; Jingang ZHENG
Chinese Circulation Journal 2025;40(9):885-891
Objectives:Coronary slow flow(CSF)has long been regarded as a marker of coronary microvascular dysfunction(CMD).This study aims to evaluate the diagnostic value of CSF for CMD in patients with angina and nonobstructive coronary arteries(ANOCA).Methods:The study data were derived from the ANOCA-CMD prospective cohort study.All enrolled patients underwent coronary angiography and concurrent coronary physiological assessments in the left anterior descending artery using pressure-wire and thermodilution techniques to obtain coronary flow reserve(CFR)and the index of microcirculatory resistance(IMR).Based on the results,CMD was classified into four subtypes:CMD with elevated IMR(IMR≥25),CMD with reduced CFR(CFR<2.5),CMD with either reduced CFR or elevated IMR(CFR<2.5 or IMR≥25),and CMD with both reduced CFR and elevated IMR(CFR<2.5 and IMR≥25).The corrected thrombolysis in myocardial infarction(TIMI)frame count(CTFC)in the left anterior descending artery was calculated from coronary angiography images,with CSF defined as CTFC>27.This study evaluated the correlation between CTFC,CFR,and IMR,and investigated the diagnostic value of CSF for CMD in ANOCA patients.Results:A total of 103 ANOCA patients were enrolled in this study,with a mean age of(64.2±10.6)years,and 53.4%were female.Among them,57 patients(55.3%)were diagnosed with coronary slow flow.Patients with slow flow had higher IMR(P<0.001)and CFR(P=0.041).Similarly,the proportion of CMD with elevated IMR was higher in the slow flow group(P<0.001),while the proportion of CMD with reduced CFR was lower(P=0.044).There was no significant difference between the groups in the proportions of CMD with either reduced CFR or elevated IMR or CMD with both reduced CFR and elevated IMR(all P>0.05).CTFC was positively correlated with hyperemic mean transit time(r=0.424,P<0.001),IMR(r=0.430,P<0.001),and CFR(r=0.211,P=0.032).The area under the curve(AUC)of CTFC for diagnosing CMD with elevated IMR was 0.721(95%CI:0.623-0.819)with an accuracy of 67%(57%,76%),for diagnosing CMD with reduced CFR was 0.610(95%CI:0.499-0.720)with an accuracy of 60%(50%,70%),for diagnosing CMD with either reduced CFR or elevated IMR was 0.549(95%CI:0.425-0.673)with an accuracy of 47%(37%,57%),and for diagnosing CMD with both reduced CFR and elevated IMR was 0.582(95%CI:0.471-0.693)with an accuracy of 47%(37%,57%).Thus,CSF demonstrated limited diagnostic values across all subtypes of CMD.Conclusions:In ANOCA patients,CSF cannot serve as an effective diagnostic marker for CMD.Therefore,in clinical practice,the slow flow phenomenon should not be directly equated with the presence of coronary microvascular dysfunction in ANOCA patients.
3.Diagnostic Value of Coronary Slow Flow for Coronary Microvascular Dysfunction in Patients With Angina and Nonobstructive Coronary Arteries
Zhaoxue SHENG ; Yuhui HUANG ; Xingliang LI ; Jingyu WANG ; Qiang CHEN ; Wuqiang CHE ; Zhen ZHANG ; Xuecheng ZHAO ; Shuoyan AN ; Yanxiang GAO ; Jingang ZHENG
Chinese Circulation Journal 2025;40(9):885-891
Objectives:Coronary slow flow(CSF)has long been regarded as a marker of coronary microvascular dysfunction(CMD).This study aims to evaluate the diagnostic value of CSF for CMD in patients with angina and nonobstructive coronary arteries(ANOCA).Methods:The study data were derived from the ANOCA-CMD prospective cohort study.All enrolled patients underwent coronary angiography and concurrent coronary physiological assessments in the left anterior descending artery using pressure-wire and thermodilution techniques to obtain coronary flow reserve(CFR)and the index of microcirculatory resistance(IMR).Based on the results,CMD was classified into four subtypes:CMD with elevated IMR(IMR≥25),CMD with reduced CFR(CFR<2.5),CMD with either reduced CFR or elevated IMR(CFR<2.5 or IMR≥25),and CMD with both reduced CFR and elevated IMR(CFR<2.5 and IMR≥25).The corrected thrombolysis in myocardial infarction(TIMI)frame count(CTFC)in the left anterior descending artery was calculated from coronary angiography images,with CSF defined as CTFC>27.This study evaluated the correlation between CTFC,CFR,and IMR,and investigated the diagnostic value of CSF for CMD in ANOCA patients.Results:A total of 103 ANOCA patients were enrolled in this study,with a mean age of(64.2±10.6)years,and 53.4%were female.Among them,57 patients(55.3%)were diagnosed with coronary slow flow.Patients with slow flow had higher IMR(P<0.001)and CFR(P=0.041).Similarly,the proportion of CMD with elevated IMR was higher in the slow flow group(P<0.001),while the proportion of CMD with reduced CFR was lower(P=0.044).There was no significant difference between the groups in the proportions of CMD with either reduced CFR or elevated IMR or CMD with both reduced CFR and elevated IMR(all P>0.05).CTFC was positively correlated with hyperemic mean transit time(r=0.424,P<0.001),IMR(r=0.430,P<0.001),and CFR(r=0.211,P=0.032).The area under the curve(AUC)of CTFC for diagnosing CMD with elevated IMR was 0.721(95%CI:0.623-0.819)with an accuracy of 67%(57%,76%),for diagnosing CMD with reduced CFR was 0.610(95%CI:0.499-0.720)with an accuracy of 60%(50%,70%),for diagnosing CMD with either reduced CFR or elevated IMR was 0.549(95%CI:0.425-0.673)with an accuracy of 47%(37%,57%),and for diagnosing CMD with both reduced CFR and elevated IMR was 0.582(95%CI:0.471-0.693)with an accuracy of 47%(37%,57%).Thus,CSF demonstrated limited diagnostic values across all subtypes of CMD.Conclusions:In ANOCA patients,CSF cannot serve as an effective diagnostic marker for CMD.Therefore,in clinical practice,the slow flow phenomenon should not be directly equated with the presence of coronary microvascular dysfunction in ANOCA patients.
4.Analysis of the Structural Changes of Adverse Drug Reaction Reports in China
Yingni HUANG ; Guangxing MENG ; Yanxiang LI
Herald of Medicine 2025;44(6):982-988
Objective To explore the structural changes and potential improvement in the reporting system,and to provide reference for improving the efficiency of drug safety supervision.Methods Descriptive statistical analysis and structural analysis were used to analyze the source of adverse drug reaction(ADR)reports,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China from 2014 to 2023.Results The structural variation of the source of ADR report,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China were 20.00%,6.20%,27.20%,9.40%and 16.62%,respectively.Among them,patients aged 65 and over(VSV=13.20)had the largest change value and positive change;the source of drug business enterprises(VSV=-9.70),intravenous injection route(VSV=-6.51)and traditional Chinese medicine category(VSV=-4.70)showed negative changes.Conclusions It is necessary to improve the laws and regulations of the industry,enhance the ability of enterprises to implement the main responsibility,improve the public's awareness and participation awareness of ADR,strengthen the monitoring and guidance strategies of drug safety in specific age groups,improve the monitoring level of adverse reactions of traditional Chinese medicine,and strengthen the supervision of adverse reactions of intravenous injection.
5.Correlation of serum angiopoietin-1,angiopoietin-2,and angiopoietin-1/angiopoietin-2 ratio with HBV DNA and alanine aminotransferase in patients with chronic hepatitis B or liver cirrhosis
Minghua LIN ; Yuan CHANG ; Fang LIU ; Yanxiang HUANG ; Hangfei XU
Journal of Clinical Hepatology 2024;40(6):1126-1129
Objective To investigate the correlation of serum angiopoietin-1(Ang-1),angiopoietin-2(Ang-2),and Ang-1/Ang-2 ratio with HBA DNA and alanine aminotransferase(ALT)in patients with chronic hepatitis B(CHB)or liver cirrhosis.Methods Clinical data and serum specimens were collected from 99 patients with CHB and 59 patients with liver cirrhosis who were admitted to Beijing YouAn Hospital,Capital Medical University,from March 2018 to October 2019,and 46 individuals who underwent physical examination were enrolled as control group.PCR was used to measure serum HBV DNA level,and ELISA was used to measure the serum levels of Ang-1 and Ang-2.The serum levels of Ang-1 and Ang-2 and Ang-1/Ang-2 ratio were compared between groups.The Kruskal-Wallis H test was used for comparison of non-normally distributed continuous data between multiple groups,and the Bonferroni method was used for further comparison between two groups;the Spearman correlation analysis was used to investigate the correlation of Ang-1,Ang-2,and Ang-1/Ang-2 ratio with HBV DNA and ALT.Results Compared with the control group,the CHB group and the liver cirrhosis group had a significant reduction in the level of Ang-1(479.0 pg/mL and 208.4 pg/mL vs 671.0 pg/mL,both P<0.05),and compared with the CHB group,the liver cirrhosis group had a significant reduction in the level of Ang-1(P<0.001).Compared with the control group,the CHB group and the liver cirrhosis group had a significant increase in the level of Ang-2(286.1 pg/mL and 438.4 pg/mL vs 198.0 pg/mL,both P<0.001),and compared with the CHB group,the liver cirrhosis group had a significant increase in the level of Ang-2(P<0.001).Compared with the control group,the CHB group and the liver cirrhosis group had a significant reduction in Ang-1/Ang-2 ratio(1.6 and 0.5 vs 3.4,both P<0.001),and compared with the CHB group,the liver cirrhosis group had a significant reduction in Ang-1/Ang-2 ratio(P<0.001).The Spearman correlation analysis showed that in the CHB group,Ang-1 was negatively correlated with HBV DNA and ALT(r=-0.400 and-0.394,both P<0.001),Ang-2 was positively correlated with HBV DNA and ALT(r=0.365 and 0.351,both P<0.001),and Ang-1/Ang-2 ratio was negatively correlated with HBV DNA and ALT(r=-0.463 and-0.473,both P<0.001);in the liver cirrhosis group,Ang-1,Ang-2,and Ang-1/Ang-2 ratio had no correlation with HBV DNA or ALT(all P>0.05).Conclusion There are significant changes in the serum levels of Ang-1 and Ang-2 and Ang-1/Ang-2 ratio in patients with CHB or liver cirrhosis,and Ang-1,Ang-2,and Ang-1/Ang-2 ratio reflects the degree of liver injury in patients with CHB to a certain extent.
6.Therapeutic effect and mechanism of astragalus on acute respiratory distress syndrome in sepsis mice
Yanxiang HA ; Po HUANG ; Rui ZHANG ; Chunxia ZHAO ; Xiaolong XU ; Yuhong GUO ; Shuo WANG ; Qingquan LIU
Chinese Journal of Emergency Medicine 2024;33(10):1407-1412
Objective:To verify the therapeutic effect of Astragalus on mice with acute respiratory distress syndrome with sepsis and to explore its mechanism.Methods:Seventy SPF-grade C57 mice were divided into astragalus group ( n=30), control group ( n=30) and sham surgery group ( n=10) according to random number table method, and CLP surgery was performed on Astragalus group and control group to induce sepsis acute respiratory distress syndrome, and CLP sham surgery was performed in the sham surgery group. After surgery, the astragalus group was treated with astragalus decoction for gastric gavage, the sham surgery group and the control group were gavaged with normal saline, and the mice were sacrificed 12 hours and 24 hours after the operation, and the lung histopathology was observed, the ratio of dry to wet weight of lung tissue, the protein concentration of alveolar lavage fluid was determined, the alveolar lavage fluid and serum were analyzed proteomics, and the differential proteins were enriched and analyzed. Results:Astragalus reduced the total protein concentration of BALF in ARDS mice, reduced the dry-to-wet ratio of ARDS mice, and HE staining of lung tissues showed that Astragalus decoction improved acute alveolar injury in ARDS mice. Proteomic analysis of serum samples and BALF samples showed that there were certain differential proteins between astragalus group and control group, and enrichment analysis showed that it was mainly enriched in the pathway of inflammatory factors, confirming that astragalus decoction may play a role by inhibiting the activation and release of inflammatory factors.Conclusions:Astragalus decoction can effectively reduce the inflammatory exudation of lung tissue in acute respiratory distress syndrome of sepsis, and its mechanism of action may be to inhibit the expression of inflammatory factors.
7.Babaodan Alleviates APAP-induced Acute Liver Injury in Mice by Inhibiting NLRP3/Caspase-1 Pathway
Ruowei ZHAO ; Qing ZHANG ; Mingxing ZHU ; Yueyang LIU ; Zaixing CHENG ; Mingqing HUANG ; Yanfang ZHENG ; Yanxiang LIN
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(5):122-128
ObjectiveTo explore the effect of Babaodan (BBD) on the NOD-like receptor pyrin domain containing 3/cysteine aspartate-specific protease-3 (NLRP3/Caspase-1) pathway proteins in mice with acetaminophen (APAP)-induced acute liver injury. MethodC57BL/6 mice were randomly grouped, and BBD (75, 150, 300 mg·kg-1, ig) was administered twice a day for three days. After 2 hours of the last administration, the mice were treated with APAP (400 mg·kg-1, ip), and the eyeballs were removed to collect blood after 14 hours. Then they were sacrificed by cervical dislocation for sample collection. Hematoxylin-eosin (HE) staining was used to observe the morphological changes of liver tissue cells, and biochemical methods were used to detect the activities of alanine aminotransferase (ALT), aspartate aminotransferase (AST), superoxide dismutase (SOD), malondialdehyde (MDA) and myeloperoxidase (MPO) in serum of mice in each group. Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) was performed to determine the mRNA expression of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β) and IL-6, and Western blot was performed to determine the protein expression of cyclooxygenase-2 (COX-2), inducible nitric oxide synthase (iNOS), NLRP3, Caspase-1 and IL-18 in the liver of mice. ResultCompared with the conditions in normal group, the hepatic lobule structure of mice in the model group was partially destroyed, and the hepatic sinusoids were dilated. And the expression levels of ALT and AST in serum, the protein levels of NLRP3, Caspase-1, iNOS, IL-18 and COX-2 and the mRNA levels of IL-1β, IL-6 and TNF-α were increased (P<0.05, P<0.01). Compared with the model group, the administration groups had improvement in liver cell rupture and hepatic sinusoidal compression, and a dose-dependent decrease in the levels of ALT and AST in serum as well as the protein levels of NLRP3, Caspase-1, iNOS, IL-18 and COX-2 and the the mRNA levels of IL-1β, IL-6 and TNF-α in liver tissue (P<0.05, P<0.01). ConclusionBBD can reduce APAP-induced acute liver injury in mice. The mechanism may be related to anti-oxidative stress, inhibition of NLRP3/Caspase-1 pathway, and decreased expression levels of IL-1β, IL-18, TNF-α and IL-6.
8.Effects of different feeding patterns on mother-to-child transmission of HBV infections in pregnant women with high viral loads after antiviral medication during pregnancy: A prospective cohort study
Ruihua TIAN ; Xingming LI ; Gaofei LI ; Qiuyun LI ; Yuzhen ZHANG ; Jing LYU ; Biyun XU ; Yanxiang HUANG ; Junmei CHEN ; Yunxia ZHU ; Yihua ZHOU
Chinese Journal of Perinatal Medicine 2021;24(7):497-502
Objective:To study the influence of different feeding patterns on mother-to-child transmission (MTCT) of hepatitis B virus (HBV) in pregnant women with high viral loads who received antiviral medication during pregnancy to the day of delivery.Methods:This prospective cohort study was conducted in Beijing You'an Hospital. From January 1, 2019, to March 31, 2020, and 574 pregnant women with positive hepatitis B surface antigen (HBsAg) and HBV DNA>2×10 5 IU/ml were enrolled. All participants received tenofovir, telbivudine, lamivudine, or propofol tenofovir from 24-28 weeks of gestation and discontinued on the day of delivery, and their neonates were postnatally given routine passive-active immunoprophylaxis. Based on the feeding patterns, the subjects were divided into three groups: breastfeeding ( n=257), bottle-feeding ( n=241) and mixed feeding groups ( n=76). The follow-up data were obtained from liver functions and HBV DNA level of the mothers at 6-8 weeks postpartum and HBV serological markers of infants at 7-12 months. One-way ANOVA, Student-Newman-Keuls, Chi-square test or Fisher exact test, and repeated measures ANOVA were used to analyze the data. Results:The average maternal HBV DNA levels before antiviral treatment did not differ significantly between the three groups [(7.90±0.67), (7.82±0.70), (7.83±0.70) log 10 IU/ml, F=0.912, P>0.05]. HBV DNA level before delivery in the mixed feeding group was slightly lower than that in the breastfeeding and bottle-feeding group [(3.87 ±1.08) vs (4.21±1.17) and (4.30±1.28) log 10 IU/ml, q= 3.052 and 3.831, both P<0.05], while the comparison between the latter two groups showed no significant differences ( P>0.05). After delivery, HBV DNA level in the bottle-feeding group was slightly lower than that in the breastfeeding group [(7.42±0.93) vs (7.69±0.90) log 10 IU/ml, q=4.583, P<0.05]. Among 580 infants (including six pairs of twins), only one bottle-fed infant (0.4%, 1/243) was infected with HBV through MTCT, and none in the breastfeeding or mixed feeding group ( P=0.553). Conclusions:For pregnant women with high viral loads of HBV who have received antiviral medication during pregnancy, although HBV DNA level will rebound after discontinuation upon delivery, breastfeeding is recommended considering it does not increase the risk of MTCT.
9.Analysis on sensory processing characteristics of mental health problems in preschoolers
JIANG Xueming, SUN Yanxiang, FENG Zhe, HUANG Yanke, CHEN Yuhuang, WAN Guobin
Chinese Journal of School Health 2020;41(8):1189-1192
Objective:
To analyze the sensory processing characteristics among preschoolers with mental health problems in Nanshan District, Shenzhen.
Methods:
Random cluster sampling was used to select kindergartens for psychological screening from March to June 2018. The Strengths and Difficulties Questionnaire (SDQ) and the Simplified Sensory Questionnaire (SSP) were used to evaluate 6 365 preschool children.
Results:
A total of 15.15% preschoolers were detected with abnormal results. The SSP scores of preschoolers with emotional symptoms/conduct problems/prosocial behaviors were lower than normal preschoolers’(P<0.01). Among the preschoolers with hyperactivity-inattention, taste/smell sensitivity (F=12.45)/underresponsive/seeks sensation(F=102.44), auditory filtering(F=93.51), low energy/weak(F=13.33), visual/auditory sensitivity (F=4.32) scores were lower than normal preschoolers’(P<0.05), the scores of tactile sensitivity movement sensitivity were no statistical difference with normal preschoolers’. Among the preschoolers with peer problem, taste/smell sensitivity(F=5.86), tactile sensitivity(F=6.05), movement sensitivity(F=4.70), auditory filtering(F=17.32), low energy/weak (F=9.56), visual/auditory sensitivity (F=4.16) scores were lower than normal preschoolers’ (P<0.05), and the scores of under-esponsive/seeks sensation were no statistical difference with normal pre-schoolers’. Prosocial behavior and tactile (r=0.30), under-responsive/seeks sensation(r=0.37), auditory filtering(r=0.37), low energy/weak (r=0.31) were positive associated(P<0.01). Emotional symptoms were negatively associated with lack of energy/weakness(r=-0.33, P<0.01).
Conclusion
Mental health problems are related to sensory processing ability in preschoolers. Preschoolers with mental health problems have weak sensory processing ability. Clinicians and occupational therapists should pay attention to evaluation and intervention of sensory processing ability in preschoolers with mental health problems.
10.Analysis on correlation between semen parameters with spontaneous abortion in early pregnancy after in vitro fertilization assisted pregnancy operation
Zhibiao LI ; Li HUANG ; Xiaohui HUANG ; Yanxiang LIU ; Aiqin PENG ; Liang CHEN
International Journal of Laboratory Medicine 2018;39(1):49-51,55
Objective To investigate the correlation between semen parameters with spontaneous abortion in early pregnancy after in vitro fertilization (IVF) assisted pregnancy operation .Methods 220 patients with successful pregnancy after IVF assisted pregnancy operation in the reproductive center of this hospital were selected as the research subjects .Among them ,40 cases of early spontaneous abortion served as the observa-tion group and 180 cases without early spontaneous abortion occurrence as the control group .The related pa-rameters of sperm hyaluronic acid unbinding rate ,sperm nucleoprotein immaturity rate and sperm morphology normal rate were measured and analyzed by adopting the computer assisted sperm analysis (CASA) .Results The sperm hyaluronic acid unbinding rate and sperm nucleoprotein immaturity rate in the observation group were significantly higher than those in the control group ,the difference was statistically significant ( P<0 .05);the sperm morphology normal rate in the observation group was significantly lower than that in the control group ,the difference was statistically significant (P<0 .05);the other semen parameters had no statis-tical differences between the two groups (P>0 .05) .The statistical analysis result showed that the sperm hy-aluronic acid unbinding rate ,sperm DNA fragmentation rate and sperm nucleoprotein immaturity had the posi-tive correlation between each other ,which had the negative correlation with the other indicators .After the stepwise analysis by the binary Logistic regression model ,the results showed that the high risk factors affect-ing spontaneous abortion in early pregnancy after IVF included sperm nucleoprotein immaturity rate and sperm hyaluronic acid unbinding rate .Conclusion The sperm nucleoprotein immaturity rate and sperm hyalu-ronic acid unbinding rate are two high-risk factors inducing early spontaneous abortion after IVF .


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