1.Analysis and Suggestions on the Problem of the Unclear Part of the Safety Content Section of Chinese Patent Medicines
Min LI ; Minhua ZHOU ; Huifei WU
Herald of Medicine 2025;44(5):727-731
Objective The content of the relevant safety items in the instructions of Chinese patent medicines is"Not Clear"to provide a reliable reference for improving the safety and effectiveness of Chinese patent medicines.Methods Search the Chinese Pharmacopoeia 2020,National Essential Medicines List,Handbook of Selected Chinese Patent Drugs in Various Clinical Subjects,and Handbook of Modern Chinese Patent Drugs.Conduct random sampling according to Chinese patent medicines'different efficacy and dosage forms and collect complete basic information and versions.There are a total of 105 latest drug instructions.The safety information in each drug instruction is extracted and entered into Excel 2019.The annotations are summarized and statistically analyzed one by one.Results After summarizing,most instructions are marked with safety item information such as adverse e-vents,contraindications,pharmacology,and toxicology.Howe ver,the degree of detail of each content varies greatly.Common problems include non-standard terminology description,content"avoiding the important and light,passing it off"or inconsistent content with the labeling,and insufficient clinical data research.Conclusions There is a severe lack of research content in the package insert of Chinese patent medicines,and it is still necessary to further strengthen the discussion and research on the mechanism of action of medicines to revise and improve the safety information of the instructions and ensure the safety of clinical use.
2.Genetic evolution analysis of chicken-origin H3N8 subtype avian influen-za virus and study on its pathogenicity to hamsters
Ting LI ; Mengyao WANG ; Fangfang QIAO ; Liji ZHANG ; Wenjing YANG ; Yuxin ZHANG ; Jiangwu HUANG ; Wanting ZHOU ; Minhua SUN ; Jun HE ; Ming LIAO
Chinese Journal of Pathophysiology 2025;41(9):1862-1872
AIM:A strain was isolated and identified as the H3N8 subtype of the avian influenza virus from a sick chicken at a farm in Yangjiang,Guangdong Province,named A/chicken/Yangjiang/552/2023(abbreviated as YJ/552).The aim of this research is to determine its genetic evolution,biological properties and pathogenicity in hamsters.This study may provide a theoretical strategy for preventing and treating the H3N8 subtype avian influenza virus-induced epidemic.METHODS:A strain of H3N8 avian influenza virus from chickens was characterised by phylogenetic analy-sis,antigenic diversity,receptor-binding specificity,neuraminidase activity,replication,and transmission in hamsters and a systematic pathological analysis was conducted.RESULTS:This novel avian influenza virus was generated through complex recombination of Eurasian avian H3 genes,North American avian N8 genes and six internal genes of H9N2 sub-type AIV.The cleavage site of the outer protein,HA,was PEKQTR↓GLF,which is characteristic of the low pathogenic avian influenza virus.The HA gene of YJ/552 exhibited the highest nucleotide homology with A/China/ZMD-22-2/2022(H3N8)at 99.09%,while the NA gene showed the highest homology with A/chicken/Dongguan/879/2022(H3N8)at 99.01%.This strain preferentially binds to avian-type receptors and could bind to human-type receptors.This virus could effectively replicate in the trachea and lungs of inoculated and contact hamsters.CONCLUSION:YJ/552 is a recombi-nant H3N8 avian influenza virus replicated in the upper respiratory system and transmitted in hamsters.This study pro-vides data support for the early warning and prevention of H3 subtype avian influenza viruses.
3.Nomogram based on clinical and DCE-MRI characteristics for predicting the depth of myometrial invasion and grade of endometrioid endometrial carcinoma
Xiaoliang MA ; Songqi CAI ; Jinwei QIANG ; Guofu ZHANG ; Jianjun ZHOU ; Mengsu ZENG ; Xiaojun REN ; Rong JIANG ; Minhua SHEN
Chinese Journal of Obstetrics and Gynecology 2025;60(3):202-215
Objective:To investigate the feasibility and value of nomogram based on base line clinical and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) characteristics for pretreatment predicting the depth of myometrial invasion and tumor grade of endometrioid endometrial carcinoma (EEC).Methods:Preoperative baseline clinical characteristics and DCE-MRI characteristics of 194 EEC patients were prospectively collected at Obstetrics and Gynecology Hospital, Fudan University from October 2020 to January 2022 and used as a training set. Univariate analysis was conducted to compare baseline clinical characteristics and DCE-MRI quantitative parameters [including tumor volume, and mean, median, and standard deviation of volume transfer constant (K trans), rate constant (K ep), extravascular extracellular volume fraction (V e), and initial area under the enhancement curve (iAUC)] between patients with deep myometrial invasion (DMI) and those with superficial myometrial invasion (SMI), as well as between high-grade and low-grade EEC. Multivariate logistics regression analysis was used to identify independent predictors for the construction of nomogram. An independent external testing set comprising 127 EEC patients was retrospectively collected from Zhongshan Hospital, Fudan University and Zhongshan Hospital, Fudan University (Xiamen Branch). The area under the receiver operating characteristic curve (AUC) and decision curve analysis (DCA) were used for evaluating the model′s predictive performance and clinical net benefit, respectively. Results:(1) The depth of myometrial invasion: univariate analysis showed that in the training set, the EEC patients with DMI differed significantly from those with SMI in clinical characteristics including higher proportion of postmenopausal state and overweight [body mass index (BMI)≥25 kg/m2], and abnormal levels of serum cancer antigen (CA) 125, CA 199, and human epididymis protein 4 (HE4), and in DCE-MRI quantitative parameters including tumor volume, and median, mean, and standard deviation of K trans, median of V e, as well as median, mean, and standard deviation of iAUC (all P<0.05). Multivariate analysis showed that the patient′s menstrual status, BMI, CA 199, tumor volume, and mean of iAUC were independent predictors of the depth of myometrial invasion, and constructed the nomogram (recorded as Nomogram_1), achieving an AUC of 0.861 (95% CI: 0.803-0.919) in the training set. In the independent external testing set, the AUC was 0.876 (95% CI: 0.815-0.938), with corresponding sensitivity of 82.0%, specificity of 80.7%, accuracy of 81.1%, positive predictive value (PPV) of 65.3%, and negative predictive value (NPV) of 91.0% for predicting DMI. (2) The EEC grade: univariate analysis showed that in the training set, high-grade EEC patients differed significantly from low-grade EEC in clinical characteristics including patient′s age, the proportion of postmenopausal state and overweight, and abnormal levels of serum CA 125, and in DCE-MRI quantitative parameters including tumor volume, median, mean, and standard deviation of K trans, median and mean of V e, as well as median, mean, and standard deviation of iAUC (all P<0.05). Multivariate analysis showed that the patient′s menstrual status, BMI, tumor volume, and median of V e emerged as independent predictors of EEC grade, and constructed the nomogram (recorded as Nomogram_2), achieving an AUC of 0.845 (95% CI: 0.786-0.893) in the training set. While in the external testing set, the AUC was 0.819 (95% CI: 0.744-0.894), with corresponding sensitivity of 72.4%, specificity of 72.4%, accuracy of 72.4%, PPV of 43.8%, and NPV of 89.9% for predicting high-grade EEC. (3) The DCA curves demonstrated that both Nomogram_1 and Nomogram_2 yielded obvious positive clinical net benefits across a wide range of threshold probabilities. Conclusion:The nomogram based on pretreatment clinical and DCE-MRI characteristics has the potential to noninvasive predict the depth of myometrial invasion and grade of EEC, providing valuable reference information for clinical management decision-making.
4.Analysis and Suggestions on the Problem of the Unclear Part of the Safety Content Section of Chinese Patent Medicines
Min LI ; Minhua ZHOU ; Huifei WU
Herald of Medicine 2025;44(5):727-731
Objective The content of the relevant safety items in the instructions of Chinese patent medicines is"Not Clear"to provide a reliable reference for improving the safety and effectiveness of Chinese patent medicines.Methods Search the Chinese Pharmacopoeia 2020,National Essential Medicines List,Handbook of Selected Chinese Patent Drugs in Various Clinical Subjects,and Handbook of Modern Chinese Patent Drugs.Conduct random sampling according to Chinese patent medicines'different efficacy and dosage forms and collect complete basic information and versions.There are a total of 105 latest drug instructions.The safety information in each drug instruction is extracted and entered into Excel 2019.The annotations are summarized and statistically analyzed one by one.Results After summarizing,most instructions are marked with safety item information such as adverse e-vents,contraindications,pharmacology,and toxicology.Howe ver,the degree of detail of each content varies greatly.Common problems include non-standard terminology description,content"avoiding the important and light,passing it off"or inconsistent content with the labeling,and insufficient clinical data research.Conclusions There is a severe lack of research content in the package insert of Chinese patent medicines,and it is still necessary to further strengthen the discussion and research on the mechanism of action of medicines to revise and improve the safety information of the instructions and ensure the safety of clinical use.
5.Nomogram based on clinical and DCE-MRI characteristics for predicting the depth of myometrial invasion and grade of endometrioid endometrial carcinoma
Xiaoliang MA ; Songqi CAI ; Jinwei QIANG ; Guofu ZHANG ; Jianjun ZHOU ; Mengsu ZENG ; Xiaojun REN ; Rong JIANG ; Minhua SHEN
Chinese Journal of Obstetrics and Gynecology 2025;60(3):202-215
Objective:To investigate the feasibility and value of nomogram based on base line clinical and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) characteristics for pretreatment predicting the depth of myometrial invasion and tumor grade of endometrioid endometrial carcinoma (EEC).Methods:Preoperative baseline clinical characteristics and DCE-MRI characteristics of 194 EEC patients were prospectively collected at Obstetrics and Gynecology Hospital, Fudan University from October 2020 to January 2022 and used as a training set. Univariate analysis was conducted to compare baseline clinical characteristics and DCE-MRI quantitative parameters [including tumor volume, and mean, median, and standard deviation of volume transfer constant (K trans), rate constant (K ep), extravascular extracellular volume fraction (V e), and initial area under the enhancement curve (iAUC)] between patients with deep myometrial invasion (DMI) and those with superficial myometrial invasion (SMI), as well as between high-grade and low-grade EEC. Multivariate logistics regression analysis was used to identify independent predictors for the construction of nomogram. An independent external testing set comprising 127 EEC patients was retrospectively collected from Zhongshan Hospital, Fudan University and Zhongshan Hospital, Fudan University (Xiamen Branch). The area under the receiver operating characteristic curve (AUC) and decision curve analysis (DCA) were used for evaluating the model′s predictive performance and clinical net benefit, respectively. Results:(1) The depth of myometrial invasion: univariate analysis showed that in the training set, the EEC patients with DMI differed significantly from those with SMI in clinical characteristics including higher proportion of postmenopausal state and overweight [body mass index (BMI)≥25 kg/m2], and abnormal levels of serum cancer antigen (CA) 125, CA 199, and human epididymis protein 4 (HE4), and in DCE-MRI quantitative parameters including tumor volume, and median, mean, and standard deviation of K trans, median of V e, as well as median, mean, and standard deviation of iAUC (all P<0.05). Multivariate analysis showed that the patient′s menstrual status, BMI, CA 199, tumor volume, and mean of iAUC were independent predictors of the depth of myometrial invasion, and constructed the nomogram (recorded as Nomogram_1), achieving an AUC of 0.861 (95% CI: 0.803-0.919) in the training set. In the independent external testing set, the AUC was 0.876 (95% CI: 0.815-0.938), with corresponding sensitivity of 82.0%, specificity of 80.7%, accuracy of 81.1%, positive predictive value (PPV) of 65.3%, and negative predictive value (NPV) of 91.0% for predicting DMI. (2) The EEC grade: univariate analysis showed that in the training set, high-grade EEC patients differed significantly from low-grade EEC in clinical characteristics including patient′s age, the proportion of postmenopausal state and overweight, and abnormal levels of serum CA 125, and in DCE-MRI quantitative parameters including tumor volume, median, mean, and standard deviation of K trans, median and mean of V e, as well as median, mean, and standard deviation of iAUC (all P<0.05). Multivariate analysis showed that the patient′s menstrual status, BMI, tumor volume, and median of V e emerged as independent predictors of EEC grade, and constructed the nomogram (recorded as Nomogram_2), achieving an AUC of 0.845 (95% CI: 0.786-0.893) in the training set. While in the external testing set, the AUC was 0.819 (95% CI: 0.744-0.894), with corresponding sensitivity of 72.4%, specificity of 72.4%, accuracy of 72.4%, PPV of 43.8%, and NPV of 89.9% for predicting high-grade EEC. (3) The DCA curves demonstrated that both Nomogram_1 and Nomogram_2 yielded obvious positive clinical net benefits across a wide range of threshold probabilities. Conclusion:The nomogram based on pretreatment clinical and DCE-MRI characteristics has the potential to noninvasive predict the depth of myometrial invasion and grade of EEC, providing valuable reference information for clinical management decision-making.
6.Evaluation of short-term outcomes of surgical intervention for severe pulmonary stenosis in infants and young children
Yong ZHANG ; Pengyu WANG ; Liang WANG ; Yiming TAN ; Fangran XIN ; Xu ZHANG ; Chunzhen ZHANG ; Zijun ZHOU ; Lihua LYV ; Minhua FANG
Chinese Journal of Thoracic and Cardiovascular Surgery 2025;41(10):584-588
Objective:To evaluate the short-term efficacy of surgical treatment for severe pulmonary stenosis(PS) in infants and young children, and to clarify the impact of different surgical timings on the efficacy of PS treatment.Methods:A retrospective analysis was conducted on 24 infants and young children who underwent surgical treatment for severe PS at the General Hospital of Northern Theater Command, PLA, from January 1, 2020, to October 1, 2024. Among them, 13 were males and 11 were females. The average weight of the patients was(9.2±3.6) kg, the average gestational age was(39.3±1.7) weeks, and the average age was(15.0±13.5) months. Preoperative clinical symptoms and signs(e.g., cyanosis, shortness of breath), transpulmonary valve pressure gradient(TPVPG), right ventricular systolic pressure(RVSP), and Em/Am were recorded. The patients were divided into two groups based on surgical timing: the infant group(under 1 year old, n=12) and the toddler group(1-3 years old, n=12).Results:There were no deaths among all patients. The postoperative ICU stay was significantly longer in the infant group compared to the toddler group( P<0.05). Compared to preoperative values, surgical treatment significantly improved TPVPG, reduced RVSP, and enhanced right ventricular diastolic function, which stabilized by 3 months postoperatively( P<0.05). Intergroup comparisons revealed that the infant group had significantly lower TPVPG at 6 months postoperatively compared to the toddler group. Additionally, right ventricular diastolic function improved significantly in the infant group postoperatively, while no significant improvement was observed in the toddler group. Younger age and reduced right ventricular diastolic function were identified as major risk factors for prolonged mechanical ventilation(>24 hours). Conclusion:Surgical treatment for PS during infancy and early childhood is safe and effective. Comprehensive preoperative evaluation is crucial, and early surgical intervention is recommended for patients with impaired right ventricular function to improve prognosis.
7.Incidence and Mortality of Liver Cancer in Fusui County of Guangxi Zhuang Autonomous Region in 2019 and Trend from 2011 to 2019
Yuman FAN ; Yunxi LI ; Jiangshi ZHAO ; Ji CAO ; Zihan ZHOU ; Qiulin LI ; Minhua RONG ; Lianying GE ; Chenglei YANG ; Xiumei LIANG ; Yingchun LIU ; Hongping YU
China Cancer 2025;34(3):195-202
[Purpose]To analyze the incidence and mortality of liver cancer in Fusui County of Guangxi Zhuang Autonomous Region in 2019 and the trend of change from 201 1 to 2019.[Meth-ods]Based on the incidence and mortality data of liver cancer in Fusui County from 2011 to 2019,the crude incidence rate,crude mortality rate,age-standardized rate by Chinese standard population(ASIRC/ASMRC),age-standardized rate by world standard population(ASMRW/ASM-RW),disability-adjusted life years(DALY),years of life lost(YLL),years of lived with disability(YLD)were calculated.The Joinpoint linear regression model was used to calculate the average annual percentage change(AAPC)of the ASIRC/ASMRC and DALY rate of liver cancer in Fusui County from 2011 to 2019.[Results]In 2019,there were 345 new cases and 298 deaths of liver cancer in Fusui County,accounting for 28.49%and 35.86%of all new cases and death cases of malignant tumors in Fusui County,respectively.The crude incidence rate,ASIRC and ASIRW were 74.71/105,67.55/105 and 65.63/105,respectively;the crude mortality rate,ASMRC and ASMRW were 64.53/105,58.78/105 and 56.88/105,respectively.In 2019,ASIRC/ASMRC of men were higher than those of women(105.32/105 and 95.67/105 for men;27.26/105 and 19.11/105 for women).The peak incidence and mortality rates were in the 65~69 and 80~84 age groups,re-spectively.The incidence rate of liver cancer in Fusui County declined from 82.50/105 in 2011 to 67.55/105 in 2019,with an AAPC of-3.01%(P=0.024),but the mortality rate did not have sig-nificant changes(AAPC=-1.44%,P=0.224).The rate of DALY decreased from 14.51/105 to 10.36/105,with an AAPC of-2.82%(P=0.050).[Conclusion]The incidence rate and DALY rate of liv-er cancer in Fusui County showed an overall decreasing trend from 2011 to 2019,but still re-mained at a high level.It is necessary to further strengthen the prevention,screening and early treatment of liver cancer in this region,especially for men and the elderly.
8.Clinical effect of She medical Shiliangcha compound prescription in treating obesity complicated with OSAHS
China Modern Doctor 2025;63(4):66-68,76
Objective To investigate the clinical efficacy and safety of She medical Shiliangcha compound prescription in treating obesity with syndrome of internal exuberance of phlegm-damp complicated with obstructive sleep apnea hypopnea syndrome(OSAHS).Methods A total of 90 patients with obesity with syndrome of internal exuberance of phlegm-damp complicated with OSAHS diagnosed and treated in Lishui Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medical University from January 2023 to February 2024 were selected and divided into control group and treatment group according to random number table method,with 45 cases in each group.Patients in control group received continuous positive airway pressure(CPAP)with non-invasive ventilator,and patients in treatment group was treated with She medical Shiliangcha compound prescription on the basis of control group.Both groups of patients were treated for 3 months.Body mass index(BMI),Epworth sleeping scale(ESS)score,sleep apnea index and adverse reactions were compared between two groups.Results After treatment,ESS score,BMI,apnea-hypopnea index(AHI)in two groups were significantly lower than before treatment,and minimum blood oxygen saturation(LSaO2)was significantly higher than before treatment(P<0.05).ESS score,BMI and AHI in treatment group were significantly lower than those in control group,and LSaO2 was significantly higher than that in control group(P<0.05).The incidence of adverse reactions in treatment group was significantly lower than that in control group(x2=6.429,P=0.011).Conclusion The She medical Shiliangcha compound prescription has a definite therapeutic effect on the treatment of obesity with syndrome of internal exuberance of phlegm-damp complicated with OSAHS.It can reduce BMI and ESS score,improve sleep apnea parameters,and reduce adverse reactions caused by non-invasive ventilator assisted ventilation.
9.Evaluation of short-term outcomes of surgical intervention for severe pulmonary stenosis in infants and young children
Yong ZHANG ; Pengyu WANG ; Liang WANG ; Yiming TAN ; Fangran XIN ; Xu ZHANG ; Chunzhen ZHANG ; Zijun ZHOU ; Lihua LYV ; Minhua FANG
Chinese Journal of Thoracic and Cardiovascular Surgery 2025;41(10):584-588
Objective:To evaluate the short-term efficacy of surgical treatment for severe pulmonary stenosis(PS) in infants and young children, and to clarify the impact of different surgical timings on the efficacy of PS treatment.Methods:A retrospective analysis was conducted on 24 infants and young children who underwent surgical treatment for severe PS at the General Hospital of Northern Theater Command, PLA, from January 1, 2020, to October 1, 2024. Among them, 13 were males and 11 were females. The average weight of the patients was(9.2±3.6) kg, the average gestational age was(39.3±1.7) weeks, and the average age was(15.0±13.5) months. Preoperative clinical symptoms and signs(e.g., cyanosis, shortness of breath), transpulmonary valve pressure gradient(TPVPG), right ventricular systolic pressure(RVSP), and Em/Am were recorded. The patients were divided into two groups based on surgical timing: the infant group(under 1 year old, n=12) and the toddler group(1-3 years old, n=12).Results:There were no deaths among all patients. The postoperative ICU stay was significantly longer in the infant group compared to the toddler group( P<0.05). Compared to preoperative values, surgical treatment significantly improved TPVPG, reduced RVSP, and enhanced right ventricular diastolic function, which stabilized by 3 months postoperatively( P<0.05). Intergroup comparisons revealed that the infant group had significantly lower TPVPG at 6 months postoperatively compared to the toddler group. Additionally, right ventricular diastolic function improved significantly in the infant group postoperatively, while no significant improvement was observed in the toddler group. Younger age and reduced right ventricular diastolic function were identified as major risk factors for prolonged mechanical ventilation(>24 hours). Conclusion:Surgical treatment for PS during infancy and early childhood is safe and effective. Comprehensive preoperative evaluation is crucial, and early surgical intervention is recommended for patients with impaired right ventricular function to improve prognosis.
10.Incidence and Mortality of Liver Cancer in Fusui County of Guangxi Zhuang Autonomous Region in 2019 and Trend from 2011 to 2019
Yuman FAN ; Yunxi LI ; Jiangshi ZHAO ; Ji CAO ; Zihan ZHOU ; Qiulin LI ; Minhua RONG ; Lianying GE ; Chenglei YANG ; Xiumei LIANG ; Yingchun LIU ; Hongping YU
China Cancer 2025;34(3):195-202
[Purpose]To analyze the incidence and mortality of liver cancer in Fusui County of Guangxi Zhuang Autonomous Region in 2019 and the trend of change from 201 1 to 2019.[Meth-ods]Based on the incidence and mortality data of liver cancer in Fusui County from 2011 to 2019,the crude incidence rate,crude mortality rate,age-standardized rate by Chinese standard population(ASIRC/ASMRC),age-standardized rate by world standard population(ASMRW/ASM-RW),disability-adjusted life years(DALY),years of life lost(YLL),years of lived with disability(YLD)were calculated.The Joinpoint linear regression model was used to calculate the average annual percentage change(AAPC)of the ASIRC/ASMRC and DALY rate of liver cancer in Fusui County from 2011 to 2019.[Results]In 2019,there were 345 new cases and 298 deaths of liver cancer in Fusui County,accounting for 28.49%and 35.86%of all new cases and death cases of malignant tumors in Fusui County,respectively.The crude incidence rate,ASIRC and ASIRW were 74.71/105,67.55/105 and 65.63/105,respectively;the crude mortality rate,ASMRC and ASMRW were 64.53/105,58.78/105 and 56.88/105,respectively.In 2019,ASIRC/ASMRC of men were higher than those of women(105.32/105 and 95.67/105 for men;27.26/105 and 19.11/105 for women).The peak incidence and mortality rates were in the 65~69 and 80~84 age groups,re-spectively.The incidence rate of liver cancer in Fusui County declined from 82.50/105 in 2011 to 67.55/105 in 2019,with an AAPC of-3.01%(P=0.024),but the mortality rate did not have sig-nificant changes(AAPC=-1.44%,P=0.224).The rate of DALY decreased from 14.51/105 to 10.36/105,with an AAPC of-2.82%(P=0.050).[Conclusion]The incidence rate and DALY rate of liv-er cancer in Fusui County showed an overall decreasing trend from 2011 to 2019,but still re-mained at a high level.It is necessary to further strengthen the prevention,screening and early treatment of liver cancer in this region,especially for men and the elderly.

Result Analysis
Print
Save
E-mail