1.Compilation Instruction and Key Point Interpretation for Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration
Wenzhe LI ; Rui MA ; Xiaoxiao ZHAO ; Hong HUA ; Xin CUI ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):260-266
To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems, including insufficient safety information in package inserts, amplified medication risks in special populations, and non-standard clinical practices, thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China (2019 revision) and the GB/T 1.1—2020 standard, a systematic search was performed in the Chinese Pharmacopoeia (2020 edition), the Catalog of Medicines Covered by Medical Insurance (2022 edition), Chinese databases [China Network of Knowledge Infrastructure (CNKI), Wanfang Data (Wanfang), and VIP journal resource integration service platform (VIP)], and international databases (Cochrane Library, PubMed, and EMbase). Guideline outlines were developed through questionnaire surveys, expert interviews, and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine (TCM) incompatibility, as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia (2020 edition) and 58 from the Catalog of Medicines Covered by Medical Insurance (2022 edition). Safety-related items in the corresponding package inserts were collected, and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting, and opinions from 61 external experts were solicited. A pharmacovigilance framework was established, covering the full chain of "monitoring, identification, assessment, and control". Based on seven anatomical sites, including nasal, ocular, and oral mucosa, a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions", "Contraindications", and "Precautions", clinical procedure standardization in healthcare institutions, risk control, and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration, filling the current gap in international pharmacovigilance standards in this field, while offering technical support for safety management across the full life cycle of medicines for mucosal administration.
2.Compilation Instruction and Key Point Interpretation for Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration
Wenzhe LI ; Rui MA ; Xiaoxiao ZHAO ; Hong HUA ; Xin CUI ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):260-266
To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems, including insufficient safety information in package inserts, amplified medication risks in special populations, and non-standard clinical practices, thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China (2019 revision) and the GB/T 1.1—2020 standard, a systematic search was performed in the Chinese Pharmacopoeia (2020 edition), the Catalog of Medicines Covered by Medical Insurance (2022 edition), Chinese databases [China Network of Knowledge Infrastructure (CNKI), Wanfang Data (Wanfang), and VIP journal resource integration service platform (VIP)], and international databases (Cochrane Library, PubMed, and EMbase). Guideline outlines were developed through questionnaire surveys, expert interviews, and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine (TCM) incompatibility, as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia (2020 edition) and 58 from the Catalog of Medicines Covered by Medical Insurance (2022 edition). Safety-related items in the corresponding package inserts were collected, and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting, and opinions from 61 external experts were solicited. A pharmacovigilance framework was established, covering the full chain of "monitoring, identification, assessment, and control". Based on seven anatomical sites, including nasal, ocular, and oral mucosa, a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions", "Contraindications", and "Precautions", clinical procedure standardization in healthcare institutions, risk control, and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration, filling the current gap in international pharmacovigilance standards in this field, while offering technical support for safety management across the full life cycle of medicines for mucosal administration.
3.Association between obesity and diffuse idiopathic skeletal hyperostosis
Luming KONG ; Diqian ZHAO ; Wenzhe BAI ; Nianhu LI
Chinese Journal of Tissue Engineering Research 2025;29(17):3705-3712
BACKGROUND:Diffuse idiopathic skeletal hyperostosis is a systemic,non-inflammatory disease characterized by calcification and ossification of ligaments,tendons,and their attachments,predominantly affecting men over the age of 50.Studies have shown a higher prevalence of diffuse idiopathic skeletal hyperostosis among obese individuals;however,the causal relationship between the two remains unclear.OBJECTIVE:To investigate the causal relationship between obesity and diffuse idiopathic skeletal hyperostosis using Mendelian randomization analysis.METHODS:The study utilized single nucleotide polymorphisms from the Genome Wide Association Study database as instrumental variables,incorporating data related to obesity and diffuse idiopathic skeletal hyperostosis.A bidirectional two-sample Mendelian randomization analysis was performed to assess the causal relationship between obesity and diffuse idiopathic skeletal hyperostosis,with evaluations for pleiotropy,heterogeneity,and sensitivity.RESULTS AND CONCLUSION:The Mendelian randomization analysis revealed a significant positive causal relationship between obesity and diffuse idiopathic skeletal hyperostosis.The inverse-variance weighted method indicated that"obesity"(odds ratio[OR]=1.111,95%confidence interval[CI]:1.068-1.156,P=1.598×10-7),"obesity due to excess calories"(OR=1.093,95%CI:1.042-1.146,P=0.000),and"obesity,other/unspecified"(OR=1.109,95%CI:1.069-1.152,P=4.908×10-8)were significantly associated with diffuse idiopathic skeletal hyperostosis.Conversely,the reverse Mendelian randomization analysis did not find a causal relationship between diffuse idiopathic skeletal hyperostosis and obesity.The robustness of the Mendelian randomization analysis results was confirmed by pleiotropy,heterogeneity and sensitivity tests,indicating that while obesity significantly increases the risk of diffuse idiopathic skeletal hyperostosis,but diffuse idiopathic skeletal hyperostosis does not pose a risk factor for obesity.
4.Ultrasonic manifestations of abdominal pregnancy
Quanhua LI ; Jie LI ; Huixia YANG ; Peng TIAN ; Hongbin ZHANG ; Bing LIU ; Yuxin SHEN ; Wenzhe ZHANG ; Liying ZHANG ; Juan WU ; Hezhou LI
Chinese Journal of Medical Imaging Technology 2025;41(1):113-117
Objective To observe the ultrasonic manifestations of abdominal pregnancy.Methods Ultrasonic and clinical data of 18 pregnant woman with abdominal pregnancy diagnosed by operation and pathology were retrospectively analyzed.Results Among 15 cases in first trimester,no preoperative ultrasonic diagnosis of abdominal pregnancy was obtained.Ultrasound showed no gestational sac in uterine cavity but mass in pelvic cavity,which located in the adnexal region in 8 cases,in the front and the post of uterus each in 2 cases,while in the adnexal region and the front of uterus in 1 case,in the post of the cervix in 1 case,and closed to uterine wall in 1 case,without obvious tubal echo around mass in all 15 cases.There were 2 cases of abdominal pregnancy in the second trimester,which were first diagnosed with ultrasound at 13+6 weeks and 21 weeks,with gestational sac located on the left side of uterus and behind the uterus,respectively.One case of abdominal pregnancy in the third trimester was first diagnosed with ultrasound at 35 4 weeks,with gestational sac located on the right side of uterus.Ultrasonic manifestations of the above three cases all showed gestational sac located outside the uterus without myometrium wrapping around the gestational sac nor placenta implanted in uterus,while echoes of fluid accumulation were detected around fetus.The ultrasonic diagnosis rate of abdominal pregnancy was 16.67%(3/18).Conclusion In the first trimester,if the ectopic pregnancy mass was large or the gestational sac located adjacent to the cervix,anterior or posterior to uterus and on the uterine wall,also no fallopian tube-like echo around the mass,the possibility of abdominal pregnancy should be considered.Ultrasonic manifestations of abdominal pregnancy in the second and third trimester present as gestational sac outside uterine cavity without wrapping uterine muscle layer around,no placenta implantation in uterine cavity,as well as echoes of fluid accumulation around fetus.Transabdominal combined with transvaginal ultrasound could improve diagnostic rate of abdominal pregnancy.
5.Ultrasonic manifestations of abdominal pregnancy
Quanhua LI ; Jie LI ; Huixia YANG ; Peng TIAN ; Hongbin ZHANG ; Bing LIU ; Yuxin SHEN ; Wenzhe ZHANG ; Liying ZHANG ; Juan WU ; Hezhou LI
Chinese Journal of Medical Imaging Technology 2025;41(1):113-117
Objective To observe the ultrasonic manifestations of abdominal pregnancy.Methods Ultrasonic and clinical data of 18 pregnant woman with abdominal pregnancy diagnosed by operation and pathology were retrospectively analyzed.Results Among 15 cases in first trimester,no preoperative ultrasonic diagnosis of abdominal pregnancy was obtained.Ultrasound showed no gestational sac in uterine cavity but mass in pelvic cavity,which located in the adnexal region in 8 cases,in the front and the post of uterus each in 2 cases,while in the adnexal region and the front of uterus in 1 case,in the post of the cervix in 1 case,and closed to uterine wall in 1 case,without obvious tubal echo around mass in all 15 cases.There were 2 cases of abdominal pregnancy in the second trimester,which were first diagnosed with ultrasound at 13+6 weeks and 21 weeks,with gestational sac located on the left side of uterus and behind the uterus,respectively.One case of abdominal pregnancy in the third trimester was first diagnosed with ultrasound at 35 4 weeks,with gestational sac located on the right side of uterus.Ultrasonic manifestations of the above three cases all showed gestational sac located outside the uterus without myometrium wrapping around the gestational sac nor placenta implanted in uterus,while echoes of fluid accumulation were detected around fetus.The ultrasonic diagnosis rate of abdominal pregnancy was 16.67%(3/18).Conclusion In the first trimester,if the ectopic pregnancy mass was large or the gestational sac located adjacent to the cervix,anterior or posterior to uterus and on the uterine wall,also no fallopian tube-like echo around the mass,the possibility of abdominal pregnancy should be considered.Ultrasonic manifestations of abdominal pregnancy in the second and third trimester present as gestational sac outside uterine cavity without wrapping uterine muscle layer around,no placenta implantation in uterine cavity,as well as echoes of fluid accumulation around fetus.Transabdominal combined with transvaginal ultrasound could improve diagnostic rate of abdominal pregnancy.
6.The dilemma of pharmacologic treatment of acute respiratory distress syndrome
Wenzhe LI ; Xinxin DU ; Xiangyou YU
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2025;32(1):122-126
With updates of the definition and guidelines of acute respiratory distress syndrome(ARDS),significant improvements have been made in the clinical recognition and management of ARDS.The lung-protective ventilation strategy remains the primary supportive therapy for ARDS,while the absence of specific pharmacological treatments continues to contribute to the persistently high mortality rate in ARDS patients.Evidence from studies reveals that the clinical and biological heterogeneity of ARDS is closely associated with differences in its etiology,disease severity,progression and gene expression,and also demonstrates the complex pathogenesis of ARDS.Therefore,how to optimize the treatment of this heterogeneous syndrome and break through the dilemma of pharmacologic therapies is a daily problem faced by every clinician.Based on the pathophysiological mechanism of ARDS,this review summarizes the clinical studies on pharmacological interventions targeting immune response modulation,restoration of alveolar epithelial cell function,reversal of endothelial cell and vascular dysfunction,stabilization of coagulation,and promotion of tissue repair.The aim is to optimize the clinical practice and scientific research,and provide reference for clinicians achieving the goal of personalized medicine.
7.Research progress in roles of pyruvate kinase M2 in neurological diseases
Jiyuan TAN ; Yan GAO ; Jingchao LI ; Yue YIN ; Wenzhe LUO ; Yan WANG
Military Medical Sciences 2025;49(2):152-157
Pyruvate kinase M2(PKM2)is closely linked to a variety of neurological disorders,involved in the onset and progression of a wide range of diseases,including Alzheimer's disease,Parkinson's disease,multiple sclerosis and traumatic brain injury through such mechanisms as aerobic glycolysis,oxidative stress,inflammation and apoptosis.This review is intended to provide an overview of the biological characteristics of PKM2 and its role in the pathophysiological mechanisms of neurological disorders.A better understanding of the correlations between PKM2 and the development of neurological diseases can offer new insights into and references for the clinical diagnosis and treatment of these conditions.
8.A study on the application status of mechanical ventilation in critical care medicine in Xinjiang Uygur Autonomous Region
Wenzhe LI ; Yi WANG ; Jingnan XU ; Jingyan WANG ; Qihang ZHENG ; Jingjie WANG ; Xiangyou YU
Chinese Journal of Emergency Medicine 2025;34(5):707-715
Objective:To clarify the current status of mechanical ventilation management in critically ill patients and identify prognostic risk factors in Xinjiang Uygur Autonomous Region, thereby providing evidence for targeted training programs and quality improvement initiatives.Methods:A cohort study was conducted across multiple ICUs in Xinjiang Uygur Autonomous Region from January 31 to February 1, 2024. Patients receiving mechanical ventilation during the study period were enrolled, with clinical outcomes followed up until February 28, 2024. Statistical analyses included demographic characteristics, therapeutic interventions, laboratory parameters, and medication regimens.Results:A total of 77 ICUs and 727 patients were screened in the study, and 253 (34.80%) patients who received mechanical ventilation were ultimately included. Among these patients, 177 patients (69.96%) were treated in tertiary hospitals, and 76 patients (30.04%) in secondary hospitals. Significant differences were observed between tertiary and secondary hospitals regarding ventilator mode selection and mechanical ventilation parameter settings (all P<0.05). No significant differences were found in the 28-day mortality rate between tertiary hospitals and secondary hospitals (33.9% vs. 43.4%, P=0.194). Compared with patients in the survival group, death group patients were older and had more severe disease severity. Multivariate Cox regression analysis demonstrated that body temperature ( HR=1.573, 95% CI: 1.173-2.110, P=0.003), white blood cell count ( HR=1.048, 95% CI: 1.012-1.084, P=0.008), pH ( HR=0.019, 95% CI: 0.001-0.349, P=0.007), age > 65 years ( HR=1.817, 95% CI: 1.086-3.041, P=0.023), and fraction of inspired oxygen ≥ 60% ( HR=2.072, 95% CI: 1.143-3.757, P=0.016) were independent influencing factors for 28-day mortality in mechanically ventilated patients. Conclusions:Mechanically ventilated patients are a major component of the ICU population in Xinjiang Uygur Autonomous Region, with the characteristics of high risk of death. The clinical practice of mechanical ventilation in this region is heterogeneous. In the future, it is urgent to strengthen the improvement of medical quality and related training to improve the success rate of patients with mechanical ventilation.
9.Association Between Triglyceride Glucose-body Mass Index and Right Pericoronary Fat Attenuation Index on Prognosis of Patients With Coronary Artery Disease
Lulin CHEN ; Meng SUN ; Tingjie YANG ; Qingman LI ; Yiming GUO ; Yuqing YANG ; Yudong CAO ; Wenzhe LI ; Jiangshu YUAN ; Honghui YANG
Chinese Circulation Journal 2025;40(7):695-702
Objectives:This study aims to evaluate the relationship between the triglyceride-glucose body mass index(TyG-BMI),the right pericoronary fat attenuation index(RCA-FAI),and prognosis in patients with coronary artery disease(CAD).Methods:This study included 513 CAD patients who underwent coronary computed tomography angiography(CCTA)and coronary angiography between April 2018 and June 2023.Data collection and parameter calculations were performed for all research variables.The patients were stratified into three groups based on TyG-BMI tertiles:T1 group(TyG-BMI≤207.02,n=171),T2 group(207.02
10.Association between coronary inflammation and malnutrition on prognosis in patients with coronary artery disease
Lulin CHEN ; Tingjie YANG ; Meng SUN ; Xin LI ; Yiming GUO ; Yuqing YANG ; Yudong CAO ; Wenzhe LI ; Jiangshu YUAN ; Honghui YANG
The Journal of Practical Medicine 2025;41(7):1010-1017
Objective This study aimed to investigate the relationship between malnutrition and coronary inflammation,and explore the interaction and mediating effects of coronary inflammation in the association between malnutrition and major adverse cardiovascular events(MACE).Methods A retrospective analysis was conducted on 428 patients diagnosed with coronary heart disease at the Central China Fuwai Hospital from May 2018 to July 2022.All patients underwent coronary angiography(CAG)and coronary computed tomography angiography(CCTA).The TCB index(triglycerides×total cholesterol×body weight)and the coronary fat attenuation index around the proximal right coronary artery(RCA-FAI)were used to assess patients' nutritional state and the degree of coronary inflammation,respectively.The study endpoint was MACE.We used linear regression models to analyze the correlation between TCBI and RCA-FAI,cox regression models to assess the correlation of TCBI and RCA-FAI with MACE,and mediation analysis to investigate whether RCA-FAI mediated the relationship between TCBI and MACE.Results A total of 428 patients were included in the study.There was a negative correlation between RCA-FAI and TCBI(r=-0.224,P<0.001).After adjusting for potential confounders,each standard deviation decrease in the TCBI index was associated with a 2.20 HU increase in RCA-FAI(95%CI:-3.40~-1.19,P<0.001).During a mean follow-up period of 2.15 years,51 MACE occurred.MACE risk in the low TCBI/high RCA-FAI group was 6.58 times higher than that in the high TCBI/low RCA-FAI group(adjusted HR=6.580,95%CI:2.237~19.360,P=0.001),and the interaction between TCBI and RCA-FAI was identified.Mediation analysis revealed that RCA-FAI mediated 37.5%of the associations between TCBI and MACE.Conclusions In patients with coronary artery disease,malnutrition is associated with increased coronary inflammation.There is a significant interaction between malnutrition and coronary inflammation in the risk of MACE,and coronary inflammation partially mediates the relationship between malnutrition and MACE.The combination of the TCBI index and RCA-FAI can help identify patients at high cardiovascular risk.Improving malnutrition and controlling coronary inflammation may provide addi-tional benefits for patients with coronary artery disease.

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