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.

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.

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.

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.

Objective To validate the diagnostic performance and risk stratification ability of an AI-based recognition system(PE-AI)for pulmonary embolism(PE)using computed tomography pulmonary angiography(CTPA)so as to analyze its diagnostic value in clinical practice.Methods A total of 416 patients with suspected PE who underwent CTPA from January 1,2023 to December 10,2023 at our hospital were included in this study.Two junior radiologists and PE-AI separately detected and diagnosed emboli in the collected cases by double-blind method,and recorded the diagnosis time respectively.Three senior radiologists reviewing with clinical follow-up results were used as the gold standard in this study.Diagnostic performance was evaluated by using the receiver operating characteristic(ROC)curve analysis and Delong-t test.For positive cases,the pulmonary artery obstruction index(PAOI)calculated by AI and manually were collected respectively and consistency analysis was performed.Results The area under the curve(AUC)of PE-AI,manual and combined diagnosis was 85.6％,90.8％and 95.1％,respectively,which differed significantly(P＜0.05).The reading time of PE-AI[(0.16±0.07)min]was significantly lower than the time of manual[(4.42±1.85)min,P＜0.001]and combined diagnosis[(4.58±1.84)min,P＜0.001].The PAOI measured by PE-AI and manually had high consistency(intraclass correlation efficient,ICC=0.80)in the subgroup analysis of confirmed cases.Conclusion AI can quickly identify pulmonary artery emboli in a short time and assist radiologists to improve diagnostic efficiency.At the same time,through the intelligent detection of PAOI,it is helpful for the risk stratification of patients with PE and optimizing the diagnosis and treatment pathway for pulmonary embolism.

Objective:To clarify the genetic associations between obesity, diabetes, smoking, non-alcoholic fatty liver disease, acute and chronic pancreatitis, and pancreatic cancer risk.Methods:Summary data from genome-wide association studies (GWAS) of individuals of European descent were used. Obesity, alcohol consumption, diabetes, and acute and chronic pancreatitis data for the UK population were obtained from the GWAS catalog, while alcohol consumption, non-alcoholic fatty liver disease, occasional smoking, and regular smoking data were obtained from the UK biobank. Pancreatic cancer-related data for the Finnish population were sourced from the latest R11 version of the Finnish database. Two-sample Mendelian randomization (MR) analysis was conducted on the associations between the aforementioned risk factors and pancreatic cancer using five MR methods, primarily inverse variance weighting. The robustness of the results was assessed through Q heterogeneity tests, pleiotropy tests, MR-PRESSO analysis, and reverse MR analysis.Results:Obesity showed a significant positive association with pancreatic cancer risk ( OR=1.407, 95% CI: 1.100-1.714, P=0.030), and the results were robust based on Q heterogeneity tests, pleiotropy tests, MR-PRESSO, and reverse MR analysis (all P>0.05). However, no significant associations were found between pancreatic cancer risk and alcohol consumption ( P=0.330), heavy drinking ( P=0.382), type 1 diabetes ( P=0.674), type 2 diabetes ( P=0.825), occasional smoking ( P=0.607), regular smoking ( P=0.758), non-alcoholic fatty liver disease ( P=0.287), acute pancreatitis ( P=0.336), or chronic pancreatitis ( P=0.545). Conclusion:This study further confirms the strong genetic association between obesity and increased pancreatic cancer risk.

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

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.

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.

OBJECTIVE: To elucidate the predictive value of norepinephrine equivalence (NEE) score on the 28-day death risk in patients with sepsis and provide evidence for its application in the diagnosis and treatment of sepsis and septic shock. METHODS: A retrospective cohort study was conducted based on the data of patients with sepsis from Medical Information Mart for Intensive Care-IV 2.2 (MIMIC-IV 2.2). The patients who received vasoactive agents within 6 hours after the diagnosis of sepsis or septic shock were enrolled, and they were divided into survival and non-survival groups based on their 28-day outcomes. The baseline characteristics, vital signs, and treatment data were collected. Multivariate Cox regression analysis was performed to identify factors influencing the 28-day death risk. Receiver operator characteristic curve (ROC curve) was drawn to analyze the predictive value of various parameters on the 28-day death risk of septic patients. Kaplan-Meier survival curve was used to evaluate cumulative survival rate in patients classified by different quantitative parameters based on the cut-off values obtained from ROC curve analysis. RESULTS: A total of 7 744 patients who met the Sepsis-3 diagnostic criteria and received vasopressor treatment within 6 hours post-diagnosis were enrolled, of which 5 997 cases survived and 1 747 died, with the 28-day mortality of 22.6%. Significant differences were observed between the two groups regarding age, gender, height, body weight, race, type of intensive care unit (ICU), acute physiology and chronic health evaluation II (APACHE II) score, sequential organ failure assessment (SOFA) score, Charlson comorbidity index (CCI) score, underlying comorbidities, and vital signs. Compared with the survival group, the non-survival group had poorer blood routine, liver and kidney function, coagulation function, blood gas analysis and other indicators. Multivariate Cox regression analysis revealed that age > 65 years old [hazard ratio (HR) = 0.892, 95% confidence interval (95%CI) was 0.801-0.994, P = 0.039] and male (HR = 0.735, 95%CI was 0.669-0.808, P < 0.001) were protective factors for 28-day death in patients with sepsis, and NEE score (HR = 1.040, 95%CI was 1.021-1.060, P < 0.001), shock index (HR = 1.840, 95%CI was 1.675-2.022, P < 0.001), APACHE II score (HR = 1.076, 95%CI was 1.069-1.083, P < 0.001), SOFA score (HR = 1.035, 95%CI was 1.015-1.056, P < 0.001), and CCI score (HR = 1.135, 95%CI was 1.115-1.155, P < 0.001) were independent risk factors for 28-day death in septic patients. ROC curve analysis showed that the area under the ROC curve (AUC) of NEE score for predicting the 28-day death risk of septic patients was 0.743 (95%CI was 0.730-0.756), which was comparable to the predictive value of APACHE II score (AUC = 0.742, 95%CI was 0.729-0.755) and ratio of mean arterial pressure (MAP)/NEE score (MAP/NEE; AUC = 0.738, 95%CI was 0.725-0.751, both P > 0.05), and better than SOFA score (AUC = 0.609, 95%CI was 0.594-0.624), CCI score (AUC = 0.658, 95%CI was 0.644-0.673), shock index (AUC = 0.613, 95%CI was 0.597-0.629) and ratio of diastolic blood pressure (DBP)/NEE score (DBP/NEE; AUC = 0.735, 95%CI was 0.721-0.748, all P < 0.05). According to the cut-off values of APACHE II and NEE scores obtained from ROC curve analysis, the patients were stratified for Kaplan-Meier survival curve analysis, and the results showed that the 28-day cumulative survival rate in the septic patients with an APACHE II score ≤ 22.5 was significantly higher than that in those with an APACHE II > 22.5 (Log-Rank test: χ² = 848.600, P < 0.001), and the 28-day cumulative survival rate in the septic patients with an NEE score ≤0.120 was significantly higher than that in those with an NEE score > 0.120 (Log-Rank test: χ² = 832.449, P < 0.001). CONCLUSIONS NEE score is an independent risk factor for 28-day death in septic patients who received vasoactive treatment within 6 hours of diagnosis and possesses significant predictive value. It can be used for severity stratification in sepsis management.
Humans ; Retrospective Studies ; Sepsis/diagnosis* ; Male ; Female ; Norepinephrine/therapeutic use* ; Middle Aged ; Aged ; Prognosis ; Predictive Value of Tests ; Shock, Septic/mortality* ; Adult ; ROC Curve ; Risk Factors ; Survival Rate ; Aged, 80 and over