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.

Objective:To evaluate the safety and efficacy of secondary transport on extracorporeal membrane oxygenation (ECMO) for critically ill children.Methods:This was a retrospective cohort study. Data from 222 pediatric patients who underwent ECMO transport from May 2019 to May 2024 at 5 ECMO centers and Chinese Database of Pediatric Extracorporeal Life Support Organization were collected. The cases were divided into primary and secondary transport groups by nature of transport. The clinical data, including demographics, ECMO indications, transport distance, pre-transport lab results, prognosis and complications were analyzed. Two independent samples t-test, Wilcoxon test, and χ2 test or Fisher′s exact probability method were used to compare the differences between 2 groups and evaluate the safety and efficacy of secondary transport. Results:Among the 222 children transported with ECMO, there were 135 males and 87 females, with an age of 3.0 (0.2, 7.0) years. There were 202 cases in the primary transport group and 20 cases in the secondary transport group. All secondary transport patients had failed attempts at weaning ECMO before transfer. The patients in the secondary transport group were older, had higher rates of surgical cannulation, circulatory support, and pre-ECMO lactate levels compared to the primary transport group (7.0 (2.8, 10.0) vs. 3.0 (0.2, 6.0) years old, 55.0% (11/20) vs. 3.6% (7/202), 80.0% (16/20) vs. 41.6% (84/202), (10±4) vs. (7±6) mmol/L, Z=3.41, χ 2=66.31, 10.99, t=2.24, all P<0.05). In the secondary transport group, the vasoactive-inotropic scores of patients on circulatory support and the oxygenation index for patients requiring respiratory support were higher than those in the primary transport group (83±33 vs. 82±68, 51.0±1.8 vs. 37.4±10.2, t=2.36, 2.63, respectively; both P<0.05). There were no statistically significant differences between the 2 groups in sex, transport distance, pre-ECMO creatinine, arterial blood gas BE values, and ECMO duration (all P>0.05). No life-threatening complications occurred during the transport in either group. Two patients in the secondary transport group underwent heart transplantation, and 1 patient underwent radiofrequency ablation. The overall survival rate between the 2 groups showed no statistically significant difference (45.0% (9/20) vs. 55.4% (112/202), χ2=1.15, P>0.05). Conclusions:Secondary ECMO transport for critically ill children don't increase mortality or life-threatening complications during transport. ECMO patients who cannot receive effective treatment locally can benefit from secondary transport to an advanced ECMO center provides further treatment opportunities.

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

OBJECTIVE: To investigate the incidence of sepsis in Xinjiang Uygur Autonomous Region and the compliance with sepsis diagnosis and treatment guidelines in intensive care unit (ICU) at different levels of hospitals, and to identify the risk factors associated with poor prognosis in patients with sepsis in this region. METHODS: A prospective cross-sectional survey was conducted in ICU of Xinjiang Uygur Autonomous Region Critical Care Medicine Alliance. The survey period was from 10:00 on January 31, 2024, to 09:59 on February 1, 2024. The patients diagnosed with sepsis admitted to the ICU during the study period were included in the analysis. Data on patient demographics, physiology, microbiology, and treatment protocols were collected, with follow-up until the 28th day after ICU admission or death. Baseline characteristics and treatment information of septic patients across different hospital levels were compared, as well as clinical data of septic patients with different 28-day outcomes. Multivariate Cox proportional hazards model was used to identify risk factors for 28-day death in septic patients. RESULTS: A total of 77 units of Xinjiang Uygur Autonomous Region Critical Care Medicine Alliance from 14 prefectures/cities in Xinjiang participated in the survey. On the survey day, 727 patients were admitted to ICU, of whom 179 (24.6%) were diagnosed with sepsis, and 64 (35.8%) died within 28 days, 115 (64.2%) survived. Among the participating institutions, 33 were tertiary hospitals (42.9%), managing 97 septic cases (54.2%), and 44 were secondary hospitals (57.1%), managing 82 septic cases (45.8%). The lactic acid monitoring rate and continuous renal replacement therapy (CRRT) rate for septic patients in tertiary hospitals were significantly higher than those in secondary hospitals [lactic acid monitoring rate: 92.8% (90/97) vs. 82.9% (68/82), CRRT rate: 17.5% (17/97) vs. 3.7% (3/82), both P < 0.05]. No statistically significant differences were observed between tertiary and secondary hospitals in length of ICU stay or 28-day mortality [length of ICU stay (days): 11.0 (16.0) vs. 10.0 (22.0), 28-day mortality: 35.1% (34/97) vs. 36.6% (30/82), both P > 0.05]. Compared with survivors, non-survivors had higher acute physiology and chronic health evaluation II (APACHE II) score, sequential organ failure assessment (SOFA) score, Charlson comorbidity index (CCI) score and lower Glasgow coma scale (GCS) score. Significant differences were noted in vital signs [heart rate, blood pressure, body temperature, pulse oxygen saturation (SpO₂)], laboratory markers [red blood cell count (RBC), white blood cell count (WBC), lymphocyte ratio (LYM%), blood urea nitrogen (BUN), total protein (TP), albumin (Alb), pH value, base excess (BE)], and monitoring, diagnosis and treatment information (invasive blood pressure monitoring, mechanical ventilation, CRRT, usage of norepinephrine). Multivariate Cox proportional hazards model indicated that body temperature [hazard ratio (HR) = 1.416, 95% confidence interval (95%CI) was 1.022-1.961, P = 0.037] and WBC (HR = 1.040, 95%CI was 1.010-1.071, P = 0.009) were independent risk factors for 28-day death in patients with sepsis. CONCLUSIONS Sepsis in Xinjiang Uygur Autonomous Region is characterized by a high mortality. In this region, tertiary hospitals demonstrate better compliance with bundled treatment strategies such as lactic acid monitoring and the usage of CRRT compared to secondary hospitals, yet they do not show significant advantages in clinical outcomes. Body temperature and WBC are independent risk factors for 28-day death in patients with sepsis in this region. However, clinicians should still consider the actual situation of patients, along with more optimal early warning indicators and comprehensive system assessments, to identify and prevent risk factors for adverse outcomes in patients.
Humans ; Sepsis/diagnosis* ; Cross-Sectional Studies ; Prospective Studies ; Risk Factors ; Intensive Care Units ; Prognosis ; China/epidemiology* ; Male ; Female ; Middle Aged ; Aged ; Proportional Hazards Models ; Incidence

Objective To discuss the application value of comfort medical mode in patients with uterine fibroids receiving interventional embolization therapy during hospitalization.Methods A total of 27 patients with uterine fibroids,who received interventional embolization at the Third Affiliated Hospital of Zhengzhou University of China,were enrolled in this study.The patient's basic data,including age,the sum of the maximum diameter of the measurable uterine fibroids and the hemoglobin level at admission,were collected.After admission and before discharge,the self-efficacy scale score,Becker anxiety scale score,and positive and negative emotions scale score were determined in all the patients.According to the different medical management mode adopted during the hospitalization,the patients were divided into study group(n=14)and control group(n=13).Comfort medical mode guided by quantitative evaluation strategy was employed for the patients of the study group,while conventional management mode was adopted for the patients of the control group.SPSS 26.0 software was used for data analysis.Measurement data within group were analyzed by independent sample t-test,and measurement data between groups were analyzed by paired sample t-test,and P＜0.05 was defined as a statistically significant difference.Results There were no statistically significant differences in the basic data between the two groups,and no statistically significant differences in the self-efficacy scale score,Becker anxiety scale score,and positive and negative emotions scale score at admission existed between the two groups.In the study group,the self-efficacy score and positive emotion score at discharge were strikingly higher than those at admission(P＜0.001),and the anxiety degree and negative emotion score at discharge were obviously lower than those at admission(P＜0.001).In the control group,the scores of the above-mentioned scales at discharge did not differ from those at admission.Conclusion The comfort medical mode guided by quantitative evaluation strategy has better clinical effect in patients with uterine fibroids receiving interventional embolization therapy,it can improve patient's comfortableness degree during hospitalization period.

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.

This study aims to investigate whether the dietary supplement coenzyme Q10(CoQ10)alleviates bisphenol A(BPA)-induced mouse Leydig cell line(TM3)damage through autophagy pathway.Cell activity was measured by CCK-8 assay when treated with different concentrations of BPA for 24 h.TM3 cells were then divided into 5 groups:CON group,BPA group,Torin2 group,CQ group and BPA+CoQ10 group,with three repeats in each group.The morphology of TM3 cells were observed under inverted light microscope.Western blot was used to determine the protein ex-pression of p62 and LC3-Ⅰ/Ⅱ.The autophagy level of TM3 cells was detected by MDC cell auto-phagy staining,the mRNA expression levels of Atg7,Beclin 1,p62 and Atg5 genes were deter-mined by RT-qPCR,and the apoptosis rate of TM3 cells was detected by flow cytometry.The results showed that compared with 0 μmol/L BPA treatment group,the viability of TM3 cells de-creased significantly after 24 h treatment with 60 μmol/L BPA(P＜0.01).Compared with CON group,the number of TM3 cells markedly reduced in the BPA-treated group,the expression of au-tophagy-related proteins(p62,LC3-Ⅱ)significantly increased(P＜0.01),comparable to the CQ group.The MDC fluorescence intensity dramatically enhanced(P＜0.01),the mRNA expression levels of autophagy-related genes(Atg7,Beclin1,p62,Atg5)significantly elevated(P＜0.01),and the apoptosis rate significantly increased(P＜0.01).Compared with BPA group,the expression levels of autophagy-related genes Atg7 and Beclin1 mRNA(P＜0.05),p 62 and Atg5 mRNA(P＜0.01)in TM3 cells treated with BPA+CoQ10 significantly decreased.Moreover,the expres-sion levels of autophagy-related protein p62(P＜0.01)and LC3-Ⅱ(P＜0.05),MDC fluorescence intensity(P＜0.05)and apoptosis rate(P＜0.01)also markedly reduced.In conclusion,CoQ10 could subsequently reduce the apoptosis of TM3 cells by improving the abnormal autophagy flux induced by BPA.

Retinal artery occlusion(RAO)is a vascular neuro-ophthalmological emergency and a rare but serious complication of carotid artery stenting(CAS).It is characterized by a sudden decrease in vision or even vision loss in one eye.This article reports a case of central RAO caused by emboli through a branch of the external carotid artery during CAS,aiming to provide insights for optimizing CAS procedures,and preventing and controlling this complication.