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.

Disruption of normal secretion or mucociliary clearance can impair airway defense mechanisms and lung function, and increase the risk of infection. Airway clearance techniques are recommended as part of a comprehensive treatment plan for patients. Among these, vibratory expectoration is an important method of airway clearance, which loosens and liquefies mucus and metabolites on the surface of the respiratory tract through chest wall oscillation, promoting ciliary movement to facilitate sputum expulsion. However, commonly used handheld vibrating head devices and vest-type vibration expectorators have several limitations in clinical practice, such as inconvenience of operation, limited treatment time, poor adaptability, and difficulty in disinfection. To address these issues, the research team from the department of critical care medicine at Ruijin Hospital, Shanghai Jiao Tong University, has designed a novel belt-type vibration expectorator, which has been granted a national utility model patent (Patent No.: ZL 2023 2 1610983.1). The device is mainly composed of a chest strap assembly, a sputum clearance component, and a fixed shoulder strap component. Several pockets are placed on the outer surface of the chest strap, with corresponding inner-side openings that allow the percussion head of the percussive expectorator placed inside the pocket to make contact with the patient's chest wall. Each pocket has markings indicating the percussion position, enabling the placement of the percussive expectorator according to the location of infection, thereby achieving multi-point, precise percussive vibration expectoration in different body positions. On the inner side of the chest strap, there are diagrams illustrating postural drainage, providing guidance on the body positions patients should assume based on the location of infection. The hook-and-loop fasteners on both sides of the chest strap can be wrapped around and secured according to the patient's body shape, ensuring that the sputum clearance components adhere tightly to the chest wall, allowing the vibrations generated by percussion to be effectively transmitted to the patient's airways. Additionally, to prevent the chest strap from slipping due to changes in the patient's position, a Y-shaped fixing strap can be selectively attached to the chest strap for further stabilization. This innovation not only simplifies the operation process, improves convenience and flexibility of use, but also supports the principle of "disinfection after each use by one person," which helps to reduce the risk of nosocomial infections and improve the efficiency of patients' respiratory rehabilitation.
Humans ; Vibration ; Equipment Design ; Chest Wall Oscillation/instrumentation* ; Sputum ; Expectorants ; Mucociliary Clearance

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 explore the clinical value of energy-spectrum CT single-energy imaging in enhancing the image quality and stent display of stent placement CT angiography(CTA)in lower extremity atherosclerotic occlusive disease.Methods Twenty patients[mean(65.61±9.65)years;male/female,16/4]who underwent stenting for chronic occlusive disease of the lower extremity arteries by lower extremity arterial energetic spectral CTA were retrospectively recruited at our hospital.The original images were reconstructed into seven sets of single energy(40-100 keV),120 kVp,virtual unenhanced images(VUE)and metal artifact reduction(MAR)technique images.Images were debossed and then scaffolded for display with volumetric reconstruction(VR),maximum density projection(MIP)and curve planar reconstruction(CPR),and were objectively and subjectively assessed and compared using one-way analysis of variance(ANOVA).Results The 80 keV and MAR images had the highest scores compared to the other reconstruction group images(P＜0.01).Conclusion 80 keV single-energy imaging and de-metallization artifacts MAR improve the image quality of lower extremity arterial stent lumen and structure display;therefore,they have higher diagnostic value for clinicians.

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 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.

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.

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