ObjectiveTo sort out the pre-ethical review status of drug clinical trials in a tertiary A hospital， summarize practical experience， and provide references for pre-ethical review. MethodA retrospective analysis was conducted on the ethical review of pre-ethical projects in a tertiary A hospital from 2018 to 2023. ResultsFrom 2018 to 2023， a total of 285 pre-ethical projects were reviewed in this tertiary hospital， including 79 projects where it served as the leading unit. Among these， 279 clinical trials ultimately received approval of the ethical review committee， while 6 projects were not approved due to sponsors’ refusal to modify study protocols. In terms of trial phases， phase III clinical trials constituted the largest proportion， and the oncology center was the department with the highest number of projects. In 2023， the average time for pre-ethical review projects from submission to approval was 43 calendar days， 3 days longer than for other project types. In 2023， this hospital reviewed 75 pre-ethical review projects， including 58 where it served as a participating unit. Among these， 42 projects received approval later than the leading unit， while 9 projects were approved earlier than the leading unit’s ethical approval date. Among the pre-ethical review projects applied in 2023， 70 projects obtained drug clinical trial notifications from the National Medical Products Administration， while 5 projects had unknown notification status due to the lack of ethical approval or discontinuation. Of the projects receiving approval notifications， 16 were annotated with matters requiring enhanced attention during clinical trials， and 7 necessitated protocol improvements. ConclusionThis tertiary A hospital has implemented multiple measures to optimize the management of pre-ethical review. This ethical review model does not compromise the quality of ethical review and contributes to accelerating the initiation of clinical trials. Notably， it is crucial to construct a patient-centered drug development system. Clinical trials guided by this concept align with ethical values， laying the foundation for the smooth conduct of clinical trials， assisting in the drug development process， and safeguarding patients’ medication needs.

To investigate the mediating role of vitamin D in the association between exerciseand triglyceride among adolescents, as well as its potential molecular mechanisms.

Objective:To investigate the association between intraoperative hypotension and postoperative cerebral ischemia in patients undergoing malignant brain tumor resection.Methods:The study was a secondary analysis of a randomized, double-blind, placebo-controlled trial. Four hundred and eighty patients with malignant brain tumor from November 2018 to September 2022 in Beijing Tiantan Hospital, Capital Medical University were selected. All patients were treated with selective supratentorial tumor resection. The demographic characteristics, perioperative indexes, postoperative outcomes and intraoperative hypotension characteristics were recorded. The cerebral ischemia during postoperative hospitalization (within 10 d after operation) was documented, and the patients were categorized based on the occurrence of postoperative cerebral ischemia.Results:Among 480 patients, 28 cases (5.83%) developed postoperative cerebral ischemia (cerebral ischemia group), while 452 cases did not experience cerebral ischemia during hospitalization (non-cerebral ischemia group). The proportion of WHO grade Ⅲ to Ⅳ, secondary surgery rate and postoperative hospital stay in cerebral ischemia group were significantly higher than those in non-cerebral ischemia group: 96.43% (27/28) vs. 81.19% (367/452), 10.71% (3/28) vs. 1.99% (9/452) and 13 (10, 16) d vs. 10 (8, 14) d, and there were statistical differences ( P<0.05); there were no statistical differences in gender composition, age, body mass index, medical history, medication history, American Society of Anesthesiologists classification, Charlson comorbidity index, preoperative Karnofsky performance status score, tumor laterality, tumor volume, midline shift, operative time, operative time >5 h, fluid intake, red blood cell transfusion, plasma transfusion, blood loss, urine output, fluid balance, serum urea, serum creatinine, glomerular filtration rate, β 2-microglobulin, prothrombin time, international normalized ratio, activated partial thromboplastin time, fibrinogen, postoperative complications, ICU admission, ICU stay duration, mechanical ventilation and hospitalization costs between the two groups ( P>0.05). There were also no statistical difference in the duration, time-weighted average and cumulative area under the threshold curve for mean arterial pressure (MAP) at 65, 70 and 75 mmHg (1 mmHg = 0.133 kPa), nor in the duration, time-weighted average and cumulative area under the threshold curve for relative reductions of 20%, 30% and 40% in MAP between the two groups ( P>0.05). Conclusions:The patients undergoing malignant brain tumor resection have the higher risk of postoperative cerebral ischemia. The association between intraoperative hypotension and postoperative cerebral ischemia is not significant. Maintenance of intraoperative circulation should be guided by individualized monitoring and target values, which requires further interventional studies for validation.

Objective To compare the efficacy and safety of flexible ureteral lithotripsy(FURL)and non-retrograde percutaneous nephrolithotomy(NR-PCNL)for treating1.5-2.0 cm upper ureteral stones.Methods We retrospectively analyzed clinical data of 130 patients with upper ureteral stones treated between October 2022 and October 2024.Sixty-two patients underwent FURL and 68 underwent NR-PCNL.Comparisons included operative time,pre-and postoperative changes in white blood cells(WBC),hemoglobin(Hb),and creatinine(Cr),postoperative C-reactive protein(CRP)levels,stone-free rate after primary surgery,postoperative hospitalization duration,pain scores,complications,and need for auxiliary treatments.Results Compared to the FURL group,the NR-PCNL group demonstrated advantages in operative time[54.0(44.3,69.3)min vs.82.5(66.0,101.0)min,Z=-5.565,P<0.001],WBC elevation[1.9(0.5,3.5)×109/L vs.4.5(3.0,6.0)×109/L,Z=-4.528,P<0.001],and secondary surgery rate[0%(0/68)vs.14.5%(9/62),P<0.001].The FURL group showed lower Hb reduction[3.0(2.0,6.3)g/L vs.8.0(5.0,11.0)g/L,Z=-4.262,P<0.001],less postoperative Visual Analogue Scale(VAS)pain scores[1.0(1.0,2.0)points vs.2.0(1.0,2.0)points,Z=-2.840,P=0.005],and shorter hospitalization duration[2.0(1.0,2.0)d vs.3.0(2.0,3.0)d,Z=-5.815,P<0.001].No significant differences were observed in Cr elevation,CRP levels,stone-free rate after primary surgery,complications,or analgesic requirements(P≥0.05).Conclusions Both NR-PCNL and FURL are safe and effective for 1.5-2.0 cm upper ureteral stones.FURL offers better patient comfort,while NR-PCNL shows superior overall safety.

Objective:To observe the application effect of nursing risk management based on PDCA (plan, do, check, action) cycle quality control concept on patients with diabetic ketoacidosis, and provide reference for improving the nursing quality of diabetic ketoacidosis.Methods:A historical control study was adopted. Using simple random sampling method, patients with diabetic ketoacidosis admitted to Emergency Intensive Care Unit of Lishui Central Hospital from January 2019 to March 2020 were selected as the research subjects, patients admitted from January to September 2019 were treated as the control group and received routine care, while patients admitted from October 2019 to March 2020 were treated as the experimental group and received nursing risk management based on PDCA cycle quality control concept. Blood glucose control time, urine ketone negative conversion time, acidosis correction time, hospital stay, occurrence of complications, depression and anxiety scores, nursing quality and nursing satisfaction were compared between the two groups after intervention.Results:A total of 89 patients were included. There were 43 patients in the control group, including 16 males and 27 females, aged (64.37 ± 15.85) years old; 46 patients in the experimental group, including 23 males and 23 females, aged (59.28 ± 13.66) years old. Before intervention, there were no significant differences in depression and anxiety scores between 2 groups (both P<0.05). After intervention, the blood glucose control time, urine ketone negative conversion time, acidosis correction time and hospital stay were (9.24 ± 1.26), (38.39 ± 3.28), (12.23 ± 1.39) h and (11.34 ± 2.28) d in the experimental group, shorter than (9.94 ± 1.40), (40.12 ± 3.67), (13.66 ± 2.47) h and (13.62 ± 3.40) d in the control group, the differences were statistically significant ( t values were 2.35-3.74, all P<0.05). The occurrence of complications, depression and anxiety scores in the experimental group were 13.04% (6/46), (3.18 ± 0.37) points, (4.69 ± 1.33) points, lower than 30.23% (13/43), (3.72 ± 0.96) points, (5.77 ± 1.60) points in the control group, the differences were statistically significant ( χ2=3.91, t=3.55, 3.47, all P<0.05). The total score of nursing quality and nursing satisfaction in the experimental group were (82.91 ± 4.22), (89.02 ± 4.95) points, higher than (76.86 ± 5.01), (81.14 ± 7.89) points in the control group, the differences were statistically significant ( t=6.18, 5.68, both P<0.05). Conclusions:Nursing risk management based on PDCA cycle quality control concept can shorten the treatment time of patients with diabetic ketoacidosis, reduce the risk of complications, ensure the nursing quality, relieve the negative emotions during hospitalization, and improve satisfaction of patients.

Objective:To evaluate the efficacy of ultrasound-guided median interspinous in-plane approach to subarachnoid puncture in obese pregnant patients.Methods:This study was a randomized controlled trial. Eighty obese parturients who underwent elective cesarean section from March 2022 to January 2024 in our hospital were divided into 2 groups( n=40 each) by the random number table method: median interspinous in-plane approach group(group M) and paramedian interlaminar in-plane approach group(group P). After successful puncture, 0.5% ropivacaine 15 mg(3 ml) was intrathecally injected in both groups. The first-attempt success of puncture, the number of puncture attempts, operation time, the total success of puncture, and the visibility scores of the anterior and posterior union, positioning structure(lamina in group P, spinous process in group M) and puncture needle under ultrasound were recorded. Results:Compared with group P, the visibility score of positioning structure under ultrasound was significantly increased, the success rate of puncture at the first attempt was increased, the number of puncture attempts was decreased, the operation time was shortened, the total success rate of puncture was increased( P<0.05), and no significant change was found in the visibility scores of the anterior and posterior union and puncture needle in group M( P>0.05). Conclusions:For obese pregnant patients, the ultrasound-guided median interspinous in-plane approach can accurately and quickly perform subarachnoid puncture, which has more advantages than the traditional paramedian interlaminar in-plane approach.

Objective:To analyze the genomic characteristics and antibiotic resistance of Listeria monocytogenes isolated from food sources in Beijing City in 2022. Methods:A total of 83 strains of Listeria monocytogenes were isolated from three major categories of food, namely raw poultry, raw livestock meat and ready-to-eat foods, in Beijing′s food safety risk monitoring in 2022. Whole-genome sequencing (WGS) was performed to determine serogroups, multilocus sequence typing (ST) and core genome multilocus sequence typing (cgMLST). Virulence genes and antibiotic resistance genes were identified using the VFDB and ResFinder 3.0 databases. Antimicrobial susceptibility to eight antibiotics was tested via the broth microdilution method. Results:The predominant serogroup was 1/2a, 3a (61.2%). All the isolates were divided into 14 STs, with ST121 (21.7%), ST8 (20.5%), ST9 (13.3%), and ST87 (13.3%) as the dominant types. All 83 isolates were classified into 75 cgMLST types, with six clusters showing identical profiles, indicating potential clonal transmission. Comparative genomic analysis revealed that strains of the same ST clustered together regardless of geographic origin, and some Beijing isolates differed by fewer than 10 alleles from strains isolated in other countries. All the isolates in the study carried virulence islands 1(LIPI-1) and LIPI-2. LIPI-3 was detected in ST1, ST11 and ST3 isolates, while LIPI-4 was found in ST87 isolates. About 42 isolates (50.6%, including ST1, ST11, ST5, ST307, ST8, ST9, ST155, and ST3) harbored SSI-1, and 18 ST121 isolates carried SSI-2. Only 3.61% (three strains) and 4.82% (four strains) of isolates exhibited resistance to tetracycline and erythromycin, respectively. No resistance to other tested antibiotics was observed.Conclusion:Foodborne Listeria monocytogenes in Beijing exhibits high genomic diversity but is dominated by specific STs, some of which are associated with hypervirulence. Some Beijing isolates have homology with food-derived isolates from other countries.

Objective To observe the effect of Sishen Pills on the expression of TREK-1 signaling pathway in rats of irritable bowel syndrome with diarrhea(IBS-D);To explore its mechanism in treating IBS-D.Methods Ten SPF-grade SD rats were randomly selected as the normal group,and the remaining 30 rats were used to prepare the IBS-D rat model by senna gavage combined with water stress avoidance method,and then the modeled rats were randomly divided into the model group,Western medicine group(15.23 mg/kg pivoxyl bromide)and Chinese medicine group(7.32 g/kg Sishen Pills).The medication groups were gavaged by corresponding drugs,and the normal group and model group were given equal volume of pure water,once a day,for consecutive 14 d.The general state of the rats was observed,the contents of serum cyclic adenosine monophosphate(cAMP),protein kinase A(PKA)and phosphorylated extracellular signal-regulated kinase(p-ERK)were detected by ELISA,the positive expressions of biportal potassium channel TREK-1 and p-ERK in colonic tissue were detected by immunofluorescence,the expressions of cAMP,PKA and p-ERK protein were detected by Western blot.Results Compared with the normal group,the body mass of rats in the model group was significantly reduced,and loose stool rate significantly increased(P<0.01);the contents of cAMP,PKA and p-ERK in serum were significantly increased(P<0.05,P<0.01);the positive expression and protein expression of TREK-1 in colonic tissue were significantly reduced,while the positive expression of p-ERK significantly increased(P<0.01),and the expressions of cAMP and PKA proteins significantly increased(P<0.01).Compared with the model group,the body mass of rats in Chinese medince group significantly increased,and loose stool rate significantly decreased(P<0.01);the contents of cAMP,PKA and p-ERK in serum were significantly reduced(P<0.05,P<0.01);the positive expression and protein expression of TREK-1 in colonic tissue significantly increased(P<0.01),while the positive expression of p-ERK significantly decreased(P<0.05),and the expressions of cAMP and PKA proteins significantly decreased(P<0.01).Conclusion Sishen Pills may regulate intestinal motility by affecting the expression of the TREK-1 signaling pathway,thereby treating IBS-D.

Objective:To explore the effect of Simo decoction improving the low duodenal inflammation and protecting the du-odenal mucosal barrier in rats with functional dyspepsia(FD).Methods:Sixty SD rats were randomly divided into control group(10 rats)and model group(50 rats),and the modeling rats were prepared by multivariate intervention method.After successful modeling,the modeling rats were randomly divided into model group,Simo decoction high-dose,medium-dose,low-dose group and mosapride group,with 10 rats in each group.The high-dose,medium-dose,and low-dose groups of Simo decoction were ga-vage given 5.62 g/kg,2.81 g/kg,and 1.40 g/kg,respectively,and the mosapride group was gavage given 0.305 mg/kg of mosapride,and the control group and model group were gavage given the same amount of distilled water for 14 days.The body weight of rats was observed;gastric emptying rate and small bowel propulsion rate were measured;transmission electron microscopy was used to observe the morphology of duodenal epithelial cells;ELISA detected serum levels of IL-17A and IL-22;Western blot and immunohistochemis-try were used to detect the expressions of protease-activated receptor 2(PAR-2)and tight junction protein(ZO-1,claudin-1)in the duodenum.Results:Compared with the control group,the body weight,gastric emptying rate and small intestinal propulsion rate of the model group were significantly reduced(P<0.01),transmission electron microscopy showed widening of the duodenal epithelial cell space,serum IL-17A and IL-22 levels were significantly increased(P<0.01),the expression of PAR-2 in duodenal tissue was in-creased,and the expressions of ZO-1 and claudin-1 were downregulated(P<0.01).Compared with model group,the gastric emptying rate and small intestinal propulsion rate in Simo decoction high-dose,medium-dose and mosapride group were increased(P<0.05,P<0.01),the contents of IL-17A and IL-22 in serum decreased(P<0.05,P<0.01),and the expression of PAR-2 in duodenal tissues was down-regulated,the expressions of ZO-1 and claudin-1 was significantly increased(P<0.01).The low-dose group of Simo soup could improve weight loss(P<0.01),reduce IL-17A content and PAR-2 expression,and increase ZO-1 and claudin-1 expression(P<0.05,P<0.01),while the effect on other indexes was not obvious.Conclusion:Simo decoction may reduce low-grade duodenal in-flammation to repair the mucosal barrier by down-regulating the levels of IL-17A and IL-22 and the expression of PAR-2,and up-regu-lating the expression of ZO-1 and claudin-1,so as to exert the effect of FD treatment.

Objective By exploring the establishment of a follow-up and pre-visit model,this study aims to facilitate the development of a modernized Chinese medical service model for public hospitals,characterized by optimized workflows,continu-ous care models,efficient services,comfortable environments,and patient-centered attitudes,thereby improving patient experi-ence and enhancing the quality of outpatient follow-up visits.Methods Under the value co-creation framework,with both healthcare providers and patients as core value stakeholders,this program introduced a self-service examination appointment plat-form,established a follow-up and pre-visit process,and implemented time-slot-based appointments for diagnosis and treatment.These steps aim to promote the equitable allocation of medical resources and refine the follow-up and pre-visit model in public hospitals.Results Implementation at Hospital P demonstrated that after process reengineering,patients'average in-hospital time reduced by nearly 135 minutes,significantly enhancing treatment efficiency,satisfaction levels among both medical staff and patients,and accessibility of medical services.Conclusion Grounded in value co-creation theory,the follow-up and pre-visit model of Hospital P is divided into three stages:mutual value positioning of both doctors and patients,collaborative value crea-tion,and sustained value continuation for both.This alignment between process reengineering goals and value co-creation out-comes helps improve the quality of medical services,better meet the medical needs of patients,and achieve a win-win scenario for both doctors and patients.