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.

OBJECTIVE To investigate the clinical characteristics of euglycemic diabetic ketoacidosis （euDKA） induced by empagliflozin， and provide references for safe medication. METHODS Case reports of euDKA induced by empagliflozin were retrieved and analyzed from PubMed， Web of Science， CNKI， and Wanfang Data. The Naranjo’s scale was adopted to assess the causal relationship between empagliflozin and euDKA. RESULTS A total of 29 patients were enrolled， including 16 males and 13 females，with a median age of 58 years. All patients were diagnosed with type 2 diabetes mellitus； 22 patients had at least one comorbidity. The median time to euDKA onset was 60 days after administration， and 7 cases occurred within 2 weeks of treatment. Perioperative periods，fasting，and low-carbohydrate or ketogenic diets were the main predisposing factors. Common presentations included nausea，vomiting， fatigue， tachypnea，and tachycardia. The causal relationship between empagliflozin and euDKA was assessed as “probable” in all cases. According to adverse reaction severity grading， 13 cases were grade 3 （severe） and 16 cases were grade 4 （life-threatening）. All patients discontinued empagliflozin and recovered after corresponding treatment. CONCLUSIONS euDKA is a serious adverse reaction to empagliflozin， which mostly occurs early in treatment. Perioperative periods， fasting， and ketogenic diets are prone to induce euDKA. Elderly patients and those with comorbidities are at higher risk. Risk assessment should be conducted before clinical administration； blood ketones and acid-base monitoring should be strengthened in the early medication period； withhold the drug before elective surgery， avoid prolonged fasting；upon diagnosis， discontinue empagliflozin and initiate intravenous insulin， provide fluid resuscitation promptly， and use other treatments to improve patient prognosis.

Body weight abnormalities, including overweight, obesity, and underweight, have become a dual public health challenge in Chinese adults: overweight and obesity lead to a variety of chronic complications, while underweight increases the risks of malnutrition, sarcopenia, and organ dysfunction. To systematically address these issues, multidisciplinary experts in endocrinology, sports science, nutrition, and psychiatry from various regions have held multiple weight management seminars. Based on the latest epidemiological data and clinical evidence, they expanded the guideline to include assessment and intervention strategies for underweight, in addition to the core content of obesity management. This guideline outlines the etiological mechanisms, evaluation methods, and multidimensional management strategies for overweight and obesity, covering key areas such as diagnosis and assessment, medical nutrition therapy, exercise prescription, pharmacological intervention, and psychological support. It is intended to provide a scientific and standardized approach to weight management across the adult population, aiming to curb the rising prevalence of obesity, mitigate complications associated with abnormal body weight, and improve nutritional status and overall quality of life.

Objective To systematically investigate biomechanical characteristics of one-finger Zen push method applied at the Fengchi acupoint under different force conditions,in order to provide precise quantitative data and enhance the treatment efficacy.Methods Ten senior Tuina practitioners were recruited.The German Novel Pliance-X 32 Expert dynamic pressure distribution system was used to record the mechanical parameters during the application of one-finger Zen push at the Fengchi acupoint under three force intensities:light,medium,and heavy,for 3 minutes.Data from the stable 1-minute segment of the mechanical output was selected for data analysis,and key biomechanical parameters such as the maximum force,average force,peak pressure,mean pressure,force-time integral(FTI),pressure-time integral(PTI),and operational frequency were evaluated.Results Under light,medium,and heavy force conditions,the mean maximum force applied by senior Tuina practitioners at the Fengchi acupoint were 6.31,9.45,and 18.27 N,respectively,while the mean force were 3.31,5.64,and 9.05 N,respectively.The mean peak pressures were 26.10,34.80,and 70.00 kPa,while the mean pressures were 11.95,21.00,and 26.15 kPa,respectively.The mean FTIs were 55.65,182.10,and 225.21 N·s,and the mean PTIs were 167.10,489.59,and 795.83 kPa·s,respectively.The mean operational frequencies were 156.00,150.60,and 154.80 times/min,respectively.Conclusions Ten senior Tuina practitioners showed a high degree of consistency between their subjective definitions of light,medium,and heavy force and the objectively measured mechanical parameters.This reflected their precise control over the applied force under different force conditions,verifying the practicality and reproducibility of the one-finger Zen push method in clinical applications.This study provides a reliable basis for quantitative research and development of standardized clinical operation guidelines.

Objective To explore the protective effect and possible mechanism of modified Shenqi Dihuang Decoction on podocytes in db/db mice based on ROS/NLRP3/GSDMD signaling pathway.Methods Fifty 8-week-old male db/db mice(SPF grade)were randomly divided into the model group,losartan group and TCM low-,medium-and high-dosage groups,with 10 mice in each group.Ten heterozygous db/m mice served as the blank group.Interventions were administered respectively for 12 weeks.The body mass,random blood glucose,serum creatinine,blood urea nitrogen and 24 h urinary protein content were detected,HE,PAS,PASM,Masson and Sirius red staining was used to observe the morphology of renal tissue,transmission electron microscopy was used to observe the ultrastructure of renal tissue,fluorescent probes were used to observe the release of ROS in renal tissue,immunofluorescence staining was used to detect the expression of Nephrin,NLRP3,Cleaved Caspase-1 and GSDMD-N in renal tissue,and Western blot was used to detect the expression of NLRP3,Cleaved Caspase-1,GSDMD-N,IL-1β,IL-18,Nephrin,Podocin,PODXL,WT-1 and Desmin proteins.Results Compared with the blank group,the body mass and random blood glucose of the model group mice significantly increased(P<0.05),and the contents of serum creatinine,blood urea nitrogen and 24 h urinary protein were significantly increased(P<0.05);glomerular hypertrophy,dilation of renal glomeruli and tubules,thickening of basement membrane,matrix proliferation in mesangial area,abnormal deposition of collagen fibers in renal interstitium,accompanied by damage to renal tubular epithelial structure and focal glomerulosclerosis,significant increase in type Ⅰ collagen deposition,extensive fusion of podocyte processes,and scattered electron dense material in the basement membrane or subepithelial layer;the ROS content in renal tissue significantly increased(P<0.05),and the protein expression of NLRP3,Cleaved Caspase-1,GSDMD-N,IL-1β,IL-18 and Desmin significantly increased(P<0.05),the protein expression of Nephrin,Podocin,PODXL and WT1 significantly decreased(P<0.05).Compared with the model group,the body mass and random blood glucose of mice in each dosage of TCM group were relatively stable,the contents of serum creatinine,blood urea nitrogen and 24 h urinary protein decreased;the pathological damage to renal tissue was reduced,the ultrastructure of podocytes was improved,and the density of podocytes increased;the ROS content decreased,and the protein expression of NLRP3,Cleaved Caspase-1,GSDMD-N,IL-1β,IL-18 and Desmin decreased,while the protein expression of Nephrin,Podocin,WT1 and PODXL increased.With the dosage of modified Shenqi Dihuang Decoction increased,the improvement effect gradually strengthened,and the differences in TCM high-dose group was statistically significant(P<0.05).Conclusion Modified Shenqi Dihuang Decoction can protects podocytes in db/db mice,potentially by modulating the ROS/NLRP3/GSDMD signaling pathway.

Objective To investigate the clinical effect of minimally invasive orthopedics combined with Akin surgical segmental osteotomy in the treatment of hallux valgus.Methods Clinical data of hallux valgus patients who underwent minimally invasive orthopedics combined with Akin surgical segmental osteotomy in Wangjing Hospital of China Academy of Chinese Medical Sciences from June 2020 to June 2022 were collected.Hallux valgus angle(HVA),intermetatarsal angle(IMA),distal metatarsal articular angle(DMAA),visual analogue scale(VAS)score,American Orthopedic Foot and Ankle Society(AOFAS)scale score and complications were compared before and after surgery.Results A total of 186 patients with hallux valgus(328 feet)were included in the study.All patients successfully completed the operation and the follow-up period was 6 months.Six months after surgery,HVA,IMA and DMAA were significantly lower than before surgery,VAS score was significantly lower than before surgery,and AOFAS scale score was significantly higher than before surgery(P＜0.05).There were no postoperative complications such as wound infection,delayed union or nonunion of the osteotomy,and metastatic metatarsalgia.Conclusion Minimally invasive orthopedic combined with Akin surgical segmental osteotomy is safe and effective in treatment of hallux valgus,which has the advantages of less injury,good deformity correction and less postoperative complications,and is worthy of clinical application and promotion.

Objective To systematically investigate biomechanical characteristics of one-finger Zen push method applied at the Fengchi acupoint under different force conditions,in order to provide precise quantitative data and enhance the treatment efficacy.Methods Ten senior Tuina practitioners were recruited.The German Novel Pliance-X 32 Expert dynamic pressure distribution system was used to record the mechanical parameters during the application of one-finger Zen push at the Fengchi acupoint under three force intensities:light,medium,and heavy,for 3 minutes.Data from the stable 1-minute segment of the mechanical output was selected for data analysis,and key biomechanical parameters such as the maximum force,average force,peak pressure,mean pressure,force-time integral(FTI),pressure-time integral(PTI),and operational frequency were evaluated.Results Under light,medium,and heavy force conditions,the mean maximum force applied by senior Tuina practitioners at the Fengchi acupoint were 6.31,9.45,and 18.27 N,respectively,while the mean force were 3.31,5.64,and 9.05 N,respectively.The mean peak pressures were 26.10,34.80,and 70.00 kPa,while the mean pressures were 11.95,21.00,and 26.15 kPa,respectively.The mean FTIs were 55.65,182.10,and 225.21 N·s,and the mean PTIs were 167.10,489.59,and 795.83 kPa·s,respectively.The mean operational frequencies were 156.00,150.60,and 154.80 times/min,respectively.Conclusions Ten senior Tuina practitioners showed a high degree of consistency between their subjective definitions of light,medium,and heavy force and the objectively measured mechanical parameters.This reflected their precise control over the applied force under different force conditions,verifying the practicality and reproducibility of the one-finger Zen push method in clinical applications.This study provides a reliable basis for quantitative research and development of standardized clinical operation guidelines.

Objective:To explore the relationship between life events, anxiety, depression, and behavior problems in adolescents.Methods:From September to October 2022, the cluster sampling method was used to select 5 341 adolescents from 4 middle schools in Xinxiang urban area.The subjects and their parents were investigated by the adolescent self-rating life events check list (ASLEC), generalized anxiety disorder scale (GAD-7), patient health questionnaire (PHQ-9), and child behavior checklist (CBCL). SPSS 27.0 software was used for Spearman correlation analysis, and AMOS 28.0 software was used to construct the structural equation model.Results:The scores of anxiety, depression, and behavioral problems were 1 (0, 4), 1 (0, 4), and 3 (0, 10). The total score of life events was 5 (1, 13), and the dimensions scored as follows: interpersonal conflict 1 (0, 4), academic pressure 2 (0, 5), punishment 0 (0, 2), loss 0 (0, 0), health and adaptation problem 0 (0, 1), and others 0 (0, 2). There were positive correlations between life events and its dimensions, depression, anxiety and behavioral problems ( r=0.28-0.69, all P<0.01). In the overall population, anxiety and depression played parallel mediating roles in the impact of life events on behavior problems. Life events could positively predict anxiety ( β=0.68, P<0.01), and anxiety could positively predict behavior problems ( β=0.04, P=0.02). Life events could positively predict depression ( β=0.77, P<0.01), and depression could positively predict behavior problems ( β=0.18, P<0.01). The standardized total effect size of the impact of life events on behavioral problems was 0.622 (95% CI=0.564-0.675). The standardized direct effect size and indirect effect size were 0.460 (95% CI=0.374-0.539) and 0.162 (95% CI=0.108-0.218), accounting for 74.0% and 26.0%of the total effect, respectively. After stratification by gender, the results for male adolescents were consistent with the overall population, while the mediating effect of anxiety was not significant in the female adolescents. Conclusion:Life events can lead to anxiety and depression in adolescents, thereby increasing the risk of behavior problems.

Objective To investigate the clinical effect of minimally invasive orthopedics combined with Akin surgical segmental osteotomy in the treatment of hallux valgus.Methods Clinical data of hallux valgus patients who underwent minimally invasive orthopedics combined with Akin surgical segmental osteotomy in Wangjing Hospital of China Academy of Chinese Medical Sciences from June 2020 to June 2022 were collected.Hallux valgus angle(HVA),intermetatarsal angle(IMA),distal metatarsal articular angle(DMAA),visual analogue scale(VAS)score,American Orthopedic Foot and Ankle Society(AOFAS)scale score and complications were compared before and after surgery.Results A total of 186 patients with hallux valgus(328 feet)were included in the study.All patients successfully completed the operation and the follow-up period was 6 months.Six months after surgery,HVA,IMA and DMAA were significantly lower than before surgery,VAS score was significantly lower than before surgery,and AOFAS scale score was significantly higher than before surgery(P＜0.05).There were no postoperative complications such as wound infection,delayed union or nonunion of the osteotomy,and metastatic metatarsalgia.Conclusion Minimally invasive orthopedic combined with Akin surgical segmental osteotomy is safe and effective in treatment of hallux valgus,which has the advantages of less injury,good deformity correction and less postoperative complications,and is worthy of clinical application and promotion.

Objective:To investigate the clinical significance and predictive efficacy of serum homocysteine(Hcy)and interleukin-6(IL-6)in women with early-pregnancy recurrent spontaneous abortion(RSA).Methods:From Aug 2021 to Aug 2024,35 women with early-pregnancy RSA were selected from Changzhi People's Hospital and designated as the RSA group,and 44 women with no history of recurrent miscarriage in early pregnancy were chosen as the control group.Enzymatic cycling assay was used to determine the serum Hcy level,and immunofluorescence assay was used to detect the serum IL-6 level.Binary logistic regression model was applied to assess the potential impact of serum Hcy and IL-6 levels on RSA.Receiver operating characteristic(ROC)curve was utilized to evaluate the diagnostic value of serum Hcy and IL-6 levels for RSA.Results:RSA group exhibited significantly higher Hcy levels(P＜0.01)and lower IL-6 levels(P＜0.01)compared to the control group.High level of serum Hcy(OR=1.628,95%CI:1.169-2.266)and low level of serum IL-6(OR=0.478,95%CI:0.289-0.791)significantly affected recurrent miscarriage(P＜0.05).ROC analysis showed AUC values of 0.765(Hcy),0.851(IL-6),and 0.919(combined),with sensitivities of 65.7%,91.4%,and 77.1%,and specificities of 86.4%,59.1%,and 100%,respectively.Conclusions:There are significant differences in the levels of serum Hcy and IL-6 between RSA patients and healthy controls.Serum Hcy combined with IL-6 detection has certain diagnostic value for predicting RSA.