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.

The Expert Consensus on Clinical Application of Qinbaohong Zhike Oral Liquid in Treatment of Acute Bronchitis and Acute Attack of Chronic Bronchitis （GS/CACM 337-2023） was released by the China Association of Chinese Medicine on December 13^th， 2023. This expert consensus was developed by experts in methodology， pharmacy， and Chinese medicine in strict accordance with the development requirements of the China Association of Chinese Medicine （CACM） and based on the latest medical evidence and the clinical medication experience of well-known experts in the fields of respiratory medicine （pulmonary diseases） and pediatrics. This expert consensus defines the application of Qinbaohong Zhike oral liquid in the treatment of cough and excessive sputum caused by phlegm-heat obstructing lung， acute bronchitis， and acute attack of chronic bronchitis from the aspects of applicable populations， efficacy evaluation， usage， dosage， drug combination， and safety. It is expected to guide the rational drug use in medical and health institutions， give full play to the unique value of Qinbaohong Zhike oral liquid， and vigorously promote the inheritance and innovation of Chinese patent medicines.

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 relationship of mindful attention awareness with sleep quality and occupational stress of soldiers.Methods A questionnaire survey was conducted on 1 100 soldiers by using the mindful attention awareness scale(MAAS),occupational stress scale(OSS),and Pittsburgh sleep quality index(PSQI).Results The PSQI of the soldiers was negatively correlated with mindful attention awareness(r=-0.446,P<0.01),and positively correlated with occupational stress(r=0.569,P<0.01).Mindful attention awareness and occupational stress were effective predictors for sleep quality,accounting for 34.7%of variance.And the mediating effect of occupational stress between mindful attention awareness and sleep quality accounted for 58.86%.Conclusion The mindful attention awareness in soldiers can not only directly affect the sleep quality,but also indirectly affect the sleep quality through their occupational stress.

Objective To investigate the impact of hyperuricemia on risk of deep vein thrombo-sis after joint replacement surgery.Methods A total of 953 patients undergoing joint replacement surgery were enrolled in this study.Among them,662 patients did not develop thrombosis postopera-tively(postoperative non-thrombosis group),while 291 patients developed thrombosis(postoperative thrombosis group).Data including gender,age,surgical procedure,body mass index,hypertension,coronary heart disease,diabetes,preoperative D-dimer positivity(≥0.5 mg/L),prothrombin time,prothrombin activity,international normalized ratio,activated partial thromboplastin time,fibrinogen,thrombin time,white blood cell count,red blood cell count,hemoglobin,hematocrit and platelet count were analyzed.Logistic regression analysis was used to identify independent risk factors for postoperative deep vein thrombosis.Results Univariate analysis showed that age,gender,surgical procedure(total knee arthroplasty),hypertension,diabetes,hyperuricemia,preoperative red blood cell count,preoperative hematocrit and preoperative D-dimer positivity were influencing factors for deep vein thrombosis after joint replacement surgery(P＜0.05).Logistic regression analysis re-vealedthat age(＞60 years),surgical procedure(total knee arthroplasty)and hyperuricemia were independent risk factors for postoperative deep vein thrombosis(P＜0.05).Conclusion Hyperuri-cemia is an independent risk factor for deep vein thrombosis after joint replacement surgery.

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 investigate the characteristics and clinical effects of laparoscopic pneumovesical Cohen and laparoscopic Lich-Gregoir ureteral replantations for the treatment of primary obstructive megaloureter (POM) in children.Methods:A randomized controlled study was conducted.The clinical data of 51 children with unilateral POM admitted to the First Affiliated Hospital of Zhengzhou University from October 2018 to October 2023 were collected.Random number table method was used in the selection of surgical methods.They were divided into the laparoscopic pneumovesical Cohen ureteral replantation group (group A, 22 cases) and the laparoscopic Lich-Gregoir ureteral replantation group (group B, 29 cases) according to the surgical method.The anterior-posterior diameter(APD), maximum ureteral diameter and differential renal function parameters on the affected side were measured by color Doppler ultrasound of the urinary system, and compared between and within the two groups before and after surgery.The operation time, blood loss and postoperative intubation time were compared between the two groups.The incidence of postoperative complications such as reflux, bladder spasm, urinary retention and urinary tract infection was recorded.The independent and paired sample t-tests were used for statistical analysis. Results:The operation time and hematuria duration of group B [(125.7±14.2) min, (1.5±0.6) d] were significantly shorter than those of group A [(142.6±14.7) min, (2.8±0.7) d] (all P<0.05). The APD, maximum ureteral diameter, and differential renal function on the affected side of group A were (21.7±7.9) mm, (11.6±3.2) mm, and (28.2±4.9)% before surgery, and (10.3±4.5) mm, (6.0±2.0) mm and (43.8±4.4)% after surgery, respectively.The APD, maximum ureteral diameter, and differential renal function on the affected side of group B were (21.1±5.6) mm, (11.3±4.6) mm, and (30.2±5.5)% before surgery, and (10.2±4.5) mm, (6.6±2.0) mm, and (42.4±5.2)% after surgery, respectively.There was no statistically significant difference in the values of APD, maximum ureteral diameter, and differential renal function before and after surgery between the two groups of children (all P>0.05). However, there were statistically significant differences in the values of APD, maximum ureteral diameter, and differential renal function before and after surgery between the same group of children (all P<0.01). No significant difference was found in intraoperative blood loss, postoperative intubation time, and postoperative complications between the two groups (all P>0.05). Conclusions:Both surgical methods are effective in the treatment of POM in children.Laparoscopic Lich-Gregoir ureteral replantation has advantages of less operation time compared with laparoscopic pneumovesical Cohen ureteral replantation.

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.