Objective To summarize the potential risk factors that may arise in the national drug sampling and testing inspection process in recent years,to focuse on the operation of the quality management system,and to put forward proposals on how to do a good job under the new drug regulatory model of sampling and testing work.Methods Focusing on the investigation of data integrity and authenticity,the analysis focuses on the analysis of risk points such as reagent management,standard substance management,instrument,and facility management,electronic data management and other issues,and carries out a comprehensive verification of the effectiveness of the operation of the quality management system and so on.Results National drug sampling and testing institutes should strengthen the overall quality management,according to the operation of the laboratory,combined with their respective risk characteristics,reagent management,standard substance management,instrument and facility management,electronic data management and other aspects of the risk of systematic sorting and the establishment of the risk alert function,the development of risk warning lists,and the implementation of the corresponding risk control strategy.Conclusion National drug sampling and testing institutes must strengthen the operation of the process of influencing factors in the effective control of the emphasis on the testing of the work of the key control points and continue to standardize and improve the inspection process of the quality system to ensure that the quality of the various activities in a controlled state.

Objective To summarize the potential risk factors that may arise in the national drug sampling and testing inspection process in recent years,to focuse on the operation of the quality management system,and to put forward proposals on how to do a good job under the new drug regulatory model of sampling and testing work.Methods Focusing on the investigation of data integrity and authenticity,the analysis focuses on the analysis of risk points such as reagent management,standard substance management,instrument,and facility management,electronic data management and other issues,and carries out a comprehensive verification of the effectiveness of the operation of the quality management system and so on.Results National drug sampling and testing institutes should strengthen the overall quality management,according to the operation of the laboratory,combined with their respective risk characteristics,reagent management,standard substance management,instrument and facility management,electronic data management and other aspects of the risk of systematic sorting and the establishment of the risk alert function,the development of risk warning lists,and the implementation of the corresponding risk control strategy.Conclusion National drug sampling and testing institutes must strengthen the operation of the process of influencing factors in the effective control of the emphasis on the testing of the work of the key control points and continue to standardize and improve the inspection process of the quality system to ensure that the quality of the various activities in a controlled state.

Objective To analyze the safety and efficacy of neuroendoscopic minimally invasive surgery and traditional extraventricular drainage in the treatment of severe hypertensive intraventricular hemorrhage.Methods The clinical data of 50 cases with neuroendoscopic ventricular hematoma evacuation(endoscopy group)and 44 cases with traditional ventricles external puncture drainage(drainage group)from July 2020 to July 2023 were retrospectively analyzed,and the hematoma clearance rates,classification of activities of daily living(ADL)scale,incidence of hydrocephalus,secondary bleeding,intracranial infection,and pulmonary infection were observed between the two groups of patients.Results After surgery,the proportion of patients with hematoma clearance rate>60％and ADL grades Ⅰ,Ⅱ,and Ⅲ in the endoscopy group were significantly higher than those in the drainage group[the proportion of patients with hematoma clearance rate>60％:88.0％(44/50)vs.47.7％(21/44),χ2=17.794,P<0.001;the proportion of individuals with ADL grades Ⅰ,Ⅱ,and Ⅲ:94.0％(47/50)vs.77.3％(33/44),respectively,χ2=5.459,P=0.019],the incidence of complications in endoscopy group was significantly lower in the drainage group[8.0％(4/50)vs.34.1％(15/44),χ2=9.879,P=0.002].Conclusion Compared with traditional ventricular puncture drainage surgery,neuroendoscopic minimally invasive surgery for the treatment of severe hypertensive intracerebral hemorrhage with ventricular casting can achieve better treatment outcomes,a higher hematoma clearance rate,and fewer postoperative complications.

Objective:To explore the current status of surgery for portal hypertension to grasp current status and future development of surgery in China.Methods:This study is jointly sponsored by China Hepatobiliary & Pancreatic Specialist Alliance & Portal Hypertension Alliance in China (CHESS).Comprehensive surveying is conducted for basic domestic situations of surgery for portal hypertension, including case load, surgical approaches, management of postoperative complications, primary effects, existing confusion and obstacles, liver transplantation(LT), laparoscopic procedures and transjugular intrahepatic portosystemic shunt(TIPS), etc.Results:A total of 8 512 cases of portal hypertension surgery are performed at 378 hospitals nationwide in 2021.Splenectomy plus devascularization predominated(53.0%)and laparoscopy accounted for 76.1%.Primary goal is preventing rebleeding(67.0%) and 72.8% of hospitals used preventive anticoagulants after conventional surgery.And 80.7% of teams believe that the formation of postoperative portal vein thrombosis is a surgical dilemma and 65.3% of hospitals practiced both laparoscopy and TIPS.The major reasons for patients with portal hypertension not receiving LT are due to a lack of qualifications for LT(69.3%)and economic factors(69.0%).Conclusions:Surgery is an integral part of management of portal hypertension in China.However, it is imperative to further standardize the grasp of surgical indications, the handling of surgical operation and the management of postoperative complications.Moreover, prospective, multi-center randomized controlled clinical studies should be performed.

【Objective】 To analyze the relevant studies on blood donor cohort and explore the current research status, research hotspots and development trends of blood donor cohort studies abroad. 【Methods】 Based on the Web of Science Core Collection, the literature related to blood donor cohort was searched. After screening and data processing, bibliometric analysis was carried out from the volume of literature trends, disciplines, authors, institutional distribution and other aspects of the included literature. At the same time, CiteSpace 5.6R5 software was used to carry out visual analysis of countries/regions, literature co-citation, keyword co-occurrence, keyword clustering and keyword emergence. Results A total of 672 papers (654 research papers, 18 review papers) were included. The total number of papers published in the field of blood donor cohort study showed a steady upward trend since 1991, the fastest growth was between 2019 and 2020. The top three cited authors were Kaaks R (1 301 citations), Rinaldi S (1 186 citations) and Riboli E (1 130 citations); the top three institutions were RLUK library in the UK, the University of California and the University of Copenhagen; the top three countries/regions in the volume of literature were the United States (176 papers), Germany (64 papers) and France (54 papers), and they all co-operated closely with other countries. The top five keywords were "blood donor" , "prevalence" , "infection" , "risk" and "antibody" . A total of 19 clusters were obtained by keyword cluster analysis, it was reflected in the immune mechanism and prevalence of blood-borne diseases, the relationship between blood donation behavior and non-communicable disease and its influencing factors, and the classification of the characteristics of blood donors. "Non-hepatitis B" was the keyword with the greatest burst intensity. The keywords that have burst out in recent years and continue to this day include "donation" , "seroprev-alence" , "donor" and "management" . Conclusion At present, the cohort study of blood donors has been paid more and more attention in the world, and its research trends mainly focus on the study of transfusion-transmitted disease risk. However, more researches begin to pay attention to the health problems and influencing factors of blood donors or recipients, which provides the research ideas and directions for establishing cohort study among blood donors in China.

Dermatomyositis(DM)is an autoimmune disease often complicated with malignant tumors.More than 50%of DM patients have myositis specific autoantibodies in their bodies.DM specific autoantibodies[including anti-migration inhibitory factor(Mi)-2 antibody,anti-nuclear matrix protein(NXP)-2 antibody,anti-transcription intermediary factor(TIF)1-γ antibody,and anti-small ubiquitin like modifier activating enzyme(SAE)antibody]play important roles in the pathogenesis of malignancy associated DM.Revealing the role of DM specific autoantibodies in the development of malignant tumors in DM patients can provide important evidence for accurately assessing the risk of developing malignant tumors in DM patients,and also provide new ideas for clinical diagnosis of DM and precise treatment.

OBJECTIVE To evalu ate the effects of perimenopausal one-day outpatient multidisciplinary model on the cognition of women to menopause hormone therapy （MHT）. METHODS The perimenopausal one-day outpatient service opened by the Third Affiliated Hospital of Chongqing Medical University in 2017 was introduced ，which was participated by doctors ，pharmacists， nutritionists，music psychotherapists ，nurses and other multidisciplinary members to provide systematic ，all-round，humanistic and face-to-face group science popularization and education ，practical experience and Q&A for women in perimenopause or about to enter perimenopause （called“students”）. The students who participated in one-day outpatient service in 2020 were selected as the survey object ， and the questionnaire was CMEI2020KPYJ（ZAMM）00206] designed to analyze the understanding of perimenopausal syndrome，awareness rate of MHT ，willingness to use and concerns. RESULTS A total of 295 students completed the questionnaire. Compared with before participation ， after participated in one-day outpatient service ，the cognition level of the students were all improved significantly ，including perimenopausal age （96.61％ vs. 99.32％，P＝0.037），the importance of perimenopausal health care knowledge （91.19％ vs. 96.95％，P＜0.001），whether the perimenopausal syndrome needs treatment （88.47％ vs. 99.32％，P＜0.001），willingness to use MHT （70.59％ vs. 94.48％ ，P＜0.001），MHT treatment timing （60.50％ vs. 95.17％ ，P＜0.001），reducing the risk of cardiovascular disease （51.68％ vs. 96.55％ ，P＜0.001），delaying aging （69.75％ vs. 97.59％ ，P＜0.001），preventing osteoporosis（65.13％ vs. 97.59％），P＜0.001）；the medical staff were higher than the non-medical staff （P＜0.05）. Totally 90％ of the students said they had gained knowledge about the prevention and treatment of common diseases ，nutrition and guidance， psychological regulation guidance hormone therapy related knowledges and exercise methods ；the proportion of the students who were willing to use MHT for 1 to 5 years（31.09％ vs. 47.93％）increased significantly. The proportion of the students who concerned about the risk of thrombosis （60.24％ vs. 36.81％），weight gain （59.64％ vs. 14.84％）and life-long dependence （52.41％ vs. 18.13％）was significantly reduced ，but that of the students who concerned about cancer risk was not diminished. From 2017 to 2020，the utilization rate of MHT was increased from 2.22％ to 62.16％ in non-medical staff among the students. CONCLUSIONS The multidisciplinary model of perimenopausal one-day outpatient service can improve the awareness of MHT among perimenopausal women ，eliminate misunderstandings ，and increase the utilization rate of MHT.

Objective:To evaluate the effect of urinary albumin creatinine ratio (UACR) on diabetic retinopathy (DR) in patients with type 2 diabetes. Receiver operating characteristic (ROC) curve was applied to find the cut-off value of UACR for diagnosing DR.Methods:A prospective cohort study of 2 490 patients with type 2 diabetes was conducted with a mean follow-up of 7 years ranging from 3 to 10 years. Dilated fundus examination was performed once a year, and patient history and clinical data were collected and analyzed. Patients were divided into three groups according to the UACR: Q1, normal urinary albumin group (UACR<30 mg/g), Q2, microalbuminuria group (30 mg/g≤UACR≤299 mg/g), and Q3, macroalbuminuria group (UACR>300 mg/g), respectively. Cox regression analysis was used to explore the influence of UACR and other factors on DR, and ROC curve was drawn to evaluate the value of UACR in diagnosis of DR.Results:Cox regression analysis showed that UACR was the risk factor of DR( HR=1.108, 95% CI 1.023-1.241, P<0.001). It showed that the patients in Q3 group had the highest risk of proliferative DR ( HR=3.128, 95% CI 2.025-4.831, P<0.001), the patients in Q2 group followed( HR=1.918, 95% CI 1.355-2.714, P<0.001), and the patients in Q1 group were the lowest. ROC curve analysis showed that area under UACR curve was 0.746(95% CI 0.681-0.812, P<0.001), and the cut-off value, sensitivity, and specificity for the diagnosis of PDR were 54.12mg/g, 0.769, and 0.653, respectively. Conclusion:The UACR can predict the progression of PDR in type 2 diabetes patients, therefore it may be used as a preliminary predictor for the progression of DR.

Objective To study the characteristics of fluid intake and central venous pressure (CVP) within 4 days after birth in very low birth weight (VLBW) premature infants complicated with bronchopulmonary dysplasia (BPD).Method From February 2015 to March 2019,VLBW preterm infants without serious complications were enrolled in two hospitals.Their CVP were measured every 4 ～ 6 hours after birth.They were assigned into BPD group and non-BPD group,and the fluid intake and CVP within 4 days after birth were compared between these two groups.Result A total of 45 VLBW preterm infants were included,including 17 in the BPD group and 28 in the non-BPD group.The fluid intake in the BPD group showed no significant difference with the non-BPD group within 4 days after birth (P ＞ 0.05).No significant correlation existed between the mean liquid intake and the mean CVP in 1 ～ 4 days after birth (r =0.093,P=0.542).From day1 to day4,the CVPs of the BPD group were (3.97 ± 0.68),(4.49 ± 0.75),(4.55 ± 0.66),(4.02 ± 1.05) cmH2O,and the non-BPD group were (3.66 ± 1.09),(3.96 ±0.76),(3.81 ± 0.69),(3.91 ± 0.65) cmH2O.The differences between the BPD group and the nonBPD group were statistically significant (P ＜ 0.05).The CVP of the BPD group was increasing from day 2 to day 3 (P ＜ 0.05).Conclusion VLBW premature infants complicated with BPD may have higher CVP at the early stage of life,which may not be related with the fluid intake.

The clinical practice teaching reform of pediatrics based on TBL combined with medical simulation teaching model was carried out. TBL teaching plan writing under the model of medical simulation teaching was researched. The principles, requirements, contents and procedures of compiling teaching plans were formed. Emphasis should be placed on medical simulation teaching, team cooperation, humanistic quality education and humanistic skills training. The purposes of the reform were to achieve standardized operation skills, improve clinical ability, ensure medical safety, and improve the quality of medical purposes, but still the reform need further improvement in the teaching practice.