Objective:To assess the current situation, advantages, and difficulties of standardized management in Investigator-Initiated Clinical Trials (IIT).Methods:This article summarized the requirements and policies for clinical research management, the development of clinical research domestically and internationally, the achievements and advantages of clinical research management development in China, and the main problems and difficulties with the standardized IIT management in China, and compiled the experiences and models of several medical institutions in IIT management.Results:While China has a large number of clinical medical publications and is ranked high in the world, the quality of the publications needs to be further improved. Domestic management requirements for IIT were gradually improving, providing a basis for medical institutions to implement standardized management throughout the lifecycle of IIT, and achieve certain progress. However, there were still challenges in the departmental divisions, the unification of management standards, whole-process management and quality control, the scientific review, high-risk project management, and registration.Conclusions:Drawing on the excellent experience of domestic medical institutions, measures including identifying a primary responsible department, establishing unified supervision and inspection standards, and implementing a whole life cycle management may help overcome the challenges in IIT management and improve the quality and efficiency of IIT management.

Faced with the increasing demand for technological innovation, how to effectively carry out and regulate the export of medical-related scientific research data has become an urgent issue. The author reviewed the current requirements and status of data export in China and abroad, as well as the relevant requirements for medical data management in China, and introduced the practical experience of the first data compliance export case of medical field in China. In view of the main difficulties in the management of medical-related scientific research data export, such as the lack of multi-professional background members of the project team, the difficulty in writing professional documents, the relatively single template, the lack of personalized templates suitable for different professional field, and the need for homogenization of regulatory standards and requirements, it is proposed to rely on a qualified third-party platform in the form of entrusted business, adopt the optional mode under the general declaration template, establish unified regulatory standards, pay attention to the important data and national core data involved in the data export, pay attention to the ethical issues, and replace the original data with derivative data, and keep to " necessity principle" and " minimization principle", so as to provide reference for medical institutions and management departments to strengthen the standardized management and security guarantee of medical-related scientific research data export.

To meet China′s requirements for scientific and technological innovation and high-quality development in the new era, it is imperative to actively implement the innovation-driven development strategy and build high-level research hospitals. Beijing Friendship Hospital, Capital Medical University has been working to build a research hospital since 2018. The hospital promoted discipline construction through the development mode of discipline clusters, made the research wards as a platform, adopted the " shared comprehensive service" mode to improve the quality and efficiency of clinical research, and strengthened talent cultivation through such key measures as a new talent recruitment system. The mode has proved successful in such aspects as improving the ranking of scientific and technological value of hospitals and disciplines, introducing high-level talents, and outputting scientific and technological achievements, supporting by research wards for other departments of the hospital, and improving the efficiency and quality of clinical trials. Such a mode can provide reference for general hospitals in building research hospitals.

Objective:To evaluate the efficacy and safety of rubber band traction-assisted endoscopic submucosal dissection (ESD).Methods:A total of 49 patients with rectal endocrine tumor who underwent ESD at Beijing Friendship Hospital Affiliated to Capital Medical University from January 2016 to December 2019 were reviewed. Thirty-two patients who underwent traditional ESD from January 2016 to May 2018 were assigned to the non-traction group. Seventeen patients who underwent the operation with a rubber band as auxiliary traction from June 2018 to December 2019 were assigned to the traction group. Basic information, ESD procedure time, complications were compared between the two groups.Results:There were no significant differences in age, gender or lesion size between the traction group and the non-traction group ( P>0.05). The ESD operation time of the traction group was significantly shorter than that of the non-traction group (13.76±5.71 min VS 22.99±10.32 min, t=-3.408, P=0.001). There were no postoperative complications in the traction group, but 3 cases of perforation occurred in the non-traction group. There was no significant difference in the incidence of perforation between the two groups ( P=0.542). Conclusion:Rubber band traction can safely improve the efficiency of ESD.

Objective To study the value of platelet/lymphocyte ratio(PLR)in predicting coronary artery lesions and their outcome in acute coronary syndrome(ACS)patients after PCI.Methods Three hundred and forty-four elderly ACS patients who underwent PCI and CAG in our hospital from May 2016to August 2018were divided into MACCE group(n=95)and MACCE-free group (n=249).They were further divided into high PLR group(n=247)and low PLR group(n=97) according to the ROC curve for PLR.Their clinical data were analyzed,and the prognostic threshold of PLR was determined according to the ROC curve for PLR and logistic regression analysis respectively.Results The number of smokers was significantly greater,the incidence of DM,serum LDL-C level,PLR and Gensini score were significantly higher in MACCE group than in MACCE-free group(P＜0.01).The area under the ROC curve for PLR in predicting the poor outcome in ACS patients after PCI was 0.898and 0.842respectively(95％CI:0.859-0.937,95％CI:0.794-0.891).The PLR was positively related with the Gensini score(r=0.654,P＜0.01).The incidence of MACCE was significantly higher in high PLR group than in low PLR group(78.35％ vs 7.69％,P＜0.01).High PLR was an independent risk factor for MACCE in elderly ACS patients after PCI(OR=2.527,95％CI:1.058-6.039,P=0.037).Conclusion PLR is related with MACCE in elderly ACS patients after PCI.

OBJECTIVETo study the reasons for the discrepancies in pathologic diagnosis of gastric dysplasia/early cancer in endoscopic submucosal dissection (ESD) specimens, and how to cope with the discrepancies.

METHODSThe pathologic diagnoses in 60 cases of ESD specimens according to the three currently used classification systems (namely Western criteria, Japanese criteria and Vienna classification) were compared. The diagnostic discrepancies were analyzed.

RESULTSFifteen of the 17 cases diagnosed as low-grade intraepithelial neoplasia according to the Western criteria were revised as adenoma by the Japanese criteria. Amongst the 43 cases of gastric intramucosal adenocarcinoma diagnosed according to the Japanese criteria, 23 cases had concordant diagnosis by the Western criteria. While the diagnosis of low-grade intraepithelial neoplasia/adenoma was basically similar irrespective of classification system used, there were significant differences in the interpretation of gastric early cancer.

CONCLUSIONSThe diagnostic discrepancies in the gastric dysplasia/early cancer are mainly related to the morphologic criteria applied in different classifications. In order to facilitate clinical and pathologic communication, a consensus using Vienna/WHO classifications, supplemented with Japanese system, is desirable.

Adenoma ; pathology ; Carcinoma in Situ ; pathology ; Dissection ; methods ; Gastroscopy ; Humans ; Hyperplasia ; pathology ; Stomach ; pathology ; Stomach Neoplasms ; pathology

Objective To explore the effect of creatine phosphate combined with salvia miltiorrhiza polyphe-nols acid salt in treatment of coronary heart disease heart failure.Methods 114 cases of patients with coronary heart disease heart failure were selected as research objectives,who were treated in our hospital from August 2012 to August 2014.And they were randomly divided into control group(55 cases)and research group(59 cases)according to the number table method.Routine therapy of heart failure were given in both groups and the research group were added creatine phosphate combined with salvia miltiorrhiza polyphenols acid salt.The clinical efficacy of two groups of patients were observed and compared.Results The total effective rate in research group was 96.61%(57 /59), significantly higher than 85.45%(47 /55)in control group,the difference was statistically significant(χ2 =4.427, P =0.035).Before treatment,the left ventricular ejection fraction(LVEF),left ventricular end diastolic diameter (LVEDD),left ventricular end systolic diameter(LVESD)and 6min walking distance between two groups had no sig-nificant difference(P >0.05).After treatment,the LVEDD and LVESD of research group were decreased and LVEF and 6 minutes walking distance of two groups were increased,the difference was statistically significant(P <0.05), the LVEDD and LVESD of research group were lower than that of the control group and LVEF and 6 minutes walking distance were higher than that of control group,the difference was statistically significant(P <0.05).No complications or side effects related to the treatment were found in both groups.Conclusion On the basis of routine therapy of heart failure,the effect of creatine phosphate sodium combined with salvia miltiorrhiza polyphenols acid salt in treat-ment of coronary heart disease heart failure can improve cardiac function of the patients with the indicators,and the clinical effect is obvious,and side effects is rarely observed.

Objective To investigate the relationship of carotid artery intima-media thickness(IMT) and blood pressure variation in patients with prehypertension. Methods Three hundred and ninety-two patients were selected as our subjects. Artery IMT was measured by Doppler ultrasonography. All patients were divided into carotid artery IMT group( n = 204 ),not carotid artery IMT group( n = 188 ) based on carotid IMT. Meanwhile,all patients were monitored by ambulatory blood pressure. Results (1)The indices of 24 h mean systolic blood pressure,systolic blood pressure variability and diastolic blood pressure variability in patients of carotid artery IMT group were(136. 85 ± 9. 67)mmHg,(4. 13 ± 0. 67)% ,(2. 97 ± 0. 45)% respectively, higher than those of Not carotid artery IMT group((121. 92 ± 6. 54)mmHg,(2. 64 ± 0. 86)% ,(2. 06 ± 0. 36)% ;t = 21. 08,5. 97,3. 32;P < 0. 05).(2)The rate of the carotid artery thickness increased with systolic blood pressure variability increasing( P = 0. 001). There were no significant correlations between rate of the carotid artery thickness and diastolic blood pressure variability,24 h mean diastolic blood pressure(P = 0. 435, 0. 126). The IMT thickening rate was higher when the average systolic blood pressure was greater(P = 0. 013). (3)Regression analysis indicated that carotid artery IMT was positively related with systolic blood pressure variability,high-sensitivity C-reactive protein,24 h mean systolic blood pressure,2-hour postprandial blood glouse. Conclusion Carotid artery IMT is independently associated with variation of blood pressure,especially with systolic blood pressure variability in prehypertension patients.

Objective To investigate the current popularity of ERCP training in China.Methods A questionnaire-based survey was performed on a professional survey website.A total of 48 questions were designed,including personal information,training information,current status of ERCP performance and sug-gestions to ERCP training.The questionnaire was completed anonymously by physicians who fulfilled full-time ERCP training in any Chinese endoscopy center for at least 1 year before.Results A total of 464 phy-sicians,from all the regions of mainland China,among which 362 people completed all the questions.More than two thirds trainees thought that they had got fruitful training and 27.4% trainees had their ERCP vol-umes greatly increased and 64.3% trainees increased practice.According to related index,the physicians who were competent in routine ERCP performance were 84.5%,with outstanding operators of 12.2%.Con-clusion China has made great progress in the training program of ERCP technique in recent decades,but problems still remain such as various admission standard,insufficient training duration,incomprehensive program,as well as lack of evaluation and follow-up system.

Biopsy ; Dissection ; Gastric Mucosa ; pathology ; surgery ; Gastroscopy ; methods ; Humans ; Neoplasm Invasiveness ; Neoplasm Staging ; Neoplastic Cells, Circulating ; Stomach Neoplasms ; pathology ; surgery ; Stomach Ulcer ; pathology