Objective:The study investigated the full-time Clinical Research Coordinators (CRCs) working in hospitals on their current working situation and explored affecting factors to provide suggestions for a professional and systemic clinical research workforce establishment in municipal medical institutions.Methods:A questionnaire survey was designed for CRCs in municipal hospitals in Shanghai, descriptive and one-way cross-tabulation analysis were conducted, using t-test for continuous numerical variables, rank-sum test for count variables and chi-square test for categorical variables.Results:Totaling 177 CRCs in 9 municipal hospitals in Shanghai answered the questionnaire. The average age of the respondents was 28.56±7.299 years old. Their professional background was mainly nursing and pharmacy (139/177, 87.53%), and bachelor degree (114/177, 64.41%). Averagely worked 2.50±1.632 years, the average number of research projects undertaken by CRC was 3.45±2.179, and the average number of cumulative projects involved was 8.72±9.341. The CRCs employed by hospitals mainly undertook Investigator-Initiated clinical Trial/Research projects (IITs) (26/36, 72.22%), while the CRCs employed by SMO companies mainly undertook Industry-Sponsored Clinical Trial (IST) projects (96/141, 68.09%). 85.88% (152/117) of CRCs held GCP certificates valid within three years, and the proportion of CRCs employed by hospitals held GCP certificates was lower than that of SMO companies ( P<0.05). Among the CRCs employed by hospitals, 23 (63.89%) said they had no position or were not clear about their position; The CRCs in SMO companies were mainly primary and intermediate (χ 2=84.119, P<0.05). The average number of research projects undertaken by CRC was 3.45±2.179, and the average number of cumulative projects involved was 8.72±9.341. Conclusions:With the development of clinical research, the full-time specialized CRCs in medical institutions mainly have 2 sources: from SMO/CRO companies or self-employment by medical institutions. In general, there are still problems in the CRC talent team as unclear entry standards, insufficient, lack career positioning planning, large mobility, imperfect training system, and imperfect promotion mechanism. It is suggested to unify occupational access standards and set specialty in colleges or universities. Strengthen post-service education and training system, establish multi-party collaborative training mechanism, standardize the assessment and evaluation, improve the job title promotion system, to promote the rapid development of CRC team.

Objective:The study investigated the full-time Clinical Research Coordinators (CRCs) working in hospitals on their current working situation and explored affecting factors to provide suggestions for a professional and systemic clinical research workforce establishment in municipal medical institutions.Methods:A questionnaire survey was designed for CRCs in municipal hospitals in Shanghai, descriptive and one-way cross-tabulation analysis were conducted, using t-test for continuous numerical variables, rank-sum test for count variables and chi-square test for categorical variables.Results:Totaling 177 CRCs in 9 municipal hospitals in Shanghai answered the questionnaire. The average age of the respondents was 28.56±7.299 years old. Their professional background was mainly nursing and pharmacy (139/177, 87.53%), and bachelor degree (114/177, 64.41%). Averagely worked 2.50±1.632 years, the average number of research projects undertaken by CRC was 3.45±2.179, and the average number of cumulative projects involved was 8.72±9.341. The CRCs employed by hospitals mainly undertook Investigator-Initiated clinical Trial/Research projects (IITs) (26/36, 72.22%), while the CRCs employed by SMO companies mainly undertook Industry-Sponsored Clinical Trial (IST) projects (96/141, 68.09%). 85.88% (152/117) of CRCs held GCP certificates valid within three years, and the proportion of CRCs employed by hospitals held GCP certificates was lower than that of SMO companies ( P<0.05). Among the CRCs employed by hospitals, 23 (63.89%) said they had no position or were not clear about their position; The CRCs in SMO companies were mainly primary and intermediate (χ 2=84.119, P<0.05). The average number of research projects undertaken by CRC was 3.45±2.179, and the average number of cumulative projects involved was 8.72±9.341. Conclusions:With the development of clinical research, the full-time specialized CRCs in medical institutions mainly have 2 sources: from SMO/CRO companies or self-employment by medical institutions. In general, there are still problems in the CRC talent team as unclear entry standards, insufficient, lack career positioning planning, large mobility, imperfect training system, and imperfect promotion mechanism. It is suggested to unify occupational access standards and set specialty in colleges or universities. Strengthen post-service education and training system, establish multi-party collaborative training mechanism, standardize the assessment and evaluation, improve the job title promotion system, to promote the rapid development of CRC team.

Objective:To study the factors influencing short-term prognosis of patients with Budd-Chiari syndrome (B-CS) presenting with upper gastrointestinal bleeding and to assess the predictive value of platelet-albumin-bilirubin score (PALBI) on death within 30 d in these patients.Methods:A retrospective study was conducted on 74 patients with B-CS who presented with upper gastrointestinal bleeding and were treated at the First Affiliated Hospital of Zhengzhou University from January 2014 to February 2020. There were 51 males and 23 females, with age of (46.5±11.1) years old. These patients were divided into the survival group ( n=58) and the death group ( n=16) according to the disease outcomes up to 30 d of follow-up. Factors influencing short-term deaths of these patients were analyzed, and the predictive values of PALBI, ALBI, CTP and MELD scores on short-term prognosis of the patients were assessed. The receiver operating characteristic (ROC) curves were plotted, and the areas under the curve (AUC) were calculated and compared. Results:The differences between patients in the survival and death groups for white blood cell, platelet, PALBI score, PALBI classification, ALBI score, CTP score, MELD score, and presence or absence of hepatic encephalopathy were significantly different (all P<0.05). Multivariate logistic regression analysis showed that CTP score≥10 or CTP grade C ( OR=1.669, 95% CI: 1.048-2.661), and PALBI score >-2.09 or PALBI grade 3 ( OR=5.245, 95% CI: 2.128-12.924) were independent risk factors for predicting death within 30 days. The areas under the ROC curves for PALBI, ALBI, CTP and MELD score were 0.89, 0.72, 0.77 and 0.76, with the cut-off values of -1.92, -1.60, 8.50 and 13.60, respectively. The differences between the PALBI score and ALBI, CTP scores were significantly different ( P<0.05). Conclusion:The PALBI score showed a positive predictive value on short-term prognostic assessment of patients with B-CS presenting with upper gastrointestinal bleeding. It was comparable to the effect of the MELD score but was significantly better than the ALBI and CTP scores.

Objective To investigate the effect of metformin on liver fibrosis in a mouse model of Budd-Chiari syndrome and its mechanism. Methods A total of 30 male C57 mice were randomly divided into sham-operation group (SHAM group) with 6 mice, sham operation+ metformin group (SHAM+M group) with 5 mice, Budd-Chiari model group (BCS group) with 10 mice, and Budd-Chiari model+metformin group (BCS+M group) with 9 mice. The mice in the model group were treated with partial ligation of the inferior vena cava, those in the SHAM group were not treated with ligation, and those in the metformin group were given 0.1% metformin in drinking water besides modeling. The mice were sacrificed after 6 weeks. HE staining and picrosirius red staining were used to observe liver histopathology and collagen deposition; immunohistochemistry was used to measure the expressions of α-smooth muscle actin (α-SMA) and fibrinogen; quantitative real-time PCR was used to measure the mRNA expression of hypoxia-inducible factor 1α (HIF-1α) and type Ⅰ collagen (collagen 1), and Western blot was used to measure the relative protein expression levels of HIF-1α, vascular endothelial growth factor (VEGF), fibrinogen, α-SMA, and collagen 1. A one-way analysis of variance was used for comparison of continuous data between multiple groups, and the least significant difference t -test was used for further comparison between two groups. Results Pathological staining showed that compared with the SHAM group, the BCS group had significant liver fibrosis, disordered arrangement of hepatocytes near the central vein, sinusoidal expansion with red blood cell deposition and a small amount of inflammatory cell infiltration, and collagen deposition. The BCS group had significant increases in the mRNA expression levels of HIF-1α and collagen 1 and the protein expression levels of α-SMA, collagen 1, HIF-1α, VEGF, and fibrinogen (all P < 0.05); compared with the BCS group, the BCS+M group had significant alleviation of liver fibrosis, red blood cell deposition, and collagen deposition and significant reductions in the mRNA expression levels of HIF-1α and collagen 1 and the protein expression levels of α-SMA, collagen 1, HIF-1α, VEGF, and fibrinogen (all P < 0.05). Conclusion Metformin can improve congestive liver fibrosis caused by Budd-Chiari syndrome, possibly by reducing microthrombus in hepatic sinusoid and inhibiting the HIF-1α/VEGF pathway.

Objective:To investigate the clinical treatment options for cavernous transformation of portal vein (CTPV).Methods:Data of 65 CTPV patients receiving invasive treatment and followed up at the First Affiliated Hospital of Zhengzhou University between Apr 2011 and Apr 2021 were collected. Patients were divided into four groups based on different treatment option, 24 patients were treated with transjugular intrahepatic portosystemic stent-shunt (TIPS) and 11 patients with splenopneumopexy, while 22 patients underwent splenectomy and devascularization , 8 were treated by endoscopic variceal ligation . The difference of postoperative upper gastrointestinal bleeding and hepatic encephalopathy between the four groups were analyzed,Results:There were no difference between four groups in sex, age, preoperative serum aspartate aminotransferase, total bilirubin, albuminand Child-Turcotte-Pugh grade. The incidence of hepatic encephalopathy in the TIPS group was 33.3%±9.6%、46.5%±10.3% and 64.4%±13.1% in half year, 1 year, and 3 years , respectively. Postoperative hepatic encephalopathy rate was higher in TIPS group( χ2=31.191, P=0.000). Three patients in the TIPS group developed upper gastrointestinal hemorrhage within 6 months after the operation, and postoperative upper gastrointestinal bleeding rate was higher in splenopneumopexy group( χ2=7.542, P=0.006), Conclusion:The clinical treatment options for CTPV patients are complicated ,we should make individual treatment options depend on the etiology, clinical symptoms and site of blood flow obstruction.

Objective:To examine the effect of thrombolytic therapy of Budd-Chiari syndrome (B-CS) with inferior vena cava (IVC) thrombosis, and the prognosis factors of it.Methods:The clinical data of 67 patients of B-CS with IVC thrombosis treated in the Department of Hepatopancreatobiliary Surgery, the First Affiliated Hospital of Zhengzhou University from January 2013 to August 2020 were analyzed retrospectively. There were 30 males and 37 females. The age was (47.7±11.1) years(range: 18 to 72 years). All patients received catheter directed thrombolysis, and the thrombolysis process, complications and outcomes were analyzed. All patients received IVC balloon angioplasty after thrombolytic therapy. The t test, χ 2 test, Mann-Whitney U test were used for univariate analysis of the prognosis factors of thrombolysis effects, while unconditional Logistic regression model were used for multivariate analysis. Results:In the 67 patients, 47 cases succerssed in thrombolytic therapy. The successful rates of thrombolysis at 1-, 2-, 3- and 4-week were 9.0%, 29.9%, 64.2% and 70.1%, respectively. The rates of thrombolytic catheter-related infection at 1-, 2-, 3- and 4-week were 1.5%, 4.5%, 14.9% and 31.3%, respectively. No serious complications such as symptomatic and acute pulmonary embolism occurred during perioperative period of IVC balloon angioplasty. Univariate analysis showed that differences in thrombus length ((36.7±18.1) mm vs. (52.0±16.4) mm, t=-3.234, P=0.002), Child-Pugh classification (class A/B/C: 37/8/2 vs. 10/8/2, Z=-2.310, P=0.021) and pre-opening IVC proportion (68.1% (32/47) vs. 35.0% (7/20), χ2=6.313, P=0.012) were statistically significant. The thrombus length ( OR=0.948, 95% CI: 0.913 to 0.984, P=0.005), pre-opening IVC ( OR=5.451, 95% CI: 1.469 to 20.228, P=0.011) were independent prognosis factors of thrombolytic effect. Conclusions:Thrombolytic therapy for B-CS with IVC thrombosis were satisfactory, and the thrombolysis duration should be confined within 3 weeks. IVC balloon angioplasty is safe and effective for patients failing in thrombolysis, and pre-opening IVC is an important method to improve the thrombolytic effect.

Objective:To examine the effect of thrombolytic therapy of Budd-Chiari syndrome (B-CS) with inferior vena cava (IVC) thrombosis, and the prognosis factors of it.Methods:The clinical data of 67 patients of B-CS with IVC thrombosis treated in the Department of Hepatopancreatobiliary Surgery, the First Affiliated Hospital of Zhengzhou University from January 2013 to August 2020 were analyzed retrospectively. There were 30 males and 37 females. The age was (47.7±11.1) years(range: 18 to 72 years). All patients received catheter directed thrombolysis, and the thrombolysis process, complications and outcomes were analyzed. All patients received IVC balloon angioplasty after thrombolytic therapy. The t test, χ 2 test, Mann-Whitney U test were used for univariate analysis of the prognosis factors of thrombolysis effects, while unconditional Logistic regression model were used for multivariate analysis. Results:In the 67 patients, 47 cases succerssed in thrombolytic therapy. The successful rates of thrombolysis at 1-, 2-, 3- and 4-week were 9.0%, 29.9%, 64.2% and 70.1%, respectively. The rates of thrombolytic catheter-related infection at 1-, 2-, 3- and 4-week were 1.5%, 4.5%, 14.9% and 31.3%, respectively. No serious complications such as symptomatic and acute pulmonary embolism occurred during perioperative period of IVC balloon angioplasty. Univariate analysis showed that differences in thrombus length ((36.7±18.1) mm vs. (52.0±16.4) mm, t=-3.234, P=0.002), Child-Pugh classification (class A/B/C: 37/8/2 vs. 10/8/2, Z=-2.310, P=0.021) and pre-opening IVC proportion (68.1% (32/47) vs. 35.0% (7/20), χ2=6.313, P=0.012) were statistically significant. The thrombus length ( OR=0.948, 95% CI: 0.913 to 0.984, P=0.005), pre-opening IVC ( OR=5.451, 95% CI: 1.469 to 20.228, P=0.011) were independent prognosis factors of thrombolytic effect. Conclusions:Thrombolytic therapy for B-CS with IVC thrombosis were satisfactory, and the thrombolysis duration should be confined within 3 weeks. IVC balloon angioplasty is safe and effective for patients failing in thrombolysis, and pre-opening IVC is an important method to improve the thrombolytic effect.

Tai Chi, developed from a kind of martial arts into a new form of exercise therapy, has received wide attention. Studies on the rehabilitation effects of Tai Chi and its mechanism have been conducted by researches in both China and other countries, and most of these studies are concerned with Tai Chi’s role in balance improvement. According to the purpose of the study and the evaluation index, the rehabilitation function and biomechanical characteristics of Tai Chi exercising were reviewed. The biomechanical mechanism of rehabilitation function was discussed by comparing the differences between the research method and the conclusion. Due to the lack of a unified specification for the standard and duration of Tai Chi exercising, some study result are inconsistent. Enhancing biomechanical researches on Tai Chi and setting different practicing standards for people with various health conditions will be a main direction for Tai Chi study in the future.