Clinical tolerability and pharmacokinetics of troxacitabine / 中华肿瘤杂志

Objective: To investigate the safety and efficacy of troxatabine in advanced or relapsed malignant tumors resistant to standard therapy in China. Methods: This is a phase Ⅰ prospective study. During dose escalation, patients in Cancer Hospital, Chinese Academy of Medical Sciences received a single-dose intravenous infusion of troxacitabine. The planned dosing groups were 1.8, 3.6, 4.8, 6.4 and 8.0 mg/m(2) on days 1 and 8 every 3 weeks. The data of all patients were collected for safety analyses. Safety and tolerability were evaluated by monitoring adverse events. Results: Nineteen patients were enrolled from April 2018 to May 2019. The major adverse events were fatigue (89.5%, 17/19), leukopenia (84.2%, 16/19) and neutropenia (78.9%, 15/19). The dose limiting toxicity was neutropenia. The maximum tolerated dose was 6.4 mg/m(2). The best effect was stable disease (43.8%). The half-life of elimination phase from 15.91 hours to 76.63 hours in each dose group. Conclusions: The toxicity of troxacitabine is well tolerant. We recommend that the dose for Phase Ⅱ clinical trial should be 6.4 mg/m(2).

Outcomes of different types of pulmonary atresia in neonates treated by ductus arteriosus stenting / 中华儿科杂志

Objective: To summarize the outcomes of different types of pulmonary atresia in neonates treated by ductus arteriosus stenting. Methods: This study was a retrospective cohort study. A total of 19 neonates who had pulmonary atresia treated by ductus arteriosus stenting in Xinhua Hospital, Shanghai Jiao Tong University School of Medicine from April 2014 to June 2021 were included. They were divided into the intact ventricular septum (PA-IVS) group and the ventricular septal defect (PA-VSD) group. Ductus arteriosus stents were implanted by different approaches. These children were followed up regularly at the 1, 3, 6, and 12 months after the surgery and annually since then to evaluate the outcome. Independent sample t-test was used for the statistical analysis. Results: There were 12 children in PA-IVS group and 7 in PA-VSD group. All of them were full term in fants. The gestational age of the PA-IVS group and the PA-VSD group was (38.8±1.1) and (37.7±1.8) weeks, the birth weights were (3.2±0.4) and (3.4±1.1) kg, and the age at operation was (10±9) and (12±7) days, respectively, without significant difference (all P>0.05). Among the 12 children with PA-IVS, 9 had stents successfully implanted through the femoral artery and 3 through the femoral vein. Of the 7 children with PA-VSD, 2 had the stents successfully implanted via the femoral artery and 2 failed, and the remaining 3 had stents successfully implanted via the left carotid artery. There was no postoperative thromboembolism, arteriovenous fistula, pseudoaneurysm or other vascular complications. Five children with PA-VSD who had successful operations were followed up at 6 months of age. They all had the operation for pulmonary atresia, repair of the ventricular septal defect, removal of arterial duct stents, and ligation of the arterial duct. All children survived without any stent displacement or stenosis and biventricular circulation was achieved during the follow-up. Conclusions: Ductus arteriosous stenting can be the first-stage treatment for children with PA-IVS and PA-VSD. In addition to the traditional femoral vein and femoral artery approach, the carotid artery can be used as a route for stent placement.

Related factors of negative conversion time of nucleic acid in children with COVID-19 / 中华儿科杂志

Objective: To explore the related factors of negative conversion time (NCT) of nucleic acid in children with COVID-19. Methods: A retrospective cohort study was conducted. A total of 225 children who were diagnosed with COVID-19 and admitted to Changxing Branch of Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from April 3rd to May 31st 2022 were enrolled in the study. The infection age, gender, viral load, basic disease, clinical symptoms and information of accompanying caregivers were retrospectively analyzed. According to age, the children were divided into<3 years of age group and 3-<18 years of age group. According to the viral nucleic acid test results, the children were divided into positive accompanying caregiver group and negative accompanying caregiver group. Comparisons between groups were performed using Mann-Whitney U test or Chi-square test. Multivariate Logistic regression analysis was used to analyze the related factors of NCT of nucleic acid in children with COVID-19. Results: Among the 225 patients (120 boys and 105 girls) of age 2.8 (1.3, 6.2) years, 119 children <3 years and 106 children 3-<18 years of age, 19 cases were diagnosed with moderate COVID-19, and the other 206 cases were diagnosed with mild COVID-19. There were 141 patients in the positive accompanying caregiver group and 84 patients in the negative accompanying caregiver group.Patients 3-<18 years of age had a shorter NCT (5 (3, 7) vs.7 (4, 9) d, Z=-4.17, P<0.001) compared with patients <3 years of age. Patients in the negative accompanying caregiver group had a shorter NCT (5 (3, 7) vs.6 (4, 9) d,Z=-2.89,P=0.004) compared with patients in the positive accompanying caregiver group. Multivariate Logistic regression analysis showed that anorexia was associated with NCT of nucleic acid (OR=3.74,95%CI 1.69-8.31, P=0.001). Conclusion: Accompanying caregiver with positive nucleic acid test may prolong NCT of nucleic acid, and decreased appetite may be associated with prolonged NCT of nucleic acid in children with COVID-19.

Expression of antigens of foot-and-mouth disease virus in plants: a review / 生物工程学报

Foot-and-mouth disease (FMD) is an acute, severe, and highly contagious infectious disease caused by foot-and-mouth disease virus (FMDV), which seriously endangers the development of animal husbandry. The inactivated FMD vaccine is the main product for the prevention and control of FMD, which has been successfully applied to control the pandemic and outbreak of FMD. However, the inactivated FMD vaccine also has problems, such as the instability of antigen, the risk of spread of the virus due to incomplete inactivation during vaccine production, and the high cost of production. Compared with traditional microbial and animal bioreactors, production of antigens in plants through transgenic technology has some advantages including low cost, safety, convenience, and easy storage and transportation. Moreover, since antigens produced from plants can be directly used as edible vaccines, no complex processes of protein extraction and purification are required. But, there are some problems for the production of antigens in plants, which include low expression level and poor controllability. Thus, expressing the antigens of FMDV in plants may be an alternative mean for production of FMD vaccine, which has certain advantages but still need to be continuously optimized. Here we review the main strategies for expressing active proteins in plants, as well as the research progress on the expression of FMDV antigens in plants. We also discuss the current problems and challenges encountered, with the aim to facilitate related research.

Target versus sub-target dose of renin-angiotensin system inhibitors on survival in elderly patients with heart failure with reduced ejection fraction: a systematic review and meta-analysis / 老年心脏病学杂志（英文版）

BACKGROUND@#The efficiency of the target versus sub-target dose of renin-angiotensin system inhibitors (RASIs) in elderly patients with heart failure (HF) with reduced ejection fraction (HErEF) remains unclear.@*METHODS@#PubMed, Embase, and the Cochrane Central Register of Controlled Trials were searched from database inception through March 2022 for randomized controlled trials (RCTs) and observational studies considering the effect of the target versus sub-target dose of RASIs on survival in elderly patients (≥ 60 years) with HErEF. The primary outcome was all-cause mortality. The secondary outcomes were cardiac mortality, HF hospitalization, and the composite endpoint of mortality or HF hospitalization. A meta-analysis was conducted to generate combined hazard ratio (HR) and 95% CI.@*RESULTS@#Seven studies (two RCTs and five observational studies) enrolling 16,634 patients were included. A pooled analysis suggested that the target versus sub-target dose of RASIs led to lower rates of all-cause mortality (HR = 0.92, 95% CI: 0.87-0.98, I2 = 21%) and cardiac mortality (HR = 0.93, 95% CI: 0.85-1.00, I2 = 15%) but not reduced rates of HF hospitalization (HR = 0.94, 95% CI: 0.88-1.01, I2 = 0) and the composite endpoint (HR = 1.03, 95% CI: 0.91-1.15, I2 = 51%). However, the target dose of RASIs was associated with a similar primary outcome (HR = 0.85, 95% CI: 0.64-1.14, I2 = 0) in a subgroup of very elderly patients > 75 years of age.@*CONCLUSIONS@#Our analysis suggests that the target dose of RASIs has a better survival benefit in elderly patients with HFrEF compared to the sub-target dose of RASIs. However, the sub-target dose of RASIs is associated with a similar mortality rate in very elderly patients > 75 years of age. Future high-quality and adequately powered RCTs are warranted.

Effect of miR-125b on T Cell Activation in Aplastic Anemia by Targetting B7-H4 / 中国实验血液学杂志

OBJECTIVE@#To investigate the effect of miR-125b on T cell activation in patients with aplastic anemia (AA) and its molecular mechanism.@*METHODS@#A total of 30 AA patients were enrolled in department of hematology, Binzhou Medical University Hospital from January 2018 to October 2021, as well as 15 healthy individuals as healthy control (HC) group. Peripheral blood mononuclear cells (PBMCs) were isolated, in which the levels of miR-125b and B7-H4 mRNA were detected by RT-qPCR. Immunomagnetic beads were used to separate naive T cells and non-naive T cells from AA patients and healthy people to detect the levels of miR-125b and B7-H4 mRNA. Lentivirus LV-NC inhibitor and LV-miR-125b inhibitor were transfected into cells, and T cell activation was detected by flow cytometry. The dual-luciferase reporter gene assay was used to detect the targetting relationship between miR-125b and B7-H4. RT-qPCR and Western blot were used to detect the levels of miR-125b, CD40L, ICOS, IL-10 mRNA and B7-H4 protein.@*RESULTS@#Compared with HC group, the expression of miR-125b was up-regulated but B7-H4 mRNA was down-regulated in PBMCs of AA patients (P <0.05), and the proportions of CD4+CD69+ T cells and CD8+CD69+ T cells in PBMCs of AA patients were higher (P <0.05). The expression of miR-125b was significantly up-regulated but B7-H4 mRNA was down-regulated in both naive T cells and non-naive T cells of AA patients (P <0.05), and non-naive T cells was more significant than naive T cells (P <0.05). Compared with NC inhibitor group, the expression of miR-125b was significantly decreased, the expression level of CD69 on CD4+ and CD8+ T cells in PBMCs was also significantly decreased, while the luciferase activity was significantly increased after co-transfection of miR-125b inhibitor and B7-H4-3'UTR-WT in the miR-125b inhibitor group (P <0.05). Compared with NC inhibitor group, the mRNA and protein levels of B7-H4 were significantly increased in the miR-125b inhibitor group (P <0.05). Compared with miR-125b inhibitor+shRNA group, the expression levels of CD69 on CD4+ and CD8+ T cells were significantly increased, and the levels of CD40L, ICOS and IL-10 mRNA were also significantly increased in the miR-125b inhibitor+sh-B7-H4 group (P <0.05).@*CONCLUSION@#MiR-125b may promote T cell activation by targetting B7-H4 in AA patients.

hiPSCs and organoids: prediction of arrhythmogenic risks for optimized traditional Chinese medicine / 中国中药杂志

Accurate assessment of the risks associated with traditional Chinese medicine(TCM), such as the potential to induce serious cardiovascular adverse reactions including cardiac arrhythmias, is crucial. This article introduced the pharmacological evaluation strategies for cardiac safety and the progress in cardiac organ research, with a focus on discussing the application prospects of human induced pluripotent stem cells(hiPSCs) and organoids in assessing the risks of TCM-induced cardiac arrhythmias. Compared with traditional animal models, hiPSCs and organoid models provide better reference and predictive capabilities, allowing for more accurate simulation of human cardiac responses. Researchers have successfully generated various cardiac tissue models that mimic the structure and function of the heart to evaluate the effects of TCM on the heart. The hiPSCs model, by reprogramming adult cells into pluripotent stem cells and differentiating them into cardiac cells, enables the generation of personalized cardiac tissue, which better reflects individual differences and drug responses. This provides guidance for the assessment of TCM cardiac toxicity risks. By combining organoid model with cardiac safety pharmacology strategies such as electrocardiogram monitoring and ion channel function assessment, the impact of TCM on the heart can be comprehensively evaluated. In addition, the application of the Comprehensive in Vitro Proarrhythmia Assay(CiPA) approach improves the accuracy of evaluation. Applying the CiPA approach to TCM research reveals potential risks and provides a scientific basis for the clinical application and industrial development of TCM. In conclusion, organoid model and cardiac safety pharmacology evaluation strategies provide important tools for assessing the cardiac toxicity risks of TCM. The combination of hiPSCs model, comprehensive assessment methods, and the CiPA strategy enables an accurate assessment of the risks of TCM-induced cardiac arrhythmias, thus providing a scientific basis for the safe use and international recognition of TCM in clinical practice. This contributes to ensuring the safety and efficacy of TCM and promoting its clinical application and global acceptance.

Stereotactic body radiation therapy for patients with lung and liver oligometastases from colorectal cancer: a phase Ⅱ trial / 中华肿瘤杂志

Objective: To explore the safety and effectiveness of stereotactic body radiation therapy (SBRT) for oligometastases from colorectal cancer (CRC). Methods: This is a prospective, single-arm phase Ⅱ trial. Patients who had histologically proven CRC, 1 to 5 detectable liver or lung metastatic lesions with maximum diameter of any metastases ≤5 cm were eligible. SBRT was delivered to all lesions. The primary endpoint was 3-year local control (LC). The secondary endpoints were treatment-related acute toxicities of grade 3 and above, 1-year and 3-year overall survival (OS) and progression free survival (PFS). Survival analysis was performed using the Kaplan-Meier method and Log rank test. Results: Petients from 2016 to 2019 who were treated in Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. Forty-eight patients with 60 lesions were enrolled, including 37 liver lesions and 23 lung lesions. Forty-six patients had 1 or 2 lesions, with median diameter of 1.3 cm, the median biologically effective dose (BED(10)) was 100.0 Gy. The median follow-up was 19.5 months for all lesions. Twenty-five lesions developed local failure, the median local progression free survival was 15 months. The 1-year LC, OS and PFS was 70.2% (95% CI, 63.7%~76.7%), 89.0% (95% CI, 84.3%~93.7%) and 40.4% (95%CI, 33.0%~47.8%). The univariate analysis revealed that planning target volume (PTV) and total dose were independent prognostic factors of LC (P<0.05). For liver and lung lesions, the 1-year LC, OS and PFS was 58.7% and 89.4% (P=0.015), 89.3% and 86.5% (P=0.732), 30.5% and 65.6% (P=0.024), respectively. No patients developed acute toxicity of grade 3 and above. Conclusion: SBRT is safe and effective treatment method for oligometastases from CRC under precise respiratory motion management and robust quality assurance.

Prevention and Treatment of Atopic Dermatitis with Traditional Chinese Medicine： A Review / 中国实验方剂学杂志

Atopic dermatitis （AD） is a chronic， recurrent and inflammatory skin disease. Modern medical research suggests that AD is related to immune function， genes， skin barrier and other factors， while the specific etiology and pathogenesis remains unclear. The disease has a long course and is prone to reoccur， which seriously affects people’s production and life. Steroids， antihistamines and immunosuppressants are commonly used western medicines for the treatment of AD， which， however， will cause adverse reactions after long-term application. Traditional Chinese medicine （TCM） has a long history， good therapeutic effect and rich clinical experience in the prevention and treatment of AD， and the research on the treatment of AD with TCM has been intensifying. Centering on the theory of TCM， we systematically summarized the research progress related to AD， discussed the etiology and pathogenesis of AD， and summarized the TCM syndrome differentiation of AD from the aspects of eight principles， etiology， Qi-blood-body fluid， zang-fu organs， six meridians， defense-Qi-nutrient-blood and triple energizer. According to the etiology and pathogenesis of AD， we proposed the therapeutic regimens corresponding to the type and stage of the disease. Considering the research progress achieved in the recent years in the prevention and treatment of AD by TCM and the modern pharmacological research on Chinese medicinal materials， we reviewed the classic famous prescriptions， self-made prescriptions and Chinese patent medicines， and expounded the mechanisms of single Chinese medicinal materials in the treatment of AD at the molecular level. The TCM external therapies such as wet compress， medicated bath， gel and ointment are safe and effective. Acupuncture and moxibustion play a role in the prevention and treatment of AD， which is worthy of promotion in clinical practice， and the syndrome differentiation methods of Qi-blood-body fluid and triple energizer are novel in the treatment of this disease. TCM， characterized by diverse therapeutic methods and good clinical efficacy， is worthy of promotion in the treatment of AD， which will contribute to the development of TCM in China.

Protective effects of micro RNA-98-5p targeting Kruppel-like factor 9 against myocardial ischemia-reperfusion injury in rats / 解剖学报

Objective To investigate the protective effect of micro RNA(miR)-98-5p targeting Kruppel-like factor 9(KLF9) against myocardial isehemia-reperfusion(MI/R) injury in rats. Methods Totally 50 rats were randomly divided into sham operation group, model group, miR-98-5p agomir group, agomir-NC group, and miR-98-5p agomir+pcDNA-3. 1-KLF9 group, 10 in each group. MI/R model was established by coronary artery ligation. The pathological changes of myocardial tissue were detected by HE staining. The myocardial apoptosis were detected by TUNEL. The levels of creatine kinase (CK), creatine kinase isoenzymes (CK-MB) and lactate dehydrogenase (LDH) in serum were detected by ELISA. The expression levels of miR-98-5p and KLF9 mRNA were detected by Real-time PCR. The expression of KLF9, Bax and JAK2/STAT3 pathway relative protein were detected by Western blotting. Dual luciferase assay verified the relationship between miR-98-5p and KLF9. Results Compared with the sham operation group, the arrangement of myocardial cells in the model group was disordered, and the myocardial cells appeared necrosis. The apoptosis rate of myocardial cells, serum CK, CK-MB and LDH contents increased, the expression level of miR-98-5p decreased, and the expression levels of KLF9 mRNA and protein, p-JAK2 and p-STAT3 protein increased (P < 0. 05) . After the overexpression of miR-98-5p, the myocardial cells arranged more orderly and the myocardial cell necrosis decreased. The apoptosis rate of myocardial tissue, the contents of CK, CK-MB and LDH in serum and the expression of p-JAK2 and p-STAT3 protein were decreased (P< 0. 05) . The result of dual luciferase assay showed that KLF9 was the target gene of miR-98-5p. The overexpression of KLF9 reversed the effects of miR-98-5p agomir on myocardial injury. Conclusion MiR-98-5p targeting KLF9 can improve the myocardial injury of MI/R rats. The mechanism may be related to the regulation of JAK2/STAT3 signal pathway by miR-98-5p which inhibit myocardial cell apoptosis.

Effectiveness of a sex education curriculum in seventh graders / 中国学校卫生

Objective@#To assess the effectiveness of sexual education intervention among seventh grade students, and to provide support tools for sex education for middle school students.@*Methods@#Seventh grade students from six schools in Longnan, Gansu Province were randomly assigned to an intervention group (251 students) and a control group (222 students). After 8 weeks of school based sex education in the intervention group, the results were compared before and after the intervention using self assessment knowledge and attitude scales.@*Results@#The knowledge score in the control group decreased by (2.46±1.21) in the follow up survey compared to the baseline survey. The intervention group scored (30.54±1.34) significantly higher than baseline ( t =22.76, P <0.01). After adjusting the sex ratio to 1∶1, the mean difference between the two groups after the intervention was (27.86±1.87) ( t =14.90, P <0.01). The interaction dit between time and intervention was (33.01±2.50) ( t =13.19, P <0.01) in difference analysis. The intervention effect size Hedge s g on knowledge in the intervention group was 1.27. The proportion of positive attitudes towards sex increased in the intervention group on 12 out of 14 questions, with percentage ranging from 7.5% to 25.9%. At the follow up, the improvement in attitudes towards 12 questions was substantial for girls and 8 questions for boys in the intervention group. The attitude effect size Hedge s g was 0.99 in the intervention group.@*Conclusion@#The implementation of school based sex education is capable of significant improving students sexual knowledge and attitude in the short term.

Progress in the pathogenesis of congenital bicuspid aortic valves and the associated complications / 国际儿科学杂志

Congenital bicuspid aortic valves(BAV)is one of the most common congenital heart diseases.It is generally diagnosed by echocardiography when deterioration of the abnormal leaflets becomes clinically evident.Patients with BAV are at increased risks of developing serious complications, including aortic stenosis, aortic regurgitation, aortic dilation, aortic dissection and/or aneurysm, which seriously threatens the health of patients.Although its diagnosis and surgical treatment have been clear, the specific pathogenesis has not been completely revealed.Recently, studies have found that gene mutations and related signaling pathway abnormalities are associated with BAV and its complications.And epigenetics and environmental factors are involved in the development and progress of BAV.Understanding the underlying cellular and molecular basis of normal and pathological aortic valve development may improve the preventative and therapeutic approaches to valve degeneration.

Progress in epigenetics of congenital heart disease / 国际儿科学杂志

Congenital heart disease(CHD)is one of the most common congenital defects that caused by fetal cardiovascular dysplasia.The global incidence rate is about 9/1 000 and is still rising.Previous reports have shown that congenital heart disease(CHD)incidence can be influenced by genetic etiology and environmental risk factors.And the gene-environmental interaction can affect the development and differentiation of myocardium through epigenetic regulation by means of DNA methylation, histone and RNA modification, etc.In this paper, we review the epigenetics of congenital heart disease to discuss the current progress and point out future direction of the etiology of congenital heart disease.

Effect of moxibustion on postpartum urodynamics and pelvic floor function in puerperal women / 中国针灸

OBJECTIVE@#To observe the effect of moxibustion on postpartum urodynamics and recovery of pelvic floor function based on the pelvic floor muscle function training.@*METHODS@#A total of 150 puerperal women were randomly divided into an observation group (75 cases, 15 cases dropped off) and a control group (75 cases, 15 cases dropped off). The control group was treated with pelvic floor muscle function training, twice a day. Based on the treatment in the control group, the observation group was treated with @*RESULTS@#Compared before treatment, the levels of FUL, MUCP, BC, Pdet Qmax and SLPP in the observation group after treatment were increased (@*CONCLUSION@#The moxibustion combined with pelvic floor muscle function training could improve postpartum urodynamics and pelvic floor muscle strength.

Xinglou Chengqi Decoction improves neurological function in experimental stroke mice as evidenced by gut microbiota analysis and network pharmacology / 中国天然药物

The current study was designed to explore the brain protection mechanism of Xinglou Chengqi Decoction (XCD) based on gut microbiota analysis and network pharmacology. A transient middle cerebral artery occlusion (MCAO) model of mice was established, followed by behavioral evaluation, TTC and TUNEL staining. Additionally, to investigate the effects of gut microbiota on neurological function after stroke, C57BL/6 mice were treated with anti-biotic cocktails 14 days prior to ischemic stroke (IS) to deplete the gut microbiota. High-throughput 16S rDNA gene sequencing, metabonomics technique, and flow multifactor technology were used to analyze bacterial communities, SCFAs and inflammatory cytokines respectively. Finally, as a supplement, network pharmacology and molecular docking were applied to fully explore the multicomponent-multitarget-multichannel mechanism of XCD in treating IS, implicated in ADME screening, target identification, network analysis, functional annotation, and pathway enrichment analysis. We found that XCD effectively improved neurological function, relieved cerebral infarction and decreased the neuronal apoptosis. Moreover, XCD promoted the release of anti-inflammatory factor like IL-10, while down-regulating pro-inflammatory factors such as TNF-α, IL-17A, and IL-22. Furthermore, XCD significantly increased the levels of short chain fatty acids (SCFAs), especially butyric acid. The mechanism might be related to the regulation of SCFAs-producing bacteria like Verrucomicrobia and Akkermansia, and bacteria that regulate inflammation like Paraprevotella, Roseburia, Streptophyta and Enterococcu. Finally, in the network pharmacological analysis, 51 active compounds in XCD and 44 intersection targets of IS and XCD were selected. As a validation, components in XCD docked well with key targets. It was obviously that biological processes were mainly involved in the regulation of apoptotic process, inflammatory response, response to fatty acid, and regulation of establishment of endothelial barrier in GO enrichment. XCD can improve neurological function in experimental stroke mice, partly due to the regulation of gut microbiota. Besises, XCD has the characteristic of "multi-component, multi-target and multi-channel" in the treatment of IS revealed by network pharmacology and molecular docking.

Survey of clinicians' needs of support for conducting clinical research / 中华医学科研管理杂志

Objective To explore and understand limitations and needs of support for conducting clinical research among clinicians in China.Methods The in-service clinician in our hospital were enrolled in as survey participants,survey questionnaires were designed and filled up by target audience in the questionnaire star platform.Results Main problems identified as restrictions for conducting clinical studies including lack of data platform,have ideas but not protocols,lack of research funding and project management.On the other hand,identified needs for support including research-related technical support,project management facilitation,training,external communication and exchange,as well as quality risk management.Conclusions Hospital should establish Clinical Research Unit to help clinicians to improve research quality by training,providing technical support and administrative service of clinical research.

Preliminary exploration and practice of clinical research assessment system based on a tertiary hospital / 中华医学科研管理杂志

Objective:To construct assessment and evaluation system of clinical research and its application in practice. To explore the reliability, validity and discrimination of this index system, and evaluate its effect.Methods:The cluster was randomly sampled from 54 clinical departments. Taking the department as units, all individuals in each department was conducted a questionnaire survey for empirical analysis. Cronbach's coefficient and factor analysis were used to verify the reliability and validity of the index system. The correlation coefficient method was used to analyze the discrimination. The t-test method was used to calculate the discrimination. Extreme grouping method was used to compare the difference between high grouping and low grouping to validate the difference of each index.Results:Cronbach′s α of the whole index system is 0.840. Through exploratory factor analysis, four common factors were extracted, and the cumulative contribution rate is 56.278%. Through correlation coefficient method and t-test method, results show that except for the " concluding situation" , " number of visitors to clinical scientists workstation" and " personnel selected into talent category clinical research program" , the differences of other indicators were statistically significant ( P<0.05), and the distinguish index was between 0.31 and 0.64. Conclusions:The clinical research assessment system has good reliability and validity. And the discrimination is good. The index system can accurately assess the clinical research situation. It can be used for reference in assessment of clinical efficiency.

Mechanism of Therapeutic Methods for Activating Blood and Removing Blood Stasis in Treatment of Cerebral Hemorrhage / 中国实验方剂学杂志

Intracerebral hemorrhage (ICH) refers to the primary non-traumatic parenchymal hemorrhage, which is one of the common cerebrovascular diseases, with a high incidence, rapid development, slow recovery and high disabling rate. After intracerebral hemorrhage, a series of pathological changes occur in the brain tissue, such as local hematoma and its space occupying effect, secondary cerebral edema, death of brain cells and destruction of blood-brain barrier, which may lead to brain injury and neurological defects, seriously affect the quality of life of patients, and even endanger the life. Therefore, it is great medical value to find effective therapeutic methods and drugs, explore the mechanisms and targets for improving neurological function, reduce sequelae and improve the quality of life of patients. According to the theory of traditional Chinese medicine (TCM), cerebral hemorrhage belongs to " abnormal flow of the blood" , which equals to blood stasis. In recent years, scholars conducted extensive research on drugs for promoting blood circulation to remove blood stasis with modern scientific methods, and made in-depth discussion for the mechanism, and found that therapies for activating blood and removing blood stasis, plays a key role in intervening a series of physiological and pathological changes after cerebral hemorrhage, with significant curative effects in removing hematoma, improving the microcirculation and reducing the mortality and morbidity. This article summarized drugs for promoting blood circulation to remove blood stasis (Notoginseng Radix et Rhizoma, Salviae Miltiorrhizae Radix et Rhizoma, Hirudo), formulas (Buyang Huanwu Tang, Didangtang, Naoxueshu oral liquid, Tongqiao Huoxuetang) and compound injections (Danhong injection) for the treatment of cerebral hemorrhage targets, and discussed the experimental research progress TCM for promoting blood circulation to remove blood stasis in treatment of cerebral hemorrhage in terms of promoting hematoma absorption, reducing brain edema and apoptosis, promoting angiogenesis, inhibiting the inflammatory response, and promoting the repair and regeneration of nerve tissue in nearly five years, and summarized the therapeutic mechanism, so as to provide scientific basis for clinical application of the therapeutic methods for activating blood and removing stasis to treat cerebral hemorrhage and the modern scientific research.

Intervening Effect of Promoting Lung and Resolving Phlegm Method on Mouse Model Combining Disease and Syndrome of Human Coronavirus Pneumonia with Cold-dampness Pestilence Attacking Lung / 中国实验方剂学杂志

Objective:To observe the therapeutic effect of Kesuting syrups and Keqing capsules, which have the function of promoting lung and resolving phlegm, on a mouse model combining disease and syndrome of human coronavirus pneumonia with cold-dampness pestilence attacking lung. Method:The therapeutic effects of Kesuting syrups (the doses of 22, 11 mL·kg-1) and Keqing capsules (the doses of 1.155, 0.577 5 g·kg-1) on this model were evaluated by the inflammatory changes of lung tissue, the expression of viral nucleic acid, the contents of inflammatory factors [interleukin (IL)-6, IL-10, tumor necrosis factor (TNF)-α and interferon-γ (IFN-γ)], and the percentages of immune cells in peripheral blood (CD4+ T cells, CD8+ T cells and B cells). Result:Compared with the model group, high- and low-dose groups of Keqing capsules and Kesuting syrups could significantly reduce the inflammatory damage in the lung tissues of mice, Keqing capsules could significantly increase the percentages of CD4+ T cells, CD8+ T cells and B cells in peripheral blood, Keqing capsules and Kesuting syrups could reduce the expression levels of IL-6, IL-10, TNF-α and IFN-γ, inhibit the viral load in lung tissue, as well as improve the pathogenic manifestations of lung tissue. Conclusion:As the first-line drugs for novel coronavirus pneumonia, Keqing capsules and Kesuting syrups have significant therapeutic effect on the mouse model combining disease and syndrome of human coronavirus pneumonia with cold-dampness pestilence attacking lung, and the mechanism may be related to regulating immune function and reducing cytokine storm.

Efficacy of transcatheter pulmonary valve perforation by micro-guidewire and balloon dilation in neonates with pulmonary atresia with intact ventricular septum / 中华儿科杂志

Objective@#To investigate the safety and efficacy of transcatheter perforation of pulmonary valve by micro-guidewire and balloon dilation in the treatment of neonatal pulmonary atresia with intact ventricular septum (PA-IVS).@*Methods@#The retrospective study included 21 neonates (14 males and 7 females) with PA-IVS who underwent transcatheter micro-guidewire pulmonary valve perforation and balloon dilation in Xinhua Hospital from January 2012 to December 2018. All patients underwent the pulmonary valve perforation by micro-guidewire through the Simmons catheter. During the follow-up period at 1, 3, 6, 12 months postoperatively and annually thereafter, the operative efficacy and the development of the right ventricle (RV) were evaluated by echocardiography. Statistical analyses were performed using t test.@*Results@#A total of 21 neonates with PA-IVS were enrolled, and 13 cases were diagnosed prenatally. The median age of surgery was 6 days, the weight was (3.2±0.5) kg. The balloon/valve ratio was 1.19±0.12, and the RV pressure measured by catheter was (121±33) mmHg (1 mmHg=0.133 kPa) . The immediate postoperative RV pressure was (47±13) mmHg. The median follow-up time was 30 months. All the cases enrolled achieved biventricular circulation without death and serious complications. According to the last follow-up data including 16 cases who were followed up for 1 year or longer, the pulmonary artery transvalvular pressure was (29±15) mmHg. The postoperation ratio of right to left ventricular transverse diameter was significantly higher than that before operation (0.86+0.10 vs. 0.73+0.13, t=-2.96, P=0.006). Compared with preoperative data, the postoperation pulmonary valvular diameter Z-score was significantly higher (-1.41±0.89 vs. -2.83±1.06, t=-3.65, P=0.001) and the tricuspid valvular diameter Z-score was significantly higher (-0.52±0.29 vs. -1.34±0.81, t=-3.55, P=0.001).@*Conclusion@#Transcatheter perforation of pulmonary valve by micro-guidewire and balloon dilation is a safe and effective initial therapy for neonatal PA-IVS.