1.Interleukin 17 decrease the polarization of macrophage and attenuate the pathology of obliterative bronchiolitis after trachea transplant modulated
Jiangang WANG ; Xiaohui ZHOU ; Yinkai NI ; Qian SHI ; Hao CAO ; Huimin FAN
Chinese Journal of Thoracic and Cardiovascular Surgery 2012;(12):732-734
Objective To investigate the role of interleukin 17 in the differentiation of macrophages from monocyte in vivo and its applicability in Obliterative bronchiolitis (OB).Methods Pathogen-free male C57BL/6 (n =20),IL-17-defcient C57BL/6 (n =10) and BALB/c (n =10) weighing 20-25 g.Weight-matched mice were assigned to three experimental groups.Experimental group A:BALB/c (n =5) →C57 BL/6 (n =10).Experimental group B:BALB/c (n =5) →IL-17-defcient C57BL/6(n =10).Normal control group:C57BL/6(n =10).The CD80 expression in macrophages in spleens were analysed by flowcytometry 7 days after operation.Native and transplanted lungs were harvested after 14 days and 28 days,stained with HE,and examined under light microscopy.Results Compared to experimental group A,CD80 expression of macrophages reveales a significant decrease in spleen of experimental group B.Furthermore,airway obliteration and destruction of the epithelium in experimental group A were significantly better compared with that of experimental group B on day 14 and 28 after transplantation.Conclusion IL-17 deficiency decreased the polarization of monocytes to macrophages and attenuate the pathology of obliteral bronchiolitis in murine model after trachea transplantaion.
2.Thinking and practice of risk-based monitoring strategies in Investigator initiated Trials
Baoshi YUAN ; Yinkai WANG ; Ruyue NI ; Wei LV ; Xia MENG
Chinese Journal of Medical Science Research Management 2023;36(3):182-188
Objective:To discuss the scientificity and feasibility of risk-based monitoring strategies in Investigator initiated Trials.Methods:" Guideline for Good Clinical Practice" promulgated by NMPA, " Oversight of Clinical Investigations-a Risk-based Approach to Monitoring" and " A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry DRAFT GUIDANCE" promulgated by the US FDA and other documents were analyzed, the practical experience of Investigator initiated Trials was also summarized.Results:It was recommended that clinical investigators use risk-based monitoring strategies in Investigator initiated Trials. The main idea of risk-based monitoring is to determine the key process and key data of the study, carry out risk rating on the project, and adopt corresponding monitoring methods according to the risk level when formulating the monitoring plan. At the same time, during the clinical trial development process, the risk and data quality of the research center should be regularly evaluated to grasp the risk changes of different centers. In accordance with trends, adjust the method, content and frequency of monitoring.Conclusions:To apply risk-based monitoring strategies in Investigator initiated Trials is scientificity and feasibility. Risk based monitoring can meet the data quality requirements of clinical trials, without affecting the analysis results of the main outcomes, and can further improve the efficiency and effectiveness of monitoring.
3.Risk factors associated with surgical treatment of infective endocarditis
CHEN Zonghui ; LI Feng ; ZHAO Jinlong ; FU Liang ; NI Yinkai ; LU Zhexin
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2019;26(6):558-564
Objective To analyze the risk factors of the death associated with infective endocarditis, and to evaluate the timing of surgical treatment of infective endocarditis. Methods We retrospectively analyzed the clinical data of 62 patients with infective endocarditis in our hospital between August 2015 and August 2017. There were 43 males and 19 females at age of 19–75 (46.1±16.6) years. The clinical data were divided into a death group and a survival group, a paravalvular leakage group and a no periannular leakage group, an emergency operation group and a non-emergency operation group.The risk factors of infective endocarditis and the choice of operation time were analyzed. Results Three of the 62 patients (4.8%) died after surgery. Postoperative perivalvular leakage (regurgitation over 2 mm) in 8 patients, accounting for 12.9% of the total. Univariate analysis showed that albumin content, creatinine level, total cardiopulmonary bypass time and ascending aorta occlusion time were significantly associated with early postoperative mortality (P<0.05). The results of logistic analysis showed that age, preoperative albumin level, creatinine level, total cardiopulmonary bypass time, and ascending aorta occlusion time were significantly associated with early postoperative perivascular leakage (P<0.05), and long ascending aorta occlusion time is an independent risk factor for early death (P<0.05). There was no statistical difference in early death and the perivalve leakage between the emergency operation and the non emergency operation. Conclusion Patients with infective endocarditis should accept early surgical treatment. The choice of surgical approach should be selected according to the actual situation of patients. And we should pay more attention to albumin and creatinine levels in preoperative patients. In the operation, to shorten extracorporeal circulation time and aortic clamping time can improve the prognosis of patients.