Preliminary study on the collaborative development of drug clinical trial institutions and Contract Research Organizations from the perspective of "government-application-industry-academia-research" / 中华医学科研管理杂志

Objective:To explore the collaborative development of drug clinical trial institutions and Contract Research Organizations from the perspective of " government-application-industry-academia-research" , and facilitate faster and better conducting of clinical trials.Methods:Based the combination of literature review and the working practice in drug clinical trial management, problems existed during the implementation of clinical trials were summarized, and then the collaborative development of drug clinical trial institutions and Contract Research Organizations were discussed from the perspective of " government-application-industry-academia-research" partnership.Results:Problems identified during the implementation of clinical trials including uneven capacity of CROs, lack of effective supervision department and insufficient cooperation with clinical trial institutions, which resulted difficulties in sharing clinical trial resources and also negatively impacted the quality of clinical trials. Some proposals were offered in this article, including making good use of the " visible hand" of the government to strengthen the supervision of CROs, accelerating the construction of innovation alliance between clinical trial institutions and CROs, establishing the incentive mechanism of collaborative development and the talent team construction, strengthening the personnel professional training.Conclusions:The application of " government-application-industry-academia-research" model in clinical trials would promote the collaboration between drug clinical trial institutions and Contract Research Organizations, which play important roles in the development of clinical trials.

Surgical treatment of Stanford A intramural hematoma / 中华胸心血管外科杂志

Objective To summarize experience and result in surgical treatment of Stanford type A intramural hematoma.Methods 60 patients with Stanford type A intramural hematoma were operated from February 2015 to August 2017.Surgery was indicated in complicated cases with penetrating ulcer or ulcer-like projection in ascending aorta,maximum aorta diameter≥50 mm,progressive maximum aortic wall thickness≥i0 mm,pericardial or pleural effusion,persistent or recurrent pain.Aortic valve regurgitation.In our group,46 patients recieved ascending aorta replacement + Sun's procedure.6 patients recieved Bentall + Sun's procedure.4 patients recieved asceding aorta + hemiarch replacement.2 patients recieved Bentall + hemiarch replacement.2 patients recieved asceding aorta replacement.Results In the whole group,there was 1 (1.7％) operative death because of multiple organ failure after operation.Hyoxemiaoccured in 5(8.3％) patients,2(3.3％) patients occurred new renal failure and required CRRT treatment,cerebrovascular complication occurred in 1 (1.7％)patient,re-sternotomy due to bleeeding occured in 1 (1.7％) patient and paraplegia occured in 1 (1.7％) patient after operation.but they recoved quickly after proper treatment.During follow up period,there were 4 cases need reintervention,including TEVAR for type B dissection at 3 months and distal stent-graft new entry at 1 year.Two other reinterventions were performed for endoleak by interventional occlusion.During the follow-up,hematoma absorption rates after treatment 1、3 and 6 months were 68.6％,84.7％ and 94.8％.Conclusion Given the dynamic evolution of acute type A IMH pre-operative accurate indications and the proper surgical strategy maybe the keys for success.

Surgical treatment of Stanford A intramural hematoma / 中华胸心血管外科杂志

Objective@#To summarize experience and result in surgical treatment of Stanford type A intramural hematoma.@*Methods@#60 patients with Stanford type A intramural hematoma were operated from February 2015 to August 2017. Surgery was indicated in complicated cases with penetrating ulcer or ulcer-like projection in ascending aorta, maximum aorta diameter≥50 mm, progressive maximum aortic wall thickness≥10 mm, pericardial or pleural effusion, persistent or recurrent pain. Aortic valve regurgitation. In our group, 46 patients recieved ascending aorta replacement+ Sun' s procedure. 6 patients recieved Bentall+ Sun' s procedure. 4 patients recieved asceding aorta+ hemiarch replacement. 2 patients recieved Bentall+ hemiarch replacement. 2 patients recieved asceding aorta replacement.@*Results@#In the whole group, there was 1(1.7%)operative death because of multiple organ failure after operation. Hyoxemiaoccured in 5(8.3%) patients, 2(3.3%) patients occurred new renal failure and required CRRT treatment, cerebrovascular complication occurred in 1 (1.7%)patient, re-sternotomy due to bleeeding occured in 1 (1.7%)patient and paraplegia occured in 1(1.7%) patient after operation. but they recoved quickly after proper treatment. During follow up period, there were 4 cases need reintervention, including TEVAR for type B dissection at 3 months and distal stent-graft new entry at 1 year. Two other reinterventions were performed for endoleak by interventional occlusion. During the follow-up, hematoma absorption rates after treatment 1、3 and 6 months were 68.6%, 84.7% and 94.8%.@*Conclusion@#Given the dynamic evolution of acute type A IMH pre-operative accurate indications and the proper surgical strategy maybe the keys for success.

Correlation between radial artery graft patency and the degree of native coronary stenosis in coronary artery bypass grafting / 中国医师进修杂志

Objective To study the correlation between radial artery graft patency and the degree of native coronary stenosis in coronary artery bypass grafting. Methods The clinical data of 290 patients who had underwent off-pump coronary artery bypass grafting were retrospectively analyzed. The left internal mammary artery, radial artery and saphenous veins were as grafts. The patients were divided into 3 groups according to the stenosis of right coronary artery before operation:group Ⅰ(right coronary artery stenosis 50%-75%, 85 cases), groupⅡ(right coronary artery stenosis 76%-89%, 95 cases) and group Ⅲ (right coronary artery stenosis 90%-100%, 110 cases). The patients were followed up for 2 to 5 years, and the graft patency was assessed using CT coronary angiography. Results There was no death and serious complications in 3 groups. Among the 3 groups, the total graft patency rate of left internal mammary artery grafts was 93.3% (270/290), the total graft patency rate of saphenous veins grafts was 70.2%(433/617), and the total graft patency rate of radial artery grafts was 69.7%(202/290). There was no statistical difference in the graft patency rate of radial artery grafts between group Ⅱ and group Ⅰ(P>0.05). The graft patency rate of radial artery grafts in group Ⅲwas significantly higher than that in groupⅡand group Ⅰ:85.5%(94/110) vs. 68.4%(65/95) and 50.6%(43/85), and there was statistical difference (P0.05). Conclusions The correlation between radial artery graft patency and the degree of native coronary stenosis is significant in coronary artery bypass grafting. Patients with severe proximal right coronary artery stenosis (≥90%) may have better patency rates at mid-term follow up after using radial artery grafts.

A case of retroperitoneal Castleman's disease with paraneoplastic pemphigus / 中南大学学报(医学版)

Paraneoplastic pemphigus is a rare autoimmune bullous dermatosis, which is caused by potential neoplasm, especially the Castleman's disease. Castleman's disease associated with paraneoplastic pemphigus is misdiagnosed frequently and easily in clinical practices. Furthermore, it is reported that the mortality rate for this disease is very high. Bronchiolitis obliterans is the most common complication and the most important cause of death. There was a female patient presenting recalcitrant mucocutaneous erosions, ulcers and scattered erythemas in the body. The patient was diagnosed and treated for pemphigus vulgaris with little success in Xiangya Hospital, Central South University in January 2015. Further investigations confirmed the diagnosis of paraneoplastic pemphigus with retroperitoneal tumor. Subsequently, the patient was treated with tumor resection in combination with intravenous immunoglobulin and corticosteroids. The pathology revealed that it was the Castleman's disease. Her mucocutaneous performance recovered obviously and the bronchiolitis obliteran did not appear in the follow-up. Castleman's disease associated with paraneoplastic pemphigus should be considered when mucosal and skin lesions showing no improvement under corticosteroids. Early and complete removal of the tumor together with immunotherapy could be beneficial to the patient's prognosis.

Reasons and treatment methods of high transprothetic pressure gradient after aortic valve replacement / 中国医师进修杂志

Objective To analyze the reasons and treatment methods of high transprothetic pressure gradient after aortic valve replacement. Methods The clinical data of 45 patients with high transprothetic pressure gradient after aortic valve replacement were retrospectively analyzed. The patients were followed up for average 24.6 (12 - 40) months. The postoperative effective orifice area (EOA) of artificial valve was measured by transthoracic color Doppler ultrasound. Compared with published referred EOA of different artificial valve, there were 2 kinds results:measured EOA=referred EOA and measured EOA0.85 cm2/m2 and EOAI<0.85 cm2/m2. The reasons of high transprothetic pressure gradient were analyzed according to the above different standard. Results In the 45 patients with high transprothetic pressure gradient after aortic valve replacement, prosthesis-patient mismatch (PPM) was in 33 cases, and prosthetic dysfunction was in 10 cases, among whom 5 cases were because of thrombus (3 cases improved after increasing the dosage of warfarin, 2 cases underwent re-aortic valve replacement), 3 cases were because of severe bioprosthetic calcification (underwent re-aortic valve replacement), and 2 cases were because of prosthetic ring pannus and influenced movement of the leaflets (underwent re-aortic valve replacement). High flow in the left ventricular outflow tract occurred in 2 cases. The patients had no obvious discomfort, and did not receive special treatment. Four cases died, among whom 2 cases were because of severe PPM, and the other 2 cases were because of noncardiac. Conclusions Many reasons can result to the high transprothetic pressure gradient, and the PMM is the most common reason. Choosing the right treatment plan can improve the survival rate of patients.

Surgical management of primary small cell carcinoma of the esophagus / 中国肿瘤临床

Objective:To retrospectively analyze the survival outcomes of the surgical management of primary small cell carcino-ma of the esophagus. Methods:The medical records were reviewed for patients diagnosed with esophageal carcinoma and underwent esophagectomy from January 2000 to December 2009 at the Department of Thoracic Surgery of the Henan Cancer Hospital. We fo-cused on the clinical data of patients with small cell carcinoma of the esophagus. The Kaplan-Meier approach with log-rank test was used for survival analysis. Results:A total of 5,062 patients underwent esophagectomy with curative intent at the Department of Thorac-ic Surgery of the Henan Cancer Hospital;among which, 57 (1.1%) were diagnosed with small cell carcinoma of esophagus. The most common surgical approach was trans-left thoracic incision esophagectomy. Cervical esophagogastrostomy was performed for all pa-tients. The most common chemotherapy regimen was EP. The overall 5-year survival rate was 12.5%, and the median survival time was 45 months. Among the various stages, the 5-year survival rate and survival time were 25% and 50 months for Stage I, 5.9% and 43 months for Stage II, and 4.3%and 43 months for StageⅢ. Subgroup analysis showed that cases treated with surgery alone had poorer overall median survival time compared with those cases that underwent surgery plus chemotherapy (23.2 months vs. 60.7 months, re-spectively;P<0.01). Even for Stage I patients, thesurgery plus chemotherapysubgroup was associated with a significantly longer me-dian survival time than the surgery alone subgroup (81.9 months vs. 22.3 months, P<0.01). Conclusion:For patients with primary small cell carcinoma of the esophagus, surgery alone cannot provide the optimal prognosis. Surgery combined with systemic chemother-apy can improve the survival time.

Methodology of BMSCs in repairing ureteral injury in mice via renal artery transplantation / 中南大学学报(医学版)

OBJECTIVE@#To investigate the effect of bone marrow mesenchymal stem cells (BMSCs) on ureteral injury repair via renal artery transplantation.@*METHODS@#The left ureteral obstruction model was set up in 49 Balb/c mice by micro vascular clamp. The microscopic vascular clamp was taken out to lift the left ureteral obstruction after 10 days. The mice were randomly divided into an experimental group (n=25) and a control group (n=24). Balb/c mice BMSCs transfected by luciferase (Luc) were transplanted immediately through the renal artery after removing the microscopic vascular clamp from the experimental group; while mice in the control group was closed the incision after the microscopic vascular clamp was removed immediately and without BMSCs transplant. Magnetic resonance imaging (MRI) was used to scan the experimental mice. By measuring the left renal pelvis volume of the experimental mice at different time points and comparing the left ureter recanalization rate after removing left ureteral obstruction of the experimental group and the control group, we evaluated the repair effect of BMSCs on ureteral injury.@*RESULTS@#The volume of the left renal pelvis in experimental mice became bigger obviously after the left ureter was obstructed (P<0.01). The left renal pelvis volume of the experimental group and the control group had no statistical significance 10 days after the left ureteral obstruction was set up (P=0.693). In the experimental group, the left ureter recanalization rate was higher than that in the control group, after removing the left ureteral obstruction (P=0.012).@*CONCLUSION@#Transplantation through the renal artery can promote the restoration of ureteral injury in mice.

Identification techniques of the recurrent laryngeal nerve in endoscopic thyroidectomy / 中南大学学报(医学版)

OBJECTIVE@#To investigate the application of identification techniques of the recurrent laryngeal nerve (RLN) in endothyroidectomies.@*METHODS@#Routine identification of the RLN was performed in a series of 20 consecutive endothyroidectomies, and the clinical data were reviewed.@*RESULTS@#Totally 20 RLNs were dissected. Neither transient nor permanent RLN injury occurred.@*CONCLUSION@#To expose RLN, both sharp and blunt dissection should be applied skillfully. Thorough liberation of the thyroid lobe is essential for the identification of RLN. It is safe and feasible to remove the thyroid and identify the RLN simultaneously.

Construction and characterization of RNAi lentiviral vector targeting rat CD80 gene / 中国免疫学杂志

Objective:To construct a RNAi lentiviral vector targeting rat CD80 gene and detect its effect of gene silencing in NRK and IEC6 cells.Methods:The effective sequence of siRNA targeting rat CD80 gene was confirmed in our previous work.Oligo-DNA fragment containing short hairpin frame was synthesized and reannealed,and then cloned into pGCSIL-GFP lentiviral expression vector.PCR and sequencing analysis were made for verifying the positive clones.The virus packaging plasmids were transfected into 293T cells to harvest shRNA lentivirus.After infection in NRK and IEC6 cells,Real-time PCR was performed to determine the expressing level of CD80.Results:PCR and sequencing revealed that shRNA plasmids was correctly constructed.Virus with a titer of 4×10~8 TU/ml was successfully packaged.CD80 expression in NRK and IEC6 cells could be knockdown by virus infection as characterized by 66.9% and 63.5% decrease of CD80 mRNA in NRK and IEC6 cells respectively,compared with negative control lentivirus.Conclusion:The recombinant lentiviral shRNA expressing vector targeting rat CD80 gene has been successfully constructed and packaged.CD80 mRNA could be down-regulated availably in NRK and IEC6 cells.

Analysis of the causes and complications of reoperation for thyroid diseases / 中国普通外科杂志

Objective To study the causes of thyroid reoperation and the prevention of operative (complications). Methods The clinical data of 96 cases who underwent reoperation of thyroid were (retrospctively) analysed. Results There were 31 cases of thyroid carcinoma(14.0%, P0.05). Conclusions Thyroid (reoperation) is more difficult than primary operation, and has a higher post-operative complications rate. (Thyroid) reoperation should be avoided or decreased, so the operator should do the best at the time of the (primary) operation, and timely reoperation should be performed when necessary. Thyroid reoperation should be performed carefully to decrease complications as much as possible.

Surgical comprehensive treatment of primary liver cancer :a report of 108 cases / 中国普通外科杂志

Objective To explore the effect of surgical comprehensive treatment(SCT) in treating primary liver cancer(PLC).Methods The clinical data of 108 patients with PLC undergoing SCT in XiangYa Hospital from January 1999 to September 2002 were reviewed retrospectively. The SCT including surgical resection ,radiofrequency ablation(RFA),transcatheter hepatic chemo-embolization(TACE),percutaneous ethanol injection(PEI),TACE via drug delivery system(DDS),cryosurgery,biological treatment,etc.Results The postoperative mortality was 0.9%, and the postoperative complications was 18.7%,intrahepatic recurrent rate and remote metastasis within 1 year after SCT were 56.1%,17.9%.The 1-,2-,3-year survival rate after SCT were 79.46%,61.83%,36.61%,respectively.Conclusions Liver resection combined with other treatment methods can cut down the rate of intrahepatic recurrence and remote metastasis, and can improve the tumor-free survival rate and long-term survival.

Study of the characteristics of lymph node metastasis in lung cancer / 中华胸心血管外科杂志

Objective: To investigate the frequency , distribution and features of lymph node metastasis in lung cancer, and to provide evidence for lymph node dissection. Methods: 348 patients with lung cancer were retrospectively studied, all patients received R_3 surgery plus systemic lymph node dissection according to the mapping system developed by Naruke. Results: Total 3 689 groups of lymph nodes were dissected . The metastatic rates of N_1 and N_2 were 23.4% and 16.5%, respectively. N_1 or N_2 metastasis was not found in Tis tumor. There was a significant difference of N_2 metastasis rates between squamous cell carcinoma and adenocarcinoma in T_1 or T_2 tumor (P

Diagnosis and treatment of Hashimoto's disease: a report of 51 cases / 中国普通外科杂志

Objective To investigate the diagnosis and treatment of Hashimoto's disease. Method The clinical data of 51cases of Hashimoto's disease admitted to our department from 1986 to 2001 were collected and analyzed. Result The preoperative misdiagnosis rate is 78.4%. 37 of 51 cases undergone surgical treatment and the results were satisfied. Follow up data, which were collected from 30 patients, showed that 6 patients(16.2%) developed hypothyroidism . Conclusion The examination of antithyroglobulin (TGA) and antimicrosomal (TMA) and the frozen section examination during operation are helpful to the diagnosis. Appropriate operation is a safe and effective treatment for patients with Hashimoto's disease who have received effectiveless thyroxine treatment.