Objective To observe the effects of soybean isoflavone in attenuating trans fatty acids-induced athero-sclerosis in rats .Methods The rats were randomly divided into normal diet group、trans fatty acids group、soybean isoflavone group and trans fatty acids +soybean isoflavone group .Research kit was used to test the amounts of TG , HDL,LDL and IL-6,TNF-αin rats'blood.Bovine aortic endothelial cells were cultured and divided into control group,trans fatty acids group and trans fatty acids group +soybean isoflavone group .Western blot was performed to test the NF-κB phosphorylation ,as well as to determine ICAM-1 and VCAM-1 protein contents in bovine aortic endo-thelial cells.Results Compared with normal diet group ,the amounts of TG,LDL,IL-6,TNF-αincreased evidently (P<0.05), whereas the amounts of HDL decreased evidently (P<0.05) in the rats'blood of trans fatty acids group . After the soybean isoflavone intervened ,the amounts of TG,LDL,IL-6,TNF-αall decreased (P<0.01), meanwhile the amounts of HDL increased significantly (P<0.01).Soybean isoflavone inhibited NF-κB phosphorylation induced by trans fatty acids ( P<0.01) .The high expression of ICAM-1 and VCAM-1 induced by trans fatty acids was de-creased by soybean isoflavone when comparing with those in the control group ( P<0.01 ) .Conclusions Soybean isoflavone has a role in attenuating trans fatty acids trans fatty acids-induced atherosclerosis in rats .

[Objective]To study the dental status,the development of jaw and the size of sella turcica of children with ectoder-mal dysplasia(ED).[Methods]Panaramic radiography and lateral cephalograms of six ED individuals(age range of 6~7 years,five males and one female)were obtained. The dental status was record. 17 measurements about the jaws and the sella turcica were mea-sured and compare them to Chinese children without ED syndrome.[Results]The mean number of missing teeth was 22.3 in perma-nent dentition and 16.2 in primary dentition;The teeth that most likely to absent were permanent lateral incisor ,maxillary first premo-lar,maxillary primary lateral incisor and mandibular primary central incisor,and all remaining teeth are in conical shape. Lateral cephalometric measurements showed that all ED subjects had lower ANS-Ptm,which suggested a short maxilla. Low Co-Po,ANB, NA-PA,N-Me,N-ANS and ANS-Me values that were found in all subjects,as well as low SNA,Y-axis,MP-FH,S-Co,and high SNB,NP-FH,NP-FH that were noted in some subjects showed counterclockwise rotation and protrusion of mandible with short-er length in ED subjects. Some subjects had low ANS-Me/N-Me × 100%and high N-ANS/N-Me × 100%,representing a short facial height. Five cases represented lower length and diameter of sella turcica;two cases showed lower depth of sella turcica ,indicating the abnormal development of sella turcica.[Conclusion]The results of this study suggest that the dentition ,jaws and sella turcica in ED children differs when compared to individuals without this syndrome.

Objective To compare the diagnostic yield of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for solid pancreatic masses performed with three different needle types through the cytological results.Methods All patients with solid pancreatic masses larger than 2cm from December 2010 to May 2011 were enrolled,and divided into two groups according to different access of EUS-FNA,trans-gastric approach with 19-,22-and 25-gauge needles (n =42) and trans-duodenal approach with 22-and 25-gauge needles (n =10).In both groups,EUS-FNA was performed with randomization of needle types.During the puncture,the suction,the number of movements,and the depth of insertion were fixed.At the end of the puncture,a liquid-based cytological (LBC) preparation was used to fix the specimen.One cytopathologists was assigned to make the diagnosis and comparison.Results Technical success was 100％ and no procedure related complications occurred.No statistically significant differences were observed in different needles in terms of all cytological parameters between two groups (P ＞ 0.05).However,the 25-gauge needle showed a trend towards a higher sensitivity,specificity,positive predictive value,negative predictive value and accuracy.Conclusion There is no significant difference in yield of cytological results between different needle types,although 25-gauge needle shows a relative superiority.

Objective To investigate the feasibility and safety of surgical device closure of doubly committed sub-arterial ventricular septal defect via left sub-axillary.Methods A total of 45 patients diagnosed as doubly committed sub-arterial ventricular septal defect (dcVSD) with transthoracic echocardiography (TTE) and transesophageal echocardiography(TEE) were enrolled from June 2014 to August 2016 in Henan Children Heart Center,Henan Provincial People's Hospital.There were 39 males and 6 females,with the mean age of (2.2 ±2.1) years old(0.5-8.0 years),the body weight (13.8 ± 7.1) kg(7.0-34.1 kg),the defect size (4.5 ± 1.0) mm (3.0-8.0 mm).After general anesthesia,the patients were in supine and evaluated by TEE which indicated whether they were fit to closure.Then,they were turned to the right lateral position while this technique was determined.A vertical incision of 2-3 cm was made between the third and the fifth intercostal space and invasion in thoracic space via fourth intercostal space.Puncture was done at the anterior surface of right ventricular outlet tract to build a delivery tract.The occluder was released and the VSD was occluded under transesophageal echocardiography guidance.Results Forty-one patients had a successful surgical dcVSD closure with asymmetric occluders sized (6.0 ± 1.5) mm(4-10 mm).Among 4 failure cases,2 cases (4.4％) were switched to open-heart surgical repair,1 case (2.2％) due to device related aortic regurgitation,the rest 1 case (2.2％) experienced a dislocation of occluder into pulmonary artery and was converted to surgical repair after retrieve of occluder.Trivial residual shunt was detected in 2 cases (4.4％) postoperatively,a spontaneous closure was observed by 1 month follow-up and 3 months follow-ups,respectively.All the patients were discharged 5 to 8 days after the operation.With a follow-up of (10.4 ±5.0) months [3-24 months],there were no complications such as pericardial effusion,displacement of device,atrioventricular block or new valvular dysfunction.Conclusions Minimally invasive device closure of doubly committed sub-arterial ventricular septal defect via left sub-axillary is a feasible and safe treatment for closure of dcVSD.This technique has advantages of minor wound,less exudation,covert incision,however,long term follow-up is necessary.

Objective To investigate the risk factors and independent risk factors associated with papillary thyroid carcinoma(PTC)cervical lymph node metastasis,and to assess the predictive efficacy of independent risk factors on metastatic lymph nodes.Methods Clinical and ultrasonographic data of 279 patients with PTC were collected,and the patients were divided into two groups according to the presence of cervical lymph node metastasis based on postoperative pathology,and the relevant characteristics of the two groups were ana-lyzed to explore the risk factors and independent risk factors associated with cervical lymph node metastasis in PTC,and the predictive ef-ficacy of independent risk factors on cervical metastatic lymph nodes was compared by receiver operating characteristic(ROC)curves.Results Age,gender and the maximum diameter,border,shape,microcalcifications,and distance from the thyroid capsule of cancer nodes were risk factors for cervical lymph node metastasis in both groups(P＜0.05);male,maximum diameter of cancer nodes 10mm,microcalcifications,and distance from the thyroid capsule ≤2mm were independent risk factors for cervical lymph node metastasis in PTC(P＜0.05);the AUC of the combination of four independent risk factors was 0.785(95％CI:0.721-0.849,P＜0.05),with the highest efficacy in predicting cervical lymph node metastasis.Conclusion Male,maximum diameter of cancer nodes ≥10mm,mi-crocalcifications,and distance from the thyroid capsule ≤2mm were independent risk factors for cervical lymph node metastasis of PTC,and the combination of four independent risk factors could assist in assessing the risk of cervical lymph node metastasis of PTC and improve patient prognosis.

Objective To assess the clinic value of three - dimensional(3D)printing models in operation scheme of double outlet right ventricle(DORV). Methods From September 2015 to December 2016,the imaging data of 29 patients (13 males and 16 females)with DORV were acquired using Dual Source CT. And then the cardiac models were generated using 3D printing technology. The cardiac models were used in diagnosing the type of DORV and guiding the surgery scheme. The 3D printed models were compared with two - dimensional imaging in diagnosis and sur-gical scheme of DORV patients. Results Both the two - dimensional imaging and 3D printed models were effective in the diagnosis and typing of DORV. According to 3D printing models,28 cases were consistent with the real operations, and 1 case was inconsistent. According to the two - dimensional imaging data,20 cases of surgical strategies were con-sistent with the real operations and 9 cases were inconsistent. For patients with DORV with non - committed ventricular septal defect (NC - VSD),3D printing models were more accurate in the designing of surgical strategies. Conclusions 3D printing models can display 3D anatomical structures and it is helpful in the diagnosis and making preoperative planning for DORV especially for DORV with NC - VSD,which provides a new method for the assessment of DORV.

Objective To summarize the outcomes and the median follow －up finding of stage 1 surgical approaches of coarctation of aorta(CoA)combined with cardiac anomalies.Methods A retrospective study was per-formed for summarizing the operative and follow－up finding of 82 patients(40 males and 42 females)of CoA combined with cardiac anomalies,who underwent stage 1 repair from February 2013 to December 2016 at the Department of Cardio-vascular Surgery,Henan Provincial People's Hospital.The operative age was ranged from 1 month to 8 years old[mean (11.92 ± 22. 51)months]and the weight was (7.31 ± 6.79)kg. Forty －five cases had ventricular septal defect (VSD)or atrial septal defect (ASD).Septal defect and patent ductus arteriosus were found in 31 patients.CoA was associated with aortic arch hypoplasia in 5 patients.Complex cardiovascular deformity was found in 7 cases.The surgical methods included end－to－end anastomosis,end－to－side anastomosis and patch augmentation of the coarctation seg-ment.Results Seven patients died after operation,3 cases of them died of low cardiac output syndrome amd circulatory failure,1 case died of circulatory failure and respiratory failure,1 patient died of malignant arrhythmia,and 2 cases died of respiratory failure.Postoperative echocardiogram suggested that anastomosis maintained patency in all the patients. The follow－up time was 8 months to 4 years,63 patients were followed up,and follow－up rate was 77%.No death or aneurysm occurred during follow－up period.Recoarctation was found in 5 cases.Conclusions Stage 1 repair for CoA combined with cardiac anomalies is effective,and has low complications during postoperative and median follow－up period.Long－term results need further study.

Objective:To analyze the short and mid-term efficacy of aortic valvuloplasty with autopericardium on children with aortic valve diseases.Methods:A total of 26 children with aortic valve diseases (stenosis or regurgitation) who underwent aortic valvuloplasty with autopericardium in Fuwai Central China Cardiovascular Hospital from September 2017 to June 2021 were retrospectively analyzed.The short-term and mid-term follow-up data were collected.The maximum aortic valve pressure gradient, subaortic regurgitation area, left ventricular end-diastolic volume (LVEDV) and left ventricular ejection fraction (LVEF) were compared before and after operation.Paired t test was used to analyze the short-term and mid-term efficacy of aortic valvuloplasty with autopericardium on children with aortic valve diseases. Results:All 26 cases were successfully operated, and there were no deaths and serious complications during the follow-up period of (22.96±6.45) months.There was a significant difference between the preoperative and postoperative maximum aortic valve pressure gradient at 1 month ( t=7.85, P<0.05), 6 months ( t=6.43, P<0.05), 1 year ( t=6.16, P<0.05) and 2 years postoperatively ( t=4.22, P<0.05) in children with aortic stenosis or that combined with mild-to-moderate closure.The follow-up data of 9 children with simple aortic stenosis showed that there was a significant difference between the preoperative (8.87±3.57) cm 2 and postoperative aortic regurgitation area at 1 month ( t=6.85, P<0.05), 6 months ( t=5.13, P<0.05), 1 year ( t=6.62, P<0.05) and 2 years postoperatively ( t=5.41, P<0.05). The LVEDV of 26 children was significantly lower at 6 months[(63.54±27.61) mL], 1 year [(53.61±20.20) mL] and 2 years postoperatively [(64.39±17.78) mL] compared with that of preoperative level[(89.42±45.89) mL]( t=3.89, 4.67, 3.58, all P<0.05). The left ventricular pressure and volume decreased, the enlarged heart was narrowed down, and the geometry of the heart was restored.The LVEF of 26 patients also from (61.65±9.67)% before surgery increased to (67.88±4.69)% 6 months after surgery( t=3.68, P<0.05), and increased to (68.62±4.46)% 1 year after surgery( t=4.01, P<0.05), and increased to (67.55±3.09)% 2 years after operation( t=3.01, P<0.05), and the heart function was improved. Conclusions:Aortic valvuloplasty with autopericardium presents an effective short and mid-term efficacy on children with aortic valve diseases, which prevents or delays the aortic valve replacement.

Extended clinical trials are medical treatment activity based on the humanitarianism to provide new medical products during the clinical trials for specific patients who have no other effective medical means to prolong life or alleviate pain. Extensive clinical trials have both medical and scientific attributes, which are significantly different from registered clinical trials and require special ethical attention. At present, the extended clinical trials in China are still in the initial stage, laws, regulations and supporting management methods are not perfect, and there is a lack of experience in ethical governance of such special clinical trials. This paper took the expanded clinical trial of medical devices as an example, referred to the current laws and regulations at home and abroad, analyzed their characteristics, and put forward some suggestions on the ethical governance of the whole process of the expanded clinical trials of medical devices in China,including special concerns in the application and acceptance, the first review approval strategy and the key points in continuing review.

Informed consent is one of the key elements to protect the rights and welfare of the patients or research subjects. With the development of electronic information technology, the diversity and convenience brought by the electronization makes the electronic informed consent (E-Consent) come into being. European and American countries have begun to apply E-Consent in the field of clinical trials, established a relatively perfect E-Consent platform and software system, and initially formed the guiding principles and recommendations of E-Consent. However, the implementation of E-Consent is still less in China, and there is no targeted legal basis and guidelines for ethical review. Therefore, this paper explored the implementation potential of E-Consent domestically by analyzing the application scenarios, advantages and disadvantages, and feasibility of E-Consent, and tried to establish the practical ethic review points of E-Consent based on the basic principles of ethical principles, to ensure that clinical trials have an appropriate E-Consent process.