The establishment of standardized ethical review mechanism for clinical trials is an objective requirement for improving the ethical review of clinical trials and ensuring the safety and smoothness of various clinical trials. According to the practice of years engaged in the ethical review of clinical trials, this paper proposed to start from six aspects, that is, to establish a scientific and reasonable ethics committee; establish a special ethics office;establish a scientific and reasonable ethical review standard;grasp the emphasis of the ethical review;attach importance to the continuing review;strictly observe the principles of ethical review, and then establish a standardized ethical review mechanism for clinical trials.

Objective To investigate the present situation and analyze the influence factors of self-management ability of schizophrenic patients in community. Methods A total of 122 cases of schizophrenic patients in community that have been discharged from Zhenjiang Mental Health Center were investigated and analyzed by general information questionnaire, Schizophrenia Self-Management Ability Scale, quality of life and Social Support Rating Scale. Results The scores of self-management ability of schizophrenic patients in community were (68.74 ± 10.24) points. Multiple stepwise regression analysis showed that long-term medication (t =2.351, P<0.05), degree of education(t =2.385, P<0.05), community rehabilitation guidance (t =3.813, P<0.01) and social support (t=2.768, P<0.01) were the influence factors of self-management ability of schizophrenic patients in community. Conclusions Schizophrenia patients in community medical staff should be aimed at strengthening the long-term medication in community rehabilitation guidance and social support, improvement, and strengthen the low degree of culture of patient care, to improve the ability of self-management.

Objective To investigate the diagnostic value of assisting stress ultrasound elastographic quantitative parameter in determination of the thrombus age in an ex-vivo model of venous thrombi.MethodsAfter 1,3,6 and 9 days,9 saphenous vein samples with venous thrombosis were scanned by both tissue touch elasticity image and acoustic radiation force impulse (ARFI) respectively.For each group of thrombus age,a mean sheer strain was calculated in all thrombosis samples of the respective age.Furthermore,correlation of two sample data was analysed.Results The stiffness of thrombus age group of 1,3,6 and 9 days by tissue touch elasticity image were (49.23±14.91)%,(68.75±10.03)%,(80.82±10.29)% and (91.98±4.10)% respectively with significant differences among the parameters (P<0.05).Quantitative data of thrombus age groups correlated positively by two kinds of these elasticity image significantly (r=0.702,P=0.000).Conclusions The assisting stress ultrasound elastographic method with HM% in this experiment setting of venous thrombosis is proved to be helpful in determination of the age of venous thrombi.The present results obtained in our experiment might provide a potential application in evaluation of deep vein thrombosis by the elastographic technology clinically.

Objective To observe the value of preoperative CT enterography(CTE)for predicting the necessity of enterectomy in ovarian cancer(OC)patients for achieving optimal debulking surgery(ODS).Methods Preoperative CTE data of 49 patients with pathologically confirmed OC were retrospectively analyzed,including 13 cases received neoadjuvant chemotherapy(NACT)and 36 cases did not.The length(L)and circumference(C)of muscular involvement shown on CTE were taken as criteria for judging the necessity of enterectomy in OC patients([degree 0:no muscular involvement,degree 1:L＜3.0 cm and C＜1/3,degree 2:L≥3.0 cm[A]or C≥1/3[B]).The patients were followed up for at least 1 year after surgery,and the actual operation results were recorded to estimate the ideal surgical strategy.The consistency of CTE evaluated necessity of enterectomy and the ideal surgical strategy was analyzed.Results For patients not undergoing NACT,according to degree 2 A or B showed on CTE,predicted results had excellent agreement with the ideal surgical strategy(Kappa=0.852,P＜0.001),while those according to degree 1 or 2,2 A,2 B were all in good agreement with the ideal surgical strategy(Kappa=0.684-0.771,all P＜0.001).For patients undergoing NACT,the predicted results of degree 2 muscular involvement showed on CTE before NACT had excellent consistencies with the ideal surgical strategy(all Kappa=0.806,all P=0.003).The predicted results of degree 2 muscular involvement showed on CTE after NACT had moderate consistencies with the ideal surgical strategy(all Kappa=0.581,all P=0.021).Conclusion Preoperative CTE could be used to predict the necessity of enterectomy in OC patients for achieving ODS.

Background and purpose:As one of the most fatal malignant tumors in China, the morbidity and mortality of lung cancer remain high. Early diagnosis and normative treatment is the key to improve the prognosis of lung cancer. The aim of this study was to explore the practice of early lung cancer screening with low-dose spiral computed tomography (CT) based on the current situation in community health service, with integration of superior resources of med-ical institutions at all levels in Shanghai.Methods:From Aug. 2013 to Aug. 2014, we screened high-risk population in selected communities of Minhang District, Shanghai, for early diagnosis of lung cancer with low-dose spiral CT combined with multidisciplinary comprehensive treatment models including minimally invasive surgery, exploring the medical service network covering prevention, diagnosis, treatment, rehabilitation and follow-up.Results:Screening population is 11 332 (male 7 144, female 4 188); Twenty-nine cases with pathological diagnosis of malignant tumor, including 27 cases of pri-mary lung cancer, 1 case of lung metastasis, 1 case of breast cancer. The morbidity of primary lung cancer is 238.26×10-5. There were 22 cases of Stage 0-Ⅰ lung cancer accounting for 81.48% of all diagnosed primary lung cancer.Conclusion:Based on community health service, screening with low-dose spiral CT could improve the early diagnosis rate of lung can-cer with feasibility and validity, which could be applicable in qualified eligible medical center and community in China.