The risk and benefit assessment is an important part of ethical review in clinical trials, of which the significance is to minimize the risk and maximize the benefit, thus to protect the rights of the subject. Begin with introducing the nature of the risk and benefit of clinical trial, this paper analyzed the way of ethical review based on risk consideration and discussed some key points of risk and benefit assessment including the minimum risk, the risk and benefit of vulnerable groups, risk informing, benefit of clinical trials, the fairness of recruitment and the importance of strengthening follow-up review. Ethical review should play a role as the balance, which neither-hinder the development of clinical trial to protect the rights of the subjects nor damage the rights and interests of subject to develop clinical trials.

With the application of HIS in hospital,a great deal of data accumulate in database.It's very important to take advantage of these data for IT and managerial staffs.It is suggested that data mart be selected to process the data at the initial stage.

It presented in detail the acquisition of Qingdao Wan Jie Hospital by the Affiliated Hospital of Medical College Qingdao University, describing the operational mechanisms in organizational setup, specialty setup, personnel management, logistic management, hospital culture and branding of the newly acquired section. It also summarized the achievements in medical resources reorganization and advantages complementary without government investment in a fast and low-cost manner. It is demonstrated that hospital acquisitions are in line with the medical reform, as they expand the service coverage of public hospitals, and extend medical service to the communities and lower levels, thus enhancing hospitals' impact and reach to integrate medical resources in a short timeframe.

ObjectiveTo evaluate the effect of transureteroscopic Holmium:YAG laser lithotripsy on ureteral calculi.Methods105 cases of ureteral stones were treated by transureteroscopic Holmium:YAG laser lithotripsy. The transverses of stones were 4～15 mm and the vertical lengths were 5～25 mm.ResultsSuccessful lithotripsy was achieved on one session in 98 cases (95%), with the stones completely expelled within 2～6 weeks. Complications occurred in 4 cases and stones moved up in 3 cases.ConclusionThe transureteroscopic Holmium:YAG laser lithotripsy is an effective and safe method for ureteral calculi.

Objective To evaluate the efficacy and security of metformin in the treatment of endocrine resistance and postmenopausal hormone receptor positive advanced breast cancer. Methods 60 cases of postmenopausal HR+advanced breast cancer whose first-line or second-line endocrine therapy failed were randomly divided into study group(n=30),treated with metformin combined with AI and control group(n=30),treated with placebo combined with AI. Standard RECIST guidelines were used to evaluate the clinical response. The objective response rate(ORR),clinical benefit rate(CBR),progression-free survival,and adverse reactions of two groups were compared. Results The ORR of two groups were 16.7%and 10%respectively and the difference was not statistically significant(P > 0.05). But CBR in study group was significantly higher than that in control group (63.3%vs 36.7%),and the difference was statistically significant(P<0.05). The median PFS in study group was slightly longer than that in control group (3.7 m vs 4.2 m),but there was no statistical difference. Multivariate regression analysis showed that PFS was only associated with the previous endocrine therapy. No serious adverse reactions occurred in two groups. Conclusion Metformin is expected to improve secondary endocrine resistance in breast cancer,but large prospective clinical studies are needed to confirm it.

Objective To investigate the job burnout status of nurses in a third-grade and A-level general hospital in Zhengzhou,and analyze the relationship between job burnout and presenteeism.Methods 300 nurses were surveyed with questionnaires by convenience sampling,including nurses' demographic data,Nurse Job Burnout Scale and Work Limitations Questionnaire.Results The scores in three dimensions of job burnout of nurses were respectively EE (25.92±11.56) points,DP (10.63±6.82) points,and PA(26.30±9.11) points.The job burnout rate in nurses was 76.2％,the rates of low,moderate,and high degree of burnout were respectively 30.4％,28.7％,and 17.4％.The scores of presenteeism for low,moderate,and high degree of work limitations were respectively (2.29±1.60)points,(5.90±3.03)points,(7.89±3.12)points.Conclusions Nurses' burnout can results in presenteeism.The more serious job burnout is,the more critical the presenteeism is.

Objective To observe the relationship of liver ultrasound class and urinary albumin excretion ratio (UAER) in type 2 diabetes mellitus (T2DM) combined with nonalcoholic fatty liver disease (NAFLD). Methods One hundred and ninety-seven T2DM patients were divided into 3 groups according to the degree of hepar adiposum: group A (66 subjects without NAFLD), group B (63 subjects with mild NAFLD) and group C (68 subjects with moderate or severe NAFLD). Their clinical indexes,UAER and biochemical parameters were measured and compared, the relative analysis of blood fat, HOMA-IR and UAER was done. Results Compared with those in group A, the levels of UAER were significantly increased [(86.49 ± 65.19) mg/24 h vs. (115.16 ± 101.99) mg/24 h vs. (159.45 ± 149.08) mg/24 h,P ＜ 0.05], and the levels of high density lipoprotein cholesterol decreased in group B and group C[(1.21 ± 0.37) mmol/L vs.(1.05 ± 0.38) mmol/L vs. (0.99 ± 0.21) mmol/L,P ＜ 0.05]. Multiple stepwise regression analysis showed that triglyeride was the most important risk factor affecting UAER(P ＜ 0.05). Conclusions There is a close relationship between NAFLD and UAER in T2DM. In the subjects with moderate or severe NAFLD, the UAER increases which indicates that these patients already have capillary vessel injury apparently.

Objective To translate the Work Limitations Questionnaire and examine its reliability and validity,and explore its applicability at home.Methods 300 nurses were surveyed with the Chinese version of the Work Limitations Questionnaire by convenience sampling; and internal consistency reliability,test-retest reliability,construct validity and criterion validity were applied to evaluate the questionnaire.Results The Cronbach α coefficients of the time managing scale,physical scale,mental-interpersonal scale,output scale and total questionnaire were 0.882,0.864,0.913,0.839 and 0.922 respectively;and their test-retest reliability coefficients were 0.857,0.837,0.871,0.803 and 0.893 respectively.Four common factors were abstracted by using factor analysis,with the cumulative variance contribution rate at 61.293％.Using SF-36 as an external criterion,the correlation coefficients of the WLQ scores with the physical function dimension and mental health dimension of the SF-36 were-0.24 and-0.33.Conclusions The reliability and validity of the questionnaire is reasonable.So this questionnaire can be used to measure employee's presenteeism.

Objective To summarize the experience in diagnosis and management for the space occupying lesion of spleen. Method The clinical data of 29 cases treated by surgery were retrospectively analyzed. Results There were 15 patients with benign masses including 7 hamartomas, 5 hemangiomas, 1 pseudocyst, 2 tuberculoses of the spleen, and 14 with malignant tumors including 9 lymphomas, 3 angiosarcomas, 2 metastatic tumors in the spleen. Splenectomy was performed in all patients. All patients with benign masses survived except 2 patients lost follow up and 1 coexisting with hepataocellular carcinoma died half a year after the operation. Twelve of 14 patients with malignant tumor were followed up.Of them, 5 patients survived more than 5 years and 2 were alive 1 and 3 years after the operation respectively; 5 patients died 6 months to 4 years after the operation. Conclusions Ultrasonography and CT or MRI are the main means of diagnosis for the space occupying lesion of spleen.It is difficalt to make diagnosis of the splenic tuberculosis before operation.Splenectomy is a primary procedure of surgery.

Objective To evaluate the effect of Aiyishu injection on the cellular immunity state of body and toxic and side reaction in post-operation patients with breast cancer after chemotherapy .Methods Seventy patients with breast carcinoma at stage Ⅰ-ⅢA were randomly divided into treatment group (Aiyishu associated CAF regimen) (n=36) and control group (CAF regimen) (n=34).The activities of T cells and NK cells were examined in two groups before and after treatment,and the toxic, side reaction and living quality were also compared.Results The levels of CD3,CD4,CD8 and the ratio of CD4/CD8 and the activity of NK cells in treatment group were higher than those in control group (P