Objective:Currently,the medical Institutional Review Board(IRB)mainly rely on experience to analyse the risks and benefits of clinical research,lacking an assessment framework of risks and benefits.Methods:Using grounded theory,interviews were conducted on 29 ethical review workers in China.Through open coding,spindle coding,and selective coding,the framework of risks and benefits for clinical research in China was constructed.NVivo11 software was used for data storage,organization,encoding,and analysis.Results:A framework of risks and benefits for clinical research was proposed based on China's national conditions.Clinical research risks consisted of physiological risk,psychological risk,economic risk,and social risk.Research benefits consisted of subject benefits and society benefits.Conclusion:This paper systematically explained the connotation of the risks and benefits of clinical research,and constructed a framework of the risks and benefits of clinical research applicable to China.It has certain innovations in theoretical research,and also provides use for reference for researchers and ethics committees to evaluate risks and potential benefits in clinical research.

Objective To observe the impact of age and menstrual status on semi-quantitative parameters of breast dynamic enhanced MRI(DCE-MRI)in healthy adult women.Methods A total of 283 adult females who underwent MR examinations due to suspected breast mass or breast discomfort but no breast tumor was detected after 1 year's clinical follow-up were retrospectively collected.Meanwhile,49 healthy adult female subjects in the menstrual period(menstruating subgroup)were prospectively recruited.All the above 332 subjects were divided into low age group(n=107),middle age group(n=114)and high age group(n=111)according to age,while into postmenopausal group(n=112)and premenopausal group(n=220,including 49 in menstruating subgroup,77 in proliferating subgroup and 94 in secreting subgroup).DCE-MRI semi-quantitative parameters,including maximum enhancement rate(ERmax)and maximum slope of increasing(Slopemax)were compared among different groups and subgroups,and the variations were observed.Results Significant differences of ERmax and Slopemax were found between high and low age groups(both P＜0.05),while no significant difference of ERmax and Slopemax was found between middle and low age group,nor between middle and high age group(all P＞0.05).Both ERmax and Slopemax in postmenopausal group were lower than those in premenopausal group(both P＜0.05),while no significant difference of DCE-MRI semi-quantitative parameters was found among different menstrual cycle subgroups(all P＞0.05).The coefficient of variance(CV)of normal breast ERmax in low,middle and high age groups was 56.20％,44.02％and 50.97％,respectively,of Slopemax was 54.74％,81.78％and 76.93％,respectively.CV of normal breast ERmax was 50.12％and 46.02％in postmenopausal and premenopausal groups,respectively,while CV of Slopemax was 72.84％and 62.04％,respectively.Among different subgroups,CV of ERmax and Slopemax in proliferative period were both the largest(61.39％,82.54％),which in menstrual period were both the smallest(33.99％,42.33％).Conclusion Semi-quantitative parameters of breast DCE-MRI were different among healthy women of different age and menstrual status,and the individual variations were large.

Objective:The aim is to construct an evaluation framework for clinical research benefits,and provide a reference for the formulate of evaluation standards for clinical research benefits.Methods:The Delphi method was used to carry out expert consultation,and the mean,score of importance,coefficient of variation and coordination,etc.of evaluation indicators were summarized and calculated,to screen evaluation indicators for clinical research benefits.Results:Twenty-three experts in this field were selected for correspondence,and their enthusiasm was 100%in both rounds,the authority coefficients were≥0.90,and Kendall's coefficients of concordance were<0.25(P<0.001).By referring to the mean and coefficient of variation of the indicators,as well as combining them with expert suggestions,an evaluation framework for clinical research benefits was ultimately formed with 2 primary indicators,5 secondary indicators,and 8 tertiary indicators.Conclusion:The evaluation framework for clinical research benefits constructed in this paper can comprehensively evaluate the research benefits,as well as provide a basis for reasonably determining the research risk-benefit ratio and developing quantitative evaluation tools for clinical research benefits.

ObjectiveTo investigate the mechanism of Yiqi Huoxue Tongluo prescription （YHTP） in the treatment of diabetic neuropathic pain （DNP）. MethodNinety SPF-grade SD male rats were randomized into blank， model， low- （2.25 g·kg^-1）， medium- （4.5 g·kg^-1）， and high-dose （9 g·kg^-1） YHTP， and mecobalamin （0.175 mg·kg^-1） groups. Except those in the blank group， the rats in the remaining 5 groups were fed with a high-fat and high-glucose diet and subjected to intraperitoneal injection of low-dose （35 mg·kg^-1） streptozotocin （STZ） to establish the model of DNP. The sciatic nerve conduction velocity in DNP rats was measured by the neurophysiological method， and the levels of interleukin-6 （IL-6）， IL-1β， and tumor necrosis factor-α （TNF-α） were measured by enzyme-linked immunosorbent assay （ELISA）. Real-time fluorescence quantitative polymerase chain reaction （Real-time PCR） was employed to measure the mRNA levels of glial fibrillary acidic protein （GFAP） and extracellular signal-regulated kinase （ERK） in the spinal cord. Western blot was employed to measure the protein levels of GFAP and phosphorylated ERK （p-ERK）， and immunofluorescence staining to measure the fluorescence intensity of GFAP and p-ERK in the spinal cord. In the cell experiments， 100 mmol·L^-1 high glucose was used to induce the activation of astrocytes （CTX-TNA2） for the modeling of nerve cell injury. The cells were randomized into the normal， model， drug-containing serum （10% YQHT）， inhibitor ［10 mol·L^-1 corynoxeine （COR）］， drug-containing serum + inhibitor （10% YHTP + 10 mol·L^-1 COR） groups. The levels of pro-inflammatory factors （TNF-α and IL-1β） and the anti-inflammatory factor IL-10 in CTX-TNA2 cells were determined by ELISA， and the protein levels of GFAP and p-ERK in CTX-TNA2 cells by Western blot. ResultThe animal experiments showed that compared with the blank group， the model group presented reduced mechanical withdrawal threshold （MWT）， thermal work limit （TWL）， and nerve conduction velocity， elevated levels of fasting blood glucose， IL-1β， TNF-α， and IL-6， and up-regulated protein levels of GFAP and p-ERK， and mRNA levels of ERK1， ERK2， GFAP （P<0.01）. Compared with model group， YHTP increased the MWT， TWL， and sciatic nerve conduction velocity （P<0.01）， lowered the levels of IL-1β， TNF-α， and IL-6 （P<0.01）， and down-regulated the protein levels of GFAP and p-ERK， and mRNA levels of ERK1， ERK2， GFAP in the spinal cord （P<0.05， P<0.01）. The cell experiments showed that compared with the blank group， the model group had decreased survival rate， elevated levels of pro-inflammatory factors， and up-regulated protein levels of ERK and GFAP （P<0.01）. Compared with the model group， the YHTP-containing serum lowered the levels of IL-1β and TNF-α （P<0.05， P<0.01）， elevated the level of IL-10 （P<0.01）， and down-regulated the protein levels of ERK and GFAP （P<0.01）. ConclusionYHTP may inhibit the activation of astrocytes by inhibiting the ERK signaling pathway to reduce inflammation and thus relieve DNP.

The passing of ethical review is a necessary conditions and prerequisite for the development of life science and medical research involving humans. At present, some medical and health institutions have no or insufficient ethical review capabilities. The lack of ethical review ability has become a bottleneck restricting the development of life science and medical research involving humans. According to documents such as Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices, Opinions on Strengthening the Ethical Governance of Science and Technology, institutions can entrust competent institutional ethics review committees or regional ethics review committees in writing to conduct ethical review. Entrustment ethical review provides a viable solution for institutions that need to carry out life science and medical research involving humans but do not have an ethics (review) committee or the ethics (review) committee is not competent to review. To conduct the entrustment ethical review, the entrustment between the principal and the trustee is required. According to The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans, if medical and health institutions and their ethical review committees do not accept the formal entrustment to provide the ethical review opinions for other institutions, the local health authorities at or above the county level will impose administrative penalties and sanctions on the relevant institutions and personnel in accordance with the law. Signing the entrustment ethical review contract, implementing legal compliance entrusted ethical review to protect the rights and interests of the trustee and the principal, and protect the research participants.

Objective:To investigate the prevalence of estimated glomerular filtration (eGFR) and risk factors among middle-aged and elderly residents in Beijing.Methods:In August-December of 2017, 6 549 residents aged 45-79 years old were randomly selected in the study by stratified multi-stage cluster sampling method. The investigation was performed by questionnaire, physical examination and laboratory tests. The contents of questionnaire included the demographic characteristic and prevalence of chronic disease. Blood pressure was tested. Fasting venous blood was collected to test the level of total cholesterol (TC), high density lipoprotein cholesterol (HLDL), low density lipoprotein cholesterol (LDL), triglyceride (TG), fasting blood-glucose (FBG), blood creatinine (Cr) and serum uric acid (UA). The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation was used to estimate GFR(eGFR). The decreased GFR was defined as eGFR less than 60 ml/min per 1.73 m 2. The statistical software SPSS 20.0 was used for analysis. The general linear model, test of independence of rows and columns, logistic regression for complex samples were generalized. The weighted mean and weighted rate were analyzed. Results:The average level of eGFR was (100.51±0.54) ml/min per 1.73 m 2. The rate of decreased GFR was 1.28%, and it showed a higher rate in subjects aged 70-79 years-old, living in urban area, with history of cardiovascular disease, hypertension, diabetes mellitus, hyperuricemia (4.53%, 1.57%, 2.90%, 2.27%, 2.12% and 4.62%; F=30.827, 10.588, 11.466, 34.693, 6.788,51.643, all P<0.05) . Logistic regression analysis of complex sampling showed that 70-79 years old ( OR=4.435, 95 %CI:2.402-8.191), living in urban area ( OR=3.145, 95 %CI: 1.540-6.420), hypertension ( OR=4.663, 95 %CI:2.177-9.988), hyperuricemia ( OR=6.751, 95 %CI:3.363-13.553) were associated with decreased GFR (all P<0.05). Conclusion:The prevalence of the decreased eGFR among middle-aged and elderly residents in Beijing is higher than the average level in the eastern part of China. Hypertension, hyperuricemia, the old age and living in urban are risk factors of decreased GFR.

Objective:To understand the awareness of smoking hazards and intention of smoking concession in residents aged 18-65 years in Beijing, and provide scientific evidence for the development and improvement of tobacco control policies and measures.Methods:Data were collected from the 2017 Beijing Non-communicable and Chronic Disease surveillance. A multi-stage stratified cluster sampling method was used to take samples from 165 communities in 16 districts of Beijing. Logistic regression was used to analyze the influencing factors.Results:Among 11 594 participants, 49.93% had no intention of smoking concession. The percentage of refusing smoking concession was higher in men (50.39%) than in women (43.01%), the difference was significant ( χ2=14.211, P=0.002), and higher in suburban residents (56.78%) than in urban residents (45.30%), the difference was significant ( χ2=51.977, P<0.001). For the smoking cessation motivation, "illness" was the reason for more former smokers (29.88%) compared with current smokers (11.50%), the difference was significant ( χ2=85.865, P<0.001). The awareness rates of smoking hazards was higher in women (34.97%) than in men (32.63%), the difference was significant ( Z=5.612, P<0.001), higher in suburban residents (35.44%) than in urban residents (33.03%), the difference was significant ( Z=-3.734, P<0.001), and higher in never smokers (35.15%) than in smokers (30.06%), the difference was significant ( χ2=62.277, P=0.005). Multiple logistic regression analysis results showed people with general awareness ( OR=0.61, 95 %CI: 0.39-0.94) and poor awareness ( OR=0.67, 95 %CI: 0.50-0.90) of smoking hazards were less likely to quit smoking and people with general awareness ( OR=0.64, 95 %CI: 0.53-0.76) and poor awareness ( OR=0.87, 95 %CI: 0.78-0.98) of smoking hazards were more likely to smoke. Conclusions:Smokers aged 18-65 in Beijing had low willingness for smoking cessation. Health problem was main consideration for smoking cessation. Never-smokers had better awareness of smoking hazards than smokers, and the awareness of smoking hazards was an influencing factor of smoking status.

Objective:To investigate the status quo of sleelated problems and relationship with dyslipidemia among adults in Beijing.Methods:From August to December 2017, 13 188 residents aged 18-79 years old were randomly selected as the subjects of this study, by stratified multi-stage cluster sampling method. Questionnaire, physical examination and laboratory testing were used in this study. The questionnaire included demographic characteristics and status quo of sleep. Height and weight were measured, with fasting venous blood collected to test the levels of TC, HDL-C, LDL-C and TG.Results:In Beijing, 52.1% of the adults involved in this study were having sleep-related problems which appeared higher in patients with dyslipidemia (55.1%) than those without (50.7%). Rates of sleep-related problems as snoring, difficult to get into sleep, waking at night, waking early and taking sleeping pills were 30.1%, 18.8%, 24.6%, 20.1% and 3.0%, respectively. The prevalence rates of high TC, high TG and high LDL-C were 7.5%, 23.5% and 6.6%, respectively among subjects with snoring and as, 5.7%, 15.5% and 4.9%, respectively among those without. The average level of TC of people easy to wake at night was 4.74 mmol/L, higher than that of those without (4.66 mmol/L). The prevalence of high TC among those waking at night was 7.5%, higher than that of those without (5.8%). After controlling potential confounding factors as age, sex, smoking, overweight and obesity, snoring was significantly positively correlated to the levels of TC, TG and LDL-C ( P<0.05) and presenting as risk factor for dyslipidemia, with OR=1.248 ( P<0.05). Conclusion:Sleep-related problems appeared serious, with snoring and waking at night the main ones among adults in Beijing. Snoring was significantly positively correlated with the levels of TC, TG and LDL-C and served an independent risk factor for dyslipidemia.

Objective:To understand the status quo of sleep and its associations with serum hemoglobin A1c (HbA1c) among nondiabetic people of 18-79 years old in Beijing.Methods:Data was gathered from the 2017 Beijing Non-communicable and Chronic Disease Surveillance Program. Multiple classified clusters sampling method was used while the 18-79 years old were sampled from the 16 districts of Beijing. Questionnaires would include information on demographic characteristics, chronic diseases and related risk factors, sleep duration and related problems (snore/asphyxia, difficult to get to sleep, waking often during the night, waking up early or taking sleeping pills) within the last 30 days. Complex sampling logistic regression models were established to analyze the association between sleep-related problems and serum HbA1c.Results:A total of 11 608 non-diabetic participants were involved in this study, with average age, reported sleep duration and median of serum HbA1c level as (43.36±15.27) years old, (7.49±1.29) h/d and 5.30%, respectively. 47.38% of them reported having sleep problems within the last 30 days. With the increasing time of sleep, serum HbA1c level was fluctuating significantly ( F=413.06, P<0.01). Significant differences appeared in serum HbA1c levels among different age groups ( t=358.3, P<0.01). Among participants with several kinds of sleep problems, the serum HbA1c levels were significantly higher than those without, through the single factor analysis ( U=15.11, P<0.01). After adjusting for potential confounding factors, the combination of one sleep-related problem ( OR=1.21, 95% CI: 1.03-1.41) and snore/asphyxia were associated with higher serum HbA1c levels (HbA1c≥5.7%) ( OR=1.37, 95% CI: 1.16-1.61). People under 60 years of age were with higher risk of having higher serum HbA1c levels. Conclusion:Duration and sleep-related problems might affect the serum HbA1c levels, especially among those younger than 60 years of age.

Objective:To investigate the comprehensive control situation and related factors of diabetes mellitus.Methods:From August to December of 2017, 13 259 residents aged 18 to 79 years old were randomly selected as the subjects by stratified multi-stage cluster sampling method. Questionnaire, physical examination and laboratory tests were conducted. The effective sample size was 13 240. A total of 1 592 diabetes patients were found. In this study, 917 diabetes patients who had been diagnosed before the investigation were selected as subjects. The comprehensive control of diabetes patients was analyzed. The situation of diabetes patients with hypertension, dyslipidemia, overweight and obesity, coronary heart diseases was analyzed. Logistic regression analysis of complex sampling was used to analyze the related factors of diabetes comprehensive control.Results:The average age of 917 patients with diabetes was (58.5±0.7) years old. The proportion of people who participated in diabetes follow-up management was 29.0%. There were 89.5% diabetes patients with one or more chronic diseases. The comprehensive control rate of diabetes mellitus was 2.0%, men and women were 1.8% and 2.3%, respectively ( P>0.05). The rate of comprehensive control among those diabetes patients with chronic diseases was 0.4%, lower than that of those without chronic diseases (15.6%, P<0.05). The comprehensive control rate of people who participated in diabetes follow-up management was 1.4%. The control rate of blood glucose, blood pressure, blood lipid and weight of diabetes mellitus was 30.9%, 30.2%, 17.4% and 27.7%, respectively. Logistic regression analysis of complex sampling showed that excessive intake of red meat, with chronic diseases and qualified core knowledge were all related with comprehensive control of diabetes mellitus, OR value was 31.41, 39.98 and 0.29, P<0.05. Conclusion:The comprehensive control rate of diabetes mellitus was low. Excessive intake of red meat, with chronic diseases and qualified core knowledge were all related with comprehensive control of diabetes mellitus.