The authors presented in the paper the following subjects: a description of risk exposures commonly found in drug clinical trials; risk types in terms of the personnel organization of ethical review boards, and the composition of the ethical review board members, as well as ethical training, ethical review procedures and supervising of the ethical review. To avoid these risks, an analysis is made on the causes of ethical review risks, and recommendations are proposed on international certification, reform of ethical review board setup, greater efforts on training, introduction of ethical supervision and ethical acceptance procedure.

Objective To find an easy and proper way to differentiate metastatic breast cancer from second primary breast cancer by analyzing the histopathological characteristics of 40 patients with bilateral breast cancer.Methods According to the Chaudary histological criteria,the histopathological and biological characteristics of 16 cases of synchronous bilateral breast cancer and 24 cases of metachronous bilateral breast cancer were evaluated.The histopathological and biological characteristics included Nottingham histological grade,immunohistochemistry (IHC) results of the estrogen receptor,progesterone receptor and expression of Her-2.Results The average age of the 40 patients at first diagnosis was 41 years old (range,26-68 years old).The average time interval between first and second diagnosis of tumors was 34 months (range,7-209 months) in metachronous cancer.The concordant histopathological type was found in 93.8 ％ (15/16) of synchronous cancer patients and 58.3 ％ (14/24) of metachronous cancer patients (P =0.02).The concordance rates of tumor stage was 68.8 ％ (11/16) in synchronous cancer patients,while it was 25.0 ％ (6/24) in metachronous cancer patients (P =0.03).For progesterone receptor status,the concordance rates were 87.5 ％ (14/16) and 54.2 ％ (13/24) in synchronous and metachronous cancer patients respectively (P =0.03).There was no statistically significant difference in terms of estrogen receptor status and Her-2 expression (P ＞ 0.05).Conclusions Without considering the limitation of Chaudary criteria and the number of patients,it seems to be an easy and proper way to differentiate metastatic cancer from second primary cancer in the patients with bilateral breast cancer by combining the histopathological type,tumor stage and progesterone receptor status.The synchronous cancer is closer to same clonal lesion (metastatic lesion).

Objective To investigate the in vitro effect of interferon-γ (IFN-γ) and ATRA on the morphological transition, proliferation of and apoptosis in a human cutaneous squamous cell carcinoma cell line SCL-1. Methods Cultured SCL-1 cells were divided into 6 groups to be treated with ATRA of 1 μmol/L, various concentrations ( 100, 500, 1000 U/ml) of IFN-γ, the combination of ATRA of 1 μmol/L and IFN-y of 1000 U/ml,respectively, or to remain untreated. MTT assay and flow cytometry were performed to evaluate the cell proliferation and apoptosis. The morphological features of apoptotic cells were observed by a transmission electron microscope (TEM) and inverted phase contrast microscope after 1% propidium iodide staining. Results IFN-γ could inhibit the proliferation of SCL-1 cells in a dose-dependent manner, and the most pronounced inhibitory effect was observed at a dose of 1000 U/ml . ATRA and IFN-γ induced an apoptosis in SCL-1 cells, and the early apoptosis rate was 4.84%, 11.96% and 18.71% in SCL-1 cells after treated with ATRA of 1 μmol/L, IFN-γ of 1000 U/ml and their combination, respectively. A series of morphological changes characteristic of apoptosis,such as bipolar changes, were observed in SCL-1 cells treated with ATRA and IFN-γ, with the presence of many early apoptotic cells, which showed a trend towards benign differentiation. Conclusions Within a certain concentration range, IFN-γcan promote the differentiation, but inhibit the proliferation of SCL-1 cells in a dose-dependent manner, and ATRA could enhance the effects of IFN-γ.

Objective To investigate the liver protective effects of Xiaoyaosan in carbon tetrachloride-induced acute liver injury in mice.Methods Thirty mice were randomly divided into a control group, a model group, and aXiaoyaosan group, with 10 mice in each group. The mice in theXiaoyaosan group were intragastrically administrated withXiaoyaosan, the mice in the remaining two groups were fed with an equal volume of distilled water. After 7 days, acute liver injury were inducedvia intraperitoneal injection of carbon tetrachloride peanut oil solution. The serum levels of alanine transaminase(ALT), aspartate transaminase (AST), malondialdehyde(MDA)and superoxide dismutase(SOD)were measured, and pathological changes of liver tissue was tested after 16 hours.Results The serum levels of ALT(136.46±15.75 U/Lvs. 22.96±6.23 U/L), AST(145.37±16.39 U/Lvs. 31.89±7.26 U/L), and MDA level in the liver tissue(17.48±3.45 nmol/mgvs. 4.22±1.08 nmol/mg)in the model group were significantly higher than those in the control group(allP<0.01), SOD level in the liver tissue significantly lower than that in the control group(261.60±20.29 U/mgvs. 336.73±25.34 U/mg,P<0.01). The serum levels of ALT(89.38±6.96 U/L,P<0.01), AST(119.04±20.44 U/L, P<0.05), MDA level(10.30±2.22 nmol/mg,P<0.01) in the liver tissue in theXiaoyaosan group levels were significantly lower than those in the model group, and SOD level(304.77±31.71 U/mg,P<0.01) in the liver tissue were significantly higher than that in the model group.ConclusionXiaoyaosan has liver protective effects in carbon tetrachloride-induced acute liver injury in mice.

ObjectiveTo observe the effect of estrogenic-like effects ofWujia-Shenghua capsule and effective medication site.MethodsThrough D-101 macroporous resin column methods,Wujia-Shenghua capsule with 60% ethanol extraction was separated for water elution part, 20% ethanol elution part, 40% ethanol elution part, 60% ethanol elution part. Then each elution part was respectively mixed into concentration of 10mg/ml,1mg/ml, 0.1mg/ml, 0.01 mg/ml and acted on the MCF-7 cell to have, MTT test and rate of PR calculation.Results Compared with the blank control group(100%), when the concentration was 0.1 mg/ml, water elution part, 20% ethanol elution part and 60% ethanol elution part(98.10%, 101.06%, 106.04%)had no effect on the proliferation of MCF-7 cells, there was not statistically significant(P>0.05), while the 40% ethanol elution part(108.22%)can promote the proliferation of MCF-7 cells,there was a statistically significant(P<0.05). When the concentration was 1 mg/ml, 20%, 40% and 60% ethanol elution part(111.72%, 122.48%, 115.35%)can distinctly promote the proliferation of MCF-7 cells, there was a significant difference between four groups(P<0.01).ConclusionThe 40% ethanol elution part ofWujia-shenghua capsule has the strongest estrogen activity on plant.

Objective To determine the serum levels of tumor necrosis factor (TNF)-α,interleukin (IL)-17,IL-22 and IL-17F in patients with palmoplantar pustulosis (PP),and to estimate their relationship with disease activity in PP.Methods Venous blood samples were collected from 30 patients with PP at both active stage and stationary stage and from 20 healthy human controls.Enzyme-linked immunosorbent assay (ELISA) was conducted to determine the serum levels of TNF-α,IL-17,IL-22 and IL-17F.The paired Wilcoxon signed rank test was carried out to compare the serum levels of cytokines between patients at active stage and at stationary stage,and the Mann-Whitney U test to compare those among different groups.Results The median serum levels of TNF-α,IL-17 and IL-22 in patients with PP at active stage were 186.35 (range,113.48-412.69) ng/L,420.45 (range,278.55-748.73) ng/L and 106.48 (range,69.13-251.86) ng/L respectively,significantly higher than those at stationary stage (42.52(18.83-95.37) ng/L,48.11 (36.43-80.04) ng/L,20.32 (10.55-48.75) ng/L,respectively,all P ＜ 0.05) and those in the controls (24.30 (12.0-61.56) ng/L,10.49 (6.24-24.44) ng/L,2.58 (1.41-5.78) ng/L,respectively,all P ＜ 0.05).Moreover,the patients at stationary stage showed a significant elevation in serum levels of TNF-α,IL-17 and IL-22 compared with the controls (u =2.71,3.53,2.18,respectively,all P ＜ 0.05).No statistical difference was noted in the serum level of IL-17F among the patients at different stages and controls (P ＞ 0.05).Conclusion The circulating levels of TNF-α,IL-17 and IL-22 were associated with disease activity in PP,hinting that they may be involved in the development of PP.

Objective To analyze the dTP value in the patients with coronary heart disease (CHD) complicating diabetes mellitus (DM) and its relationship with major adverse cardiovascular events (MACE) and rehospitalization.Methods Two hundreds and seventy CHD patients were selected as the research subjects,including 136 cases of non-MD and 134 cases of DM.Their clinical condition was recorded.The indicators such as height,body mass,blood pressure and heart rate were measured.ECG,echocardiography,coronary angiography and other examiantions were carried out.The various indicators were detected.11-dh-TXB2 and 6-k-PGF1a levels were detected in the two groups and then dTP value was calculated.The 1-year follow-up was performed,MACE and rehospitalization were recorded.Epdate software was used for building a database and SPSS 17.0 software was applied for conducting the statistical analysis.Results The dTP level in the f non-DM and DM patients were 1.8 ± 0.6 and 2.0 ± 0.7 respectively,the difference was statistically significant (P＜ 0.05).For the non-DM CHD group,hs-CRP,systolic blood pressure,diastolic pressure,lesions number and severe lesions number were correlated with dTP level(P＜0.05).For the complicating DM CHD group,hs CRP,blood glucose,CHO level,lesions number and severe lesions number were correlated with dTP level(P＜0.05).After 1-year follow-up,MACE had 33 cases (24.3％) in the non-DM group and 44 cases (32.8％) in the DM group respectively,the difference was not statistically significant (P＞0.05).The rehospitalized cases had 12 cases (8.8％) in the non-DM group and 24 cases (17.9 ％).in the DM group respectively,the difference was statistically significant (P＜ 0.05).The dTP levels of MACE occurrence and non-MACE occurrence were 2.3 ± 0.8 and 1.8 ± 0.6 respectively,the difference was statistically significant (P＜0.05).The dTP levels of rehospitalized patients and non-rehospitalized patients were 2.4 ± 1.0 and 1.9 ±-0.6 respectively,the difference was statistically significant(P＜0.05).Conclusion The dTP level in the patients with CHD complicating DM is significantly increased,suggesting that platelet is obviously activated,moreover higher dTP level increases the risk of MACE and rehospitalization.So the anti-platelet therapy should be strengthened.

Objective:To analyze the arsenic exposure of industrial residents and its influencing factors, so as to provide scientific basis for protecting the health of industrial residents.Methods:In 2017, the samples of PM 2.5, drinking water and soil were collected by using cross-sectional survey and were tested for arsenic contents in Xigu District, Lanzhou City. The environmental arsenic exposure was analyzed by using Environmental Protection Agency of USA health risk assessment models. The levels of urinary arsenic and blood arsenic were measured in residents who included adults, children and teenagers. The internal exposure level of arsenic and its influencing factors were analyzed. The correlation between arsenic and internal and external exposure factors were also analyzed. The content of arsenic was expressed by geometric mean. Results:A total of 84 samples of PM 2.5 were collected, and the content of air arsenic was 7.53 ng/m 3. A total of 108 samples of drinking water were collected, and the content of water arsenic was 0.002 2 mg/L. A total of 40 samples of soil were collected, and the content of soil arsenic was 0.14 mg/kg. The total non-carcinogenic risk of environmental arsenic was 0.39, which was lower than the acceptable level of non-carcinogenic risk (1.00). The total carcinogenic risk of environmental arsenic was 6.59 × 10 -5. The total carcinogenic risk of arsenic was the highest through drinking water exposure and followed by the respiratory inhalation exposure, accounting for 78.60% [(5.18 × 10 -5)/(6.59 × 10 -5)] and 20.79% [(1.37 × 10 -5)/(6.59 × 10 -5)] of the total carcinogenic risk of environmental arsenic, respectively. There were 135 subjects, and 135 blood samples were collected. The content of blood arsenic was 0.92 μg/L. The level of blood arsenic of adults (1.05 μg/L) was higher than that of children and teenagers (0.75 μg/L, U = - 3.594, P < 0.05). One hundred and thirty-five urinary samples were collected, and the content of urinary arsenic was 14.17 μg/L. There was a positive correlation between urinary arsenic and blood arsenic ( r = 0.357, P < 0.05). Blood arsenic levels were positively correlated with the total carcinogenic risk and the risk of carcinogenesis through respiratory, oral and skin exposures ( r = 0.252, 0.244, 0.255, 0.255, P < 0.05). Conclusion:Arsenic in the environment of industrial areas has a potential carcinogenic risk to the residents, so the intake of arsenic in drinking water through oral exposure and respiratory inhalation exposure should be limited.

Objective To analyze Clopidogrel Resistance (CR) and influencing factors of coronary heart disease (CHD) with diabetes (DM) patients and evaluatc the relationship of CR and major adverse cardiovascular events (MACE) and readmission of CHD with DM patients.Methods 270 CHD patients were enrolled.Clinical conditions of CR were measured by adenosine diphosphate (ADP) induced maximum platelet aggregation rate (MPAR).After 1-year follow-up,MACE events and rehospitalization were recorded.Results CR of NDM and DM patients were 45 (33.1％) and 78 cases (58.2％) respectively,and the difference was significant (P ＜ 0.001).Factors of CR of CHD DM patients included heart rate,TG level,the number of severe coronary artery disease.MACE events of CS and CR patients were 35 (23.8％) and 47 patients (38.2％) respectively,and the difference was significant (P =0.010).The readmitted patients of CS and CR groups were 15 cases (10.2％) and 27 patients (22.0％) respectively,and the differcnce was significant (P =0.008).The MACE of CR and CS patients in DM group were 32 (41.0％) and 12 cases (21.4％) respectively,and thc difference was significant (P ＜ 0.05).The Readmitted cases of CR and CS patients in DM group were 19 (24.4％) and 5 (8.9％) respectively,and the diffcrcnce was significant (P ＜ 0.05).Conclusions CR of CHD DM patients increased significantly.The influencing factors of CR of CHDDM are including heart rate,TG level,the number of severe coronary artery disease.MACE events and rehospitalization rate were significantly increased in CHD patients with DM AR.Therefore,it should be further strengthened the anti-platelet therapy for CHD patients with DM.

Objective To observe the influence of phentolamine on N terminal B-type natriuretic peptide precursor(NT-proBNP),blood gas analysis,hypersensitive c-reactive protein and plasma D-dimer in patients with chronic cor pulmonale Methods One hundred and one cases patients with chronic cor pulmonale were randomly divided into two groups,51 patients in the treatment group,50 patients in the control group.All patients were treated with normal anti-infection,eliminating phlegm to smooth wheezing antithrombotic for one week,as the same time patients in the treatment group were treated with phentolamine for one week.Through observed the treatment effect of phentolamine to chronic cor pulmonale,the level of NT-proBNP,blood gas analysis,hypersensitive c-reactive protein and plasma D-dimer in patients with chronic cor pulmonale before and after the treatment were analyzed.Results Compared with before treatment,the levels of NT-proBNP,PCO2,hypersensitive c-reactive protein,plasma D dimer were lower than after one week in two groups,while the level of PO2 was higher.Treatment group:NT-proBNP (1 712.76±572.32) ng/L vs.(271.59±163.05) ng/L,t=20.42,P<0.05,PCO2 (66.34±5.81) mmHg vs.(52.58±5.82) mmHg,t=16.46,P<0.05,PO2 (59.28±6.13) mmHg vs.(73.64±6.10) mmHg,t=23.02,P<0.05,hypersensitive c-reactive protein 86.0(28.0) mg/L vs.23.0(12.0) mg/L,Z=-6.22,P<0.05 mg/L,plasma D-dimer (4 953.37±1 654.09) μg/L vs.(1 847.90±838.66) μg/L,t=17.11,P<0.05.Control group:NT-proBNP (1 527.24±658.70) ng/L vs.(612.58±357.59) ng/L,t=14.52,P<0.05,PCO2 (65.41±5.23) mmHg vs.(56.46±5.65) mmHg,t=13.04,P<0.05,PO2(60.57±5.84) mmHg vs.(67.21±5.19) mmHg,t=-10.06,P<0.05,hypersensitive c-reactive protein 79.0(29.0) mg/L vs.43.0(20.0) mg/L,Z=-6.16,,P<0.05,plasma D-dimer (4 408.02±1 682.83) μg/L vs.(2 598.28±1 242.73) μg/L,t=12.15,P<0.05.But the levels of NT-proBNP,PCO2,hypersensitive c-reactive protein and plasma D-dimer reduced significantly,the level of PO2 increased more significantly in treatment group(t(z)=-6.19,-3.39,-7.16,-3.56,5.70,all P<0.05).Conclusion Phentolamine can reduce the level of NT-proBNP,PCO2,hypersensitive c-reactive protein and plasma D-dimer and increased the level of PO2 in patients with chronic cor pulmonale.Phentolamine combined with routine treatment can improve the clinical efficacy of patients with chronic cor pulmonale.