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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.
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The seventh article of Measures for the Ethical Review of Biomedical Research Involving Humans (2016) stipulated that medical and health institutions without an ethics committee shall not carry out biomedical research involving Humans. The Opinions on Strengthening the Governance of Ethics in Science and Technology, issued in March 2022, clearly stated that the institutions that do not meet the conditions for establishing a scientific and technological ethics (review) committee should entrust other institutions to conduct the review. The fourteenth article of Measures for Ethical Review of Life Science and Medical Research Involving Humans (2023) proposes that if an institution, which carries out life science and medical research involving humans, has not established an ethics committee or its ethics committee is not competent for ethics review, it can entrust a competent ethics committee or regional ethics committee in writing to carry out ethical review. Most medical institutions at or above the second level in China have set up ethics committees. While most universities and colleges, scientific research institutions, enterprises and grass-roots medical and health institutions have not set up ethics committees, which lack a working system to protect the safety and interests of the participants, and is difficult to conduct life sciences and medical research involving humans. At present, there is a need for some research institutions that do not have the conditions to establish ethics committees to entrust their projects of life science and medical research involving humans to other institutions for ethical review. The entrusted review is still in the exploratory stage, and there is no relevant specification. The hasty implementation of entrusted review may not achieve the goal of effectively protecting the safety and interests of the participants, and even cause legal disputes. Based on the thematic discussion, with reference to the relevant laws and regulations, departmental rules, ethical standards, and the experience of the ethics committees of some domestic institutions in implementing the entrusted review, the guideline was formulated for the reference of the current entrusted review to ensure the safety and interests of the participants.
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Ethical review is an important protective measure for research participants when conducting life sciences and medical research involving humans. "Exemption from ethical review" was proposed in The Measures for Ethical Review of Human Life Sciences and Medical Research Involving Humans issued in February 2023. To implement the exemption from ethical review within the permitted scope of laws and regulations, and to protect the privacy and rights of research participants when utilizing their data information and biological samples, multiple factors need to be considered, including the person responsible for exemption from ethical review, the conditions for exemption from ethical review, and the specific process for exemption from ethical review. As with other review procedures, exemption from ethical review also required the development of corresponding systems, implementation of responsibilities, and reliance on the construction of subject protection systems. It is hoped that this discussion can provide considerations for the implementation of exemption from ethical review.
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Objective To analyze the occupational hazards and protective measures for personnel in an iodine-125(125I) seed source production company. Methods In 2022, a 125I seed source production enterprise in Guangdong Province was selected as the research subject. The occupational hazards in the workplace of the research subject was identified using the system engineering analysis method. The FLUAK program based on Monte Carlo method was used to simulate the blocking protection of the production of the 125I seed source, and to estimate the dose of internal and external irradiation of seed source that affected workers. Results The main occupational radiation hazards in the seed production were non-sealed radioactive materials, including external irradiation from X-ray and γ ray and internal irradiation from aerosols formed by iodine volatilization. Estimated maximum dose equivalent rate around the chest and eye lens for workers were 0.52 and 0.02 μSv/h, respectively. The expected annual effective dose for workers in each work site was 0.035 mSv, and the expected annual equivalent dose to the eye lens for all workers in various work sites was 0.001 mSv. The maximum annual equivalent dose of operator's hand was 80.620 mSv. The maximum dose of internal irradiation to the worker was 18.750 mSv, which was caused by the volatilization of nuclides. Conclusion With effective protection measures for internal and external irradiation in place, the annual exposure doses for seed production personnel and operator’s hand are below the national limits. Adequate measures should be taken on hand protection.
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Objective To analyze the dose distribution of induced radiation in fixed proton beam therapy room and the influence of shielding materials, and to provide a basis for radiation protection and shielding material selection in proton therapy. Methods FLUKA was used to simulate the dose distribution of induced radiation in fixed proton beam therapy room, the dose over time, and the influence of different concrete materials. Results The dose of induced radiation was mainly concentrated around the target, and the dose rapidly decreased to 1/5-1/10 of the value at the time of stopping irradiation after cooling for 3-5 min. The induced radiation in concrete formed a slightly higher dose area at the end of the main beam near the inner side of the shield. The content of Fe, O, and H in concrete had significant effects on induced radiation (P < 0.01), and the dose was negatively correlated with the content of Fe. Conclusion The patients after proton therapy as well as the induced radiation in air and shielding materials are the main sources of external radiation dose for workers, and waiting for a period of time is the most effective way to protect the staff. Without considering the difficulty in construction and based on the analysis of shielding materials in protection against external irradiation and their influence on induced radiation, heavy concrete with a relatively high level of Fe is the best choice of the shielding material for proton therapy room.
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In November 2018, the U.S. food and drug administration (FDA) issued guidance for the development of drugs for chronic hepatitis B virus infection (draft for comments) (hereinafter referred to as draft for comments), and in April 2022, the FDA issued Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment, which has been updated with some details based on the Draft for Comments. This guidance further emphasizes the importance of HBsAg clearance in clinical trials, and classifies chronic suppressive therapy into two categories, namely noninferiority (NI) (or superiority) test with nucleos(t)ide analogues as control and add-on superiority trial with nucleos(t)ide analogues as control, and as for the latter, HBV DNA is no longer recommended as a primary endpoint of the trial, which poses a huge challenge to the development of innovative drugs targeting HBV DNA. The new finite duration therapy should aim to eliminate HBsAg and reduce virologic relapse and the risk of liver disease progression during treatment cessation. Reduction in HBsAg from baseline is not recommended as a primary endpoint for phase Ⅲ clinical trials, since the correlation between such reduction and clinical response remains unclear. In addition, this guidance also specifies the duration of treatment cessation and treatment consolidation period and the criteria for withdrawal of nucleos(t)ide analogues.
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Objective:To analyze the differences of clinicopathological features and prognosis between secretory breast carcinoma (SBC) and invasive ductal carcinoma (IDC), and to explore the influence of SBC on the prognosis of breast cancer.Methods:We retrieved data of patients diagnosed with SBC and IDC from The National Cancer Institute′s Surveillance, Epidemiology, and End Results (SEER) database between 1990 and 2016. 109 cases of SBC (SBC group) and 558 814 cases of IDC (IDC group) were collected. The clinicopathological features were compared between SBC and IDC groups. The tendency score matching method was used to match the balance confounding factors according to 1∶4 proportion. The breast cancer-specific survival time (BCSS) and overall survival time (OS) of the two histological types of breast cancer before and after matching were analyzed. The survival curve was drawn using the Kaplan-Meier method and compared with the log-rank test. Univariate and multivariate Cox regression analysis was used to determine the independent prognostic factors of breast cancer.Results:There were significant difference in diagnostic age, marital status, sex, histological grade, American Joint Committee on Cancer (AJCC) N stage, estrogen receptor (ER) and progesterone receptor (PR) expression between SBC and IDC group (all P<0.05). The BCSS of SBC group was similar to IDC group, and OS was better than IDC ( P<0.05). Univariate and multivariate regression analysis showed that diagnostic age, race, marriage, sex, location, histological grade, AJCC stage, treatment mode and ER, PR expression were all related factors affecting BCSS and OS (all P<0.05). SBC was an independent prognostic factor for OS ( P<0.05). After propensity score matching according to 1∶4, there was no significant difference in BCSS and OS between the two groups ( P<0.05). Cox regression analysis showed that AJCC T stage and PR negative expression were the influencing factors of BCSS (all P<0.05), and diagnostic age and AJCC T stage were the influencing factors of OS (all P<0.05). SBC was no longer an influencing factor of OS in breast cancer. Conclusions:There was no significant difference in prognosis between SBC and IDC. SBC was not an independent risk factor for breast cancer.
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@#<b>Objective</b> To study the dose level of proton beams outside the main shield of the 230 MeV proton therapy room with six different types of concrete as the main wall, and to obtain the shielding performance of six different types of concrete. <b>Methods</b> The FLUKA program was used to build a calculation model, and different concrete compositions were introduced into the FLUKA program to simulate the change in ambient dose equivalent rate of the focus with concrete thickness under 230 MeV proton beam irradiation. The transmission curves of six different types of concrete were fitted to obtain shielding performance parameters. <b>Results</b> On the condition that the 230 MeV proton beam irradiated to the water target in 90° direction and the concrete thickness exceeded 40 cm, the proton beam was exponentially decayed for six different types of concrete, and the fitted decay curves had a <i>R</i><sup>2</sup> of > 0.99. The linear attenuation coefficients for normal concrete, barite concrete, magnetite concrete, limonite concrete, phosphorite concrete, and ferrosilicate concrete were 0.0148 cm<sup>−1</sup>, 0.0172 cm<sup>−1</sup>, 0.0196 cm<sup>−1</sup>, 0.0219 cm<sup>−1</sup>, 0.0256 cm<sup>−1</sup>, and 0.0290 cm<sup>−1</sup>, respectively. <b>Conclusion</b> The composition and proportion of elements in concrete materials directly affect the shielding ability of concrete against proton beams to a large extent, and the shielding performance of six different types of concrete against proton beams varies greatly. Therefore, shielding materials for the proton therapy room should be selected by a comprehensive consideration of the material compositions and shielding performance of concrete, the difficulty of construction, and construction cost.
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@#<b>Objective</b> To investigate the radiation dose at the entrance of the accelerator treatment room, and to guide the radiation protection detection at the entrance of the treatment room. <b>Methods</b> The FLUKA program was used to build the model of accelerator head and treatment room. Under the simulation conditions of 10 MV and 600 cGy/min for the accelerator, the radiation dose rate inside the entrance of the treatment room was measured at different gantry angles, irradiation conditions, and labyrinths. <b>Results</b> The entrance dose rate with a water tank was significantly higher than that without a water tank under different inner labyrinth wall thicknesses and gantry angles. The entrance dose rate reached the maximum at the inner labyrinth wall thickness of 1800 mm and the gantry angle of 90°. When the inner labyrinth wall thickness was 1000 mm and the gantry angles were 0° and 180°, the entrance dose rate was significantly higher than that at other conditions. The dose rate at the entrance of the treatment room reached (82.26 ± 48.95) μSv/h to (314.09 ± 96.34) μSv/h under the following conditions: the inner labyrinth wall thickness of 1800 mm, the gantry angle of 90°, with a water tank, and the width of the inner labyrinth entrance of 1400-2200 mm. <b>Conclusion</b> The dose at the entrance of the accelerator treatment room mainly comes from the scattering and leakage radiation of the useful wire harness on the patient’s body surface, and the entrance dose rate increases with the increase in the width of the inner labyrinth entrance. In the entrance protection test, the gantry angle should be determined considering the inner labyrinth wall thickness, and the test should be performed at four angles in the uncertain case to ensure the comprehensiveness and accuracy of test results.
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ObjectiveTo explore the accuracy of clinical common serum fibrosis indexes hyaluronic acid （HA）， type Ⅳ collagen （CⅣ）， laminin （LN）， and type Ⅲ procollagen peptide （PⅢNP）， in combination with liver stiffness measurement （LSM， measured by transient elastography） and non-invasive markers of fibrosis aspartate aminotransferase to platelet ratio index （APRI） and fibrosis-4 （FIB-4） in the prediction of the hepatic fibrosis of Wilson's disease （WD） and to observe the clinical effect of Gandouling （GDL）. MethodThe data of 76 WD patients were collected and the LSM， serum fibrosis indexes （HA， PⅢNP， CⅣ， LN）， APRI， and FIB-4 before treatment were recorded. The correlation of LSM with serum fibrosis indexes， APRI， and FIB-4 was discussed via Pearson′s correlation analysis. According to the therapeutic schemes， patients were classified into the control group （36 cases） and treatment group （40 cases）. Patients in control group were treated with sodium dimercaptopropylsulfonate （DMPS）， while those in the treatment group received GDL in addition to the western medicine therapy. The treatment lasted 6 courses （8 days/course） and the influence of GDL on the indictors was evaluated. ResultHA， CⅣ， LN， PⅢNP， APRI， and FIB-4 were in positive correlation with LSM （r=0.517， 0.438， 0.281， 0.457， 0.778， 0.847， P<0.01）. HA， CⅣ， LN， and PⅢNP in the treatment group were lower after treatment than before treatment （P<0.05， P<0.01）. HA， CⅣ， and LN in the control group were lower after treatment than before treatment （P<0.05， P<0.01）， and PⅢNP showed no significant difference. LSM， FIB-4， and APRI in both groups decreased after treatment （P<0.05）. After treatment， LSM， FIB-4， APRI， HA， and PⅢNP in the treatment group were lower than those in the control group （P<0.05， P<0.01）， but CⅣ and LN demonstrated no significant difference from the control group. ConclusionLSM in combination with serum fibrosis indexes （HA， PⅢNP， CⅣ， LN）， FIB-4， and APRI can help accurately identify the level of the hepatic fibrosis in WD. Moreover， on the basis of decoppering by western medicine， GDL can significantly improve the liver function and hepatic fibrosis of WD patients.
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Objective To understand the prevalence of nosocomial infection and its potential risk factors through a cross-sectional study, to construct a predictive model of the probability of nosocomial infection, and to provide a basis for nosocomial infection management. Methods The prevalence rate of nosocomial infection and potential risk factors of all inpatients in a tertiary general hospital were investigated on a certain day. The possible risk factors of nosocomial infection were analyzed, and a nomogram prediction model on the probability of nosocomial infection was established. The calibration curve and ROC curve were used to evaluate the predictive efficiency of the model. Results A total of 419 hospitalized patients were investigated, and the prevalence rate of nosocomial infection was 3.58%. The top three nosocomial infections were in ICU, neurosurgery, and cardiac surgery. The top three infection sites were surgical site infections, lower respiratory tract infections, and urinary tract infections. The results of univariate analysis showed that the length of hospital stay, surgery, antimicrobial use and underlying diseases were statistically related to the occurrence of nosocomial infections (all P<0.05). Logistic regression analysis showed that compared with the length of stay (LOS)＜14, the risk of nosocomial infection in patients with long LOS (≥14) was 5.48 (95% CI: 1.68-19.16). The risk of nosocomial infection in patients with two basic diseases was 7.61 times that (95%CI: 1.50-44.79) of patients without underlying diseases. The risk of nosocomial infection in patients with surgery was 4.88 times that of patients without surgery (95%CI: 1.47-19.6). According to the coefficients of the related risk factors calculated by logistic regression, a nomogram model of the occurrence probability of nosocomial infection was established. The C-index of the model was 0.839, and the area under the ROC curve for predictive efficiency was 0.809 (95%CI: 0.740-0.942). Conclusion Nosocomial infection control and management should be strengthened. Individual risk assessment of patients' nosocomial infection should consider about the age, underlying diseases, surgical status, glucocorticoid or immunosuppressive agents, and antimicrobial drug use. It is essential to identify the high-risk groups as soon as possible and take prevention and control measures to reduce the prevalence rate of nosocomial infection.
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Objective@#To investigate the expression of macrophage migration inhibitory factor (MIF) in pulmonary tissues from patients with chronic obstructive pulmonary disease (COPD) and the relationship with its clinical features.@*Methods@#One hundred and eighty patients who underwent pulmonary bullectomy lobectomy due to pneumatocele from January 2015 to September 2018 in Longgang Central Hospital were enrolled and classified into patients without COPD (control group)and patients with COPD (COPD group), with 90 patients each group. According to the lung function parameters, 90 patients with COPD were divided into the mild COPD group, the moderate COPD group, and the severe COPD group. The levels of mRNA and protein of MIF were measured with RT-PCR, ELISA and Western blot. One-way ANOVA, Pearson correlation analysis and SNK-q test were used to analyze the results with SPSS 18.0, and P<0.05 was considered statistically significant.@*Results@#The level of MIF in pulmonary tissues from the control group was obviously lower than those in the COPD group (P<0.05). The level of MIF in pulmonary tissues in the severe COPD group was obviously higher than those in pulmonary tissues in the mild COPD, moderate COPD and control groups (P<0.05). MIF was positively correlated with the lung function parameters (P<0.05).@*Conclusion@#The high expression of MIF in pulmonary tissues is closely related to the severity of COPD.
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Objective To understand the epidemiological characteristics of recent brucellosis in Hohhot.Methods Clinical data of patients with brucellosis in Hohhot City were retrospectively analyzed,and the patients were diagnosed in the outpatient clinic of Comprehensive Center for Disease Prevention and Control of Inner Mongolia Autonomous Region from 2014 to 2017.To analyze the patient's area,age,gender,occupation and time distribution of the disease.Results A total of 1 940 patients with brucellosis were diagnosed in Hohhot from 2014 to 2017,with an average age of 50.8 years old.There were 1 464 males with an average age of 50.4 years old and 476 females with an average age of 51.9 years old;the male-female ratio was 3:1.The number of cases of brucellosis in 2014-2017 was 612,649,402,and 277,respectively.Brucellosis was mainly distributed in three districts including Horinger County (937 cases),Tumd Left Banner (236 cases) and Tuoketuo County (191 cases),accounting for 70.31％ (1 364/1 940) of the total number of cases in the city.The age of onset was at least 1 year old,the oldest age was 86 years old,and most cases were in the 45-＜ 65 age group,the total number of cases was 1 046,accounting for 53.92％ (1 046/1 940) of the total number of cases in the city;the occupational distribution was mainly farmers (1 795 cases),herders (13 cases) and veterinarians (17 cases),with a total of 1 825 cases,accounting for 94.07％ (1 825/1 940).The time distribution was mainly concentrated in March-July,and the number of cases was 1 157 cases.Conclusions The number of brucellosis cases in Hohhot area of Inner Mongolia is mainly from Horinger County,Tumd Left Banner and Tuoketuo County;the cases occur frequently in Spring and Summer;the age of onset is mainly between 45-＜ 65 years old,they are mainly male farmers.
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Objective To investigate the expression of macrophage migration inhibitory factor (MIF) in pulmonary tissues from patients with chronic obstructive pulmonary disease (COPD) and the relationship with its clinical features.Methods One hundred and eighty patients who underwent pulmonary bullectomy lobectomy due to pneumatocele from January 2015 to September 2018 in Longgang Central Hospital were enrolled and classified into patients without COPD (control group) and patients with COPD (COPD group), with 90 patients each group. According to the lung function parameters, 90 patients with COPD were divided into the mild COPD group, the moderate COPD group, and the severe COPD group. The levels of mRNA and protein of MIF were measured with RT-PCR, ELISA and Western blot. One-way ANOVA, Pearson correlation analysis and SNK-qtest were used to analyze the results with SPSS 18.0, andP<0.05 was considered statistically significant.Results The level of MIF in pulmonary tissues from the control group was obviously lower than those in the COPD group (P<0.05). The level of MIF in pulmonary tissues in the severe COPD group was obviously higher than those in pulmonary tissues in the mild COPD, moderate COPD and control groups (P<0.05). MIF was positively correlated with the lung function parameters (P<0.05).Conclusion The high expression of MIF in pulmonary tissues is closely related to the severity of COPD.
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Objective To investigate the expression of hypoxia-inducible factor-1α (HIF-1α) in patients with traumatic brain injury (TBI) and their clinical significance. Methods Peripheral blood and brain tissue samples were obtained from 60 TBI patients. According to the GCS score, 60 TBI patients were divided into the moderate damage group, the severe damage group and the especially severe damage group. According to the different time points after the injury, the patients were divided into <6 hours group, 6-24 hours group, 24-72 hours group and >72 hours group. The 60 control brain tissue samples were obtained from patients with cerebral aneurysms and undergoing craniotomy at the same time; and control peripheral blood were collected from 60 healthy people. The levels of HIF-1α were measured with RT-PCR and Western blot . One-way ANOVA and t-test were used to analyze the results with SPSS 18.0. Results The expression of HIF-1α in the control group [peripheral blood: HIF-1α mRNA (0.35±0.12), HIF-1α protein (0.28±0.06) ;brain tissue: HIF-1α mRNA (0.65±0.08),HIF-1α protein (0.78±0.08)] was obviously lower than those in the TBI groups, and the differences were statistically significant (P<0.05). Along with the damage degree aggravating, the expression of HIF-1α was increased. The expression of HIF-1α in the especially severe damage group was statistically higher than those of the severe damage group and the moderate damage group (P<0.05). The expression of HIF-1α was increased along with the extension of time after the injury. The expression of HIF-1α in the 24-72 h group was significantly higher than those of the >72 h group, 6-24 h group and <6 h group (P<0.05). Conclusions The expression of HIF-1α is closely related to the severity of TBI and may play an important role in the progress of TBI.
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Through the questionnaire survey on the current situation of human research ethical management in Beijing medical and health institutions, this paper analyzed the problems existing in ethical management of Beijing medical and health institutions and put forward corresponding countermeasures and suggestions. The results showed that overall status of human research ethical management in Beijing medical and health institutions was satisfying. But the ethical management levels of different types of medical and health institutions were quite different, and medical and health institutions, health family planning administration departments and academic teams should all make corresponding contributions.
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Objective To explore the clinical value of maternal and umbilical blood inflammatory markers,interleukin-6 (IL-6),neutrophil-to-lymphocyte ratio (NLR),C-reactive protein (CRP) and procalcitonin (PCT),in the diagnosis of histologic chorioamnionitis (HCA).Methods A total of 102 suspected chorioamnionitic cases were enrolled from January 2014 to July 2017.They were assigned into two groups based upon postpartum histopathological examination of placenta:HCA group (48 cases) and control group (54 cases).Maternal and umbilical blood samples were collected for routine blood test and tested for IL-6,NLR,CRP and PCT levels.T,Mann-Whitney U or Chi-square (or Fisher's exact) test was used for data comparison.Meaningful indicators in maternal and umbilical cord blood were analyzed by logistic regression analysis and correlation analysis.At the same time,receiver operating characteristic (ROC) curve was drawn to evaluate their diagnostic values.Results (1) IL-6 level and NLR in maternal blood in HCA group were higher than those in control group [6.95 (2.40-13.50) vs 3.90 (2.30-9.20) pg/ml,Z=-5.147;5.03 (1.92-9.20) vs 3.94 (1.85-11.17),Z=-3.097;both P＜0.05],and the levels of white blood cells,neutrophile granulocytes,CRP and IL-6 as well as NLR in umbilical cord blood were also higher [(9.4± 2.0)× 109/L vs (8.6 ± 1.4)× 109/L,t=-2.522;(6.87t1.62)× 109/L vs (5.99± 1.26)× 109/L,t=-3.071;12.30 (0.50-89.04) vs 3.18 (0.50-88.93) mg/L,Z=-4.519;(8.78±2.56) vs (4.78±1.45) pg/ml,t=-7.025;(4.45±1.36) vs (3.78±1.22),t=-3.020;all P＜0.05].(2) Logistic regression analysis showed that elevated levels of IL-6 and NLR in maternal blood and CRP and IL-6 in umbilical cord blood were independent risk factors for HCA [OR (95％CI):1.65 (1.32-2.06),1.34 (1.02-1.77),1.05 (1.00-1.11) and 2.39 (1.72-3.32),all P＜0.05].Positive correlations were found between the levels of IL-6 in maternal and umbilical cord blood,and between NLR in maternal blood and CRP level in umbilical cord blood (correlation coefficient:0.680 and 0.230,both P＜0.05).(3) IL-6 level in umbilical blood was of the greatest value in the diagnosis of HCA among all single markers,followed by IL 6 in maternal blood,CRP in umbilical blood and NLR in maternal blood [area under the ROC curve (AUC):0.904,0.796,0.760 and 0.678].When two indexes were combined,NLR in maternal blood+IL 6 in umbilical cord blood showed the highest diagnostic value,followed by,IL 6 in maternal blood+CRP in umbilical cord blood,IL-6+NLR in maternal blood and NLR in maternal blood+CRP in umbilical cord blood (AUC:0.917,0.870,0.823 and 0.791).When three indexes was used in combination,the diagnostic value of IL-6 in maternal and umbilical cord blood+NLR in maternal blood was higher than that of IL-6 and NLR in maternal blood+CRP in umbilical cord blood (AUC:0.919 and 0.836).(4) There were 13 cases (27.1％) with neonatal complications in HCA group and two (3.7％) in control group (P＜0.05).Conclusions Changes in NLR and IL-6 levels in maternal blood and NLR,IL-6 and CRP levels,and white blood cells and neutrophile granulocytes counts in umbilical cord blood are associated with HCA.The diagnostic efficacy of two indexes combined is superior to that of single index,while the combination of three indexes can significantly improve the diagnostic accuracy and authenticity.
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OBJECTIVE: To investigate the current status and influencing factors of occupational stress in female workers of labor-intensive enterprises. METHODS: Totally 910 female workers from 5 labor-intensive enterprises in Guangdong Province was selected as the research subjects by random cluster sampling method. A questionnaire survey on occupational stress was conducted using the Occupational Stress Inventory-Revised Edition. RESULTS: Among the 910 female workers,14. 9%( 136/910) showed medium or higher scale on occupational role level,20. 1%( 183/910) showed medium or higher scale on occupational stress level,and 21. 4%( 195/910) showed medium or higher scale on personal resources lack. Multivariate logistic regression analysis indicated that the risk of occupational stress was high in single female workers and/or those exposed to occupational hazards( P < 0. 01). The higher the occupational role level,the higher risk of occupational stress( P < 0. 01). The less personal resources,the higher risk of occupational stress( P < 0. 01).CONCLUSION: Some female workers in labor-intensive enterprises showed medium or higher occupational stress level. The main influencing factors of occupational stress are marital status,exposure to occupational hazards,occupational role and personal resources.
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Objective To analyze and research the Chinese medicine of tonifying kidney recipe on the mechanism of recurrent spontaneous abortion IL-4, IFN-gamma cytokine.Methods60 patients in accordance with the inclusion criteria with recurrent miscarriage from January 2013 to December 2015 were selected, according to the random number table method, the patients were randomly divided into Chinese medicine group, Western medicine group,Combine traditional Chinese and western medicine group, Chinese medicine group treated with traditional Chinese medicine of tonifying kidney recipe, Western Medicine group were given intramuscular injection of progesterone injection,combining traditional Chinese and Western medicine group was treated with acupuncture combined with progesterone Chinese medicine.The course of treatment was 15 days, before and after treatment in patients with pregnancy outcome and IL-4, IFN-gamma levels.ResultsThere was no significant difference between the three groups before treatment with IL-4 and IFN-.After treatment,compared with the traditional Chinese and Western medicine group, western medicine group, Chinese medicine group of IL-4, IFN-, respectively, showed a rise and fall, the difference was statistically significant(P<0.05).After treatment, compared with the traditional Chinese medicine group, the IL-4 and IFN-of the western medicine group were increased and decreased, respectively, and the difference was statistically significant (P<0.05).Combination of traditional Chinese and Western medicine to obtain a higher clinical cure rate.ConclusionThe combination of TCM and Western medicine for improving the efficacy of pregnancy outcome of recurrent spontaneous abortion and exact expression may obviously improve the IL-4 and IFN-gamma, help to improve the IL-4, reduce the expression of IFN-gamma, improve the outcome of pregnancy.
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Objective:This thesis aims to construct the evaluation index system ethics management in Beijing medical institutions for application research.Method:The author applied the evaluation system which was agreed and adjusted by expert groups in four medical and health institutions.Result:After three rounds of expert groups have reached the agreement,the Evaluation Index System on Human Research Ethics Management in Beijing Medi-cal Institutions is established,which contains 6 first-class indicators,16 second-class indicators and 39 third-class indicators.The application on four medical and health institutions show that the evaluation index system is practical,operable and is of high degree of distinction.Conclusion:The evaluation index system is scientific,rea-sonable,practical and is of high degree of validity,credibility and distinction.