Thinking from the Perspective of Medical Institutions on Measures for Ethical Review of Life Science and Medical Research Involving Humans / 中国医学伦理学

From the perspective of medical institutions, this paper sorted out the background of the promulgation and important changes of Measures for Ethical Review of Life Science and Medical Research Involving Humans, and summarized the changes that may significantly affect the ethical review of medical institutions. It involved terminology changes and expansion of the scope of ethic review, clarification of the responsibilities and independence of the ethics committee, the refinement of the ethical review process, the emphasis on the protection of personal information and the rights and interests of subjects, and first proposal to exempt from ethical review. In addition, based on the concept of strengthening the ethical governance of science and technology in the new version of regulations, this paper shared the consideration on the governance of ethical review within medical institutions, including safeguarding the dignity and rights of subject, clarifying the role and position of ethical review, exempting the implementation of ethical review, and managing entrusted ethical review. With a view to providing a certain reference for the ethics practitioners and researchers in various medical institutions.

Reflection and Practice on the Implementation of "Exemption from Ethical Review" in Medical Institutions / 中国医学伦理学

From the perspective of medical institutions, this paper sorted out the contents of Article 32 of the Measures for Ethical Review of Life Sciences and Medical Research Involving Human regarding "exemption from ethical review". At the same time, combined with domestic and foreign regulations, this paper deeply considered and analyzed the applicable premise and special circumstances of the provisions from the implementation level, and then put forward suggestions from the perspective of practical operation of medical institutions, with a view to providing some practical guidance and reference for ethical practitioners of medical institutions.

Challenges and Countermeasures of Science and Technology Ethics Governance Faced by Research-oriented Hospitals / 中国医学伦理学

Research-oriented hospitals are the currently development direction of large hospitals, and their research ethics management has played an important role in China’s scientific and technological innovation and clinical research development through years of practice. However, at present, China’s overall scientific and technology ethics governance framework system is still incomplete, governance authority is insufficient, ethics committee members lack ethical professional technical training, and the awareness and understanding of science and technology ethics among medical staff still need to be improved, which indicates that the level of technology ethics governance in research-oriented hospitals needs to be improved. It is suggested to improve from the aspects of regulatory system, governance responsibilities, training of ethical practitioners, supervision and punishment measures, and ethical education of scientific and technological research talents, so as to better protect subjects and promote the construction of scientific and technological ethics in the research-oriented hospitals.

Characteristic Analysis and Ethical Review Strategy of Medical Device Expanded Clinical Trials / 中国医学伦理学

Extended clinical trials are medical treatment activity based on the humanitarianism to provide new medical products during the clinical trials for specific patients who have no other effective medical means to prolong life or alleviate pain. Extensive clinical trials have both medical and scientific attributes, which are significantly different from registered clinical trials and require special ethical attention. At present, the extended clinical trials in China are still in the initial stage, laws, regulations and supporting management methods are not perfect, and there is a lack of experience in ethical governance of such special clinical trials. This paper took the expanded clinical trial of medical devices as an example, referred to the current laws and regulations at home and abroad, analyzed their characteristics, and put forward some suggestions on the ethical governance of the whole process of the expanded clinical trials of medical devices in China,including special concerns in the application and acceptance, the first review approval strategy and the key points in continuing review.

Cross-country orienteering: interventions for the prevention and control of myopia among children and adolescents / 中国学校卫生

Abstract@#The visual health of children and adolescents in China has become a major issue that is relevant to the nation s present and its future. This article analyzed the value of map reading and searching for specific features during orienteering projects for myopia prevention and control. The findings suggest that orienteering exercises show good regulatory effects on eye muscles, effectively improve concentration, and help to stimulate mental activity and visual system. Targeted exercises, including scanning maps for specific features, is beneficial for myopia prevention and control. It is proposed that, by changing the teaching style of cross-country orienteering, teaching space, and teaching scene, exercises can be tailored to treat and relieve eye strain, as well as to prevent and control myopia, which is essential to promote the visual health of children and adolescents.

Correlation between trace elements levels and humoral immunity in children aged 0-9 years in Shenyang / 中国基层医药

Objective:To investigate the levels of trace elements(iron, zinc, magnesium and copper) in 0~9 years old children in Shenyang, and to explore the relationship between trace elements and humoral immunity(IgA, IgG and IgM).Methods:From September 2018 to October 2019, retrospective analysis was performed in children aged 0-9 who admitted to the Fourth Hospital Affiliated to China Medical University and underwent trace elements and humoral immunity(IgA, IgG and IgM).Results:A total of 422 children met the criteria, including 228 boys and 194 girls.The rates of iron deficiency in children aged 0-3, 4-6 and 7-9 were 17.5%, 18.2% and 14.0%, respectively, and zinc deficiency rates were 10.0%, 9.0% and 10.5%, respectively.There were no statistically significant differences in the rates of iron deficiency and zinc deficiency in each age group(χ 2=0.520, P>0.05; χ 2=0.135, P>0.05). Magnesium and copper levels in all children were in the normal range.The levels of IgA and IgG [(1.24±0.77)g/L, (9.07±3.04)g/L] in the zinc deficiency group were significantly lower than those in the normal group [(0.94±0.55)g/L, (8.18±2.11)g/L], the differences were statistically significant( t=-2.858, -2.440, all P<0.05), while there was no statistically significant difference in IgM level between the two groups( t=-0.870, P>0.05). There were no statistically significant differences in IgA, IgG and IgM levels between the iron deficiency group and the iron normal group( t=-1.346, -0.960, 0.029, all P>0.05). There was a significant positive correlation between zinc level and IgA, IgG levels( r=0.184, 0.142, all P<0.05), but there was no significant correlation with IgM( r=0.08, P>0.05). Iron, copper and magnesium levels were not significantly correlated with IgA, IgG and IgM levels( P>0.05). Conclusion:Deficiency of zinc can cause reduction of IgA and IgG, which may be related to repeated infection in children.

Clinical value of serum iron in the diagnosis and treatment of children with pulmonary infectious diseases / 中国基层医药

Objective To observe the changes of serum iron in patients with bronchopneumonia (bacterial pneumonia,mycoplasmal pneumonia) before and after treatment,and to discuss whether it can be used as an indicator of infection.Methods Forty cases with bacterial pneumonia and 41 cases with mycoplasmal pneumonia were recruited.The serum iron levels before and after treatment in bacterial pneumonia group and mycoplasmal pneumonia group were compared and analyzed.The correlation between white blood cell count,percentage of neutrophils,serum C-reactive protein (CRP) levels and the serum iron levels before treatment,and changes of the serum iron before and after treatment were analyzed.Results The level of serum iron after treatment in the bacterial pneumonia group [(16.28 ±5.81) μmol/L] was significantly higher than that before treatment [(4.83 ± 2.12) μ mol/L] (t =-11.19,P＜0.001).The level of serum iron after treatment in the mycoplasmal pneumonia group [(15.17 ±5.31) μmoL/L] was also significantly higher than that before treatment [(4.77 ± 1.99) μmol/L] (t =-11.29,P ＜0.001).The serum iron levels between the two groups before and after treatment had no statistically significant differences (t =0.135,0.898,P =0.893,0.373).There was no correlation between white blood cell count,percentage of neutrophils,CRP and serum iron levels before treatment (bacterial pneumonia group:r =-1.87,-0.219,-0.152;mycoplasmal pneumonia group:r =-0.032,-0.302,-0.274) and changes of the serum iron before and after treatment (bacterial pneumonia group:r =0.098,0.062,0.205;mycoplasmal pneumonia group:r =0.01 1,0.171,-0.105,P ＞ 0.05).Conclusion The serum iron level is significantly decreased in children with pulmonary infectious diseases and increased to normal level after anti-infection treatment.Serum iron can not be used as an indicator of infection in children.

Clinical trial investigators′ satisfaction with clinical research coordinators and discussion on managing strategy / 中华医院管理杂志

Objective To learn the investigators′ satisfaction with CRCs and to identify the shortcomings with the CRC industry or institutional management for improvement. Methods A questionnaire survey was conducted among 120 clinical trial investigators at three tertiary general hospitals in January 2018. The questionnaire covered the basics, satisfaction with CRC, and comments of the investigator on other works of the CRC. The data acquired were subject to descriptive analysis, and the count data comparison method was Fisher precise test. Results The investigators were satisfied with CRCs in general. Specifically, their satisfaction with the " sense of responsibility" , " work hours" , and " command of GCP protocols"ranged 72.6% to 83.2% . That with " initiative" , " work stability" , and " rich clinical trial experience" fell below 60.0%. Affiliation of CRCs was correlated to "initiative"(P=0.007), and "command of clinical trial schemes and trial procedures" ( P =0.043), while investigators′ satisfaction with CRCs of uncertain affiliation fell significantly. Investigators′ experience was correlated to the " command of GCP protocols" of CRCs(P=0.035 ), as the more experienced the investigator, the less their satisfaction with the CRC. Conclusions Hospitals are expected to build a CRC standardized training system and hierarchical certification system; to standardize their CRC recruitment mechanism for overall management; to enhance their budgeting capability for sufficient CRC expenses, higher investigator efficiency and assured clinical trial quality.

Determination of the Plasma Concentration of Ropivacaine in Rabbits by HPLC / 中国药房

OBJECTIVE:To determinate the plasma concentration of ropivacaine in rabbits by HPLC,and study the secu?rity of ropivacaine in rabbits.METHODS:Nine rabbits were injected with ropivacaine drop by drop with a speed of1mg/(kg?min)until the rabbits died.RESULTS:The mean plasma concentration of ropivacaine in rabbits was224.54?107.45mg/L when the rabbits died.CONCLUSION:Ropivacaine has high security in rabbits.