Objective:To study the immunoisolation effects of alginate-polylysine-alginate(APA)-microcapsules in vito.Methods:To observe changes of cellular immune and tectology of sheeps after hollow microcapsules, Bovine Chromaffin Cells(BCCs) and APA Microencapsulated BCCs(APA-BCCs) transplanted to the spinal subarachnoid space.Results:The blood lymphocyte numbers of each group didn't change; APA-microcapsule could prevent blood CD4 +T lymphocyte , CD4 +/CD8 + and CSF lymphocyte from increasing caused by BCCs transplantation; APA microencapsulation could reduce histological reactions in transplantation area and prolong the survival of the transplant.Conclusion:APA microcapsules possess the immunoisolation effects and can efficiently prevent immunoreactions.

AIM To invesigate the effect of subarachnoid transplantation of APA microcapsulized bovine chromaffin cells (BCCs) on mRNA expression for Nav1.8 in the dorsal root ganglia neurons(DRG) of rats with neuropathic pain by means of in situ hybridization. METHODS SD rats were randomly divided into four groups of five. Normal rats were used as control group (group C). Rats with right sciatic nerve been ligated were used as CCI group. Five to six hundred empty APA microcapsules(group APA) or 5?10 6 APA microcapsulized BCCs (group APA-BCCs) were grated into subarachnoid space of CCI rats 7 days after operation. Allodynia and hyperalgesia were measured by Von-Frey filaments and CO 2 laser 7 days after transplantation. DRG in lumbar four and five was taken out and 15 ?m freezing sections were made 7 days after tansplantation. Sections was used to detect mRNA expression for TTX-resistent Na + Nav1.8 by in situ hybridization with Dig-labeled RNA probe. RESULTS The mRNA hybridization signal for Nav1.8 in DRG of group CCI and group APA was lower than that of group C. The expression of mRNA for Nav1.8 in DRG was higher in group APA-BCCs than that in group CCI and group APA with abatement of allodynia and hyperalgesia. There was no difference in the mRNA hybridization signal for Nav1.8 in DRG between group APA-BCCs and group C. CONCLUSION mRNA expression for Nav1.8 in DRG of CCI ratswas down-regulated. APA microcapsulized BCCs grafting can reverse the down-regulation of mRNA expression for Nav1.8 in DRG of CCI rats. Restoration of mRNA expression for Nav1.8 in DRG contributes to the analgesic effect of subarachnoid transplantation of APA microcapsulized BCCs.

Objective To observe the effect of APA-BCC(alginate-polylysine-alginate microencapsulated bovine adrenal medullary chromaffin cells)microcapsules transplantation into the subarachnoid space of cancer pain patients on endogenous opioid peptides and catecholamine concentration in cerebrospinal fluid(CSF).Methods The different doses of APA-BCC microcapsules were transplanted into the spinal subarachnoid space of cancer patients with moderate or serious pain.The concentrations of Leu-enkephalin(L-EK),β-endorphin(β-EP),dynorphin A(DynA),noradrenaline(NA)and adrenaline(AD)in CSF were tested.Results L-EK concentration in CSF increased remarkably after transplantation,and the increase was most remarkable when transplantation doses were 1.0×107and 1.25×107;there were no remarkable changes of β-EP,DynA,NA and AD after transplantation.Conclusion The analgetic effects of APA-BCC microcapsules tranplantation may correlate with the increase of L-EK in CSF of cancer pain patients;the dose of 1.0×107 and 1.25×107cells may be the most effective dose.

Objective To investigate the regulation role of gastric cancer related miR-148a on gastrin receptor CCKBR expression, and find the correct binding sites of miR-148a in CCKBR 3’UTR.Methods The potential binding sites of miR-148a in the CCKBR 3’UTR were predicted with the bioinformatic tools;The miR-148a expressing plasmid was constructed by PCR, and miR-148a expression was verified by Northern Blot;The luciferase report plasmids containing the wild type and mutated binding sites of CCKBR 3’ UTR were constructed, and were used to study the regulation mechanism and identify the binding sites of miR-148a by luciferase activity analysis; The regulation effect of miR-148a on CCKBR protein expression was checked by Western Blot.Results Three potential binding sites of miR-148a in the CCKBR 3’ UTR were found; The miR-148a expressing plasmid was constructed successfully, and highly expressed miR-148a after transfected to gastric cancer cells;The inhibitory effect of miR-148a on CCKBR protein expression was checked by Western Blot.Over-expression of miR-148a inhibited CCKBR expression by directly binding to the binding site in CCKBR 3’UTR 423bp.Conclusion CCKBR is a target of miR-148a, and its expression is inhibited by the binding of miR-148a on its 3’ UTR, indicating that miR-148a may participates in the progression of gastric cancer by regulating CCKBR expression.

This paper summarizes the current situation and problems of the research on the theory of "Taibai Seven Medicines" through literature summary and surveys. Although the "Four Beams and Eight Pillars" theory of compounding has a long history, the current research progress of "Taibai Seven Medicines" is mostly focused on plant resources. There lacks researches on the theory of compounding, or development of compounding and large varieties based on "Taibai Seven Medicines". We call for the inheritance and protection of folk experience, and hope that the "Four Beams and Eight Pillars" theory can guide the application and development of the seven Taibai medicines. Therefore, increasing the research on the theory and teaching in undergraduate courses formulary in Chinese medicine are necessary in our province.

Medical institutions are not only the research and development end,but also the application end of innovative achievements,which makes the transformation of medical scientific and technological achievements different from the others in colleges and universities.It also faces new problems and challenges in ethical governance.Meanwhile,the ethics of promoting the transformation of medical scientific and technological achievements also needs to be paid attention to and maintained.Improving people's health level and quality of life are the ultimate ethical goals of process supervision.The objectives,systems,and behaviors of ethical evaluation need to have their own emphasis to avoid repeated evaluation,improve evaluation efficiency,and ensure the ethics of evaluation work itself.This paper discusses the specific classification and common forms of ethical challenges in the supervision of the transformation process of achievements in medical institutions.It is suggested to focus on ethical values to improve the legal system,clarify the relationship between the public welfare and transformation profitability of medical institutions,and explore new positions of the transformation advantages in medical institutions.

Objective:To explore the development, application and practical experience of investigator-initiated integrated clinical research information platform.Methods:The process of developing and constructing an integrated clinical research platform in a tertiary hospital in Beijing was introduced, the functions and advantages of the platform were described and displayed, and the main problems and risk points in the development and construction process were analyzed.Results:The integrated clinical research platform meets the management requirements of clinical research initiated by investigators, and the standardized management of the whole life cycle of the project can be realized through the platform, and the key issues of data security, information capture, sharing and interoperability need to be further explored in terms of platform docking.Conclusions:The integrated clinical research platform effectively improves the standardization, management quality and efficiency of investigator-initiated clinical research.

Objective:To assess the current situation, advantages, and difficulties of standardized management in Investigator-Initiated Clinical Trials (IIT).Methods:This article summarized the requirements and policies for clinical research management, the development of clinical research domestically and internationally, the achievements and advantages of clinical research management development in China, and the main problems and difficulties with the standardized IIT management in China, and compiled the experiences and models of several medical institutions in IIT management.Results:While China has a large number of clinical medical publications and is ranked high in the world, the quality of the publications needs to be further improved. Domestic management requirements for IIT were gradually improving, providing a basis for medical institutions to implement standardized management throughout the lifecycle of IIT, and achieve certain progress. However, there were still challenges in the departmental divisions, the unification of management standards, whole-process management and quality control, the scientific review, high-risk project management, and registration.Conclusions:Drawing on the excellent experience of domestic medical institutions, measures including identifying a primary responsible department, establishing unified supervision and inspection standards, and implementing a whole life cycle management may help overcome the challenges in IIT management and improve the quality and efficiency of IIT management.

To meet China′s requirements for scientific and technological innovation and high-quality development in the new era, it is imperative to actively implement the innovation-driven development strategy and build high-level research hospitals. Beijing Friendship Hospital, Capital Medical University has been working to build a research hospital since 2018. The hospital promoted discipline construction through the development mode of discipline clusters, made the research wards as a platform, adopted the " shared comprehensive service" mode to improve the quality and efficiency of clinical research, and strengthened talent cultivation through such key measures as a new talent recruitment system. The mode has proved successful in such aspects as improving the ranking of scientific and technological value of hospitals and disciplines, introducing high-level talents, and outputting scientific and technological achievements, supporting by research wards for other departments of the hospital, and improving the efficiency and quality of clinical trials. Such a mode can provide reference for general hospitals in building research hospitals.

Faced with the increasing demand for technological innovation, how to effectively carry out and regulate the export of medical-related scientific research data has become an urgent issue. The author reviewed the current requirements and status of data export in China and abroad, as well as the relevant requirements for medical data management in China, and introduced the practical experience of the first data compliance export case of medical field in China. In view of the main difficulties in the management of medical-related scientific research data export, such as the lack of multi-professional background members of the project team, the difficulty in writing professional documents, the relatively single template, the lack of personalized templates suitable for different professional field, and the need for homogenization of regulatory standards and requirements, it is proposed to rely on a qualified third-party platform in the form of entrusted business, adopt the optional mode under the general declaration template, establish unified regulatory standards, pay attention to the important data and national core data involved in the data export, pay attention to the ethical issues, and replace the original data with derivative data, and keep to " necessity principle" and " minimization principle", so as to provide reference for medical institutions and management departments to strengthen the standardized management and security guarantee of medical-related scientific research data export.