Reflection and Practice on Exemption from Ethical Review / 中国医学伦理学

According to the Ethical Review Measures for Life Sciences and Medical Research Involving Humans jointly issued by the National Health Commission, the Ministry of Education, the Ministry of Science and Technology and the State Administration of Traditional Chinese Medicine in 2023, to optimize the ethical review process and reduce the burden on clinical researchers, it is proposed that some eligible situations can be "exempted from ethical review". This is a breakthrough progress in China’s ethical review management measures that firstly aimed at "exemption from ethical review". This paper reviewed and sorted out the relevant situations about exemption from review at home and abroad, focused on analyzing and exploring the four situations of exemption from review, especially discussed and analyzed the understanding of anonymization and personal sensitive information in exemption from review, and proposed practical suggestions for the four situations. Based on the actual situation of ethical review work, this paper also explored the establishment of practical standards and processes for exemption from review, providing reference for other medical institutions to implement the exemption from ethical review process.

Development, application and practical experience of clinical research integration platform of a third-class hospital in Beijing / 中华医学科研管理杂志

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.

Construction of collaborative development system of medical disciplines with dominant disciplines as the domi -nant disciplines :Taking the department of the digestive medical coordinated development center of Beijing Mu -nicipal Administration of Hospitals as an example / 中华医学科研管理杂志

Objective Taking the Digestive Medical Coordinated Development Center of Beijing Municipal Administration of Hospitals (hereinafter referred to as the "Digestive Medical Coordinated Development Center") as an example ,this paper aims to ex-plore the idea of building a collaborative development system of medical disciplines dominated by advantageous disciplines .Methods Summarizing the construction experience of the Digestive Medical Coordinated Development Center to illustrate the significance ,identify existed challenges and construction pathways of the center .Results The Digestive Medical Coordinated Development Center has built a series of public service platforms for its member institutions ,and improved the system and incentive mechanism to gather the develop-ment synergy of the center .Conclusions Based on the advantages of the collectivized management of Beijing Municipal Administration of Hospital ,the Digestive Medical Coordinated Development Center advances synchronously in the dimensions of scientific research , medical treatment ,information construction and talent ,as well as formed its own development characteristics and accumulated valuable experience for the construction of discipline collaboration center of municipal hospitals .

Gastric cancer related miR-148 a targets gastrin receptor CCKBR / 中国比较医学杂志

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.

Effect of APA Microencapsulized Bovine Chromaffin Cells Transplantation on Endogenous Opioid Peptides and Catecholamine Concentration in CSF of Cancer Pain Patients / 中国康复理论与实践

@#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.

Study of APA microcapsules in transplantation / 中国免疫学杂志

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.

Reversion of down-regulated mRNA expression for Nav1.8 in dorsal root ganglia of rats with neuropathic pain by APA microcapsulized BCCs subarachnoid transplantation / 中国药理学通报

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.