The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use （ICH） issued the ICH E6（R3）： Guideline for Good Clinical Practice on January 14， 2025， which will enhance the speed and quality of global clinical trials， including those in China. As the ethical， scientific and quality standards for global drug clinical trials， the highlights of the revision in the ICH E6 （R3） include encouraging innovation to improve efficiency and quality， motivating research participants to participate in the design and implementation of clinical trials throughout the process， emphasizing quality originating from design and based on the quality management of risks， as well as underlining proportionality and standalone chapter to data governance. ICH E6 （R3） adopts an appendix and appendix structure， enabling future revisions to be more convenient and efficient. ICH E6 （R3） restructures the principles section， adding two new principles and reducing the total from 13 to 11， while incorporating extensive explanatory notes. Major revisions also encompass multiple aspects， including regular review by ethics committees to ensure the safety， rights and interests， and well-being of research participants； diversification of informed consent methods， refinement of its processes， and clarification of detailed rules for minors’ consent； qualifications， authorization， and oversight of investigators and their service providers； risk-proportionate design and implementation by sponsors； joint data governance by investigators and sponsors； and the addition and revision of terms， along with updates to three appendices. The design， implementation， and review of drug clinical trials in China are increasingly aligning with international standards. ICH E6 （R3） will accelerate the revision of China’s Guideline for Good Clinical Practice， promote the speed and quality of drug research and development， and further facilitate the internationalization of China’s new drug research and development.

Non-human primates are the closest relatives of human beings and possess similar morphological， anatomical， physiological， and behavioral characteristics， making them indispensable in fields such as neuroscience， reproduction， infectious diseases， and drug research and development. Currently， the restrictions on using non-human primates in experiments are becoming increasingly stringent in Europe and the United States. These experiments have ethical particularities that are different from those involving ordinary animals， and they also pose ethical challenges such as lack of necessity assessment， no unified assessment standards， and ethical dumping hazards. Supervision and ethical review should be strengthened. The key points of their ethical review include the necessity of the experiments， the assessment of the harm-benefit ratio， and the implementation of the “3R” principles.

Objective:To study the revised content of the 2024 version of the Helsinki Declaration on vulnerability and the responsible inclusion of vulnerable participants, and to provide suggestions for improving regulations and ethics review in China. Methods:We analyzed the requirements of the Declaration of Helsinki and the preconditions for the inclusion of vulnerable groups, sorted out the international ethical principle and the relevant vulnerability provisions of China's laws and regulations, and proposed feasible recommendations for the inclusion and protection of vulnerable participants in China.Results:The Helsinki Declaration had been revised many times to involve the inclusion and protection of vulnerable participants, especially the Helsinki Declaration in 2024 for the first time proposed that vulnerability may originate from fixed or situational and dynamic factors, and vulnerability was no longer applicable to the traditional entire vulnerable group, and stipulated the prerequisites for the inclusion of vulnerable participants, because paying attention to " vulnerable groups" would affect the judgment of individual vulnerability, and should focus on the views and priorities of vulnerable individuals. Investigators and ethics committees should strengthen the identification and protection of vulnerable participants. The international ethical guidelines and China′s regulations had content on vulnerability, but there was a lack of consensus on the inclusion and protection of vulnerable participants. Conclusions:Feasible recommendations for the inclusion and protection of vulnerable participants in China include improving the relevant regulations on the inclusion of vulnerable participants in medical research, setting ethics review standards for vulnerable participants at the national level, strengthening the construction of ethics committees and training on the topic as well as clarifying key points of ethics review to maintain impartiality and avoid the misuse of vulnerable participants.

Objective:To study the revised content of the 2024 version of the Helsinki Declaration on vulnerability and the responsible inclusion of vulnerable participants, and to provide suggestions for improving regulations and ethics review in China. Methods:We analyzed the requirements of the Declaration of Helsinki and the preconditions for the inclusion of vulnerable groups, sorted out the international ethical principle and the relevant vulnerability provisions of China's laws and regulations, and proposed feasible recommendations for the inclusion and protection of vulnerable participants in China.Results:The Helsinki Declaration had been revised many times to involve the inclusion and protection of vulnerable participants, especially the Helsinki Declaration in 2024 for the first time proposed that vulnerability may originate from fixed or situational and dynamic factors, and vulnerability was no longer applicable to the traditional entire vulnerable group, and stipulated the prerequisites for the inclusion of vulnerable participants, because paying attention to " vulnerable groups" would affect the judgment of individual vulnerability, and should focus on the views and priorities of vulnerable individuals. Investigators and ethics committees should strengthen the identification and protection of vulnerable participants. The international ethical guidelines and China′s regulations had content on vulnerability, but there was a lack of consensus on the inclusion and protection of vulnerable participants. Conclusions:Feasible recommendations for the inclusion and protection of vulnerable participants in China include improving the relevant regulations on the inclusion of vulnerable participants in medical research, setting ethics review standards for vulnerable participants at the national level, strengthening the construction of ethics committees and training on the topic as well as clarifying key points of ethics review to maintain impartiality and avoid the misuse of vulnerable participants.

To further standardize the ethical review of life science and medical research involving humans,the National Health Commission,the Ministry of Education,the Ministry of Science and Technology,and the State Administration of Traditional Chinese Medicine jointly issued the Measures of the Ethical Review of Life Science and Medical Research Involving Humans in 2023.The provisions concerning research related to health information data within it include:emphasizing the protection of personal information and privacy rights,personal information can only be collected,stored,and used under the premise that research participants know and permit,and must not be disclosed to third-party without the authorization of research participants;the ethical committee should focus on reviewing the adequacy of confidentiality measures of personal information;for research that provides information and data or cooperation with external organizations,it is necessary to fully understand the research,conduct a full ethical review,and clarify the use,processing,and disposal after completion of information data through an agreement.The research institutions should improve the information data governance and supervision system in conjunction with the key points of information data management in the new regulations.The initial ethical review should focus on the risk-benefit ratio of the research,the reasonableness of the informed consent procedure,the feasibility of the opt-out procedure,the protection measures for the privacy of the research participants,and the data management capability of the research team.The knowledge training of researchers should be strengthened,policy advisory services should be provided for them,and even a unified information data management platform should be built for them from the overall level of research institutions.The ethical follow-up review emphasizes whether the researchers continue to protect the participant's right to independent information or personal information,and privacy.It is believed that through a series of governance measures,the health information data of research participants in China will be better protected,thus safeguarding their legitimate rights and interests.

Objective: This is a retrospective study of nursing 99 disable and mental retarded children with dental treatment under dental general anesthesia (DGA). This study may show a reference to nursing this kind of patients. Methods: We choose the patients in our hospital from July 2017 to July 2018. And start the special nursing for disable and mental retarded children with dental treatment under dental general anesthesia. Results: 99 cases of children with disabilities can successfully complete all oral treatment. Among them, children with social disorders account for the majority of the visiting population; among disabled children, the incidence of caries, pulpitis and periapical periodontitis was increased. Conclusions Our nursing work should be done individually for this kind of children, improve the children obedience and can ensure the treatment smoothly and successfully, reduce the pain through the treatment and improve the recovery. It will give a theoretical and practical reference of nursing this kind of children for dental treatment.

BACKGROUND: New-type tissue engineering materials and post-proliferation Schwann cells are implanted into biosynthesis tube for repairing peripheral nerve defect, which are two great developments in the field of artificial biomaterial tube.OBJECTIVE: Taking chitosan-collagen as scaffold, activated Schwann cells as seed cells, we are in attempt to observe the affinity between them as well as growth rule of activated Schwann cells on Chitosan-collagen, so as to provide basis for pre-construction of artificial nerve.DESIGN: Open experiment.SETTING: Department of Hand Surgery, Huashan Hospital Affiliated to Fudan University.MATERIALS: This experiment was conducted at the Key Laboratory of Hand Function Reconstruction, Ministry of Public Health from July 2003 to December 2003. Four male SD rats, of clean degree, were used in this experiment. Chitosan-collagen film was made in Qisheng Biomaterial Technique Institute, Shanghai, Schwann cells activator solution was made in our laboratory (self-made).METHODS: After rats were anaesthenia, the sciatic nerve was cut off to perform predegeneration for 7 days. Another anaesthenia later, the rats were euthanized. Both sides of sorciatic nerves were cut off quickly and put in the D-HANK's solution containing penicillin and streptomycin.Epineurium was eliminated and chipped into 1 mm pieces, then put in the centrifuge tube containing 5 g/L trypsinase and 0.6 g/L collagenase. 0.5 mL activator solution every 2 mL liquid was added and the activated Schwann cells were harvested with the way of two-step enzymolysis. 2×107 L-1 activated Schwann cells in 200 μL were inoculated to Chitosan-collagen film and Petri dish . Two weeks later, cellular growth was observed under phase contrast microscope and scanning electron microscope. Cellular purity was identified with S-100 staining.MAIN OUTCOME MEASURES: ① Drawing cell growth curve and confirming in vitro doubling time. ②Observation of activated Schwanri cells under an inverted phase contrast microscope. ③ Observation of activated Schwann cells inoculated on Chitosan-collagen film under scanning electron microscope.RESULTS: ① Confirmation of in vitro doubling time: Concentration of activated Schwann cells inoculated on both Chitosan-collagen and Petri dish was 2×107 L-1, the final concentration was up to 3.0×108 L-1 and 2.0×108 L-1 respectively 2 weeks later. Doubling time of activated Schwann cells cultured on Chitosan-collagen film was 4 days calculated according to DT=(t-t0) lg2/(lgn-lgn0). ②Observation of activated Schwanncells under an inverted microscope: 24 hours later, the activated Schwann cells inoculated to Petri dish mostly changed from spherical to long shuttle-shape,mutation appeared and most were two-pole shape, fewer were three-pole shape; Morphologically, there was no significant difference between activated Schwann cells inoculated on Chitosan-collagen film and on Petri dish. Activated Schwann cells inoculated to Chitosan-collagen film were like "words cayed on the sand" under phase contrast microscope and the purity was over 95%. ③ Observation of activated Schwann cells inoculated to Chitosan-collagen under scanning electron microscope: Most of activated Schwann cells grew in the introcession of Chitosan-collagen or closely to surface of Chitosan-collagen, presenting regular head-to-end connection and adhesion to Chitosan-collagen film. The cell body was fusiform,with diameter of 4-6 μm, 60-80 μm in length. Cells were shuttle-shape with some small branches. Morphology of Chitosan-collagen film was still complete at week 1.CONCLUSION: There exists great affinity between Chitosan-collagen film and high-purity activated Schwann cell; so tissue-engineering scaffold made of the two components probably promote peripheral nerve regeneration.

Schwann cells proliferate and the axis cylinder regenerates after the injury of the peripheral nerves. Schwann cells are a vital factor in the process of regeneration of injured nerves. The article summarizes the survival and apoptosis adaptation of Schwann cells after the injury of the peripheral nerves. It discusses massive NGF secreting, P75 expressing, and IGF 2, PDGF BB, NT 3 and CNTF secreting. It also supposes that there might be a homeostasis between survival and apoptosis in the proliferated Schwann cells and brings forward the question regarding reassessment of administration of NGF to enhance regeneration of the injured peripheral nerves.

10?g/L may be very valuable for diagnosis of lung cancer, especially for adenocarcinoma. Cyfra21-1 and NSE were better biomarkers for squamous cell carcinoma and SCLC, respectively. The combined detection of Cyfra21-1 and CEA could be used as a better pattern for diagnosis of lung cancer.

Objective To explore the relationship between the expression of thrombospondin-2 (TSP-2), the changes of MVD and angiogenesis in non-small cell lung cancer (NSCLC). Methods By using SP immunohistochemical staining, the expression of TSP-2 and microvessel counting were evaluated in surgically resected specimens from 55 patients with NSCLC and 30 patients' pancancerous tissues, using the anti-TSP-2 and anti-CD34 monoclonal antibodies respectively. Results Active angiogenesis took place in NSCLC tumor tissues. Microvessel density (MVD) was associated with metastasis and clinical stage of NSCLC. Expression level of TSP-2 in the tumor tissues of 55 NSCLC patients was significantly higher than that in the pancancerous tissues from other 30 patients (149.10?2.94 vs. 145.70?4.74, P