Discussion of Application Status and Key Attentions on Registration for Ossicular Replacement Prosthesis / 中国医疗器械杂志

The ossicular replacement prosthesis should have good biocompatibility, stability, easy to install, and excellent sound transmission capacity. In this study, the characteristics of ideal materials for the ossicular replacement prosthesis were analyzed by searching the types of materials used in clinical practice and comparing the advantages and disadvantages of various materials and structures. At the same time, in combination with the current evaluation requirements and evaluation experience, the focus of the performance research project of ossicular replacement prosthesis in the process of registration is discussed to clarify the performance evaluation requirements of these products, so as to provide reference for the future work of manufacturers and regulators. The performance evaluation of ossicular replacement prosthesis focuses on its mechanical properties, fixation stability, sound transmission characteristics, biological characteristics, and magnetic resonance compatibility.

Discussion and Concern on Animal Study for Orthopaedic Implantable Devices / 中国医疗器械杂志

In recent years, new orthopaedic implantable devices continue to emerge, which require higher requirements for technical evaluation. Animal study is an important part of the research and development process for the new orthopedic implantable devices, which provides relevant evidence for product design and stereotyping. By introducing the purpose of animal study, and the application of 3R principle (replacement, reduction, refinement) in this field, we summarize the concern on the animal study, in order to provide reference for the development and research of new orthopedic implantable devices and biomaterials. At the same time, the application of evidence-based research methods such as systematic review in the field is introduced, which provides new tools and approaches for the technical review and regulatory science.

Concerns of Technical Evaluation on Registration of All-inside Meniscus Suture System / 中国医疗器械杂志

OBJECTIVE@#To summarize the product registration declaration ideas and registration technical review of the all-inside meniscal suture system, and to systematically think about of the technical review concerns of the all-inside meniscal suture system products to provide technical guidance for improving the quality of registration and application and regulatory efficiency.@*METHODS@#Consult the public information of such products at home and abroad, and summarize the experience of registration review of such products.@*RESULTS@#The technical review of the all-inside meniscus suture system registration mainly focuses on product basic information, pre-clinical research, clinical evaluation and product technical requirements.@*CONCLUSIONS@#The difficulty of product registration and declaration of the all-inside meniscus suture system lies in the provision of pre-clinical research data of the product, and the applicant needs to strengthen the basic research ability, formulate scientific technical indicators and test methods to ensure the safety and effectiveness of the product, and also provide sufficient supporting data for the registration declaration.

Immune responses elicited by influenza A mRNA vaccine based on lipopolyplex-encapsulated virus nucleoprotein and matrix protein 2 extracellular domain fusion in mice / 中华微生物学和免疫学杂志

Objective:To evaluate the immunogenicity of a novel influenza virus mRNA vaccine based on conserved antigens delivered by lipopolyplex (LPP) platform in a mouse model.Methods:Four copies of genes coding for extracellular domain of matrix 2 protein (M2e) and nucleoprotein (NP) of influenza A virus were synthetized after codon optimization. The fusion antigens were transcribed in vitro and delivered by LPP platform, named as LPP-4M2eNP. Expression of M2e and NP in eukaryotic cells was detected by immunofluorescence assay (IFA). BALB/c mice were inoculated intramuscularly twice with 10 μg or 30 μg LPP-4M2eNP vaccine at an interval of four weeks. Antibody response was detected by ELISA and cellular-mediated immunity (CMI) was detected by enzyme-linked immunospot assay (ELISPOT). Results:IFA showed that NP and M2e were expressed correctly in eukaryotic cells. Single dose immunization could induce significant antigen (NP, M2e)-specific CMI and antigen (NP, M2e)-specific antibody response was induced in mice with Th1 type bias after boost immunization. Moreover, NP-specific CMI was increased significantly after the second immunization, while no significant change in M2e-specific CMI was observed.Conclusions:Stronger CMI was triggered in mice by single dose of LPP-4M2eNP vaccine. Furthermore, robust humoral and cellular immune responses were induced after boost immunization. This study suggested that LPP-4M2eNP vaccine, which based on conserved antigen of influenza A and delivered by LPP platform, had great potential for development and application.

Analysis of Key Points and Difficulties in Registration Application of Inflatable Bone Expander / 中国医疗器械杂志

With the advantages of inflatable bone expander in the treatment of osteoporotic vertebral compression fractures, the number of applications for registration of such products is increasing. Based on the characteristics of the medical device, this article analyzed and summarized the relevant requirements for the basic information, product performance research, product manufacturing, clinical evaluation, and product instructions that should be focused on the registration application dossiers, as well as comply with the requirements of CMDE. The focus of the registration application for Inflatable Bone Expander should be the standardization of the application dossiers, while the difficulty was the scientific rationality of the research data. Comments and suggestions are provided to relevant practitioners on standardization of registration application dossiers. It may help them to optimize the quality of registration application dossiers while improve the efficiency of registration applications.

Research advances in nonalcoholic fatty liver disease in lean individuals / 临床肝胆病杂志

The incidence rate of nonalcoholic fatty liver disease (NAFLD) is continuously increasing in the world, and NAFLD is a major cause of chronic liver disease in developed countries such as the United States and may become the most common chronic liver disease in China in the future. NAFLD is often observed in the obese population; however, it is also commonly seen in lean individuals. This article summarizes the latest studies on lean NAFLD and elaborates on the following pathogeneses of this disease: the change in single nucleotide polymorphism is one of the predisposing factors for NAFLD in the lean population; the change of gut microbiota and sarcopenia may induce a variety of metabolic disorders including hyperlipidemia, hyperuricemia, insulin resistance, and iron metabolic disorders, and such metabolic disorders may promote the development of NAFLD; in addition, unhealthy dietary habits and lifestyle may contribute to the accumulation of fat and increase the burden of the liver. The combined effect of these factors eventually lead to the development of NAFLD, but further studies are still needed to clarify the pathogenesis of lean NAFLD.