Objective?To analyze and compare the domestic quality standard and foreign quality standard of sodium hyaluronate (HA), and to expatiate on the critical process monitoring parameters.?Methods?Different quality standards of HA were compared by translating and sorting, and some experimental data were analyzed as well as the manufacturing practice was elaborated.?Results? Differences exist in raw materials standard or specifications of products between domestic and foreign, but the basic control points are concordant.?Conclusion?The company should set up reasonable and controllable quality standard based on quality requirements and related process characteristics so as to assure the safety and effectiveness of the clinical application.
Fullfield electroretinalgraphy (ffERG) is an indispensablemeans in assessment of retinal disease; it is invasive, effective, objective, quantifiable, and reproducible. Currently ffERG has been extensively applied domestically, but it also has disadvantages such as too few detected diseases, nonstandardised methodology, and inaccurate description of the results. It is important to place more emphasis on the internationalization, standardisation, and normalization of the application; obtaining the differences of indication, detection techiniques, and description of the results among ffERG, multifocal ERG and pattern ERG; expanding the new fields and methods of clinical applications. So that ffERG could play an more important role in the diagnosis and management for the patients with retinal disease.
ObjectiveTo summary the standardized management in research and applications of platelet derivatives for tissue regeneration.MethodsThe related literature about bottlenecks and standardized management of platelet derivatives in recent years was reviewed and analyzed.ResultsAlthough the platelet derivatives are increasingly used to accelerate the regenerative processes of injured joint, skin, nerve, ligament/tendon, and alveolar bone, etc., the large variation in preparation methods, diverse nomenclature, incomplete reporting system, and lack of quantitative and standardized management of the preparation process have caused uncertainty and incomparability of research and application results. In recent years, there has been a trend towards standardized research and management of platelet derivatives.ConclusionThe implementation of standardized research and quality management will contribute to promote the research and application of platelet derivatives in the field of tissue regeneration.
ObjectiveTo explore the feasibility of introducing student-standardized patients in the teaching reform of medical nursing course.
MethodsWe chose four classes of nursing students from grade 2012 between September and December 2014 as the research subjects.Cluster sampling was used to choose two classes of 84 nursing students randomly as trial group, who received student-standardized patients in their practical learning; while the rest 2 classes of 83 students were chosen as control group, who received traditional teaching method.The course scores and the effect evaluation were compared between the two groups.
ResultsThe basic knowledge test score of the trial group 31.28±4.81 was not significantly different from that of the control group 32.10±2.15(P > 0.05).The case analysis test score of the trial group 54.36±3.45 was significantly higher than that of the control group 43.12±1.37(P < 0.05).The communication ability, health education ability, skill operation ability and professional quality score of nursing students in the trial group were also significantly higher than those in the control group (P < 0.05).
ConclusionIntroducing student-standardized patients in practical teaching of medical nursing can improve the teaching effect and students' comprehensive ability.
Objective To introduce the research progress in the immune of composite tissue allotransplantation. Methods The related articles were reviewed to summarize the immune characteristics, experimental developments, and cl inical experiences of composite tissue allotransplantation. Results Composite allogeneic tissue is on the body surface, including the composition of the complex with high antigenicity. There are a lot of differences in the immune responsesbetween composite tissue allotransplantation and organ transplantation, such as immunosuppressant protocol, rejectiondiagnosis, and chronic rejection. Conclusion In the next study, it is urgently needed to learn these experiences and toestabl ish the special standard of composite tissue allotransplantation in induction of immune tolerance, local medication, and rejection diagnosis.
ObjectiveTo report the short-term outcomes of a standardized, simplified and reproducible strategy of mitral valvuloplasty (MVP), which was focused on leaflet foldoplasty and anatomic anomalies of congenital mitral regurgitation (MR).MethodsConsecutive 74 patients who underwent MVP by our standardized strategy in our institution from 2016 to 2018 were included retrospectively. There were 30 males and 44 females with a median age of 18.5 (6-146) months and weight of 15.4 (7-51) kg.ResultsAnatomic anomalies of MR included: (1) subvalvular apparatus: 72 (97.3%) patients with mal-connected chordae tendineae, 31 (41.9%) with absent chordae tendineae and 14 (18.9%) with fused or dysplastic papillary muscle; (2) leaflet: 10 (13.5%) patients with cleft of anterior leaflet, 61 (82.4%) with leaflet prolapse including 56 (91.8%) with anterior leaflet prolapse; (3) annulus: 71 (95.9%) patients with annular dilatation. Leaflet foldoplasty was performed in 61 (82.4%) patients with leaflet prolapse. All patients were successfully discharged and 4 (5.4%) patients were with moderate MR. The follow-up time was 22.0 (9.1-41.8) months. During the follow-up period, 3 patients had moderate MR and 1 patient had reoperation for severe MR. All patients were in normal cardiac function with a mean left ventricular ejection fraction of 66.0%±6.1%. In addition, the mean left ventricular end-diastolic dimension was 31.8±6.0 mm, which was significant smaller than that before the operation (t=6.090, P<0.000 1).ConclusionThe standardized leaflet foldoplasty with resection of mal-connected chordae tendineae and posterior annuloplasty technique is safe and feasible with favorable short-term outcomes in MR patients.
Cardiac surgery presents specific challenges in conducting randomized controlled trials (RCTs). The American Heart Association made a scientific statement of methodological standards, with the purpose to review key concepts and standards in design, implementation, and analysis of cardiac surgery RCTs, and to provide recommendations. Recommendations include an evaluation of the suitability of the research question, clinical equipoise, feasibility of enrolling a representative patient cohort, impact of practice variations on the effect of the study intervention, likelihood and impact of crossover, and duration of follow-up. Trial interventions and study end points should be predefined, and adequate deliverability of the trial interventions should be ensured. Every effort must be made to keep a high completeness of follow-up. Trial design and analytic techniques must be tailored to the specific research question and trial setting. In this paper, the authors made an interpretation of this scientific statement based on their practical experience.
According to the "Regulations on clinical application management of medical technologies", physicians intending to carry out restricted technologies must undergo standardized training and pass assessments in accordance with the clinical application management standards for the respective technology. As ventricular assist technology is classified as a nationally restricted technology, standardized training is one of the essential conditions for its application. This paper primarily explores the standardized training for the clinical application of ventricular assist technology in Shanghai, in light of its background, clinical application, and current training status. It proposes the training requirements for ventricular assist technology, animal training assessment standards, and clinical practice assessment standards in Shanghai, aiming to promote the standardized development and high-quality advancement of ventricular assist technology in Shanghai.
Objective To study the USA government’s administrative system about medical device standards as well as the standard making. Methods The relevant documents, regulations, website that USA Food and Drug Administration announced were extensively reviewed, knowing the USA medical device standards synthetically. Results The USA standards system of medical device included regulatory requirements and voluntary consensus standards. This article simply introduced the laws, regulations, performance standards and consensus standards. Conclusion The USA’s administrative system about medical device standards as well as many standards can be referenced.
