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1.
Article in Chinese | WPRIM | ID: wpr-922069

ABSTRACT

In order to provide a thorough summary and analysis over sperm toxicity evaluation of medical devices for human


Subject(s)
Humans , Male , Reproductive Techniques, Assisted , Spermatozoa , Toxicity Tests
2.
Article in Chinese | WPRIM | ID: wpr-922068

ABSTRACT

OBJECTIVE@#To introduce the test methods of embryo toxicity applied to medical devices for human assisted reproductive technology (ARTMD), and provide the evaluation reference.@*METHODS@#The embryo toxicity test methods of ARTMD were summarized, and the key procedures and challenges in their safety evaluation were also discussed.@*RESULTS@#Establishing sensitive and stable test system is important to guarantee the safety and efficacy of ARTMD.@*CONCLUSIONS@#It remains development opportunities in improving sample preparation, extending test technology and expending evaluation method.


Subject(s)
Humans , Reproductive Techniques, Assisted , Toxicity Tests
3.
Article in Chinese | WPRIM | ID: wpr-922067

ABSTRACT

OBJECTIVE@#In this paper, the key points of quality control and safety evaluation of human assisted reproductive medium were summarized to provide reference for the establishment of relevant standards and quality control in the future.@*METHODS@#Through literature research, the key factors of quality control and risk control of human assisted reproductive medium were summarized, and the problems in clinical transformation were discussed.@*RESULTS@#It is very important for the development of human assisted reproduction technology to study the active ingredients and their harmful degradation products and drugs in the culture medium of assisted reproduction.@*CONCLUSIONS@#At present, the biggest challenge is to effectively control the quality of the culture medium for human assisted reproduction, establish corresponding inspection methods and quality standards for the key components, ensure the safety and effectiveness during the product shelf life, and thus improve the success rate of human assisted reproduction technology.


Subject(s)
Humans , Quality Control , Reproduction , Reproductive Techniques, Assisted
4.
Article in Chinese | WPRIM | ID: wpr-922066

ABSTRACT

Infertility has become one of the global problems, with the continuous improvement and penetration of human assisted reproductive technology, appliance products of medical devices for assisted reproductive technology, such as aspiration needles, micromanipulator and embryo transfer catheter, have been widely used. In order to ensure the safety and effectiveness of such products, it is necessary to establish an appropriate quality control system. This paper mainly discusses the quality control points of human assisted reproductive medical devices from the aspects of raw materials, product design, production process, key performance, packaging, preservation and transportation, so as to provide technical reference for the research and development, production and supervision of such products.


Subject(s)
Cross-Sectional Studies , Humans , Quality Control , Reproductive Techniques, Assisted
5.
Article in Chinese | WPRIM | ID: wpr-922065

ABSTRACT

This study summarizes the status of domestic industries of medical devices for assisted reproductive technology, product category, the status of product classification management, the status of technical review, the progress of quality evaluation technology, and the progress of standardization. The domestic industry of medical devices for assisted reproductive technology in my country has begun to take shape, and a solid foundation has been laid for standardization and supervision technology. These will become an important driving force and guarantee for the subsequent development of medical devices for assisted reproductive technology. Under the guidance of the new development concept and the trend of accelerating the construction of the main body of the domestic cycle, my country's independent and controllable assisted reproductive medical device industry is gaining momentum.


Subject(s)
China , Humans , Industry , Reference Standards , Reproductive Techniques, Assisted , Technology
6.
Article in Chinese | WPRIM | ID: wpr-880472

ABSTRACT

Silk fibroin has the characteristics of good biocompatibility, mechanical properties, degradation performance and easy shaping, which makes silk fibroin become the focus of biomedical material preparation and research, and has received extensive attention. This article reviews the prior art methods of silk fibroin degumming, dissolution and regeneration processing. The specific applications of silk fibroin materials in the field of biomedical materials are reviewed, and the application prospects of silk fibroin in the field of biomedical materials are prospected.


Subject(s)
Biocompatible Materials , Fibroins
7.
Article in Chinese | WPRIM | ID: wpr-772550

ABSTRACT

Skin-substitute has developed rapidly and it is essential to evaluate its effectiveness before clinical use.This paper reviews the development of skin-substitute,methods to evaluate the effectiveness of skin-substitute and relevant standards.This paper highlights the and means of preclinical effectiveness evaluation and provides theoretical basis for preclinical safety evaluation of skin-substitute.


Subject(s)
Skin, Artificial
8.
Chinese Journal of Nephrology ; (12): 481-487, 2018.
Article in Chinese | WPRIM | ID: wpr-711129

ABSTRACT

Objective To investigate the clinico-pathological features and renal outcomes of primary IgA nephropathy (IgAN) with glomerular IgM deposition.Methods Primary IgAN diagnosed with biopsy from January 2006 to December 2011 were recruited.Patients were divided into groups according to IgM deposition (Group A) and without IgM deposition (Group B).In addition,Group A was subdivided into two groups based on the position of IgM deposits as the mesangium (Group A1) and both mesangium and capillary wall (Group A2).Renal outcomes were defined as end stage renal disease (ESRD) and/or the doubling of baseline serum creatinine.Clinico-pathological features were retrospectively compared.Kaplan-Meier was conducted for renal outcomes,and Cox regression model was used to analyze the prognostic value of IgM deposition and the position of IgM deposition in the progression of nephropathy in IgAN patients.Results 939 patients were enrolled with 422 (44.9%) having IgM deposition (Group A).Of the 422 patients,382 patients were divided as Group A 1,whereas 40 patients were noted as Group A2.Compared to Group B,hemoglobin,serum protein,albumin and serum IgG levels in group A were significantly lower,and the cholesterol and serum IgM levels were significantly higher (all P < 0.05).There was no significant difference in serum creatinine,estimated glomerular filtration rate (eGFR),urinary protein,blood pressure and uric acid between group A and B.In terms of pathological manifestations,patients in Group A exhibited more severe histological lesions including glomerular sclerosis,S1,M1 and interstitial inflammatory cell infiltration (all P<0.05).Immunofluorescence showed that the proportion of IgG,C1q and Fg deposition in group A was significantly higher than that in group B (all P < 0.05).By Kaplan-Meier,cumulative renal survival rate has no significant difference between Group A and B (Log-rank test x2=0.019,P=0.891).Univariate and muhivariable Cox regression analysis showed that IgM deposition had no significant effect on the renal progression in IgAN patients.Subgroup analysis showed that patients in Group A2 exhibited higher urine protein,creatinine and blood pressure,and lower eGFR and serum albumin,also had worse histological lesions including M1,E1 and T1-2 of Oxford classification (all P<0.05),Immunofluorescencc showed that the proportion of IgG,C1q and Fg deposition in group A2 was significantly higher than that in group A1 (all P < 0.05).By Kaplan-Meier,renal survival rates calculated from outcomes were lower in Group A2 (Log-rank test x2=1 8.207,P < 0.001).In addition,IgM deposited both in the mesangium and capillary wall was a risk factor for renal progression of IgAN patients with IgM deposition by a univariate Cox hazards regression mode and multivariable-adjusted Cox models (HR=3.621,95%CI 1.924-6.814,P< 0.001;HR=2.309,95%CI 1.176-4.533,P=0.015respectively).Conclusions The IgAN patients with IgM deposition relatively had more severe clinicopathological changes,especially those with IgM deposited both in the mesangium and capillary wall.In this study,IgM deposition was not found to be an independent risk factor for the prognosis of kidney in IgAN patients.However,IgM deposited both in the mesangium and capillary wall was an independent risk factor for renal prognosis in IgAN patients with IgM deposition.

9.
Herald of Medicine ; (12): 27-30, 2018.
Article in Chinese | WPRIM | ID: wpr-665260

ABSTRACT

Objective To discuss the effect of α-asarone on the expression level of Cyt-c,Smac,Caspase3 mRNA and protein in human esophageal carcinoma Eca-109 cell mitochondria. Methods The Eca-109 cells were cultured in vitro,and divided into the negative control group and the α-asarone treatment groups(final concentration:25,50,100 μg·mL-1).After 48 h,the morphological changes of Eca-109 cells were observed by fluorescence inversion microscope.The total RNA of cells were extracted by TRIzol method,the expressions of Cyt-c、Smac and Caspase3 were measured by RT-PCR and Western blotting. Results After Eca-109 cells were treated with different concentrations of α-asarone for 48 h,and obvious changes in the morphology were observed,the expressions of Cyt-c,Smac and Caspase3 genes and protein were increased significantly compared to the negative control group( P<0.05). Conclusion α-asarone can induce the human Eca-109 cells apoptosis by regulating expressions of mitochondrial apoptosis pathway correlation genes such as Cyt-c,Smac and Caspase3.

10.
Article in Chinese | WPRIM | ID: wpr-689807

ABSTRACT

Various types of medical devices used in assisted reproductive technologies (ART) should be detected for their safety by strict biological assays. Mouse embryo assay(MEA)has been recognized as one of the most important and standardized methods with the threshold more than 80% of blastocyst formation rate (BR) after 96 h culture of fertilized eggs. The disadvantage using BR for embryonic quality control has been concerned as it is ubiquitously dependent of embryonic morphology and the detailed data including molecular and genetic information is obviously missing and incomplete. This leads to the urgent requirement for more sensitive and efficient assessments for the quality control of ART. This study evaluated the reliability of an immunofluorescent MEA by counting total cell and differential number of the cells in the inner cell mass (ICM) and trophectoderm (TE) in the blastocyst. This method improved the traditional MEA, provided a sensitive and powerful platform to assess embryonic developmental viability and should be suggested as a standard assay to be globally used for the quality control of medical devices and pre-clinical procedures in ART.


Subject(s)
Animals , Blastocyst , Embryonic Development , Equipment Safety , Mice , Reproducibility of Results , Reproductive Techniques, Assisted
11.
The Journal of Practical Medicine ; (24): 1568-1572, 2017.
Article in Chinese | WPRIM | ID: wpr-619402

ABSTRACT

Objective To investigate the relationship between diabetes and bone metabolism and the potential epigenetic mechanisms. Methods BMSCs were cultured for 7 and 15 days in cell culture medium with different concentrations of glucose. The mRNA and protein expression of HDACs and osteogenesis-related genes were detected by RT-PCR and Western blot assay ,respectively. Moreover ,the combination of HDAC to the promoter region of Runx2 was tested by the chromatin immunoprecipitation (ChIP) assay. Results ThemRNA expression of osteogenesis-related genes ,incuding OCN(P < 0.05)and Col1(P < 0.05),in the bone marrow of diabetic mice was significantly reduced compared with the control mice. The mRNA and protein expression of ALP ,OCN ,Runx2 and OSX was gradually reduced with the increasing concentration of glucose ,while HDAC2 mRNA and protein expression was increased. The binding activity of HDAC2 to the upstream and downstream of Runx2 promoter region in 25mM glucose-treated BMSCs was higher than the control group(P < 0.05). Conclusoins Diabetes might repress osteogenesis of BMSCs via inhibiting the activity of Runx2 through upregu-lating the expression of HDAC2.

12.
Article in Chinese | WPRIM | ID: wpr-617060

ABSTRACT

Infertility has become a global problem affecting human reproductive health.As an important treatment for infertility, assisted reproductive technology has made great progress over the past few decades.Rapid development has also taken place in medical devices for human assisted reproductive technology.It is imperative to establish the risk management and safety evaluation system of these products.In 2016, the industry standard YY/T 1434-2016 Human in vitro Assisted Reproductive Technology With Medical Equipment in vitro Mouse Embryo Test was officially released.In this paper, the key notes and elements of this in vitro mouse embryo test are briefly reviewed.

13.
Article in Chinese | WPRIM | ID: wpr-479398

ABSTRACT

BACKGROUND:Tissue engineering scaffolds can create proper nerve regeneration microenvironment, enrich nutritional factors for nerve regeneration and promote axonal growth. OBJECTIVE:To review the progress of tissue engineering scaffolds in nerve repair in recent years. METHODS:A computer-based retrieval was performed to search ful-text articles addressing tissue engineering scaffolds used to repair nerve damage published from 2009 to 2014 in PubMed databases using the keywords of “nerve regeneration, prostheses and implants” as wel as articles published from 2004 to 2014 in CNKI database using the keywords of “nerve repair, material” in Chinese. RESULTS AND CONCLUSION: Currently, scaffold materials for nerve damage mainly include natural materials, naturaly derived materials, synthetic materials and composites, al of which have their own advantages and disadvantages. By chemical crosslinkers or chemical modification, the naturaly derived polymer can be combined with other natural or synthetic composite materials, to improve their physicochemical and biological properties, i.e., the composite scaffolds have better effects than single materials in nerve regeneration. Therefore the current research focus is composite materials. In clinical research, colagen scaffold for nerve repair has entered the clinical research stage.

14.
Article in Chinese | WPRIM | ID: wpr-465266

ABSTRACT

BACKGROUND:The blastula culture medium can assist the development of zygote from the fertilized egg to the blast blastula. The safety and quality of blastula culture medium directly influences the quality of blastula. OBJECTIVE:To evaluate the effect of blastula culture medium on the development of mouse embryos. METHODS: In this study, B6D2F1 mice were used. The female mice were superovulated and mated with male B6D2F1 mice. One day later, the zygotes were colected and cultured in the M16 medium to 4-cel stage. Then, 4-cel stage embryos were transferred into the tested blastula culture medium (experimental group). After 5 days of culture, the forming rate of blastula was examined. Meanwhile, the M16 medium containing endotoxin was used to culture 1-cel mouse zygote (positive control group). The M16 medium with no embryo toxicity was used to culture 1-cel zygote (negative control group). RESULTS AND CONCLUSION:The formation rate of blastula was 0 in the positive group, 87.1% in the negative control group, and 87.3% in the experimental group. From the results, the tested blastula culture medium could assist the 1-cel zygote growing to the stage of blastula, and the formation rate of blastula was above 80%. The tested blastula culture medium had no toxicity to the mouse embryo.

15.
Journal of Biomedical Engineering ; (6): 1058-1062, 2013.
Article in Chinese | WPRIM | ID: wpr-352114

ABSTRACT

Using the E. coli, we fabricated the gene reconstructed brain derived neurotrophic factor with a fibrin binding domain (FBD-BDNF). We then tested the neurotrophic bioactivity and fibrin-binding ability of the FBD-BDNF. The E. coli was used to express the recombinant protein. The inclusion body was purified with column chromatography and renaturated to construct the right 3D formation. In this study, we successfully fabricated the FBD-BDNF and tested the binding ability and neurotrophic activity. The results demonstrated that FBD-BDNF had special binding ability of fibrin and significant neurotrophic activity for DRG cells. FBD-BDNF could have a promising application prospect in nerve tissue engineering.


Subject(s)
Brain-Derived Neurotrophic Factor , Genetics , Escherichia coli , Genetics , Metabolism , Fibrin , Metabolism , Genetic Vectors , Genetics , Humans , Protein Binding , Recombinant Fusion Proteins , Genetics
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