Expression of BZW2 and IVD in hepatocellular carcinoma tissues and effect on prognosis of liver transplant recipients with hepatocellular carcinoma / 器官移植

Objective To investigate the expression levels of basic leucine zipper and W2 domain 2 (BZW2) and isovaleryl-CoA dehydrogenase (IVD) in hepatocellular carcinoma (HCC) and evaluate their effect on clinical prognosis of liver transplant recipients with HCC. Methods Pathological specimens and clinical data of 87 liver transplant recipients with HCC were collected and retrospectively analyzed. The recurrence and metastasis of HCC after liver transplantation were assessed. Immunohistochemical staining was used to detect the expression levels of BZW2 and IVD. The relationship between BZW2, IVD and clinicopathological parameters of HCC and their effect on postoperative recurrence and clinical prognosis of the recipients was analyzed. Results Among 87 recipients, 31 cases recurred with a recurrence rate of 36%. HCC recurred at postoperative 2-49 months and the median recurrence time was postoperative 7 months. Immunohistochemical staining demonstrated that the positive expression rate of BZW2 in the HCC tissues was significantly higher than that in normal liver tissues (76% vs. 30%), and the positive expression rate of IVD was significantly lower compared with that in normal liver tissues (51% vs. 69%) (both P < 0.01). BZW2 expression was significantly correlated with tumor diameter and tumor capsule (both P < 0.05), whereas IVD expression was significantly associated with tumor diameter, alpha-fetoprotein (AFP) level, tumor, node and metastasis (TNM) staging and whether vascular invasion was found or not (all P < 0.05). In the high BZW2 expression group, the cumulative recurrence rate of HCC was significantly higher and the cumulative survival rate was significantly lower than those in the low BZW2 expression group. In the low IVD expression group, the cumulative recurrence rate of HCC was significantly higher and the cumulative survival rate was significantly lower compared with those in the high IVD expression group (all P < 0.05). Conclusions The expression level of BZW2 protein is up-regulated, whereas that of IVD protein is down-regulated in the HCC tissues. Moreover, the cumulative recurrence rate of HCC is relatively high and the cumulative survival rate is relatively low in liver transplant recipients with high BZW2 expression and low IVD expression.

Discussion on Supervision and Sampling of Biochemical Test Kits / 中国医疗器械杂志

As an important part of medical devices, in vitro diagnostic reagents are important means to prevent and diagnose and protect people's health. Supervision and sampling is an important and key supervision method to ensure the in vitro diagnostic reagent products are qualified. This paper summarizes the problems encountered in recent years in vitro diagnostic quantitative testing kit supervision sampling, analyzes the causes of these problems, and puts forward corresponding suggestions, hoping to provide constructive suggestions for supervision sampling.

Research on Application of Intelligent Tracing System for IVD Reagents Based on Blockchain Technology / 中国医疗器械杂志

In recent years, the IVD industry has developed rapidly based on the increasing market demand, and plays an important role in disease prevention, clinical diagnosis, health monitoring and guiding treatment. Therefore, followed quality and safety issues are highly concerned. The unique advantages of blockchain technology, decentralization, distrust and non-tampering, can write into trusted node data in every link covering production, circulation and usage of IVD reagents, and establish a distributed ledger with full backup, which makes the anti-conterfeiting and traceability for IVD reagents possible. We discuss whole process intelligent tracing system for IVD reagents based on blockchain technology. Through the strong mechanism of pre-supervision and post-punishment, the source of reagents can be traced, quality and responsibility can be investigated, and the medical inspection quality and diagnostic safety can be guarded.

Influence Factor and Evaluation Discuss of IVD Medical Equipment Service Life / 中国医疗器械杂志

In order to help the IVD medical equipment manufacturers to establish the service life of products scientifically, we analyze the main factors that may affect the service life of IVD medical equipment in accordance with the guiding principles for technical review of active medical devices issued by the center of medical device evaluation of NMPA, and focuse on an evaluation method of accelerated fatigue test, in order to standardize and guide the IVD medical equipment manufacturers to evaluate and formulate the product service life scientifically.

Brief Introduction about New Regulation of EU on IVDR / 中国医疗器械杂志

There are five-year transitional period for manufacturers after the issue of regulation(EU) 2017/746 on

Screening and clinical analysis of isovaleric acidemia newborn in Zhejiang province / 浙江大学学报·医学版

OBJECTIVE@#To investigate the incidence,clinical,biochemical and genetic characteristics of isovaleric acidemia (IVA) in Zhejiang province.@*METHODS@#Between January 2009 and December 2019, a total of 3 510 004 newborns were screened for IVA using tandem mass spectrometry. Patients of IVA were confirmed by urine organic acid and @*RESULTS@#A total of 15 patients with IVA were diagnosed, with an incidence of 1/234 000. Three patients had acute neonatal IVA, and the rest were asymptomatic. The isovalerylcarnitine (C5) levels were increased in all patients. Twelve children underwent urinary organic acid analysis, of which 11 cases had elevated isovalerylglycine levels, 4 cases with 3-hydroxyisovalerate increased simultaneously. Eleven IVA patients underwent genetic testing, 9 patients were compound heterozygous variants in @*CONCLUSIONS@#The clinical manifestations of IVA are non-specific, and the gene spectrum is scattered. Newborn patients screened by tandem mass spectrometry can receive early diagnosis and treatment, so as to correct metabolic defects and pathophysiological changes.

Design of the Intelligent POCT Network Architecture / 中国医疗器械杂志

A new concept and solution of architecture of the intelligent POCT network, based on Internet of Things and intelligent POCT devices, is proposed. This network's topology structure and components with basic requirements are introduced. Through the experience of clinical application scenario, the main characteristics of the network and superiority over traditional POCT device have been analyzed.

Analysis of electric shock protection requirements for IVD diagnostic equipment in IEC 61010-1:2010 / 医疗卫生装备

Objective To study the electric shock protection requirements of in vitro diagnostic equipment and to help manufacturers understand the relevant requirements in order to design products reasonably. Methods The requirements of IEC 61010-1:2010 were analyzed, the electric shock protection measures were explored, and the principles for protecting ground impedance against electric shock were described. An example was taken to study the electric shock protection measures for the sampling needle of the automatic bio-chemical analyzer, so that the existence of electric shock hazard could be determined. Results The sampling needle proved its rationality in structure design by avoiding the risk for being electriferous in case of failed basic insulation, although the requirements for protective earthing, double insulation or reinforced insulation were not met efficiently. Conclusion The requirements for electric shock protection can be determined based on comprehensive understanding of the standard, determination of electriferous components of the equipment as well as analysis on electric shock protection measures.

Translocación de dispositivo intrauterino. Reporte de un caso / Translocation of intrauterine device. Report of a case

La translocación de dispositivo intrauterino (DIU) es poco frecuente, con afección a órganos vecinos como el recto-sigmoide, la vejiga y el ovario; luego de la perforación uterina por migración de DIU se justifica su inmediata extracción de la cavidad abdominal. Presentamos el caso clínico de una mujer de 38 años de edad, que cursó con una perforación parcial de dispositivo intrauterino que causó dolor pélvico en la mujer.

Translocation of an intrauterine device (IUD), is slightly frequent, affecting neighboring organs like the rectal sigmoid, bladder and ovaries. After uterine perforation, because of IUD migration, immediate removal of the abdominal cavity is justified. We present a case of a 38 year-old woman who had a partial perforation by an intrauterine device causing pelvic pain.

Clinical and genetic features of three patients with non-classical isovaleric aciduria / 临床儿科杂志

Objective To explore the clinical, therapeutic and genetic features of IVD gene in late-onset non-classical isovaleric aciduria. Methods One boy and two girls presented with intractable vomiting were admitted. Urine organic acids and blood acylcarnitines proifles were analyzed. Isovaleric aciduria was diagnosed and conifrmed by IVD gene analysis. The patients were treated with leucine-restricted diet and the supplements of L-carnitine and glycine. Results Three patients had recurrent vomiting, drowsiness, odor of sweaty feet and metabolic acidosis from the age of 1 to 2 years. All of them had normal intelligence and leukopenia. One had oligocythemia. The blood isovalerylcarnitines (4.6 to 8.2μmol/L) and urine isovalerylglycines (36.1 to 1783.56 mmol/mmol creatinine) were elevated. Six mutations were found in their IVD gene. Four mutations (c.157C>T, c.214G>A, c.1183C>G and c.1208A>G) were reported. Two (c.1039G>A and c.1076A>G) were novel. The patients completely recovered after treatment with protein-restricted diet and the supplements of L-carnitine and glycine. Currently, they were aged 19 months to 14 years with normal physical and psychomotor development. Conclusions The clinical features of late-onset non-classical isovaleric aciduria are complex. It is onset in infants and young children and characteristic of recurrent vomiting and metabolic acidosis, which can be diagnosed by the blood acylcarnitine spectrum, urine organic acid analysis, and conifrmed by genetic analysis. L-carnitine supplement and diet intervention has signiifcant effects.

Intravenous device associated blood stream staphylococcal infection in paediatric patients.

Background & objectives: Intravenous device (IVD) associated nosocomial blood stream infections due to staphylococci are major cause of morbidity and mortality. The present study was carried out to assess the frequency of staphylococcal IVD associated infections in a paediatric ward of a tertiary case hospital. Prevalence of resistance to commonly used antimicrobials in hospital acquired staphylococcal isolates was also tested. Methods: Children admitted in paediatric wards with IVD for more than 48 h were enrolled. Blood, IVD tip at the time of removal, skin swab at the site of insertion of IVD and nasal swab were collected and cultured by standard protocol. All staphylococcal isolates from any source were analyzed for antimicrobial susceptibility by disk diffusion method. Genotyping matching of those staphylococcal isolates was done which were isolated from different sites of the same patient, but were phonotypically similar. Genotype of blood isolate was compared with genotype of isolate from nose/IVD/skin. Results: Staphylococcus aureus was the most frequent blood isolate (8.7%) followed by Candida (2.9%), coagulase negative staphylococci (CoNS 2.6%), Pseudomonas spp. (0.4%), Klebsiella spp. (0.3%) and Escherichia coli (0.1%). Isolation of microorganisms from blood was significantly higher in patients whose skin, IVD and nose were colonized by same microorganism (P<0.001). None of the staphylococcal isolate was found to be resistant to glycopeptides (vancomycin and teicoplanin). High penicillin and oxacillin resistance was present in both S. aureus (penicillin resistance; 76.8%, oxacillin resistance; 66.7%) and CoNS (penicillin resistance; 73.3%, oxacillin resistance; 60.0%). Among CoNS biotypes, S. haemolyticus was commonest blood isolate while S. epidermidis was commonest isolate from Skin/nose. Only 33.3 per cent of S. aureus blood stream infections and most of S. epidermidis and S. haemolyticus blood infections were IVD associated. Interpretation & conclusions: Staphylococci were the major causative agent of nosocomial blood stream infections. All episodes of septicaemia due to S. epidermidis and S. haemolyticus were IVD associated while only 1/3 of S. aureus septicaemia was IVD associated.

Dengue serosurveillance in Kolkata, facing an epidemic in West Bengal, India.

Background & objectives: A dengue outbreak occurred throughout West Bengal, India starting from August 2005. The objectives of this study were: (i) documentation of suspected cases, confirmed by MAC ELISA; (ii) a longitudinal serosurveillance of dengue in Kolkata by detecting denguespecific IgG and IgM antibodies in suspected cases and to note the seasonal incidence; (iii) to get information about proportion of primary, secondary and old dengue cases and persons free from dengue in the population tested; and (iv) to get some idea to forecast advent of dengue and dengue epidemic/precipitation of DHF. Methods: The epidemiological data were collected from different sources including Calcutta School of Tropical Medicine and Government of West Bengal. For serosurveillance in Kolkata, serum of each suspected patient was examined for detection of IgG and IgM antibodies using the microwell ELISA dengue fever kit. Results: Altogether, 6293 ELISA IgM reactive cases were documented out of 12,059 persons (52.18%) tested in the whole of West Bengal, involving 18 districts with 34 deaths. Serosurveillance of 1668 persons from August 2005 to December 2007 in Kolkata showed that only 18.1% (302) suffered from dengue, 6.03% (101) from primary, 12.03% (201) from secondary dengue, 20.44% (341) were not sufferers of dengue and 61.45% (1025) were old dengue cases. Though stray dengue cases were found perennially, most of the cases occurred in the post-monsoon season, with a peak in September. Of dengue patients, 63.24% (191) were males. Secondary dengue cases outnumbered primary dengue cases. So, possibility of DHF would remain in all age groups and in those persons who suffered from dengue on earlier occasion. Dengue cases drastically reduced in two subsequent post-epidemic years (2006 and 2007). Interpretation & conclusion: Dengue serosurveillance studies may give some idea about advent, intensity, transmission season, seasonal incidence, waxing and warning, and impending epidemic of dengue and DHF. A large-scale active longitudinal serosurvey along with the study of vector capacity and vector competence would provide more correct information.

Effects of Mechanical Stimulation and Scaffolds for Nucleus Pulposus Replacement of Intervertebral Disc / 대한정형외과연구학회지

PURPOSE: In this study, we investigated the potential of injectable hydrogel scaffolds for the regeneration of nucleus pulposus. MATERIALS AND METHODS: We prepared injectable hydrogels [Chitosan-Pluronic (CP), CP/Osteogenic Protein-1 (CP/OP-1), CP/Gly-Arg-Gly-Asp-Ser (CP/GRGDS), CP/GRGDS/OP-1] for this study. One of the four potential materials was selected through the cell viability tests. For each material, primary cultured nucleus pulposus (NP) cells from New Zealand rabbits were seeded onto each material. For the investigation of the effects of mechanical stimulation, the commercially available bioreactor was used. 0.2 MPa of intermittent hydrostatic pressure was imposed for 3 days after 7th day of seeding with the pattern of 2 min and 15 min for stimulating and resting, respectively. The specimens were harvested at 1, 10, 14 day after seeding for analyses. RESULTS: The MTT assay for 5 days revealed that CP/OP-1 group showed significant increase. The other two groups (CP/GRGDS and CP/GRGDS/OP-1) showed that the proliferation rate increased until 3 days after culture, while it decreased on day 5. The mechanical stimuli induced higher amounts of DNA measured in CP/OP- 1 on day 5 after culture. However, no significant difference was observed between two groups. CONCLUSION: We came to the conclusions that the biochemical environment as well as mechanical stimulation may play an important role in regenerating nucleus pulposus matrix, especially in CP/OP-1 in this study. However, further study are recommended in relation to mechanical effects as well as biochemical conditions.

Phenotypical Stability and Matrix Synthesis of Human Intervertebral Disc Cells in Response to Dexamethasone and Transforming Growth Factor-beta1 / 대한척추외과학회지

STUDY DESIGN: An in vitro experiment. OBJECTIVES: To evaluate the mRNA expressions of matrix components, and analyze the cellular proliferation and proteoglycan synthesis of human intervertebral disc cells in response to dexamethasone and TGF-beta1 SUMMARY OF LITERATURE REVIEW: Corticosteroids are responsible for the regulation of a diverse range of biological processes through modulation of the expression of target genes. The direct injection of methylprednisolone to the intervertebral disc (IVD) has been shown to cause degeneration and calcification of the disc in rabbits. Systemic administration of hydrocortisone induced degeneration of notochordal cells, which accelerated the aging process of the disc in mice. Transforming growth factor beta-1 (TGF-beta1) is known as a potent agent for the proliferation, differentiation and matrix synthesis of IVD. MATERIALS AND METHODS: IVD cells were isolated from ten patients, and subsequently cultured. Various doses of dexamethasone (DEX) and/or TGF-beta1 were administered to the IVD cultures. DNA and proteoglycan syntheses were measured by the incorporation of [3H]-thymidine and [35S]-sulfate, respectively. RT-PCRs were performed for the expressions of aggrecan, collagen types I and II, and osteocalcin mRNA. RESULTS: Cultures with DEX showed increased cellular proliferation and decreased proteoglycan synthesis (p<0.05). TGF-beta1 potentiated the proliferative effect of DEX, but failed to stimulate proteoglycan synthesis in the cultures containing DEX. There were no recognizable changes in the mRNA expressions of aggrecan, collagen types I and II, and osteocalcin in response to DEX and TGF-beta1. CONCLUSIONS: DEX demonstrated a proliferative effect on human IVD cells, with the combination of DEX and TGF-beta1 showing potentiation of the proliferative effect, while at high doses(100 and 1000nM, the DEX was shown to down-regulate the proteoglycan synthesis. Caution should be exercised in the use of corticosteroid in the therapeutic approaches for the treatment of disc disease or in the regenerative matrix of the IVD.

The Effect of Pulsed Electromagnetic Field in Human Intervertebral Disc Cell / 대한척추외과학회지

STUDY DESIGN: An in vitro experiment. OBJECTIVES: To assess the effect of pulsed sinusoidal EMF on human intervertebral disc (IVD) cells. LITERATURE REVIEW SUMMARY: Electromagnetic field (EMF) is known to modify some relevant physiological parameters of cells cultured in vitro, such as proliferation, synthesis, secretion of growth factors and transcription. EMF induces bone formation in delayed, non union and spinal fusion models. Also, the exposure of EMF has been shown to protect against the hazardous effect of smoking in the rabbit IVD. MATERIALS AND METHODS: Human IVD cells were three-dimensionally cultured in alginate beads and exposed to a 650 omega, 1.8millitesla magnetic flux density, 60Hz sinusoidal wave of EMF. The cultures were divided into the control and EMF groups, with various exposure times. The cytotoxicity, and DNA and proteoglycan syntheses were measured by the MTT assay, and [3H]-thymidine and [35S]-sulfate incorporation, respectively. RT-PCRs were performed for aggrecan, and collagen types I and II mRNA expressions. RESULTS: There was no recognizable cytotoxicity in the EMF group, but cellular proliferation was stimulated (p<0.05). Newly synthesized proteoglycan, normalized by DNA synthesis, was decreased in the EMF group (p<0.05) as were the expressions of aggrecan (48hour exposure) and type II collagen (72 hours exposure) mRNA compared to the control group. CONCLUSIONS: EMF seems to be hazardous in the synthesis of the chondrogenic matrix, while marginally beneficial in the cellular proliferation of human IVD cells.

The Effect of Pulsed Electromagnetic Field in Human Intervertebral Disc Cell / 대한척추외과학회지

STUDY DESIGN: An in vitro experiment. OBJECTIVES: To assess the effect of pulsed sinusoidal EMF on human intervertebral disc (IVD) cells. LITERATURE REVIEW SUMMARY: Electromagnetic field (EMF) is known to modify some relevant physiological parameters of cells cultured in vitro, such as proliferation, synthesis, secretion of growth factors and transcription. EMF induces bone formation in delayed, non union and spinal fusion models. Also, the exposure of EMF has been shown to protect against the hazardous effect of smoking in the rabbit IVD. MATERIALS AND METHODS: Human IVD cells were three-dimensionally cultured in alginate beads and exposed to a 650 omega, 1.8millitesla magnetic flux density, 60Hz sinusoidal wave of EMF. The cultures were divided into the control and EMF groups, with various exposure times. The cytotoxicity, and DNA and proteoglycan syntheses were measured by the MTT assay, and [3H]-thymidine and [35S]-sulfate incorporation, respectively. RT-PCRs were performed for aggrecan, and collagen types I and II mRNA expressions. RESULTS: There was no recognizable cytotoxicity in the EMF group, but cellular proliferation was stimulated (p<0.05). Newly synthesized proteoglycan, normalized by DNA synthesis, was decreased in the EMF group (p<0.05) as were the expressions of aggrecan (48hour exposure) and type II collagen (72 hours exposure) mRNA compared to the control group. CONCLUSIONS: EMF seems to be hazardous in the synthesis of the chondrogenic matrix, while marginally beneficial in the cellular proliferation of human IVD cells.

Market Analysis and Prospect for Korean In-Vitro Diagnostics / 대한임상병리학회지

BACKGROUNDS: Korean "in-vitro diagnostics (IVD)" market experienced rapid growth of almost 1800 folds in 20 years from 1970's to 1990's. Until recent financial crisis of Asia, the business showed very brisk annual growth rates; more than 20% for immunoserologic tests and 10-15% for other tests. Around 80-85% of all laboratory goods are imported and 15-20% are local products. MATERIALS AND METHODS: Market analyses of the world and Korean IVD business were done with interviews and written quesionnaires. Other data used were "List of trading in medical and pharmaceutical materials" by Korea Pharmaceutical Trader's Association and "List of production in medical and pharmaceutical materials" by the Korea Phamaceutical Manufacturers Association. RESULTS: In 1996, the Korean IVD was 151.64 million US Dollars (USD). Local products were responsible for 15-20% of market and imports for 80-85%. With recent financial crisis, importance of local IVD business and its R/D activity are getting keen attention. Market share by sectors, revenue analysis of local products, revenue according to product categories, export and import figures, comparison of import and local IVD product by sectors and manufacurers by their products were done and listed. CONCLUSIONS: Market analyses would be used by laboratorians to have a better knowledge and understanding of laboratory business and by the industry to view the Korea as a emerging and stabilizng market and by researchers to focus their resources into more feasible areas.