In this paper, industry development and market tendency, supervision and standardization of nanomaterial-contained medical devices are overviewed comprehensively based on a large number of reference data including national and international information. Furthermore, the consideration about standardization of biological evaluation for nanomaterial-contained medical devices is discussed by combined some works performed in our laboratory.
Device Approval ; Equipment and Supplies ; standards ; Nanostructures ; standards

The serum sialic acid level and its relation to stroke in syndrome X was observed in 21 syndrome X patients with history of stroke,21 syndrome X patients without history of stroke, 21 simple NIDDM patients and 21 healthy subjects matched for age, sex, duration of diabetes and HBAlc level.The results showed that the serum sialic acid level was significantly higher in all NIDDM patients than in normal subjects(P

Intervertebral disc (IVD) degeneration is considered to be the main cause of low back pain (LBP),however,there are lack of long-lasting and effective methods of clinical treatment.Tissue engineering technique based on stem cells becomes an essential research direction on repair of IVD degeneration at present,and its effectiveness and feasibility have been confirmed,but it is difficult to maintain the sufficiency and vitality of stem cells in IVD.Previous studies showed that stem cells existed naturally in IVD,and stem cells from stem cell niche could migrate to IVD physiologically to maintain the IVD environment balance under the adverse microenvironment.Unfortunately,these behaviors cannot preclude IVD degeneration.Therefore,theoretical basis for the regeneration of nucleus pulposus (NP) in situ can be obtained from studying the mechanism that the endogenous repair failure during IVD degeneration,the cell death and the migration of stem cells in IVD,and the key regulatory targets to sustain the quantity and quality of the stem cells.Although there have been few researches to study the mechanism of the cell death and the migration of stem cells in IVD so far,studies demonstrated that the major inducing factors of IVD degeneration (pressure and hypoxia) could decrease the number of NP cells by autophagy,apoptosis and necroptosis,and chemokines and their receptors played a critical role in the migration of mesenchymal stem cells.These researches provide a clue for studying the mechanism of endogenous repair failure during IVD degeneration.We reviewed the current research situation and progress of the mechanism that endogenous repair failure during IVD degeneration in the following articles.First,we exhibited the potential of IVD stem cells in IVD degeneration repair.Second,the effect of the adverse microenvironment (pressure,hypoxia,etc) on the migration of IVD stem cells was discussed.Third,the mechanism of the stem cell death,autophagy,apoptosis and necroptosis under the adverse (pressure,hypoxia,etc.) microenvironment,and the correlation between the IVD stem cells migration and autophagy,apoptosis and necroptosis was studied.And then tissue engineering of NP was also discussed to achieve the endogenous repair of IVD degeneration.These studies will provide an innovative research direction on endogenous repair and a new strategy of early therapy for IVD degeneration.

With the appearance and development of ultrasonic surgical installation, ultrasonic therapy enters on a new epoch. High-amplitude and high-power ultrasonic vibration produced during the operation, ultrasonic surgical installation can be used to decrease the amount of bleeding or stop bleeding according to the acoustic properties of different tissues. The part where pathological changes happen can be excised selectively by ultrasonic surgical installation. This article introduces the principle, structure, classification and clinical application of ultrasonic surgical installation in detail.

Objective To analyze the balance function of injured lower lim b by dynam ic posturography. Methods Using the dynam ic posturography instrum ent, the postural evoked responses of sixty-two norm al people and two hundred and fifty-eight people with injured lower lim b bones and joints were detected. The test was included sensory organization test(SO T) and adaption test(ADT).The results of two groups were com pared by t test. Results Com pared with the norm al people, the im paired people had significant statistical differences in balance scores of SO T3-SO T6 and proportion score of dynam ic proprioception (P<0.05). There was no obvious decrease in ADT. Conclusion The balance function of injured lower lim b significantly decreases.

Objective To discuss the technique′s characteristics, manifestation, clinical application, and limit in normal and abnormal pediatric airway by using CTVB (CT virtual bronchoscopy) in comparison with FOB (fiberoptic bronchoscopy). Methods Spiral scans were performed by a GE Hispeed spiral scanner in 113 pediatric chests The reformed images of 45 patients were transported to a workstation by which 3 D reconstructions were performed with a software named Navigator and CTVB was generated Results Bronchi were manifested 100% in grades Ⅰ-Ⅲ, 46 7% and 13 3% were revealed in grade Ⅳ and V with CTVB, respectively FOB can only enter grade Ⅰ-Ⅲ bronchi, only 62 2% of the lobar bronchi can be manifested by FOB The findings of CTVB were stenosis ( n =34), occlusion ( n =11), and mass ( n =16) Only 3 radiotransparent foreign bodies and 2 inflammatory emboli were misdiagnosed as tumors, the rest was consistent with FOB Conclusion CTVB is an important supplement to conventional CT, CTVB can detect intraluminal space occupying lesions and occlusions or stenosises caused by all kinds of causes,but lack specificity CTVB can fly through the occlusions or stenosises of the lumen and enter the distal bronchi, thus can make up for the disadvantages of FOB It can′t make the diagnosis independently and must join together the CT primitive the diagram resemble or rebuild the diagram resemble proceeds to synthesize the analysis

The aim of this study was to establish an assessment method for determining α-Gal (α-1, 3-galactosyle) epitopes contained in animal tissue or animal tissue-derived biological materials with ELISA inhibition assay. Firstly, a 96 well plate was coated with Gal α-1, 3-Gal/bovine serum albumin (BSA) as a solid phase antigen and meanwhile, the anti-α-Gal M86 was used to react with α-Gal antigens which contained in the test materials. Then, the residual antibodies (M86) in the supernatant of M86-Gal reaction mixture were measured using ELISA inhibition assay by the α-Gal coating plate. The inhibition curve of the ELISA inhibition assay, the R2 = 0.999, was well established. Checking using both α-Gal positive materials (rat liver tissues) and α-Gal negative materials (human placenta tissues) showed a good sensitivity and specificity. Based on the presently established method, the α-Gal expression profile of rat tissues, decellular animal tissue-derived biological materials and porcine dermal before and after decellular treatment were determined. The M86 ELISA inhibition assay method, which can quantitatively determine the α-Gal antigens contained in animal tissues or animal tissue-derived biomaterials, was refined. This M86 specific antibody based-ELISA inhibition assay established in the present study has good sensitivity and specificity, and could be a useful method for determining remnant α-1, 3Gal antigens in animal tissue-derived biomaterials.
Animals ; Antibodies ; Biocompatible Materials ; Enzyme-Linked Immunosorbent Assay ; methods ; Epitopes ; analysis ; Humans ; Rats ; Sensitivity and Specificity ; Serum Albumin, Bovine ; Trisaccharides ; analysis

To explore the expression of Beclin1 in osteosarcoma and investigate the effects of down-regulation of autophagy on the chemotherapeutic sensitivity to cisplatin (DDP), the expression of Beclin1 in 28 specimens of osteosarcoma (group A) and 19 specimens of normal bone tissues (group B) were immunohistochemically detected. The expression of Beclin1 mRNA in MG63 cells treated with different concentrations of DDP was examined with RT-PCR. After down-regulation of autophagy in MG63 cells by an autophagy inhibitor, 3-methyladenine (3-MA), the cell proliferation inhibition rate of MG63 cells treated with DDP was evaluated by using the MTT assay. The positive rates of Beclin1 were 67.85% in group A and 94.73% in group B. Its expression was lower in osteosarcoma than in normal bone tissues, with a significant difference found between them (P<0.05). RT-PCR showed that the expression of Beclin1 mRNA in the cells treated with high-dose DDP were higher than that in the non-treated cells, and no significant difference in the expression of Beclin1 mRNA was found between the cells treated with low-dose DDP and the non-treated cells. There was a positive correlation between the level of Beclin1 mRNA expression and the concentration of DDP. MTT assay showed that the proliferation inhibition rates of the cell treated with 3-MA and DDP combined were substantially increased when compared with those treated with DDP alone (P<0.01). This study demonstrated that autophagy may be implicated in the carcinogenesis of osteosarcoma, and DDP may induce autophagy in the MG63 cells. It also suggests that the down-regulated autophagy could increase chemotherapeutic sensitivity of DDP to osteosarcoma.

BACKGROUND:Islet and islet cel transplantation for the treatment of diabetes has achieved effect, but the research is limited dut to the shortage of islet and immune rejection. OBJECTIVE:To observe the effect of transplantation of islet-like cells that in vitro differentiated from bone marrow mesenchymal stem cells on the treatment of diabetes in rats. METHODS:The rat bone marrow mesenchymal stem cells were induced with basic fibroblast growth factors and hepatocyte growth factors, and then received immunocytochemistry staining to detect the induction. The Sprague Dawley rats received intraperitoneal injection of streptozotocin to establish the diabetes models. After modeling, the rats were randomly divided into control group and experimental group (transplanted with induced islet-like cells). The experimental group was transplanted with the induced islet-like cells through renal capsule, and the control group was transplanted with normal saline in the same dose. The blood glucose and body mass of the diabetes rats were observed after transplantation. RESULTS AND CONCLUSION:The bone marrow mesenchymal stem cells could differentiate into islet-like cells after in vitro induced with basic fibroblast growth factors and hepatocyte growth factors. There was no significant change in blood glucose of the control group after transplantation (P>0.05), and the blood glucose of the rats in the experimental group was significantly decreased compared with the control group (P<0.05). The bone marrow mesenchymal stem cells can differentiate into islet-like cells after in vitro induced with the induction system containing basic fibroblast growth factors and hepatocyte growth factors, and the islet-like cells have a certain ability of insulin secretion. The transplantation of induced islet-like cells after transplanted into the diabetes rats through renal capsule can decrease the blood glucose level of the rats.

BACKGROUND: Bone exposed wounds are frequently required to deal with in orthopaedic surgeries, involving the treatment of open fractures, bone tumors, osteomyelitis, and many other diseases, in which the defect of soft tissue caused by open fractures is the most difficult to deal with. Conventional debridement or negative pressure closed drainage technology is difficult to make bone exposed wounds heal, and the process is extremely cumbersome, during which,patients suffer a lot of pain.OBJECTIVE: To evaluate the advantages and disadvantages of the various types of dressings, and review the application of new hydrogel dressing in bone exposed wounds based on its advantages, such as keeping wound environment moisture, restoring skin physical barrier, contributing to routine dressing change.METHODS: A computer-based online retrieval of PubMed and CNKI databases was performed to search papers published between 2000 and 2016 using the key words hydrogel dressing, bone exposed wound, traditional wound dressing, antibiotic in English and Chinese, respectively. A total of 55 papers suitable for final analysis from the application of traditional and new dressings in bone tissue engineering were reviewed.RESULTS AND CONCLUSION: The treatment of bone exposed wounds involves the treatment of many diseases, such as open fractures, bone tumors, osteomyelitis, which is still an orthopedic problem to solve. The novel hydrogel dressings with unique advantages are able to provide better plans for bone exposed wounds, and the use of these dressings solves the regeneration and repair of exposed bone, and improves the infection of antibiosis. In addition, the gel dressings currently have become a hot spot of research because of the characteristics of sustained-release.