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.

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.

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 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

Objective To summarize the experience in the diagnosis and treatment for solidpseudopapillary tumors of the pancreas (SPTP). Method In this study, 27 cases of SPTP from September 2000 to June 2007 were retrospectively analyzed. Results The median age of these 27 cases was 26 years. There were 26 females and 1 male. Epigastric pain was complained in 16 cases, abdominal aponia mass in 11 cases. Tumour marker level was within normal range. Ultrasonic manifestation usually shows cystic and solid lesion without blood signal. Lesions were typical with high blood supply in enhanced CT scan, cystic and solid component confounding in it. MRI revealed low-middle signal in T1 and middle-high signal in T2. Pancreaticoduodenectomy was performed in 9 cases, pancreatic local excision and pancreaticojejunostomy were performed in 4 cases, pancreatic local excision was performed in 6 cases, Distal pancreatectomy and spleen resection were performed in 8 cases. Post-operative pathology shows local lesion in 12 cases, invading the pancreatic parenchyma in 14 cases and intravascular tumor thrombi and lymphnode metastasis in 1 case. All cases were followed up with an average period of 26.1 months. There was no recurrence nor metastasis. Conclusion Solid-pseudopapillary tumor of the pancreas has a low malignant potential, affecting primarily young women. It has no typical clinical appearance. Enhanced CT scanning has the relative characteristic imaging. Complete resection usually results in long-term survival.

Objective To investigate the clinical characteristics, diagnosis, treatment and prognosis of hepatic angiomyolipoma (HAML). Methods The clinical data of 14 patients with hepatic angiomyolipoma admitted in our hospital from 1989 to 2007 were analyzed retrospectively. Result There were 4 male patients and 10 female patients. Median age was 41 years old. The lesions located in right lobe in 8 patients, and in left lobe in 6 patients. B-US was taken in 12 patients before operation, and other examinations included CT in 8 patients, MRI in 7 patients and angiography in 2 patients. Five patients were diagnosed with HAML by imagine features. Fine needle biopsy was taken in 1 patient with no definite diagnosis. All patients underwent resection and got the histopathologic diagnosis with HAML. All specimens were HMB-45 positive. S-100 and SMA were tested in 7 and 6 patients respectively, and were positive in all those patients. All cases were followed up for 6 months to 18 years (median time was 3 years). 13 patients were still alive without recurrence and 1 patient died of postoperative DIC and heart failure. Conclusion There was marked female predominance in HAML. Imaging features are helpful for preoperative diagnosis of HAML, but correct diagnosis was achieved in only a fraction of patients. HMB-45 positive was definitive proof for histopathologic diagnosis of HAML. Hepatectomy was an effective treatment for HAML.

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

BACKGROUND:Recent studies have demonstrated that Niacinamide is capable of promoting the proliferation of intervertebral cells and improving intervertebral disc degeneration.Overloading is thought to the main cause of intervertebral disc degeneration.However,the protective effects of Niacinamide in loading induced intervertebral disc degeneration remains uncertain,OBJECTIVE:To investigate the protective effects of Niacinamide against axial loading induced degeneration of rabbit lumbar disc.DESIGN,TIME AND SETTING:A randomized controlled experiment was carded out in the Central Laboratory and the Laboratory of Department of Orthopaedics,Union Hospital Affiliated to Tongji Medical College,Huazhong University of Science and Technology from November 2008 to April 2009.MATERIALS:Twenty-four Japanese white rabbits (4 months old,weighing 2.0 kg).Niacinamide was supplied by Tianjin Damao Chemical Reagent Factory.METHODS:Twenty-four Japanese white rabbits were randomly divided into 6 groups.The controllable axial loading induced rabbit lumbar disc degeneration model was adopted to impose 98N pressure on the rabbit discs to induce degeneration.Various doses of Niacinamide were given intragastrically to the rabbits in different groups:2 rabbits in group 1,the loading device was installed without pressing,and no Niacinamide was given;2 rabbits in group 2,given 50 mg/kg Niacinamide for 1 week;5 rabbits in group 3,loaded with 98N for 1 week;5 rabbits in group 4,loaded with 98N for 1 week,then the pressure was released for another week's recovery;5 rabbits in group 5,loaded with 98N and given 50 mg/kg Niacinamide for 1 week;5 rabbits in group 6,loaded with 98N for 1 week and then the pressure was released for another week's recovery,50 mg/kg Niacinamide was continually given during the 2 weeks.MAIN OUTCOME MEASURES:Magnetic resonance image and Thompson's grading system were used to assess degeneration degree of the discs;hematoxylin and eosin staining,immunohistochemical staining for type Ⅱ collagen,and Safranin O staining were used to evaluate histological changes;immunohistochemical staining for P161NK4A was used to evaluate cell proliferation and senescence.RESULTS：①According to the Thompson's grading system，there was no disc exhibited degeneration in group 2；5 rabbits graded Ⅱ in group 3；4 rabbits graded Ⅱ and 1 rabbit graded Ⅲ in group 4；2 rabbits graded Ⅰ and 3 rabbits graded Ⅱ in group 5；3 rabbits graded Ⅰ and 2 rabbits graded Ⅱ in group 6.MRI results revealed the alleviated degeneration in Niacinamide given groups.②The content of type Ⅱ collagen of annulus fibrosus of group 6 was 53.2% higher than that of group 4 (P＜0.01).③Safranin O-Fast Green staining density of group 2 was higher than that of group 1；The staining density of nucleus pulposus and annulus fibrosus of groups 5 and 6 was higher than the corresponding parts of group 4，especially that of nucleus pulposus (P＜0.01，P＜0.01)，and group 6 exhibited slightly increased levels than group 5.④P16INK4A positive staining rates decreased with the extension of Niacinamide administration time.CONCLUSION：Niacinamide can help to alleviate overloading-caused damage to intervertebral disc，and can benefit the recovery of damaged intervertebral disc.