This article analyzes the status quo of sales supervision on medical devices through some aspects, including the relevant regulation system, the standards of sales admittance, the supervision team and the approval of business license. According to the exiting problems, some improving countermeasures are proposed for reference.
Materials Management, Hospital ; organization & administration

Objective To evalute the value of spiral CT in diagnosis and treatment of chronic suppurative otitis media.Methods Sixty-five cases including seventy-nine ears underwent the direct axial plane and coronal multiplanar reformation and three-dimensional reconstruction of auditory ossicular chain in chronic suppurative otitis media spiral CT imaging of temporal bone. Results The direct axial plane and coronal multiplanar reformation in diagnosing of the chronic suppurativeotitis media were correspondent,but in showing of the most middle ear structure were difference. Three-dimensional images was superior to axial and coronal MPR images in showing of the change of malleus and incus,the contrary situation in showing stapes. Only 3D image may not select application for definition.The rate of agreement between spiral CT diagnosis by combination of three different imaging methods and definition of chronic suppurative otitis media and operative findings(89.9%～97.5%) were higher, false positive rate(2.9%～6.0%) and false negative rate(0～14.6%) of the CT diagnosis were lower.Conclusion Combination of three different imaging methods(axial images, coronal MPR images and three-dimensional images of the ossicular chain) can improve the value of the spiral CT diagnosis and therapy of chronic otitis media.

AIM:To discuss the application value of retro-mode imaging by F-10 confocal scanning laser ophthalmoscope (cSLO) for detecting drusen in patients with age-related macular degeneration (AMD).METHODS:This was a retrospective case study.During the period of October 2015 to December 2016, 67 patients with unilateral AMD (67 affected eyes and 67 fellow eyes) were included in this study.All patients underwent color fundus photography, optical coherence tomography (OCT) and retro-mode imaging by F-10 cSLO.The features of drusen by color fundus photography, OCT and retro-mode imaging were comparatively observed in the affected eyes of patients with unilateral AMD.Positive numbers of drusen in the fellow eyes of patients with unilateral AMD detected by color fundus photography, OCT and retro-mode imaging were calculated and compared.RESULTS:Retro-mode imaging by F-10 cSLO gave easier to identify images of drusen than color fundus photography and OCT in the affected eyes of patients with unilateral AMD.In the fellow eyes of 67 patients with unilateral AMD, retro-mode imaging showed drusen in 56 cases(84%), color funds photography showed drusen in 36 cases(54%), OCT showed drusen in 48 cases(72%), the difference was statistically significant(χ2=14.31, P<0.05).The positive numbers of drusen detected by retro-mode imaging were significantly higher than color fundus photography, the difference was statistically significant(χ2=13.87, P′<0.0125).There was no statistically significant difference in the positive numbers of drusen detected by retro-mode imaging and OCT(χ2=2.75, P′>0.0125).CONCLUSION:Retro-mode imaging by F-10 cSLO provides a non-invasive technique and should be useful for detecting and monitoring drusen in AMD.

Objective To study the role of hematopoietic growth factor(HGF)of placenta chorionic villus in fetal hematopoiesis during embryo ontogeny by observation of the appearance time and the content changes with the fetal growth, which was compared with HGF in cord blood. Methods Thirty embryo villus (2 g each) and 30 cord blood (2 mL each) were collected separately from early pregnant stage(6- 8 weeks), middle pregnant stage(16-22 weeks)and late pregnant stage (37-42 weeks). The levels of HGF were detected by enzyme - linked immunosorbent assay. Results HGF were produced on the early pregnant stage and the content of FL-T3,IL-3 increased gradually.There were significantly differences at different stages(P

Animals ; Animals, Newborn ; Cerebral Cortex ; drug effects ; metabolism ; Hypoxia-Inducible Factor 1, alpha Subunit ; metabolism ; Hypoxia-Ischemia, Brain ; metabolism ; Progesterone ; pharmacology ; Rats ; Rats, Sprague-Dawley

ObjectiveTo explore the effects of the conjugate prepared from the cholera toxin B subunit(CB) and nerve growth factor(NGF) on the spatial learning and memory abilities and cholinergic function.MethodsThe conjugate of CB-NGF was prepared by the improved sodium metaperiodate method and nasally administrated to the β-amyloid protein(Aβ25-35) induced amnesic mice for 7 days with 2 dosage (7-5 μg/d、15 μg/d). Spatial learning and memory abilities were evaluated by Morris water maze and cholinergic function was assessed with the choline acetyl transferase (ChAT) immunohistochemical methods.ResultsMorris water maze test showed that the escape latency in Aβ25-35-treated mice prolonged and the staying time reduced in the crossed first quadrant where the platform had been located, compared with the control mice (P<0-01). In addition, the number of ChAT positive neuron declined in the model mice(P<0-001). CB-NGF nasal administration significantly shortened the escape latency and elevated the staying time and number of ChAT positive neuron(P<0-01).ConclusionCB-NGF treatment can improve the spatial and memory performance which may involve the neuroprotection to cholinergic system.

Objective To evaluate the effect of group health education for nasopharyngeal carcinoma patients who received radiotherapy.Methods Eighty cases of previously untreated patients with nasopharyngeal carcinoma who accepted radical radiotherapy from June 2009 to June 2010 were chosen as the control group,and 80 cases with the same conditions through June 2010 to June 2011 were chosen as the experimental group.The control group and experimental group were given oral health education and group health education respectively.The incidence of radiotherapy-related complications in patients who accepted two different methods of discharge guidance were compared.Results The improvement of patient compliance to rehabilitation guidance including regular reexamination,gargling,nasopharyngeal washing,mouth opening excise and neck excise was better in the experimental group than in the control group (85％ vs 68％,97％ vs 88％,99％ vs 70％,100％ vs 72％ and 95％ vs 60％),and the differences were statistically significant (X2 =6.892,5.766,25.079,25.507,12.822,respec.tively; P ＜ 0.05).The decreases in rate of complications including difficulty in mouth opening,neck movement restriction,sinusitis,otitis media and nasal bleeding were also better in the experimental group than in the control group (1.2％ vs 15.0％,1.2％ vs 5.0％,3.8％ vs 23.0％,1.2％ vs 12.0％ and 2.5％ vs 17.0％),and the differences were statistically significant (x2 ＝ 11.568,11.568,12.333,7.907,10.000,respectively; P ＜ 0.05).Conclusions Group health education can better meet the rehabilitation needs of patients with nasopharyngeal carcinoma,strengthen their subjective awareness of persisting in rehabilitation functional exercise,improve patient' s compliance and reduce the incidence of complications,so as to promote their rehabilitation and improve their life quality.

This study was aimed to analyze the biological characteristics of rabbit bone marrow mesenchymal stem cells (rBM-MSCs) and their response to different growth factors. Rabbit BM-MSCs were separated from bone marrow mononuclear cells by using adherent cultivation. Biological characteristics were investigated by optical and electron microscopy. Immunophenotype of rBM-MSCs was measured by flow cytometry. The expression of collagen was detected by RT-PCR. Differentiation potential was identified by specific staining and RT-PCR. The response of rBM-MSCs to IL-1, 3, 8 and HGF with different concentrations were tested by MTT. The results showed that the rBM-MSCs gave rise to a population of adherent cells characterized by the presence of a predominant cell type with a typical fibroblast-like morphology and could be cultured for over 15 passages. CD44 was highly expressed on F5 rBM-MSCs (32%) and CD45 was lowly expressed (4.7%). Type I collagen was highly expressed, while type II collagen was lowly expressed and type X collagen was not detected on rBM-MSCs using RT-PCR method. In various conditions inducting differentiation, rBM-MSCs could differentiate into the osteoblast, chondrocyte, adipocyte and neuron-like cells. The rBM-MSCs were sensitive to IL-3, even low concentration (10 ng/ml) of IL-3 could promote the proliferation of rBM-MSCs effectively (>32%, P < 0.01), whereas high concentration IL-3 inhibited it significantly. It is concluded that rabbit BM-MSCs were successfully isolated and culture-expanded. The biological characteristics of rabbit BM-MSCs are similar to those of human and rhesus BM-MSCs. IL-3 with low concentration can promote the proliferation of rBM-MSCs effectively, but high concentration of IL-3 can inhibit their proliferation.
Animals ; Bone Marrow Cells ; cytology ; physiology ; Cell Differentiation ; Cell Proliferation ; Cells, Cultured ; Cytokines ; pharmacology ; Granulocyte-Macrophage Colony-Stimulating Factor ; pharmacology ; Male ; Mesenchymal Stromal Cells ; cytology ; physiology ; Rabbits ; Recombinant Proteins

OBJECTIVETo apply the single cell nested multiplex polymerase chain reaction (PCR) to HLA typing, and analyze the influence factors on the amplification results.

METHODSSingle cell DNA templates were prepared with different methods. The exon 2, 3 and intron 2 of HLA-A, B, and exon 2 of DRBI were amplified using multiplex PCR. The second round of SSP-PCR HLA typing was carried out according to the large scale routine HLA typing results.

RESULTSEnzyme lysis method was the most efficient procedure for preparing the single cell DNA template, with a success rate (SR) of 93.3%, while the SRs of alkali lysis and freezing-thaw lysis methods were 83.3% and 73.3%, respectively. The second round amplification using enzyme lysis and SSP-PCR in 20 samples obtained a 95% success rate and a 15% allele drop out rate. The time for performing the whole procedure was less than 6 hours.

CONCLUSIONThe modified nested multiplex PCR technique is efficient for single cell HLA typing and might be applied to clinical preimplantation genetic diagnosis.

Histocompatibility Testing ; methods ; Humans ; Polymerase Chain Reaction ; methods

OBJECTIVECord blood (CB) provides a rich source of stem cells for transplantation. CB transplantation has been used widely after myeloablative therapy. One major disadvantage of CB transplantation is delayed platelet engraftment. The aim of this study was to hasten platelet engraftment by investigating the ability of different hematopoietic growth factor combinations to generate large numbers of megakaryocyte (Mk) from CB and by evaluating the biologic characteristics and function of the expanded Mk.

METHODSCB samples were obtained at the end of normal full-term deliveries with informed consent. Mononuclear cells (MNCs) were isolated from CB using Ficoll density centrifugation. MNC population was positively selected for CD(34) expression by magnetic cell sorting (MACS). CD(34)(+) cells were cultured in serum-free and stroma-free medium containing the following two different cytokine combinations: thrombopoietin (TPO) + stem cell factor (SCF) + interleukin (IL) -3 + IL-6 and TPO + SCF. Cultures were characterized after 3, 7, 10 and 14 days by flow cytometry, colony forming unit-megakaryocyte (CFU-Mk) and maturation evaluation (Mk ploidy). The expanded Mk function was examined by the platelet activation in vitro and severe combined immunodiffiency (SCID) mice transplantation in vivo.

RESULTSDifferent results were observed with different culture conditions. With the first cytokine combination optimal expansion of CD(41)(+) cells was observed on day 10, but the optimal expansion of Mk progenitors (CD(34)(+)CD(41)(+)) was observed on day 7, with a median 121 and 44-fold increase at the starting cell dose. This result was also proven by CFU-Mk. The largest numbers of CFU-Mk were also observed on day 7. The degree of maturation of Mk cells also increased as suggested by DNA content of CD(41)(+) cells, which means that CD(34)(+) cells cultured for 3 - 7 days were richer in primitive Mks, while those cultured for 10 - 14 days had greater numbers of more differentiated Mks. For the second cytokine combination, CD(41)(+) and CD(34)(+)CD(41)(+) cells were fewer than the first one, but it produced 36 and 85-fold CD(34)(+)CD(41)(+) and CD(41)(+) respectively on day 7. Platelet activation test confirmed that the expanded Mks had normal function. Therefore, the expanded Mks could be transplanted into the SCID mice bone marrow and produce human platelet in the peripheral blood of the mice.

CONCLUSIONEx vivo expanded Mk might facilitate CB transplantation and help shorten the period of post-transplant thrombocytopenia.

Animals ; Antigens, CD34 ; Cell Culture Techniques ; methods ; Cells, Cultured ; Culture Media ; Fetal Blood ; cytology ; Humans ; Leukocytes, Mononuclear ; cytology ; Megakaryocytes ; cytology ; Mice ; Mice, SCID