By analysis on existing problems of the classification, the suggestions were put forward to provide a reference for improving the classification of medical devices.
Equipment and Supplies ; classification

Objective To observe the change of nitric oxide(NO) content and explore its cell source following brain ischemic injury. Methods We established the model of transient global brain ischemia/reperfusion (IR) in rat. The concentration of NO and its cell source were investigated by detection of NO content, NDP histochemical staining, double label technique of immunofluorescence and stereological analysis after brain ischemia. Results (1)The content of NO increased at 12 h and peaked on days 1～3 after IR. The content of NO decreased gradually on the 5th day after IR. (2)The density of NDP positive cells increased and peaked on the 1st day after IR. The positive cells distributed mainly in the temporal cortex, hippocampus and periventricular zone after IR. The positive cells were found to reduce gradually or disappear on the 14th day after IR. (3)Few NDP positive and GFAP immunofluorescence positive cells were found to coexist at the early period of IR(1～3 d). The percentage of coexisting cells was 10%～15%. Conclusion The content of NO increases at the early period after ischemic brain injury. The main cell type to produce NO is neuron.

AIM: To prepare Ganmaoqing micro-pills (Rhizomaer Radix Baphicacanthis Cusiae. Folium Isatidis, etc). METHODS: Extruded-spheronizing granulator and fluidized coating-machine were applied for Ganmaoqing micro-pills' production. RESULTS: According to the method mentioned above, the content of Ganmaoqing micro-pills wasreached 96.27% paracetauol in labelled indicator. CONCLUSION: The method is feasible and convenient, the result is extract with stable quality.

Objective To investigate the effect of lipid ultrasonic microbubble on the cellular absorption rate of antiparallel phosphorothioate triplex-forming oligonucleotide(TFO) and the expression of the tissue factor(TF) in endothelial cells.Methods The GT21-apsTFO,specific to the gene sequence of the shearing stress response element,was synthesized and the lipid ultrasonic microbubble carrying TFO was constructed.The ECV304 cells were divided into 4 groups:control group(SSRE),received shear stress only for 6h;TFO+ ultrasonic irradiation group(TFO+U),treated with 60?l TFO in final concentration of 0.2?mol/L and ultrasonic irradiation for 30s simultaneously;TFO-lipid microbubble group(TFO-M),treated with 60?l lipid microbubble loaded with TFO in final concentration of 0.2?mol/L;and TFO-lipid microbubble + ultrasonic irradiation group(TFO-M+U),treated with 60?l lipid microbubble loaded with TFO(final concentration was 0.2?mol/L) and ultrasonic irradiation for 30s simultaneously.Cells in the last 3 groups were treated with shear stress for 6h with pressure of 1.2Pa 24h after transfection.The fluorescent microscope was used to observe the cellular absorption rate of TFO.The immunofluorescence method and RT-PCR were employed to determine the protein and mRNA expressions of TF.Results The transfection efficiency of the TFO was higher in TFO-M+U group(38.83%?6.52%) than in TFO-M group(9.50%?2.88%) and TFO+U group(12.66%?3.01%,P

Objective To comparatively analyze the HIV disease progression and the death situa-tion between injecting drug users (IDUs) with HIV infection and those with HIV/HCV co-infection.Meth-ods The counts of CD4+T cells were collected through a retrospective study and the data about death situa-tion were collected with follow-up cards from 2006 to 2014 .A statistical analysis was conducted for the two groups .Results Among the 175 cases with HIV infection , the average value of primary CD 4+T cell counts was 370 cell/μl and 25.71%of them, primary CD4+T cell counts were less than 200 cell/μl.The average change rate of CD4+T cell counts was -1.50 cell/μl in month.The annual mortality rate was 18.18%. Among the 325 cases with HIV/HCV co-infection, the average value of primary CD4+T cell counts was 420 cell/μl and 20.45%of them, primary CD4+T cell counts were less than 200 cell/μl.The average change rate of CD4+T cell counts was -2.76 cell/μl in month.The annual mortality rate was 32.14%.The differ-ences between the groups were significant (P<0.05).Conclusion Compared with patients with HIV infec-tion, those with HIV/HCV co-infection showed significantly decreased CD 4+T cell counts , resulting in a faster disease progression and a faster death .It was urgent for the management department to work out HIV prevention and therapeutic measures .

Immunogenicity for medical devices of animal origin is the key and difficult point during immune safety evaluation for these devices. This paper firstly investigated the effect of collagen sponge of animal origin on mouse splenic lymphocyte transformation and proliferation, and then analyzed the influence factors on the MTT method and CFSE method. The results showed that collagen sponge extract cannot significantly induce transformation and proliferation of mouse splenic lymphocyte in vitro.
Animals ; Cells, Cultured ; Collagen ; pharmacology ; Lymphocyte Activation ; drug effects ; Mice ; Porifera ; chemistry ; Spleen ; cytology

ObjectiveTo study the metastructure volumes of medial temporal lobe in diagnosis the patients with Alzheimer's disease (AD) using 3 dimensional MRI.Methods23 AD patients according to DSM-Ⅳ criteria and 23 normal controls (NC) were examined with 3D-MRI.Hippocampus formation,amygdala,entorhinal cortex ( EC ),perirhinal cortex ( PC),and comu temporale were measured with 3D-MRI.ResultsSensitivity and specificity of diagnosis AD were 73.9％,97％ ( Hippocampus formation) ;39.1％,95.7％ (amygdala) ;73.9％,95.7％ (EC) ;95.7％,87.0％ (PC) and 34.8％,39.1％ ( cornu temporale).Overall discriminate function =cornu temporal × 3.887 + PC × 5.960 - EC × 0.074 + amygdale × 3.489 + hippocampus formation × 6.656- 22.449.Over-all-accuracy was 91.3％.ConclusionThe total volume of PC can better diagnosis the mild to moderate AD than other structure of medial temporal lobe.The changes of the medial temporal lobe volume could be used in diagnosis the patients with Alzheimer's disease.

To discuss IC50 application in cytotoxicity tests of medical devices, we firstly investigated the vibrating condition and endpoint of MTT method specified in ISO 10993-5: 2009. Furthermore, we demonstrated the application of IC50 in the result evaluation of MTT method. The experimental results show that usage of IC50 in quantitative evaluation of MTT method is feasible.
Equipment and Supplies ; adverse effects ; standards ; Inhibitory Concentration 50 ; Toxicity Tests ; methods

Objective To investigate the gestation-specific reference intervals (GRIs) and dynamic changes of thyroid function at different gestational ages in Chongqing .Methods Combining self-sequential longtitudinal with cross-sectional study, the serum samples from 640 pregnant women with different gestational age were collected from June 2014 to September 2015 in the Third Military Medical University. The free triiodothyronine (FT3), free thyroxine (FT4), thyroglobulin (TG), thyroid-stimulating hormone (TSH), thyroid peroxidase antibody (TPOAb), and antithyroglobulin antibody (TGAb) were detected by the direct chemiluminescence method.According to China Guideline for the diagnosis and treatment of thyroid disease in pregnancy and postpartum in 2012, the reference interval of the thyroid function was calculated.The data were analyzed by Chi square test .Results Established GRIs of thyroid function during pregnancy in Chongqing:The GRIs was 3.68-5.59 pmol/L for FT3, 9.34-17.02 pmol /L for FT4, 0.18-5.26 mIU/L for TSH in 6-9+6 weeks of pregnancy; the GRIs was 3.69-6.03 pmol /L for FT3, 8.42-15.75 pmol/L for FT4、0.09-4.85 mIU/L for TSH in 10-13+6 weeks of pregnancy; the GRIs was 3.24-5.46 pmol /L for FT3, 6.50-14.24 pmol/L for FT4, 0.11-5.13 mIU/L for TSH in 14-27+6 weeks of pregnancy;the GRIs was 3.06-5.05 pmol /L for FT3, 6.12-11.69 pmol/L for FT4, 0.75-3.67 mIU/L for TSH in 30-34 weeks of pregnancy; the GRIs was 2.96-5.00 pmol/L for FT3, 6.26-11.36 pmol /L for FT4, 0.84-5.54 mIU/L for TSH in 36-40 weeks of pregnancy.Screening by GRIs, the prevalence of thyroid dysfunction was 8.75% (46), however, the prevalence was 37.07% (195) in according with the guidelines,χ2 =120.5,P =0.000.The overdiagnosis rate was 28.32%(149 /526).Using the guidelines of thyroid disease and our GRIs, the thyroid disease was found 116 (22.05%) and 30 (5.70%) in the first screening. Moreover, the thyroid disease was found 79(19.27%) and 10(3.23%) during the repeat screening in the normal population.Conclusions Using the GRIs for thyroid function tests in normal singleton pregnant women could reduce the risk of over diagnosis .The detection rate of repeat screening of TPOAb negative patients was close to the first screening detection rate , and repeated screening could reduce the risk of missed diagnosis for thyroid dysfunction in pregnancy women .(Chin J Lab Med, 2016, 39:511-515 )

Objective To observe the change of plasma neuropeptide Y(NPY) concentration in patients with essential hypertension,and its relevance to target organ damage.Methods The plasma NPY concentration was determined by radioimmunoassay(RIA) in 115 patients with essential hypertension,including 45 patients with single target damage(left ventricle hypertrophy 21,stroke 13,nephropathy 11) and 19 patients with multiple target damage,with 30 normal as controls.Results 1) Plasma NPY concentration in patients with essential hypertension was significantly higher than normal controls(P0.05).Conclusion NPY may involve in the physiopathologic progress of essential hypertension and associate with the development of target organ damage.Evaluation of plasma NPY concentration may be valuable biomarker in estimation the severity of hypertension and target organ damage.