Objective To compare the sensitivity and accuracy of amplified luminescent proximity homogeneous assay linked immunosorbent assay (AlphaLISA) and magnetic particles-based chemiluminescence immunoassay (MP-CLIA) for detection of staphylococcal enterotoxin C (SEC) in the simulated milk samples. Methods The AlphaLISA was constructed using goat anti-SEC polyclonal antibody-coupled receptor microspheres, biotin-labeled SEC monoclonal antibody and streptavidin-coupled donor microspheres. The MP-CLIA was constructed using goat anti-SEC polyclonal antibody conjugated alkaline phosphatase, biotin-labeled anti-SEC monoclonal antibody and streptavidin conjugated magnetic beads. Results The sensitivity of AlphaLISA to detect SEC content in simulated milk samples was 4.04 ng/L, and the coefficient of variation (CV) was 1.98%~9.82%. The sensitivity of MP-CLIA was 108.19 ng/L and CV was 4.63%~20.40%. Conclusion Compared with MP-CLIA, AlphaLISA is more sensitive and accurate to detecting SEC.
Animals ; Streptavidin ; Biotin ; Luminescence ; Milk ; Antibodies, Monoclonal ; Goats ; Immunoassay/methods*

Objective:The standardized medical device clinical trials in China began in a short time, and the quality of trials needs to be improved.This article intends to explore possible ways for the improvement of quality management of the medical device clinical trials.Methods:Through working practice and literature review, analyze the current status of medical device clinical trials and in vitro diagnostic reagent in China; put forward targeted improved measures for the quality management system; as well as verify its feasibility through practice.Results:This article summarizes three factors that limit the improvement of the quality of medical device clinical trials, including the insufficient research and development strength of sponsors, the limited professional level of research teams, and the differences in verification and drugs, based on the risk-based quality management concepts, puts forward improved measures from three aspects, which including building risk-based quality certification system, making full use of electronic information systems to ensure the trial quality, and strengthening training of clinical trial capacity of researchers, and verifies the feasibility of these measures via the practical experience of our hospital since 2016.Conclusions:The application of risk-based quality management system, electronic information system and clinical trial capacity training can improve the management quality for medical device clinical trial centers.

Objective:To evaluate the feasibility of brain injury after cardiopulmonary resuscitation (CPR) in rats based on T2WI image texture analysis.Methods:Eighteen SD rats were randomly divided into the sham group ( n=8) and model group ( n=10). The rats in the model group underwent MRI scanning at 6 h after return of spontaneous circulation (ROSC), and the rats in the sham group received MRI scanning at 6 h after the operation. The differences in the texture features of T2WI images and the expressions of AQP4 and NSE between the two groups were analyzed. The receiver operating characteristic curve (ROC) was used to evaluate the diagnostic efficacy of statistically different texture features between the two groups for brain injury. The associations between texture features and AQP4 and NSE expressions in the sham group and model group were analyzed using Spearman correlation coefficients. Results:The minimum intensity, standard deviation, and inverse difference moment of the whole brain T2WI texture features of the model group were significantly lower than those of the sham group ( P<0.05), while the difference entropy and characteristics of high gray in homogeneity were significantly higher than those of the sham group ( P<0.05). The difference entropy was the best with an area under curve (AUC) of 0.922, a sensitivity of 100% and a specificity of 75%. The AQP4 and NSE expressions in the model group were significantly higher than those in the sham group ( P<0.05). The minimum intensity value was positively correlated with AQP4 and NSE expressions ( r=0.501, 0.568, P=0.048, 0.022). The standard deviation was positively correlated with AQP4 and NSE expressions ( r=0.620, 0.530, P=0.010, 0.035). The difference entropy was negatively correlated with AQP4 expression ( r=-0.535, P=0.033). Conclusions:Texture analysis on T2WI images can evaluate the degree of brain edema and neuronal damage. The minimum intensity, standard deviation, and difference entropy are sensitive indicators to evaluate brain injury after CPR, and difference entropy has the highest sensitivity and specificity.

Distant metastasis is one of the main obstacles to cancer treatment.Overexpression of S1PR1 in malignant tumors enhances cell invasion and migration activity,mediates EMT and induces lymphangiogenesis and angiogenesis via activation of its downstream signaling pathways,eventually results in the occurrence of tumor metastasis.S1PR1 is also closely related to generation of acquired radiotherapy resistance.This article discusses the roles of S1PR1 in tumor metastasis and radiotherapy resistance.

Objective To investigate radiation-induced carotid and cerebral vascular injury and its relationship with radiation-induced temporal lobe necrosis in nasopharyngeal carcinoma (NPC) patients.Methods Fifty-eight NPC patients with radiation-induced temporal lobe necrosis (TLN) were recruited in the study.Duplex ultrasonography was used to scan bilateral carotid arterials to evaluate the intima-media thickness (IMT) and occurrence of plaque formation.Flow velocities of bilateral middle cerebral arteries (MCAs),internal carotid arteries (ICAs) and basal artery (BA) were estimated through Transcranial Color Doppler (TCD).The result were compared with data from 33 patients who were free from radiation-induced temporal lobe necrosis after radiotherapy and 29 healthy individuals,to study the relationship between IMT,occurrence of plaque and ventricular diastolic dysfunction.Results Significant differences in IMT,occurrence of plaques of ICAs and flow velocities of both MCAs and ICAs were found between patients after and healthy individuals (t =18.624,8.221,P ＜0.05;x2 =17.886,P ＜0.05;t =14.367,10.112,P ＜0.05).IMT had positive correlation with post radiation interval (r =0.368,P =0.049).IMT or incidence of plaques may be related to dose of radiotherapy,course of treatment and T stage (x2 =-17.635,12.006,-3.125,P ＜ 0.05).Compared with result from patients without radiation-induced TLN,the mean IMT was significantly thicker in patients with TLN (t =10.208,P ＜ 0.05).Plaques were more common in patients with TLN than patients without TLN (x2 =13.118,P ＜0.05).In addition,flow velocities of MCAs and ICAs in patients with TLN were much faster (t =5.011,5.035,P ＜ 0.05).Among patients with unilateral TLN,flow velocity of MCAs was significantly different between ipsilateral and contralateral sides to the lesion (t =18.362,P ＜ 0.05).Conclusions Thickening of IMT,occurrence of plaque formation and hemodynamic abnormality are more common in patients after radiotherapy,especially in those with TLN,compared with healthy individuals.

On the basis of summarizing the general situation of current internal and external network construction of hospitals,the paper introduces the main hidden dangers of hospital network security,puts forward internal and external network security management measures,and elaborates the internal and external network security construction principle,network topology structure,and network construction achievements of the First Affiliated Hospital of Guangxi Medical University.

Objective:To evaluate the clinical application of human serum albumin in the inpatients in our hospital to promote its rational use. Methods:Totally 1 183 cases were selected from the inpatients treated with human serum albumin from January to De-cember in 2014, the clinical department, classification of diseases, age distribution and relevant concentration checks of serum albumin in the inpatients were analytically reviewed. Results: Totally 26 clinical departments were involved in the use of human serum albu-min,mainly in the digestive departments and ICU. The elderly patients aged above 65 years accounted for great proportion (47. 68%). In addition, all patients had relevant concentration checks of serum albumin. Conclusion:The patients with digestive diseases tend to have the largest consumption proportion of human serum albumin in our hospital. It is important for physicians to strictly follow the indi-cations of medication in using human serum albumin.

Objective To evaluate the effectiveness and safety of mouse nerve growth factor in treating dysphagia in patients with nasopharyngeal carcinoma after radiotherapy.Methods Fifty-eight post-radiotherapy nasopharyngeal carcinoma patients with dysphagia were randomly divided into an observation group and a control group.Both groups received routine treatment,but the observation group was additionally injected with mouse nerve growth factor intramuscularly every day for four weeks.Before and after the 4 weeks of treatment,both groups were evaluated using Kubota's water drinking test,videofluoroscopy and the brief version of the WHO's Quality of Life scale.Results After 4 weeks,the patients in the observation group displayed significantly greater improvement in swallowing compared with the control group.There was a significant difference in the groups' average scores on the drinking water test and in the videofluoroscopy results.Moreover,the patients in the observation group had significantly higher quality of life scores than those in the control group,on average.Conclusions Mouse nerve growth factor may have a rapid and safe therapeutic effect on dysphagia induced by radiation.No obvious adverse reactions were observed.

Objective To evaluate the correlation between MRI and X-Ray discography findings and pain response at provocative discography in patients with discogenic back pain. Methods Two hundred and fifty-six lumbar intervertebral discs in 93 patients who underwent MRI and X-Ray discography were included in this study. MR images were retrospectively evaluated regarding disc degeneration, endplate abnormalities and high intensity zone. Disc degeneration was graded according to the modified criteria of Pearce, et el. Evaluation of disc morphology was performed with X-Ray discography by using the classification of Adams, et al. Endplates and adjacent bone marrow abnormalities were classified according to Modic,et al. During discography concordant pain was regarded as positive, whereas discordant pain and no pain were regarded as negative. The data were analyzed using the Chi-squnre test. Results There were 116 discs with concordant pain and 140 discs with discordant pain or no pain. Of 256 discs on discography, 17 discs were type Ⅰ17(6.6%),type Ⅱ were 25(9.8%),type Ⅲ were 91(35.5%), type Ⅳ were 77(30.1%) and type Ⅴ were 46(18.0% ). On MR images, discs of grade Ⅰ were 23 (9.0%) ,grade Ⅱ were 34(13.3%), grade Ⅲ were 84(32.8%), grade Ⅳ were 85 (33.2%) and grade Ⅴ were 30(11.7%). There was positive correlation between Pearce graded of MRI and classification of Adams of discography (r=0.62, X2 =160.87,P <0.01).In 123 discs of type Ⅳ to type Ⅴ on discography, 104 discs were with concordant pain. There was positive correlation between type Ⅳ-Ⅴ and concordant pain( r=0.60, X2 = 144.08, P < 0.01). In 115 discs of Ⅳ-Ⅴ grade degeneration, 99 discs presented with concordant pain. There was positive correlation between Ⅳ-Ⅴ grade disc degeneration and concordant作者单位:510120 广州,中山大学附属第二医院放射科 pain(r = 0.59, X2 = 137.11, P <0.01 ). In 60 discs with high intensity zone(HIZ), 52 discs presented with concordant pain. There was positive correlation between HIZ and concordant pain ( r=0.41, X2= 51.93, P <0.01 ). In 58 discs with endplate degeneration, 51 presented with concordant pain. There was positive correlation between Modic degeneration and concordant pain ( r = 0.41, X2= 52.76, P < 0.01 ). Conclusion In patients with chronic low back pain, MR imaging may present moderate to severe disc degeneration, high intensity zone, endplates and adjacent bone marrow abnormalities. MR findings with concordant pain can raise the diagnostic possibility of discogenic lumbar pain. Typical discography findings, fissured or ruptured disc, with concordant pain are important diagnostic evidence for discogenic lumbar pain.

BACKGROUND: Looking for effective measures to ensure the survival of the implanted stem cells against ischemia-induced hypoxia becomes the major concern in the research of cell transplantation therapy for cerebral infarction.OBJECTIVE: To study the effects of human Persephin gene transfer on hypoxia-induced apoptosis of neural stem cells.DESTGN: A randomized controlled basic study on cells.SETTTNG: Department of Neurology, the Second Affiliated Hospital of Sun Yat-sen University.MATERTALS: This study was completed in the Lin Baixing Laboratory Center of the Second Affiliated Hospital of Sun Yat-sen University from July to December in 2006. Recombinant adenovirus pAdCMV persephin was constructed in our lab. C17.2 neural stem cells were kindly provided by Prof. Snyder, Harvard Medical University, USA. Trypsin and DMEM/F12 were purchased from Gibco Company (USA), fetal bovine serum (FBS) from Sijiqing Biological Engineering Materials Co. Ltd (Hangzhou, China); Poly-lysine from Sigma Company (USA), TUNEL assay kit and FuGENE kit from Roche Molecular Biochemicals Company (Swiss), and S-P immunohistochemical detection kit and DAB reaction kit from Mycine Biological Engineering Company (Fujian). Rat anti-human monoclonal Nestin antibody and rabbit anti-human polyclonal persephin antibody were manufactured by Santa Cruz Company (USA), and persephin anti-senseoligodeoxynucleotide (ODN) was synthesized by Shanghai Biological Engineering Company.METHODS: ① Interventions: C17.2 neural stem cells cultured in vitro were infected by recombinant adenovirus containing persephin gene, and they were divided into four groups: blank control group (Group A, in which the C17.2 neural stem cells were not treated with hypoxia), hypoxic group [Group B, in which the cells were cultured at 37 ℃ in anaerobic incubation containing N2 (0.95 in volume fraction) and CO2 (0.05 in volume fraction)], hypoxia + pAdCMV persephin infection group [Group C, where the cells were cultured under the conditions as in group B after pAdCMV persephin infection for 48 hours], and hypoxia + pAdCMV persephin infection + anti-sense persephin ODN group (Group D, where the cells were infected by pAdCMV persephin and anti-sense persephin ODN. ② Evaluation: The expression of Persephin protein was analyzed using Western blotting; Apoptotic index was detected with terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate nick end-labeling (TUNEL) assay; The changes of apoptotic rate was determined with flow cytometry.MAIN OUTCOME MEASURES: Expression of Persephin protein; Apoptotic index; Apoptotic rate.RESULTS: ① Expression of Persephin protein: A specific band (relative molecular mass of 24 000) was detected by Western blotting in pAdCMV persephin infected cells, suggesting the successful expression of persephin gene.Interestingly, the cells infected with both pAdCMV persephin and anti-sense persephin ODN also showed the specific band of about 24 000, but with much less density, indicating that anti-sense persephin ODN could effectively inhibit the expression of pAdCMV persephin. However, this band was not presented in the blank control groups. ② Apoptotic index:The apoptotic index in group C was significantly lower than those in groups B and D (P＜0.01), but still higher than that of group A (P＜0.01), suggesting that persephin gene transfer could attenuate apoptosis to some extent. ③ Apoptotic rate: The apoptotic rate in groups B and D were obviously higher than that in group A (P ＜ 0.01), and it was lower in group C than in groups B and D (P＜0.01).CONCLUSION:Recombinant adenovirus can efficiently mediate Persephin gene transfer into C17.2 neural stem cells,resulting in high expression of the exogenous Persephin in vitro, which effectively reduces C17.2 neural stem cell apoptosis induced by hypoxia.