Common problems analysis of domestic Class II active medical devices registration in China / 医疗卫生装备

Objective To improve the quality of registration and reporting and the efficiency of examination and approval of ClassⅡactive medical devices in China.Methods Classification analysis of common problems in the submitted materials was executed based on the requirements of new laws and regulations for ClassⅡactive medical devices and the experience, and then some measures were put forward with considerations on the new laws and regulations. Results The common problems in the registration and submitting of ClassⅡactive medical devices were described in detail,and some counter-measures were brought out based on the laws and regulations related to provide guidance for other enterprises.Conclusion The enterprise has to study related laws,regulations,standards and guidance when executing registration and application,so that the quality of submitted materials can be enhanced to facilitate the evaluation and approval of ClassⅡactive medical devices.

Research progress on polysaccharide of Chinese materia medica against gastrointestinal tumors in vitro experiments / 药物评价研究

Tumor is a seriously disease that endanger human health.Gastrointestinal cancer is one of the most prevalent types of digestive system cancers among the Chinese population.While radiotherapy and chemotherapy kill cancer cells,their toxicity to normal cells cannot be ignored.Hence,polysaccharides from Chinese materia medica (CMM) have been the focus of anti-tumor research,as they can improve functions of the immune system and do not harm to normal cells.In this review,we have analyzed the recent advances in the study of the effects of polysaccharides from CMM on human gastric cancer cell lines (MGC-803 and SGC-7901) and intestinal tumor cell lines (LoVo,HCT-116,and HT-29) in vitro.The purpose of this study is to provide a material basis for clinical research of polysaccharides from CMM.

Investigation of subjective well-being and influence factors among residents living in old districts in Wuhan, China / 中华预防医学杂志

<p><b>OBJECTIVE</b>To investigate the subjective well-being and its influence factors among residents living in old districts in Wuhan.</p><p><b>METHODS</b>In June, 2011, a total of 500 residents living in Shanghai Street in Wuhan were recruited as subjects for this study by two-stage stratified random sampling method. The information of demographic features, health status, spare time, family status, interpersonal relationship and social environment were collected by self-made questionnaires naming "survey of satisfaction of residents living in old districts". The results were analyzed by single-factor and multi-factors analysis method.</p><p><b>RESULTS</b>In this study, 448 samples of questionnaire were answered qualified (89.6%, 448/500). The subjects aged (51.3 ± 16.1) years old. The single-factor analysis showed that male and female influence the subjective happiness got 5.43 ± 1.66, 5.77 ± 1.65 (U = -2.32, P < 0.05);the age of 0 - 45, 46 - 59, 60 and above group got 5.12 ± 1.68, 5.47 ± 1.81, 6.29 ± 1.23, respectively (H = 43.07, P < 0.01); the unmarried, married, divorced, loss of spouse and remarriage groups got 5.18 ± 1.94, 5.74 ± 1.54, 4.00 ± 2.04, 5.68 ± 1.91, 6.63 ± 0.92, respectively (H = 17.41, P < 0.01); education background were primary school and blow, junior middle school, senior high school, bachelor degree, master degree and above got 6.30 ± 1.42, 5.55 ± 1.82, 5.90 ± 1.46, 5.07 ± 1.74, 4.75 ± 2.22 (H = 26.99, P < 0.01); monthly household income was ¥0 - 2000, ¥2001 - 4000, ¥4001 - 8000, ¥8001 - 10 000, ¥10 000 and above got 5.34 ± 1.87, 5.68 ± 1.53, 6.20 ± 1.07, 7.33 ± 0.58, 6.00 ± 0.00, respectively (H = 13.85, P < 0.01). The subjective satisfaction of social environment ranked from high to low were: city public security (56.0%, 248/448), traffic environment (44.9%, 199/448), community environment (14.9%, 66/448), housing conditions (13.8%, 61/448) and medical environment (8.2%, 36/448). Multiple regression model suggested that the determinant coefficient was 0.53(P < 0.01), with a good degree of fitting. The model showed that the factors influencing the residents' happiness were ranked: social environment (β' = 0.34), family status (β' = 0.32), health status (β' = 0.21), education background (β'(0-6) school year = 0.00, β'(7-9) school year = -0.12, β'(9-12) school year = 0.04, β'(>12) school year = -0.14), monthly household income (β' = 0.07) and marital status (β'(unmarried) = 0.00, β'(married) = 0.03, β'(divorced) = -0.03, β'(widowed) = 0.01, β'(remarried) = 0.02).</p><p><b>CONCLUSION</b>The factors that social environment, family status, health status, education background, monthly household income and marital status could influence the subjective happiness of residents living in old districts in Wuhan. A perfect social security system could improve the subjective happiness of residents in old districts in Wuhan.</p>

Astaxanthin inhibits sodium azide-induced cytotoxicity in hepatocyte L-02 cells probably by H+ transferring function / 药学学报

This study is to investigate the protective effect of astaxanthin against injured hepatocyte L-02 cells induced by sodium azide (NaN3) and reveal the possible mechanisms. Hepatocyte L-02 cells were exposed to 100 mmol.L-1 NaN3 with various concentrations of astaxanthin pre-incubated, then the cell viability was measured by MTT method; The level of reactive oxygen species (ROS) was determined by DCFH-DA method; The changes of mitochondrial membrane potential (MMP) and apoptosis ratio were detected by JC-1 method and Annexin V-FITC/PI double stain method, respectively. Results showed that after cells were exposed to 100 mmol.L-1 NaN3 for 3 hours, the cell viability significantly decreased; ROS level and the percentage of late phase apoptosis increased obviously; MMP was also declined. When cells were pretreated with astaxanthin, the cell damage and late phase apoptosis ratio reduced and MMP was maintained. However, the level of ROS showed insignificant decrease (P>0.05). The beneficial concentration of astaxanthin in improving cell viability and MMP was not in a dose dependent manner and the most effective of which was 0.10 nmol.L-1 (P<0.01). In order to reveal its possible non-antioxidant mechanism, mitochondrial membrane was imitated and H+ transferring function of astaxanthin was also detected by bilayer lipid membrane (BLM) method. Results showed that 2.0% astaxanthin could transfer H+ efficiently. These suggested the mechanisms of astaxanthin in protection of hepatocyte L-02 cells not via its ROS quenching capability but via its H+ transferring function, which improved the mitochondrial function and had the sequence biology effects.

Anti-proliferation of human cervical cancer HeLa cell line by fascaplysin through apoptosis induction / 药学学报

This study is to investigate the effect of fascaplysin on human cervical cancer cells (HeLa) in order to provide insights into the mechanisms of growth suppression involved in fascaplysin-mediated apoptosis. Cytotoxic activity of fascaplysin on HeLa cells was determined using MTT assay, cell cycle analysis, and apoptosis (Annexin V-FITC and PI double staining) studies. The role of the molecules in cell cycle regulation and apoptosis was analyzed by Western blotting and flow cytometry. Fascaplysin markedly inhibited HeLa cells proliferation in a dose-dependent manner, however, did not provoke G1 phase arrest in HeLa cells with downregulation of CDK4, cyclin D1 and CDK4-specific Ser795 pRb phosphorylation. Furthermore, fascaplysin induced significantly apoptosis evidenced by sub-G1 peak and Annexin V-FITC and PI double staining. The molecular mechanism of fascaplysin-induced apoptosis was characterized with the activation of caspase-3, -8, and -9, truncation of Bid, release of cytochrome c into cytosol, and down-regulation of Bcl-2 level. Fascaplysin exhibits anti-proliferation effect towards human cervical cancer HeLa cells through induction of apoptosis via extrinsic death pathway and mitochondrial pathway, but not arresting cell cycle progression at G1 phase. All together, these data sustain our contention that fascaplysin has anticancer properties and merits further investigation as a potential therapeutic agent.

Proliferation inhibition of lambda-carrageenan oligosaccharides on HUVEC and expression of apoptotic relevant genes / 药学学报

To study the anti-proliferation effect of lambda-carrageenan oligosaccharides (lambda-CO) on human umbilical vein endothelial cells (HUVECs) and expression of apoptotic relevant genes, the influence of lambda-CO on HUVECs proliferation was measured by MTT assay; apoptotic rate, cell cycle distribution and the level of active caspase-3 of HUVECs were analyzed using flow cytometry; the mRNA level of apoptosis related genes was determined by RT-PCR. At a high concentration of 1 mg x mL(-1), lambda-CO significantly inhibited the endothelial cell proliferation. Annexin-V FITC/PI double stain assay showed that when treated with 0, 0.8, 1 mg x mL(-1) of lambda-CO for 24 h, cell apoptotic rates were (1.67 +/- 1.6)%, (11.48 +/- 2.4)% and (13.81 +/- 2.2)%, respectively, when treated for 48 h, cell apoptotic rates were (2.02 +/- 2.3)%, (13.84 +/- 1.9)% and (38.72 +/- 2.5)%, respectively, cell cycle assay showed the decrease of cells in G0/G1 phase, and increase in S phase. Furthermore, we observed the level of active caspase-3 increased in a dose-dependent manner at 24 th and 48 th. RT-PCR results indicated that mRNA of TNFalpha, p53, caspase-8 and caspase-3 in cells increased after treated with lambda-CO. lambda-CO induce apoptosis of HUVECs in a dose-dependent way and arrests cells at S phase, which mainly due to the up-regulation of apoptotic genes such as TNFalpha, p53, caspase-8, caspase-3 and increase the level of active caspase-3.

Subclinical Cushing's syndrome:analysis of diagnosis and surgical effect / 中华外科杂志

<p><b>OBJECTIVE</b>To improve the diagnostic and therapeutic ability on subclinical Cushing's syndrome.</p><p><b>METHODS</b>Retrospective analysis for the clinical data of 24 cases of subclinical Cushing's syndrome, the clinical and biological characters pre and post operation were compared.</p><p><b>RESULTS</b>None of the 24 cases of subclinical Cushing's syndrome had the classic symptoms and signs of Cushing's syndrome. The common symptoms of these patients were hypertension in 17 cases, diabetes mellitus in 11 cases, hyperlipidemia in 9 cases, high plasma cortisol value in 13 cases and high 24 h UFC value in 9 cases. None of patients did respond to low dose dexamethasone suppression test, but 16 cases of them did not respond to high dose dexamethasone suppression test. All the cases were found adrenal tumors by CT scan, 10 cases in left adrenal and 14 cases in right adrenal. All the patients underwent retroperitoneal laparoscopic operation and were pathologic diagnosed to adrenal adenomas. During follow-up, the symptoms of 20 cases (83.3%) were cured after surgery, and hormone supplement was required in 8 cases.</p><p><b>CONCLUSIONS</b>Subclinical Cushing's syndrome may be incidentally detected on clinical manifestations, laboratory findings and imaging examinations. CT scan, assays of plasma cortisol, urinary free cortisol and dexamethasone suppression test are most useful in the diagnosis. The potential benefit of surgery should be considered in those who have a definite diagnosis of subclinical Cushing's syndrome. Hormone supplement is required in some patients. It is safe and practical to perform retroperitoneal laparoscopic surgery on the patients with subclinical Cushing's syndrome.</p>

In vitro anti-angiogenic action of lambda-carrageenan oligosaccharides / 药学学报

This study was designed to evaluate the inhibition effect of lambda-carrageenan oligosaccharides on neovascularization in vitro by chick chorioallantoic membrane (CAM) model and human umbilical vein endothelial cell ( HUVEC). lambda-Carrageenan oligosaccharides caused a dose-dependent decrease of the vascular density of CAM, and adversely affected capillary plexus formation. At a high concentration of 1 mg x mL(-1), this compound inhibited the endothelial cell proliferation, while low concentration of lambda-carrageenan oligosaccharides (< 250 microg x mL(-1)) affected the cell survival slightly (> 95%). Different cytotoxic sensitivity of lambda-carrageenan oligosaccharides in three kinds of cells was observed, of which HUVEC is the most sensitive to this oligosaccharides. The inhibitory action of lambda-carrageenan oligosaccharides on the endothelial cell invasion and migration was also observed at relatively low concentration (150 - 300 microg x mL(-1)) through down-regulation of intracellular matrix metalloproteinases-2 (MMP-2) expression on endothelial cells. Current observations demonstrated that lambda-carrageenan oligosaccharides are potential angiogenesis inhibitor with combined effects of inhibiting invasion, migration and proliferation.

The significance of Ki-67 antigen expression in the distinction between benign and malignant pheochromocytomas / 中华外科杂志

<p><b>OBJECTIVES</b>To investigate the expression of Ki-67 antigen in benign and malignant pheochromocytomas, and to evaluate whether the expression of Ki-67 antigen could serve as a diagnostic marker for predicting the biological behaviour of these tumors.</p><p><b>METHODS</b>Ki-67 antigen were detected by immunohistochemical technique and image analysis in 57 cases of clinically documented benign and malignant pheochromocytomas were analyzed. Aside from histological study, Ki-67 immunohistochemistry studies were performed to get the Ki-67 index. Statistical analysis was performed between these groups.</p><p><b>RESULTS</b>Ki-67 index was low in benign pheochromocytomas (average 0.98%), and high in malignant pheochromocytomas (average 3.78%). There was statistically significant difference in expressions of Ki-67 antigen between benign and malignant pheochromocytomas. The Ki-67 index of 2 cases in benign pheochromocytomas (5.1%, 2/39) and 10 cases in malignant pheochromocytomas (55.6%, 10/18) was higher than 3%. The accuracy, sensitivity, specificity, positive predictive value and negative predictive value of Ki-67 index higher than 3% to diagnosis malignant pheochromocytomas was 82.5%, 55.6%, 94.9%, 83.3% and 82.2%. The follow-ups indicated the survival rate of patients with higher Ki-67 index was lower than those with lower Ki-67 index.</p><p><b>CONCLUSIONS</b>Ki-67 may serve as a useful marker of the biological behavior of tumors, and can provide useful information for prognosis of tumor patients. Immunohistochemical assessment of Ki-67 antigen can be useful in the differential diagnosis of malignant from benign pheochromocytomas. Ki-67 index (> 3%) is a useful marker for distinguishing benign from malignant tumors or for predicting the malignant potential of pheochromocytomas.</p>

Study on the carbapenemase genotype and molecular epidemiology of Acinetobacter baumannii / 中华流行病学杂志

<p><b>OBJECTIVE</b>To investigate antibiotic resistance, clonal relatedness and carbapenemase genotype among carbapenem-resistant Acinetobacter baumannii collected from 3 comprehensive hospitals in Ningbo city, Zhejiang province.</p><p><b>METHODS</b>28 strains of carbapenem resistant Acinetobacter baumannii were collected from Ningbo Li Hui-li Hospital, Ningbo Li Hui-li Hospital, Ningbo First Hospital, and N ingbo Second Hospital. The minimum inhibitory concentrations (MIC) of these strains were examined by agar dilution and E-test method. Homology of these isolates was analyzed by pulse-field gel electrophoresis (PFGE) and Genotype of carbapenemases were analyzed by PCR and verified by DNA sequencing.</p><p><b>RESULTS</b>28 strains of Acinetobacter baumanii were highly resistant to all of the antibiotics except polymyxin E. They were classified into 4 clones based on PFGE pattern. Clone A and B had been spreading widely. All of the 28 strains produced carbapenemases which were confirmed as OXA-23 by PCR and sequencing. Metallo-beta-lactamase was not detected in any of the isolates.</p><p><b>CONCLUSION</b>All of t hecarbapenem-resistant Acinetobacter baumannii collected from Ningbo were producing OXA-23 carbapenemase, suggesting that the transmission of clones had occurred in the 3 hospitals.</p>

Review on Metabolic Mechanism of Glycogen-accumulating Organisms in Biological Phosphorus Removal System / 微生物学通报

Enhanced biological phosphorus removal (EBPR) is widely accepted as one of the most economical and sustainable processes to remove phosphorus from wastewater.Poor performance or complete failure of EBPR processes has been substantially reported because of the proliferation of glycogen-accumulating organisms (GAOs) in the system.This paper presented the GAOs' metabolic mechanism and the impact factors, such as influent substrate, P/C ratio, pH value, temperature and SRT, on competition between GAOs and PAOs to better understand GAOs' characteristics and improve the performance and reliability of EBPR systems.