0.05). PLI was significantly correl ated with GI (P

Bio-evaluation within the medical device quality/risk management system is a risk analyzing and assessing process. On the basis of data from characterization of materials, scientific literatures, application history, bio-toxicology testing and so on, weighing the benefit and the risk, bio-evaluation does a conclusion to "take" or "quit" the product design. There is no "zero risk" though "no toxicity" always is the most desirable conclusion in a testing report. The application history data is the most comprehensive among the information available, since no testing system can "clone" the human body. In addition, the capital cost has to be taken into account when bringing the sophisticated testing technologies into the evaluating system. Investigating the #G95-1 of FDA CDRH and the changes of ISO 10993-1, the trend to integrate bio-evaluation into a quality/risk management process can be figured out.
Equipment and Supplies ; adverse effects ; standards ; Quality Control ; Risk Management

Background:It has been demonstrated that H + -K + -ATPase expression in human parietal cells had a tendency to increase with aging. However,the effect of aging on activity of H + -K + -ATPase is still unclear. Aims:To investigate effect of aging on activity of H + -K + -ATPase. Methods:Fifteen male Sprague-Dawley(SD)rats were divided into 4,21,24, 27 and 30 months group,and 19 healthy beagle dogs were divided into younger group,junior elderly group and senior elderly group. The activity of H + -K + -ATPase in gastric fundal mucosa was assessed. Results:The activity of H + -K + -ATPase in gastric fundal mucosa in 4,21,24,27 and 30 months old rats were(4. 850 ± 0. 312)μmol·mg - 1 ·h - 1 , (5. 466 ± 0. 379)μmol·mg - 1 ·h - 1 ,(6. 068 ± 0. 228)μmol·mg - 1 ·h - 1 ,(5. 733 ± 0. 767)μmol·mg - 1 ·h - 1 and (6. 223 ± 0. 428)μmol · mg - 1 · h - 1 ,respectively. With aging,H + -K + -ATPase activity in rats had a tendency to increase(F = 4. 519,P = 0. 031). The activity of H + -K + -ATPase in beagle dogs in younger group,junior elderly group and senior elderly group were(11. 087 ± 4. 320)μmol·mg - 1 ·h - 1 ,(8. 549 ± 3. 250)μmol·mg - 1 ·h - 1 ,(12. 071 ± 2. 820)μmol·mg - 1 ·h - 1 ,respectively. There was no statistically significant difference among the three groups(F =1. 339,P = 0. 290). Conclusions:With aging,the activity of H + -K + -ATPase in rats and beagle dogs does not decline, but even has a tendency to increase.

OBJECTIVETo study the inhibitory effect of wogonin on the growth and proliferation of breast cancer cells MDA-MB-23, and observe its effect on the adhesion, migration and invasion of MDA-MB-23 cells, in order to further study its molecular mechanism.

METHODMTT assay was used to detect the effect of wogonin on MDA-MB-23 cell growth. Ki-67 assay was adopted to test the effect of wogonin on cell proliferation. Scratch test, adherence test and invasion chamber assay were taken to detect the effect on the migration and invasion abilities of MDA-MB-231 cells. Proliferation and metastasis-related proteins and relevant signaling pathways were detected by Western blotting.

RESULTWogonin could remarkably inhibit the growth and proliferation of MDA-MB-231 cells, significantly inhibit migration, adhesion and invasion abilities of breast cancer cells at a low concentration, and effectively inhibit the expression of Survivin, Bcl-2, ICAM-1, MMP-2, MMP-9 proteins of MDA-MB-231 cells.

CONCLUSIONWogonin could notably inhibit growth and proliferation of breast cancer cells, and inhibit migration, adhesion and invasion of MDA-MB-231 cells. Its invasive and adhesive effects on MDA-MB-231 cells may be related to the decrease in ICAM-1, MMP-2, MMP-9 expressions.

Breast Neoplasms ; genetics ; metabolism ; pathology ; physiopathology ; Cell Line, Tumor ; Cell Movement ; drug effects ; Cell Proliferation ; drug effects ; Drugs, Chinese Herbal ; pharmacology ; Female ; Flavanones ; pharmacology ; Gene Expression Regulation, Neoplastic ; drug effects ; Humans ; Intercellular Adhesion Molecule-1 ; genetics ; metabolism ; Matrix Metalloproteinase 2 ; genetics ; metabolism ; Matrix Metalloproteinase 9 ; genetics ; metabolism ; Neoplasm Invasiveness ; Signal Transduction ; drug effects

Objective:Present study was aimed to analyze the immunogenicity of recombinant Lugurus zona pellucida-3 protein (r-LZP3) expressed in E.coli,and to evaluate the efficacy of its antiserum to affect in vitro mouse sperm-egg binding.Methods:Female mouse were immunized using LZP3 DNA vaccine for priming,and boosted with r-LZP3 protein.The antibody response level of LZP3 antisera was determined by ELISA.The immunoreactivity and specificity of the anti-LZP3 antisera were tested by immunoblot, indirect immunofluorescence and immunohistochemistry using native mouse ZP.A sperm-zone pellucida binding assay was used to evaluate the efficacy of anti-LZP3 antisera to inhibit mouse sperm-egg binding in vitro.Results: The result of ELISA showed that LZP3 DNA vaccine was able to induce higher antibody titers in mouse.Antiserum could specifically recognize or bind to r-LZP3 protein expressed in E.coli and native mouse ZP in vitro.The LZP3 antisera and r-LZP3 protein also inhibited sperm-egg binding in vitro.Condusion:These results show that r-LZP3 protein is of strong immunogenicity.

Objective To investigate the results of follow-up visits of pregnancy course, delivery and infants of women who got clinically pregnant by assisted reproductive technique after gonadotropin-releasing hormone agonist (GnRH-a) added for luteal support, and to analyse the influence of adding GnRH-a in luteal support on the safety of mother and infant. Methods A retrospective analysis was carried out on the medical record from 215 patients who got clinically pregnant after luteal phase long regimen fresh-cycle transfer was operated. According to the differences in luteal support methods, the patients were assigned to Group A (124 patients, progesterone+dydrogesterone group), Group B (91 patients, GnRH-a added group). The patients′ pregnancy course, delivery time, and the growth and development of infants within 1-2 years were followed up. Results (1)There was no obvious difference between Group A and Group B in terms of the abortion ratio during the early pregnancy (8.1%, 12.1%), the rate of abortion villous deformity (50.0%, 9.1%), the rate of heterotopic pregnancy (10.5%, 5.5%) and rate of twin pregnancy (19.4%, 28.6%;all P>0.05).(2)Compared to group A, during the middle and late pregnancy of single or twin pregnancy in Group B , there was no obvious difference in the rate of fetal chromosomal abnormality, organ malformation incidence, late abortion rate and stillbirth rate (all P>0.05).(3)As to childbirth, in the case of twin pregnancy, there was a higher rate of premature delivery (60.0%, 39.1%;P=0.041), as well as rate of lower birth weight of newborn (56.0%, 34.8%; P=0.037) in group B.(4)The statistics on general growth and development as well as infantile common diseases within 2 years after birth indicated that there was no obvious difference between the two groups in single birth and twin birth subgroup (all P>0.05). Conclusion On the basis of controlling of implanted embryos and reducing the occurrence of twins, GnRH-a luteal support maybe relatively safe and effective.

One strain of Pseudoalteromonas sp. E18 was isolated from the sea mud of Ningbo, Zhejiang. It can produce indigo pigment. The morphological, cultural and biochemical characteristics of the bacterium were studied. The indigo pigment was also extracted. The results showed that the maximum absorption peak of the pigment was at 579nm. The pigment was stable to UV, Na_2SO_3,It was also stable at pH 3～9. The pigment was unstable to the sunlight and high concentration H_2O_2. Temperature of 60℃～80℃ could increase the hue while temperature higher than 90℃ could reduce the hue.

OBJECTIVE: The purpose of this study is to assess the effects of aging on air-conducted sound elicited cervical vestibular evoked myogenic potential (cVEMP) and ocular vestibular evoked myogenic potential(oVEMP) in normal people. METHOD: Sixty normal subjects were recruited for the vestibular evoked myogenic potential examination. Among them, 20-40 year-old group was setted as the first group, 41-60 year-old group was setted as the second group, > 60-year-old group was setted as the third group. Each group included 20 normal subjects. SPSS 16.0 software was used to analyze the data. RESULT: As the age growing, P1 latency prolonged, N1-P1 amplitude decreased, and amplitude asymmetric ratio increased in cVEMP; N1 latency prolonged, P1-N1 amplitude decreased, and amplitude asymmetric ratio increased in oVEMP. CONCLUSION With the age growing, the time of otolithic organ input pathways prolonged, the function of otolithic organ decreased and the decrease level may be asymeetrical on both sides.
Adult ; Aging ; Eye ; Head ; Hearing ; Humans ; Middle Aged ; Otolithic Membrane ; Vestibular Evoked Myogenic Potentials ; Vestibule, Labyrinth ; Young Adult

OBJECTIVETo study the characteristics and regular pattern of the medicine in common use and combined medication in patients of acute pancreatitis in real world.

METHODCollect the information of 5 433 acute pancreatitis patients in 19 grade IIIA general hospitals in China, analysis by descriptive statistics and association rule.

RESULTIn the 5 433 patients of acute pancreatitis, the glycyrrhizic acid injection and somatostatin are the frequency top used Chinese traditional and western medication. Glycyrrhizic acid injection, somatostatin and insulin are the frequency top used drug combination pattern.

CONCLUSIONThe Chinese and western integrative medicine drug use pattern are accord with the clinical guideline of acute panceatitis. The hepatic and renal function, blood routine and coagulation function should be monitored when the medicines are used.

Adolescent ; Adult ; Aged ; Anti-Inflammatory Agents ; therapeutic use ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Glycyrrhizic Acid ; therapeutic use ; Humans ; Male ; Medicine, Chinese Traditional ; methods ; Middle Aged ; Pancreatitis ; drug therapy ; Somatostatin ; therapeutic use ; Young Adult

Objective To study the changes of gonadotropin releasing hormone agonist (GnRH-a) in pinopodes during luteal phase and to explore the possible mechanism of GnRH-a in luteal phase support of assisted reproductive technology (ART).Methods Totally 40 primary infertility women who were treated with ART due to male factors were enrolled,according to the order of the group they were randomly divided into experimental group and control group.On the 7th day after ovulation,the experimental group received a subcutaneous injection of 0.1 mg of GnRH-a,while the control group received a subcutaneous injection of placebo only (0.9％ salinc 2 ml),3 days later they came to the clinic again.Serum estradiol and progesterone levels were measured before and after treatment in each group.Pinopodes were collected for electron microscopic examination.Levels of ER and PR were detected by western blot.Results (1) There was no significant difference between the experimental group and the control group in the estrogen level before and after the treatment (all P＞0.05).The level of progesterone in the experimental group after treatment [(66.8± 14.9) nmol/L] was significantly higher than that before treatment(P＜0.05);also significantly higher than the same period of the control group (P＜0.05).(2) There was no significant difference in the expression of ER protein in the experimental group before and after treatment (P＞0.05).The expression of PR in the experimental group after treatment was significantly lower than that before treatment (P＜0.05);also lower than the same period of the control group (P＜0.05).(3) Expression amount of pinopodes in the experimental group after treatment was significantly higher than that before treatment [65％ (13/20) versus 25％ (5/20),P＜ 0.05],and the development trend was more mature [the percentage of maturation:75％ (15/20) versus 35％ (7/ 20),P＜0.05].Expression amount of pinopodes after treatment and the percentage of maturation in the experimental group were significantly higher than those in the same period of control group (P＜0.05).Conclusion GnRH-a in luteal phase support may play a role through the corpus luteum,which may promote the secretion of progesterone,downregulation of PR expression,promote the growth of pinopodes,and improve the endometrial receptivity.