According to the registered product standards specification of medical devices, combined with the standard reviewing work, the common problems of standards during medical devices registration were analyzed and corresponding suggestions were proposed to standardize the standard of the registered product, accelerate the standardization and promote the industry standardized.
Device Approval ; Equipment and Supplies ; standards

Objective To describe the echocardiographic and clinical findings of patients with accessory mitral valve(AMV).Methods Four adult patients were diagnosed to have AMV by Doppler echocardiography.Results All the four patients had cardiac murmur but 2 were asymptomatic.Echocardiogram showed that two cases had isolated AMV with significant left ventricular outflow tract (LVOT)obstruction.Another patient was complicated by idiopathic hypertrophic subaortic stenosis and his systolic pressure gradient across the LVOT reduced to normal after taking negative inotropic drugs.The fourth patient was associated with complex congenital cardiac anomalies but without LVOT obstruction.Conclusions AMV may not be very rare as previously reported.An echocardiographic examination Can detect AMV and difierentiate it from other causes of LVOT obstruction.

Objective To investigate the therapeutic effect of topical corticosteroids injection and systemic application in the treatment of sudden hearing loss.Methods Total of 58 patients with sudden hearing loss were ran-domly divided into two groups.The systemic application group:dexamethasone (DEX)was applied by intravenous injection in dose of 10mg ×3d,followed by 5mg ×4d.And the postauricular injection group:methylprednisolone sodium succinate of 40mg was injected into cortical bone of mastoid region every three days,until hearing back to normal,or 15 days.SPSS 13.0 software was used to analyze the data.Results The total effective rate of systemic application group was 67.7%,the total effective rate of postauricular injection group was 64.7%.There was no statistical differ-ence between the two groups (χ2 =2.58,P =0.316).The recovery rate in cases with postauricular injection group was significantly increased in comparison with the systemic application group,but no statistical difference between the two groups(t =2.71,P =0.062).Patients with hearing loss in low frequencies(250Hz,500Hz),the recovery rate in cases with postauricular injection group was significantly increased in comparison with the systemic application group (t =3.82,P =0.031;t =3.26,P =0.042).Conclusion Postauricular topical injection and systemic application of glucocorticoids in the treatment of sudden hearing loss are all have good curative effect.Systemic application is select-ed by conventional treatment,and topical injection has a better effect in the hearing loss of low -middle frequencies.

Arthritis, Juvenile ; blood ; Child ; Humans ; Interleukin-15 ; blood

Adult ; Aged ; Antipsychotic Agents ; adverse effects ; Child ; China ; epidemiology ; Combined Modality Therapy ; Drugs, Chinese Herbal ; therapeutic use ; Dyskinesia, Drug-Induced ; drug therapy ; epidemiology ; Female ; Humans ; Male ; Middle Aged ; Phytotherapy ; Prevalence

Objective: To investigate the mechanism of butyrate,which is the by-products of diet fiber fermented in colon and induce the apoptosis of human colon cancer cell. Methods: The subculture of human colon cancer cell line SW1116 was cultured in medium with different concentration of butyrate(0、2 、3 、4、7 and 10 mmol/L).The mRNA and proteins of bcl-2 or bax in cell lines were detected respectively by RT-PCR and Western Blotting while the concentration of p53 protein and the activity of caspase-3 was detected by flow cytometer and fluorescent quantitative assay respectively after 6、24、48 and 72h cultivation.Results: There was no expression of bcl-2 mRNA and its protein in SW1116 cell during the study periods but the expression of bax mRNA and its protein,the p53 protein concentration and the caspase-3 activity increased gradually when the butyrate concentration was increased and the cultivation time was prolonged. Conclusion: By up-regulating the expression of bax mRNA and its protein,butyrate induce the apoptosis of colon cancer cell on a p53 dependent way.

Objectives: To investigate the effect of butyrate, the by-products of diet fiber fermented in colon, on the apoptosis of human colon cancer cell and its mechanism for colon cancer prevention. Methods: The subculture of human colon cancer cell line SW1116 was cultured in medium without or with different concentration of butyrate(2、3、4、7 and 10 mmol/L). The cell proliferation rate and apoptosis were measured by MTT and flow cytometer or electro-microscopy respectively after 6、24、48 and 72 cultivation. Results: By the increasing of butyrate concentration and cell culture time, the proliferation of SW1116 cell was inhibited gradually with a highest rate of 59.19% during the study period. The percent of G 1 cell was increased gradually whereas the percent of S cell was decreased. The apoptosis rate of SW1116 was increased gradually with a highest rate of 30.62% at the same time. The ultrastructure of SW1116 cell was changed after butyrate was added to culture medium. Conclusions: Butyrate could not only inhibit the proliferation of colon cancer cell line but also induce it apoptosis.

Objectives:To study the methionine dependence (Met-dependence) of human primary gastric cancer cells in vitro when Met in the culture medicine was replaced by its precussor homocysteine(Hcy). Methods:Fresh and sterile gaotric cancer samples and normal gastric mucosa were managed into single-cell suspension and were cultured in the Met -Hcy + and Met\++ Hcy\+- medium separately.proliferation of these cells in the two different culture media was examined by cell counter and flow cytometry (FCM). Results:In the Met\++Hcy\+- medium,the growth of primary gastric cancer cells was inhibited,manifesting that the percentage of G 0G 1 tumor cells decreased and that of the S phase increased signiflcantly.However,normal gastric mucosal cells grew well and their cell cycles had no change. Conclusions:Human primary gastric cancer cells are Met dependent in vitro whereas normal gastric mucosal cells have no similar results.

OBJECTIVETo elucidate whether the plasma concentration of NT-proBNP in patients with acute coronary syndrome (ACS) correlated with severity of the diseases and whether NT-proBNP is a reliable biochemical marker correctly indicates the severity of ACS.

METHODSEighty-nine subjects came from CCU of Cardiology Department of People's Hospital Beijing University from October 2003 to June 2004 and aged 34-85 y (66.89 +/- 11.12 y). In this study the spectrum of ACS only included unstable angina pectoris (UA) and acute myocardial infarction (AMI). Patients with UA were separated into 3 groups by Braunwald classes and those with AMI were separated into 4 groups by Killip classes when their venous blood samples were collected. Plasma concentration of NT-proBNP was measured by enzyme linked immunoabsorbent assay. Data was estimated by SPSS.

RESULTSThe concentration of NT-proBNP in patients with ACS was dramatically correlative with the severity of the diseases: with the upgrading of Braunwald classes, the concentration of NT-proBNP in patients with UA increased gradually; in patients with AMI it also raised gradually with the upgrading of killip classes; furthermore, the plasma concentration of NT-proBNP in patients with AIM increased much more than that in patients with UA when they are at the similar NYHA functional class.

CONCLUSIONPlasma concentration of NT-proBNP in patients with ACS might be a reliable biochemical marker which can objectively indicate the degree of this diseases.

Acute Coronary Syndrome ; blood ; physiopathology ; Adult ; Aged ; Aged, 80 and over ; Humans ; Middle Aged ; Natriuretic Peptide, Brain ; blood ; Peptide Fragments ; blood

Cellular fibronectin (cFn) is a type of bioactive non-collagen glycoprotein regarded as the main substance used to maintain periodontal attachment. The content of cFn in some specific sites can reflect the progress of periodontitis or peri-implantitis. This study aims to evaluate the expression of cFn messenger RNA (mRNA) in tissues of adult periodontitis and peri-implantitis by real-time fluorescent quantitative polymerase chain reaction (PCR) and to determine its clinical significance. A total of 30 patients were divided into three groups of 10: healthy, adult periodontitis and peri-implantitis. Periodontal tissue biopsies (1 mm×1 mm×1 mm) from each patient were frozen in liquid nitrogen. Total RNA was extracted from these tissues, and the content, purity and integrity were detected. Specific primers were designed according to the sequence, and the mRNA expression levels of cellular fibronectin were detected by real-time PCR. The purity and integrity of the extracted total RNA were both high, and the specificity of amplified genes was very high with no other pollution. The mRNA expression of cFn in the adult periodontitis group (1.526±0.441) was lower than that in the healthy group (3.253±0.736). However, the mRNA expression of cFn in the peri-implantitis group (3.965±0.537) was significantly higher than that in the healthy group. The difference revealed that although both processes were destructive inflammatory reactions in the periodontium, the pathomechanisms were different and the variation started from the transcription level of the cFn gene.
Adult ; Alveolar Bone Loss ; metabolism ; Female ; Fibronectins ; analysis ; genetics ; Gingiva ; metabolism ; Humans ; Male ; Middle Aged ; Peri-Implantitis ; metabolism ; Periodontal Attachment Loss ; metabolism ; Periodontal Index ; Periodontal Pocket ; metabolism ; Periodontitis ; metabolism ; Periodontium ; metabolism ; RNA, Messenger ; analysis ; Real-Time Polymerase Chain Reaction ; Transcription, Genetic ; genetics ; Young Adult