This paper introduced the medical device classification in China and USA. Through the comparison between the two systems, several problems in Chinese classification system were exposed. To the end, some suggestions were proposed referred to the classification system of USA.
China ; Device Approval ; standards ; Equipment and Supplies ; classification ; United States

Objective To observe the effect of ShenQi Wuweizi Tablet (Tablet composed of pilose asiabell root, astragalus root, and schisandra fruit) on anxiety before college entrance examination.Methods Totally 227 patients were randomized into a treatment group (113 cases, treated with Shenqi Wuweizi Tablet, 3 tablets each time and 3 time a day), and a control group (114 cases, treated with alprazolam, 0.4 mg each time and 3 times a day). The treatment course was 6 weeks for both groups. Before treatment and at the end of the 1st, 2nd, 4th and 6th week of treatment, the clinical effect was assessed with Hamilton Anxiety Scale (HAMA) and Clinical Global Impression (CGI), and Self-Rating Anxiety Scale (SAS). And at the same time, the untoward reactions was also observed.Results At the end of the 1st week of treatment, the HAMA score was significantly decreased in the control group (P

For the preparation of implementing IEC 60601-1 Ed. 3.1 in advance, this paper analyzes the main difference between IEC 60601-1 Ed. 3.1 and GB 9706.1-2007, and discusses the possible influence to medical device designing and testing.
Equipment Design ; standards ; Equipment and Supplies ; standards

Objective To investigate the genotype of HPV and L1 gene polymorphism of HPV subtype 6b in patients with condyloma acuminatum (CA) from Wenzhou region. Methods Gene chips were used to profile the genotype of HPV in tissue samples from 73 patients with CA. PCR was performed to amplify the L1 gene in 11 samples positive for HPV type 6 followed by sequencing. Results Of the 73 patients, 61 (83.56%) were positive for HPV DNA. Among the 61 HPV-positive patients, 93.44% were infected with single type of HPV, and 6.56% with mixed type of HPV. In patients infected with single type of HPV, type 11 predominated with a prevalence of 29.51% followed by HPV 6 (18.03%); in those infected with mixed type of HPV, 6and 11 were the most common genotypes. Besides, sequencing analysis revealed single nucleotide polymorphism at 6 sites of HPV 6b type L1 gene, and an A/T polymorphism at position -810 was present in all samples, which was considered to be a local mutation of HPV from Wenzhou region. Conclusions In Wenzhou region, HPV types 11 and 6 prevail in patients with CA, and multiple mutations are present in L1 gene of HPV 6b type.

Objective To investigate the action of inorganic arsenic in the induction of DNA strand breaks in primary cultured human skin fibroblasts. Methods Sodium arsenate and sodium arsenite were used as test inorganic arsenics. DNA strand breaks were assessed by single cell gel electrophoresis assay (SCGE). Results Arsenate at 1～10 ?mol/L dose_dependently induced DNA strand breaks in cells. Arsenate at lower concentrations induced mainly degree I DNA strand breaks, while the proportion of cells with degree Ⅱ DNA strand breaks increased to 50% when treated with 10?mol/L arsenate,but no cells with degree ⅢDNA strand breaks were observed.Cells treated with 1?mol/L arsenite showed no significant increase in DNA strand breaks. At the concentration of 10?mol/L, however, arsenite induced DNA strand breaks with different degrees, and the apoptotic type DNA strand breaks were the major type. Conclusion Sodium arsenate mainly induced general type DNA strand breaks and sodium arsenite induced apoptotic type,beside general type of DNA strand breaks in primary cultured human skin fibroblasts. This could be explained by their different reaction modes with DNA, and further studies were needed.

ve To investigate the intake of fluoride of residents in pastoral area of Beier Lake and its main source. Methods Two of the typical endemic fluorosis villages were selected as observation sites in Xinbaerhuyouqi County of Inner Mongolia Autonomous Region. The amount of milk-tea drank by residents was investigated, the drinking water samples, brick-tea samples and milk-tea samples were collected from 10 families randomly selected as observation families. The contents of fluoride of 3 kinds of samples were determined by iron selective electrode method. Results The contents of fluoride in drinking water samples, brick-tea samples and milk-tea samples reached higher levels, namely, 4.12-4.37 mg/L, 780.3-800.0 mg/L and 5.80-5.88 mg/L respectively in two investigation sites. The intake of fluoride from milk-tea of adults was (8.70 ?3.91) mg/d and (9.50?3.22) mg/d respectively, of which, 75.34% and 70.07% came from drinking water, 24.66% and 29.93% came from brick-tea in two observation sites. Conclusion The two observation sites with the higher levels of fluoride intake far exceeding the related Na-tional Standards were composite endemic fluorosis area with a fluoride exposure route mainly via drinking water.

Objective To explore the investigative studies of experimental value on the children suffered from a parotitis with pancreatitis.Methods 108 children patients were divided into 3 sub-groups:parotitis,parotitis with minigitis,parotitis with pancreatitis.45 cases were pantitis,24 were parotitis with pancreatitis and 39 were parotitis with minigititis.All the patients had serum amylase,serum lipase and abdominal B-ultrasound detected.All the results were statistically analyzed.Results The patients who had parotitis with pancreatitis were higher at abnonmal serum lipase and B-ultrasound(?~2=58.68,P

Objective To investigate the prevalence of aspirin resistance(AR)in the patients with metabolic syndrome and the clinical characteristics.Methods A total of 221 patients with metabolic syndrome received 200 mg of aspirin daily for 10 days and no other antiplatelet agent.The blood samples were analyzed by platelet aggregation test(pAgT)using arachidonic acid(AA).We identified aspirin resistance when arachidonic acid induced aggregation≥20%.Results 17.6%of the patients showed AR.The AR fibrinogen level was significantly higher than AS patients(2.6?0.4 vs 2.4?0.4,P=0.017).Patients who were AR had no statistically significant difference in blood pressure,age,fasting blood glucose,blood fat and BMI compared with aspirin-sensitive patients(AS).There was also no difference in sex,smoking and history of myocardial infarction or ischemic stroke between AR and AS patients.When stratified by sex,we found history of myocardial infarction was predictor for AR in male(50.0% vs 14.5%,P=0.020)and so was diastolic blood pressure higher than 85mmHg in female(34.0% vs 15.5%,P=0.043).Conclusion The AR accounts for 17.6%(39/221)of all.In this research.AR patients have higher level of fibrinogen than AS.History of myocardial infarction and higher level of diastolic blood pressure may be the predictor for AR in male and female individually.

Objective To explore the effect of kangfuxin liquid topical treatment on open wound of postoperative perianal abscess.Methods200 cases of patients with open wound abscess surgery in our hospital from February 2014 to September 2016 were randomly divided into control group and experimental group,with 100 cases in each group.The control group was given conventional treatment, the experimental group were treated by kangfuxin liquid.The relevant therapeutic indicators and clinical healing time between two groups were compared.ResultsThe effective rate of the treatment group was 93.0%, which was significantly higher than that of the control group (85.0%), the difference was statistically significant(P<0.05).The granulation growth period of the experimental group was (5.14±1.41) days, and the average healing time was (15.21±2.49) days.Which were significantly shorter than those of the control group[(7.45±1.32) days, (21.16±2.69) days], and the differences were Statistical differences (P<0.05).ConclusionTo improve the treatment effect to a great extent open wound infection of kangfuxin liquid in treatment of perianal abscess after surgery, shorten the healing time, improve the patient's symptoms, with further clinical promotion and application significance.

Objective This experiment will use from yu liquid Elimination hemorrhoids decoction in the treatment of inflammatory external piles,and to evaluate the clinical curative effect analysis.MethodsThe experiment selected the June 2016-December 2016 in our hospital 120 cases of patients with inflammatory external piles as the research object,were randomly divided into control group and observation group,60 cases in each group.Among them,the control group were treated by hemorrhoid better treatment.observation group to adopt the yu fumigation sitz bath liquid Elimination hemorrhoids soup treatment.Recorded before and after treatment in patients with symptoms of 3 days, 7 days, 14 days, including bleeding, anal discomfort, lower rectal mucosa, emergence, defecate unwell, etc., and score four grade three points method.Then compared two groups of patients was improved and the recurrence rate,further to explore the treatment effectiveness.ResultsTwo groups after treatment in patients with the disease were eased,and the observation group has better effect to improve patients,in particular,involves the bleeding,anal discomfort,lower rectal mucosa,hernia,defecate unwell wait for a problem,and group therapy 3 days, 7 days, 14 days total score, respectively (10.2±4.0), (8.6±3.5), (5.3±3.1) and control group corresponding to(11.3±4.2), (9.9±3.5), (6.4±3.2) and significant difference comparing the two groups, with statistical significance(P<0.05).But in comprehensive treatment efficiency,small difference between the two groups,no statistically significant.ConclusionUsing the quasi yu liquid elimination hemorrhoids decoction in the treatment of inflammatory external piles have good improvement effect, eliminate edema, quick effect, medical expenses low salient features, and avoid the operation of psychological pressure and economic pressure, is worthy of popularization and application in the process of clinical treatment.