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

Objective To investigate the neuromuscular blocking effects and clinical pharmacology of different dosage of mivacurium chloride in infants during sevoflurane anesthesia. Methods Forty ASA I infants undergoing sevoflurane general anesthesia were randomly assigned to tow groups according to the dose level of mivacurium: group1: 200 μg/kg ( n =20) and group2: 250 μg/kg ( n =20) . TOFs were determined synchronously. The onset time of mivacurium, recovery time of spontaneous breathing and cardiovascular reactions were measured. Results The onset time was significantly shortened in group 2 compared with group 1 (P<0.05) . There was no significant difference in the recovery time of spontaneous breathing between the two groups. 2 minutes after mivacurium was injected, DBP in group 2 decreased significantly compared with baseline and group 1. 3 minutes after mivacurium was injected,SBP in group 2 decreased significantly compared with baseline and group 1. Conclusion In infants undergoing sevoflurane general anesthesia, the onset time of mivacurium can be shortened when 250μg/kg was administered,but the depression of cardiovascular system may occurr simultaneously.

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.

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 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.

Objective To investigate the hemostasis effect of alginate dressing for puncture point bleeding after peripherally inserted central catheter (PICC) by ultrasound-guided modified Seldinger technique (MST).Methods Between November 2013 and May 2016, 538 cases of cancer in our department underwent PICC, including 270 cases from November 2013 to February 2015 selected as control group (after PICC was successfully placed, sterile gauze and 3M transparent film were used to fix the puncture point) and 268 cases from March 2015 to May 2016 selected as observation group (after PICC was successfully placed, alginate dressing, sterile gauze and 3M transparent film were used to fix the puncture point).The patients in both groups were given 20 minutes of pressure for puncture point and elastic bandage compression fixation for 24 h.The degree of puncture point bleeding and times of dressing change in 24 h and 24-72 h between the two groups were compared.Results In the observation group, mild, moderate, and severe bleeding was seen in 232 cases, 34 cases, and 2 cases within 24 h, and in 242 cases, 25 cases, and 1 case between 24-72 h, respectively.In the control group, mild, moderate, and severe bleeding was seen in 12 cases, 196 cases, and 62 cases within 24 h, and in 21 cases, 212 cases, and 37 cases between 24-72 h, respectively, with significant differences (Z=-18.647, P=0.000;Z=-18.768, P=0.000).In the observation group, there were zero, once, twice, and ≥3 times of puncture point dressing change in 232 cases, 33 cases, 3 cases, and 0 case within 24 h and in 242 cases, 25 cases, 1 case, and 0 case between 24-72 h, respectively.In the control group, there were zero, once, twice, and ≥3 times of puncture point dressing change in 12 cases, 196 cases, 51 cases, and 11 cases within 24 h and in 21 cases, 209 cases, 37 cases, and 3 cases between 24-72 h, respectively, with significant differences (Z=-18.560, P=0.000;Z=-18.755, P=0.000).Conclusion The hemostasis effect of alginate dressing for puncture point bleeding after ultrasound-guided PICC by MST is satisfactory.

Objective To explore clinical efficacy of compound sulfamethoxazole combined with conventional atomization in treatment of bronchial tuberculosis.Methods 190 cases were selected from January 2012 to October 2013 who diagnosised bronchial tuberculosis treated in minda hospital affiliated of Hubei institute for Nationalities,then the patiens were randomly divided into two groups(n=95 ),the control group underwent conventional spray treatment,the observation group row treatment on the basis of atomization,while giving sulfamethoxazole treatment,observation and comparison of two groups clinical outcomes and adverse reactions. Result After continuous treatment for 4~6 months in the observation group therapy effective rate of 70.5%,total effective rate was 89.5%in the control group significant efficiency and total efficiency of 48.4%and 76.8%,respectively,two groups of significant efficiency and total efficiency,there were significant differences(P<0.05 );bacterial turn negative time indicator on the observation group and the control group were respectively(2.6 ±0.9)months and(4.2 ±1.1)months,there was significant difference(P<0.05);adverse reactions in observation group and control group was 7.4% and 11.6%,respectively,which compared no significant difference.Conclusion Application of compound sulfamethoxazole combined with conventional atomization in treatment of bronchial tuberculosis,has quickly and significantly effect,and bacterial clearance time is short,with low adverse reactions,safety and reliable.

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