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 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.

[Summary] Next-generation sequencing is a revolution in the approach of genetic testing. It broadens the insight on the genetic diagnosis and research of monogenetic diabetes,which is represented by neonatal diabetes mellitus and maturity onset diabetes of the young.And it reveals advantages in exploring novel mutations.

Objective To evaluate the diagnostic and prognostic value of the serum procalcitonin ( PCT ) level in the non-acquired immune deficiency syndrome ( AIDS ) immunocompromised critically ill patients suspected to have infection. Methods A retrospective study was conducted in the non-AIDS immunocompromised patients who were admitted to Department of Critical Care Medicine of Xiangya Hospital, Central South University during January 2011 to December 2014. Demographic characteristics, underlying disease, acute physiology and chronic health evaluationⅡ( APACHEⅡ) score at admission, and clinical records including baseline and peak levels of temperature, white blood count ( WBC ), PCT, and survival rate within 28 days, infection focus, infectious agents ( bacterial, fungi or mixed infection ), and the severity of infection ( sepsis, severe sepsis, or septic shock ) were recorded. Receiver operating characteristic ( ROC ) curve was plotted, and the diagnostic and protective value of above parameters was evaluated. Results A total of 98 patients ( 43 male and 55 female ) were enrolled in the study with a median age of 44 ( 28, 52 ) years old and a median APACHEⅡscore of 17 ( 11, 20 );47 with malignant hematological tumor, 45 with autoimmune diseases, and 6 post solid organ transplantation. Among them 53 patients ( 54.1%) died within 28 days. Twenty-seven patients were diagnosed as systemic inflammatory response syndrome ( SIRS ) without infection. Among 71 patients with infection, 45 were diagnosed as bacterial infection, 10 with fungal infection, and 16 with mixed infection. Sepsis was diagnosed in 7 patients, severe sepsis in 32 patients , and septic shock in 32 patients .①There was no statistical significance in the baseline and peak levels of PCT and WBC, or baseline level of temperature between the groups of SIRS patients without infection and infected patients. The peak level of temperature was significantly higher in the patients with infection as compared with that of the SIRS without infection patients [℃:39.4 ( 38.9, 40.0 ) vs. 38.8 ( 37.8, 39.2 ), Z=-3.268, P=0.001 ]. It was showed by subgroup analysis that in patients with hematological malignant disease or autoimmune diseases, higher level of body temperature was found in infection group compared with non-infection SIRS group [℃:39.5 ( 39.0, 40.0 ) vs. 39.0 ( 38.4, 39.4 ), Z=-2.349, P=0.019;39.0 ( 38.4, 39.5 ) vs. 38.2 ( 37.0, 38.9 ), Z=-2.221, P=0.026 ].②The baseline level of PCT (μg/L ) were 0.54 ( 0.20, 4.19 ), 2.78 ( 0.50, 9.54 ), 1.00 ( 0.45, 6.89 ), and 0.22 ( 0.07, 1.86 ) in non-infection SIRS patients or the patients with bacterial, fungal, and mixed infection, respectively. The peak level of PCT (μg/L ) were 4.19 ( 1.95, 13.42 ), 12.37 ( 3.82, 45.89 ), 1.82 ( 0.49, 17.86 ), and 5.14 ( 2.66, 12.62 ), respectively, in each subgroup. When the comparison was conducted among the patients with different infectious agent, the baseline level of PCT in patients with bacterial infection was significantly higher than that in SIRS patients without infection ( P=0.026 ) and mixed infection patients ( P=0.001 ), and the peak level of PCT was significantly higher than that in the SIRS patients without infection ( P=0.009 ) and the patients with fungal infection ( P=0.016 ). ROC curve showed that the higher value was found in the baseline and peak levels of PCT for diagnosis of septic shock in all patients [ area under ROC curve ( AUC ) of baseline level = 0.681±0.054, P = 0.001; AUC of peak level = 0.690±0.054, P=0.002 ], and the same value was also found in the baseline and peak levels of PCT for diagnosis of bacterial infection in the patients with malignant hematological tumor ( AUC of baseline level=0.687±0.080, P=0.008;AUC of peak level=0.697±0.079, P=0.021 ).③The peak level of PCT (μg/L ) were 4.05 ( 0.53, 31.22 ), 5.78 ( 2.14, 16.68 ), and 11.64 ( 2.94, 58.14 ) in subgroup of patients with sepsis, severe sepsis and septic shock, respectively, and they showed no statistical significance among subgroups ( P>0.05 ). A high serum level of peak PCT strongly indicated the presence of septic shock ( AUC=0.646±0.060, P=0.019 ), especially in the subgroup of patients with systemic autoimmune disease ( AUC=0.689±0.081, P=0.035 ).④The peak level of PCT (μg/L ) in the APACHEⅡ>18 group ( 38 cases ) was significantly higher than that of APACHEⅡ≤18 group [ 60 cases, PCT (μg/L ):11.64 ( 3.36, 39.39 ) vs. 4.42 ( 1.32, 14.70 ), P=0.016 ];there was a certain correlation between the peak level of PCT and the severity of the disease.⑤The peak level of PCT in death group was significantly higher than that of the survival group [μg/L:9.07 ( 3.05, 33.09 ) vs. 4.19 ( 1.26, 14.61 ), P=0.043 ]. ROC curve showed that the peak level of PCT might be valuable in predicting the prognosis in immunocompromised patients ( AUC=0.619±0.057, P=0.043 ). Conclusions The serum level of PCT is found to be a reliable marker for the diagnosis of bacterial infection in immunocompromised critical patients, especially in those with hematologic malignancy. Additionally, PCT provides a useful tool for evaluating the severity of infection and the prognosis of critically ill patients.

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.

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.