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 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.

[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 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 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 evaluate the effect of mining waste water on drinking water quality and tumor mortality of villagers. Methods Analyse quality of drinking water sampled from well which only supply water to a family which the well belongs to and survey the death reasons of whole population in the polluted area and the control area. Results Mining waste water discharged by a mine contaminated the nearby river and impacted the drinking water quality of the nearby village also. Compared with the control, the concentration of lead, arsenic and mercury in drinking water of polluted area was much higher. The 5,year total mortality in polluted area and in the control was 3.09% and 1.55% respectively. Tumor mortality in polluted area was 50%, esophagus cancer mortality was 54.24%. Tumor mortality in the control area was 20% only and most tumors were liver cancer. Conclusion The adverse effect of mining waste water on drinking water quality and human health in polluted area has been seen.