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 evaluated the surgical techniques and results of open reduction and internal fixation performed for ankle fracture. Methods Eighty-two patients with ankle fracture were treated with open reduction and internal fixation from March 1995 to June 1999. Fifty-eight patients with complete clinical data were analyzed. The patient group consisted of 36 males and 22 females. According to Weber-AO classification, the group was made up of 30 Weber B cases,28 Weber C cases. All patients were evaluated with modified Baird and Jackson scoring system. The relationship between final result and fracture pattern, fixation methods, the time of exercise initiation after operation were analyzed respectively. Results The followed-up period varied from 2 months to 52 months, with an average of 17 months. The number of patients whose results was excellent, good, fair and poor was respectively 31, 18, 6 and 3. The total percentage of good to excellent clinical results was 84.5%. Fifty-four ankles were completely pain free and the remainders had only slight pain after long time walking. Conclusion Operative treatment may provide satisfactory fracture reduction and clinical results for ankle fracture. Correct fracture pattern estimation and proper internal fixation is of importance to achieve and maitain reduction, and then, to gain better long term results.

Objective To determine whether vascular endothelial growth factor (VEGF) could be used as a tumor marker by detecting the VEGF levels in serum and effusion from malignant tumor patients. Methods VEGF concentrations were measured using an enzyme-linked immunosorbent assay in the serum from the healthy donors and in the serum and the malignant effusion from the patients. Results The serum VEGF levels from the malignant tumor patients was higher than that from the healthy donors, and there was a significant difference ( P

Psoriasis is a non-infectious chronic inflammatory skin disease. It′s acknowledged that interleukin (IL)-17 signaling pathway dominantly drives the development of psoriasis. Recently, the role of neuro-immune axis in psoriasis has attracted widespread attention. Lidocaine, a local anesthetic, has ability to block the conduction of nerve impulses, while its therapeutic efficacy on psoriasis remains to be confirmed. Here, we evaluated the therapeutic efficacy of topical application of compound lidocaine cream (LIDO) on imiquimod (IMQ)-induced mouse psoriasis model. Animal welfare and experimental procedures follow the regulations of the Ethics Committee of China Pharmaceutical University. The psoriasis area and severity index (PASI) scoring was used to evaluate the severity of psoriasis-like symptoms. Hematoxylin-eosin staining was used to examine histopathological changes and epidermal thickness was measured. Ki67 immunofluorescence staining was used to evaluate the proliferation of keratinocytes. The relative mRNA expression of inflammatory cytokines (including Il17, Il22, Il23 and Il36) in skin was measured by real-time quantitative PCR. Results show that IMQ-induced increases in the PASI score, epidermal thickness, number of Ki67⁺ cells and the mRNA expression of inflammatory cytokines are significantly alleviated by topical application of LIDO, whose therapeutic efficacy is also better than that of the positive control drug calcipotriol. Our study suggests that LIDO could be used for psoriasis treatment.

ObjectiveTo study infection status of voluntary blood donors and epidemic trends of related infectious diseases in Bengbu area.MethodsBlood infection markers(ALT, HBsAg,Anti-HCV,TP and Anti-HIV) of 130 118 voluntary blood donors were detected.Voluntary blood donors were divided into college students group,reservation group and street group.Then, the positive rates of blood infection markers of three groups were compared.ResultsAccounting for 4.41％ ,5 748 voluntary donors of 130 118 volunteers were unqualified.The positive infection rates of students group, reservation group and street group were 2.42％, 4.08％ and 4.85％.The statistical differences of ALT and anti-HCV among these groups were significant (x2 = 35.07,12.31,12.45,116.49, all P ＜0.01),and no statistical significance was found in ALT difference among these groups(x2 = 3.82,0.59, all P ＞0.05).ConclusionThe infection rates of these blood donation related diseases of voluntary donors in bengbu aera showed increasing tendency, and that of college students in bengbu area was relatively lower.

Objective To investigate the changes in the levels of motilin in the gastric body in a rat model of incisional pain.Methods Eighty-four healthy male Sprague-Dawley rats,weighing 180-220 g,were randomized into 2 groups (n =42 each):normal saline group (NS group) and incisional pain group (P group).In group P an 1 cm long incision was made in the plantar surface of right hindpaw under sevotlurane anesthesia.Six rats were chosen from each group and paw withdrawal threshold to mechanical stimulation (MWT) and paw withdrawal latency to nociceptive thermal stimulation (TWL) were measured at 24 h before operation (To) and 1,6,24,48 and 72 h after operation (T1-5).Six rats were chosen from each group at T0-5 and sacrificed and the gastric mucosal tissues were prepared for measurement of motilin levels by ELISA.Results Compared with group NS,MWT,TWL and motilin levels were significantly decreased at T1-4 (P ＜ 0.05) and no significant change was found at T0 and T5 in P group (P ＞ 0.05).Compared with the baseline value at To,MWT,TWL and motilin levels were significantly decreased at T1-4,and no significant change was found at T5 in group P (P ＞ 0.05).MWT,TWL and motilin levels were significantly higher at T3-T5 than at T1 in group P (P ＜ 0.05).MWT,TWL and motilin levels were increased gradually at T3-T5 in P group (P ＜ 0.05).The motilin levels were positively correlated with MWT and TWL (r =0.9597 and 0.9231,respectively,P ＜ 0.01) in group P.Conclusion The levels of motilin in the gastric body is significantly decreased in a rat model of incisional pain and the decreasing range is positively corre lated with the degree of incisional pain.

Objective To study the effect of low molecular weight heparin on the growth and metastasis of hepatocarcinoma in vivo Methods Metastatic model simulating human hepatocarcinoma was established by orthotopic implantation of the tumor tissue into nude mice Animals were randomly divided and submitted to different treatment groups: control group treated with nornal saline, chemotherapy group with 5 FU and CDDP i p , Fragmin group (low molecular heparin), combination group After 5 weeks of treatment, tumor volume、 microvessel density (MVD)、 VEGF smoothmuscle actin (SMA) and metastasis in Fragmin group significantly decreased and tumor inhibitive rate increased ( P

Objective To investigate the differences in sex hormone levels between hypospadias and circumcision groups.Methods Fifty cases of circumcision and 137 cases of hypospadias the dihydmtestosterone (DHT) value was tested with radioimmunoassay,and testosterone was tested with lightimmunoassay.Results DHT value was (64.51 ±32.10)pg/ml in circumcision group,and (46.72 ±28.94)pg/ml in hypospadias group (P ＜0.05).DHT value in hypospadias type Ⅰ,Ⅱ,Ⅲ,and Ⅳ were (50.20 ±32.90)pg/ml,(46.63 ±25.67)pg/rnl,(51.60 ±32.16)pg/ral,and (39.02 ±26.32)pg/ml,respectively (P =0.29).The differences between circumcision and hypospadias groups were statistically significant (P =0.00).Luteinizing hormone (LH) and testosterone (T) in children with hypospadias were significantly lower than those in children in the circumcision group (P ＜ 0.05).No statistically significant difference was found between two groups in follicle-stimulating hormone (FSH),estradiol (F2),and prolactin (PRL) (P ＞ 0.05).No statistically significant differences were found in FSH among all types of hypospadias (P ＞ 0.05).Conclusions Inadequate secretion of T or activity insufficiency and functional deficiency of 5 alpha reductase (SRD5A) are likely found in children with hypospadia.Inadequate secretion and low T value might be found in LH-T shaft in children with hypospadia.The normal T value in some children with hypospadia does not show that androgens produced during pregnancy are normal.

Objective To explore the effect of early goal-directed therapy (EGDT) according to pulse indicated continuous cardiac output (PiCCO) on septic shock patients.Methods Eighty-two septic shock patients in Subei People's Hospital of Jiangsu Province from January 2009 to December 2012 were enrolled and randomly divided into two groups using a random number table,standard surviving sepsis bundle group (n=40) and modified surviving sepsis bundles group (n =42).The patients received the standard EGDT bundles in standard surviving sepsis bundle group.PiCCO catheter was placed in modified surviving sepsis bundles group.Fluid resuscitation was guided by intrathoracic blood volume index (ITBVI) with the aim of 850-1 000 mL/m2.Dobutamine was used to improve the heart function according to left ventricular contractile index (dPmax) and stroke volume index (SVI).The mean arterial blood pressure (MAP) was maintained 65 mmHg (1 mmHg=0.133 kPa) or above with norepinephrine.Extra-vascular lung water was monitored for the titration of liquid and diuretics.The acute physiology and chronic health evaluation Ⅱ (APACHE Ⅱ) score,sequential organ failure assessment (SOFA) score,the number of patients needed vasopressor,serum procalcitonin (PCT),lactic acid and lactate extraction ratio,the amount of fluid resuscitation,duration of mechanical ventilation,duration of intensive care unit (ICU) stay,hospital mortality were recorded in both groups.Results After treatment,the APACHE Ⅱ score,SOFA score and the number of patients needed vasopressor were gradually reduced in both groups,and those in modified surviving sepsis bundle group were significantly lower than those of standard sepsis bundle group at 72 hours (APACHE Ⅱ score:13.1 ± 6.5 vs.20.9 ± 7.5,SOFA score:8.8 ± 4.3 vs.14.6 ± 4.9,the number of patients needed vasopressor:8 vs.17,all P＜0.05).Arterial blood lactate clearance rate was gradually increased after treatment in both groups.Lactate clearance rate in modified surviving sepsis bundle group was significantly higher than that of standard surviving sepsis bundle group [6 hours:(18.2 ± 8.3)％ vs.(10.8 ± 7.5)％,t=-6.036,P=0.001 ; 12 hours:(22.6 ± 7.3)％ vs.(12.4 ± 8.1)％,t=-4.536,P=0.001 ; 24 hours:(27.8 ± 5.6)％ vs.(16.4 ± 9.5)％,t=-5.882,P=0.000].The amount of fluid resuscitation within 6 hours in modified surviving sepsis bundle group increased significantly compared with standard surviving sepsis bundle group (mL:3 608 ± 715 vs.2 809 ± 795,t=-3.865,P=0.033).The amount of fluid resuscitation within 24,48 and 72 hours in modified surviving sepsis bundle group was significantly less than that of standard modified surviving sepsis bundle group with the nadir at 72 hours (mL:918 ± 351 vs.1 805 ± 420,t=5.907,P=0.037).Duration of mechanical ventilation (hours:98.4 ± 20.3 vs.143.3 ± 29.6,t=9.766,P=0.001) and ICU stay (days:7.1 ± 3.1 vs.9.5 ± 2.5,t=2.993,P=0.004) were significantly reduced in modified surviving sepsis bundle group compared with standard surviving sepsis bundle group.The hospital mortality in modified surviving sepsis bundle group was slightly lower than that in standard surviving sepsis bundle group [16.7％(7/42)比 17.5％(7/40),x2=0.010,P=0.920].Conclusions Modified surviving sepsis bundle treatment according PiCCO can reduce the severity of disease in patients with septic shock,can make more accurately guide fluid resuscitation,and can reduce lung water and duration of mechanical ventilation and ICU stay.It has great clinical significance.

Objective To study the effects of russel viper venom X(RVV X)on blood coagulation protein.Methods We divide diluted protein into control and RVV-X groups,then use chromogenic substract assay to detect the activation effect of RVV-Ⅹ on coagulation factor Ⅶ,Ⅸ,Ⅹ and antithrombin,plasminogen,with or without activator.Results In RVV-Ⅹ group,the coagulation factor Ⅶ, Ⅸ and plasminogen displayed weakly enhanced chromogenesis,all P