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.

AIM: To study the effects of intrathymic inoculation of liver specific antigen (LSA) on hepatocyte apoptosis after liver allotransplantation. METHODS: Orthotopic liver transplantation was used in this study. Group Ⅰ: syngenic control (Wistar-to-Wistar); Group Ⅱ: acute rejection (SD-to-Wistar); Group Ⅲ: thymus inoculation of SD rat LSA day 7 before transplantation. The observation of general situation and survival time, hepatocyte apoptosis and LAT expression in liver transplants were used to analyze immune state of animals in different groups. RESULTS: The general situation of group Ⅰ was very well after transplantation. Recipients of groupⅡ lost body weight progressively and all died within day 9 to day 13 post transplantation. As for group Ⅲ, the general situation of recipients was remarkably better than that in group Ⅱ. The positive cells of apoptosis in group Ⅲ detected by TUNEL were not significantly different from that in group Ⅰ, but was significantly lower than that in group Ⅱ. LAT was detected at any time in group Ⅱ with peak expression at day 5 and day 7 post transplantation. In contrast, LAT was not detected in any other groups. CONCLUSION: Intrathymic inoculation of LSA protects hepatocytes from apoptosis after liver allotransplantation.

Objective To evaluate the changes in the levels of motilin in the duodenum in a rat model of incisional pain.Methods Eighty-four healthy male Sprague-Dawley rats,aged 6-8 months,weighing 180-220 g,were randomized into 2 groups (n =42 each) using a random number table:control group (group C) and incisional pain group (group P).The animals were anesthetized with sevoflurane.In group P,a 1 cm long incision was made in the plantar surface of right hindpaw.Six rats were chosen from each group and mechanical paw withdrawal threshold (MWT) and thermal paw withdrawal latency (TWL) were measured at 24 h before operation (T0) 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 duodenal mucosal tissue was prepared for measurement of motilin levels by ELISA.Pearson linear correlate analysis was performed between the motilin level and pain threshold at each time point in group P.Results Compared with group C,MWT was significantly decreased,TWL was shortened,and motilin levels were significantly increased at T1-4,and no significant change was found at T0 and T5 in group P.The motilin levels were negatively correlated with MWT (r =-0.8 910) and TWL (r =-0.8 463) in group P.Conclusion Incisional pain can promote the secretion of motilin in the duodenum.

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 investigate the clinical effects of the pulse indicator continuous cardiac output (PiCCO) in goal-optimized fluid management on patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) with respiratory failure.Methods A total of 71 AECOPD patients with respiratory failure who were hospitalized in department of Critical Care Medicine in our hospital were selected from October 2010 to September 2013.The PiCCOtechnology was applied to monitor intrathoracic blood volume index (ITBI) and extravascular lung water index (ELWI).We compared the relationship of ELWI with ITBI and oxygenation index,and a simple correlation analysis was used for statistical analysis.Results A significantly negative correlation was found between ELWl and oxygenation index (r=-0.743,P＜0.01).ELWI =14 ml/kg was defined as the cutoff value for the subgroup analysis.A negative correlation still was found between ELWI and oxygenation index in the subgroup with ELWI ＜ 14 ml/kg,but it had no significant difference (r=-0.533,P=0.080),while a significantly negative correlation was found in the subgroup with ELWI≥14 ml/kg (r=-0.961,P＜0.01).There was no significant correlation between ELWI and ITBI (r=0.477,P=0.072).ITBI=1 000 ml/m2 was defined as the cutoff value for the subgroup analysis.There is no significant correlation between ELWI and ITBI in the subgroup with ITBI＜1 000 ml/m2(r=0.338,P=0.116),but in the subgroup with ITBI≥1 000 ml/m2,a significantly positive correlation between ELWI and ITBI was found (r=0.677,P＜ 0.01).Conclusions The results suggest that when ELWI is higher than 14 ml/kg,ELWI becomes an important influencing factor for oxygenation,which can be decreased to improve oxygenation in patients with AECOPD,and when ITBI≥ 1 000 ml/m2,ITBI can be reduced by decreasing ELWI.PiCCO has an important clinical significance on a goal-optimized fluid management in AECOPD patients with respiratory failure.

Objective To research patients with ophthalmologic perioperative information systems, strengthening the information management of nursing work, achieving consensus and sharing of health care information resources, and then to explore the clinical application effects of this ophthalmologic peri- opera-tive information systems. Methods The convenient sampling method was used in the study. The control group was consisted of 1 740 patients in our hospital from January to March 2013 (before the application of ophthalmologic perioperative information systems). The observation group included 2 078 patients of the same hospital (after the application of ophthalmologic perioperative information systems). The control group adopted routine pre- operative information acquisition method, the observation group applied ophthalmologic perioperative information systems, which included input function, reading function and statistical function. The incidence rate of canceled operation and satisfaction were compared between two groups. Results Ophthalmologic peri- operative information systems provided patients with information gathering, query and analysis in different periods. The rate of the canceled operation reduced in the observation group from 3.74% (65/1 740) to 2.69% (56/2 078) in the control group, χ2=3.91, P<0.05. The satisfaction degree increased from 91.84 % (1 598/1 740) in the observation group to 96.78% (2 011/2 078) in the control group, χ2=44.60, P<0.05, the difference was statistically different. The hospitalization days from April to September in 2013 shortened compared with those of the same period in 2012. Conclusions Ophthalmologic peri- operative information systems promotes the scientific and informatization of nursing information, which is worthy of wide clinic application.

Objective To detect the expression and function of ZNRF3 in different kinds of thyroid cancer tissues and cells.Methods Immunohistochemistry was used to detect the expressions of ZNRF3 protein in 35 cases of papillary thyroid carcinoma and 10 cases of poorly differentiated thyroid carcinoma.The expressions of ZNRF3 gene in TPC-1 and 8505C were detected by RT-PCR,and the cell lines were derived from papillary thyroid carcinoma and poorly differentiated thyroid carcinoma respectively.After silenced ZNRF3 gene expression with lentivirus,the proliferation ability of TPC-1 cells were detected with CCK-8,the invasion and metastasis ability of TPC-1 cells were detected with Transwell.Results According to results of immunohistochemistry and RT-PCR,the expressions of ZNRF3 in papillary thyroid carcinoma cells and tissues were higher than those in poorly differentiated thyroid carcinoma cells and tissues,the differences were statistically significant (4.83±0.44 vs.3.13 ±0.59,t =2.20,P ＜0.05;1.01±0.06 vs.0.21±0.04,t =11.80,P＜0.01).After ZNRF3 geng silencing,according to the results of CCK8,the proliferation ability of TPC-1 cells was significantly enhanced in 72 h,the difference was statistically significant (0.96 ± 0.10 vs.0.64 ± 0.05,t =3.19,P ＜ 0.05);and according to the results of Transwell,the TPC-1 cell's invasion (0.12 ± 0.01 vs.0.09 ±0.00,t =5.48,P＜0.01) and migration (0.22 ±-0.01 vs.0.17 ±0.01,t =4.58,P ＜0.05) also increased,the differences were statistically significant.Conclusion The expression of ZNRF3 in papillary thyroid carcinoma is higher than that in poorly differentiated thyroid cancer.ZNRF3 is tumor suppressor gene in the thyroid tumors.