Objective:To enhance the functional safety of medical electrical equipment and reduce the risk to patient when using the medical electrical equipment.Methods: Theory and rationale introduction of functional safety and provide application cases.Results: Introduce the definition and application scope of functional safety standards IEC 61508, the determination of safety integrity level of functional safety in the Medical Electrical equipment, and the design structure and development, meanwhile show some application examples.Conclusion: Provide suggestions for the manufactures for safety design that introduce functional safety standards IEC 61508 to the development process of Medical Electrical equipment will help enhance the safety level of Medical Electrical equipment and reduce the unacceptable risk’s probability to patient.

Objective To study the variations of hypothalamus pituitary-gonad axis in Tibetan male patients with hepatic diseases and to understand the serum levels of gonadal hormone in different hepatic diseases.Methods We randomly selected 93 Tibetan male hepatic patients from Tibet Autonomous Region.The types of hepatic diseases included hepatitis A,hepatitis B,alcoholic hepatitis,cirrhosis and serious hepatitis.Meanwhile we selected 19 healthy Tibetan males as controls from the same region.We detected the serum levels of testoid (T),estradiol (E 2),follicle-stimulating hormone (FSH),luteinizing hormone (LH),prolactin (PRL) and luteinizing hormone-releasing hormone (LHRH).Statistical analysis was performed by double t-test.Results The serum levels of E 2,PRL and LHRH were all significantly different in patients with hepatic disease compared with the control.(P

Objective To develop a new multiplex allele-specific PCR(MAS-PCR) assay to detect mutation in codon 315 of katG gene of Mycobacterium tuberculosis , mutation in this codon has been reported to be able to account for the Mycobacterium tuberculosis clinical isolates resistant to isoniazid(INH).Method Based on the sequence of katG gene of Mycobacterium tuberculosis , three specific primers are designed to carry out the MAS-PCR, 84 purified DNA preparation with known katG 315 variation detected by PCR-restriction fragment length polymorphism (PCR-RFLP) are used to optimize PCR.Results 84 Mycobacterium tuberculosis clinical stains are detected by the MAS-PCR and PCR-RFLP, respectively.The sensitivity of detection by MAS-PCR is 77.8%,and the specificity is 95.2%.katG mutation S315N(AGC→AAC), neglected in RFLP, can be detected by MAS-PCR.Conclusion MAS-PCR assay is sensitive, specific, economic and easy to carry out , can be used in clinical laboratories to detect the INH-resistant Mycobacterium tuberculosis strains.

Objective To elucidate the relationship between polymorphisms of NRAMP1 gene and susceptibility to tuberculosis in Chinese Han nation by case control study. Methods We selected 127 patients with active pulmonary tuberculosis who were all Han people with mean age of 52.5 years and 58 ethnically matched healthy controls. We typed the polymorphisms of NRAMP1, INT4 and D543N, through polymerase chain reaction restriction fragment length polymorphism (PCR RFLP) techniques. Results Two NRAMP1 polymorphisms were both significantly associated with smear positive pulmonary tuberculosis. Subjects who were heterozygous for polymorphisms in INT4 and D543N were related with tuberculosis. It was the cooperation of different polymorphisms of NRAMP1 that led to the susceptibility to tuberculosis. Conclusions The polymorphisms in NRAMP1 gene affect susceptibility to tuberculosis in Han people in China.

Objective To evaluate the number and function of peripheral Vγ2Vδ2+T lymphocytes during Mycobacterium tuberculosis(MTB)infection in human immunodeficiency virus (HIV)infected individuals.Methods Seventy-six HIV/acquired immune deficiency syndrome(AIDS) patients co-infected with MTB were divided into active tuberculosis(TB)group(HIV+TB)and latent TB group(HIV+LTB).T cell subsets of peripheral blood lymphocytes were analysed by flow cytometry.Stimulated by protein purified derivative(PPD)and hydroxymethylbutenyl diphosphate (HMBPP),specific interferon(IFN)-γ producing T cells were detected using enzyme-linked immunospot(ELISPOT)and intracellular cytokine staining(ICS).Data were analyzed by t test.Results The absolute number of CD3'T cells and DroDortion of V72VB2'T cells in CD3+T cells in HIV+TB group were both significantly lower than those in HIV+LTB group(t=-3.67,P<0.01;t=-2.06,P<0.05).PPD-specific IFN-y-producing T cells and percentage of PPD-specific CD4+Tcells in CD3+T cells in HIV+LTB group were both similar with those in HIV+TB group.While HMBPP-specific IFN-γ-producing T cells and percentage of HMBPP-specific Vγ2Vδ2+T cells in CD3+Tcells in HIV+LTB group were both higher than those in HIV+TB group(t=2.71 and t=3.003,respectively;both P<0.0 1).Conclusion The number and function of Vγ2Vδ2+T cells were impaired in HIV/AIDS patients coinfected with active MTB infection,which indicates that Vγ2Vδ2+T cells may be the key immune cells against MTB in individuals with impaired CD4+T cells.

Objective Cerebral small vessel disease is closely related to kidney disease .Chronic kidney disease ( CKD) may increase the risk of hemorrhage stroke .However, its impact on hemorrhage-prone small vessel disease represented by cerebral microb-leeds( CMBs) remains unclear .The purpose of this study was to investigate the relationship of CKD with the presence and location of CMBs in patients with acute lacunar stroke . Method Consecutive patients with acute lacunar stroke within 7 days from onset were enrolled retrospectively from January 2014 to July 2016 and scanned by gradient-echo T2*-weighted imaging (GRE-T2*WI).Their demographic, clinical, laboratory and imaging data were collected .Estimate glomerular filtration rate (eGFR) was calculated individu-ally by the following chronic kidney disease epidemiology collaboration (CKD-EPI) equation for the Asian population .CKD was defined as the level of eGFR<60 mL/min/1.73 m2. Results Finally, 308 patients (mean age:65.79±8.67 years; median NHISS:3(2-5);42.2%Female) with lacunar ischemic stroke were enrolled in the final analysis .Among these patients, CMBs were present in 116 patients ( 37.7%) and CKD in 62 patients ( 20.1%) .Patients were divided into CKD group and normal group according to GFR level . The result of univariate analysis showed that patients with CKD had higher prevalence of diabetes ( P=0.014) and higher degrees of CMBs (P=0.001) compared with normal group.CMBs were refined by its location .The result of multivariable analysis showed that CMBs in deep brain [ OR=7.61, 95%CI 4.18-16.55, P=0.001] were sig-nificantly associated with CKD incidence , while no significant rela-tionship was found in CKD incidence and CMBs in the lobe and mixed location of brain . Conclusion The CKD incidence in patients with acute lacunar stroke is in dependent relationship with CMBs in deep brain and without significant correlation with CMBs in the lobe and mixed location of brain .

Objective To observe hepatitis B virus (HBV) reactivation in 12 patients with rheumatic disease undergoing immunosuppressive therapy and to evaluate whether preemptive antiviral therapy is necessary for patients receiving disease-modifying anti-rheumatic drugs (DMARDs).Methods From January 2008 to March 2012,a total of 12 HBV-infected patients with rheumatic diseases were consecutively enrolled into this long-term follow-up study.Liver function and serum levels of HBV DNA were tested during the follow-up.Results The medium duration of follow-up was 41 months (range 16-48).Four patients received steroid treatment,and among them two patients without pre-emptive antiviral therapy developed HBV reactivation.After administr-ation of LAM or ETV,HBV replication was controlled in both patients.Five patients were treated with disease-modifying anti-rheumatic drugs and the other three patients received tumor necrosis factor-alpha-blocking agents.None of these patients received pre-emptive antiviral therapy.HBV reactivation did not occur in any of them.Conclusion HBV reactivation does occur in HBV-infected patients with rheumatoid diseases after immunosuppressive therapy.Pre-emptive antiviral therapy should be administered in patients who are receiving steroid therapy for rheumatic diseases.In contrast,DMARDs and TNFBA are relatively safe for HBV-infected patients with rheumatic diseases.Close monitoring of HBV DNA and ALT levels is necessary to the mana-gement of HBV reactivation.

Objective To analyze the expression of interleukin (IL)-31 in tuberculous pleural effusion,and to evaluate its diagnostic value of tuberculous effusion.Methods Seventy-one patients with pleural effusion were enrolled,including 40 cases of tuberculous pleural effusion and 31 cases of malignant pleural effusion.Luminex method was applied to detect the IL-31 expression in pleural effusion.IL-31 levels were compared using non-parametric Mann-WhitneyU test,and the receiver operator characteristic (ROC)curve was used to elvaluate the diagnostic value of IL-31 .Results IL-31 expression in tuberculous pleural effusion was significantly higher than that in malignant pleural effusion with statistical significance (529.4 ng/L vs 13.8 ng/L,U =62,P <0.01 ).Based on the level of IL-31 expression,area under the ROC curve was 0.95 with the optimum cut-off value of 67.5 ng/L.Thus,the sensitivity and specificity of IL-31 ≥67.5 ng/L for diagnosis of tuberculous pleurisy were 82.5 % (95 %CI :73.3% - 94.2%)and 100.0% (95 %CI :91 .4%-100.0%),respectively.Conclusion IL-31 is highly sensitive and specific for the diagnosis of tuberculous pleural effusion, which favors the differentiation of tuberculosis from malignance.

Objective To investigate the incidence of Mycobacterium tuberculosis (TB) infection among human immunodeficiency virus (HIV)-infected individuals in Shanghai and Yunnan Province and to analyze the risk factors of TB infection.Methods Seventy HIV-infected individuals from Yunnan Province and 67 from Shanghai were enrolled.T-SPOT.TB was employed to detect TB-specific T cells in the peripheral blood mononuclear cells (PBMC).CD4+ and CD8+ T cells in PBMC from the enrolled subjects were detected by flow cytometry.Data were analyzed using Mann-Whitney test,Fisher's exact test and Logistic regression.Results The incidence of latent tuberculosis (LTB) infection among HIV-infected individuals in Yunnan Province was 64.3 ％ (45/70),which was much higher than Shanghai (20.8％ [14/ 67]).The median CD4+ T cell count of HIV-infected individuals with LTB infection in Yunnan Province was 509/μL,while that in Shanghai was 324/μL,which was significant different (U=148,P=0.003).The median CD4+ T cell count in HIV single infected individuals from Yunnan Province was 418/μL,which was not significantly different from that of H IV + LTB individuals from that area (U =378,P =0.120).Moreover,the median CD8+ T cell counts of HIV-infected individuals with latent tuberculosis infection in Yunnan Province and Shanghai were 409/μL and 781/μL,respectively (U=109,P＜0.01).Conclusions The incidence of LTB infection among HIV-infected individuals in Yunnan Province is significantly higher than Shanghai.CD4+ and CD8+ T cell counts are correlated with TB infection among HIV-infected individuals.

Objective To investigate the incidence,bacterial pathogen and risk factors of bacterial meningitis after major craniotomy.Methods Clinical data of patients who underwent at least one craniotomy in Huashan Hospital Affiliated to Fudan University in 2008 were collected.All subjects were ≥ 18 years old,and survived at least 7 days after surgery.Patients with only cerebrospinal fluid drainage,burr holes,cranioplasty,vascular interventional surgery,transsphenoidal or spinal surgery were excluded.Risk factors for bacterial meningitis after major craniotomy were analyzed by Logistic regression.Results A total of 691 patients were enrolled,in 60 of whom (8.68％) bacterial meningitis was identified.Among 44 samples,5 were positive in culture with 2 of Acinetobacter baumannii,1 of Enterococcus faecalis,1 of Streptococcus intermedius and 1 of Klebsiella pneumonia.Diabetes (OR =5.79,95％ CI:1.40-23.93,P =0.02),Glasgow Coma Scale score ＜ 12 (OR =6.56,95％ CI:1.17-36.80,P =0.03),external ventricular drainage (OR =4.31,95％ CI:1.57-11.82,P =0.01),and continuous lumbar cistern drainage (OR =22.82,95％ CI:10.31-50.52,P =0.00) were independent risk factors for bacterial meningitis after major craniotomy.Patients with external ventricular drainage ＞ 7 d were 11.82 times more likely to develop bacterial meningitis,and those with continuous lumbar cistern drainage ＞ 10 d were 25.50 times more likely to develop bacterial meningitis.Conclusions Bacterial meningitis remains a common complication after major craniotomy,and most are induced by Gram-negative bacilli.Diabetes,Glasgow Coma Scale score,external ventricular drainage and continuous lumbar cistern drainage may increase its incidence.