Analysis on Focus of Clinical Evaluation of Dental Implants (Systems) / 中国医疗器械杂志

From the perspective of technical evaluation, this article introduces the focus of clinical evaluation of dental implants (systems) in comparison with the comparable devices and discusses the clinical evaluation of such products，combined with the clinical evaluation review of dental implants (systems) products in recent years, in order to provide reference for the registration of these products.

Study on the Medical Device Registration Submission Dossier Requirements in China / 中国医疗器械杂志

The evolution throughout the whole supervision history of Class II/III safety and effectiveness related NMPA submission dossier requirements was studied in this study, meanwhile elaborating the revolution progress of clinical evaluation domestically. The relationship between submission dossier requirements and Essential Principles of Safety and Performance of Medical Devices as well as IMDRF relevant documents was deeply analyzed and illustrated, in order to comprehensively understanding the background and future reform direction of NMPA submission dossier requirements under the background of the government's deepening reform of medical device evaluation and approval system strategy.

Advances in research on extracapsular lymph node invasion and its prognostic significance in lung cancer / 中华胸心血管外科杂志

The status of lymph node metastasis is an important prognostic factor for many malignant tumors, including lung cancer. In the 8th edition of the TNM staging system for lung cancer, the T staging had obvious changes and refinements, but the N staging had little changes. Recently, several studies have found that the prognosis of patients with the same N stage can vary greatly, suggesting that a more detailed subgroup of patients with the same N stage should be subdivided, including the inclusion of extra-capsular lymph node metastases (ENE). In this review, we reviewed the definition, classification/grading, imaging diagnosis, pathological diagnosis, related molecular markers and their relationship with the prognosis of lung cancer patients.

The effect of triclosan on the immune function of Kunming mice / 公共卫生与预防医学

Objective To explore the effects of triclosan (TCS) on the immune function of mice. Methods Forty male and female Kunming mice (25±2 g) were selected. The animals were divided into 5 groups according to body weight ratio, including a blank control (saline solution) group, dimethyl sulfoxide (DMSO) group, and three triclosan solution groups (59.375 mg/kg, 118.75 mg/kg, and 237.5 mg/kg, respectively). There were 8 mice in each group, half male and half female. Animals were treated with TCS by intragastric administration once a day for two weeks. Upon the completion of the treatment, animals were sacrificed, the spleen, thymus and other tissues were collected, and the ratios of their weight to body weigh were calculated. The peripheral blood was taken by eye-ball removal method, and the half hemolysis value was determined. Results Compared with the positive control group, the spleen index of male mice in the medium dose group and high dose group increased significantly (P < 0.05), and the spleen index of female mice in the high dose group showed significant difference (P < 0.05). Compared with the positive control group, the thymus index of male high dose group was significantly different (P < 0.05). The thymus indexes of female high, medium, and low dose groups all were significantly different compared to the control group (P < 0.05). HC50 results showed that the HC50 of both male and female mice decreased (P < 0.05). Conclusion High concentration of triclosan can inhibit the immune function of Kunming mice.

Association between resting heart rate trajectory pattern and risk of cardiovascular and cerebrovascular diseases / 中华心血管病杂志

Objective@#To examine whether the long-term resting heart rate (RHR) pattern can predict the risk of cardiovascular and cerebrovascular diseases (CVDs).@*Methods@#This prospective cohort study included 63 040 participants who took part in the health examination in 2006 and one of the health examinations on 2008 or 2010 and were free of myocardial infarction, stroke, arrhythmia, cancer and not treated with β-recepter blocker. The outcomes were the first occurrence of myocardial infarction and stroke during the follow up ended on December 31, 2015. RHRs were measured in 2006, 2008, and 2010. We used latent mixture modeling SAS Proc procedure to identify RHR trajectories. We identified 4 distinct RHR trajectory patterns based on the data derived from 2006 and on the pattern change during 2006 to 2010 (low-stable, moderate-stable, moderate-increasing, elevated-decreasing). Collected the general clinical data of the patients. Cox regression model was used to determine the association between RHR trajectory patterns and the risk of CVDs during follow up. Hazard ratio (HR) with 95% confidence intervals (CI) were calculated using Cox regression modeling.@*Results@#There were statistical significance among the 4 distinct RHR trajectory patterns on the following variables: age, gender, smoking status, drinking status, physical activity, education status, history of use antihypertensive drugs, history of hypertension,history of diabetes, body mass index, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, fasting blood glucose, and the level of high-sensitivity C-reactive protein (all P<0.01). The moderate-increasing pattern experienced the highest risk of developing stroke and CVDs among all 4 patterns. The cumulative incidence of cerebral infarction, cerebral hemorrhage and CVDs in the order of low-stable trajectory, moderate-stable trajectory and moderate-increasing trajectory. The cumulative incidences of cerebral infarction, cerebral hemorrhage and CVDs in elevated-decreasing trajectory group were significantly lower than those in moderate-increasing trajectory group, but higher than those in moderate-stable trajectory group. Compared to the low-stable pattern, adjusted HR was 1.3 (95%CI 1.0-1.6) for the moderate-increasing pattern after adjustment for potential confounders.@*Conclusion@#Our study finds that individuals with moderate-increasing RHR trajectory pattern are associated with higher risk of cardiovascular and CVDs.

Discussion on Clinical Trial Design of Artificial Hip Prosthesis / 中国医疗器械杂志

Recently, the registration of artificial hip prosthesis products increased year by year. In the new version of the provisions for medical device registration, the domestic or import of such products in the registration declaration may need to complete a clinical trial in the country. How to carry out scientific clinical trials of the product design is the common concern of enterprises and clinical trial institutions. To review the guideline and literature concerning registration for artificial hip prosthesis, the focus on clinical trial design of artificial hip prosthesis include clinical inclusion, evaluation standard, sample size. Through the discussion, we hope to provide advice and guidance for clinical trials of this kind of products.

c-Fos expression in visual cortex of infant rhesus monkeys with myopia induced by hyperopic defocus / 中华实验眼科杂志

Objective To observe c-Fos expression in visual cortex of infant rhesus monkeys with myopia induced by hyperopic defocus and preliminarily investigate the possibility of visual cortex participating in myopia. Methods Eight SPF grade healthy infant rhesus monkeys aged 20 to 30 days were randomly divided into hyperopic defocused group and control group,4 monkeys for each group. The monkeys in hyperopic defocused group wore -3 D spectacle lenses. The monkeys in control group wore 0 D lenses. The monkeys' refractive error,corneal topography, vitreous chamber depth were measured at the start of lens wear and at 2,4,6,8,12 weeks post-treatment. At 12 weeks post-treatment,the visual cortex tissues were removed for c-Fos protein measurement by immunohistochemistry and Western blot assays. The results were analyzed semiquantitatively to compare the differences of c-Fos expression between hyperopic defocused group and control group. The use and care of the animals complied with Regulations for the Administration of Affair Concerning Experimental Animals by State Science and Technology Commission. This study protocol was approved by Ethic Committee of Zhongshan Ophthalmic Center ( No. 2013-014). Results After 12 weeks'lens wear,the vitreous chamber elongation amplitude of hyperopic defocused group monkeys was more obvious than that of the control group ([0.93±0.24]mm vs. [0.72±0.09]mm;t=2.292,P=0.047). The decrease of hyperopic degrees of hyperopic defocused group monkeys was more obvious than that of the control group ([-3.23± 1.36]D vs. [-1.55±0.52]D;t=-3.273,P=0.006). The eyes of hyperopic defocused group monkeys appeared a remarkable myopic shift after treatment. The number of c-Fos immunoreactive neurons was less in the hyperopic defocused group than that in the control group,with a statistically significant difference between them ([1 843±191]/mm2vs. [2 296±503]/mm2;t=2.381,P=0.041). Western blot assay showed that the optical density of c-Fos protein in the hyperopic defocused group was significantly less than that in the control group (0.50±0.17 vs. 0.99± 0.22;t=-4.982,P<0.01). Conclusions Hyperopic defocus,as an abnormal visual stimulus,can induce the onset of myopia in infant rhesus monkeys and inhibit c-Fos expression in visual cortex. Visual cortex may participate in myopia induced by hyperopic defocus.

The different types and stages of folate receptor alpha expression in endometrial carcinoma and assessment on its diagnostic performance / 实用医学杂志

Objective To explore the folate receptor alpha(FRA)expression in different types and stages of in endometrial carcinoma(EC). The sensitivity and specificity of FRA testing were compared with CA125 to evaluate its diagnostic performance.Methods Serum from 50 cases of EC patients and 30 cases of normal patients was collected.Tissue from 83 cases of typeⅠEC and 30 cases of normal endometrium and typeⅡEC were collected. The expression of serum FRA was detected by ELISA.The expression ofserum CA125 was detected by electrochemi-luminescence.The expression of FRA and CA125 in tissues was detected by immunohistochemistry. Results The rate of elevated FRA expression of in typeⅠEC tissue was higher than that in typeⅡEC(P < 0.05). The rate of elevated FRA expression in type I EC was higher than that in the early stage(P < 0.05). The ROC curve showed that the sensitivity and specificity of FRA was higher than these of CA125′s. Further,they are higher in the com-bined serum FRA and CA125.Conclusions This study shows that the FRA expression level in endometrial carci-noma varies in different subtypes,indicating the potential different pathogeneses. The rate of elevated FRA expression in type I endometrial carcinoma was higher than that in the early stage. This provides the possibility for the application of FRA targeted fluorescent developer in advanced endometrial carcinoma meticulous surgery. Combination of FRA and CA125 have better diagnostic value in detecting EC.

Expression of folate receptor alpha and CA125 and its clinical significance in endometrial carcinoma / 实用医学杂志

Objective To explore the expression and the pathomechanism of folate receptor alpha(FRα) and CA125 in the development and progression of endometrial carcinoma.Methods Sixty samples of endometrial carcinoma tissues,46 samples of endometrial hyperplasia tissues and 10 normal endometrial tissues were collected in the study.Immunohistochemical methods were used to detect the expression of Frαand CA125 in all tissues.The expressions of FRα and CA125 and their correlation with clinicopathological characteristics were analyzed.Results FRα was positively expressed in 93.9％ of the endometrial carcinoma tissues,with a strongly positive rate of 65.0％,which was significantly higher than that in endometrial hyperplasia tissues and normal endometrial tissues (P ＜ 0.05).The highly expressed FRαin endometrial carcinoma tissues was associated with age,FIGO stage and histologic types (P ＜ 0.05),while no statistical significance was found between the high expression of FRαand myometrial invasion.The expression of FRα in endometrial atypical hyperplasia was higher than that in other hyperplasia subgroups.The expression of CA125 in endometrial carcinoma tissues and endometrial hyperplasia tissues were both higher than that in normal endometrial tissues (P ＜ 0.05).Conclusion FRα may play an important role in the carcinogenesis and progression of endometrial carcinoma,and act as a target of therapy and a kind of assessment for prognosis in endometrial carcinoma.CA125 may be involved in the development of endometrial lesions and further researches are needed to confirm a physiological mechanism between FRA and CA125 in carcinogenesis of endometrial carcinoma.

Tryptophan metabolism in patients with primary immune thrombocytopenia with high dose of dexamethasone / 中华血液学杂志

Objective@#To test whether the tryptophan metabolism was abnormal in newly diagnosed ITP patients as well as in these patients after treatment with dexamethasone.@*Methods@#Newly diagnosed patients with ITP between Jan 2014 and May 2015 were enrolled, including 14 females and 11 males, with a median age of 57 years and a median PLT count of 16 (0-32) ×109/L. All patients were treated with oral dexamethasone. The expression levels of IDO mRNA and TTS mRNA in peripheral blood mononuclear cells (PBMC) were analyzed by real-time quantitative polymerase chain reaction. ELISA was used to test the concentrations of IDO and TTS in serum. The concentrations of plasma kynurenine and tryptophan were detected by high-pressure liquid chromatography. Samples from healthy individuals were tested as controls.@*Results@#①After dexamethasone treatment, 17 patients resulted in persistent remission, 2 cases were ineffective, and relapse occurred in 6 cases at a median follow-up of 11 (6-18) months. ②Before and after dexamethasone treatment, the relative expression of indoleamine2,3-dioxygenase (IDO) mRNA and tryptophanyl t-RNA synthetase (TTS) mRNA showed that there were significant decline in persistent remission group (2.54±0.86 vs 19.85±5.36, t=3.188, P=0.003; 0.68±0.19 vs 45.39±15.83, t=2.842, P=0.008) , compared with the normal control group, the difference was not statistically significant (t=2.313, P=0.027; t=1.127, P=0.268) . After treatment, the IDO concentration decreased [ (19.34±0.42) U/ml] and the TTS concentration was markedly increased [ (13.37±0.54) μg/L] in sustained remission group compared with that before treatment [ (21.91±0.37) U/ml] as well as that in normal controls. In particularly, abnormal tryptophan catabolism could be recovered in these 17 patients with persistent remission [Try: (19.85±5.36) μmol/L vs (19.65±4.55) μmol/L, t=1.027, P=0.311; Kyn: (0.56±0.26) μmol/L vs (0.58±0.23) μmol/L, t=2.075, P=0.448]. ③There was no obviously difference in the relative expression of IDO mRNA and TTS mRNA, the concentration of IDO and TTS and the abnormal tryptophan catabolism between before and after treatment of dexamethasone in patients without response and relapsed patients (all P>0.01) .@*Conclusion@#The tryptophan catabolism was abnormal in ITP patients, and it could be recovered in patients with persistent remission.

Research advances on relationship between CXC chemokine ligand 10 and viral hepatitis / 中华临床感染病杂志

In the progress of viral hepatitis, lymphocytes migrate and infiltrate liver tissues, which is relevant to antiviral therapy.However, the related mechanism is still poorly understood.In recent years,CXC chemokine ligand (CXCL)10 and its receptor CXCR3 have been extensively studied.The interaction between CXCL10 and CXCR3 would be a breakthrough point for study of the mechanism of viral hepatitis pathogenesis.This article reviews the research advances of CXCL10 in the progression of viral hepatitis and in the evaluation of antiviral therapy.

Prognostic significance of monosomal karyotype in acute myeloid leukemia / 中华血液学杂志

<p><b>OBJECTIVE</b>To explore the prognostic significance of monosomal karyotype (MK) in patients with acute myeloid leukemia (AML).</p><p><b>METHODS</b>The clinical data of 498 AML patients were analyzed retrospectively.</p><p><b>RESULTS</b>Of the 498 patients, 233 (46.8%) cases had an abnormal karyotype. 42 patients fulfilled the criteria for MK, which were 8.4% of all cases and 18.0% of patients with abnormal karyotype, respectively. The most frequent autosomal monosomies were -7 and -17. 70 patients had complex karyotype (CK), in all patients and patients with abnormal karyotype accounted for 14.1% and 30.0%, respectively. Patients with MK were associated with significantly older (median age 62.5 vs 52 years, P=0.003), and lower HGB concentrations (62.5 vs 77 g/L, P=0.009) and lower WBC counts (7.0×10⁹/L vs 11.7×10⁹/L, P=0.008). Among MK cases, the most frequent chromosome abnormalities were complex karyotype, -7, -5, 7q-, and 5q-. In univariate analysis, MK patients had worse survival than those without MK (7.3 months vs 26.3 months, P<0.001). CK patients also had poorer outcomes than patients without CK (14.8 months vs 26.3 months, P<0.001). In CK patients, survival was worse in MK patients than patients without MK (7.4 months vs 19.2 months, P=0.007). By COX analysis, MK was an independent prognostic factor, beyond NCCN criteria and CK [HR=2.610 (1.632-4.175), P<0.001].</p><p><b>CONCLUSION</b>MK was an independent adverse prognostic factor in AML patients.</p>

Perioperative complications of stent angioplasty for intracranial arterial stenosis：clinical analysis and therapeutic strategy / 介入放射学杂志

Intracranial artery stenosis is one of the main causes inducing transient ischemic attack (TIA) or cerebral ischemic stroke. Being a minimally-invasive and reliably-effective technique, intracranial artery stent angioplasty has brought about a new approach for the treatment of intracranial artery stenosis , and thus provides more opportunities to the patients who are not suitable for intracranial vascular bypass surgery. However, the higher occurrence of perioperative complications caused by stent angioplasty should be seriously taken into consideration by clinical physicians. In order to reduce the occurrence of complications , in this paper the perioperative complications of stent angioplasty for intracranial artery stenosis are analyzed , and the therapeutic strategies as well as the proper approaches are discussed.

Clinical analysis of patients with hepatitis B virus-related liver failure complicated with invasive pulmonary aspergillosis / 中华传染病杂志

Objective To investigate the clinical features, risk factors, diagnose, treatments and prognosis of patients with hepatitis B virus (HBV)-related liver failure complicated with invasive pulmonary aspergillosis (IPA). Methods A case-control study was performed to retrospectively analyze the clinical data of 43 patients with HBV-related liver failure complicated with IPA. A cohort of 43 patients with HBV-related liver failure complicated with bacterial infection only was analyzed at the same time and another cohort of 43 patients with HBV-related liver failure without any infections served as the control group. Results Compared with the control group, patients with infection had lower platelet counts and prothrombin activity, higher scores of model for end-stage liver disease (MELD), especially the patients with IPA (F=42.43,13.69,14, 22, all P＜0.01). And the similar results were observed in patients with IPA group before and after Aspergillus infection (F= 12.09,14.52,-16.74, all P＜0.01). Furthermore, the annual mortality was 100. 0% in patients with IPA,which was higher than that of patients complicated with bacterial infection only; and both groups were higher than control group of patients without infection. The statistic results showed that patients with longer length of stay, more antibiotics usage, and more invasive procedures were all risk factors of HBV-related liver failure complicated with IPA. Conclusions Conditions of patients with HBV-related liver failure deteriorate rapidly after complicated with IPA and patients have higher mortality and poorer prognosis.Therefore, it will be effective to enhance the recognition of the early clinical manifestations, and make diagnosis timely and treat with potent anti-fungal therapy to improve their survival.

The mechanism of quinolone resistance in Pseudomonas aeruginosa / 中华临床感染病杂志

Objective To investigate the mechanism of quinolone resistance in Psendomonas aeruginosa.Methods The minimum inhibitory concentrations (MICs)of ciprofloxacin and levofloxacin with and without carbonylcyainde-m-chlorophenylhydrazone(CCCP)were determined by agar dilution method.Polymerase chain reaction(PCR)and DNA sequencing were used to study the mutations in quinolone resistance-determining region of gyrA and parC genes.The strains were genotyped by enterbacterial repetitive intergenie consensus-PCR(ERIC-PCR).Results Sixteen quinolones-resistant Pseudomonas aeruginosa strains were obtained.The MICs of ciprofloxacin and levofloxacin were not reduced significantly by adding CCCP.Thr-83→Ile of gyrA and Ser-87→Leu of parC were found simultaneously in 16 strains of resistant Pseudomonas aeruginosa.Analysis of ERIC-PCR products indicated that 16 quinolone-resistant strains had an identical band pattern which was different from that seen in the sensitive strains.Conclusion Mutations in gyrA and parC may be the main mechanism of quinolone resistance in clinical isolates of Pseudomonas aeruginosa.

Factors Influencing Agrobacterium-mediated Transformation of Foxtail Millet (Setaria italica) / 中国生物化学与分子生物学报

An efficient and repeatable approach in transforming the foxtail millet (Setaria italica ) using Agrobacterium LBA4404 horboring the plasmid pBI121 was established. Factors affecting transformation efficiency were investigated including the genotype, explants, the density of bacteria, the duration for inoculation and co-cultivation, and the concentration of acetosyringone in the medium. The maximum transformation conditions were: the callus induced from inflorescence was used as explant; the duration for inoculation with Agrobacterium at low cell density was 30-40 min; for the co-cultivation , the suitable concentration of acetosyringone in the medium was 0.1 mmol/L, and the duration was 2 days.

Role of two kinds of adipokines on hepatocellular apoptosis in mice with acute liver injury / 基础医学与临床

Objective To investigate the interference role that two kinds of adipokines,adiponectin and leptin,exert to hepatocellular apoptosis in mice with acute liver injury induced by Concanavalin A(ConA).MethodsTwenty-six male BALB/c mice were divided into four groups randomly:ConA group(8 mice),adiponectin group(5 mice),leptin group(5 mice) and control group(8 mice).Mice were sacrificed 8 hours after ConA-treatment for observing hepatic injury and hepatocellular apoptosis.Results Comparison to ConA group,the mice in adiponectin group showed less hepatic injury and lower ALT level and less hepatocellular apoptosis(P

Complications and conversions in myeloproliferative disorders: an analysis of 356 cases / 中华血液学杂志

<p><b>OBJECTIVE</b>To investigate the complications and conversions in myeloproliferative disorders (MPD).</p><p><b>METHODS</b>Three hundred and fifty six patients with MPD were reviewed, including 78 with etiologic thrombocythemia (ET), 93 with primary myelofibrosis (MF), 185 with polythythemia vera (PV). The clinical observation, follow-up, analysis with SPSS statistic software were performed.</p><p><b>RESULTS</b>Out of the 356 cases, 101 (28.5%) developed thromboembolic events, 81 (22.8%) hemorrhage, 60 (16.9%) hypertension, 20 (5.6%) coronary heart disease, 3 (0.8%) hemolysis and 1 (0.3%) gastrointestinal ulcer, 2 (0.6%) calculus and 1 (0.3%) bone marrow necrosis. Twenty four patients (6.7%) developed MF (9 in ET, 15 in PV), 2 (0.6%) erythrocytosis (1 in ET, 1 in MF), 3 (0.8%) thrombocythemia (all in PV), 5 (1.4%) acute leukemia (2 in ET, 3 in MF) and 1 (0.3%) multiple myeloma (in ET). Eleven cases (3.1%) died, 5 (1.4%) from acute leukemia, 2 (0.6%) fatal hemorrhages, 1 (0.3%) each myocardial infarction and infectious shock, 2 (0.6%) unknown causes.</p><p><b>CONCLUSION</b>Embolism and bleeding were the main complications in MPD. Conversions among ET, MF and PV hematological malignancies could occur.</p>

Expression of nm23 Gene Protein in Epithelial Ovarian Cancer / 中国医科大学学报

Objective: Our purpose was to study the expression of protein of nm23 gene in patients with epithelial ovarian carcinoma.Methods:Protein of nm23 gene was detected by immunohistochemical technique in 45 patients with epithelial ovarian cancer, 12 with borderline, and 10 with benign ovarian tumor.Results:The positive expression rate in ovarian cancer (73.3%) was significantly higher than that of the benign and borderline tumors. There was no significant correlation between the expression of nm23 gene and the histological type, grade, the existence of ascites or the size of residul after operation. However, the expression of nm23 gene protein was negatively related with the FIGO stage. The overall survival rate of the patients with positive expression of nm23 gene was much higher than that of the patients with negative expression. Conclusion:The findings suggest that nm23 gene protein might serve as a valuable and independent marker for the prognosis of ovarian cancer.

The establishment of the method of precise lung slicing and the evaluation of neutral red assay for measuring viability of lung slices / 中国药理学通报

Aim To establish the metho d of precise lung slicing and examine the validity of neutral red(NR) assay for measuring lung slices viability.Method Inflated with 1% low melting agaro se solution, lung lobes were cut into slices by shaking microtome. With the thic kness of 400,500,600,700 ?m,lung slices were cultured in medium pH 6.8,7 .0,7.2, 7.4, respectively. After 1 h pre-incubation, lung slices were cont inuously submerged in 24-well plate, incubated for 0,2,4,6 h,respectively. NR assay, MTT assay, LDH leakage and SOD activity were used to assess the slices viability under different slices thickness, medium pH and culturing time. Result When the slice thickness was 600 ?m and medium pH was 7.0, t he viability of slices maintained best and steady for 6 h. There were positive c orrelations between NR uptake and MTT reduction in slices under different thickn ess(r 1 = 0.91, P