Analysis of Factors Affecting Effectiveness of Medical Device Registration Self-inspection from Perspective of Technical Evaluation / 中国医疗器械杂志

Type inspection is a necessary precondition of technical evaluation of medical device. The implementation of The Provisions for Administration of Self-Test for Medical Device Registration facilitates the registration pathway for applicants. How to improve the effectiveness of registration self-test has drawn attention from many stakeholders. In this study, we analyzed and discussed the factors affecting the validity of registration self-test from technical evaluation perspective, and proposed suggestions for improvement accordingly. The aim of this article is to boost the reliability and effectiveness of registration self-test and offer a reference for applicants to carry out registration self-test.

Preliminary study on the competence of Chinese assistant general practitioners / 中华全科医师杂志

Objective:To explore the competency for the assistant general practitioners in China to provide theoretical support for the construction of the post competence model of assistant general practitioners and training and evaluation of assistant general practitioners.Methods:During January 22 to June 18, 2019, Using snowball sampling method and behavioral event interviews, 23 general practitioners and assistant general practitioners were interviewed in China, including 14 general practitioners in the superior performance group and 9 assistant general practitioners in the average performance group. The interview contents were coded and analyzed, and the statistical methods of t test and rank sum test of two independent samples were used to screen competency characteristics and construct the competence model of assistant general practitioners.Results:The total classification consistency and the total coding reliability coefficient was respectively 0.79, 0.87. 59 competency characteristics of assistant general practitioners were obtained including 3 differentiated competency characteristics "Understanding the medical and health system and related policies", "Critical thinking skills" and "General practitioner clinical thinking" and 10 baseline competency characteristics. There was no statistically significant difference between the average performance group and the superior performance group in the total frequency of competency [(29.4±12.7) times to (23.4±7.0) times, t=1.27, P=0.22]. Conclusion:The preliminary competency characteristics of assistant general practitioners have good reliability and can provide references for further exploration of the competency model.

Effects of cytomegalovirus infection on structure and function of mitochondria / 中华实验和临床病毒学杂志

Cytomegalovirus (CMV) is a kind of common opportunistic pathogenic virus in nature. Infections with human cytomegalovirus (HCMV) always lead to serious consequences among immunodeficiency and immunocompromised individuals. And congenital HCMV infection is the most common cause of newborn malformation which result in neurodevelopmental abnormalities in children. Mitochondria are not only the leading sites of aerobic respiration, but also play important roles in regulating cell growth and cycle. Infection with cytomegalovirus will disrupt the structure of mitochondria and affect the function of mitochondria-associated membrane (MAM). This review summarized the progress about the effects of CMV infection on the structure and function of mitochondria and reveal the role of mitochondria in CMV infection on body damage.

Comparative analysis of methylation profiles in tissues of oral leukoplakia and oral squamous cell carcinoma / 中华口腔医学杂志

Objective@#To compare the methylation profiles in tissues of oral leukoplakia (OLK) and oral squamous cell carcinoma (OSCC) with healthy tissues of oral mucosa, in order to identify the role of DNA methylation played in tumorigenesis.@*Methods@#DNA samples extracted from tissues of 4 healthy oral mucosa, 4 OSCC and 4 OLK collected from patients of the Department of Oral Medicine, Capital Medical University School of Stomatology were examined and compared using Methylation 450 Bead Chip. The genes associated with differentially methylated CpG sites were selected for gene ontology (GO) analysis and Kyoto encyclopedia of genes and genomes (KEGG) pathway enrichment.@*Results@#Multiple differentially methylated CpG sites were identified by using the above mentioned assay. Hypermethylation constitutes 86.18% (23 290/27 025) of methylation changes in OLK and hypomethylation accounts for 13.82% (3 734/27 025) of methylation changes. Both hypermethylated and hypomethylated CpG sites were markedly increased in OSCC tissue compared with OLK tissue. The majority of differentially methylated CpG sites were located outside CpG islands, with approximately one-fourth in CpG shores flanking the islands, which were considered highly important for gene regulation and tumorigenesis. Pathway analysis revealed that differentially methylated CpG sites in both OLK and OSCC patients shared the same pathway enrichments, most of which were correlated with carcinogenesis and cancer progression (e.g., DNA repair, cell cycle, and apoptosis).@*Conclusions@#In the present study, methylation-associated alterations affect almost all pathways in the cellular network in both OLK and OSCC. OLK and OSCC shared similar methylation changes whether in pathways or genes, indicating that epigenetically they might have the same molecular basis for disease progression.

Application of exfoliated cells in early diagnosis of oral cancer / 中华口腔医学杂志

Exfoliative cytology is a simple and non-invasive examination method that is easily accepted by the patient. A number of new techniques are used to further increase the accuracy of sample collecting. It is widely used in the detection of cervical, oral cavity and various coelom exfoliated cells. This article reviews the development of exfoliative cytology in oral cancer diagnosis. It is realized that the qualitative and quantitative analysis of cancer and precancerous lesions, through DNA quantitative analysis to calculate DNA index (DI value), multiple parameter analysis and statistical modeling calculation to evaluate oral cancer risk index (OCRI) of the patient has great significance in cancer screening, early diagnosis and prognosis review, especially in the field of oral cancer.

Establishment of Evaluation Model of O2O Platform Service Quality Based on SERVQUAL Scale / 中国药房

OBJECTIVE:To establish a pharmacy online to offline (O2O) platform service quality evaluation model,and to provide reference for platform operators to improve the service quality. METHODS:Using SERVQUAL scale,combining the situa-tion of pharmacy O2O platform development in China,the reliability,safety and aspects of O2O platform were analyzed to sum up primary evaluation index of pharmacy O2O platform service quality. Based on this,the expert interviews questionnaire was de-signed. According to the questionnaire results,indicators were modified and empowered to construct the pharmacy O2O platform service quality evaluation model;the reliability and validity of model were validated. RESULTS & CONCLUSIONS:According to the connotations of each dimension analysis in the SERVQUAL scale and expert interview results of pharmacy O2O platform ser-vice quality,pharmacy O2O platform service quality evaluation model is constructed,including five indicators as“reliability”“se-curity”,and 18 secondary indexes as the“number of platform pharmacy”“pharmacy qualification show”“pharmacy type”. The re-sults of model index reliability and validity verification show that model construction is reasonable and can provide reference for platform operators improving service quality. Follow-up research should give full consideration to the Chinese consumer behavior habits,personal preferences and other factors to build more suitable pharmacy O2O platform service quality evaluation model in China.

Epidemiological characteristics of Middle East Respiratory Syndrome outbreak in the Republic of Korea, 2015 / 中华流行病学杂志

<p><b>OBJECTIVE</b>To analyze the epidemiological characteristics of Middle East Respiratory Syndrome (MERS) outbreak in the Republic of Korea in 2015 and provide related information for the public health professionals in China.</p><p><b>METHODS</b>The incidence data of MERS were collected from the websites of the Korean government, WHO and authoritative media in Korea for this epidemiological analysis.</p><p><b>RESULTS</b>Between May 20 and July 13, 2015, a total of 186 confirmed MERS cases (1 index case, 29 secondary cases, 125 third generation cases, 25 fourth generation cases and 6 cases without clear generation data), including 36 deaths (case fatality rate: 19%), were reported in Korea. All cases were associated with nosocomial transmission except the index case and two possible family infections. Sixteen hospitals in 11 districts in 5 provinces/municipalities in Korea reported confirmed MERS cases, involving 39 medical professionals or staff. For the confirmed cases and death cases, the median ages were 55 years and 70 years respectively, and the cases and deaths in males accounted for 60% and 67% respectively. Up to 78% of the deaths were with underlying medical conditions. Besides the index case, other 12 patients were reported to cause secondary cases, in which 1 caused 84 infections. One imported MERS case from Korea was confirmed in China on May 29, no secondary cases occurred. The viruses strains isolated from the cases in Korea and the imported case in China show no significant variation compared with the strains isolated in the Middle East.</p><p><b>CONCLUSION</b>The epidemiological pattern of the MERS outbreak in Korea was similar to MERS outbreaks occurred in the Middle East.</p>

Effect of aminoguanidine on cell apoptosis induced by acute myocardial ischemia in rats / 中华麻醉学杂志

Objective To evaluate the effect of aminoguanidine on cell apoptosis induced by acute myocardial ischemia in rats.Methods Thirty adult male Sprague-Dawley rats,weighing 250-290 g,were randomly divided into 3 groups (n =10 each):sham operation group (group S),myocardial ischemia group (group Ⅰ),and aminoguanidine group (group AG).The model of acute myocardial ischemia was established by ligating the left anterior descending branch of the coronary artery of rats anesthetized with chloral hydrate.Aminoguanidine 100 mg/kg was intraperitoneally administrated at 6 h of ischemia in AG group,while the equal volume of normal saline was given instead of aminoguanidine in group Ⅰ.The chest was opened at 3 h after aminoguanidine administration and hearts were quickly removed for detection of apoptosis in cardiomyocytes (by TUNEL) and expression of Bcl-2 and Bax in cardiomyocytes (by immuno-histochemistry),and for microscopic examination with light microscope.Apoptotic rate was calculated.Results Compared with group S,the apoptotic rate was significantly increased,the expression of Bax was up-regulated,and the expression of Bcl-2 was downregulated and the ratio of Bcl-2/Bax was decreased in group Ⅰ.Compared with group Ⅰ,the apoptotic rate was significantly decreased,the expression of Bax was down-regulated,and the expression of Bcl-2 was up-regulated,and the ratio of Bcl-2/Bax was increased in group AG.The pathological changes of myocardial cells were significantly attenuated in AG group as compared with group Ⅰ.Conclusion Amionguanidine can inhibit apoptosis in cardiomyocytes and is helpful in mitigating injury induced by acute myocardial ischemia in rats.

Consistency of gene amplification and its expression at protein level of human epidermal growth factor receptor 2 in gastric carcinoma / 中华消化杂志

Objective To investigate the consistency of gene amplification and its expression at protein level of human epidermal growth factor receptor 2 (HER2) in gastric carcinoma.Methods From 2010 to 2012,120 gastric cancer specimens of patients with gastric cancer were collected,of which 100 were surgical specimens and 20 were specimens from biopsy under gastroscope.The protein expression of HER2 in 120 specimens was detected by immunohistochemistry (IHC).According to the results of IHC,the positive parts of HER2 expression of IHC slices were developed into tissue microarrays for fluorescence in situ hybridization (FISH) to test the gene amplification of HER2.The different parts with different color intensity of focal (+ + +) (≤ 10％ tumor cell strongly staining) specimens detected by IHC detection were compared with the results of FISH.Kappa test was performed for statistical analysis.Results Among 120 gastric cancer specimens,the results of IHC indicated that 77 specimens were positive with different staining intensity including 16 strong positive (+++),six focal positive (+++),37 moderate positive (++) and 18 weak positive (+).The positive rate of HER2 protein expression detected by IHC was 18.3％ (22/120).The results of FISH showed 41 specimens were positive and the rate of gene amplification was 34.2％.Among which,21 were moderate positive (++) detected by IHC,15 were strong positive (+ + +) and five were focal positive (+ ++).The positive rate of HER2 was 35.0％ (42/120) with IHC and FISH combined detection.The consistent rate of IHC and FISH was 91.6 ％ (76/83).Kappa coefficient was 0.960 (P＜0.01).In five positive specimens detected by FISH and which were focal positive (+ + +) by IHC,the different parts with different color intensity were compared with the results of FISH and gene amplification was found in all specimens.Conclusion Tissue microarray technology is consistent with IHC in HER2 detection in gastric cancer specimens and could help to improve the detection rate.

Detection and distribution of Helicobacter pylori antibodies by protein chip in gastroduodenal disease / 中国医师杂志

Objective To detect Helicobacter pylori (H.pylori) multiple antibodies of urease (Ure),cytotoxin associated gene A protein (CagA),vacuolating toxin A (VacA),heat shock protein 60 (Hap60) and nitroreductase ( RdxA),and disclose their relations with chronic gastritis,peptic ulcer and gastric cancer.Methods A volume (3 ml) of venous blood was taken from 300 patients of gastroduodenal disease diagnosed by endoscopy,to centrifuge and detect antibodies of Ure,CagA,VacA,Hsp60,RdxA by protein chip technique.Results The infective rates of H.pylori in chronic gastritis,peptic ulcer,and gastric cancer were 34.0％,58.0％,34.0％ ( P ＜ 0.01 ),respectively.In the H.pylori positive chronic gastritis,peptic ulcer and gastric cancer,the positive rates of CagA antibody were 54.9％,75.9％,64.7％ ( P =0.070) ; the positive rates of VacA antibody were 31.4％,22.4％,17.6％ ( P =0.412) ;and the positive rates of Hap60 antibody were 56.9％,48.3％,41.2％ ( P =0.466),respectively.The total positive rate of RdxA antibody was 4.0％ (5/126).Conclusions H.pylori infection and virulence factor CagA are closely related to peptic ulcer,while it did not show the exact correlation between VacA,Hsp60 and gastroduodenal disease.The level of RdxA antibody can not represent the level of H.pylori resistance to metronidazole.

Early risk factors for pneumonia in acute stroke patients with dysphagia: a prospective case series study / 国际脑血管病杂志

Objective To investigate the early risk factors for stroke-associated pneumonia (SAP) in acute stroke patients with dysphagia.Methods The modified Mann assessment of swallowing ability (MMASA) was used to screen dysphagia in patients with acute stroke admitted to hospital within 24 hours after symptom onset.The patients with dysphagia were used as research subjects.They were divided into either a SAP group or a non-SAP group according to whether they had SAP or not within one week of symptom onset.Univariate and multivariate logistic recession analyses were used to analyze the data of demography,past history,clinical practice,and laboratory.The early risk factors for the occurrence of SAP in patients with dysphagia were identified.The independent risk factors were analyzed with receiver operating characteristic (ROC) curves in order to assess their predictive value for SAP.Results Of the 113 patients with acute stroke,55 had dysphagia,and 30 of them (54.54％ ) had SAP.Univariate analysis showed that the National Institutes of Health Stroke Scale (NIHSS) score (median,[ interquartile range] 16,[ 13 - 21 ] vs.3,[ 1 - 7 ] ; P =0.000),neut rophil counts ([ 8.22 ± 3.75 ] × 109/L vs.[ 5.39 ± 2.56 ] × 109/L; t =3.198; P =0.002),proportion of hemorrhagic stroke (96.00％ vs.4.00％ ;x2 =7.333; P =0.007),and proportion of mechanical ventilation (20.00％ vs. 0.00％;x2=5.612; P=0.018) in the SAP group (n=30) were significantly higher than those in the non-SAP group (n =25),while the MMASA score (median,[ interquartile range ] 53,[ 27 - 84 ] vs.88,[ 66 - 92 ] ; P =0.002),Glasgow Coma sCale (GCS) score (median,[ interquartile range] 10,[7-13] vs.15,[11-15];P=0.001),lymphocytecounts([1.17±0.54] ×109/L vs.[1.75±0.81 ] × 109/L; t =-3.563,P =0.001),CD3+ T lymphocyte counts ([0.73 ± 0.42] × 109/L vs.[ 1.14 ±0.85] × 109/L; t=-2.307; P=0.025),and CD4+ T lymphocyte counts ([0.38± 0.22] × 109/L vs.[ 0.69 ±0.57] × 109/L; t =-2.761; P =0.008) were significantly lower than those in the non-SAP group.Multivariate logistic regression analysis showed that the NIHSS score was higher at admission (odds ratio [ OR ],1.206,95％ confidence interval [ CI ] 1.076- 1.351; P=0.001) and the CD4+ T lymphocyte counts decreased ( OR,0.974,95％ CI 0.952 - 0.997; P =0.025) were the independent risk factors for SAP in stroke patients with dysphagia.The NIHSS score ≥ 10.5 had good predictive value for SAP,and its sensitivity and specificity were 86.7％ and 72.0％ respectively (P =0.000).Conclusions More than half of the acute stroke patients with dysphagia occurred SAP.The NIHSS score at admission,neutrophil counts,stroke types,mechanical ventilation,MMASA score,GCS score,lymphocyte counts,CD3+ T lymphocyte counts,CD4+ Tlymphocyte counts,and other factors were associated with occurrenee of SAP in patients with dysphagia,in which a higher NIHSS score and a decreased CD4+ T lymphocyte counts were independent risk factors for the occurrence of SAP in stroke patients with dysphagia.The NIHSS score ≥ 10.5 at admission had higher predictive value.

Screening tools of dysphagia after stroke / 国际脑血管病杂志

The incidence of dysphagia after stroke is high.It may affect the rehabilitation of patients and increase mortality.The assessment is of great significance for early objective examination of dysphagia,in which the bedside screening tests are the most common assessment methods in the routine clinical work.This article reviews the advances in research on the commonly used bedside screening tests of dysphagia.

Disease spectrum difference in patients with craniocerebral injury in high altitude and plain areas / 中华创伤杂志

Objective To compare the differences of disease spectrum between patients with brain trauma injury (TBI) in the high altitude areas and those in the plain areas.Methods The front page information of medical records of local TBI patients admitted to military hospitals from 2001 to 2007 was extracted from the Chinese Trauma Database.Ten military hospitals from high altitude areas (high altitude group) and 10 military hospitals with the same hospital level from plain areas (plain group) were selected and the patients in the two groups were compared for their differences in general condition and disease spectrum.Results High altitude group displayed a larger proportion of male patients (P＜0.01),a lower age (P＜0.01),a smaller proportion of patients with Han nationality (P＜0.01),asmaller proportion of emergency patients (P＜0.01),a larger proportion of critically ill patients (P＜0.01),a lower median of hospital days (P＜0.01),a lower operation rate (P＜0.01),as compared with the plain group.The injury of the patients with TBI in turn were intracranial organ injury (excluding those with skull fracture),open wound of head,neck,and trunk,skull fracture,injury of nerves and spinal cord.The orders of TBI disease spectrum of the high altitude and plain groups were the same,but the disease compositions of the two groups had significant difference (P＜0.01).Conclusions Thereexist significant differences in demographics,admission status and disease spectrum of TBI patients inhigh altitude and plain areas.However,the current clinical treatments of TBI in high altitude areas are usually with reference to the experience in plain areas,which is worthy of paying attention by relevant departments.

Protective effects of aldioxa tablets on aspirin-induced gastric mucosal lesions in rats / 中国医师杂志

Objective To study the protective effects of aldioxa tablets on aspirin-induced gastric mucosal lesions in rat model. Methods Sixty healthy male Wistar rats were randomly divided into five groups: Ⅰ (injury group), Ⅱ (control group), Ⅲ (sucralfate protective group), Ⅳ (aluminium hydroxide protective group), and Ⅴ (aldioxa protective group). The three protective groups were treated with sucralfate, aluminium hydroxide and aldioxa tablets respectively before gastric mucosal injury was induced. Then the ulcer index (UI), epithelial damage scoring (EDS) were measured, and the pathological changes on histological sections and ultrastructural sections of gastric mucosa were assessed under microscope or electron microscope. Results The data of group Ⅰ, Ⅱ, Ⅲ, Ⅳ, Ⅴ obtained were as follow: ulcer index: 42.13±6.22, 3.13±1.46, 8.63±3.48, 18.00±6.16, 8.00±3.17, respectively; epithelial damage scoring: 3.67±0.49, 1.25±0.45, 1.41±0.51, 2.42±0.79, 1.50±0.52, respectively. In comparison with injury group, the ulcer index and epithelial damage scoring of gastric mucosa in aldioxa protective group were significantly decreased. Conclusions The results revealed that aldioxa tablets had a significant protection effect on rats with acute gastric mucosal injury induced by aspirin.

The relationship between Alzheimer disease and plasma homocysteine level / 中国基层医药

Objective To investigate the relationship between Alzheimer disease(AD) and plasma homocysteine (HCY) level. Methods Rate of mini mental state examination(MMSE) and levels of plasma homocysteine and folate and vitamin B12 were determined in 68 AD patients, which were compared with 60 healthy older. Results The mean plasma level of HCY was higher in AD patients than that in contrast group,and the very reverse of plasma level of folate and vitamin B12(P15?mol/L,the odd ratio(OR) was 4.3(95% CI 1.89～7.43). Plasma level of HCY was negatively correlated with that of folate and vitamin B12 and rate of MMSE in two groups. Conclusion The high level of plasma HCY is an important risky factor to AD patients. The lack of nutrition elements of folate and vitamin B12 et al can result in the rising of plasma HCY.

Monitoring novel ovarian carcinoma associated genes using cDNA expression microarray / 中华妇产科杂志

Objective To explore the gene expression pattern of sample of human ovarian carcimoma Method The difference in gene expression between normal and neoplastic human ovarian tissues were investigated,we described the assembly and utilization of a 512 member cDNA microarray Result Thirty seven genes expressed in ovarian cancer were screened out,14 genes were up regulated,23 genes were down regulated Conclusion cDNA microarray for analysis of gene expression pattern is an effective method to identify novel ovarian cancer associated genes

Studies on the therapy of endometriosis by antiangiogenesis with endostatin gene / 解放军医学杂志

Objective To study the inhibitory effect of recombinant adenoviruses carrying the mouse endostatin gene on the therapy of endometriosis in nude mice.Methods Animal endometriosis models were established by inoculating human endometrial fragments.Mice were randomly divided into three groups(10 each):PBS control group,Ad-lacZ group and Ad-mEndo therapy group when ectopic lesion diameter reached 5-10mm.The ectopic lesion size was measured every day.The expression of endostatin in ectopic lesion was detected by immunohistochemical stainining.The microvessel density(MVD) of ectopic lesion was traced by CD34 immunohistological labeling.Meanwhile,the contents of steroid hormone and histological changes in mice uterus and ovary were detected.Results The titer of the recombinant adenovirus was about 5.0?109pfu/ml.The endostatin gene was transferred into mice successfully and expressed effectively.The lesion volume was significantly less in Ad-mEndo group(34.3?11.2mm3) than that in Ad-lacZ group(93.3?10.7mm3) and PBS group(90.4?18.7mm3,P

Expression and purification of HgbA from Haemophilus ducreyi and its partial fragment for development of a Sandwich ELISA to detect infection of Haemophilus ducreyi using specific polyclonal antibodies / 中国免疫学杂志

Objective:To express and purify hemoglobin receptor(HgbA) and its partial fragment(HgbAF) from Haemophilus ducreyi and to develop a sandwich ELISA for the detection of H.ducreyi infection.Methods:The HgbA,a hemoglobin-binding outer membrane protein of H.ducreyi and its partial fragment(HgbAF) were expressed by cloning the genes of hgbA and its 705bp fragment into pET30a and pET28a respectively,and the expressing products were purified from E.coli BL21 with Ni-NTA-His affinity chromatography.The polyclonal antibodies were developed by immunizing rabbits with the rHgbA and rHgbAF.The anti-rHgbA IgG and anti-rHgbAF IgG were purified respectively by saturated amine sulphate precipitation,and their immunoactivity with rHgbA and rHgbAF was tested by Westen blot and ELISA analysis.A Sandwich ELISA was developed for the detection of chinical infection of H.ducreyi using the specific polyclonal antibodies.Results:The HgbA and its partial fragment,HgbAF of H.ducreyi,were expressed and purified successfully by cloning their genes respectively.The results obtained by Western blot analysis showed that each of the antibodies could react with both antigens,rHgbA and rHgbAF.The results of the ELISA analysis showed that H.ducreyi strain was strongly positive,and all other bacteria,including H.influenzae and the bacteria known to relate to genital ulcers were negative.The results of the ELISA analysis showed that the minimum amount of rHgbA detected was 1.56 ng/ml and the minimum number of CFU of H.ducreyi detected was 2?105 cfu/ml in buffer and 1?106 cfu/ml in pus.Conclusion:HgbA and its partial fragment,HgbAF of H.ducreyi are expressed and purified successfully.The polyclonal antibodies developed by immunizing rabbits using rHgbA and rHgbAF could react not only with rHgbA and rHgbAF,but also with H.ducreyi specifically.They do not react with other bacteria,including H.influenzae and the bacteria known to relate to genital ulcers.So the ELISA based on the polyclonal antibodies was specific for the detection of H.ducreyi.Although the level of sensitivity of the ELISA may not be sufficient to detect H.ducreyi in all clinical specimens,further work to increase the sensitivity could potentially make this assay a valuable tool in areas where chancroid is endemic.