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Objective:To evaluate the performance of an artificial intelligent (AI)-based automated digital cell morphology analyzer (hereinafter referred as AI morphology analyzer) in detecting peripheral white blood cells (WBCs).Methods:A multi-center study. 1. A total of 3010 venous blood samples were collected from 11 tertiary hospitals nationwide, and 14 types of WBCs were analyzed with the AI morphology analyzers. The pre-classification results were compared with the post-classification results reviewed by senior morphological experts in evaluate the accuracy, sensitivity, specificity, and agreement of the AI morphology analyzers on the WBC pre-classification. 2. 400 blood samples (no less than 50% of the samples with abnormal WBCs after pre-classification and manual review) were selected from 3 010 samples, and the morphologists conducted manual microscopic examinations to differentiate different types of WBCs. The correlation between the post-classification and the manual microscopic examination results was analyzed. 3. Blood samples of patients diagnosed with lymphoma, acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome, or myeloproliferative neoplasms were selected from the 3 010 blood samples. The performance of the AI morphology analyzers in these five hematological malignancies was evaluated by comparing the pre-classification and post-classification results. Cohen′s kappa test was used to analyze the consistency of WBC pre-classification and expert audit results, and Passing-Bablock regression analysis was used for comparison test, and accuracy, sensitivity, specificity, and agreement were calculated according to the formula.Results:1. AI morphology analyzers can pre-classify 14 types of WBCs and nucleated red blood cells. Compared with the post-classification results reviewed by senior morphological experts, the pre-classification accuracy of total WBCs reached 97.97%, of which the pre-classification accuracies of normal WBCs and abnormal WBCs were more than 96% and 87%, respectively. 2. The post-classification results reviewed by senior morphological experts correlated well with the manual differential results for all types of WBCs and nucleated red blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, immature granulocytes, blast cells, nucleated erythrocytes and malignant cells r>0.90 respectively, reactive lymphocytes r=0.85). With reference, the positive smear of abnormal cell types defined by The International Consensus Group for Hematology, the AI morphology analyzer has the similar screening ability for abnormal WBC samples as the manual microscopic examination. 3. For the blood samples with malignant hematologic diseases, the AI morphology analyzers showed accuracies higher than 84% on blast cells pre-classification, and the sensitivities were higher than 94%. In acute myeloid leukemia, the sensitivity of abnormal promyelocytes pre-classification exceeded 95%. Conclusion:The AI morphology analyzer showed high pre-classification accuracies and sensitivities on all types of leukocytes in peripheral blood when comparing with the post-classification results reviewed by experts. The post-classification results also showed a good correlation with the manual differential results. The AI morphology analyzer provides an efficient adjunctive white blood cell detection method for screening malignant hematological diseases.
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Objective:To investigate the efficiency of biochemical screening and hotspot gene screening in the detection of neonatal inherited metabolic diseases.Methods:This was a prospective multi-center study.The study was carried out on 21 442 neonatal samples collected from 12 hospitals in 10 provinces from November 2020 to November 2021.The results of biochemical screening and hotspot gene screening were analyzed jointly.Biochemical screening methods included glucose-6-phosphate dehydrogenase deficiency enzyme activity assay and neonatal tandem mass spectrometry.Genetic screening analysis involved 135 genes associated with 75 neonatal diseases.Results:Of all the 21 442 neonates enrolled in the study, 21 205 were subject to biochemical screening.A total of 813 cases were positive in the initial screening, and 0.45% of them (95 cases) were diagnosed after recall.All the 21 442 neonates underwent gene screening.About 168 positive cases were detected in the initial screening, and 0.73% (156 cases) of them were confirmed finally.Biochemical and genetic screening improved the detection sensitivity of such diseases as primary carnitine deficiency, neonatal intrahepatic cholestasis caused by citrin deficiency, and 2-methylbutyrylglycinemia.Moreover, biochemical and genetic screening enabled the detection of more diseases, including the common single-gene genetic diseases such as thalassemia and Wilson disease.Conclusions:In neonatal screening, the combination of biochemical screening and gene screening expands the number of diseases detected and improve screening efficiency.
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Objective:To explore the performance of the commonly used whole blood C-reactive protein (CRP) detection systems and give related recommendation on the performance requirements of detection systems.Methods:A total of 7 540 venous blood samples from 26 maternal, child and children′s hospitals were collected to conduct this multi-center study on the analytical performance of 5 commonly used whole blood CRP detection systems from March to April in 2019. The blank check, carryover, repeatability, intermediate precision, linearity, sample stability, influence of hematocrit/triglyceride/bilirubin, comparison with SIEMENS specific protein analyzer and trueness were evaluated. The 5 systems included BC-5390CRP autohematology analyzer, AstepPLUS specific protein analyzer, Ottoman-1000 Automated Specific Protein POCT Workstation, i-CHROMA Immunofluorometer equipment Reader and Orion QuikRead go detecting instrument. The 5 systems were labeled as a, b, c, d and e randomly.Results:Within the 5 systems, all values of blank check were less than 1.00 mg/L, the carryovers were lower than 1.00%. The repeatability of different ranges of CRP concentrations including 3.00-10.00, 10.00-30.00 and>30.00 mg/L were less than 10.00%, 6.00% and 5.00%, respectively, and the intermediate precision was less than 10.00%. The linearity correlation coefficients of the 5 systems were all above 0.975, while the slope was within 0.950-1.050. Whole blood samples were stable within 72 hours both at room temperature (18-25 ℃) and refrigerated temperature (2-8 ℃). The CRP results were rarely influenced by high triglyceride or bilirubin, except for the immmunoturbidimetric test based on microparticles coated with anti-human CRP F(ab) 2 fragments. When triglyceride was less than 15.46 mmol/L, the deviation of CRP was less than 10.00%. When bilirubin was less than 345.47 μmol/L, the deviation of CRP was less than 10.00%. CRP was more susceptible to Hct on the systems without Hct correction. The deviation of CRP between different Hct dilution concentration and 40% dilution concentration can reach as high as 67.48%. The correlation coefficients ( r) of 5 systems were all more than 0.975 in the range of 0-300.00 mg/L compared with Siemens specific protein analyzer. All systems passed the trueness verification using the samples with specified values of 12.89 and 30.60 mg/L. Conclusion:The performance of 5 systems can basically meet the clinical needs, but it is suggested that the whole blood CRP detection system without automatic Hct correction should be modified manually.
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Objective: To investigate epidemiological characteristics of geriatric hip fractures between 2010 and 2011 in Hebei province. Methods: The digital radiography image data and basic information of patients above 60 years old with hip fractures (femoral neck fracture, femoral intertrochanteric fracture, and femoral head fracture) in 5 hospitals of Hebei province between January 2010 and December 2011 were analyzed retrospectively. All the data including patients' gender, age, and AO types were abstracted and analyzed to investigate the epidemiologic characteristics of geriatric hip fractures in Hebei province. Results: A total of 4 207 hip fracture patients above 60 years old were included, accounting for 59.61% of all patients with hip fractures and 26.24% of all fractures patients over 60 years old in the same period. There were 1 703 (40.48%) males and 2 504 (59.52%) females (M∶F=1∶1.47). The patients ranged in age from 61 to 99 years, with an average of 75.4 years; the majority of patients aged 70-79 years (43.97%) and the minority of the patients aged 90-99 years (2.02%); women of all ages were more than men, but the difference was not significant ( P>0.05). According to AO classification, there were 2 118 cases (50.34%) of type 31-A, 2 004 case (47.63%) of type 31-B, and 85 cases (2.02%) of type 31-C. Except for the type 31-A1, 31-A3, and 31-C1 of 60-69 age group, and the type 31-A3 of 80-89 age groups, women were significantly more than men. Conclusion: There are more women than men in hip fractures in Hebei province, and 70-79 age group is the high-risk age group of geriatric hip fractures. Among them, intertrochanteric comminuted fractures are common types.
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Objective To investigate the epidemiological data of nosocomial sepsis of premature infants with gestational age less than 34 weeks and the distribution characteristics of pathogenic bacteria in Shaanxi province.Methods A retrospective analysis of clinical data of premature infants born with gestational age ＜ 34 weeks born between January 1 and December 30,2018 in Neonatal Intensive Care Units(NICU) in 4 Grade A Class Three hospitals in Shaanxi province was performed.The high risk factors and pathogenic bacteria were analyzed by using chi-square test and t test for statistical analysis.Results Totally 823 infants were included in this study,among whom,73 patients developed nosocomial sepsis,and the incidence was 8.9％.The mean gestational age of the 73 patients with nosocomial sepsis was (30.6 ± 2.2) weeks and mean birth weight was (1 320.3 ± 450.5) g.The rate of invasive ventilator was 23.4％ (52/222 cases).The rate of peripherally inserted central catheter (PICC) was 20.1％ (61/303 cases).The rate of early antibiotic use was 8.1％ (39/481 cases) and breast feeding rate was 9.3％ (63/675 cases).The rate of PICC and ventilator use were statistically different between the non-infection group and the infection group (all P ＜0.05).There were 31 strains of pathogenic bacteria,among which gram-negative bacilli was the most common (22 strains,70.9％),which mainly were klebsiella pneumoniae strains (15 strains,48.4％),and 6 strains (19.4％) of Fungus was detected.Conclusions The incidence of nosocomial sepsis in NICU in Shaanxi province is higher,gram-negative bacilli was the most common pathogenic bacteria,among which,klebsiella pneumoniae was main,it is necessary to strengthen the regular monitoring and analysis of nosocomial infection in NICU in order to reduce the incidence of nosocomial infection and sepsis.
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Objective@#To investigate the epidemiological data of nosocomial sepsis of premature infants with gestational age less than 34 weeks and the distribution characteristics of pathogenic bacteria in Shaanxi province.@*Methods@#A retrospective analysis of clinical data of premature infants born with gestational age < 34 weeks born between January 1 and December 30, 2018 in Neonatal Intensive Care Units(NICU) in 4 Grade A Class Three hospitals in Shaanxi province was performed.The high risk factors and pathogenic bacteria were analyzed by using chi-square test and t test for statistical analysis.@*Results@#Totally 823 infants were included in this study, among whom, 73 patients developed nosocomial sepsis, and the incidence was 8.9%.The mean gestational age of the 73 patients with nosocomial sepsis was (30.6±2.2) weeks and mean birth weight was (1 320.3±450.5) g. The rate of invasive ventilator was 23.4%(52/222 cases). The rate of peripherally inserted central catheter (PICC) was 20.1% (61/303 cases). The rate of early antibiotic use was 8.1% (39/481 cases) and breast feeding rate was 9.3% (63/675 cases). The rate of PICC and ventilator use were statistically different between the non-infection group and the infection group(all P<0.05). There were 31 strains of pathogenic bacteria, among which gram-negative bacilli was the most common (22 strains, 70.9%), which mainly were klebsiella pneumoniae strains (15 strains, 48.4%), and 6 strains(19.4%) of Fungus was detected.@*Conclusions@#The incidence of nosocomial sepsis in NICU in Shaanxi province is higher, gram-negative bacilli was the most common pathogenic bacteria, among which, klebsiella pneumoniae was main, it is necessary to strengthen the regular monitoring and analysis of nosocomial infection in NICU in order to reduce the incidence of nosocomial infection and sepsis.
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Objective To illustrate the clinical and pathological features of Chinese upper tract urothelial carcinoma (UTUC) patients and to investigate the regional difference and the possible prognostic factors.Methods A retrospective study was performed on 2 628 patients from 9 centers of three different regions (Beijing:2 centers with 1 022 cases,Shanghai:1 center with 814 cases,Sichuan:6 center with 792 cases).The median age was 68 (range 20 to 93) and the mean age was 66.3.There were 1 447 male patients (55.1％) and 1 181 female patients (44.9％).The clinical information,pathological outcomes and prognosis were collected and analyzed based on South (Shanghai and Sichuan) and North (Beijing)region.Results The distribution of Ta + T1,T2,T3 and T4 was 914 (34.8％),715 (27.2％),857(32.6％) and 142(5.4％).Patients from North were more likely to be female (55.9％ vs.38.0％,P＜0.001) and suffer from ureteral tumors (43.4％ vs.35.9％,P ＜ 0.001);while in patients from South higher tumor stage(T3 or T4,42.5％ vs.31.0％,P ＜ 0.001),high grade(72.0％ vs.34.0％,P ＜0.001) and larger tumor size [(3.73 ±2.17) cm vs.(3.36 ±2.02) cm,P＜0.001] were more prevalent.Subgroup indicated that female patients in North had obviously lower tumor stage (T3 or T4,27.2％ vs.35.9％,P =0.014),while relatively higher tumor stage were noticed in female patients in South (T3 or T4,48.2％ vs.38.9％,P =0.004).The median follow-up was 41 (1-206) months,and 963 patients (36.6％) died including 815 (31.0％) died from cancer.In North female patients had better 5-year overall survival (75.5％ vs.62.2％,P ＜0.001) and cancer-specific survival (78.3％ vs.65.0％,P＜0.001),but in South gender had no impact on overall survival (58.5％ vs.60.1％,P =0.927) or cancer-specific survival (62.0％ vs.65.8％,P =0.345).Conclusions This study demonstrated that in Chinese patients with UTUC,those from North were featured for lower tumor stage and grade,higher proportion of females and females had better survival.High age,high tumor stage and grade,large tumor diameter,and the presence of lymph node metastasis or lymphovascular invasion were risk factors for poor prognosis in Chinese UTUC patients.
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Objective To evaluate the clinical performance of chemiluminescent immunoassay (CLIA) on anti-nuclear antibody(ANA) specific autoantibodies testing.Methods A multi-center clinical study A total of 811 Sera samples were collected from 6 collaborating hospitals during the period of April to July 2016, and tested with CLIA and line immunoassay (LIA) in parallel for autoantibodies to ribonucleoprotein(RNP), smith antigen(Sm), SSA/Ro60,SSB/La, centromere protein B(CENPB), double-stranded DNA(dsDNA), nucleosome(Nuc), and ribosome P protein(Rib-P).The positive rate,specificity and qualitative coincidence rate for each antibody between CLIA and LIA methods were analyzed.All discrepant samples for systemic lupus erythematosus (SLE) highly specific autoantibodies (including anti-Sm, dsDNA, Nuc and Rib-P) were retested by enzyme linked immunosorbent assay (ELISA) and further analyzed with SLE disease cohort using McNemar test.Results The positive rate and specificity of CLIA and LIA for antibodies to ANA specific antigens were comparable.Excellent qualitative coincidence were found between CLIA and LIA for the detection of anti-RNP, SSA/Ro60, SSB/La and CENPB (Kappa>0.75), while the coincidence rate foranti-Sm, dsDNA, Nuc and Rib-P detection were moderate (0.4
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The Korean Neonatal Network (KNN), a nationwide prospective registry of very-low-birth-weight (VLBW, < 1,500 g at birth) infants, was launched in April 2013. Data management (DM) and site-visit monitoring (SVM) were crucial in ensuring the quality of the data collected from 55 participating hospitals across the country on 116 clinical variables. We describe the processes and results of DM and SVM performed during the establishment stage of the registry. The DM procedure included automated proof checks, electronic data validation, query creation, query resolution, and revalidation of the corrected data. SVM included SVM team organization, identification of unregistered cases, source document verification, and post-visit report production. By March 31, 2015, 4,063 VLBW infants were registered and 1,693 queries were produced. Of these, 1,629 queries were resolved and 64 queries remain unresolved. By November 28, 2014, 52 participating hospitals were visited, with 136 site-visits completed since April 2013. Each participating hospital was visited biannually. DM and SVM were performed to ensure the quality of the data collected for the KNN registry. Our experience with DM and SVM can be applied for similar multi-center registries with large numbers of participating centers.
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Humans , Infant, Newborn , Data Collection , Hospitals , Infant, Very Low Birth Weight , Registries , Republic of Korea , Societies, Medical/organization & administration , Support Vector MachineABSTRACT
Objective To compare effect of trichosanthin and methotrexate in the treatment of uterine scar pregnancy by a multi-center study. Methods 90 uterine scar pregnancy patients were selected from department of obstetrics and gynecology,in xinyang central hospital,the second affiliated hospital of zhengzhou university,zhumadian central hospital,using random number table divided into 2 groups.The control group of 45 cases were treated by methotrexate,gluteal muscle injection,50 mg one time,and took mifepristone 50 mg,two times a day,a week for a course of treatment;45 cases in the experimental group,were treated with trichosanthin,intramuscular injection of 1.2 mg/time,two times a day,and oral administration of bloven,0.6 g/d,a week for a course of treatment.The end of a course of treatment,2 groups of patients before and after treatment were compared of the serum progesterone level,β-HCG,side reactions after treatment.Results After treatment,progesterone levels were significantly reduced,and the experimental group levels were lower than the control group obviously,the difference has statistical significance(P<0.05).Serum -HCG level after the treatment significantly reduced,and the experimental group in serum -HCG levels were significantly lower,with statistical difference (P <0.05 ). Comparison of adverse reaction of the patients,the experimental group was obviously lower than control group,with statistically significant difference (P<0.05).Conclusion For the treatment of uterine scar pregnancy,trichosanthin and methotrexate have certain effect,but trichosanthin could lower serum progesterone,β-HCG levels more significantly than methotrexate,trichosanthin group side reaction rate is low.
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Objective To analyze the current situation of domestic multi-center study of medicine research in order to improve the scientific research level.Method Using the bibliometrics method to analyze the number of coauthors,research institutions, research states distribution,foundation paper numbers and large sample papers of 200 multicenter original research papers published in 10 domestic and foreign journals in 2010.Results There were 112 domestic original research papers,the number of average coauthor was 6.1± 1.1; 15.2％ of them were more than 3research institutions; 2.7％ of them were cooperative study of more than 2 countries.49 papers (43.8％)were supported by fund; 10.7％ of which were more than 3 foundations; large sample papers account for 24.1 ％.In 88 foreign original research papers,the number of average coauthors is 9.8± 2.7; 86.4％ of them are under more than 3 research institutions; 44.3％ of them are cooperative study of more than 2 countries.Fund papers account for 69.3 ％ ; large sample papers account for 50％.There were significant difference in the number of coauthors,research institutions,number of countries,large sample papers and the number of ≥3 foundation papers between both domestic and international paper(P ＜ 0.05).The number of domestic and foreign funded papers had no significant difference (P ＞0.05).ConclusionThere are some differences between domestic and foreign medical cooperative research. We should strengthen the international and domestic cooperative research in order to improve the scientific research level and reduce the waste of resources.
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Objective To compare the antibody response between preterm and full-term infants after primary immunization of hepatitis B vaccine (HepB).Methods Infants who were aged 7-12 months and had completed primary immunization with 5 μg HepB made by recombinant dexyribonucleic acid techniques in saccharomyces cerevisiae (HepB-SC) or 10 μg HepB made by recombinant dexyribonucleic acid techniques in Hansenula polymorpha (HepB-HP) on 0-1-6 schedule were investigated in four provinces (municipality) including Beijing,Shandong,Jiangsu and Guangxi of China.Among them,all preterm infants were selected to form the preterm group and the 1:1 matching full-term infants with the same month-age,gender and residence were randomly selected to form the full-term group.Their HepB history was determined by immunization certificate and all of their parents were interviewed with standard questionnaire to get their birth information.Blood samples were obtained from all anticipants and were tested for Anti-HBs by chemiluminescence microparticle immuno-assay (CMIA).Results Total anticipants were 648 pairs of infants.The rates of non-response,low-response,normal-response and high-response after the primary immunization were 1.39％,8.64％,45.83％ and 44.14％ in the preterm group,respectively.The corresponding rates were 1.08％,9.26％,44.91％ and 44.75％ in the full-term group.The above four rates did not show significant differences between the two groups (P＞0.05).The geometric mean concentrations (GMC) of anti-HBs in the pre-term and full-term group were 755.14 and 799.47 mIU/ml respectively.There was no significantly difference in the GMCs between the two groups (P＞0.05).Results from multivariable conditional logistic analysis showed that preterm was not an influencing factor to the antibody response after HepB primary immunization among newborns even after debugging the other influencing factors.Conclusion The autibody response after HepB primary immunization were similar among the preterm and full-term infants.The preterm newborns could be immunized under the same HepB immunization strategy.
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PURPOSE: The aim of this study was to evaluate the variations of brain volumetry between the different MR scanners or the different institutes. MATERIALS AND METHODS: Ten normal subjects were scanned at four different MR scanners, two of them were the same models, to measure inter-MR scanner variations using intraclass correlation coefficient (ICC), coefficient of variation (CV) and percent volume difference (PVD) and to calculate minimal thresholds to detect the significant volumetric changes in gray matter and subcortical regions. RESULTS: Averaged statistical reliability (ICC = 0.837) and volumetric variation (CV = 4.310%) in all segmented regions were observed on overall MR scanners. Comparing the segmented volumes with PVD between two MR scanners, volumetric differences on same models were the lowest (PVD = 3.611%) and volume thresholds were calculated with 7.168%. PVD results and thresholds values on systemically different MR scanners were evaluated with 5.785% and 11.340% respectively. CONCLUSION: Authors conclude that the reliability of brain volumetry is not so high. Calibration studies of MRI system and image processing are essential to reduce the volumetric variability. Additionally, frameworks comprised of database and algorithms with high-speed image processing are also required for the efficient image data management.
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Brain , CalibrationABSTRACT
STUDY DESIGN: Multi-center study, questionnaire survey. OBJECTIVES: To offer a database of spinal cord injury (SCI) by reviewing statistics and literatures of other countries, investigating the overall mechanism, injury patterns and treatment of SCI. SUMMARY OF LITERATURE REVIEW: There are no preexisting domestic studies (collectively conducted by multi-centers) of the prevalence and treatment of SCI. MATERIALS AND METHODS: From September 2006 to August 2009, 47 cases of SCI in 6 universities were investigated retrospectively. 17 questionnaire contents including the courses of injury-to-treatment were studied with data gathered from surveys. RESULTS: The average age of patients was 48.4-years-old, male to female ratio was 33 to 14. The cases of falling from a height were 22 cases (47%), lumbar area 19 cases (40%), and unstable bursting fracture 24 cases (51%) the most. Complete and incomplete paralyses were 19 cases (40%) and 28 cases (60%), respectively. High dose steroids were injected in 16 cases (NASCIS II) and 9 cases (NASCIS III). 14 cases presented complications and operations were performed 46 cases (98%). 12 cases (26%) arrived at the hospital within 4 hours of injury, 11 cases (23%) in 8 hours. On the way to the hospital, proper emergency treatment was performed in 25 cases (53%), and 30 cases (64%) had a clear understanding of SCI after the final diagnosis. CONCLUSIONS: This is the first study that offers a comprehensive database of spinal cord injury (SCI), by investigating the overall mechanism, injury patterns, and treatment of SCI; this study is expected to be used in the future as an important reference material for spinal cord injury statistics and a standard for care.
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Female , Humans , Male , Cauda Equina , Emergency Treatment , Paralysis , Prevalence , Surveys and Questionnaires , Retrospective Studies , Spinal Cord , Spinal Cord Injuries , SteroidsABSTRACT
OBJECTIVE: We report here on analyzing 3,128 subjects with stroke and who were discharged from the Departments of Rehabilitation Medicine of secondary or tertiary hospitals, and all the hospitals subscribed to the Online Database System developed by the Korean Society of Neurorehabilitation. METHOD: This is a retrospective analysis of the brain rehabilitation registry database for outcome of stroke outcome in the year 2006 to 2008. RESULTS: The male stroke subjects and cerebral infarction were 58.4% and 66.3%, respectively. Cerebral infarction in the middle cerebral artery territory was the most common, and the basal ganglia and cerebral cortex were the common areas for the cases of intracranial hemorrhage. The mean age of the patients was 61.7 years, and the most common ages were 45~64 years for all the stroke subjects. The subjects with cerebral hemorrhage (56.1 years) were younger than those with cerebral infarction (63.9 years). Seasonal variation was observed in the occurrence of stroke; spring (34.1%), winter (27.4%), summer (21.6%) and autumn (16.8%) in this order. There was no significant difference of the changes on the Korean version of the modified Barthel index between the patients with cerebral infarction and cerebral hemorrhage after rehabilitation. On analyzing the two groups of stroke subjects admitted before and after 100 days from stroke onset, the changes on the Korean version of the modified Barthel index and the Brunnstrom stage scores of the early admission group were higher that those of the late rehabilitation group. CONCLUSION: The above findings suggest that 1) the incidence, lesion sites and seasonality of stroke in this database system are similar to those of the worldwide data, 2) the length of hospital stay for the subjects with stroke is about 46 days and 3) early rehabilitation is more effective in improving the outcome of stroke subjects.
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BACKGROUND/AIMS: Phase IIb clinical study of Stillen(TM), a novel cytoprotectant, for gastritis showed 180 mg of Stillen, t.i.d. for 2 weeks results in a significant increase of cure rate when compared with a placebo group. It is reported that antioxidative effect and strengthening the endogenous cytoprotective molecules of the gastric mucosa play a pivotal role for cytoprotective action of Stillen(TM). The aim of this phase III multicenter, double-blind comparative study was to assess the efficacy of Stillen(TM) for the treatment of erosive gastritis. METHODS: Five hundred and twelve patients with erosive gastritis were enrolled and divided into three groups. Each group received 180 mg or 360 mg of Stillen(TM) or 600 mg of cetraxate (Neuer(TM)) t.i.d. for 2 weeks, respectively and a follow-up endoscopic examination for evaluation. RESULTS: Patients treated with 180 mg and 360 mg of Stillen(TM) had a significantly improved endoscopic cure rate of gastritis (55.6% and 57.5%, respectively) compared with patients treated with 600 mg of cetraxate (35.5%, p<0.001). Endoscopic improvement rate was also significantly higher in 180 mg group (67.3%) and 360 mg group (65.0%) of Stillen(TM) treated patients than cetraxate treated group (46.4%, p<0.001). During the study, both Stillen(TM) and cetraxate were well tolerated. CONCLUSIONS: These results clearly demonstrate that Stillen(TM) is an efficacious, safe, and well-tolerated treatment for gastritis.
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Humans , Follow-Up Studies , Gastric Mucosa , GastritisABSTRACT
OBJECTIVE: Our purpose was to establish a birth defects monitoring system in Korea by multi-center study. This novel study was initiated in 1999, and extended to detect the frequencies and trends of birth defects in Korea. METHODS: Six centers participated in this study. The actively ascertained surveillance data was collected from May 1999 to November 2001. RESULTS: Of the 65,653 births included in this study, 1,143 (1.7%) had birth defects. About one third of them were terminated. While disease of the genitourinary tract was more frequent in isolated defects, cardiovascular disease was more frequent in combined defects (19.7% and 21.7%, respectively). Chromosomal anomalies were detected 23.5 per 10,000 births. And it showed increasing tendency for 3 years. CONCLUSION: We could establish multi-center monitoring system for birth defects successfully. But, many of the problems arising in the collection of accurate, valid, and comparable epidemiological data about birth defects have not yet been overcome. It appears that the development of joint projects at national level is essential for upgrading the quality and usefulness of this study.
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Cardiovascular Diseases , Congenital Abnormalities , Joints , Korea , ParturitionABSTRACT
BACKGROUND: Comprehensive geriatric assessment is identified as a dynamic process responsive to the changes on health status that occurs over time in the context of extremely increasing trend in the numbers of the elderly people, their office visit, and the medical cost universally. We completed the comprehensive geriatric assessment and applied it to the Korean elderly through the multi-center trials. METHODS: We performed studies variables using questionnaires, with interviewing, physical examination to the number of total 312 elderly people who visited the department of family medicine or physical medicine and rehabilitation of the 11 university hospital or general hospital in Korea from July 1, 1999 through October 31, 1999. We, the geriatrician, met and discussed 3 times to complete the comprehensive geriatric assessment through the consensus panel. RESULTS: We found the sex ratio of 312 subjects was 1 to 2 (104 males and 208 females) and the average age was 73.2 years old. The orders of more frequency of self-reported health status of the respondents were hypertension, arthritis, cataract, gastrointestinal disturbance, diabetes mellitus, urinary/fecal incontinence, depression, cerebrovascular accident, anemia, and heart disease. Nearly 15% of those showed depression, 41.6% of those were in the status of socially isolation. We found 43.1% of those showed hypertension, 3.7% isolated systolic hypertension, and 20.2% orthostatic hypotension. Of those, cognitive impairment were measured in 37.1%, gait disturbance 13.0%, and the risk of malnutrition 39.6%. Geriatrician spent 21.1 minutes per person during the process of comprehensive geriatric assessment. CONCLUSION: We realized we could diagnose and intervene effectively certain hidden conditions/diseases, particularly urinary incontinence, falls, visual impairment, hearing impairment, pain, depression, social isolation, cognitive impairment, and orthostatic hypotension, with using the comprehensive geriatric assessment. These results reflected the fact that the comprehensive geriatric assessment might be necessary for the care of the elderly.
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Aged , Humans , Male , Anemia , Arthritis , Cataract , Consensus , Surveys and Questionnaires , Depression , Diabetes Mellitus , Gait , Geriatric Assessment , Hearing Loss , Heart Diseases , Hospitals, General , Hypertension , Hypotension, Orthostatic , Korea , Malnutrition , Office Visits , Physical and Rehabilitation Medicine , Physical Examination , Sex Ratio , Social Isolation , Stroke , Urinary Incontinence , Vision DisordersABSTRACT
Objective: The aim of the study was to assess the safety/tolerability and the efficacy of sildenafil citrate (Viagra TM) in Filipino patients diagnosed with erectile dysfunction (ED) of different etiologies and severityMethodology: This is an open-label, multi-center study, with the primary objective of obtaining adverse reactions that may occur with the use of sildenafil citrate (Viagra TM) 25 mg, 50 mg or 100 mg once daily on as per needed basis, in the out-patient clinic setting across the Philippines. As a secondary endpoint, the study evaluates the efficacy of sildenafil citrate (Viagra TM) in the everyday clinical practice of Filipino physicians, using the Patient Global Efficacy Assessment Questions. Safety and toleration were assessed on the follow-up visit using unsolicited and non-leading questioning. All observed and reported events were recorded regardless of a suspected causal relationship to the study drugResults: Within a three year period, a total 3,955 study participants were enrolled in the study. Majority (57.4 percent) of the patients were suffering from organic or mixed type (a combination of both psychogenic and organic) of erectile dysfunction while 39.5 percent were of psychogenic origin. Among the adverse events reported by the patients, headache (4.5 percent), vasodilatation (2.4 percent) and dizziness (1.7 percent), showed the highest proportions. Majority (75.1 percent) reported that these were mild in nature. There were no reported serious adverse events nor were there reported deaths with the use of sildenafil citrate (Viagra TM) during the study. Majority (78.9 percent) reported improvement in their erection after taking the treatment. A fifth (19.8 percent) of the respondents failed to provide information on this item. However, almost all of the patients were either satisfied or very satisfied with the treatment representing 91.6 percent of the patientsConclusion: Sildenafil citrate (Viagra TM) is a safe and effective medication for the treatment of erectile dysfunction of various etiologies in the Filipino population. Almost all of the patients taking sildenafil citrate (Viagra) were satisfied with the treatment. The results of this study reinforce the proven safety and efficacy profile of sildenafil citrate (Viagra) among Filipino patients with erectile dysfunction. (Author)