• Pediatric Infection and Vaccine
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• v.13 no.2
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• pp.163-173
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• 2006

Purpose : To reduce the number of injections necessary to vaccinate young infants, various combined vaccines have been developed. The $Comvax^{TM}$ manufactured by Merck & Co. is a combination of Hepatitis B and PRP-OMP conjugate Haemophilus influenzae Type b vaccine. The purpose of this study is to evaluate the immunogenicity and safety of $Comvax^{TM}$ in Korean infants. Methods : The infants who were vaccinated at 0 months of age with Hepatitis B vaccine, were recruited for this study after parental informed consent was obtained. The subjects were vaccinated with $Comvax^{TM}$ at 2 and 4 months of age. At each visit, infants were also immunized with DTaP, inactivated poliovirus vaccine, and pneumococcal vaccine when indicated. The serum anti-PRP and anti-HBs were measured at 2 months after the 1st dose(4 months age), and the 2nd dose(6 months age) by the ELISA and chemiluminescent microparticle immunoassay method, respectively. The local and systemic adverse reactions of vaccination were monitored for 3 consecutive days after each immunization. Results : Among sixty-five healthy infants(35 male infants) enrolled in this study; fifty eight(32 male infants) completed the scheduled immunizations. The geometric mean titers (GMTs) of anti-PRP at 2 months after the 1st dose and the 2nd dose were 1.96 ${\mu}g/mL$ (95% CI; 1.38~2.78) and 10.02 ${\mu}g/mL$ (95% CI; 7.04~14.26), respectively. Anti-PRP ${\geq}1.0$ ${\mu}g/mL$, was obtained in 63.2%(95% CI; 53.75~72.65) after 1 dose, and 96.6%(95% CI; 93.05~100) after 2 doses. The GMTs of anti-HBs were 38.32 mIU/mL(95% CI; 22.42~65.51), and 101.17 mIU/mL(95% CI; 65.94~155.25) at 2 month after the 1st dose and 2nd dose of $Comvax^{TM}$, respectively. Anti-HBs ${\geq}10$ mIU/mL was observed in 73.7%(95% CI; 65.07~82.33) after 1 dose and 94.8%(95% CI; 90.45~99.15) after 2 doses. Most of the adverse reactions after vaccination were mild. Irritability, the most common systemic reaction, was observed in 24.8%, followed by drowsiness(19.2%), poor feeding(19.2%) and fever(7.2%). Among the local reactions tenderness was observed in 25.6%, redness(${\geq}5$ mm) in 19.2% and swelling(${\geq}5$ mm) in 4.8%. Conclusion : The $Comvax^{TM}$ vaccine was highly immunogenic for PRP and safe in Korean infants. Although the hepatitis B vaccine component was administered at 0, 2, 4 months, this study showed good immunogenicity against HBsAg.

• The Korean Journal of Nuclear Medicine Technology
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• v.23 no.1
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• pp.35-39
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• 2019

Purpose Hepatitis B virus (hepatitis B virus, HBV) infection is a worldwide major public health problem and it is known as a major cause of chronic hepatitis, liver cirrhosis and liver cancer. And serologic tests of hepatitis B virus is essential for diagnosing and treating these diseases. In addition, with the development of molecular diagnostics, the detection of HBV DNA in serum diagnoses HBV infection and is recognized as an important indicator for the antiviral agent treatment response assessment. We performed HBeAg assay using Immunoradiometric assay (IRMA) and Chemiluminescent Microparticle Immunoassay (CMIA) in hepatitis B patients treated with antiviral agents. The detection rate of HBV DNA in serum was measured and compared by RT-PCR (Real Time - Polymerase Chain Reaction) method Materials and Methods HBeAg serum examination and HBV DNA quantification test were conducted on 270 hepatitis B patients undergoing anti-virus treatment after diagnosis of hepatitis B virus infection. Two serologic tests (IRMA, CMIA) with different detection principles were applied for the HBeAg serum test. Serum HBV DNA was quantitatively measured by real-time polymerase chain reaction (RT-PCR) using the Abbott m2000 System. Results The detection rate of HBeAg was 24.1% (65/270) for IRMA and 82.2% (222/270) for CMIA. Detection rate of serum HBV DNA by real-time RT-PCR is 29.3% (79/270). The measured amount of serum HBV DNA concentration is $4.8{\times}10^7{\pm}1.9{\times}10^8IU/mL$($mean{\pm}SD$). The minimum value is 16IU/mL, the maximum value is $1.0{\times}10^9IU/mL$, and the reference value for quantitative detection limit is 15IU/mL. The detection rates and concentrations of HBV DNA by group according to the results of HBeAg serological (IRMA, CMIA)tests were as follows. 1) Group I (IRMA negative, CMIA positive, N = 169), HBV DNA detection rate of 17.7% (30/169), $6.8{\times}10^5{\pm}1.9{\times}10^6IU/mL$ 2) Group II (IRMA positive, CMIA positive, N = 53), HBV DNA detection rate 62.3% (33/53), $1.1{\times}10^8{\pm}2.8{\times}10^8IU/mL$ 3) Group III (IRMA negative, CMIA negative, N = 36), HBV DNA detection rate 36.1% (13/36), $3.0{\times}10^5{\pm}1.1{\times}10^6IU/mL$ 4) Group IV(IRMA positive, CMIA negative, N = 12), HBV DNA detection rate 25% (3/12), $1.3{\times}10^3{\pm}1.1{\times}10^3IU/mL$ Conclusion HBeAg detection rate according to the serological test showed a large difference. This difference is considered for a number of reasons such as characteristics of the Ab used for assay kit and epitope, HBV of genotype. Detection rate and the concentration of the group-specific HBV DNA classified serologic results confirmed the high detection rate and the concentration in Group II (IRMA-positive, CMIA positive, N = 53).

• Asian Pacific Journal of Cancer Prevention
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• v.13 no.12
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• pp.6391-6395
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• 2012

Background: Ovarian cancer is ranked as the fifth most common cause of cancer death in women. In Malaysia, it is the fourth most common cancer in females. CA125 has been the tumor marker of choice in ovarian cancer but its diagnostic specificity in early stages is only 50%. Hence, there is a critical need to identify an alternative tumor marker that is capable of detecting detect ovarian cancer at an early stage. HE4 is a new tumor marker proposed for the early diagnosis of ovarian cancer and disease recurrence. Currently, none of the normal ranges of HE4 quoted in the literature are based on data for a multiethnic Asian population. Therefore, the aim of this study was to determine reference intervals for HE4 in an Asian population presenting in University Malaya Medical Centre, a tertiary reference hospital. Materials and Methods: 300 healthy women were recruited comprising 150 premenopausal and 150 postmenopausal women, aged from 20-76 years. All women were subjected to a pelvic ultrasonograph and were confirmed to be free from ovarian pathology on recruitment. Serum HE4 levels were determined by chemiluminescent microparticle immunoassay (CMIA, Abbott Architect). The reference intervals were determined following CLSI guidelines (C28-A2) using a non-parametric method. Results: The upper limits of the $95^{th}$ percentile reference interval (90%CI) for all the women collectively were 64.6 pmol/L, and 58.4 pmol/L for premenopausal) and 69.0 pmol/L for postmenopausal. The concentration of HE4 was noted to increase with age especially in women who were more than 50 years old. We also noted that our proposed reference limit was lower compared to the level given by manufacturer Abbott Architect HE4 kit insert (58.4 vs 70 pmol/L for premenopausal group and 69.0 vs 140 pmol/L in the postmenopausal group). The study also showed a significant difference in HE4 concentrations between ethnic groups (Malays and Indians). The levels of HE4 in Indians appeared higher than in Malays (p<0.05), while no significant differences were noted between the Malays and Chinese ethnic groups. Conclusions: More data are needed to establish a reference interval that will better represent the multiethnic Malaysian population. Probably a larger sampling size of equal representation of the Malay, Chinese, Indians as well as the other native ethnic communities will give us a greater confidence on whether genetics plays a role in reference interval determination.

• Tuberculosis and Respiratory Diseases
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• v.80 no.4
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• pp.385-391
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• 2017

Background: Men with chronic obstructive pulmonary disease, have reduced endogenous testosterone levels, but the relationship between pulmonary function and endogenous testosterone levels, is inconsistent. Testicular volume is a known indicator of endogenous testosterone levels, male fertility, and male potency. In the present study, the authors investigated the relationship, between testicular volume and lung function. Methods: One hundred and eighty-one South Korean men age 40-70, hospitalized for urological surgery, were retrospectively enrolled, irrespective of the presence of respiratory disease. Study subjects underwent pulmonary function testing, prior to procedures, and testicular volumes were measured by orchidometry. Testosterone levels of patients in blood samples collected between $7{\small{AM}}$ and $11{\small{AM}}$, were measured by a direct chemiluminescent immunoassay. Results: The 181 study subjects were divided into two groups, by testicular volume (${\geq}35mL$ vs. <35 mL), the larger testes group, had better lung functions (forced vital capacity [FVC]: $3.87{\pm}0.65L$ vs. $3.66{\pm}0.65L$, p=0.037; forced expiratory volume in 1 second [$FEV_1$]: $2.92{\pm}0.57L$ vs. $2.65{\pm}0.61L$, p=0.002; FVC % predicted: $98.2{\pm}15.2%$ vs. $93.8{\pm}13.1%$, p=0.040; $FEV_1$ % predicted: $105.4{\pm}19.5%$ vs. $95.9{\pm}21.2%$, p=0.002). In addition, the proportion of patients with a $FEV_1/FVC$ of <70%, was lower in the larger testes group. Univariate analysis conducted using linear regression models, revealed that testicular volume was correlated with FVC (r=0.162, p=0.029), $FEV_1$ (r=0.218, p=0.003), $FEV_1/FVC$ (r=0.149, p=0.046), and $FEV_1$ % predicted (r=0.178, p=0.017), and multivariate analysis using linear regression models, revealed that testicular volume was a significant predictive factor for $FEV_1$ % predicted (${\beta}=0.159$, p=0.041). Conclusion: Larger testicular volume was independently associated, with favorable indices of lung function. These results suggest that androgens, may contribute to better lung function.

• The Korean Journal of Blood Transfusion
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• v.29 no.3
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• pp.301-309
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• 2018

Background: If donors who were deferred due to the reactivity or grey zone in HBV surface antigen (HBsAg) assay want to donate blood again, they need to pass reentry tests. On the other hand, approximately half of the donors who are subject to the reentry tests cannot be reentered. This study examined the association between the sample to cutoff (S/Co) value of the HBsAg assay and the final results of the reentry test. Methods: This study analyzed the S/Co values of the HBsAg assay and the final results of the reentry tests for the 3,947 donors from January 2008 to December 2017 using the database of Blood Information Management System of the Korean Red Cross. Results: 1,767 donors (44.8%) were not reentered among 3,947 deferred donors. Among 1,585 donors showing ${\geq}10$ of the S/Co value in the HBsAg screening test, 1,542 donors (97.3%) were not reentered. The additional reentry tests were performed on 120 donors who were not reentered in the first reentry test; 98 donors (81.7%) were still not reentered. Overall, 4.6% of the donors showing a grey zone in the HBsAg assay were not reentered. Conclusion: The reentry test needs to be restricted for the deferred donors showing a more than 10 S/Co value. The application of the grey zone of current HBsAg assay will need to be continued to enhance the HBV-related blood safety.

• Korean Journal of Psychosomatic Medicine
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• v.27 no.1
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• pp.60-68
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• 2019

Objectives : The association between thyroid-related hormones and cognitive function has been controversial. The purpose of this study is to compare the levels of thyroid-related hormones in patients with Alzheimer's disease (AD) and mild cognitive impairment (MCI). Furthermore, we investigated the relationship between thyroid-related hormones and cognitive function. Methods : From January 2011 to December 2018, we retrospectively reviewed 105 patients who were diagnosed with AD and MCI by visiting a dementia clinic at Ilsan Paik Hospital. Thyroid-related hormones [triiodothyronine (T3), thyroxine (T4), and thyroid stimulating hormone (TSH)] was measured using chemiluminescent immunoassay. An independent sample t-test was performed to analyze the mean value of thyroid-related hormones in patients of AD and MCI. To investigate whether thyroid-related hormones correlate significantly with Global deterioration scale (GDS), Clinical dementia rating (CDR) and scores of each The Korean version of the consortium to establish a registry for Alzheimer's disease items, we conducted a partial correlation analysis with geriatric depression scale-Korean version (GDS-K) scores as covariates. Results : There was no significant difference in the mean serum T3, T4 and TSH levels between patients of the AD and the MCI, but the Construction Praxis Test (CPT) showed a significant positive correlation with the serum TSH concentration (p-value=0.004). Conclusions : In our study, the positive correlation between serum TSH level and the CPT associated with executive function was found to be helpful in understanding the association between thyroid-related hormones and the pathophysiology of dementia. Prospective studies in regard of the pathophysiology of thyroid-related hormones on cognitive function will be necessary in the future.