• Pediatric Infection and Vaccine
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• v.26 no.3
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• pp.148-160
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• 2019

Purpose: This study aimed to investigate the molecular epidemiology of a methicillin-resistant Staphylococcus aureus (MRSA) outbreak at a newborn nursery and neonatal intensive care unit (NICU). Methods: During the outbreak, from August to September 2017, MRSA isolates collected from neonates and medical staff underwent genotyping and screened for virulence factors. Antibiotic susceptibilities were tested. Results: During the study period, 41 neonates were admitted at the nursery (n=27) and NICU (n=14). Of these, 7 had MRSA infections (skin infection [n=6] and sepsis [n=1]) and 4 were colonized with MRSA. Associated medical staff (n=32) were screened; three were nasal MRSA carriers. Staphylococcal chromosomal cassette mec (SCCmec) type II, sequence type (ST) 89, spa type t375 was found to be the skin infection outbreak causing strain, with multi-drug resistance including low-level mupirocin resistance. SCCmec type IVa, ST 72, and a novel spa type designated t17879, was the cause of MRSA sepsis. Many different types of MRSA were colonized on the neonates; however, SCCmec type IVa, ST 72, spa type t664 was colonized in both neonates and a NICU nurse. All MRSA isolates from colonized infants were positive for the Panton-Valentine leukocidin (PVL) toxin gene. Conclusions: The strain causing an outbreak of skin infections had multi-drug resistance. Also, MRSA colonized in the neonates were found to carry the PVL toxin gene. Because different strains are present during an outbreak, molecular epidemiologic studies are important to identify the outbreak strain and colonized strains which aid in effective control and prevention of future MRSA outbreaks.

• The Korean Society of Law and Medicine
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• v.21 no.1
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• pp.223-259
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• 2020

With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

• Pediatric Infection and Vaccine
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• v.8 no.1
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• pp.94-100
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• 2001

Purpose : Enterovirus is a common cause of aseptic meningitis and nonspecific febrile illness in young children. During the summer and fall months, enterovirus-infected young children are frequently admitted and evaluated to rule out bacterial sepsis and/or meningitis. The purpose of this study was to evaluate the relationship between nonpolio enterovirus infection and febrile illness in infants under 3 months of age during the summer, fall months by using a stool culture to identify the presence of enterovirus. Methods : Patients included febrile infants under 3 months of age admitted to Masan Fatima Hospital for sepsis evaluation from May 1999 to September 1999. Cultures were performed from stool and Cerebrospinal fluid samples and then were tested for enterovirus infection. Viral isolation and serotype identification were performed by cell culture and immunofluorescent testing. Enteroviruses not typed by immunofluorescent testing were confirmed by reverse transcription-polymerase chain reaction. Results : A total of 44 febrile infants were enrolled; of those, 20(45%) were positive for enterovirus. Two enterovirus culture-positive infants had concomitant urinary tract infection and one had Kawasaki disease. All infants infected with an enterovirus recovered without complications. Serotype of 20 enteroviruses were isolated from stool, 3 of echovirus type 9, 1 of echovirus type 11, 1 Coxsachievirus type B4, 15 of untyped enteroviruses. One untyped enterovirus was isolated in the CSF. Conclusion : Nonpolio enterovirus infections are associated with nonspecific febrile illnesses in infants under 3 months of age.

• Pediatric Infection and Vaccine
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• v.12 no.1
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• pp.52-60
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• 2005

Purpose : The aim of this study is to know seasonal distribution of group A streptococci obtained from one center using emm genotyping and T serotyping in Masan from 2003 through 2004. Methods : Among children who visited the Changwon Fatima Hospital at Masan, Korea from June 2003 through February 2004, 100 patients who had clinical findings of acute pharyngitis, scarlet fever, and cellulitis were confirmed as GAS by culture, and were enrolled in our study. All obtained GAS were sent to the WHO Collaborative Center for Reference and Research on Streptococci, University of Minnesota, Minneapolis for T serotyping and emm genotyping. We classified these results again according to seasonal and disease's entities. Results : 19 different T serotypes was typed. T4(27.5%), T1(17.6%), T6(13.7%), and T12(13.7%) serotypes were relatively common in summer, while T4(28.3%), T12(15.2%), and T12/B3264(8.7%) were common in winter. T4 and T12 were persistent all year around. Distribution of T serotypes in 89 patients with pharyngotonsillitis were T4(26.7%), T12(14.0%), T1(12.8%), and T6(11.6%) in order of frequency. 15 different emm genotypes was typed. The number of emm 1, emm 6, emm 9, and emm 44 genotypes decreased or disappeared in winter, and the number of emm 3, emm 12, and emm 89 genotypes increased or reappeared in winter. Conclusion : Because T serotyping and emm genotyping are useful tools for evaluating epidemiology and pathogenesis of group A streptococci, we should monitor these strains every year, and should serotype and genotype GAS obtained from the invasive streptococcal infections.

• Pediatric Infection and Vaccine
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• v.12 no.1
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• pp.61-66
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• 2005

Purpose : Since hepatitis A virus almost is transmitted by fecal-to-oral route, individual and public sanitation affects the prevalence and ages of hepatitis A infection. We researched the positivity rate of hepatitis A antibody at Pohang to make the basic data for subclinical infection and vaccination schedule. Methods : From January 2004 to February 2005, a total of 603 patients who were admitted at Hangdong University Sunlin Hospital, Dongguk University Hospital, and Christianity Hospital without any hepatic disease and vaccination of hepatitis A were enrolled. IgG antibody to hepatitis A virus were measured by electrochemiluminescence immunoassay(ECLIA). Results : Among 603 patients, 523 patients were less than 15 year of age and 80 patients were in above 15 years. The prevalence rate was 19.3%(101/523) in pediatric group and 70.0%(56/80) in above 15 years. In detail, the prevalence rate was 73.2%(52/71) in 0~5 months, 14.9%(11/74) in 6~11 month, 8.9%(7/79) in 12~17 month, 7.3%(6/82) in 18~23 month, 5.5%(4/72) in 2~3 years, 12.1%(9/74) in 4~8 years, 16.9%(12/71) in 9~14 years, 52.5%(19/40) in 15~29 years, and 92.5%(37/40) in group aged over 30 years. The prevalence rates in male and female showed no significant differences. Conclusion : The prevalence rate of hepatitis A in the group of 4~8 years and 9~14 years at Pohang was lower comparing with previous reports of other cities in Korea. We can postulate that the sanitation of children living at Pohang is at least not bad than other cities. And for the prevalence rate of hepatitis A is increased after 3 years, we should recommend that the vaccination of hepatitis A may be finished until 3 years.

• Pediatric Infection and Vaccine
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• v.16 no.2
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• pp.162-166
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• 2009

Purpose : Urinary tract infection (UTI) is one of the most common bacterial infectious disease in childhood. Renal scarring is an important complication of UTIs. Known risk factors for renal scarring are younger age, anatomic defects, delayed treatment, and causative pathogens other than Escherichia coli. The aim of this study was to compare the characteristics of clinical and laboratory features of UTI with E. coli to those with non-E. coli in infants. Methods : We reviewed the medical records of 1,120 infants under 12 months of age who had been admitted for UTIs between January 1998 and December 2007. All patients who were diagnosed with UTIs were divided into two groups (E. coli and non-E. coli UTIs). Results : Three hundred twenty-four of 1,120 cases met the inclusion criteria. The number of E. coli and non-E. coli UTIs was 273 (84.3%) and 51 (15.7%), respectively. As compared to the non-E. coli UTI group, the E. coli UTI group was younger (3.59 vs. 4.47 months, P =0.008), a longer duration of pyuria (3.96 vs. 3.06 days, P =0.01), higher peripheral white blood cell counts (13.89 vs. $12.13{\times}10^3/mm^3$, P =0.043), and lower rates of high degree (III-V) vesico-ureteral reflux (P =0.005). Conclusion : UTIs with E. coli might have more severe clinical features and a lower prevalence of high grade vesicoureteral reflux than UTIs with non-E. coli. However, no difference was noted in the clinical response to antibiotic therapy between the two groups.

• Pediatric Infection and Vaccine
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• v.25 no.2
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• pp.61-71
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• 2018

Purpose: Research on the clinical role of Staphylococcus aureus as a pathogen in acute gastroenteritis (AGE) in children has been scarce. This study aimed to clarify the prevalence and clinical correlation of S. aureus detection in children with AGE. Methods: Fecal samples were collected from children with symptoms of AGE who visited a secondary hospital between January 2012 and December 2015. The samples were sent to the Seoul Metropolitan Government Research Institute of Public Health and Environment to test for pathogenic organisms. Clinical patterns were analyzed through medical record review. Results: Among the 663 participants, the bacteria detection rate was 26.2% (n=174), the virus detection rate was 29.7% (n=197), and the non-detection rate was 43.1% (n=286). S. aureus was tested positive from 102 cases and was confirmed as a single pathogen in 53 cases. It was the third most common pathogen. The prevalence by age was highest (45.3%) in 0-2 year-olds. Most cases occurred in summer. Symptoms included diarrhea (71.7%), vomiting (67.9%), fever (49.1%), and abdominal pain (37.7%). Only vomiting showed a significant difference between the S. aureus group and the non-detection group (67.9% vs. 43.0%; P=0.001). Among enterotoxins, the higher incidence of vomiting was associated with classical staphylococcal enterotoxins (SEA, SEB, SEC, SED, and SEE) and SEH (P=0.027). Conclusions: S. aureus was the bacteria commonly isolated from children with AGE. Our study identified cases of staphylococcal AGE in children based on fecal samples and confirmed the characteristic symptoms, affected age groups, seasonal distribution, and correlation with enterotoxins.

• Pediatric Infection and Vaccine
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• v.9 no.1
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• pp.61-66
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• 2002

Purpose : To determine wether varicella can be prevented by administration of oral acyclovir(ACV) during the incubation period of the disease. Methods : Starting 9 days after exposure to the index case in their families, ACV(40 mg/kg/day in four divided doses) was given orally to 20 exposed children for 5 days. Their clinical features was compared with those of 20 control subjects. Antibody titers to VZV were measured in both group 1 week and 4 weeks after finishing the oral ACV administration. Results : The mean age of family members with varicella(51.4 months) were significantly high compared to that of ACV prophylaxis group(28.5 months) and control group(31 months) (P<0.05). Among the 12 children with ACV prophylaxis who completed follow up blood sampling, nine children were diagnosed as VZV infection on the serologic test(75%). Among them six children showed positive VZV IgM on the first blood sample and two children showed serocoversion to positive IgM on the second test after ACV prophylaxis. One child who was negative on both IgM and IgG, showed positive IgG on the second test. The incidence of fever and severity of skin rashes were significantly low in children received oral ACV than in the control group. No or reduced number of maculopapular eruption were observed in the oral ACV group compared to multiple vesicles of the control group. Conclusion : In the present study, we observed that oral ACV prophylaxis to the family contacts is effective in reducing severity of skin lesion. It is likely that oral ACV 9 days after contact prevents or reduces blood dissemination of VZV. Little is known about clinical effect and immunity to the virus in exposed children with no varicella symptom after treatment. We propose the checking up antibody to VZV some period after oral ACV, and considering vaccination to whom with no antibody. But further more studies are needed to practical application of oral ACV for the postexposure prophylaxis of varicella.

• Pediatric Infection and Vaccine
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• v.9 no.1
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• pp.79-84
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• 2002

Purpose : About 41% of obtained group A streptococci in the 1998 was reported as erythromycin-resistant streptococci in Seoul, Korea. The most common T serotype was T12, followed by T4 and T28. We'd like to monitor the serological changes and antibiotic sensitivity test of Streptococcus pyogenes obtained from the patients with pharyngotonsillitis and invasive diseases from 1999 through 2001. Also, it could be proposed to choose the proper antibiotic selection in the area where the rate of erythromycin-resistant streptococci is high. Methods : From Jan. 1999 to Oct. 2001, 208 isolates of group A streptococci were collected from inpatients and outpatients with pharyngotonsillitis, scarlet fever, and invasive infections in Seoul and Southern part of peninsula. All isolates were serotyped by T-agglutination, minimum inhibitory concentrations(MICs) which were determined by agar dilution methods, according to the guidelines of the National Committee for Clinical Laboratory Standards (NCCLS). Results : The most common T serotype was T12(29.8%), followed by T1(23.1%), T4 (14.9%). T1 was prominent serotype compared with previous year. T serotyping, among 25 isolates obtained from the patients with scarlet fever in Southern part of peninsula mostly, was T12, T1, and T4 in order of frequency. All the isolates tested were susceptible to penicillin, cefprozil, vancomycin, ceftriaxone, and chloramphenicol. However, 23 isolates(14.2%) was resistant to erythromycin and 18 isolates(11.1%) was resistant to clarithromycin. Serotype T12 was found to be the most resistant serotype to erythromycin and/or clarithromycin. Conclusion : High rate of erythromycin-resistant streptococci which surveyed in 1998 were reduced to 14.2% in this study. We should have to further evaluate the reason of decreased resistant strains and consider the resistant strains of streptococci in choosing the antibiotics. There was no serological characteristics according to the types of disease entities. Between the serologic distributions in Seoul and the Southern part of peninsula area are same, we could presume that the serological typing of strains obtained over the country may be not different.

• Pediatric Infection and Vaccine
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• v.24 no.2
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• pp.95-101
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• 2017

Purpose: Acute bacterial gastroenteritis (ABG) can cause more severe symptoms than acute viral gastroenteritis in children. This study was aimed at determining the etiologic trends and to examine the clinical characteristics of ABG in children. Methods: We sent stool samples from the children with acute gastroenteritis who were treated at a secondary hospital located in Seoul, Korea between January 2011 and December 2014 to Seoul Metropolitan Government Research Institute of Public Health and Environment to find the causative organisms. Clinical characteristics of patient were analyzed through a medical records review. Results: Out of 664 stool samples, 183 (27.6%) yielded bacterial pathogens. Staphylococcus aureus was the most common bacterial pathogen, found in 72 cases (39.3%), even though it was only tested for since 2012. The monthly isolation rate was the highest (24.6%) in August. The isolation rate of Campylobacter spp. by patient's age group was high (16.7%) in the 12- to 18-year-age group (P=0.04). In patients with bloody stool, Campylobacter spp. was the most commonly isolated (31.0%, P=0.04). When comparing C-reactive protein, the Salmonella spp.- or Campylobacter spp.-isolated group showed higher values than the S. aureus- or pathogenic Escherichia coli-isolated group ($5.7{\pm}0.6mg/dL$ vs. $2.1{\pm}0.3mg/dL$, P<0.01). Conclusions: S. aureus, Salmonella spp., pathogenic E. coli, and Campylobacter spp. were important pathogens of ABG among children. Considering the differences in pathogens found according to age, a clinical symptom and inflammation index might be helpful in assuming the causative organism.