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No abstract available.
ABSTRACT
Recommended infant vaccination in Korea includes DTaP-IPV and Hib vaccines administered as separate injections. In this randomized, open, controlled study we assessed the non-inferiority of immunogenicity of DTaP-IPV//Hib pentavalent combination vaccine (Pentaxim™) compared with licensed DTaP-IPV and Hib (PRP~T) vaccines. We enrolled 418 healthy Korean infants to receive either separate DTaP-IPV and Hib vaccines (n = 206) or the pentavalent DTaP-IPV//Hib (n = 208) vaccine at 2, 4, 6 months of age. Antibodies to all components were measured before the first vaccination and one month after the third, and safety was assessed after each vaccination including recording of reactions by parents. We confirmed the non-inferiority of DTaP-IPV//Hib compared with DTaP-IPV and Hib vaccines; 100% of both groups achieved seroprotection against D, T, IPV and PRP~T, and 97.5%-99.0% demonstrated seroresponses to pertussis antigens. Antibody levels were similar in both groups, except for those to the Hib component, PRP~T. In separate and combined groups geometric mean concentrations of anti-PRP~T antibodies were 23.9 and 11.0 µg/mL, respectively, but 98.3% and 97.4% had titers ≥ 1 µg/mL, indicative of long-term protection. All vaccines were well tolerated, with no vaccine-related serious adverse event. Both groups had similar safety profiles, but the combined vaccine group had fewer injection site reactions. The immunological non-inferiority and similar safety profile of DTaP-IPV//Hib vaccine to separate DTaP-IPV and Hib vaccines, with the advantage of fewer injections and injection site reactions, supports the licensure and incorporation of DTaP-IPV//Hib into the Korean national vaccination schedule (Clinical trial registry, NCT01214889).
Subject(s)
Humans , Infant , Antibodies , Appointments and Schedules , Haemophilus influenzae type b , Korea , Licensure , Parents , Vaccination , Vaccines , Whooping CoughABSTRACT
PURPOSE: This study (NCT00751348) evaluated the immunogenicity and safety of a combined measles-mumps-rubella-varicella (MMRV) vaccine compared to co-administration of measles-mumps-rubella and varicella (MMR+V) vaccines in Korean children during their second year of life. MATERIALS AND METHODS: Healthy children aged 11-24 months received one dose of MMRV or MMR+V. Antibody titers against measles, mumps and rubella were measured using enzyme-linked immunosorbent assay and against varicella using an immunofluorescence assay. Parents/guardians recorded adverse events in diary cards for up to 43 days post-vaccination. The primary objective was to demonstrate non-inferiority of MMRV to MMR+V for all antigens in terms of seroconversion rates (SCRs), defined as a group difference with a lower limit of the 95% confidence interval (CI)>-10%. RESULTS: Of 474 subjects enrolled, 458 (MMRV, 301; MMR+V, 157) were included in the according-to-protocol cohort. For measles (98.0% vs. 99.4%), rubella (99.7% vs. 100%) and varicella (98.9% vs. 100%) SCRs, the lower limits of the 95% CIs for group differences were greater than -10%; however, for mumps SCRs (88.8% vs. 94.2%), it was -10.40%. The primary objective of non-inferiority in mumps SCRs was therefore not met, although the observed group difference in a post-hoc analysis of anti-mumps antibodies using a plaque reduction neutralization assay was 0.39% with a 95% CI lower limit of -4.03%. Adverse events occurred at comparable frequencies for both groups, except for more frequent fever in MMRV recipients. CONCLUSION: Based on the pre-specified non-inferiority criterion, SCRs of the MMRV vaccine were non-inferior to that elicited by MMR+V vaccines for all antigens except mumps.
Subject(s)
Child , Humans , Antibodies , Chickenpox , Cohort Studies , Enzyme-Linked Immunosorbent Assay , Fever , Fluorescent Antibody Technique , Korea , Measles , Mumps , Rubella , VaccinesABSTRACT
Intestinal tuberculosis (TB) is presented with nonspecific and variable clinical manifestations such as abdominal pain, diarrhea, fever and weight loss. Diagnosis of tuberculous enteritis may be missed or confused with many other chronic gastrointestinal disorders such as the Crohn disease and intestinal neoplasms. The diagnosis should be based on careful clinical evaluations, such as extra-intestinal signs and colonoscopic and histologic findings. Newer techniques such as PCR tests from the specimens through colonoscopic biopsy may be helpful to confirm diagnosis of tuberculous enteritis. The treatment regimens for pulmonary tuberculosis are generally effective for tuberculous enteritis as well. If not treated early, the prognosis of intestinal tuberculosis is poor. We report a case of tuberculous enteritis diagnosed by colonoscopic biopsy and TB PCR which was presented with diarrhea, abdominal pain, intermittent fever and weight loss in a 12-year-old girl with active pulmonary tuberculosis. The patient was treated successfully with antituberculosis agents for 11 months without any complications.
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Child , Female , Humans , Abdominal Pain , Biopsy , Crohn Disease , Diagnosis , Diarrhea , Enteritis , Fever , Intestinal Neoplasms , Polymerase Chain Reaction , Prognosis , Tuberculosis , Tuberculosis, Pulmonary , Weight LossABSTRACT
This study aimed to identify the risk factors associated with acute hepatitis A virus (HAV) infection in the Korean population. Participants were recruited from five referral hospitals across the country in 2007 and from 11 hospitals in 2009. Patients with positive anti-HAV IgM antibody tests became the case group, while patients treated for non-contagious diseases at the same hospitals were recruited as controls. A total of 222 and 548 case-control pairs were studied in the 2007 and 2009 surveys, respectively. Data from the surveys were analyzed jointly. In a multivariate analysis, sharing the household with HAV-infected family members (OR, 6.32; 95% CI, 1.4-29.6), contact with other HAV-infected individuals (OR, 4.73; 95% CI, 2.4-9.4), overseas travel in 2007 (OR, 19.93; 95% CI, 2.3-174.4), consumption of raw shellfish (OR, 2.51; 95% CI, 1.8-3.5), drinking bottled water (OR, 1.64; 95% CI, 1.3-8.4), and occupation that involve handling food (OR, 3.30; 95% CI, 1.3-8.4) increased the risk of HAV infection. Avoiding contact with HAV-infected individuals and avoiding raw foods eating could help minimize the risk of hepatitis A infection. Immunization must be beneficial to individuals who handle food ingredients occupationally or travel overseas to HAV-endemic areas.
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Adolescent , Adult , Child , Child, Preschool , Female , Humans , Infant , Infant, Newborn , Male , Middle Aged , Young Adult , Acute Disease , Case-Control Studies , Food Handling , Hepatitis A/diagnosis , Hepatitis A Antibodies/blood , Immunoglobulin M/blood , Interviews as Topic , Multivariate Analysis , Odds Ratio , Referral and Consultation , Risk Factors , Seafood , Travel , VaccinationABSTRACT
PURPOSE: This study aimed to study the antibody response of Japanese encephalitis vaccination in children using different kinds of vaccines (inactivated vaccine, live attenuated vaccine or interchanged) and evaluate the effectiveness of the vaccines to provide the basis of efficient immunization schedule of Japanese encephalitis. METHODS: Measurement of the neutralization antibody (NTAb) titers following Japanese encephalitis vaccination using different vaccines for 170 children, 2-6 year of age, who visited six university hospitals and are confirmed by immunization records. RESULTS: Among 170 children who were given primary immunization on Japanese encephalitis, 103 children were given inactivated vaccine, 64 children were given live attenuated vaccine and 3 children were given interchangeably. NTAb titers were more than 1:10 in all children of three groups. The geographic mean antibody titer was 322 in inactivated vaccine group and 266 in live attenuated vaccine group. However, there was no significant difference between two groups. In both groups, the NTAb titer showed the peak at 1-4 months after the third immunization and declined. The NTAb titers of three children who were given two kinds of vaccines alternately were 1:135, 1:632, and 1:2511, respectively. CONCLUSION: According to the results of this study in children younger than 6 years old, there is no significant difference in effectiveness between inactivated and live attenuated vaccines. However, further studies for the changes of antibody titers for a longer period of time on larger population are required.
Subject(s)
Child , Humans , Antibodies, Neutralizing , Antibody Formation , Asian People , Cohort Studies , Encephalitis, Japanese , Hospitals, University , Immunization , Immunization Schedule , Prospective Studies , Vaccination , Vaccines , Vaccines, AttenuatedABSTRACT
PURPOSE: This study was conducted to evaluate the difference of clinical characteristics of pneumonia in children caused by Mycoplasma pneumoniae, according to their chest radiographic patterns. METHODS: We analyzed medical records of 921 children who were admitted to Soonchunhyang University Buchon Hospital due to M. pneumoniae pneumonia from January 2008 to December 2011. Enrolled children were divided into 2 groups by radiological patterns: lobar/lobular pneumonia group (group 1) and broncho/interstitial pneumonia group (group 2). RESULTS: The number of patients in group 1 was 295 (32%) and in group 2, 626 (68%). Lobar/lobular pneumonia occurred in older children compared to broncho/interstitial pneumonia (mean age, 6.4 years vs. 4.2 years; P=0.00). Group 1 had significantly longer durations of fever and hospitalization than group 2. The frequency of pleural effusion was significantly higher in group 1. Erythrocyte sedimentation rate and C-reactive protein values were higher in group 1. Coinfections with respiratory viruses were more frequent in group 2. The history of allergic diseases were more common in group 2 (P=0.006). In 2011, lobar/lobular pneumonia was more frequent and the duration of fever was longer compared with 2008-2010. CONCLUSION: In M. pneumoniae pneumonia, patients with lobar/lobular pneumonia were more older and had more severe clinical features and laboratory findings. Because there was an outbreak with severe clinical course in 2011, we wonder that the outbreak was related to the macrolide resistant M. pneumoniae. Careful attention about clinical course and consequences of patients with lobar/lobular pneumonia is required.
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Child , Humans , Blood Sedimentation , C-Reactive Protein , Coinfection , Fever , Hospitalization , Medical Records , Mycoplasma pneumoniae , Mycoplasma , Pleural Effusion , Pneumonia , Pneumonia, Mycoplasma , Radiography, ThoracicABSTRACT
This study represents the first epidemiological study based on the national registry of primary immunodeficiencies (PID) in Korea. Patient data were collected from 23 major hospitals. A total of 152 patients with PID (under 19 yr of age), who were observed from 2001 to 2005, have been entered in this registry. The period prevalence of PID in Korea in 2005 is 11.25 per million children. The following frequencies were found: antibody deficiencies, 53.3% (n = 81), phagocytic disorders, 28.9% (n = 44); combined immunodeficiencies, 13.2% (n = 20); and T cell deficiencies, 4.6% (n = 7). Congenital agammaglobulinemia (n = 21) and selective IgA deficiency (n = 21) were the most frequently reported antibody deficiency. Other reported deficiencies were common variable immunodeficiencies (n = 16), X-linked agammaglobulinemia (n = 15), IgG subclass deficiency (n = 4). Phagocytic disorder was mostly chronic granulomatous disease. A small number of patients with Wiskott-Aldrich syndrome, hyper-IgE syndrome, and severe combined immunodeficiency were also registered. Overall, the most common first manifestation was pneumonia. This study provides data that permit a more accurate estimation PID patients in Korea.
Subject(s)
Adolescent , Child , Child, Preschool , Female , Humans , Infant , Infant, Newborn , Male , Young Adult , Agammaglobulinemia/congenital , Age Distribution , Common Variable Immunodeficiency/epidemiology , Genetic Diseases, X-Linked/epidemiology , IgA Deficiency/epidemiology , IgG Deficiency/epidemiology , Immunologic Deficiency Syndromes/epidemiology , Job Syndrome/epidemiology , Prevalence , Surveys and Questionnaires , Registries , Republic of Korea/epidemiology , Severe Combined Immunodeficiency/epidemiology , Sex Distribution , Wiskott-Aldrich Syndrome/epidemiologyABSTRACT
PURPOSE: The development of postnatal pneumothorax and its common causes and clinical aspects were studied to promote early diagnosis and proper management. METHODS: A retrospective study of neonates who were hospitalized in the neonatal intensive care unit at Soonchunhyang University Bucheon Hospital from 2001 to 2010 was performed. Term neonates were divided into a spontaneous pneumothorax group and a secondary pneumothorax group. The secondary group was divided into term and preterm groups. RESULTS: Of 4,414 inpatients, 57 (1.3%) were diagnosed with pneumothorax. Of term newborn patients, 28 (80%) had a secondary pneumothorax, and seven (20%) had a spontaneous pneumothorax. No differences were observed for gender, birth weight, resuscitation, or duration of admission between the spontaneous and control groups. The duration of treatment with a thoracostomy (20 patients, 57%) was longer in the spontaneous group (5.4+/-2.9 days vs. 2.7+/-2.0 days) than that in the control group. Patients with respiratory distress syndrome (RDS) developed a pneumothorax 22.8 hours after surfactant treatment, whereas patients with transient tachypnea of the newborn (TTN), pneumonia, and meconium aspiration syndrome (MAS) developed pneumothorax after 16.6 hours. Of 50 patients with a secondary pneumothorax, 19 (38%) had RDS, 11 (22%) had MAS, 7 (14%) had TTN, and six (12%) had pneumonia. Among term newborns, 42.9% were treated only with 100% oxygen. Among preterm newborns, 72.6% and 27.3% needed a thoracostomy or ventilator care, respectively. CONCLUSION: A pneumothorax is likely to develop when pulmonary disease occurs in neonates. Therefore, it is important to carefully identify pneumothorax and provide appropriate treatment.
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Humans , Infant, Newborn , Birth Weight , Early Diagnosis , Inpatients , Intensive Care, Neonatal , Lung Diseases , Meconium Aspiration Syndrome , Oxygen , Pneumonia , Pneumothorax , Resuscitation , Retrospective Studies , Thoracostomy , Transient Tachypnea of the Newborn , Ventilators, MechanicalABSTRACT
Neonatal lupus erythematosus (NLE) is an acquired autoimmune disorder caused by the transplacental passage of maternal autoantibodies, usually anti-Ro/SSA or anti-La/SSB antibodies, and less commonly U1-ribonucleoprotein. NLE usually involves a single organ, but multiple organ involvement has also been reported. Manifestations of NLE may include cutaneous lesions, congenital heart block, hematological diseases (anemia, thrombocytopenia, neutropenia), hepatic diseases (hepatitis, hepatosplenomegaly, cholestasis), and neurological diseases. Neurological involvement is very rare in infants with NLE. Here, we report a 2-day-old female neonate, born to a clinically asymptomatic mother, presenting with cutaneous lupus lesions and brain infarction as a neurological disease.
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Female , Humans , Infant , Infant, Newborn , Antibodies , Autoantibodies , Brain , Brain Infarction , Heart Block , Hematologic Diseases , Lupus Erythematosus, Systemic , Mothers , ThrombocytopeniaABSTRACT
The purpose of this study was to identify the major etiological agents responsible for invasive bacterial infections in immunocompetent Korean children. We retrospectively surveyed invasive bacterial infections in immunocompetent children caused by eight major pediatric bacteria, namely Streptococcus pneumoniae, Haemophilus influenzae, Neisseria meningitidis, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pyogenes, Listeria monocytogenes, and Salmonella species that were diagnosed at 18 university hospitals from 1996 to 2005. A total of 768 cases were identified. S. agalactiae (48.1%) and S. aureus (37.2%) were the most common pathogens in infants younger than 3 months. S. agalactiae was a common cause of meningitis (73.0%), bacteremia without localization (34.0%), and arthritis (50%) in this age group. S. pneumoniae (45.3%) and H. influenzae (20.4%) were common in children aged 3 months to 5 yr. S. pneumoniae was a common cause of meningitis (41.6%), bacteremia without localization (40.0%), and bacteremic pneumonia (74.1%) in this age group. S. aureus (50.6%), Salmonella species (16.9%), and S. pneumoniae (16.3%) were common in older children. A significant decline in H. influenzae infections over the last 10 yr was noted. S. agalactiae, S. pneumoniae, and S. aureus are important pathogens responsible for invasive bacterial infections in Korean children.
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Adolescent , Child , Child, Preschool , Humans , Infant , Bacteria/pathogenicity , Bacterial Infections/etiology , Republic of Korea , Retrospective StudiesABSTRACT
Bacterial meningitis remains a serious cause of morbidity and mortality in childhood, despite the availability of effective vaccines against Haemophilus influenzae type b (Hib) or Streptococcus pneumoniae. The purpose of this study was to analyze data on bacterial meningitis cases in Korea from 1996 through 2005. The information of all hospitalized bacteria-proven meningitis cases was obtained from 17 university hospitals nationwide. A total of 402 cases were identified. Of these, 125 (29.9%) cases were neonates. Streptococcus agalactiae was the most common bacteria responsible for 99 (24.6%) of all cases regardless of age, followed by S. pneumoniae for 91 (22.6%) and H. influenzae for 67 (16.7%) patients. The common etiology beyond the neonatal period was S. pneumoniae for 91 (33.0%) followed by H. influenzae for 63 (22.8%) patients. The overall case fatality rate was 9.4%, which was similar with that in 1986-1995. In conclusion, S. agalactiae, S. pneumoniae and H. influenzae were important etiologic agents of bacterial meningitis in children in the last 10 yrs. It is required to establish the preventive strategy of the three bacteria. The nationwide epidemiologic study should be continued to evaluate immunization strategy and efficacy.
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PURPOSE: To compare immunogenicity and reactogenicity of a combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine (DTPa-IPV, Infanrix(TM) IPV, GlaxoSmithKline Biologicals) with co-administration of commercially available DTPa and IPV vaccines at separate injection sites (DTPa+IPV). METHODS: A total of 458 infants aged 8-12 weeks were randomized to receive three-dose primary vaccination at 2, 4 and 6 months with DTPa-IPV or DTPa+IPV. Blood samples were collected pre and post vaccination for measurement of immune responses. Reactogenicity was assessed following each dose using diary cards. RESULTS: One month post-dose 3, seroprotection rates for anti-diphtheria, anti-tetanus and anti-poliovirus types 1, 2 and 3 were > or =99.5% and vaccine response rates to pertussis antigens were at least 98.6% in both DTPa-IPV and DTPa + IPV groups. Non-inferiority between the groups was demonstrated based on pre-defined statistical criteria. Incidences of both local and systemic symptoms were within the same range across both groups with grade 3 symptoms reported following no more than 4.3% of DTPa-IPV doses and 4.5% of DTPa + IPV doses. Two serious adverse events (both pyrexia) after DTPa-IPV administration were considered vaccine-related. Both infants recovered fully. CONCLUSION: Combined DTPa-IPV vaccine was immunogenic and well tolerated when used as a three-dose primary vaccination course in Korean infants. DTPa-IPV could be incorporated into the Korean vaccination schedule, reducing the number of injections required to complete primary immunization.
Subject(s)
Aged , Humans , Infant , Appointments and Schedules , Immunization , Incidence , Pentetic Acid , Poliovirus , Vaccination , Vaccines , Whooping CoughABSTRACT
OBJECTIVES: This study was performed to investigate the mumps transmission control status and inapparent infection rate among middle and high school students in Daegu City during a mumps outbreak. METHODS: Nine schools (two middle schools and seven high schools), which reported a number of mumps cases between 2007 and 2008 were selected for investigation. During March-May 2008, a standard questionnaire was distributed to gather information about case identification, instructed isolation measure, isolation status of mumps cases and related factors, and outdoor activities of non-isolated mumps case. Inapparent infection rate was estimated by serum mumps IgM and IgG antibodies status and self-reported mumps symptoms in three of the nine schools. RESULTS: Among 2,560 respondents, more than half of students answered that they did not receive instructions in mumps transmission control measures during the outbreak. Among the 327 mumps cases identified by the questionnaire, 131 cases (40.1%) were considered as isolated and the isolation rates were significantly different among schools, grades, and gender. Of the non-isolated cases, 88.3% continued attending school. Inapparent mumps infection rates were between 56.3% and 70.2%. CONCLUSIONS: Mumps transmission control was inadequate to control the mumps outbreak. Although high inapparent infection rate would mitigate the transmission control effect of case isolation, this measure is fundamental for infection control. The reasons of this inadequate status need to be explored to develop an effective intervention strategy.
Subject(s)
Adolescent , Child , Female , Humans , Male , Communicable Disease Control/methods , Disease Outbreaks/statistics & numerical data , Immunoglobulin G/blood , Immunoglobulin M/blood , Mumps/epidemiology , Patient Isolation , Surveys and Questionnaires , Republic of Korea/epidemiology , Schools/statistics & numerical data , StudentsABSTRACT
PURPOSE: Iron-deficiency anemia remains the most common nutritional deficiency in young infants. This study aimed to survey the actual condition of feeding patterns and weaning diet and to study the association between these factors and the prevalence of anemia in infants aged over 9 months. METHODS: We studied 171 infants aged 9-24 months who were hospitalized in the general ward with mild to moderate acute illnesses. The mothers answered a questionnaire about the feeding patterns and the status of the weaning diet of their infants. The infants were divided into three groups: infants who were exclusively breast-fed, those who had been given mixed feeding, and artificial milk feeders. RESULTS: The incidence of anemia was significantly higher in exclusively breast-fed infants (23/68, 33.8%) than in the infants with mixed feeding (11/62, 17.7%) and artificial milk feeders (5/41, 12.1%). The mothers' awareness about the state of their infants' weaning diet was not related to the presence of anemia in the exclusively breast-fed infants. About 70% of the infants had started the weaning diet before age 6 months in all three groups, without any difference according to feeding patterns. CONCLUSION: The incidence of anemia was significantly higher in the breast-fed group than in the other infants. Many mothers of breast-fed infants with anemia also believed that their infants were taking sufficient weaning foods. Therefore, further education of the mothers about iron-rich weaning foods and the importance of iron intake during infancy is needed to prevent anemia, especially in breast-fed infants.
Subject(s)
Aged , Humans , Infant , Anemia , Anemia, Iron-Deficiency , Diet , Feeding Behavior , Incidence , Iron , Malnutrition , Milk , Mothers , Patients' Rooms , Prevalence , Surveys and Questionnaires , WeaningABSTRACT
PURPOSE: The aim of this study was to investigate the epidemiologic status of Kawasaki disease (KD) in infants 6 months of age. RESULTS: A total of 1,739 patients 6 months old with data from 1,739 KD patients < or =6 months old showed significantly higher incidences of CA abnormalities and CA aneurysms in the younger patients.
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Aged , Female , Humans , Infant , Male , Age of Onset , Aneurysm , Coronary Aneurysm , Echocardiography , Epidemiologic Studies , Incidence , Korea , Mucocutaneous Lymph Node Syndrome , Retrospective StudiesABSTRACT
PURPOSE: It has been reported that deep neck abscesses are recently increasing again. We analyzed pediatric cases with deep neck abscesses during the last several years to contribute to the treatment of the disease. METHODS: The clinical data of 30 children under 16 years of age with deep neck abscess from February 2001 to July 2006 were analysed retrospectively. RESULTS: The mean age was 9 years (2-16 years), and the male/female ratio was 19/11. Abscesses in the peritonsillar space were most common (57%), followed by the retropharyngeal (30%) and parapharyngeal (13%) spaces. Upper respiratory infection in 10 cases (33%), dental infection in four case (14%), cervical lymphadenitis in three case (10%) and sinusitis in two case (6%) contributed to the development of deep neck infections. The frequent symptoms were fever in 16 case (53%), sore throat in 15 case (50%), poor oral intake in 10 (33%), odynophagia in eight (27%), and neck pain in eight (27%). Unilateral tonsillar hypertrophy and displacement in 15 case (50%) were most common. Neck mass in 13 patients (43%), neck stiffness in three (10%) and trismus in three (10%) were also found. Bacteria were isolated in 8 among 10 pus cultures; Streptococcus species 7 and Micrococcus luteus 1. All of those bacteria except Micrococcus luteus were sensitive to penicillin G. Surgical intervention was applied to 12 cases (40%), and the remaining 18 patients (60%) were treated with antibiotics only. There were no differences between the two groups in the duration of admission and antibiotic treatment. No complicated cases were observed. CONCLUSIONS: Peritonsillar abscesses were most frequent. Upper respiratory infection was the most common predisposing factor, followed by dental infection and sinusitis. Symptoms of respiratory tract obstruction were not found. The most common pathogens were Streptococcus species. Deep neck abscesses in children, if diagnosed at the early stage, possibly can be treated by antibiotics only, without surgical intervention.
Subject(s)
Child , Humans , Abscess , Anti-Bacterial Agents , Bacteria , Causality , Fever , Hypertrophy , Lymphadenitis , Micrococcus luteus , Neck Pain , Neck , Penicillin G , Peritonsillar Abscess , Pharyngitis , Respiratory System , Retrospective Studies , Sinusitis , Streptococcus , Suppuration , TrismusABSTRACT
PURPOSE: We conducted the study to evaluate the immunogenicity and safety of three component DTaP vaccine (Infanrix(R)) in a group of Korean healthy infants on a three-dose primary vaccination. And we compared the immunogenicity of this DTaP vaccine with two component DTaP vaccine which has been widely used in Korea. METHODS: We enrolled one hundred fifty one healthy infants aged 8-9 weeks. These infants were vaccinated at age 2, 4 and 6 months of age with three component DTaP vaccine. Solicited adverse events were actively monitored for 72 hours following each vaccination, and all adverse events after each vaccination were observed for three weeks. Anti-diphtheria toxoid Ab., anti-tetanus toxoid Ab., anti-pertussis toxin Ab., anti-filamentous hemagglutinin Ab., and anti-pertactin Ab. were measured using ELISA for assessing immunogenicity of study vaccine in 60 infants. Immunogenicity analysis of two component DTaP vaccine was performed with same methods in 14 infants as control. RESULTS: The seroconversion rates of anti-diphtheria toxoid Ab, anti-tetanus toxoid Ab. anti- filamentous hemagglutinin Ab. were 100% in both group. Seroconversion rate of anti-pertactin Ab in study group was 100%, but the rate in control group was 50%. However, geometric mean concentration of anti-pertussis toxin Ab. was higher in control group. Mild local and systemic reactions were observed within three days after vaccination, and no serious adverse events related study vaccine were happened during study period. CONCLUSIONS: Our study results suggest that three component DTaP vaccine (Infanrix(R)) is a well- tolerable and high immunogenic vaccine, especially anti-Pertactin Ab. of the study vaccine is very immunogenic. It can be available as routine DTaP vaccination in our infants.