• Title/Summary/Keyword: experimental population

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The Safety and Immunogenicity of a Trivalent, Live, Attenuated MMR Vaccine, PriorixTM (MMR(Measles-Mumps-Rubella) 약독화 생백신인 프리오릭스주를 접종한 후 안전성과 유효성의 평가에 관한 연구)

  • Ahn, Seung-In;Chung, Min-Kook;Yoo, Jung-Suk;Chung, Hye-Jeon;Hur, Jae-Kyun;Shin, Young-Kyu;Chang, Jin-Keun;Cha, Sung-Ho
    • Clinical and Experimental Pediatrics
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    • v.48 no.9
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    • pp.960-968
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    • 2005
  • Purpose : This multi-center, open-label, clinical study was designed to evaluate the safety and immunogenicity of a trivalent, live, attenuated measles-mumps-rubella(MMR) vaccine, $Priorix^{TM}$ in Korean children. Methods : From July 2002 to February 2003, a total of 252 children, aged 12-15 months or 4-6 years, received $Priorix^{TM}$ at four centers : Han-il General Hospital, Kyunghee University Hospital, St. Paul's Hospital at the Catholic Medical College in Seoul, and Korea University Hospital in Ansan, Korea. Only subjects who fully met protocol requirements were included in the final analysis. The occurrence of local and systemic adverse events after vaccination was evaluated from diary cards and physical examination for 42 days after vaccination. Serum antibody levels were measured prior to and 42 days post-vaccination using IgG ELISA assays at GlaxoSmithKline Biologicals (GSK) in Belgium. Results : Of the 252 enrolled subjects, a total of 199 were included in the safety analysis, including 103 from the 12-15 month age group and 96 from the 4-6 year age group. The occurrence of local reactions related to the study drug was 10.1 percent, and the occurrence of systemic reactions was 6.5 percent. There were no episodes of aseptic meningitis or febrile convulsions, nor any other serious adverse reaction. In immunogenicity analysis, the seroconversion rate of previously seronegative subjects was 99 percent for measles, 93 percent for mumps and 100 percent for rubella. Both age groups showed similar seroconversion rates. The geometric mean titers achieved, 42 days pos-tvaccination, were : For measles, in the age group 12-15 months, 3,838.6 mIU/mL [3,304.47, 4,458.91]; in the age group 4-6 years, 1,886.2 mIU/mL [825.83, 4,308.26]. For mumps, in the age group 12-15 months, 956.3 U/mL [821.81, 1,112.71]; in the age group 4-6 years, 2,473.8 U/mL [1,518.94, 4,028.92]. For rubella, in the age group 12-15 months, 94.5 IU/mL [79.56, 112.28]; in the age group 4-6 years, 168.9 IU/mL [108.96, 261.90]. Conclusion : When Korean children in the age groups of 12-15 months or 4-6 years were vaccinated with GlaxoSmithKline Biologicals' live attenuated MMR vaccine ($Priorix^{TM}$), adverse events were limited to those generally expected with any live vaccine. $Priorix^{TM}$ demonstrated excellent immunogenicity in this population.

Recognition and Attitude to Implement at ion of Service Area Assigned System of Public Health Programs among the Health Officer (공공보건사업의 지역담당제 실시에 관한 보건기관 근무 공무원의 인식과 태도)

  • Kim, Mi-Soon;Lee, Moo-Sik;Kim, Nam-Song
    • Journal of agricultural medicine and community health
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    • v.26 no.2
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    • pp.15-41
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    • 2001
  • Since medical clients and the community they live in are expected to be center of future public health and medical care system, new service programs must be developed with patients focused on in line with widening public access of information and social participation. Patients- focused service shall mean the area- oriented provision of public health service. In this study, health officers working at public health centers, public health sub- centers and medical offices in Jeonbuk- do area were taken for population in order to investigate their attitudes toward and knowledge about the service area assigning system under the public health programs. Findings from the survey to 260 health officers, divided by general category, are as follows : Government officers at public health organizations appeared to have high grade of understanding to the service area assigning system and also great appreciation for the necessity of it. Regarding the timing for the system to be introduced, they support the gradual implementation and, as for the type of service to be provided, they preferred home nursing and treatment of chronic diseases. Highly positive responses were centered on the health classes under the health promotion projects, and as far as health projects for the old are concerned, services for home nursing, for the disabled and for home- alone people are favored most. On the other hand, budgeting, manpower and reorganization are rated as prerequisite to establishment of the service area assigning system. From the viewpoint of system side, the improvement of working conditions is rendered as most urgent, while the information system for establishing the service area assigning system is conceived far from satisfactory. Proper assignment of specialists was noted as mostly important to establish the delivery system for medical service through the service area assigning system by team. As merits of the service area assigning system, it is pointed out that, through the system, health clients can better be managed and the nursing quality will be improved thank to the enhanced specialization. It is also perceived that the district health service is not well prepared to respond to the increased and diversified needs of community people and, furthermore, service programs of health centers have not been fully developed. The most serious problem standing in the way to expansion of health projects is, it is noted, uniformity (formality) of the project. Based on the results of the survey which suggest time has ripen to introduce the service area assigning system, following strategies are proposed to anchor down the system as soon as possible: First, we should introduce the system gradually, starting from the area selected, and in consideration of area specialities, refraining from the hitherto stereotyped way of providing health service. Second, we should seek to properly assign the specialists and improve the working conditions of the assigned officers by securing sufficient budget, since it is a most urgent step to lay foundation for the service area assigning system. Third, best service program should be developed to meet the satisfaction of community people by responding to their needs and solidifying the management of medical clients. Fourth, wide scope of study should further be conducted in order to help this system take roots in the central living of community residents since pilot project on the experimental base attended by specialists only can not win popularity among the masses.

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Multicenter clinical study of childhood periodic syndromes that are common precursors to migraine using new criteria of the International Classification of Headache Disorders (ICHD-II) (편두통의 전 단계인 소아기주기성증후군의 다기관 임상 연구: 국제두통질환분류 제2판 제1차 수정판 적용)

  • Park, Jae Yong;Nam, Sang-Ook;Eun, So-Hee;You, Su Jeong;Kang, Hoon-Chul;Eun, Baik-Lin;Chung, Hee Jung
    • Clinical and Experimental Pediatrics
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    • v.52 no.5
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    • pp.557-566
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    • 2009
  • Purpose : To evaluate the clinical features and characteristics of childhood periodic syndromes (CPS) in Korea using the new criteria of the International Classification of Headache Disorders (ICHD)-II. Methods : The study was conducted at pediatric neurology clinics of five urban tertiary-care medical centers in Korea from January 2006 to December 2007. Patients (44 consecutive children and adolescents) were divided into three groups (cyclic vomiting syndrome [CVS], abdominal migraine [AM], and benign paroxysmal vertigo of childhood [BPVC]) by recurrent paroxysmal episodes of vomiting, abdominal pain, dizziness, and/or vertigo using the ICHD-II criteria and their characteristics were compared. Results : Totally, 16 boys (36.4%) and 28 girls (63.6%) were examined (aged 4-18 yr), with 20 CVS (45.5%), 8 AM (18.2%), and 16 BPVC (36.4%) patients. The mean age at symptom onset was $6.3{\pm}3.6$ yr, $8.5{\pm}2.7$ yr, and $8.5{\pm}2.9$ yr in the CVS, AM, and BPVC groups, respectively, showing that symptoms appeared earliest in the CVS group. The mean age at diagnosis was $8.0{\pm}3.4$ yr, $10.5{\pm}2.6$ yr, and $10.1{\pm}3.2$ yr the CVS, AM, and BPVC groups, respectively. Of the 44 patients, 17 (38.6%) had a history of recurrent headaches and 11 (25.0%) showed typical symptoms of migraine headache, with 5 CVS (25.0%), 2 AM (25.0%), and 4 BPVC (25.0%) patients. Family history of migraine was found in 9 patients (20.4%): 4 in the CVS group (20.0%), 2 in the AM group (25.0%), and 3 in the BPVC group (18.8%). Conclusion : The significant time lag between the age at symptom onset and final diagnosis possibly indicates poor knowledge of CPS among pediatric practitioners, especially in Korea. A high index of suspicion may be the first step toward caring for these patients. Furthermore, a population-based longitudinal study is necessary to determine the incidence and natural course of these syndromes.

Effects of Hysteroscopic Septotomy on Pregnancy in Patients with History of Infertility or Recurrent Spontaneous Abortion (불임 또는 습관성 유산 환자에서 중격자궁의 치료가 임신에 미치는 영향)

  • Koo, Hwa-Seon;Cha, Sun-Hwa;Yang, Kwang-Moon;Bae, Ju-Youn;Ahn, Hyun-Suk;Han, Ae-Ra;Park, Chan-Woo;Kang, Inn-Soo;Koong, Mi-Kyoung;Lee, Kyung-Sang
    • Clinical and Experimental Reproductive Medicine
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    • v.37 no.4
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    • pp.361-368
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    • 2010
  • Objective: The aim of this study was to evaluate the influences of uterine septum and their elimination on the reproductive outcomes in women who have history of recurrent spontaneous abortion (RSA) and/or infertility. Methods: The medical records of reproductive outcomes in patients who have had history of RSA and infertility who were diagnosed with uterine septum only by hysterosalpingogram (HSG) between January 2008 and December 2009 were retrospectively analyzed. The subjects who have had severe male factor, tubal factors, other uterine factors, endocrine abnormalities, peritoneal factors, and abnormal karyotyping among both partners were excluded. In 27 patients, confirmation of diagnosis by laparoscopy and elimination of uterine septum by trans-vaginal hysteroscopy was done. Seventeen patients were strongly suspected to uterine septum on HSG but tried to get pregnancy without any other procedure for evaluation and management of uterine anomaly. Age matched 42 patients who have history of RSA and/or infertility and diagnosed to normal HSG finding at same period were randomly selected as control. The medical records of reproductive outcomes were analyzed and compared between groups. Results: The mean time of observation after diagnosis was 21.8 months (10 to 32). 55.6% (15/27) of patients in patients who received trans-vaginal hysteroscopic uterine septotomy were success to get pregnancies and was significantly higher than that of 17 patients who did not receive proper management (23.5%, 4/17, p<0.05). In control population, 40.5% (17/42) were success to pregnancies and the differences were not statistically significant compared to both two study groups. The live birth rate which was excluded pregnancy loss by abnormal fetal karyotyping and congenital anomaly were 75% (9/12) in treated septated uterus group and 84.6% (11/13) in control group each which have no statistically significant different. In patients with septated uterus who did not receive proper management showed lower delivery rate (50%, 2/4) than that of other groups but was not statistically significant. Conclusion: According to present data, women with a uterine septum have an increased chance of successful pregnancy with improved obstetric outcome after proper management of the uterine cavity. And these results were showed in patients with no regard to their reproductive history. But, in case of failed to receive proper management, uterine septum can affect not only pregnancy ongoing but successful pregnancy too.

Expression of Decidual Natural Killer (NK) Cells in Women of Recurrent Abortion with Increased Peripheral NK Cells (말초혈액자연살해세포가 증가된 반복유산 환자의 탈락막자연살해세포의 발현)

  • Yeon, Myeong-Jin;Yang, Kwang-Moon;Park, Chan-Woo;Song, In-Ok;Kang, Inn-Soo;Hong, Sung-Ran;Cho, Dong-Hee;Cho, Yong-Kyoon
    • Clinical and Experimental Reproductive Medicine
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    • v.35 no.2
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    • pp.119-129
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    • 2008
  • Objective: The purpose of this study was to quantify decidual $CD56^+$ and $CD16^+$ NK cell subtype population and to evaluate the correlation between decidual NK cell expression and peripheral $CD56^+$ NK cell expression in women with a history of recurrent abortion and increased peripheral NK cells. Methods: Twenty-nine women with recurrent abortion and elevated peripheral $CD56^+$ NK cell percentage who had chromosomally normal conceptus were included in this study. Thirty-two women with recurrent abortion who had chromosomally abnormal conceptus were used as controls. Distribution of $CD56^+$ and $CD16^+$ NK cells in decidual tissues including implantation sites was examined by immunohistochemical staining. The degree of immunohistochemical staining was interpreted by score and percentage. Results: There was a significant difference in decidual $CD56^+$ NK cell score ($43.6{\pm}24.5$ vs. $23.9{\pm}16.3$ P =0.001) and $CD56^+$ NK cell percentage ($42.1{\pm}11.7$ vs. $33.9{\pm}15.8$ P =0.027) between increased peripheral NK cell group and control group. However, there was no statistically significant difference in decidual $CD16^+$ NK cell score ($18.7{\pm}9.5$ vs. $13.2{\pm}39.4$ P =0.108) and $CD16^+$ NK cell percentage ($24.7{\pm}5.9$ vs. $23.4{\pm}11.7$ P =0.599). There was no significant correlation between decidual NK cell score and peripheral NK cell percentage in increase peripheral NK cell group (peripheral $CD56^+$ NK cell percentage vs. decidual $CD56^+$ NK cell score, r=-0.016, P =0.932, peripheral $CD16^+$ NK cell percentage vs. decidual $CD16^+$ NK cell score, r=0.008, P =0.968). Conclusion: This study shows that $CD56^+$ decidual NK cells are increased in decidua of women exhibiting a history of recurrent abortion with increased $CD56^+$ peripheral NK cell. There was no significant correlation between decidual and peripheral NK cell increment in increase peripheral NK cell group. This study suggests the possibility that decidual NK cells may play an important role in the immune mechanism of recurrent abortion.

Studies on the Environmental Factors Affecting the Cocoon Crops in Summer and Autumn in Korea (한국의 하추잠작 안정을 위한 환경요인에 관한 연구)

  • 이상풍
    • Journal of Sericultural and Entomological Science
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    • v.16 no.2
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    • pp.1-34
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    • 1974
  • These experiments pertain to various factors influencing the quantitative characters of cocoon crops in summer and early autumn seasons. Initially, in order to establish the possible ways of the silkworm rearing more than three times a year in Korea, the author attempted to get further information about the various factors affecting the cocoon crop in every silkworm rearing season. The trials were conducted eleven times a year at four places for three years. The field trial was conducted with 19 typical sericultural farmers who had been surveyed. At the same time the author statistically analyzed the various factors in close relation to tile cocoon crop in autumn season. The effect of guidance on 40 sericultural farmers was analyzed, comparing higher level farmers with lower level farmers ; and the author surveyed 758 non-guided farmers near the guided farmers during both spring and autumn seasons. In addition, another trial on the seasonal change of leaf quality was attempted with artificial diets prepared with leaves grown in each season. It was found that related factors to cocoon crops in summer and early autumn seasons appeared to be leaf quality, and temperature for young and grown larvae. A 2$^4$ factorial experiment was designed in summer season, and another design with one more level of varied temperature or hard leaf added to a 24 factorial experiment was conducted in early autumn. The experimental results can be summarized: 1. Study on the cocoon crops in the different rearing seasons 1) It was shown that earlier brushing of silkworm generally produced the most abundant cocoon crop in spring season, and earlier or later than the conventional brushing season, especially earlier brushing was unfavorable for the abundant cocoon crop in autumn season. 2) The cocoon crop was affected by the rearing season, and decreases in order of sire with spring, autumn, late autumn, summer and early autumn seasons. 3) It was Proved that ordinary rearing and branch rearing were possibles 4 times a year ; in the 1st, 3rd, 8th, and 10th brushing season. But the 11th brushing season was more favorable for the most abundant cocoon crop of branch rearing, instead of the 10th brushing season with ordinary rearing. 2. Study on the main factors affecting the cocoon crop in autumn season 1) Accumulated pathogens were a lethal factor leading to a bad cocoon crop through neglect of disinfection of rearing room and instruments. 2) Additional factors leading to a poor cocoon crop were unfavorable for rearing temperature and humidity, dense population, poor choice of moderately ripened leaf, and poor feeding techniques. However, it seemed that there was no relationship between the cocoon crop and management of farm. 3) The percentage of cocoon shell seemed to be mostly affected by leaf quality, and secondarily affected by the accumulation of pathogens. 3. Study on the effect of guidance on rearing techniques 1) The guided farms produced an average yearly yield of 29.0kg of cocoons, which varied from 32.3kg to 25.817g of cocoon yield per box in spring versus autumn, respectively. Those figures indicated an annual average increase of 26% of cocoon yield over yields of non-guided farmers. An increase of 20% of cocoon yield in spring and 35% of cocoon yield in autumn were responsible. 2) On guided farms 77.1 and 83.7% of total cocoon yields in the spring and autumn seasons, respectively, exceeded 3rd grade. This amounted to increases of 14.1 and 11.3% in cocoon yield and quality over those of non-guided farms. 3) The average annual cocoon yield on guided farms was 28.9kg per box, based on a range of 31.2kg to 26.9kg per box in spring and autumn seasons, respectively. This represented an 8% increase in cocoon yield on farms one year after guidance, as opposed to non-guided farms. This yield increase was due to 3 and 16% cocoon yield increases in spring and autumn crops. 4) Guidance had no effect on higher level farms, but was responsible for 19% of the increases in production on lower level farms. 4. Study on the seasonal change of leaf quality 1) In tests with grown larvae, leaves of tile spring crop incorporated in artificial diets produced the best cocoon crop; followed by leaves of the late autumn, summer, autumn, and early autumn crops. 2) The cocoon crop for young larvae as well as for grown larvae varied with the season of leaf used. 5. Study on factors affecting the cocoon crops in summer and early autumn A. Early autumn season 1) Survival rate and cocoon yield were significantly decreased at high rearing temperatures for young larvae 2) Survival rate, cocoon yield, and cocoon quality were adversely affected by high rearing temperatures for grown larvae. Therefore increases of cocoon quantity and improvement of cocoon quality are dependent on maintaining optimum temperatures. 3) Decreases in individual cocoon weight and longer larval periods resulted with feeding of soft leaf and hard leaf to young larvae, but the survival rate, cocoon yield and weight of cocoon shell were not influenced. 4) Cocoon yield and cocoon quality were influenced by feeding of hard leaf to grown larvae, but survival rate was not influenced by the feeding of soft leaf and hard leaf. 5) When grown larvae were inevitably raised at varied temperatures, application of varied temperature in the raising of both young and grown larvae was desirable. Further research concerning this matter must be considered. B. Summer season 1) Cocoon yield and single cocoon weight were decreased at high temperatures for young larvae and survival rate was also affected. 2) Cocoon yield, survival rate. and cocoon quality were considerably decreased at high rearing temperatures for grown larval stages.

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