• Title/Summary/Keyword: diary methods

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Efficacy and safety of electrolytes-free polyethylene glycol (PEG) 4000 for disimpaction in children with chronic functional constipation (소아 만성 기능성변비 치료에서 전해질이 함유되지 않은 polyethylene glycol (PEG) 4000의 분변박힘 제거효과 및 안전성)

  • Lee, Jeong Hee;Lee, Ran;Bae, Sun Hwan
    • Clinical and Experimental Pediatrics
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    • v.51 no.4
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    • pp.391-395
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    • 2008
  • Purpose : This study was performed evaluate optimal dose for disimpaction, efficacy and safety of PEG 4000 in children with chronic functional constipation. Methods : Eighty six children with chronic functional constipation were enrolled in this prospective study at Konkuk university hospital March, 2003 through August, 2006. Success in disimpaction with PEG 4000 was defined as meeting at least two out of three criteria; resolution of chief complaint, getting easiness of defecation with respect to frequency of bowel movement and hardness of stool based on defecation diary, and decrease in fecal impaction on simple abdominal X-ray test. Adverse effects of PEG 4000 were monitored clinically and biochemically. Results : Eighty three out of 86 children completed the study, and success rate of disimpaction was 99% (82/83). The mean dose of PEG 4000 for disimpaction was $0.93{\pm}0.28g/kg/day$ (0.4-2.0 g/kg/day, Max.: 30 g/day). Frequency of bowel movement increased ($5.02{\pm}2.71/wk$ vs. $11.25{\pm}5.43/wk$) in most children (79/83). Fecal impaction on simple abdominal X-ray test improved with statistical significance in 25 children (P=0.0007). Because of adverse effect of PEG 4000, 3 children did not complete the study; urticaria, severe diarrhea, diarrhea and abdominal pain. One 6-year-old girl who completed the study complained tingling sensation in the hand and foot without laboratory abnormality (4/86, 4.7%). Laboratory test revealed hyperosmolality without clinical symptom in 1 child, and eosinophilia in 6 children. Conclusion : The average safe and effective dose of PEG 4000 for disimpaction was $0.93{\pm}0.28g/kg/day$ (0.4-2.0 g/kg/day, Max : 30 g/day) in children with chronic functional constipation.

Immunogenicity, Reactogenicity and Safety of a Combined DTPa-IPV Vaccine Compared with Separate DTPa and IPV Vaccines in Healthy Korean Infants (한국의 건강한 영아를 대상으로 DTPa-IPV 혼합백신을 접종한 경우와 DTPa 백신과 IPV 백신을 각각 투여하였을 경우의 면역원성, 반응원성 및 안전성)

  • Kim, Chang Hwi;Cha, Sung Ho;Shin, Son Moon;Kim, Chun Soo;Choi, Young Youn;Hong, Young Jin;Chey, Myoung Jae;Kim, Kwang Nam;Hur, Jae Kyun;Jo, Dae Sun;Kim, Sung Shin;Lee, Sang Lak;Song, Eun Song;Ramakrishnan, Gunasekaran;Ok, Jin Ju;Van Der Meeren, Olivier;Bock, Hans L.;Kim, Jung Soo
    • Pediatric Infection and Vaccine
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    • v.17 no.2
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    • pp.156-168
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    • 2010
  • 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-ose 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 ${\geq}99.5%$ 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.

Safety and Reactogenicity of the Inactivated Poliomyelitis Vaccine (PoliorixTM) in Korea (2006-2012) (우리나라 영아에서 주사용 소아마비 백신(PoliorixTM)의 안전성 및 이상반응에 대한 연구)

  • Sin, Jong Beom;Park, Moon Sung;Ma, Sang Hyuk;Choi, Young Youn;Shin, Son Moon;Kim, Won Duck;Kuriyakose, Sherine;Ulianov, Liliana;Hardt, Karin
    • Pediatric Infection and Vaccine
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    • v.20 no.3
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    • pp.139-146
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    • 2013
  • Objective: As per the requirement of Korean Food and Drug Administration, this post-marketing surveillance was conducted in Korea to evaluate the safety and reactogenicity of Poliorix$^{TM}$ following its introduction in 2006. Methods: In this open, multicenter study, the vaccine was administered as per the current practice of Korean doctors and in reference to the guidebook by the Korean Pediatric Society and as indicated in the Korean label which was as follows - for primary vaccination three doses were given to infants at ages 2, 4 and 6 months whereas, for the booster dose a single dose was given to children aged 4-6 years. Safety data during this six year surveillance was collected using diary cards which were distributed to the parents to record adverse events. Results: A total of 639 subjects were enrolled into the study. Of these, 617 subjects and 22 subjects received the vaccine as a primary and booster dose, respectively. At least one unsolicited symptom was reported in 11.4% (73/639) of the subjects during the 7-day follow-up period; upper respiratory tract infection (2.5%;16/639) was the most frequently reported unsolicited symptom. One subject reported at least one unsolicited symptom (gastroenteritis) of grade 3 intensity within the 31-day post-vaccination period. Approximately 1.7% (11/639) of subjects reported 13 serious adverse events (SAEs). All SAEs were resolved by the end of the study. Conclusion: In Korea, primary and booster vaccination with Poliorix$^{TM}$ was well-tolerated in healthy subjects when administered according to the prescribing information as part of routine clinical practice.

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Clinical Parameters Predicting Responsiveness to Treatment in Enuresis Patients (야뇨증 치료반응 예측에 관계하는 평가지표)

  • Lee, Kang-Gyoon;Lee, Hyun-Jung;Lim, Yun-Ju;Kwon, Duck-Geun;Kim, Eun-Jin;Pai, Ki-Soo
    • Childhood Kidney Diseases
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    • v.11 no.2
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    • pp.272-279
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    • 2007
  • Purpose : We tried to find out the clinical parameters which predict the outcome of treatment in children with enuresis. Methods : Enuresis patients who visited our hospital during 2003-2007 were included. Parameters such as age, gender, height, weight, minimal voided volume, maximal voided volume, maximum functional bladder capacity, frequency of voiding, urine S,G. before and after sleep were measured and an enuresis diary was also recorded. The reduction in wetting frequencies were classified into three groups; none(<50%), partial(50-90%) and complete(90%) response groups. We also compared the 'initial responders' who showed improvement(${\ge}50%$) during the 2 weeks of evaluation and behavioral therapy to the 'initial non-responders'. Results : Parameters mentioned above showed no significant relation to the treatment out-come. The response rate during the 2 weeks of the evaluation period was 32%(49/151) [complete in 1.3% (2/151), partial in 29.6% (47/151)]. Two-months' treatment responses were complete in 14(40%), partial in 19(54.3%) and none in 2(5.9%) responders(n=35), while they were 10(13.5%), 46(62.2%) and 18(24.3%), respectively in the non-responders(n=73) (P<0.05). Conclusion : We suggest that initial 'responsiveness' can be used as a predictor for good treatment outcome in patients with enuresis.

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Functional Magnetic Resonance Imaging of Brain Reactivity to Insomnia-Related vs. General Anxiety-Inducing Stimuli in Insomnia Patients with Subjective-Objective Discrepancy of Sleep (주관적-객관적 수면시간 차이를 보이는 불면증 환자에서 일반적 불안에 비해 불면증 관련 자극으로 인한 뇌활성에 관한 기능적 자기공명영상 연구)

  • Kim, Nambeom;Lee, Jae Jun;Cho, Seo-Eun;Kang, Seung-Gul
    • Sleep Medicine and Psychophysiology
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    • v.27 no.1
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    • pp.24-31
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    • 2020
  • Objectives: Subjective-objective discrepancy of sleep (SODS) is a common symptom and one of the major phenotypes of insomnia. A distorted perception of sleep deficit might be related to abnormal brain reactivity to insomnia-related stimuli. We aimed to investigate differences in brain activation to insomnia-related stimuli vs. general anxiety-inducing stimuli among insomnia patients with SODS, insomnia patients without SODS, and healthy controls (HCs). Methods: All participants were evaluated for subjective sleep status using a sleep diary and questionnaires; occult sleep disorders and objective sleep status were assessed using polysomnography and actigraphy. Task functional magnetic resonance imaging was performed during insomnia-related stimuli (Ins) and general anxiety-inducing stimuli (Gen). Brain reactivity to Ins versus Gen was compared among insomnia with SODS, insomnia without SODS, and HC groups, and a combined insomnia disorder group (ID, insomnia with and without SODS) was also compared with HCs. Results: In the insomnia with SODS group compared to the insomnia without SODS group, the right precuneus and right supplementary motor areas showed significantly increased BOLD signals in response to Ins versus Gen. In the ID group compared to the HC group, the left anterior cingulate cortex showed significantly increased BOLD signals in response to Ins versus Gen. Conclusion: The insomnia with SODS and ID groups showed higher brain activity in response to Ins versus Gen, while this was not observed in the insomnia without SODS and HC groups, respectively. These results suggest that insomnia patients with sleep misperception are more sensitive to sleep-related threats than general anxiety-inducing threats.

Effect of xylobiose-sugar mixture on defecation frequency and symptoms in young women with constipation (자일로바이오스를 함유한 설탕이 젊은 여성의 변비 개선에 미치는 효과)

  • Lee, Jung-Sug;Kim, A-Reum;Nam, Hye-kyoung;Kyung, Myungok;Jo, Sung-Eun;Chang, Moon-Jeong
    • Journal of Nutrition and Health
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    • v.50 no.1
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    • pp.41-52
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    • 2017
  • Purpose: The objective of the study was to investigate the effects of xylobiose-sugar mixture intake on defecation frequency and constipation symptoms in 31 young women with constipation. Methods: Thirty-one subjects were assigned to two groups, and subjects in each group were administered 10 g of a 7% xylobiose-sugar mixture (Experiment 1: XBS, n = 15) or 10 g of a 7% xylobiose-sugar mixture containing coffee mix (Experiment 2: XBS coffee mix, n = 16) twice per day for 6 weeks. During the study, clinical efficacy was assessed by a daily diary record. The subjects recorded their defecation frequency and fecal characteristics. Results: During pretreatment week, mean defecation frequency of XBS subjects was 2.13 times/week, whereas that of XBS coffee mix subjects was 1.56 times/week. The mean defecation frequencies of XBS and XBS coffee mix subjects increased significantly to 3.73 times/week (p < 0.05) and 3.56 times/week by week 6 (p < 0.05), respectively. After treatment with either XBS or XBS coffee mix, patients presented significant improvements in their amounts of stool, feelings of residual stool leftness, and abdominal pain symptoms (p < 0.05). The total constipation scoring system (CSS) for diagnosing constipation symptoms significantly decreased in the XBS group (10.53 score vs 7.22 score) and in the XBS coffee mix group (10.75 score vs 6.51 score) after 6 weeks. Improvement due to intake of 7% xylobiose-containing sugar seemed to last during the experimental period. Conclusion: The addition of approximately 7% xylobiose to commercially available sweeteners has been shown to improve constipation.

Effect of a public health center-based nutrition education program for hypertension in women older than 50 years of age (50세 이상 여성을 대상으로 한 보건소 기반 고혈압 영양교육의 효과 평가)

  • Park, Seoyun;Kwon, Jong-Sook;Kim, Hye-Kyeong
    • Journal of Nutrition and Health
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    • v.51 no.3
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    • pp.228-241
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    • 2018
  • Purpose: The health risk of women increases after menopause. This study evaluated the effectiveness of a public health center-based nutrition education program for hypertension in women older than 50 years of age. Methods: The program included 8-week nutrition education and 8-week follow-up with keeping a health diary and nutrition counseling. The program was evaluated three times: before and after the nutrition education, and after the follow-up. The subjects were classified into hypertensives (n = 44) or normotensives (n = 71). Results: The rate of taking antihypertensive drugs in the hypertensive group was 86.4%. The systolic blood pressure decreased in the hypertensive and normotensive groups after nutrition education (p < 0.05). The body weight (p < 0.001), BMI (p < 0.001), waist circumference (p < 0.001), and percent body fat (p < 0.01) were also decreased after nutrition education in both groups. The hypertensive group showed an increase in HDL-cholesterol level (p < 0.001) and decreases in triglycerides (p < 0.01) and LDL-cholesterol (p < 0.05) levels after completion of the program. The normotensive group also displayed significant changes in HDL-cholesterol (p < 0.001) and triglycerides (p < 0.01). The dietary habits and nutrition knowledge on sodium and hypertension were improved in both groups (p < 0.001). The total score of dietary behavior related to the sodium intake was improved in the normotensive group (p < 0.001). The total score of the high sodium dish frequency questionnaire decreased in both groups after nutrition education and completion of the program compared to that before the program. Decreases in the consumption frequencies of noodles, pot stews and stews, Kimchi, and beverages were significant. The total self-efficacy score was increased in both groups by the program (p < 0.001). In particular, the hypertensive group showed improvement in all items. Conclusion: This public health center-based nutrition education program may contribute to the prevention and management of hypertension and chronic diseases in women over 50 years of age.

Validation of the physical activity classification table for Korean youth and assessment of total energy expenditure, estimated energy requirement and physical activity in Korean children and adolescents (한국 소아청소년을 위한 신체활동분류표의 타당도 평가 및 이를 이용한 일일 총에너지소비량, 에너지필요추정량과 신체활동 평가)

  • Ji-Yeon Gwak;Myung-Hee Kim;Jonghoon Park;Kazuko Ishikawa-Takata;Eun-Kyung Kim
    • Journal of Nutrition and Health
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    • v.56 no.1
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    • pp.35-53
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    • 2023
  • Purpose: The purpose of the first part of this study was to evaluate the validity of the physical activity classification table for youth (Youth-PACT). The second part of this study was aimed at comparing the estimated energy requirement (EER) with the total energy expenditure (TEE) and evaluating the physical activity patterns of Korean children and adolescents. Methods: The subjects of the first part of the study were 17 children aged 10 to 12 years, and their total energy expenditure (TEEDLW) was measured using the double labeled water (DLW) method. A total of 166 children and adolescents aged 6-18 years participated in the second part of this study. Their resting energy expenditure (REE) was measured using indirect calorimetry and the TEEYouth-PACT and physical activity level were calculated by applying the Youth-PACT to the physical activity diary prepared by the subjects. Results: In the first part of this study, there were no significant differences between the TEEDLW and the TEEYouth-PACT. The TEEYouth-PACT accurately predicted TEEDLW in 37.5% of the subjects. In the second part of the study, the rates at which EER accurately predicted TEE YouthPACT and overestimated TEE Youth-PACT were 29.6% and 47.3%, respectively. The time spent based on intensity of physical activity and the physical activity categories which were obtained using Youth-PACT showed different patterns according to sex and age group. Age showed significant positive correlations with REE, TEE, and the time spent in sedentary behavior, but age was significantly negatively correlated with REE/body weight, TEE/body weight, and the time spent in low-intensity and high-intensity activities. Conclusion: The results of this study showed that the Youth-PACT can be used to evaluate the TEE and PAL of children and adolescents. However, further studies are needed to validate the TEEYouth-PACT and to set the EER for children and adolescents.

A Systematic Study of the Intervention Effect of Social Stories in Children with Sleep Disorders (수면장애 아동을 위한 사회적 이야기 중재 효과: 체계적 고찰)

  • Kim, Ji-Ho;Yoo, Eun-Young
    • The Journal of Korean Academy of Sensory Integration
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    • v.21 no.2
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    • pp.69-83
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    • 2023
  • Objective : This study sought to systematically examine the intervention effect of social stories when applied in relation to children with sleep disorders. Methods : Studies available in the SCOPUS, ScienceDirect, PsycArticles, and PubMed databases that were published from 2001 to 2022 were searched. The keywords used for the search were as follows: ("social story" OR "social stories") AND ("sleep" OR "sleep disorders" OR "sleep wake disorder bedtimes" OR "sleep initiation and maintenance disorders" OR "sleep wake disorder" OR "sleep arousal disorders"). Based on the selection criteria, six experimental studies were selected and analyzed. Results : The selected studies were two randomized controlled trials, three individual trials, and one case study. The subjects were mostly children diagnosed with autism spectrum disorder who were school-aged or adolescent. The intervention types were often complex interventions, including social stories and other interventions, while the durations of the interventions varied from one day to more than 40 days. The interventions had a positive effect on the subjects' sleep quality, with night wakings, sleep onset delay, and sleep anxiety all being improved. As standardized assessment tools to evaluate the effectiveness of social stories, the Child Sleep Habits Questionnaire and the Child Behavior Checklist were used in two papers each, and were the most commonly used. As non-standardized assessment tools, each of the four papers used turbulence and sleep diaries as assessment tools. Conclusion : The effect of social story mediation can be divided into sleep quality and sleep-related behavior. In terms of sleep quality, studies showing improvements in night wakings, sleep onset delay, and sleep anxiety accounted for a large proportion of the sample. The detailed effect area of sleep quality showed a significant improvement after the interventions in most studies, and in all six studies analyzed in the present study, the continuation of the effect after the intervention was confirmed via follow-up tests. Thus, the findings of this study are expected to be helpful when applying social stories in children with sleep disorders in clinical practice due to presenting the intervention effects, outcome evaluation tools, and intervention periods in children with sleep disorders in prior investigations involving social stories.

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.