• Title/Summary/Keyword: Multicenter study

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Efficacy and Safety during the Combination Therapy of Imipramine and Desmopressin in Primary Monosymptomatic Nocturnal Enuresis (어린이의 일차성 단일 증상성 야뇨증에서 Imipramine과 Desmopressin 복합 약물치료의 효과 및 안전성)

  • Yeo Ji-Hyun;Choi Jung-Youn;Chung Hyo-Seok;Lee Kyung-Soo;Ko Cheol-Woo;Kim Kyo-Sun;Kim Kee-Hyuk;Kim Jung-Soe;NamGoong Mee-Kyung;Park Young-Seo;Pai Ki-Soo;Yoo Kee-Hwan;Park Yong-Hoon
    • Childhood Kidney Diseases
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    • v.8 no.2
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    • pp.129-137
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    • 2004
  • Purpose : Nocternal enuresis is a common disorder. Tricyclic antidepressant and desmopressin have been accepted pharmacological treatment for this disorder We conducted a cooperative study to investigate the efficacy and adverse reactions of imipramine, desmopressin and combination treatment in children with primary monosymptomatic nocturnal enuresis(PMNE). Methods: Data from a large multicenter study were analysed. In the period of 8 months in 2002, the study comprised of 168 children(78 boys and 90 girls, 5 to 15 years old) with PMNE for imipramine, desmopressin or combination treatment. Before treatment a history, physical examination and laboratory tests were performed and the children were observed for 2 weeks. Response rate, adverse reactions and enuresis episodes after stopping drug administration were evaluated after 12-weeks of imipramine, desmopressin or combination of both. Results: After 4 weeks, the frequency of bed wetting in all treated patients decreased during treatment significantly Even though a 30-50%, reduction in the number of wet nights were 68.6%, 74.4% and 86.1% during 12 weeks treatment by imipramine, desmopressin and both of them respectively, there was no significant difference between them. The most common adverse reaction was decreased appetite from imipramine administration. But no serious drug-related adverse events were reported. Conclusion: Efficacy of the combination therapy of imipramine and desmopressin in PMNE appears not to be better than either drug alone. It is necessary to pay attention on account of adverse reactions during imipramine treatment even though imipramine and desmopressin were generally well tolerated.

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A Clinicopathological Study of Rapidly Progressive Glomerulonephritis in Children (소아 급속 진행성 사구체 신염의 임상-병리학적 고찰)

  • Cho Hee-Yeon;Chung Dae-Lim;Kang Ju-Hyung;Ha Il-Soo;Choi Yong;Cheong Hae-Il
    • Childhood Kidney Diseases
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    • v.8 no.2
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    • pp.176-185
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    • 2004
  • Purpose: Rapidly progressive glomerulonephritis (RPGN) is a clinicopathologic entity characterized by extensive crescent formation and rapid deterioration of renal function within few months. For better understanding of its clinical course and designing better treatment strategies, a clinicopathological study of childhood RPGN was performed. Methods: The clinical manifestations and pathological findings were reviewed retrospectively in 12 children who were diagnosed as having RPGN by clinical manifestations and renal biopsy during a period from 1991 to 2003. Several clinicopathological parameters were analyzed as prognostic factors. Results: Among a total of 12 patients, 4 were male and 8 were female. The median onset age was 11.5 years(range 5.5-14.6 years), and the median period of follow-up was 25 months(range 7 months-6.6 years). According to the pathological classification, 10 patients (83%) were type II RPGN(immune-complex mediated glomerulonephritis), 2 patients were type III RPGN(pauci-immune glomerulonephritis), and none was type I RPGN(anti-glomerular basement membrane nephritis). All patients were treated with oral steroid in various combinations with methylprednisolone pulse therapy(10 patients, 83%), cyclophosphamide(8 patients, 67%), or plasmapheresis(4 patients, 33%). Clinical outcomes of 12 patients were complete remission in 1(8%), end-stage renal disease in 2(17%), chronic renal insufficiency with persistent proteinuria in 2(17%), and normal renal function with persistent proteinuria in 7(58%) at the last follow-up. Poor prognosis is associated with increased serum creatinine level, severe anemia and younger age at the time of diagnosis. Conclusion: Immune-complex mediated glomerulonephritis is the major cause RPGN in children and most cases showed improvement of renal function with aggressive management. For better understanding of this rare disease, a prospective multicenter study should be done.

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Current Status of Children on Peritoneal Dialysis in Korea : A Cross-Sectional Multicenter Study (소아복막투석의 현황: 다기관 공동연구 결과보고)

  • Youn, Ji-Seok;Lee, Joo-Hoon;Park, Young-Seo;Yim, Hyung-Eun;Paik, Kyung-Hoon;Yoo, Kee-Hwan;Ha, Il-Soo;Cheong, Hae-Il;Choi, Yong
    • Childhood Kidney Diseases
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    • v.13 no.2
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    • pp.176-188
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    • 2009
  • Purpose : Peritoneal dialysis (PD) is the major form of dialysis in use for infants and children with end-stage renal disease (ESRD). The aim of this study was to gain insight into the current status of children on PD in Korea. Methods : In May 2008, questionnaires were sent to the pediatric nephrologists via e-mail. Four centers replied and those data were reviewed. Results : A total of 103 patients were included in this study. Male to female ratio was 1.6:1. Mean age was $11.5{\pm}4.9$ years (0-19 years). Primary renal diseases diagnosed were as follows: primary glomerular disease (34%), chronic pyelonephritis-reflux nephropathy (14.6%), systemic disease (9.7%), renal hypoplasia/dysplasia (8.7%), heredofamilial disease (6.8%), vascular disease (3.9%), drug-induced nephropathy (1.0%), and unknown (12.6%). PD modalities were as follows: CAPD (42.7%), CCPD (27.2%), NIPD (11.7%), and Hybrid (18.4%). Weekly total Kt/V was $2.1{\pm}0.7$ (0.3-4.1). Results of peritoneal equilibrium test were as follows: low 36.8%, low average 31.6%, high average 19.7%, and high 11.8%. Z-score for weight was $-1.00{\pm}1.20$ (-4.54~+2.50). Z-score for height was $-1.55{\pm}1.65$ (-9.42~+1.87). Growth hormone was administered in 24.3% of patients. Anti-hypertensive drugs were administered in 64.0% of patients. Laboratory findings were as follows: hemoglobin $10.5{\pm}1.4$ g/dL, calcium $9.7{\pm}0.7$ mg/dL, phosphorus $5.4{\pm}1.4$ mg/dL, and parathyroid hormone $324.2{\pm}342.8$ pg/mL. Conclusion : Primary glomerular disease was the most common cause of ESRD. CAPD was the most prevalent PD modality. Low and low average peritoneal transport type were common. Growth disturbance were noted in many patients. Some patients had hypertension even with anti- hypertensive drugs. Calcium-phosphorus levels were maintained adequately, but many patients had secondary hyperparathyroidism.

DEVELOPMENTAL AND CLINICAL CHARACTERISTICS IN CHILDREN WITH NOCTURNAL ENURESIS : RESULTS OF A MULTICENTER STUDY (야뇨증 환아들의 심리사회적 특성에 대한 다기관 연구 : 발달학적 및 임상적 특성을 중심으로)

  • Cho Soo-Churl;Shin Min-Sup;Hwang Jun-Won;Han Sang-Won;Park Kwan-Hyun;Lee Sang-Don;Kim Kyung-Do;Kim Kun-Suk;Suh Hong-Jin;Lee Yoo-Sik;Chung Jae-Yong;Kim Young-Kyoon;Kim Jae-Won
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.17 no.1
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    • pp.32-39
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    • 2006
  • Objectives : The aim of this study was to examine the developmental and clinical characteristics associated with nocturnal enuresis in Korean children. Methods : Three hundred eighteen children with nocturnal enuresis, together with their parents, completed a parent questionnaire consisting of a Child Behavior Checklist(CBCL). Data related to the prenatal, perinatal and developmental history, past and current medical history were collected. Ninety-three normal students were selected as the control group. Results : The nocturnal enuresis group attained diurnal and nocturnal urinary control significantly later than those in the normal control group.49.2% of the children with nocturnal enuresis had the family history of nocturnal enuresis. Daytime incontinence was present in 41.3% of the nocturnal enuresis group. The percentages of sleep-related disturbances were significantly higher in the nocturnal enuresis group when compared to the normal control group.42.6% of the children with nocturnal enuresis experienced pharmacotherapy, and 0.4% experienced enuresis alarms. Conclusion : The results of this study suggest that children with nocturnal enuresis in Korea have a high genetic load and a possibility of developmental delay, which supports the neurodevelopmental point of view with regard to the etiology of nocturnal enuresis. The physicians in Korea prefer pharmacological interventions to alarm interventions in treating Korean children with nocturnal enuresis.

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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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Serotypes and Antimicrobial Susceptibility of Streptococcus pneumoniae (폐구균의 혈청형 분포와 항생제 감수성에 관한 연구)

  • Choi, Kyoung-Min;Kim, Jeong-Hyun;Shin, Kyoung-Mi;Yeon, Soo-In;Shin, Jeon-Soo;Yong, Dong-Eun;Lee, Kyoung-Won;Kim, Dong-Soo
    • Pediatric Infection and Vaccine
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    • v.10 no.2
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    • pp.159-166
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    • 2003
  • Purpose : Streptococcus pneumoniae is part of the normal flora but is also responsible for causing many invasive diseases such as pneumonia, meningitis, and sepsis in addition to noninvasive diseases such as otitis in children. Multi-drug resistant strains has raised a lot of concern worldwide and thus the importance of prevention has been emphasized. We have analyzed the current serotypes and antibiotic sensitivity of each serotype as a baseline study to estimate the efficacy of the pneumococcal vaccine in Korean children. Methods : One hundred sixteen cases of pneumococcus cultured at Yonsei Medical Center from September 2001 to January 2003 were analyzed. The serotyping was done with the Quellung reaction and penicillin resistance was tested using the oxacillin disc diffusion method. Results : Pneumococcus were cultured from the sputum in 76 cases(65.5%), from the blood in 13 cases(11.2%), from the ear discharge in 12 cases(10.3%), from the throat in 7 cases(6.0%), from the nasal cavity in 2 cases(1.7%), and one case(0.9%) each from the cerebrospinal fluid, eye discharge, peritoneal fluid, post-operational wound, brain abscess, and catheter tip. Serotyping was possible with 98 cases and the following serotypes were found; 15 cases of type 19F(15.3%), 11 cases of 19A(11.2%), 8 cases of 11A(8.2%), 7 cases each of 6A, 14 and 3(7.1%), 6 cases each of 35, 6B and 23F(6.1%). Eighty two cases(70.7%) out of 116 cases were penicillin resistant and serotypes 19F, 19A, 11A, 23F, 6A, 9V constituted the majority, 48 cases(59.8%). These serotypes showed resistance to cotrimoxazole (74.4%), tetracycline(69.5%), and erythromycin(90.3%) as well. In the 22 cases cultured from children, 19A and 19F were found in 25.0%, 6A, 6B, and 23F in 10.0%, 11A, 14, 19, and 29 in 5.0%. Fifty percent(10/20) of the clinical isolates were represented in the current 7-valent pneumococcal protein conjugate vaccine, and 85%(17/20) when the cross-reacting serotypes were included. Penicillin resistance was found in 86.4%(19/22). Conclusion : The percentage of serotypes included in the 7 valent pneumococcal protein conjugate vaccine found in our study was 40.8% which was less than other prior studies. In anticipation of a change of pneumococcal serotypes, a nationwide multicenter study is needed before the initiation of pneumococcal vaccines in Korea.

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The Prognosis following Radiation Therapy or Surgical Resection for Stage 1 Non-Small Cell Lung Cancer (방사선치료 혹은 외과적 절제술을 받은 임상적 제 1기 비소세포폐암의 치료성적)

  • Park, Jun-Goo;Won, Jun-Hee;Cha, Seung-Ick;Park, Ki-Soo;Kim, Chang-Ho;Park, Jae-Yong;Jung, Tae-Hoon
    • Tuberculosis and Respiratory Diseases
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    • v.42 no.5
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    • pp.731-736
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    • 1995
  • Background: Surgical resection is the treatment of choice for localized, operable non-small cell carcinoma of the lung. Curative radiotherapy, however, is considered an alternative to surgery in patients with poor performance state, poor cardiopulmonary function, or who refuse surgery. However, the difference in prognosis after surgery and radiotherapy is not well established in the patients with stage I non-small cell lung cancer. Method: To evaluate the difference in progonsis between surgery and radiotherapy in stage I non-small cell lung cancer, a retrospective study was done with 15 patients treated with curative radiotherapy and 24 patients treated with curative surgery. Results: The overall response rate was 80%, with 33% complete response, after radiotherapy. The median survival time of the patients with radiotherapy was 14.9 months, with 2-year and 5-year survival rates of 22% and 0%, respectively. The median survival time of the patients with surgery was 37.7months, with 2-year and 5-year survival rates of 65% and 41%, respectively. Conclusion: These results suggest that surgery is better than the radiotherpy in view of survival rate and it is necessary to recommend, more strongly, curative surgery to patients with stage I non-small cell lung cancer if the patients are able to receive operation. To compare, more accurately, the difference in prognosis by the modality of therapy, large multicenter study is needed.

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Long-term Results of Taking Anti-oxidant Nutritional Supplement in Intermediate Age-related Macular Degeneration (중기 나이관련황반변성 환자에서 항산화영양제 복용 후 장기 관찰 결과)

  • Bang, Seul Ki;Kim, Eung Suk;Kim, Jong Woo;Shin, Jae Pil;Lee, Ji Eun;Yu, Hyeong Gon;Huh, Kuhl;Yu, Seung-Young
    • Journal of The Korean Ophthalmological Society
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    • v.59 no.12
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    • pp.1152-1159
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    • 2018
  • Purpose: We prospectively investigated clinical changes and long-term outcomes after administration of the drugs recommended by the Age-Related Eye Disease Study-2 to patients with intermediate age-related macular degeneration (AMD). Methods: This prospective multicenter study enrolled 79 eyes of 55 patients taking lutein and zeaxanthin. The primary endpoint was contrast sensitivity; this was checked every 12 months for a total of 36 months after treatment commenced. The secondary endpoints were visual acuity, central macular thickness, and drusen volume; the latter two parameters were assessed using spectral domain optical coherence tomography. Results: The mean patient age was $72.46{\pm}7.16years$. Contrast sensitivity gradually improved at both three and six cycles per degree. The corrected visual acuity was $0.13{\pm}0.14logMAR$ and did not change significantly over the 36 months. Neither the central macular thickness nor drusen volume changed significantly. Conclusions: Contrast sensitivity markedly improved after treatment, improving vision and patient satisfaction. Visual acuity, central retinal thickness, and drusen volume did not deteriorate. Therefore, progression of AMD and visual function deterioration were halted.

Multicenter Evaluation on the Efficacy of N-Acetyl Cystine in Relieving the Symptoms of Laryngopharyngeal Reflux Disease (인후두 역류질환에서 N-Acetyl Cysteine의 증상 개선 효과에 대한 다기관 평가)

  • Kim, So Yean;Kwon, Tack Kyun;Kim, Han Su;Son, Young Ik;Woo, Seung Hoon;Woo, Jeong-Soo;Lee, Seung Won;Lim, Jae Yol;Chung, Man Ki;Joo, Young Hoon;Cha, Wonjae;Choi, Seung Ho;Hong, Hyun Jun;Lee, Sang Hyuk
    • Journal of the Korean Society of Laryngology, Phoniatrics and Logopedics
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    • v.29 no.2
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    • pp.87-93
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    • 2018
  • Background and Objectives : Laryngopharyngeal reflux disease (LPRD) is relatively common disease. N-acetyl cysteine (NAC) has both mucolytic and antioxidant effect, also may be beneficial in inflammatory airway diseases. The purpose of this study was to evaluate the efficacy and safety of inhaled NAC therapy in LPRD. Materials and Method : We retrospectively reviewed the medical records of 525 LPRD patients at 12 medical centers. Finally 401 patients subjected to inhaled NAC therapy for 2 months were enrolled in the study. We analyzed the change of Reflux Symptom Index (RSI) and Reflux Finding Score (RFS) after use of NAC for 4 weeks and 8 weeks in addition to the patient's compliance of the treatment. Results : The RSI score significantly decreased from $19.87{\pm}6.34$ to $12.78{\pm}6.93$ after 4 weeks and to $10.65{\pm}7.47$ after 8 weeks. The RFS score also significantly decreased from $9.29{\pm}3.4$ to $7.17{\pm}3.41$ after 4 weeks and to $6.1{\pm}3.73$ after 8 weeks (p<0.05). During the treatment periods, 42 patients (10.4%) reported to have 80 episodes of discomfort. Throat discomfort (33%) and nausea (28%) were most common complaints, but the duration of discomfort was usually less than 4 weeks. Conclusion : Inhaled NAC treatment is highly effective for the reduction of both subjective and objective findings in LPRD patients. This study will provide the evidence of new treatment option for patients with LPRD. However, further studies will be needs to assess the real effect of inhaled NAC therapy as a standard treatment regimen of LPRD.

The Eradication of Helicobacter pylori in the Duodenal Ulcer in Children and the Duodenal Recurrence (소아 십이지장궤양에서의 H. pylori 박멸과 궤양재발에 대한 연구)

  • Choe, Yon-Ho;Ko, Jae-Sung;Kim, Soon-Yeong;Yoo, Young-Mee;Seo, Jeong-Kee
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.1 no.1
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    • pp.30-36
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    • 1998
  • Purpose: It is well known that duodenal ulcer disease does not relapse if H. pylori is cleared from the gastric mucosa. Little is known about the recurrence of duodenal ulcer in children. The purpose of this study was to evaluate the effect of the eradication of H. pylori in duodenal ulcer in children upon the duodenal ulcer recurrence. Methods: 105 patients (M:F=78:27) diagnosed as duodenal ulcer by endoscopy in 1987~1995 were reviewed clinically, and were parted into two groups. The two treatment groups were ranitidine/antacid (RAN/ANT) and ranitidine/amoxicillin/denol (RAN/AMX/D). The latter was for H. pylori-positive children with duodenal ulcer who were diagnosed by serology and/or antral biopsies for histology, culture, and urease testing. The recurrence rates were compared between the two groups. Results: 1) 30 patients with primary duodenal ulcer underwent endoscopy for H. pylori and 27 (90.0%) of them were positive for H. pylori. 2) 27 of H. pylori-positive children received RAN/AMX/D. 23(85.2%) of them showed cure of duodenal ulcer and eradication of H. pylori. 3) The duodenal ulcer recurrence rate in RAN/ANT group was 65.3% and the rate in RAN/AMX/D was 4.3% by a year. Conclusions: There is a strong correlation between the duodenal ulceration and H. pylori infection in children, and the eradication of H. pylori in duodenal ulcer patients reduces the recurrence of the ulcer. Because of the low incidence of duodenal ulcers in children, a multicenter prospective study is required to determine the effect of treating H. pylori infetion on the long term natural history of duodenal ulcer disease.

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