• Clinical and Experimental Pediatrics
• /
• v.48 no.5
• /
• pp.518-522
• /
• 2005

Purpose : To evaluate the effect of inhaled hypertonic saline solution in hospitalized infants with bronchiolitis. Methods : A randomized double blind trial was performed from October 2003 to May 2004. A total of eighty patients <1 year of age with a clinical diagnosis of acute viral bronchiolitis were enrolled and assigned to receive either of the following : inhalation of 2 mL(0.5 mg) fenoterol added to 2 mL of 0.9 percent saline solution(group 1; n=40) or 2 mL(0.5 mg) fenoterol added to 2 mL of 3 percent saline solution(group 2; n=40). This therapy was repeated at six hours interval after admission. They were evaluated daily just before and 20 minutes after nebulization. The outcome measures included changes in clinical severity score(based on respiratory rate, presence of wheezing, retraction, and general condition) after nebulization and duration of hospitalization. Results : In the clinical severity score, a significant improvement was observed during the 72 hours of hospitalization in both groups(P<0.05). The basic clinical severity scores before inhalation were decreased significantly faster in group 2 as compared to group 1 on each day of treatment(P<0.05). The mean duration of hospital stay was significantly reduced in group 2 than group 1($5.9{\pm}1.9days$ versus $7.4{\pm}2.0days$, P<0.05). No adverse effects were associated with inhaled therapy. Conclusion : These results suggest that a nebulized 3 percent saline solution plus 0.5 mg fenoterol may be more effective than a 0.9 percent saline solution plus 0.5 mg fenoterol in accelerating the clinical recovery of infants with viral bronchiolitis.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
• /
• v.14 no.1
• /
• pp.12-25
• /
• 2003

Objectives：As increasing number of new antidepressants have been being introduced in clinical practice, pharmacological understanding has been broadened. These changes mandate new information and theories to be incorporated into the treatment process of children with depressive disorders. In light of newly coming knowledge, this review intended to recapitulate the characteristics of new antidepressants and to consider the pivotal issues to develope guidelines for the treatment of depression in childhood and adolescence. Methods：Searching the Pub-Med online database for the articles with the key words of 'new', 'antidepressants' and 'children' ninety-seven headings of review articles were obtained. The author selected the articles of pertinent subjects in terms of either treatment guideline or psychopharmacology of new antidepressants. When required, articles about the clinical effectiveness of individual antidepressants were separatedly searched. In addition, the safety information of new antidepressants was acquired by browsing the official sites of the United States Food and Drugs Administration and Department of Health and Human Services. Results：1) For the clinical course, treatment phase, and treatment outcome, the reviews or treatment guidelines adopted the information from adult treatment guidelines. 2) Systematic and critical reviews unambiguously concluded that selective serotonin reuptake inhibitors(SSRIs) excelled tricyclic antidepressants( TCAs) for both efficacy and side effect profiles, and were recommend for the first-line choice for the treatment of children with depressive disorders. 3) New antidepressants generally lacked treatment experiences and randomized controlled clinical trials. 4) SSRIs and other new antidepressants, when used together, might result in pharmacokinetic and/or pharmacodynamic drug-to-drug interaction. 5) The difference of the clinical effectiveness of antidepressants between children and adults should be addressed from developmental aspects, which required further evidence. Conclusion：Treatment guidelines for the pharmacological treatment of childhood and adolescence depression could be constructed on the basis of clinical trial findings and practical experiences. Treatment guidelines are to best serve as the frame of reference for a clinician to make reasonable decisions for a particular therapeutic situation. In order to fulfill this role, guidelines should be updated as soon as new research data become available.

• Pediatric Infection and Vaccine
• /
• v.31 no.1
• /
• pp.12-24
• /
• 2024

The number of pediatric coronavirus disease 2019 (COVID-19) cases worldwide are increasing compared to the early phase of the pandemic, along with highly transmissible severe acute respiratory syndrome coronavirus variant and the increase in adult COVID-19 vaccination. We conducted a rapid systematic review and meta-analysis of published randomized clinical trials (RCTs) of the COVID-19 vaccines and the observational retrospective studies on adverse events after COVID-19 vaccination in adolescents. Seventeen studies were finally included in this systematic review. Meta-analysis showed that although vaccination in adolescents was significantly effective to prevent COVID-19 infection in retrospective studies (risk ratio [RR], 0.29; 95% confidence interval [CI], 0.22-0.37; I² =100%), however the effect of preventing COVID-19 infection was lower than in RCTs (RR, 0.05; 95% CI, 0.01-0.27). In five retrospective studies, the pooled estimated proportion of participants with myocarditis and/or pericarditis was 2.33 per 100,000 of the population (95% CI, 0.97-5.61 per 100,000). Sub-group analysis with sex and vaccine doses showed that male (5.35 per 100,000) and the second dose (9.71 per 100,000) had significantly higher incidence of myocarditis and/or pericarditis than female (1.09 per 100,000) and the first dose (1.61 per 100,000), respectively. Our study showed that mRNA COVID-19 vaccines in adolescent recipients were favorable and effective against COVID-19 in RCT as well as observational studies. The safety findings of BNT162b2 vaccine in adolescents were explored and we found the difference of safety according to sex and vaccine doses. The occurrence of adverse events after mRNA COVID-19 vaccination should be monitored.

• Radiation Oncology Journal
• /
• v.18 no.1
• /
• pp.17-25
• /
• 2000

Purpose : To evaluate the side effects, pattern of failure, and survival rate according to the sequence of postoperative adjuvant radiotherapy and chemotherapy, patients with stages II and III rectal cancer who had undergone curative resection were randomized to 'early radiotherapy group (arm I)' or' late radiotherapy group (arm II)', then we intend to determine the most effective sequence of the radiotherapy and chemotherapy. Materials and Methods . From January 1996 to March 1999, 313 patients with curatively resected stages II and III rectal cancer have been randomized to' early' or' late' radiation therapy group and received combined chemotherapy (5-FU 375 mg/m$^{2}$/day, ieucovorin 20 mg/m$^{2}$, IV bolus daily Dl-5, 8 cycles) and radiation therapy (whole pelvis with 45 Gy/25 fractions/s weeks). Arm I received radiation therapy from day 1 with first cycle of chemotherapy and arm II received radiation therapy from day 57 with third cycle of chemotherapy after completion of first two cycles. Preliminary analysis was peformed with 228 patients registered up to Jun 1998. Two out of the 228 patients were excluded because of double primary cancer. Median follow-up period was 23 months. Results :Local recurrence occurred in 11 patients (9.7$\%$) for arm I and 9 patients (8$\%$) for arm 11. There was no significant difference between both groups ( p=0.64). However, distant metastasis was found in 22 patients (19.5$\%$) for arm I and 35 patients (31.0$\%$) for arm II and which showed statistically significant difference between the two groups ( p=0.046). And neither 3-year disease-free survival (70.2$\%$ vs 59.2$\%$, p=0.2) nor overall survival (89.4$\%$ vs 88.0$\%$, p=0.47) showed significant differences. The incidence of leukopenia during radiation therapy and chemotherapy was 78.3$\%$ and 79.9$\%$ respectively but leukopenia more than RTOG grade 3 was only 2.1$\%$ and 6.0$\%$ respectively. The incidence of diarrhea more than 10 times per day was significantly higher in the patients for arm I than for arm II (71.2$\%$ vs 41.6$\%$, p=0.02) but this complication was controlled with supportive cares. Conclusion : Regardless of the sequence of postoperative adjuvant radiation therapy and chemotherapy after curative resection for rectal cancer, local recurrence rate was low with combined chemoradlotherapy. But distant metastasis rate was lower in early radiation therapy group than in late radiation therapy group and the reason is unclear. Most patients completed these treatments without severe complication, so these were thought to be safe treatments but the treatment compliance should be improved.

• Therapeutic Science for Rehabilitation
• /
• v.5 no.1
• /
• pp.77-87
• /
• 2016

Objective : The purpose of this study is to investigate the impact of task-oriented approach based on upper limb coordinated movement on the ability of the Korean handwriting in children with developmental coordination disorder(DCD). Methods/Design : This randomized controlled trial designed as a pre-/post- test will compare the effectiveness of task-oriented approach and process-oriented approach on handwriting performance for children with DCD aged 5 to 10. These interventions consist of 10 training sessions and 4 assessment sessions over 7weeks. Children will be measured regard to handwriting legibility, speed and pre-handwriting skills including upper limb movement skills, visual perception and visual motor coordination. Conclusion : This is the first attempt to investigate effects of a task-oriented approach in children with DCD. The significance of this study is to provide the clinical evidences to apply the task-oriented approach improves the children's handwriting performance. Furthermore it will also present a more effective intervention for handwriting by figuring out each approach's impact on the improvement of pre-handwriting skills.

• Journal of Pharmacopuncture
• /
• v.11 no.1
• /
• pp.55-69
• /
• 2008

Objective : We investigated the effects of distilled Wild Ginseng Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Wild Ginseng Herbal Acupuncture on the balance of the autonomic nervous system. Method : We investigated the effects of distilled Wild Ginseng Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Wild Ginseng Herbal Acupuncture on the balance of the autonomic nervous system. 1 healthy volunteers consisted of 31 subjects in experiment(distilled Wild Ginseng Herbal Acupuncture) group and 30 subjects in control(Normal Saline) group. Study form was a randomized, placebo-controlled, double-blind clinical trial. 31 subjects in experiment group were injected distilled Wild Ginseng Herbal Acupuncture at $GB_{21}$(Kyonjong) and 30 subjects in control group were injected Normal Saline at $GB_{21}$(Kyonjong). except of 2 subjects(in control group) who can't be measured and 11 subjects(7 in experiment group and 4 in control group) who move or make unforceable error during measuring. Finally 24 subject in experiment group and 24 subject in control group are studied. We measured HRV by PolyG-I on 7 times : before and after injection per 5 minutes during 30 minutes. The SPSS 10.0 for windows was used to analyze the data and the paired t-test(in group) and Student t-test(between two groups) were used to verify the result. Result : 1. After distilled Wild Ginseng Herbal Acupuncture injection, Mean HRV is significantly low only for first 5 minute, SDNN is significantly high after 5 minute, Complexity is significantly low after 5 minute, HRV index is significantly high after 10 minute and pNN50 is significantly low after 5 minute. 2. SDNN of distilled Wild Ginseng Herbal Acupuncture Group significantly increased from 20minute to 25minute, and pNN50 of distilled Wild Ginseng Herbal Acupuncture Group significantly decreased from 10minute to 15minute and 20 minute to 30 minute compared with those of Normal Saline group. 3. After distilled Wild Ginseng Herbal Acupuncture injection, Ln(TP), Ln(VLF) and Ln(LF) are significantly high after 5 minute, normalized LF is significantly high after 5 minute and normalized HF is significantly low after 5 minute. 4. Ln(TP) and Ln(VLF) of distilled Wild Ginseng Herbal Acupuncture Group significantly increased from 20minute to 25 minute compared with those of Normal Saline group. Conclusion : The results suggest that distilled Wild Ginseng Herbal Acupuncture in healthy adult man tend to activate the autonomic nervous system and sympathetic nervous system compared to Normal Saline within normal range.

• Nutrition Research and Practice
• /
• v.5 no.5
• /
• pp.435-442
• /
• 2011

At present, lifestyle-related diseases are one of the most critical health issues worldwide. It has been reported that lipopolysaccharide derived from a Gram-negative bacteria (IP-PA1) symbiotic with wheat exhibited several advantageous biological effects, such as the reduction of plasma glucose levels in NOD mice and low-density lipoprotein (LDL) levels in WHHL rabbits. In this study, the beneficial effects on plasma glucose and lipids of a tea (SI tea) consisting of IP-PA1 and Salacia (which contains an inhibitor of ${\alpha}$-glucosidase) were investigated in the KK-Ay/TaJcl type 2 diabetic model mice and in human subjects with premetabolic syndrome in a double-blind, randomized study. S1 tea significantly decreased plasma glucose levels in KK-Ay/TaJcl mice. A clinical trial of SI tea was performed with 41 subjects between the ages of 40 and 69, who belonged either to a high plasma glucose group (HG: FPG 100-125 mg/dl) or to a hyperlipidemia group (HL: TG ${\geq}$ 150 mg/dl, or LDL ${\geq}$ 120 mg/dl, or HDL <40 mg/dl). These subjects ingested either Salacia without IP-PA1 (the control) or SI tea. Blood samples were collected at 0, 30, and 60 days after initiating SI tea treatment, and were measured for FPG, HbA1c, TG, LDL, and HDL. These results showed that SI tea reduced FPG and HbA1c more rapidly than the control in the HL group, and also significantly improved LDL and HDL levels in the HG group. Thus, SI tea may be helpful in preventing lifestyle-related diseases.

• Radiation Oncology Journal
• /
• v.31 no.4
• /
• pp.199-205
• /
• 2013

Purpose: To assess the clinical efficacy and toxicity of whole pelvic intensity-modulated radiotherapy (WP-IMRT) for high-risk prostate cancer. Materials and Methods: Patients with high-risk prostate cancer treated between 2008 and 2013 were reviewed. The study included patients who had undergone WP-IMRT with image guidance using electronic portal imaging devices and/or cone-beam computed tomography. The endorectal balloon was used in 93% of patients. Patients received either 46 Gy to the whole pelvis plus a boost of up to 76 Gy to the prostate in 2 Gy daily fractions, or 44 Gy to the whole pelvis plus a boost of up to 72.6 Gy to the prostate in 2.2 Gy fractions. Results: The study cohort included 70 patients, of whom 55 (78%) had a Gleason score of 8 to 10 and 50 (71%) had a prostate-specific antigen level > 20 ng/mL. The androgen deprivation therapy was combined in 62 patients. The biochemical failure-free survival rate was 86.7% at 2 years. Acute any grade gastrointestinal (GI) and genitourinary (GU) toxicity rates were 47% and 73%, respectively. The actuarial rate of late grade 2 or worse toxicity at 2 years was 12.9% for GI, and 5.7% for GU with no late grade 4 toxicity. Conclusion: WP-IMRT was well tolerated with no severe acute or late toxicities, resulting in at least similar biochemical control to that of the historic control group with a small field. The long-term efficacy and toxicity will be assessed in the future, and a prospective randomized trial is needed to verify these findings.

• Journal of Acupuncture Research
• /
• v.23 no.6
• /
• pp.239-254
• /
• 2006

The 3rd Japan-Korea Workshop on Acupuncture and EBM was held at Kanazawa on June $16^{th}$. From Korea team, 4 papers were presented. Dr. Hahn introduced a new approach of data analysis on series of n-of-1 trials using the Bayesian statistics. It offered important information for the future n-of-1 trials. Dr. Park clearly demonstrated the significance of various sham devices proposed and stressed the importance of research questions when we choose the control intervention in RCT. Dr. Lee reported the results of survey in Korean Medical Doctors (KMD) for their point selection and techniques to the distal and local points. Dr. Kim presented the results of face to face survey on the KMD with 28 items for acupuncture treatment on the knee OA. Finally, a draft of protocol was introduced by Dr. Kim. The title was "multi-center, a randomized, single blinded, two arms, parallel-group study to compare the effectiveness and safety of 'individualized acupuncture' and 'standardized minimal acupuncture' in Korean and Japanese patients with knee osteoarthritis (Phase IV)". From Japan team, 7 speakers presented their comments and proposals on the protocol. Dr. Takahashi introduced several issues regarding n-of-1 trials and pointed out the importance of obtaining generalizability from n-of-1 trials. Dr. Shichidou pointed the importance of research design, selection of outcome measures and reduction of biases. Dr. Itoh presented the results of point selection for the knee OA based on the literature survey. Dr. Sumiya introduced several differences between KMD and Japanese acupuncturists based on the questionnaire used in KMD survey. Dr. Furuya demonstrated a result of press tack needle and its sham device on shoulder stiffness. Dr. Yamashita introduced the results of literature survey regarding adverse events occurred by acupuncture on knee OA. Dr.Tsukayama stressed the importance of responsibility of Institutional Review Board (IRB) for the conduction of clinical trials. After several issues were discussed, the need of continued meeting for final protocol development was agreed, then the workshop was closed.

• Journal of Nutrition and Health
• /
• v.47 no.1
• /
• pp.23-32
• /
• 2014

Purpose: This study was conducted in order to investigate the effect of Sargassum confusum extracts on the reduction of body fat for eight weeks in overweight women ($BMI{\geq_-}23kg/m^2$). Methods: Subjects were classified by double-blind randomized trial as the control group (C group, n = 14) and the Sargassum confusum extract supplementation group (SC group, n = 16), which consumed 12 tablets per day. Questionnaires related to their health status were assessed twice (week 0 and week 8). Their dietary intake status was evaluated by 24-recall method and body compositions were measured using a bioelectrical impedance analyzer. In addition, we assessed the anti-obesity effect and the occurrence possibility of health risk factors during the supplementation periods by hematological and clinical analysis of blood. Results: Waist circumference and body fat (%) were significantly decreased in the SC group. Serum leptin level was also significantly decreased in the SC group. Defecation frequency was significantly increased in the SC group. The above results indicate that Sargassum confusum extract supplementation improves overweight on visceral fat and blood leptin level by increasing bowel movement. These results imply a decrease of health risk factors in overweight women. Seven subjects withdrew from the study due to adverse events; however, no differences regarding adverse events were observed between the control and treatment group. Conclusion: Therefore, Sargassum confusum extract is a plausible effective agent for body fat reduction in humans.