• Title/Summary/Keyword: Clinical safety

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Growth and clinical efficacy of fortified human milk and premature formula on very low birth weight infants (극소 저체중출생아에서 강화된 모유와 미숙아 전용분유가 성장 및 임상에 미치는 효과)

  • Chueh, Heewon;Kim, Myo Jing;Lee, Young-A;Jung, Jin-A
    • Clinical and Experimental Pediatrics
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    • v.51 no.7
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    • pp.704-712
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    • 2008
  • Purpose : A prospective, controlled trial was conducted to evaluate growth, efficacy, safety and nutritional status for very low birth weight infants fed with human milk fortified with Maeil human milk fortifier (Maeil $HMF^{(R)}$; Maeil Dairies Co., Ltd.). Methods : We enrolled 45 premature infants with a birth weight <1,500 g and gestational age <33 weeks, who were born at Dong-A University Hospital from October, 2006 through December, 2007. They were divided into 2 groups: infants in one group were fed with human milk fortified with $HMF^{(R)}$, and the second were fed with preterm formula. Growth, biochemical indices, feeding tolerance, and other adverse events in each group were assessed serially and compared relatively. Follow-up data were also collected after discharge at 1, 3, and 6 months corrected age. Results : Characteristics of the 2 groups including average gestational age, birth weight, sex, respiratory distress syndrome, patent ductus arteriosus, and other adverse events (sepsis, retinopathy of prematurity, and intraventricular hemorrhage) showed no significant difference. Average feeding start day ($8.00{\pm}3.27d$ vs. $8.86{\pm}5.37d$) (P=0.99) and the number of days required to reach full feeding after start feeding ($41.78{\pm}20.47d$ vs $36.86{\pm}20.63d$) (P=0.55) were not significantly different in the group fed human milk fortified with $HMF^{(R)}$ when compared with the group that was fed preterm formula. The duration of total parenteral nutrition and the incidence of feeding intolerance also showed no differences between the 2 groups. Although infants fed with human milk fortified with $HMF^{(R)}$ showed faster weight gain than those fed with preterm formula at the end stage of the admission period, other growth indices of the two groups showed no significant difference. No significant correlations were found between the 2 groups with regard to weight gain velocity, height gain velocity, head circumference velocity, and post-discharge follow up growth indices. Conclusion : Premature infants fed human milk fortified with $HMF^{(R)}$ showed no significant difference compared with those fed preterm formula in growth, biochemical indices, and adverse events. Using human milk fortifier can be an alternative choice for very low birth weight infants, who need high levels nutritional support even after discharge from NICU.

Maintenance dose of electrolyte free polyethylene glycol (PEG) 4000 in Korean children with chronic functional constipation (한국인 소아에서 만성 기능성 변비치료 시 전해질이 함유되지 않은 PEG 4000의 유지용량)

  • Lee, So Hee;Bae, Sun Hwan
    • Clinical and Experimental Pediatrics
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    • v.50 no.12
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    • pp.1212-1216
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    • 2007
  • Purpose : To determine optimal maintenance dose and to evaluation the efficacy and safety of polyethylene glycol 4000 (PEG4000) in children with chronic functional constipation. Methods : This study enrolled 41 children with chronic functional constipation at the Konkuk university hospital August 2005, then June, 2007. Effective maintenance dose was designed as initial amount of PEG4000 that improved frequency, bowel movement, stool consistency for 2 months. Clinical outcome was analysed on the basis of defecation diary. Adverse effect was monitored clinically and biochemically. Results : As a whole group effective maintenance dose of PEG4000 was $0.55{\pm}0.16g/kg/day$ (0.25-0.86). With respect to age, 3-5 years ($0.60{\pm}0.15$), 6-8 years ($0.57{\pm}0.16$), 9-13 years ($0.44{\pm}0.14$) (P=0.024). With respect to body weight, <30 kg ($0.62{\pm}0.14$), ${\geq}30kg$ ($0.41{\pm}0.10$) (P=0.001). One child comlained apigastric soreness on medication. Conclusion : PEG4000 is effective and safe in children with chronic constipation. Initial maintenance dose of PEG4000 was 0.55 g/kg/day.

Clinical Study of Long Term Effect of Transvaginal Ultrasound Guided Radiofrequency Myolysis for Treatment of Uterine Leiomyoma (자궁근종 치료를 위한 질경유 초음파 유도하 고주파 자궁근종용해술의 장기간 효과에 대한 임상적 연구)

  • Lee, Woo-Seok;Lee, Il-Han;Kim, Dong-Ho;Lee, Sang-Hun
    • Clinical and Experimental Reproductive Medicine
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    • v.35 no.1
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    • pp.77-82
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    • 2008
  • Objective: This study was performed to investigate the efficacy and safety of radiofrequency (RF) myolysis under transvaginal ultrasound guidance. Methods: Transvaginal RF myolysis had been performed in one hundred nine women with uterine leiomyoma at Chung-Ang University hospital between Dec. 2004 and Mar. 2007. All patients, mean aged $42.8{\pm}5.8$ years, desired their uterine conservation. Patients underwent physical examination, transvaginal pelvic ultrasound for measurement of the lesions preoperatively. Follow up was done at 1 week, 1 month, 3 months, 6 months after RF myolysis by same physician and measurement of size and volume of myoma and improvement of myoma specific symptoms such as menorrhagia and dysmenorrhea were checked at each visit. Results: The mean maximal diameter of myomas treated by RF myolysis was $6.1{\pm}0.5\;cm$ and average time of the procedure was $16.3{\pm}8.5$ minutes. A significant decrease of myoma size and volume was observed at 1 month after myolysis. Mean reduction in maximal diameter was $29.9{\pm}4.8%$ at 1 week (p<0.001), $41.5{\pm}1.5%$ at 1 month (p=0.05), $46.2{\pm}3.9%$ at 3 months (p=0.003), $54.6{\pm}6.1%$ at 6 months (p<0.001) after RF myolysis respectively. Mean reduction in volume was $44.4{\pm}8.3%$ (p=0.001), $68.1{\pm}4.2%$ (p=0.035), 73.9$73.9{\pm}4.8%$ (p=0.042), $84.5{\pm}5.1%$ (p<0.001) at the same follow up period respectively. Significant improvement of symptom was observed at 3 months after RF myolysis. Transient low abdominal pain and prolonged vaginal bleeding were detected in 3 patients each but spontaneously resolved and no serious complication has been noticed or found. Conclusion: This study shows transvaginal RF myolysis could be a safe and effective method to treat uterine leiomyoma, allowing uterine conservation with significant volume reduction and rapid return to normal activity.

Comparison of the Nutritional Status and the Acute Inflammatory Reaction between Laparoscopy-assisted Distal Gastrectomy and Conventional Open Distal Gastrectomy for Early Gastric Cancer (조기위암에서 복강경 및 개복 위아전절제술에 따른 영양학적 및 면역염증반응의 비교)

  • Chae, Hyun-Dong
    • Journal of Gastric Cancer
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    • v.10 no.1
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    • pp.19-25
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    • 2010
  • Purpose: Laparoscopy-assisted gastrectomy (LAG) is gaining wider acceptance as a minimally invasive treatment for early gastric cancer, but the safety, efficacy and clinical benefits of this type of surgery are still unclear. The purpose of this study is to compare laparoscopy-assisted gastrectomy (LADG) and conventional open distal gastrectomy (CODG) for early gastric cancer (EGC) according to the changes of the postoperative nutritional status and acute inflammatory reaction. Materials and Methods: Eighty seven patients with EGC and who underwent a LADG between March 2006 and May 2009 at Daegu Catholic University Hospital, was enrolled. Over the same period, we enrolled 30 patients who underwent CODG and they were confirmed to have EGC from their pathology. The clinico-pathological features and serologic parameters were evaluated from the medical records and then retrospectively analyzed. Results: There were no differences in the preoperative white blood cell (WBC), C-reactive protein (CRP) level, albumin level, the T4/T8 ratio and the other clinical data between the two groups. The total WBC counts gradually increased and they were significant lower at the $1^{st}$ and $3^{rd}$ postoperative days in the LADG group than that in the CODG group (P=0.001 and 0.008, respectively). The postoperative CRP levels were significantly lower at postoperative $5^{th}$ day in the LADG group (P<0.001). The postoperative albumin and T4/T8 ratio gradually decreased, and the T4/T8 ratio was significantly higher at the $3^{rd}$ postoperative day in the LADG group compared to that in the CODG group (P=0.003). Conclusion: This study demonstrates that the LADG has less of an influence on an acute inflammatory reaction than does CODG. Therefore, it is one of the safe and feasible procedures for the treatment of early gastric cancer.

Analysis of temperature changes and sterilization effect of diode laser for the treatment of peri-implantitis by wavelength and irradiation time (임플란트 주위염 치료용 diode laser의 파장 및 조사시간에 따른 온도 변화와 살균효과 분석)

  • Seol, Jeong-Hwan;Lee, Jun Jae;Kum, Kee-Yeon;Lee, Jong-Ho;Lim, Young-Joon
    • Journal of Dental Rehabilitation and Applied Science
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    • v.33 no.3
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    • pp.178-188
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    • 2017
  • Purpose: We compared the effects of newly developed diode laser (Bison 808 nm Diode laser) on the treatment of peri-implantitis with conventional products (Picasso 810 nm Diode laser) by comparing the surface temperature of titanium disc and bacterial sterilization according to laser power. Materials and Methods: The titanium disc was irradiated for 60 seconds and 1 - 2.5 W using diode laser 808 nm and 810 nm. The surface temperature of the titanium disc was measured using a temperature measurement module and a temperature measurement program. In addition, in order to investigate the sterilizing effect according to the laser power, 808 nm laser was irradiated after application of bacteria to sandblasted large-grit acid-etched (SLA) and resorbable blast media (RBM) coated titanium discs. The irradiated disks were examined with scanning electron microscopy. Results: Both 808 nm and 810 nm lasers increased disk surface temperature as the power increased. When the 810 nm was irradiated under all conditions, the initial temperature rise rate, the descending rate, and the temperature change before and after was higher than that of 808 nm. Disk surface changes were not observed on both lasers at all conditions. Bacteria were irradiated with 808 nm, and the bactericidal effect was increased as the power increased. Conclusion: When applying these diode lasers to the treatment of peri-implantitis, 808 nm which have a bactericidal effect with less temperature fluctuation in the same power conditions would be considered safer. However, in order to apply a laser treatment in the dental clinical field, various safety and reliability should be secured.

Tow-Year Follow-up Study for Clinical Feature and Immunity of The Children, Vaccinated by 47 Passaged Oka Strain Live Attenuated Varicella Vaccine (47계대 Oka주 약독화 생백신 접종 후 2년간 임상 및 면역성의 추적 연구)

  • Kang, Jin Han;Kim, Jong Hyun;Hur, Jae Kyun;Woo, Koo
    • Pediatric Infection and Vaccine
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    • v.7 no.1
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    • pp.129-135
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    • 2000
  • Purpose : We previously reported the short-term immunogenecity and safety of 47 passaged Oka strain live attenuated varicella vaccine in healthy children in 1997. Now, we conducted this two-year follow-up study to confirm the maintenance of immunity, the occurrence of natural varicella infection and the activation of vaccine induced latent infection on the same vaccine. Methods : 99 children who had been immunized by 47 passaged Oka strain live attenuated varicella vaccine in 1997 were followed up by questionnaire, and 46 children out of study group were followed up serologically. They were asked to report any instance of varicella or herpes zoster since they had been immunized. If there was any evidence of varicella or herpes zoster, they should be clinically or serologically confirmed by doctor. Also, those patients' parents were asked to report any instance of varicella or herpes zoster in their family, playmate, kindergarten, school, or other settings. The immunity to VZV was confirmed by EIA and FAMA test. Results : 6 recipients developed breakthrough varicella after exposure to VZV in family, kindergarten and school during follow-up period. However, clinical features of those patients were very mild and self limited without therapy. And none of the recipients developed herpes zoster during this observation period. The results of EIA test showed that study subjects were all seropositive except one, and the antibody titers and GMT of FAMA test were seropositively maintained in all subjects. Statistically, the antibody titers of EIA and FAMA test confirmed two years after vaccination were higher than those results confirmed one month after vaccination. Conclusion : Our study results suggest that the immunity of 47 passaged Oka strain live attenuated varicella is well maintained until 2 years later after vaccination, and mild natural infection after exposure to VZV can be occurred with low rate. There were not developing zoster in study vaccine after vaccination for two-years.

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Comparison of Clinical Efficacy Between Percutaneous Dilatational Tracheostomy and Surgical Tracheostomy (경피적 확장 기관절개술 (Percutaneous Dilatational Tracheostomy)의 시술 용이성 및 합병증)

  • Ahn, Jong-Joon;Koh, Youn-Suck;Chin, Jae-Yong;Lee, Ki-Man;Park, Wann;Hong, Sang-Bum;Shim, Tae-Sun;Lee, Sang-Do;Kim, Woo-Sung;Kim, Dong-Soon;Kim, Won-Dong;Lim, Chae-Man
    • Tuberculosis and Respiratory Diseases
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    • v.45 no.6
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    • pp.1277-1283
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    • 1998
  • Background : Surgical tracheostomy(ST) is usually performed by surgeons in operating room. For a patient with mechanical ventilation, however, transportation to operating room for ST could be dangerous for patients. In addition, ST is often delayed due to unavailability of operating room or surgeon. Percutaneous dilatational tracheostomy(PDT), although novel in Korea, is gaining popularity as a bedside procedure in the hospitals of western countries. We evaluated the technical ease and safety of PDT in comparison with ST. Method : Thirty-eight patients in medical intensive care unit (ICU) who were either under mechanical ventilation for more than 7 days or required airway protection, were randomly assigned to ST(18 patients) or PDT(20 patients). Between two groups, there was no significant clinical difference except that female to male ratio was higher in the ST group. ST was performed by second year residents of the department of otolaryngology while PDT was performed by third grade medical resident and pulmonologist under bronchoscopic guide using Ciaglia Percutaneous Tracheostomy Set(Cook Critical Care, Bloomington, USA) in medical ICU. The following factors were compared between two groups : number of delayed cases after the decision for tracheostomy, procedural time, complications related to tracheostomy. Results : Delayed cases were 11 in ST group and 3 in PDT group (P<0.05). Procedural time was significantly shorter in PDT group ($15.6{\pm}7.1min$) than in ST group ($29.1{\pm}11.6min$, P<0.0001). Complications related to tracheostomy occurred in 5 cases in ST group : accidental decannulation (1), subcutaneous emphysema (2) and minor bleeding (2), and in 4 cases in PDT group : minor bleeding (2), subcutaneous emphysema (1) and premature extubation (1) (P>0.05). Conclusion : Since percutaneous dilatational tracheostomy was easy to practice and its complications were not different from surgical tracheostomy, PDT can be a useful bedside procedure for mechanically ventilated patients.

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Customer Acceptance Procedure for Clinac (21EX-Platinum)

  • Hong, Dong-Ki;Lee, Woo-Seok;Kwon, Kyung-Tae;Park, Kwang-Ho;Kim, Chung-Man
    • The Journal of Korean Society for Radiation Therapy
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    • v.16 no.2
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    • pp.43-61
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    • 2004
  • Purpose : For qualify improvement in radiotherapy, it is important to set up and evaluate equipment (linac) accurately. In addition, technicians are needed to be fully aware of the equipment's detailed quality and its manual. Therefore, the result of ATP is evaluated and introduced, in order that the technicians are skilled by participating in quality assurance (QA) and understanding the quality of the equipment before clinical use. Method and Material : QA for LINAC 21EX (Varian, US) was done with suppliers its procedure was divided into radiation survey, mechanical test, radiation isocenter test, bean performance, dosimetry, and enhanced dynamic wedge and using X-omat film (Kodak), multidata, densitometer, and electrometer. QA of MLC (Millennium, 120 leaf) attached to LINAC and EPID (Portal vision) were done separately. Result : The leakage dose by survey meter was below the tolerance. In mechanical test, collimater, gantry, and couch rotation were less than 1mm, and the angles were ${\pm}0.1^{\circ}$ for digital and ${\pm}0.5^{\circ}$ for mechanical. The alignment test of the light field and crosshair were evaluated less than 1mm. The (a)symmetrical jaw field was less than ${\pm}0.5mm$. The radiation isocenter test using X-mat film was less than 1mm. The consistency of light field and radiation field was less than ${\pm}0.1mm$. PDD for photon energy was less than ${\pm}1\%$ and for electron energy of $90\%,\;80\%,\;50\%,\;and\;30\%$ were evaluated within the tolerance. Flatness for photon and electron energy was evaluated $2.3\%$ (tolerance $3\%$) and $3\%$ (tolerance $4.5\%$), respectively, and symmetry was $0.45\%$ (tolerance $2\%$) and $0.3\%$ (tolerance $2\%$), respectively. Dosimetry test for short term, MU setting, rep rate, and dose rate accuracy of photon and electron energy was within the tolerance depending on energy, MU, and gantry angle. Conclusion : Accuracy and safety for clinical use of Clinac 21EX was verified through customer acceptance procedure and the quality of the equipment was found out. These can reduce the difficulties in using the equipment. Furthermore, it is useful for clinically treatment of patients by technicians' active participations.

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Multicenter, Open-Labeled, Observational Clinical Trial to Investigate the Efficacy and Safety of Oral Administration of Megace Suspension in Patients with Head and Neck Cancer During Radiotherapy (방사선 치료 중인 두경부 종양 환자를 대상으로 메게이스 내복 현탁액 경구투여 후 유효성 및 안전성에 관한 다기관, 공개, 관측연구)

  • Kim, Se-Heon;Kim, Min-Sik;Kim, Young-Mo;Kim, Hyun-Su;Nam, Soon-Yuhl;Rho, Young-Soo;Park, Young-Hak;Baek, Chung-Hwan;Bong, Jung-Pyo;Lee, Kang-Dae;Lee, Yong-Seop;Jung, Kwang-Yoon;Chung, Sung-Min;Chung, Pil-Sang;Joo, Young-Hoon;Chu, Hyung-Ro;Choi, Eun-Chang;Tae, Kyung;Hong, Ki-Hwan
    • Korean Journal of Head & Neck Oncology
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    • v.24 no.1
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    • pp.57-63
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    • 2008
  • Background and Purpose:Nausea, vomiting and weight loss are common problems that are encountered in the course of cancer patient treatment who are receiving radiotherapy. In this study, we are aiming to analyze the effect of megestrol acetate on quality of life of head and neck cancer patients receiving radiotherapy, resulting from improvement of weight loss, appetite and nutritional status via multicenter, open-labeled, observational clinical trial. Material and Methods:A total of 270 patients from 10 medical institutes who are receiving radiotherapy or who have completed radiotherapy within 3 months, between February 2007 and February 2008, were selected as candidates for the study. Megestrol acetate suspension(megace) was given to the subjectives once a week for 4 weeks with the amount of 20ml(megestrol 800mg). Measurement of weight and questionnaire surveys were carried out three times: at the start of the study, 4 weeks after the start of the medication, and 4 weeks after the end of the medication, respectively. Results:The group who has received megace had a total number of 199, and control group was 70. The group who have received megace showed mean weight loss of 1kg in 8 weeks, compared with the weight loss of 5.5kg in control group, which showed that the medication was effective in reducing the amount of weight loss(P=0.027). The group who received megace had a tendency to report a reduced rate of decrease in the score of appetite, nausea and vomiting, and QOL score, but it did not have statistical significance(P>0.05). Conclusion:Megestrol acetate have reduced the degree of weight loss significantly, and it has a tendency to reduce the rate of decrease in appetite, aggravation of nausea and vomiting, and quality of life.

Studies on Anti-Wrinkle and Whitening Effects of Liposomes Containing Acerola Extract Mixture (아세로라 추출물 혼합 리포좀의 주름, 미백 효과에 대한 연구)

  • Kim, Su Jin;Oh, Won Jun;Kwon, Sung Pil;Nam, Gaewon
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.47 no.4
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    • pp.341-352
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    • 2021
  • Acerola is an excellent ingredient because of its high natural vitamin C content, but it is difficult to stabilize and has hardly been studied as a cosmetic material. Therefore, this study developed a mixed liposome preparation for stabilizing acerola extract. As a safety test, the skin irritation test was evaluated by BCOP assay and HET-CAM assay. We evaluated the inhibition of tyrosinase activity, the whitening effect of melanin production, and the wrinkle effect of prochloragentype-I C-peptide production, and confirmed the possibility of functional cosmetics. In addition, a cream of liposomes containing acerola extract mixture was developed to evaluate the clinical studies of skin wrinkles and whitening. BCOP assay, HET-CAM assay and human skin primary irritation test results of liposomes containing acerola extract mixture showed no irritation and were safe from skin and eye. The result of tyrosinase activity by 75.8% at 1,000 ㎍/mL. As a result of the melanogenesis inhibition test, liposome with acerola extract showed the melanin content by 46.2% at 1,000 ㎍/mL that does not effect the viability of the B16F10 cell line. The result of collagen production test using ELISA kit, liposomes containing acerola extract mixture showed collagen synthesis ability by 152.1% at 1,000 ㎍/mL that does not affect the viability of the HS68 cell line. But it did not showed any inhibition of collagenase (MMP-1) activity at all concentrations in the MMP-1 activity inhibition test in the HS68 cell line. We performed clinical studies for the whitening and skin-wrinkle activity of cream containing acerola extract mixes liposome, was showed that the melanin contents and wrinkle was statistically significant reduction. These results suggest that liposomes containing acerola extract mixture have safe natural material, and skin wrinkle, whitening effects allowing their application in cosmetics as a natural product.