• Title/Summary/Keyword: Clinical trial,

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Effects of Fractionated Stereotactic Radiotherapy for Primary Hepatocellular Carcinoma (원발성 간암의 분할 정위방사선치료 효과)

  • Choi Byeong Ock;Kang Ki Mun;Jang Hong Seok;Lee Snag-wook;Kang Young Nam;Chai Gyu Young;Choi Ihl Bhong
    • Radiation Oncology Journal
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    • v.23 no.2
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    • pp.92-97
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    • 2005
  • Purpose : Reports on the outcome of curative radiotherapy for the primary hepatocellular carcinoma (HCC) are rarely encountered in the literature. in this study, we report our experience of a clinical trial where fractionated stereotactic radiotherapy (SRT) was used in treating a primary HCC. Materials and Methods : A retrospective analysis was peformed on 20 patients who had been histologically diagnosed as HCC and treated by fractionated SRT. The long diameter of tumor measured by CT was $2\~6.5$ cm (average: 3.8 cm). A single dose of radiation used in fractionated SRT was S or 10 Gy: each dose was prescribed based on the planning target volume and normalized to $85\~99\%$ isocenter dose. Patients were treated $3\~5$ times per week for 2 weeks, with each receiving a total dose of 50 Gy (the median dose: 50 Gy). The follow up period was $\~55$ months (the median follow up period: 23 months). Results : The response rate was $50\%$ (12 patients), with 4 patients showing complete response ($20%$), 8 patients showing partial response ($40\%$), and 8 patients showing stable disease ($40\%$). The 1-year and 2-year survival rates were $70.0\%$ and $43.1\%$, respectively, and the median survival time was 20 months. The 1-year and 2-year disease free survival rates were $65\%$ and $32.5\%$, respectively, and the median disease-free survival rate was 19 months. Some acute complications of the treatment were noted as follows: dyspepsia in 12 patients ($60\%$), nausea/emesis in 8 patients ($40\%$), and transient liver function impairment in 6 patients ($30\%$). However, there was no treatment related death. Conclusion : The study indicates that fractionated SRT is a relatively safe and effective method for treating primary HCC. Thus, fractionated SRT may be suggested as a local treatment for HCC of small lesion and containing a single lesion, when the patients are inoperable or operation is refused by the patients. We thought that fractionated SRT is a challenging treatment modality for the HCC.

Etiology and Analysis of Severity in Childhood Pancreatitis (소아 췌장염의 원인과 중증도 분석)

  • Park, Jun-Eun;Kim, Kyong-Mo
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.2 no.2
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    • pp.194-203
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    • 1999
  • Purpose: Childhood pancreatitis has more various and somewhat different etiology than adult. Until now the analysis of severity in childhood pancreatitis were not well-known, although several studies have been made. Therefore, we studied the etiology and complications in childhood pancreatitis and analyzed whether Ranson and CT criteria could be applicated to evaluate the severity of childhood pancreatitis patients. Methods: The records of 30 patients with pancreatitis under 15 years of ages who were diagnosed in Asan medical center were reviewed. Age, sex, history, etiology, clinical features and treatment was reviewed in all patients but complications, Ranson and CT criteria were available in only 12 patients. Correlation between the number of complications and both Ranson and CT criteria were calculated with Spearman correlation coefficient. Results: 1. Median age at diagnosis was 7.3 years of age. 28 cases were acute pancreatitis and 2 cases were chronic pancreatitis. 2. Etiology: choledochal cyst(8 cases), drug (7 cases), trauma (4 cases), infection (3 cases), biliary stone or bile sludge (3 cases), idiopathic (2 cases) Hemolytic uremic syndrome, pancreatic duct obstruction, iatrogenic (1 case). 3. Local complications were ascites (5 cases), pseudocyts (4 cases) and systemic complications were hyperglycemia (4 cases), hypocalcemia (3 cases), pleural effusion (3 cases), etc. 4. Positive correlation was found between the number of complication and Ranson creteria (r=0.78, P=0.0016) and between the number of complication and CT criteria (r=0.65, P=0.015) in 13 cases. Conclusion: A trial to search the biliary duct anomaly may help to find the causes of childhood idiopathic pancreatitis, and both Ranson and CT criteria can be applicated to pediatric patients to evaluate the severity of childhood pancreatitis.

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Synthesis of trans-(3R,5S)-Atorvastatin Ca and Curative Effect on Hyperlipidemia Induced by a High-Fat Diet in Rats (trans-(3R,5S)-Atorvastatin Ca의 합성 및 Rat에서 고지방식이로 유도된 고지혈증 치료효과)

  • Choi, Won-Sik;Nam, Seok-Woo;Lee, Gyung-Rak
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.12 no.11
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    • pp.4940-4950
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    • 2011
  • cis-(3R,5R)-Atorvastatin Ca (1) used for hyperlipidemia have four stereomers. However, It is very difficult to prepare stereoselective stereomers. In this paper, the reduction of 3,5-diketo atorvastatin ester (3) was performed using $Me_4NHB(OAc)_3$ in acetic acid as a reductant and showed excellent stereoselectivity in the double reduction of 3,5-diketo atorvastatin ester (3). As a result, reduction of compound 3 by $Me_4NHB(OAc)_3$ was purely obtained with cis-(3R,5R)-atorvastatin ester (4) of 1.5% and trans-(3R,5S)-atorvastatin ester (5) of 98.5%. Also, cis-(3R,5R)-atorvastatin Ca (1) and trans-(3R,5S)-atorvastatin Ca (7) were used to determine efficacy in the treatment of liver damage and hyperlipidemia induced by a high-fat diet in rats and to study the performance of the January 2010 experient was conducted. As a result, total cholesterol (TC), high-density lipoprotein-cholesterol (HDL-c), low-density lipoprotein-cholesterol (LDL-c), and triglyceride (TG) levels of compound 1 and 7 groups were $93.0{\pm}0.5$, $43.5{\pm}0.8$, $40.4{\pm}1.4$, $45.6{\pm}0.9\;mg/d{\ell}$ and $110.0{\pm}0.7$, $33.3{\pm}0.6$, $65.8{\pm}1.9$, $54.8{\pm}1.2\;mg/d{\ell}$, respectively. Atherogenic index (AI) and cardiac risk factor (CRF) in compound 1 and 7 were $1.14{\pm}0.05$, $2.14{\pm}0.05$ and $2.31{\pm}0.06$, $3.31{\pm}0.06$, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were $51.9{\pm}4.6$, $16.0{\pm}2.1\;IU/{\ell}$ and $75.8{\pm}4.4$, $35.1{\pm}9.7\;IU/{\ell}$. Taken together, while compound 1 treat against high-fat diet-induced hyperlipidemia by attenuating hepatic lipid depots and reducing oxidative stress, compound 7 group had a low curative effect on hyperlipidemia induced by a high-fat diet in rats. These findings suggest that new method about synthesis of stereoselective stereomers and indicate that it may consider using in a clinical trial.

3D analysis of soft tissue around implant after flap folding suture (Flap folding suture를 활용한 판막의 고정에 따른 임플란트 주변 연조직 3차원 부피 변화 관찰)

  • Jung, Sae-Young;Kang, Dae-Young;Shin, Hyun-Seung;Park, Jung-Chul
    • Journal of Dental Rehabilitation and Applied Science
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    • v.37 no.3
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    • pp.130-137
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    • 2021
  • Purpose: The various suture techniques can be utilized in order to maximize the keratinized tissue healing around dental implants. The aim of this study is to compare the soft tissue healing pattern between two different suture techniques after implant placement. Materials and Methods: 15 patients with 18 implants were enrolled in this study. Simple implant placement without any additional bone graft was performed. Two different suture techniques were used to tug in the mobilized flap near the healing abutment after paramarginal flap design. Digital intraoral scan was performed at baseline, post-operation, stitch out, and 3 months after operation. The scan data were aligned using multiple points such as cusp, fossa of adjacent teeth, and/or healing abutment. After subtracting scan data at baseline with other time-point results, closed space indicating volume increment of peri-implant mucosa was selected. The volume of the close space was measured in mm3. The volume between two suture techniques at three time-points was compared using nonparametric rank-based analysis. Results: Healing was uneventful in both groups. Both suture technique groups showed increased soft tissue volume immediately after surgery. The amount of volume increment significantly decreased after 3 months (P < 0.001). Flap folding suture group showed higher median of volume increment than interrupted suture group after 3 months without any statistical significance (P > 0.05). Conclusion: After paramarginal flap reflection, the raised flaps stabilized by flap folding suture showed relatively higher volume maintenance after 3-month healing period. However, further studies are warranted.

Clinical Characteristics in Panic Disorder Patients in Emergency Department (공황발작으로 응급실에 내원한 공황장애 환자들의 임상 특징)

  • Lee, Chang-Ju;Nam, Beom-Woo;Sohn, In-Ki
    • Korean Journal of Psychosomatic Medicine
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    • v.29 no.1
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    • pp.26-33
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    • 2021
  • Objectives : This study was designed to investigate datas related to panic attack and treatment in emergency room of panic disorder patients who visited emergency room for panic attack. Methods : A retrospective analysis of medical records was conducted on 92 patients with panic disorder who visited Chungju Konkuk university hospital emergency department due to panic attack and had bodily symptoms from 1st January 2010 to 31th December 2019. In addition to demographic characteristics and comorbid disorders, triggering stressors and alcohol consumption were corrected as pre-panic attack datas, bodily symptoms at the time of panic attack were corrected as datas during attack, electrocardiogram trial, consultation with psychiatrist, admission and information of used psychotropic drugs were corrected as post-attack data. Depending on size of data, Chi-square test or Fisher's exact test was used. Collected data was analyzed using R 4.03. Results : Cardiovascular disease was accompanied by 5.4% and depressive disorder was the most common coexisting mental disorder. Among triggering stressors, economic problem/work-related stress was significantly higher in men than women (𝛘2=4.322, p<0.005). The most common physical symptom during attack was circulatory (65.2%), followed by respiratory (57.6%), numbness-paralysis (33.7%), dizziness (19.6%), gastro-intestinal (14.1%) and autonomic symptom (12.0%). Electrocardiogram was taken at higher rate when patients complained circulatory symptom (𝛘2=8.46, p<0.005). The psychotropic drug most commonly used in emergency room was lorazepam, used in 92.1%. Conclusions : The most common bodily symptom during panic attack was circulatory symptom and the most common triggering stressor in men was economic problem/work-related stress. The most commonly used psychotropic for panic attack was lorazepam.

Study on the Safety of Firefly Luciferase in Human as a Transient Reporter Gene of Oncolytic Virotherapy (항암 바이러스 치료제의 보고유전자로써 반딧불이 루시퍼레이즈의 인체 내 안전성에 대한 연구)

  • Hong, Young Mi;Yoon, Woong Hee;Lee, You Ra;Kim, Soo Ji;Ngabire, Daniel;Narayanasamy, Badrinath;Ornella, Mefotse Saha Cyrelle;Kim, Myunghee;Cho, Euna;Lee, Bora;Hwang, Tae-Ho
    • Journal of Life Science
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    • v.31 no.11
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    • pp.1028-1036
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    • 2021
  • Firefly luciferase (FLuc) can function as an efficient marker in the gene and viral therapies. Nonetheless, its clinical translation has been unaccomplished with the concerns on its exogenous nature and the similarity with human fatty acyl-CoA synthetase. In this study, we aimed to show safety of FLuc by conducting a set of preclinical experiments and a human use. Initially, FLuc permeability across the plasma membrane was investigated by delivering the FLuc-carrying viral vector, OTS-412, or the FLuc recombinant protein. After in vitro infection of OTS-412 into different cancer cell lines, FLuc activity was detected only in the cell lysates, but not in culture media. In addition, recombinant FLuc protein further showed the impermeability against the plasma membrane. Similar result was also observed in the in vivo experiment. After being injected into the VX2 tumor-bearing rabbit, the FLuc exclusively resided within the tumor tissue without being detected in the blood plasma or other organs. Human cancer cell lines originated from various organs were lysed and treated to the FLuc, and none of the human substrates was reactive against the FLuc. As a final step, FLuc recombinant protein was intravenously injected into a human. The luciferase was degraded with the half-life of 20 to 30 minutes in blood, and was untraceable from 1.5 hr after the injection. In addition, the blood plasma was nonresponsive against the fatty acids. Hematological analysis was also comparable between the pre- and post-injection. Altogether, our study collectively demonstrates the safety of the firefly luciferase.

Efficacy evaluation dental plaque and halitosis removal of mouthwash containing sodium chloride (염화나트륨 함유 구중청량제의 치면세균막 및 구취 제거 효능평가)

  • Lee, Jong-Cheon;Cho, Ja-Won;Yoo, Hyun-Jun;Kim, Chan-Ho;Choe, Byeong-Gi
    • Journal of Dental Rehabilitation and Applied Science
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    • v.38 no.1
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    • pp.1-8
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    • 2022
  • Purpose: The purpose of this study was to evaluate the effects of mouthwash containing sodium chloride on dental plaque, gingival inflammation index, and bad breath through clinical trials. Materials and Methods: This trial was designed as 12 weeks and subjects were instructed to put an appropriate amount of the provided standard detergent on a toothbrush and brush their teeth 3 times a day. They were instructed to gargle a mouthwash provided to each group after brushiung. Efficacy was evaluated by performing gingival and periodontal-related index tests, dental plaque changes, and bad breath tests a total of 5 times. All data were statistically analyzed using 2-sample t-test, paired t-test to compare between groups at 95% significance level using IBM SPSS Statistics 24.0. Results: As a result of the PMA index measurement, the gingivitis improvement effect rate of the experimental group compared to the control group was 107.63% after 8 weeks and 73.08% after 12 weeks. As a result of the PHP index measurement, the plaque improvement effect rate of the experimental group compared to the control group was 79.37% after 8 weeks and 74.06% after 12 weeks. As a result of measuring volatile sulfur compounds using Oral Chroma, the effectiveness of improvement in bad breath in the experimental group was 65.06% after 8 weeks and 99.33% after 12 weeks, compared to the control group. Conclusion: As a result of this study, it was confirmed that effective gingivitis alleviation, plaque removal effect and bad breath removal effect can be expected when a mouthwash containing sodium chloride, green tea extract, and sodium monofluorophosphate is used.

Efficacy and Safety of COVID-19 Vaccines in Adolescents: Systematic Review of Randomized Controlled Studies and Observational Studies

  • Soo-Han Choi;Su-Yeon Yu;Jimin Kim;Miyoung Choi;Youn Young Choi;Jae Hong Choi;Ki Wook Yun;Young June Choe
    • Pediatric Infection and Vaccine
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    • v.31 no.1
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    • pp.12-24
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    • 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.

The Effects of Functional Tea (Mori Folium, Lycii Fructus, Chrysanthemi Flos, Zizyphi Fructus, Sesamum Semen, Raphani Semen) Supplement with Medical Nutrition Therapy on the Blood Lipid Levels and Antioxidant Status in Subjects with Hyperlipidemia (고지혈증 환자에서 의학영양치료와 병행하여 섭취한 기능성차(상엽, 구기자, 국화, 대추, 참깨, 나복자)의 혈중 지질 농도 저하 및 항산화 효과)

  • Lim, Hyun-Jung;Cho, Kum-Ho;Choue, Ryowon
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.34 no.1
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    • pp.42-56
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    • 2005
  • Hyperlipidemia is one of the risk factors for coronary artery disease. Despite of epidemiological evidence that tea consumption is associated with the reduced risk of coronary heart disease, experimental studies designed to show that drinking tea affects blood lipid concentration or oxidative stress have been unsuccessful. The purpose of this study was to investigate whether functional tea (three servings/day) supplement with medical nutrition therapy (MNT) lead to a beneficial outcomes in mildly hyperlipidemic adults. From February to October, 2003, the 43 hyperlipidemic (23 men, 20 women) subjects (total cholesterol$\geq$200 mg/dL or triglyceride$\geq$150 mg/dL) admitted to K Medical Center were studied. Subjects were randomly divided into 3 groups; placebo tea (PT), half dose of functional tea (HFT), full dose of functional tea (FFT). During 12 weeks of study period, the subjects were given placebo or functional tea daily with MNT. Anthropometric measurements, blood chemical analysis including lipid levels, total superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) levels, and dietary assessment were carried out at the beginning and end of experiment. The effects of functional tea were compared with the placebo in randomized clinical trial study. The placebo was prepared to match with the functional tea in color and taste. After the 12 weeks of MNT, the subjects had regular and balanced meal pattern. Consumption of foods high in cholesterol and saturated fat, salty foods, fried foods, and instant foods decreased significantly in all three groups (p<0.05). Intake of energy and cholesterol also decreased (p<0.05). Drinking three servings per day (390 mL/day) of functional tea significantly reduced the levels of blood triglyceride (HFT, 42.5%; FFT, 29.4%), total cholesterol (HFT, 8.5%; FFT, 13.7%), and atherogenic index (HFT, 14.6%; FFT, 21.7%). Whereas no changes were found in the LDL-, HDL-cholesterollevels, and LDL/HDL ratio. Plasma homocysteine (Hcy) concentration decreased significantly (p<0.05) in functional tea groups (HFT, 14.9%; FFT, 14.1%). SOD increased significantly (p<0.05) in HFT (8.3%). GSH-Px increased significantly (p<0.05) in FFT (12.8%). In conclusion, the MNT improved the dietary habits, in addition, functional tea supplement decreased blood lipid levels and Hcy, and increased SOD and GSH-Px levels. These results indicate that functional tea consumption may decrease the risk of cardiovascular disease via improving blood lipid levels and antioxidant status.

A Phase I/II Trial of $DCVac/IR^{(R)}$ Dendritic Cell Immunotherapy Combined with Irradiation in Cases of Refractory Colorectal Cancer with Multiple Liver Metastases (기존의 치료에 반응하지 않는 다발성 간전이 대장암 환자에서 방사선조사와 병합한 수지상세포 면역치료의 1, 2상 임상시험)

  • Choi, Young-Min;Lee, Hyung-Sik;Kwon, Hyuk-Chan;Han, Sang-Young;Choi, Jong-Cheol;Chung, Ju-Seop;Kim, Chang-Won;Kim, Dong-Won;Kang, Chi-Duk
    • Radiation Oncology Journal
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    • v.26 no.2
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    • pp.104-112
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    • 2008
  • Purpose: To assess the toxicity and tumor response induced by $DCVac/IR^{(R)}$ dendritic cell(DC) immunotherapy combined with irradiation for refractory colorectal cancer patients with multiple liver metastases. Materials and Methods: Between May 2004 and November 2006, applicants from a pool of refractory colorectal cancer patients with multiple liver metastases were enrolled. The patients were registered after having signed the informed consent form, which had been approved by the Institutional Review Board from the Dong-A University and Busan National University Hospital. DCs were obtained from peripheral blood of each patient, and then cultured in vitro. A total of $6{\times}10^6$ DCs were packed into a vial($DCVac/IR^{(R)}$, 0.5 ml) at the convenience of each patient's schedule. On the day before and on the day of each vaccination, each patient received a 4 Gy radiation dose to the target tumor. On the day of vaccination, the indicated dose of autologous DCs was injected into the irradiated tumor using ultrasound-guided needle injection procedures. A total of four vaccinations were scheduled at three 2-week intervals and one 4 week interval at the Dong-A University and Busan National University Hospital. If the tumor status was deemed to be stable or responding to therapy, an additional vaccination dose or two was approved at 4 week intervals beyond the fourth immunization. A tolerance test for DCs was conducted by injecting a range of doses($3{\times}10^6\;to\;12{\times}10^6$ DCs) after the 3rd injection. Moreover, the maximal tolerable dose was applied to additional patients. Treatment safety was evaluated in all patients who had at least one injection. Treatment feasibility was evaluated by the 10th week by assessing the response of patients having at least 4 injections. For systemic toxicities, the evaluation was performed using the National Cancer Institute Common Toxicity Criteria, whereas adverse effects were recorded using common WHO toxicity criteria. Results: Of the 24 registered patients, 22 received the DCs injections. Moreover, of the 14 patients that applied for the tolerance test, only 11 patients completed it because 3 patients withdrew their testing agreement. A grade 3 or more side effect, which was possibly related to the DC injection, did not occur in additional patients. The $12{\times}10^6$ DC injection was identified as the maximum tolerable dose, and was then injected in an additional 8 patients. Patients tolerated the injection fairly well, with no fatal side effects. In order to assess the feasibility of DC immunotherapy, the response was evaluated in other hepatic lesions outside of the targeted hepatic lesion. The response evaluation was performed in 15 of the 17 patients who received at least 4 injections. Stable and progressive disease was found in 4 and 11 patients, respectively. Conclusion: The DC-based immunotherapy and radiotherapy is theoretically synergistic for the local control and systemic control. The $DCVac/IR^{(R)}$ immunotherapy combined with irradiation was tolerable and safe in the evaluated cases of refractory colorectal cancer with multiple liver metastases. Future work should include well designed a phase II clinical trials.