Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study

Choi, Yoon Jin,Lee, Dong Ho,Choi, Myung-Gyu,Lee, Sung Joon,Kim, Sung Kook,Song, Geun Am,Rhee, Poong-Lyul,Jung, Hwoon-Yong,Kang, Dae-Hwan,Lee, Yong Chan,Lee, Si Hyung,Choi, Suck Chei,Shim, Ki-Nam,Seol, KOREAN ACADEMY OF MEDICAL SCIENCE 2017 JOURNAL OF KOREAN MEDICAL SCIENCE Vol.32 No.11

<P>This study compared the efficacy of DA-9601 (Dong-A ST Co., Seoul, Korea) and its new formulation, DA-5204 (Dong-A ST Co.), for treating erosive gastritis. This phase III, randomized, multicenter, double-blind, non-inferiority trial randomly assigned 434 patients with endoscopically proven gastric mucosal erosions into two groups: DA-9601 3 times daily or DA-5,204 twice daily for 2 weeks. The final analysis included 421 patients (DA-5204, 209; DA-9601, 212). The primary endpoint (rate of effective gastric erosion healing) and secondary endpoints (cure rate of endoscopic erosion and gastrointestinal [GI] symptom relief) were assessed using endoscopy after the treatment. Drug-related adverse events (AEs), including GI symptoms, were also compared. At week 2, gastric healing rates with DA-5204 and DA-9601 were 42.1% (88/209) and 42.5% (90/212), respectively. The difference between the groups was −0.4% (95% confidence interval, −9.8% to 9.1%), which was above the non-inferiority margin of −14%. The cure rate of gastric erosion in both groups was 37.3%. The improvement rates of GI symptoms with DA-5204 and DA-9601 were 40.4% and 40.8%, respectively. There were no statistically significant differences between the two groups in both secondary endpoints. AEs were reported in 18 (8.4%) patients in the DA-5204 group and 19 (8.8%) in the DA-9601 group. Rates of AE were not different between the two groups. No serious AE or adverse drug reaction (ADR) occurred. These results demonstrate the non-inferiority of DA-5204 compared to DA-9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis. Registered randomized clinical trial at ClinicalTrials.gov (NCT02282670)</P>

급성전골수성백혈병에서 백혈구성분채집술에 이은 치명적인 뇌출혈 2예

오윤정,박소윤,김윤정,한동석,김현수,최진혁,남동기,임호영,김효철,주희재 아주대학교 의과학연구소 1998 아주의학 Vol.3 No.1

The aim of this study is to report 2 cases of acute promyelocytic leukemia who died from intracranial hemorrhage following leukapheresis and to provide proper preventive measures against hemorrhage following leukapheresis. From 1994 to 1997, a total of twenty-six patients with leukemia underwent leukapheresis to control hyperleukocytosis at Ajou University Hospital. Two patients with acute promyelocytic leukemia received all-trans retinoic acid but developed drug-induced hyperleukocytosis. Shortly after leukapheresis, they died from intracranial hemorrhage. The risk factors for fatal hemorrhage are thought to be coexisting disseminated intravascular coagulation(DIC), thrombocytopenia aggravated by leukapheresis, exacerbated coagulopathy related to mechanical trauma through leukapheresis and the excess use of citrate during leukapheresis. To reduce the risk of the bleeding associated with leukapheresis, it is necessary to replace platelet sufficiently before and after leukapheresis and to give calcium to correct coagulopathy induced by excess citrate which is used as anticoagulant as well as the correction of disseminated intravascular coagulation.

족과관절염좌 환자에 대한 동씨침법과 일반침법의 효과에 대한 비교 연구

안호진,정동화,황규선,윤기붕,김태우,문장혁,백종엽,이상무,Ahn, Ho-jin,Jeong, Dong-hwa,Hwang, Kyu-seon,Yoon, Ki-bung,Kim, Tae-woo,Moon, Jang-huyk,Baek, Jong-yeob,Lee, Sang-moo 대한침구의학회 2003 대한침구의학회지 Vol.20 No.1

Objective: The purpose of this study is to compare the effects of Dong-si acupuncture therapy and General acupuncture therapy for the patients with acute ankle sprain. Methods : This study has been carried out for 60 cases of ankle sprain patients who have visited Dong-Seo Oriental medical Hospital from May 1, 2002 to September 30, 2002. We have treated 30 cases of them by Dong-si acupuncture therapy and the other 30 cases by General acupuncture therapy. And we have compared those two group. Results : 1. There was no significant difference at the treatment period and the number of treatment times in comparing two groups. 2. The number of treatment times for good effect is that : Dong-si took $1.57{\pm}0.85$ times and General acupuncture therapy took $2.15{\pm}0.96$ times. And we have found that the effect of Dong-si acupuncture therapy is faster than the other.

정신분열병에 대한 리스페리돈의 효과 및 안정성

이민수,김용구,김영훈,연병길,오병훈,윤도준,윤진상,이철,정희연,강병조,김광수,김동언,김명정,김상훈,김희철,나철,노승호,민경준,박기창,박두병,백기청,백인호,손봉기,손진욱,양병환,양창국,우행원,이정호,이종범,이홍식,임기영,전태연,정영조,정영철,정인과,정인원,지익성,채정호,한상익,한선호,한진희,서광윤 大韓神經精神醫學會 1998 신경정신의학 Vol.37 No.1

연구목적 : 본 시험의 목적은 임상시험 시작전에 연구자들을 대상으로 PANSS Workshop을 통하여 PANSS, ESRS에 대한 국내에서의 표준화 작업을 구축하고 새로운 정신병 치료제인 리스페리돈의 효과와 안정성을 재확인하여 리스페리돈 사용에 대한 적정화를 이루는데 있다. 연구방법 : 1996년 4월부터 1996년 9월까지 국내 39개 대학병원 정신과에 입원중인 혹은 증상이 악화되어 입원하는 정신분열병 환자 377명을 대상으로 다시설 개방 연구를 시행하였다. 1주일간의 약물 배설기간을 가진후, 리스페리돈을 8주간 투여하였고, 기준점, 1주, 2주, 4주, 그리고 8주후에 평가되었다. 용량은 제1일에는 리스페리돈 1mg씩 1일 2회, 제2일에는 2mg씩 1일 2회, 제3∼7일에는 3mg씩 1일 2회 투여하였다. 이후 환자의 임상상태에 따라 임의로 증량할 수 있으며, 최대 일일 16mg을 초과하지 않도록 하였다. 추체외로 증상을 조절하기 위한 투약을 허용하였다. 임상증상 및 부작용의 평가는 PANSS(Positive and Negative Syndrome Scale), CGI(Clinical Global Impression) 그리고 ESRS(Extrapyramidal Symptom Rating Scale)을 사용하였다. 연구결과 : 377명중 343명(91%)이 8주간의 연구를 완결하였다. 치료 종결시점인 8주후 PANSS 총점수가 20% 이상 호전된 경우를 약물 반응군으로 정의할때, 약물반응군은 81.3%였다. 리스페리돈에 반응하는 예측인자로는 발병연령, 이전의 입원 횟수, 유병기간이 관련 있었다. 리스페리돈은 1주후부터 PANSS양성, 음성, 및 일반정신병리 점수상에 유의한 호전을 보여 효과가 빨랐다. CGI의 경우도 기준점에 비해 1주후부터 유의한 감소를 나타내었다. ESRS의 경우, 파킨슨 평가점수는 기준점과 비교해 투여 1주, 2주, 4주후 유의하게 증가되었다가 8주후 기준점과 차이가 없었다. Dystonia 평가점수는 1주후만 유의한 증가를 보였으며, dyskinesia 평가점수는 유의한 차이가 없었다. 혈압, 맥박수의 생명징후 및 일반 혈액학 검사, 생화학적 검사, 심전도 검사에서 유의한 변화는 없었다. 결 론 : 이상의 다시설 개방 임상 연구를 통해 리스페리돈은 정신분열병 환자에서 양성증상뿐만 아니라 음성증상 및 전반적인 증상에도 효과적인 것으로 사료된다. 보다 명확한 평가를 위해서는 다른 항정신병약물과의 이중맹검 연구가 필요할 것으로 생각되며, 또한 장기적 치료에 대한 평가도 함께 이루어져야 하겠다. Objective : The purpose of this study was to investigate the efficacy and safety of risperidone in the treatment of Korean schizophrenic patients. Method : This multicenter open study included 377 schizophrenic patients drawn from 39 university hospitals. After a wash-out period of 1 week, the schizophrenic patients were treated with risperidone for 8 weeks and evaluated at 5 points ; at baseline, and 1, 2, 4 and 8 weeks of treatment. The dose was increased from 2mg/day(1mg twice daily) to 6mg/day(3mg twice daily) during the first week and adjusted to a maximum of 16mg/day over the next 7 weeks according to the patient's clinical response. Medication to control extrapyramidal symptoms was permitted. The psychiatric and neurological status of the patients was assessed by PANSS, CGI, and ESRS scales. Results : 343(91%) of 377 patients completed the 8-week trial period. Clinical improvement, as defined by a 20% or more reduction in total PANSS score at end point, was shown by 81.3% of patients. The predictors of response to risperidone were associated older age, shorter duration of illness, fewer previous hospitalization. Risperidone had rapid onset of action ; a significant decrease of the total PANSS and three PANSS factor(positive, negative, general), and CGI was already noticed at the end of first week. For the ESRS, parkinsonism rating scores were significantly increased until week 4 comparing with baseline. Dystonia rating scores were significantly increased until week 1, and dyskinesia rating scores were not significantly changed during the study. Laboratory parameters including vital sign, EKG, hematological, and biochemical values showed no significant changes during the trial. Conclusions : This study suggests that risperidone is generally safe and effective against both the positive and negative symptoms in our group of patients.

결합재 페이스트 충전에 따른 포러스콘크리트의 물성에 관한 기초적 연구

윤상혁,양동일,정근호,김성식,이영도,정상진 대한건축학회 2003 대한건축학회 학술발표대회 논문집 - 계획계/구조계 Vol.23 No.1(구조계)

Although porous concrete is recently used as a pavement at a parking lot, a public squre and a bicycle road, we use without enough examining. Most the maintenance of quality for porous concrete is only dealt with strength and color tone. Also, there is not et enough fundamental data about dynamical properties for strength, rate of void and water permeability. Even when it is applied to at the scene, it is been a matter. Accordingly in this study analyzed influences through the dynamical properties, combination, and time to vibration. After the analyzation, they investigated peculiar dynamics which are strength of porous concrete, rate of void, and water permeability follow the rate of increase on an admixture making pozzolan reaction. This is purpose to improve capacity of the sidewalk permeable concrete and development of the economical technique for pavement.

관개수심에 따른 벼의 생육 및 수량

윤성탁,전태웅,이동진 한국국제농업개발학회 2002 韓國國際農業開發學會誌 Vol.14 No.1

논토양에 있어서 관개수심에 따른 온도분포를 파악하고, 벼 재배에서 관개수심을 달리했을 때 수온과 지온의 온도환경변화와 이에 따른 수도의 생육 및 수량반응을 구명코자 실시한 시험결과는 다음과 같다. 우리나라 수원지방에서 수도재배기간 중 평균기온범위는 23.4∼29.1℃의 분포를 보였으며, 평균기온은 25.3℃이었다. 평균수온은 21.4∼26.7℃의 범위를, 지온은 21.7∼25.7℃의 범위를 보였으며, 수온 및 지온은 평균기온의 상승ㆍ하강에 따라 상승ㆍ하강하였다. 관개수심에 다른 생육특성을 보면 초장, 엽면적, 건물중 등은 처리간 차이가 없었다. 그러나 유수형성기는 12cm관개구에서 이앙 후 87일, 4cm구에서 83.3일이 각각 소요되어 관개수심이 깊을수록 유수형성기는 늦어지는 경향이었다. 수량 및 관련형질은 ㎡당 수수는 4cm관개구에서 413.3개/㎡로 가장 많았으나, 수당립수 및 ㎡당 입수는 오히려 8cm관개구가 각각 99.0개. 38,808개/㎡로 가장 많았으나, 관개수심별 정조수량은 대차 없었다. This experiments were carried out to evaluate the characteristics of temperature and the response of growth and yield characteristics under different irrigation depth in paddy rice field. Range of mean air temperature showed from 23.4℃ to 29.1℃ and mean of these air temperature was 25.3℃, while range of water temperature was from 21.4℃ to 26.7℃ and mean water temperature was 24.7℃. Range of soil temperature also was shown from 21.7℃ to 25.7℃ and mean temperature was 24.4℃ during growing periods of rice in Suwon. Plant height, leaf area index and dry matter were not shown difference among different irrigation depth, but date of panicle formation between irrigation depth showed difference such as that 12cm irrigation depth required 87.0 days while 4cm irrigation depth 83.3 days from transplanting showing that the deeper the irrigation depth, the later the panicle formation delayed. Number of panicles per ㎡ was shown highest in 4cm irrigation depth with 413.3/㎡, but 8cm irrigation depth showed higher number of grain per panicle and number of grain per ㎡ with 99.0, 2560.0/㎡ respectively. Unhulled rice yield among different irrigation depth showed no difference statistically.

머리염색이 인체에 미치는 영향

윤형식,황성호,이현륭,김수호,박연석,권낙현,정호진,김동훈,노현주,홍성호,박병찬,이관,정해관 東國大學校醫學硏究所 2002 東國醫學 Vol.9 No.1

일상생활에서 모발염색은 흔히 접할 수 있는 미용의 한 종류로 특히 젊은층을 중심으로 폭발적으로 유행하고 있다. 염색을 위항 사용하는 약제는 표백제와 발색제 등 각종 화학약품이 사용되고 있으나 이로 인한 건강장해에 대한 연구는 그리 많지 않다. 저자들은 염색이 인체의 모발건강에 미치는 영향을 파악하기 위하여 염색과 관련된 주관적 증상과 모발의 변화에 대한 실험적 연구를 시행하였다. 동국대학교 경주 캠퍼스 재학생 80명을 대상으로 설문조사를 시행하여 염색 유 ·무 및 염색 후에 경험한 증상에 대해 설문 조사하였고, 의과대학 재학생 46명을 대상으로 피부 반응 테스트를 실시하였다. 또한 염색 전후의 모발 탄성도를 측정하였고 모발의 상태를 파악하기 위해 전자 현미경검사를 실시하였다. 설문조사 결과 염색 전에 비하여 염색 후 안구혼탁, 안구건조, 시력저하, 발진 및 접촉성 피부염, 모발손상, 모근손상 등의 증상을 더 많이 경험한다고 호소하였다(p<0.05). 모발손상과 모근손상은 헤어드라이어 사용 빈도에 따라 증가하는 것으로 조사되었다(p<0.05). 피부반응검사에서 가려움증이 가장 많은 증상이었으며 이는 여성보다는 남성에서 높은 것으로 조사되었다. 염색 전후의 모발장력은 염색 전 134.5±10.37g, 염색 128.0±30.69g, 염색 이틀 후 112.5±19.69g으로 나타났다. 염색 전후의 모발의 전자현미경 케라틴 층이 현저히 감소하고 모발이 가늘어지는 차이를 보였다. 염색은 모발손상, 모발 케라틴 손상 및 모근 손상, 발진 및 접촉성 피부반응, 안구혼탁, 안구건조, 시력 저하를 유발한다. 따라서 염색약으로 인한 손상에 대한 주의와 예방이 필요하다고 생각한다. 예방대책으로 염색 전 피부테스트를 통한 적합성 여부를 판단하는 것이 필요하며 가급적 염색을 피하는 것이 좋을 것이다. 염색약에 발암물질이 포함되어있다는 보고도 있어 염색 제조사의 철저한 실험과 염색 물질의 선별이 염색으로 인한 부작용을 최소화하는데 중요한 역할을 할 것이다. Hair coloring has became one of the most popular cosmetic activities to younger generations during last decade. However, there are few studies on the health effect of widespread use of chemical dyes. This study was conducted to study the effects of hair coloring dye on hair and other systems. We conducted a questionnaire survey of 80 persons in Kyongju campus, Dongguk University. We have done open patch skin test on 46 medical students. We also conducted scanning electron microscopy to examine the hair strength and structure before and after hair coloring process. Injury of hair and hair bulb, contact dermatitis, turbid eyes, xerophthalmia, and poor visual acuity were the main symptoms complained after hair coloring (p<0.05). Injury of hair and hair bulb were increased by frequency of hair-dryer use(p<0.05). In open patch test, pruritus was complanined by more than half of the subjects. Mean strength of hairs before and after hair coloring was as follows; 134.5 (SD 10.37)g before hair coloring, 128.0 (SD 30.69)g immediately after hair coloring, and 112.5 (SD 19.69)g after two days. The scanning electron microscopic findings of hair surface before and after hair coloring showed decreased keratin layer and thinning of the hair. Hair coloring induces injury to hair, its keratin layer, and hair bulb as well as contact dermatitis, turbid eyes, xerophthalmia, and poor visual acuity. Therefore, we think that precaution is needed in use of hair coloring dye. To prevent complications induced by hair coloring dye, it is necessary, especially to those with allergy or skin disorders, to perform skin test before action and avoid hair coloring whenever possible. Longterm health effects of hairdye should be studied and manufacturing companies should try to minimize complications induced by hair coloring dye.

자궁경부 상피종양에서 human papillomavirus 감염과 survivin 발현

윤재호,정동준,이정은,박동명,배동한,선우재근,백무준,김창진 순천향의학연구소 2004 Journal of Soonchunhyang Medical Science Vol.10 No.1

Human papillomavirus (HPV) has been considered a causative agent of uterine cervical carcinoma. HPV is a DNA oncogenic virus, which is well known as a causative virus in uterine cervical carcinoma. The virus is classified into two groups genotypically, low risk and high risk, according to the carcinogenic potentiality, and the determination of the viral genotype is important in clinical practice. Recently, numerous genotypes can be determined by high throughput method using DNA chip. Survivin is a recently characterized inhibitor of anti-apoptosis (IAP) protein, which is abundantly expressed in most solid and hematological malignancies, but undetectable in normal adult tissues. In this study, HPV genotypes are determined by DNA chip and the expression of survivin was examined by immunohistochemistry in 80 cases of uterine cervical intraepithelial neoplasia (CIN) and invasive carcinoma to see the roles of HPV and survivin in the carciogenesis of uterine cervical epithelial neoplasia. The results were as follows: 1. HPV positive rate was 72.5%, while negative rate was 27.5% in 80 cases of CIN and invasive carcinoma. The CIN and invasive carcinoma showed higher HPV positive rate (p <0.05). 2. HPV positive rate according to the histologic grade were 60%, 65%, 77% and 90% in CINI, CINII, CINII and invasive carcinoma, respectively. HPV positive rate showed increasing tendency according to the histologic grade, though there was no statistical significance. 3. The most frequent genotype was type 16 and the next were 58, 52, 18 and 33 in order of frequency. 4. Survivin was expressed in 96.3% of CIN and invasive carcinoma. The expression rate of survivin showed no significant difference between the histologic grade of CIN and invasive carcinoma, but showed tendency of increased expression rate in invasive carcinoma. 5. Survivin was expressed in HPV positive and in HPV negative each as in 95.5% and 96.6% respectively. There was no significant difference of survivin expression between HPV positive and negative cases. The above results suggest that HPV has no effect on the regulation of survivin expresson level in the uterine cervical intraepithelial neoplasia and invasive carcinomas.

주성분 회귀분석 및 인공신경망을 이용한 AE 변수와 응력확대계수와의 상관관계 해석

윤동진,김기복,정중채,박휘립,이승석 한국비파괴검사학회 2001 한국비파괴검사학회지 Vol.21 No.1

AE 신호와 재료의 기계적 물성과의 관계를 정량적으로 제시할 수 있는 방법을 개발하였다. 재료의 여러 가지 기계적 성질들 중 피로균열 거동에 관련된 응력확대계수를 중심으로 AE 신호와 같은 다변량 데이터의 처리에 많이 사용되고 있는 주성분 회귀분석과 비선형적 문제 해결에 적합한 신경회로망 기법을 이용하였다. 이를 위하여 강교량 부재인 SWS490B 강에 대한 피로균열전파 실험을 수행하였으며 표준 CT 시편에 대한 피로균열진전 시 발생하는 AE 신호의 각 변수와 응력확대계수와의 관계를 고찰하였다. 통계분석 방법인 변수선택법을 적용한 결과 AE 카운트(RC), 에너지(EN), 신호지속시간(ED)의 각각에 대한 유의성이 높은 것으로 나타났으나 전반적으로 전체 AE 변수를 모두 이용할 경우 통계적 유의성이 높은 것으로 나타났다. 부재의 반복하중 시 발생하는 피로균열진전을 정량적으로 도출할 수 있는 응력확대계수 추정모델을 개발하고 평가하였다. 미지 시료에 대하여 개발된 모델의 응력확대계수 예측 성능을 분석한 결과 주성분 회귀모델과 인공신경망 모델 모두 우수한 예측성능을 나타내었으나 전반적으로 인공신경망 모델이 주성분 회귀모델보다 다소 양호한 것으로 분석되었 다. The aim of this study is to develop the methodology which enables to identify the mechanical properties of element such as stress intensity factor by using the AE parameters. Considering the multivariate and nonlinear properties of AE parameters such as ringdown count, rise time, energy, event duration and peak amplitude from fatigue cracks of machine element, the principal component regression(PCR) and artificial neural network(ANN) models for the estimation of stress intensity factor were developed and validated. The AE parameters were found to be very significant to estimate the stress intensity factor. Since the statistical values including correlation coefficients, standard error of calibration, standard error of prediction and bias were stable, the PCR and ANN models for stress intensity factor were very robust. The performance of ANN model for unknown data of stress intensity factor was getter than that of PCR model.

석유화학 공정의 가상사고 시나리오 유형분석

윤동현,강미진,이영순,김창은 한국안전학회 2003 한국안전학회지 Vol.18 No.3

This paper presents a set of typical pseudo-accident scenarios related to major equipments in petrochemical plants, which would be useful for performing such quantitative risk analysis techniques as fault tree analysis, event tree analysis, etc. These typical scenarios address what the main hazard of each equipment might be and how the accident might develop from an "initiating event". The proposed set of accident scenarios consists of total thirteen (13) scenarios specific for five (5) major equipments like reactor, distillation column, etc., and has been determined and screened out of one hundred and twenty-five (125) potential accident scenarios that were generated by performing semi-quantitative risk analysis practically for twenty-five (25) petrochemical processes, considering advices from the operation experts. It is assumed that with simple consideration or incorporation of plant-specific conditions only, the proposed accident scenarios could be easily reorganized or adapted for the relevant process with less time and labor by the safety engineers concerned in the petrochemical industries.