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만성 간질환 환자에 대한 고덱스 캅셀의 유효성.안정성에 관한 다기관, 무작위할당, 이중맹검 3상 비교임상시험
박문승,강주섭,전재윤,백승운,임규성,곽민정,전용철,이민호,Park, Moon-Seung,Kang, Ju-Seop,Chon, Chae-Yoon,Paik, Seung-Woon,Rim, Kyu-Sung,Kwak, Min-Jung,Jeon, Yong-Cheol,Lee, Min-Ho 대한임상약리학회 2001 臨床藥理學會誌 Vol.9 No.2
Background/Aims : Godex is a mixture of PMC(diphenyl-dimethyl-dicarboxylate) and Hepadif, each of which has been used for managing chronic liver disease in Korea and other countries. The purpose of this study was to evaluate the efficacy and safety of Godex in Korean patients with chronic liver disease. Methods : In this study, 154 patients with chronic hepatitis, who showed increased level of serum alanine aminotransferase(ALT), were randomly allocated into three groups. Fifty-two patients were administered 100mg/day of PMC, 48 patients were administered low dose of Godex(PMC 100mg+hepadif 600mg/day) and 53 patients were administered high dose of Godex(PMC 150mg+hepadif 900mg/day) orally for 8 weeks. To evaluate the efficacy and safety of Godex capsule, we considered primary variable as the proportion of patients who showed normal ALT blood level after treatment for 8 weeks and second variable as a proportion of patient who showed normal ALT at 4 weeks, the degree of difference of serum ALT level between 0 and 8 weeks, and incidence of adverse events during treatment period. Results : The percentage of subjects whose serum ALT levels decreased below upper normal level in control, low-dose and high-dose group were 64.54%, 67.35%, 81.13% after 8 weeks-treatment(p=0.0407) and 59.62%, 63.27%, 81.13% after 4 weeks-treatment of Godex(p=0.0790) using ITT analysis. There were no significant difference in incidence of adverse events among three groups. Conclusions : Response rate of high-dose group was significantly higher than those of low-dose group and control group. It is suggested that Godex 6 capsules per day(PMC 150mg+hepadif 900mg/day) is optimal dose for Korean patients with chronic liver disease who show elevated serum alanine aminotransferase(ALT) level.
박문승(Mun Seung Park),박근태(Geun Tae Park),김진배(Jin Bae Kim),황선호(Seon Ho Hwang),윤호주(Ho Joo Yoon),함준수(Joon Soo Hahm),기춘석(Choon Suhk Kee),박경남(Kyung Nam Park),이민호(Min Ho Lee) 대한내과학회 1997 대한내과학회지 Vol.53 No.1
N/A About a third of the patients with decompensated liver cirrhosis have reduced arterial oxygen saturation and are sometimes cyanosed in the absence of any apparent lung or heart disease; There is a reduction of diffusing capacity without a restrictive ventilatory defect. The aim of this study was to determine diffusing capacities in patients with chronic liver- diseases. The diffusing capacities and arterial oxygen saturations were measured in 25 patients with chronic active hepatitis(CAH), 9 early cirrhotics (early LC), 36 cirrhotics(Child`s class A) and 11 cirrhotics(Child`s class B). The anterior tibial area was observed for pitting edema, and Thallium-201 test per rectum(shunt index) was done. Hypoxemia was not observed in all subjects. The number of cases with decreased pulmonary diffusing capacity (DLco) is 3/25(12.0%) for CAH, 3/9(33.3%) for CAH with early liver cirrhosis(LC), 17/36(47.2%) for LC(Child`s class A) and 6/11(54.5%) for LC(Child`s class B). The mean±standard deviation of Dlco(% predicred) are 93.1±12.1 for CAH, 85.7±12.3 for CAH with early LC, 82.2±14.7 for LC(Child`s class A) and 80.4±6.9 for LC(Child`s class B), There is a significant difference between DLco in CAH and that in LC(Child`s class A)(p<0.01). Patients with higher shunt index(>0.3) had significantly lower DLco than these with lower shunt index(<0.3)(76.4±9.7% vs. 89.3±13.3%)(p<0.01). The DLco was also lower in patients with pitting edema(77.3±10.2%) than in those without pitting edema(85.5±13.8%) (p<0.01). These results summarized that the DLco was low in patients with cirrhosis and with higher shunt index(>0.3) or pitting edema. This may be due to an increased systemic blood flow shunt and an increased generalized interstitial edema. Pulmonary function tests including diffusing capacity may be useful as prognostic parameters in patients with chronic liver disease, especially in those with CAH or early LC.
만성 간질환 환자에서 고덱스 캅셀의 단기간(8주) 유효성.안전성에 대한 연구
강주섭,홍정희,박문승,이정복,이재원,이민호,Kang, Ju-Seop,Hong, Jung-Hee,Park, Moon-Seung,Lee, Jung-Bok,Lee, Jae-Won,Lee, Min-Ho 대한임상약리학회 2001 臨床藥理學會誌 Vol.9 No.1
Background/Aims: To evaluate the effect and safety of Godex(hepadif+PMC, diphenyl-dimethyl-dicarboxylate) in 95 patients with chronic liver disease, a prospective randomized double blind controlled clinical trial of a short-term(8 weeks) therapy with Godex was performed in a total 95 patients with chronic hepatitis who was diagnosed by liver biopsy or recently have a abnormal serum transaminase(ALT and/or AST) concentrations during longer than 6 months. Methods : In this clinical trial, 95 patients with chronic hepatitis patients were enrolled and allocated by a table of random digits in three groups. 32 patients received 150mg/day of PMC(control group), 30 patients received low dose of Godex(low-dose group, PMC 150mg+hepadif 600mg/day) and 33 patients received high dose of Godex(high-dose group, PMC 150mg+hepadif 900mg/day) orally for 8 weeks, and they were followed until 2 weeks without drugs to evaluate rebounding phenomenon of liver enzymes. We evaluate the effect and safety by biochemical laboratory test variables such as liver enzymes and clinical observed data at each visit date such as before(0) and 4, 8 weeks after drug treatment and 2 weeks after 8 weeks treatment. Compliance and side effects were evaluated at the same time. Results : After 4 weeks-treatment of Godex, the percentage of decrease of serum ALT levels within normal range in the low-dose and high-dose groups are about 63.6 and 80.8%, respectively and were significantly(p<0.05) lower than that of control group, 29.6%. Otherwise, after 8 weeks-treatment of Godex, those of low-dose and high-dose groups are about 54.6 and 88.5%, respectively and were significantly(p<0.05) lower compared of control group, 44.4% and that of high-dose group were more significant than low-dose group. But after 2 weeks without drugs, the rebounding phenomenon of serum ALT levels were not different within three groups and adverse effects were negligible and transient during 10 weeks. Conclusions : It is suggested that Godex is more effective and safe than PMC in the short-term treatment of chronic liver disease in Korean patients, but further evaluation about efficacy and safety of Godex for adequate duration of treatment in the large population of patients are needed.
간조직 소견이 정상인 HbsAg 건강 보유자에 대한 임상적 연구
황선호(Seon Ho Hwang),박문승(Mun Seung Park),한동수(Dong Soo Han),손주현(Joo Hyun Sohn),윤병철(Byung Chul Yoon),함준수(Joon Soo Hahm),기춘석(Choon Suhk Kee),박경남(Kyung Nam Park),이민호(Min Ho Lee) 대한내과학회 1995 대한내과학회지 Vol.49 No.6
N/A Objectives: Thallium-201 test per rectum (Shunt Index) and ICG-Rmax have been used for the evaluation of portosystemic shunt and functional reserve of the liver. The mean values of Shunt Index and ICG-Rmax have not been determined in HBsAg healthy carriers confirmed by liver biopsy. In this stud)', the mean values and correlation between Shunt Index, ICG-I4max and ICG- B15 in these subjects were estimated, and the progression from HHsAg healthy carrier to chronic liver disease was observed prospectively. Methods: Twenty-four HHsAg healthy carriers (male 15 and female 9) were analyzed from 1988 to 1993. The mean duration of follow-up is 17months(range : 2~59). All subjects were diagnosed by liver biopsy. Shunt Index, ICCi-Rmax and ICG-l415 were obtained for each subject 3times weekly. Results: Vive from 24subjects(20.8%) were disclosed chronic persistent hepatitis associated with HHsAg during follow-up period. The mean values of Shunt Index. ICCi-Iimax and ICG-R15 were 0.24±0.07, 4.15±2.21mg/kg/min, and 7.85±3.00% respectively, in seventeen cases whose conventional laboratory data were continuously nor- mal. Shunt Index was well correlated (R-square= 0.34, p<0.0:) with 1.ICG-Rmax. Hut, ICG-Il15 was not correlated with both ICCi-Rmax and Shunt Index. Conclusion: One fifth of the biopsy proven HHsAg healthy carriers progressed to chronic persistent hepatitis associated with HBsAg. We suggest that laboratory follow-up for regular interval is necessary even in HHsAg healthy carriers. The mean values of Shunt Index and ICG-Rmax may be useful in the diagnosis of the chronic liver disease and assessment of outcome of the treatment.
한동수,이민호,최춘식,박근태,이오영,기춘석,박경남,정진웅,조윤주,박문승,손주현,윤병철,최호순,권오정,임현철 대한소화기학회 1998 대한소화기학회지 Vol.31 No.2
Intestinal malrotation is a rare disorder typically found in childhood. In adults it is an uncommon disease, and usually presents as bowel obstruction. Occasionally the clinical picture is confusing and the diagnosis of mahotation is not discovered until operation. Intestinal malrotation represents an arrest in the normal counterclockwise rotation of the cecum from the left lower quadrant to the right upper quadrant. The example is nondescent of the cecum, in which this structure remains in the subhepatic position. These are the diagnostic problems of differentiating between acute appendicitis and acute cholecystitis and the difficulty of appendectomy through a lower abdominal incision. In some patients, the cecum that cross the duodenum (Ladd's bands) is often fixed in an abnormal position by dense adhesion. In addition, the colon and the small intestine have a common mesentery with a lack of fixation to the lateral and posterior regions of the abdominal cavity. The usual mechanism of obstruction is adhesive compression of the duodenum and volvulus of the small intestine. Herein we experienced the case with intestinal malrotation associated with Ladd's bands with duodenal compression, presenting with acute abdominal pain and vomiting.