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        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.

      • KCI등재

        질염 의심 환자에서 플라즈마 활성수 분사법을 이용한 질 세정 효과

        강주섭(J. S. Kang),강은경(E. K. Kang),전아름(A. Jeon),안문(Wen An),신현아(H. A. Shin),김윤정(Y. J. Kim),엄애선(A. S. Om) 한국재활복지공학회 2023 재활복지공학회논문지 Vol.17 No.1

        플라즈마 활성수(PAW)는 플라즈마에서 발생하는 이온 및 라디칼을 물과 반응시킴으로써 물속에 다양한 활성종이 포함되도록 한 기능성 물이다. 본 연구에서 사용되는 방법은 질염(의심) 환자에서 PAW를 질벽 주름에 분사하고 도포하여 질염 원인균을 세정 후 바로 흡입하여 제거할 수 있는 장점이 있다. 본 임상연구에서는 질염(의심) 환자 총 94명을 대상으로 무작위 배정 후 베타딘 처치와 PAW 분사법을 적용하였으며, 세정 효과는 세정 전과 후의 질 분비물을 이용하여 12종 STD PCR을 수행하였으며, 세정 전 STD PCR 결과가 음성인 피험자를 제외한 대조군(베타딘 처치) 40명과 시험군(PAW 분사) 46명의 결과를 분석하였다. 베타딘 처리군에서는 베타딘 처리 전 PCR 양성 환자가 처리 후에도 모두 양성으로 재확인되어 처치효과가 나타나지 않았으나, PAW 분사군에서는 세정 전과 후의 유의적인 감소율을 보였는데, 그 중에도 Mycoplasma hominis의 경우 세정효과가 30±15.28%, Ureaplasma urealyticum은 25±9.93%, Ureaplasma parvum은 23±8.42%(P<0.001), Candida albicans은 28±10.86%로 각각 나타났다. 그러므로 PAW를 이용한 세정만으로도 질염 원인균을 세정하는데 효과가 있음을 보여주었으므로 PAW 분사 세정방법은 화학적 소독제 및 항생제, 항진균제의 새로운 대안으로 임상적 적용이 가능할 것으로 판단되었다. Plasma-activated water (PAW) is functional water in which various ionized gases and free radicals that originated primarily from oxygen and nitrogen gases in the air and water. In this study, PAW was applied by spraying the vaginal wall of vaginitis (suspected) patients, and the vaginal cleansing effect of PAW was evaluated by the sterilization effect on various vaginitis-causing microorganisms. In this clinical study, a total of 94 vaginitis (suspected) patients were randomly assigned, and the vaginal cleansing effect was compared and evaluated by applying betadine treatment (control) and PAW spray method. Vaginal secretions were collected before and after cleansing, and the cleansing effect of infectious microorganisms was evaluated by polymerase chain reaction (PCR) for 12 types of vaginitis causative microorganisms (STD). PCR results for infectious microorganisms were compared and analyzed for betadine (control, n=40) and PAW groups (experimental, n=46), excluding subjects with negative STD PCR results before washing. In the case of the control group, PCR-positive patients before betadine treatment were all positive after treatment, and no treatment effect was observed. However, in the experimental group, a significant decrease was observed after treatment compared to before treatment, with Mycoplasma hominis 30±15.28%, Ureaplasma urealyticum 25±9.93%, Ureaplasma parvum 23±8.42%, and Candida albicans 28±10.86%. Also, through comparison between the two groups, it was confirmed that PAW had a better cleansing effect than betadine. Therefore, spray treatment using PAW is expected to be clinically applied to vaginal cleaning of patients with suspected vaginitis as a new alternative to chemical disinfectants, antibiotics, and antifungals.

      • SCIESCOPUSKCI등재

        편측신절제 흰쥐에서 Cyclosporin A- 유발 신독성에 대한 Verapamil 의 효과

        강주섭(Ju Seop Kang),고현철(Hyun Chul Koh),이창호(Chang Ho Lee),신인철(In Chul Shin) 한국응용약물학회 1998 Biomolecules & Therapeutics(구 응용약물학회지) Vol.6 No.2

        In this study, the effect of verapamil (VER) on cyclosporin A (CsA)-induced nephrotoxicity was investigated in uninephrectomized rats. Male Wistar rats were administered CsA (50 mg/kg/day, p.o.) or VER (0.5 mg/kg/day, i.p.) with CsA (50 mg/kg/day, p.o.) for 20 days. The urinary N-acetyl-β-D-glucosaminidase (NAG) activity along with BUN, serum creatinine, creatinine clearance (CLcr), body weight, and 24 hr-urine output were measured and histopathologic changes of kidney were evaluated by light and electron microscopy. The results obtained from this study can be summarized as follows: While NAG activity, BUN and serum creatinine was progressively increased and CLcr significantly decreased in CsA group, VER almost significantly (p<0.05) suppressed and normalized CsA-induced changes in VER+CsA group. While urine output increased until 12th days and thereafter progressively decreased in CsA group, it gradually increased in control and VER+CsA group. While body weight progressively made a gain in control and VER+CsA groups, it significantly (p<0.05) lost in CsA group. Qn light microscopy, the glomerular hyperemia and proximal convoluted tubular (PCT) dilatation, focal tubular cell vacuolation and necrosis were clearly evident in CsA group, but, were not seen in other groups. Ultrastructural studies revealed thickened glomerular endothelium and basal lamina of capillary, irregular shaped pedicels of podocytes, indistinct slit pores and narrowed bowman`s space. The large oval vacuoles with dense debris and phagosome were distributed in apical zone and deformed microvilli and mitochondria were seen in the PCT cell of CsA group. But, glomeruli and PCT cell were relatively preserved in normal apperance in other groups. In conclusion, it is suggested that verapamil has a protective effect on cyclosporine-induced nephrotoxicity in uninephrectomized rats.

      • SCIESCOPUSKCI등재
      • KCI등재

        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.

      • KCI등재후보
      • SCIESCOPUSKCI등재
      • SCIESCOPUSKCI등재

        흰쥐에서 Cyclosporine 의 약동학적 지표에 대한 Nicardipine 의 영향

        김희규(Hee Kyu Kim),강주섭(Ju Seop Kang),이창호(Chang Ho Lee),신인철(In Chul Shin) 한국응용약물학회 1998 Biomolecules & Therapeutics(구 응용약물학회지) Vol.6 No.4

        Cyclosporine (CsA) is a major immunosuppressive drug used widely to prevent organ allograft rejection. Its potential organotoxicity by prolonged use is known to cause both direct tissue damage and indirect pharmacokinetic interactions with other drugs. This study was performed to determine the effect of nicardipine (NCP) on the pharmacokinetic parameters of CsA in Sprague-Dawley rats. Each rat was administered with CsA in saline-treated group or in NCP-treated group which was pretreated with NCP (5 mg/ kg/12 hours, i.p.) for 6 days. The plasma CsA concentration were analyzed by reversed HPLC: UV system at 0.5, 1, 2, 4, 6, and 8 hours after bolus injection of CsA (10 mg/kg). Pharmacokinetic parameters (mean ±SD, n=7) such as initial plasma concentration (C(0)), mean residence time (MRT), steady-state volume of distribution (Vdss), terminal half-life (t_(½( β)))and plasma clearance (CLp) of CsA in each groups (saline-group vs NCP-group) were determined as follows: C(0) (5.66 ±1.98 vs 11.98 ±2.36, p<0.01); Vdss (2.68 ±1.6 vs 0.94 ±0.25, p<0.01); CLp (0.53 ±0.18 vs 0.21 ±0.06, p<0.01). Therefore, Our results indicate that nicardipine significantly affects the pharmacokinetic parameters of cyclosporine, especially C(0), Vdss, and CLp in NCP-treated group. We suggest that the significant pharmacokinetic interaction between cyclosporine and nicardipine should be considered and cyclosporine level should be closely monitored and dosage reduction made as necessary in clinical situation that was coadministered with CsA and NCP.

      • KCI등재

        Streptozotocin 유발 당뇨쥐에서 팽화가공 처리한 홍삼의 항당뇨 효과

        김신희(Shin-Hee Kim),강주섭(Ju-Seop Kang),이상준(Sang Jun Lee),정영진(Young-Jin Chung) 한국식품영양과학회 2008 한국식품영양과학회지 Vol.37 No.6

        본 실험에서는 STZ로 당뇨를 유발시킨 흰쥐에 홍삼과 팽화홍삼의 항당뇨 효능에 대한 생리활성을 규명하고자 홍삼을 7주간 경구투여 후 체중, 혈당, 혈청 인슐린 및 아밀라아제, 지질관련 지수, OGTT, DNA의 산화적 손상정도 분석 및 췌장의 조직병리학적 변화를 관찰하였다. 체중증가는 실험 7주 후에 DM군과 비교 시 RG군에서 6.67배, PG군에서 5.25배 증가하였으나 DM군과 유의적인 차이는 없었다. 공복혈당은 DM군에 비해 RG군에서 11.54%, PG군에서 20.22%의 감소를 보였다. 구강내당능 검사결과 공복혈당, 포도당 투여 2시간 후 혈당은 DM군과 통계적 유의성은 없었다. 혈청 인슐린 농도는 PG군에서 가장 높게 나타났고, 혈청 아밀라아제 농도의 경우 RG군에서 높았으나 NC군보다는 낮게 나타났다. 혈청 총 콜레스테롤은 NC군을 제외한 모든 실험군 간에 유의적인 차이를 보이지 않았으나 혈청 중성지방의 경우 PG군에서 현저한 감소를 보였다(p<0.05). HDL-C는 NC군에 비해 당뇨유발군 모두에서 높게 나타났다. DNA 손상정도를 알아보기 위한 comet 분석에서는 PG군의 TL 및 TM은 NC군에서와 유사한 수준을 보였다. 췌장조직의 병리학적 관찰결과, 당뇨유발군 중 DM군의 췌장조직의 exocrine acinal cell 및 췌도세포에서는 focal 또는 multifocal cytoplasmic vacuolation과 췌장실질의 괴사 및 출혈성 병변이 관찰되었다. 이상의 결과로서 팽화홍삼의 투여가 홍삼에 비해 항당뇨 효과가 더 큰 경향을 보였으나 보다 확실한 결과를 위해 8주 이상의 홍삼 장기투여에 의한 항당뇨 효과 확인이 필요할 것으로 사료된다. Antidiabetic effect of Korean red ginseng (RG) processed by puffing in streptozotocin (STZ)-induced diabetic (DM) rats was investigated. Five week-old SD rats were divided into four groups; normal control (NC) group, DM group, red ginseng (RG) group and puffed red ginseng (PG) group. The RG and PG groups were orally provided with RG or PG dissolved in water (500 ㎎/㎏) respectively for seven weeks after single injection of STZ (50 ㎎/㎏, i.v.) followed by identification of DM. NC group received saline vehicle instead of STZ. At the end of feeding of RG or PG, the changes of fasting blood glucose, serum insulin and amylase level and serum lipid profiles were evaluated. Also, oral glucose tolerance test (OGTT), comet assay and histopathological examination were performed. At 7th week, the fasting blood glucose levels of the RG and PG groups were reduced compared to the DM group by 11.54% and 20.22%, respectively. The result of OGTT did not show significant differences among DM and two red ginseng groups. While serum insulin and TG levels were predominantly improved in PG group (p<0.05), serum amylase level was increased in RG group. Alkaline comet assay for checking the oxidative damage of DNA showed that TL (tail length, ㎛) and TM (tail moment) in the blood lymphocyte of PG group significantly decreased in contrast with DM group. Histopathological results of pancreas showed that destruction of exocrine as well as endocrine might be cured by the administration of RG and PG. These results suggest that PG could exert more protection against STZ-induced toxicity than RG group.

      • SCIESCOPUSKCI등재

        일산화탄소 폭로후 고압산소 투여가 흰쥐 신장에서의 malondialdehyde 함량과 catalase 및 superoxide dismutase 활성에 미치는 영향

        신인철(In Chul Shin),강주섭(Ju Seop Kang),고현철(Hyun Chul Koh),하지희(Ji Hee Ha) 한국응용약물학회 1999 Biomolecules & Therapeutics(구 응용약물학회지) Vol.7 No.2

        In an attempt to define the effects of hyperbaric oxygen treatment on the lipid peroxidation and oxygen free radical reactions in rats exposed to carbon monoxide, we studied malondialdehyde (MDA) level and activities of catalase and superoxide dismutase in the kidney of the rats exposed to carbon monoxide. Male Sprague-Dawley albino rats weighing 240 to 260 gm were used. Experimental groups consist of Control group (=breathing with air), HBO group (=exposed to hyperbaric oxygen [HBO, 3ATA, 100%] after air breath), CO group (=exposed to CO[3,970 ppm] after air breath), CO-Air group (=exposed to CO after air breath followed by air breath) and CO-HBO group (=exposed to CO after air breath followed HBO treatment). The CO group showed significantly higher MDA level, catalase activity and SOD activity as compared to that of control group. The CO-HBO group showed significantly lower MDA level as compared to that of CO group, and did not show significantly lower catalase activity and SOD activity as compared to that of CO group. These results suggest that the excessive oxygen free radicals is an important determinant in pathogenesis of CO-induced nephrotoxicity and HBO inhibits the lipid peroxidation caused by excessive oxygen free radicals in the kidney of the rats exposed to carbon monoxide.

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