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HBeAg 양성 만성 활동성 간염의 치료에 있어 α2b-Interferon의 효과 및 안정성에 관한 연구
신동현 ( Sin Dong Hyeon ),김신묵 ( Kim Sin Mug ),한상우 ( Han Sang U ),김세종 ( Kim Se Jong ) 대한내과학회 1993 대한내과학회지 Vol.44 No.1
연구배경 : B형 만성 활동성간염에서 B형 간염바이러스와 지속적인 증식은 만성 활동성간염의 간경변증과 원발성 간암으로 천이하는데 중요한 요인으로 알려져 B형 만성 활동성간염의 치료에 B형 간염바이러스의 증식을 억제할려고 하는 노력들이 진행되었었다. 그러나 최근에는 면역기능조절 장애가 만성 활동성 간염의 발생에 중요한 요인임을 감안하여 면역조절기능과 항바이러스 작용을 동시에 갖고 있는 interferon으로 만성 활동성간염을 치료해 보려는 연구들이 시도되고 있다. 방법 : 저자는 HBeAg 양성인 만성 활동성간염 환자 28예를 대상으로 합성 interferon 인 Intron-A^(R)을 1회에 300만 단위로 1주에 3회씩 12주간 피하주사하고 B형 간염 바이러스 증식의 표지자인 HBV DNA 및 HBeAg의 음전율과 간기능의 변화, 말초 혈액소견의 변화, BUN, 혈청 Creatinine, 요검사소견의 변화 및 부작용들을 2년간 추적 관찰하였기에 그 결과를 보고하는 바이다. 결과 : 1) 6주이상 지속적으로 음전된 HBeAg음전율은 HBeAg양성인 27예중 10예로 37% 이었다. 2) 6주이상 지속적으로 음전된 HBV DNA 음전율은 HBV DNA 양성인 187예중 16예로 88% 보였다. 3) 혈청 AST 및 ALT치는 투여 2주째부터 감소하기 시작하여 2년까지 투여 시작전에 비해 유의하게 감소된 상태를 유지하고 있었다(p<0.05). 4) 말초 혈액소견은 투여 2주째부터 백혈구, 과립백혈구 및 혈소판수의 감소가 관찰되었으나 6주내지 8주부터 증가하기 시작하여 24주경부터는 투약전의 상태로 정상화 되었다. 5) BUN, 혈청 creatinine 및 요검사 소견은 2년간 추적관찰에서 이상없이 모두 정상이었다. 6) a_2b-interferon 투여로 인한 부작용은 발열(89%), 근육통(89%), 피로감(67%), 두통(57%), 식욕부진(50%), 오심(35%), 주사부위 피부발진(25%), 설사(17%), 탈모증(7%), 불면증(3%), 극심한 전신 근무력중(3%)등의 순이었으나 전례에서 경미한 정도였고 6주째 극심한 근무력증을 호소한 1예에서는 투여를 중단하였다. 결론 : B형 만성 활동성 간염 환자에서 300만 단위 IFN를 주3회, 12주간 피하투여하는 방법은 HBV DNA와 HBeAg을 소실시키며 aminotransferase를 감소 또는 정상화 시키고, 조혈기관이나 신기능에 장애를 일으키지 않고, 심한 임상적 부작용을 나타내지는 않는 비교적 안전한 치료방법으로 생각되었다. Background : It was Known that the persistent replication of hepatitis B virus in chronic active hepatitis was an important cause of developing liver cirrhosis and hepatocellular carcinoma and several antiviral agents was tried in protecting viral replication. But recently, interferon functioning as an immune modulator and antiviral agents has been tried in treating chronic active hepatitis B. Methods : The efficacy and safety of recombinant interferon a_2b (Intron-A^(R) was studied in twenty eitght cases with HBeAg positive chronic active hepatitis (CAH). Three million units of interferon were administrated subcutaneously three times a week for 12 weeks. The negativity of HBV DNA and HBeAg,m activities of aminotransferase, BUN, serum creatinine and urinalysis were followed up for 2 years in 28 cases with HBeAg positive CAH. The peripheral blood white blood cell, granulocyte and platelet count were followed-up for 2 years. The negativity of HBV DNA and HBeAg was regarded as persistent negativity more than 6 weeks in follow up period. Results : the result were as follows 10 HBeAg negativity more than 6 weeks for 2 years were observed in 10 cases (37%) out of 27 cases. 2) HBV DNA negativity more than 6 weeks for 2 years were observed in 16 cases(88%) out of 18 cases with HBV DNA positive cases. 3) During administration of interferon, serum aspartate aminotransferas (AST) and allanin aminotransferase (ALT0 were decreased significantly from the 2nd week after th initial injection to the 116th week (p<0.05). 4) The peripheral white blood cell, granulocyte and platelet counts were decreased from the 2nd week but recovered from the 6th to the 8th week in 28 cases. These were within normal limits within 24 weeks. 5) There were no specific changes in BUN, serum creatinine and urinalysis by a_2b-interferon administration. 6) Fever(89%), myalgia(89%), fatigue(67%), headache(57%), anorexia(50%), nausea(35%), skin eruption at injected site (21%), diarrhea(17%), alopecia(7%), insomnia(3%) and severe generalized muscle weakness (3%) were noted in the first few weeks as adverse effects. But these were mild in all cases and subsided within first few weeks. We stopped the injection in a case with uncontrollable severe generalized muscle weakness at the 6th week. Conclusion : In chronic active hepatitis B, a subcutaneous administration of three million units of interferon at interval of theree times a week for 12 weeks can be used safely without a significantly adverse effects. Also it may cause a loss of HBV DNA and HBeAg and reduce or normalize the titers of aminotransferase.
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인터페론을 사용한 만성 B 형 간염환자에서 인터페론 중화항체의 발현
지종대(Jong Dae Ji),이신형(Sin Hyeung Lee),김연수(Yun Soo Kim),서동진(Dong Jin Suh) 대한내과학회 1994 대한내과학회지 Vol.46 No.2
N/A Background: It has been suggested that the deveolpment of neutralizing antibody to interferon (anti-IFN) in patients treated with recombinant IFN-α may decrease the therapeutic effect of interferon. We studied the incidence of development and the clinical significance of interferon neutralizing antibody in patients with chronic HBV infection treated with recombinant interferon α-2b (intron A). Methods: 32 patients with chronic HBV infection, who had been positive for HBeAg and HBV DNA for more than twelve months were studied. Serum samples were collected before IFN trial, within 1~2 months after administration and 1 month after cessation of therapy. When duration of treatment were long, serum samples were collected repeatedly within 4~5 months after administation. Sera were stored at -20℃ and subsequently tested for anti-IFN. Test for anti-IFN were performed by an assay which measures the neutralization of the antiviral activity of interferon alfa-2b in a system using EMC virus and FS-4 cells (strain of dipoloid fibroblsasts derived from a neonatal foreskin). Results: 1) 1nterferon neutralizing antibody developed in 6(18.6%) of 32 patients treated with interfern α-2b and titers of anti-IFN were low at 10~20. 2) No correlation was seen between sex, age, or pretreatment serum ALT level and the development of anti-IFN. But anti-INF was significantly more likely to develop in patients who received lower dose (3 MU) of IFN than in those patients received higher doses (5 MU or 6 MU): 36% VS 5% (p=0.04). 3) HBV DNA became negative in 5(19%) patients without anti-IFN and in 1(17%) patients with anti-IFN (p=0.46, not significant). 4) HBeAg was seroconverted in 8(31%) patients with- out anti-IFN and in 1(17%) patients with anti-IFN (p= 0.41, not significant). Conclusion: It is suggested that interferon neutralizing antibody would not influence the therapeutic effect of interferon in chronic HBC infection.
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