Tacrolimus 주사에서 경구로 투여 경로 변경 시 용량 설정비율의 변경에 따른 효과 비교
Evaluation of the Effects of Tacrolimus According to the Adjustment of Dosage Conversion Ratio in Switching from Intravenous to Oral Administration
2
조회
0
다운로드
1
인용
0
참고문헌
키워드
초록
In Seoul St. Mary’s Hospital, tacrolimus is used for prophylaxis of graft versus host disease (GVHD) after unrelated hematopoietic stem cell transplantation (HSCT). On the basis of our previous study, we changed the conversion ratio of 1:4 to 1:2.5 when the route of administration is switched from IV (intravenous) to PO (per oral). In this study, we aimed to confirm the pharmacokinetic and clinical reasonability of the adjustment of the conversion ratio by comparing the incidence of GVHD and the adverse drug reactions of tacrolimus before and after adjustment. Patients were evaluated in two different groups. Group A received HSCT in 2008 and was applied conversion ratio of 1:4 and group B received HSCT in 2010 and was applied conversion ratio of 1:2.5. We retrospectively reviewed the patient’s monitoring profile and electronic medical records for 3 months after HSCT. The proportion of maintaining the oral dosage that was set at the time of switching from IV to PO was higher in group B than group A (41.9% vs. 64.2%, P<0.0001). The incidence of acute GVHD was not significantly different between the two groups (51.4% vs. 60.5%, p=0.252). The incidence of the adverse drug reactions of tacrolimus appeared to be decreased in group B, except for neurological toxicity and hyperkalemia. In particular, diarrhea was statistically decreased in group B (p=0.0004). As clinical outcomes were not significantly different and the proportion of maintaining the initially set oral dosage was increased in group B, we suggest that the application of the 1:2.5 conversion ratio is reasonable when the route of tacrolimus administration is changed from IV to PO.
Abstract
In Seoul St. Mary’s Hospital, tacrolimus is used for prophylaxis of graft versus host disease (GVHD) after unrelated hematopoietic stem cell transplantation (HSCT). On the basis of our previous study, we changed the conversion ratio of 1:4 to 1:2.5 when the route of administration is switched from IV (intravenous) to PO (per oral). In this study, we aimed to confirm the pharmacokinetic and clinical reasonability of the adjustment of the conversion ratio by comparing the incidence of GVHD and the adverse drug reactions of tacrolimus before and after adjustment. Patients were evaluated in two different groups. Group A received HSCT in 2008 and was applied conversion ratio of 1:4 and group B received HSCT in 2010 and was applied conversion ratio of 1:2.5. We retrospectively reviewed the patient’s monitoring profile and electronic medical records for 3 months after HSCT. The proportion of maintaining the oral dosage that was set at the time of switching from IV to PO was higher in group B than group A (41.9% vs. 64.2%, P<0.0001). The incidence of acute GVHD was not significantly different between the two groups (51.4% vs. 60.5%, p=0.252). The incidence of the adverse drug reactions of tacrolimus appeared to be decreased in group B, except for neurological toxicity and hyperkalemia. In particular, diarrhea was statistically decreased in group B (p=0.0004). As clinical outcomes were not significantly different and the proportion of maintaining the initially set oral dosage was increased in group B, we suggest that the application of the 1:2.5 conversion ratio is reasonable when the route of tacrolimus administration is changed from IV to PO.
참고문헌 (29)
- Fortune K., "Tacrolimus in hematopoietic stem cell transplantation", Expert Opin Drug Metab Toxicol, 5(7), pp.835~841 (2009)
- Ferarra J.L., "Advances in the clinical management of GVHD", Best Pract Res Clin Haematol, 21(4), pp.677~682 (2008)
- Ratanatharathorn V., "Chronic graftversus- host disease: clinical manifestation and therapy", Bone Marrow Tranplant, 28(2), pp.121~129 (2001)
- Nash R.A., "FK506 in combination with methotrexate for the prevention of graft-versus-host disease after marrow transplantation from matched unrelated donor", Blood, 88(9), pp.3634~3641 (1996)
- Arai S., "Management of graft-versus-host disease", Blood Rev, 14(4), pp.190~204 (2000)
- Pidala J., "Graft-vs-host disease following allogeneic hematopoietic cell transplantation", Cancer control, 18(4), pp.268~275 (2011)
- Starzl T.E., "FK506 for liver, kidney and pancreas transplantation", Lancet, 2(8670), pp.1000~1004 (1989)
- Nash R.A., "Phase 3 study comparing methotrexate and tacrolimus with methotrexate and cyclosporine for prophylaxis of acute graft-versus-host disease after marrow transplantation from unrelated donors", Blood, 96(6), pp.2062~2068 (2000)
- Ratanatharathorn V., "Phase III study comparing methotrexate and tacrolimus(prograf, FK 506) with methotrexate and cyclosporine for graftversus- host disease prophylaxis after HLA-identical sibling bone marrow transplantation", Blood, 92(7), pp.2303~2314 (1998)
- Park K., "A randomized, open-label, two-period, crossover bioavailability study of two oral formulations of tacrolimus in healthy Korean adults", Clin Ther, 29(1), pp.154~162 (2007)
- Scott L.J., "Tacrolimus: A further update of its use in the management organ transplantation", Durgs, 63(12), pp.1247~1297 (2003)
- Felipe C.R., "The impact of ethnic miscegenation on tacrolimus clinical pharmacokinetics and therapeutic drug monitoring", Clin Transplant, 16(4), pp.262~272 (2002)
- Jusko W.J., "Consensus document: therapeutic drug monitoring of tacrolimus (FK 506)", Ther Drug Monit, 17, pp.606~614 (1995)
- 여미진, "조혈모세포 이식환자에서의 현행 tacrolimus 치료방법 평가", 한국임상약학회지, 20(3), pp.193~199 (2010), 한국임상약학회
- Venkataramanan R., "Clinical pharmacokinetics of tacrolimus", Clin Pharmacokinet, 29(6), pp.404~430 (1995)
- "National Cancer Institute. Common Terminology Criteria for Adverse Events v4.0. Publish date"[URL]
- Przepiorka D., , 1994 Consensus Conference on Acute GVHD Grading, 15(6), pp.825~828 (1995)
- El-Cheikh J., "Acute GVHD is a strong predictor of full donor CD3+ T cell chimerism after reduced intensity conditioning allogeneic stem cell transplantation", Am J Hematol, 87(12), pp.1074~1078 (2012)
- Wingard J.R., "Relationship of tacrolimus (FK506) whole blood concentrations and efficacy and safety after HLA-identical sibling bone marrow transplantation", Biol Blood Marrow Transplant, 4(3), pp.157~163 (1998)
- Przepiorka D., "Tacrolimus does not abrogate the increased risk of acute graft-versushost disease after unrelated-donor marrow transplantation with allelic mismatching at HLA-DRB1 and HLADQB1", Biol Blood Marrow Transplant, 6(2A), pp.190~197 (2000)
- Przepiorka D., "Relationship of tacrolimus whole blood levels to efficacy and safety outcomes after unrelated donor marrow transplantation", Biol Blood Marrow Transplant, 5(2), pp.94~97 (1999)
- Watanabe N., "Relationship between tacrolimus blood concentration and clinical outcome during the first 4 weeks after SCT in children", Bone Marrow Transplant, 45(7), pp.1161~1166 (2010)
- Mori T., "Effect of early posttransplantation tacrolimus concentration on the development of acute graft-versus-host disease after allogeneic hematopoietic stem cell transplantation from unrelated donors", Biol Blood Marrow Transplant, 18(2), pp.229~234 (2012)
- Medd P.G., "Evidence for a GVL effect following reduced-intensity allo-SCT in ALL: a British Society of Blood and Marrow Transplantation study", Bone Marrow Transplant, 14, pp.1~6 (2013)
- Marks D.I., "The outcome of full-intensity and reduced-intensity conditioning matched sibling or unrelated donor transplantation in adults with Philadelphia chromosome- negative acute lymphoblastic leukemia in first and second complete remission", Blood, 116(3), pp.366~374 (2010)
- Anasetti C., "Blood and Marrow Transplant Clinical Trials Network : Peripheral-blood stem cells versus bone marrow from unrelated donors", N Engl J Med, 367(16), pp.1487~1496 (2012)
- Eapen M., "Peripheral blood grafts from unrelated donors are associated with increased acute and chronic graftversus- host disease without improved survival", Biol Blood Marrow Transplant, 13(12), pp.1461~1468 (2007)
- Ho V.T., "Use of matched unrelated donors compared with matched related donors is associated with lower relapse and superior progression-free survival after reduced-intensity conditioning hematopoietic stem cell transplantation", Biol Blood Marrow Transplant, 17(8), pp.1196~1204 (2011)
- Mohty M., "Acute Leukemia Working Party of EBMT : Reducedintensity versus conventional myeloablative conditioning allogeneic stem cell transplantation for patients with acute lymphoblastic leukemia: a retrospective study from the European Group for Blood and Marrow Transplantation", Blood, 116(22), pp.4439~4443 (2010)
