Paricalcitol주사제(품명: 젬플라주)
기준 내용
※ 동 고시는 고시 제2020-161호(2020.8.1.)로 변경되었습니다
기준 내용
허가사항 범위 내에서 아래와 같은 기준으로 투여 시 요양급여를 인정하며, 동 인정기준 이외에는 약값 전액을 환자가 부담토록 함.
○ 만성신부전으로 인한 이차성 부갑상선 기능항진증이 있는 환자 중 투석을 받는 환자로서 Calcitriol 주사제의 적절한 치료에도 불구하고 동 약제를 투여하기 전 부갑상선호르몬(iPTH)이 300pg/mL 이상인 경우
- 다만, 동 약제 투여 중 부갑상선호르몬(iPTH)이 150pg/mL 이상인 경우 지속 투여를 인정함.
고시 개정 사유
교과서, 임상진료지침, 임상연구 논문, 학회의견 등을 참조하여, 교과서 등에서 목표 iPTH 수치를 150∼300 pg/mL로 설정하고 있는 점을 반영하여 동 약제 투여 중 부갑상선호르몬이 150 pg/mL 이상인 경우 지속투여를 인정하는 유지요법 기준을 신설함.
관련문헌 등 20줄
· Harrison's Principles of Internal Medicine, 19e
· Goldman cecil medicine Twenty-Fifth Edition (2015)
· Brenner & Rector's the kidney, Tenth Edition> 2019-2033. e5 Copyright ⓒ 2016 by Elsevier
· Current medical Diagnosis & Treatment 2017
· KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) Kidney International Supplements (2017) 7, 1-59
· KDOQI US Commentary on the 2017 KDIGO Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) Am J of Kidney Dis., 2017
· Management of chronic kidney disease-mineral and bone disorder: Korean working group recommendations. Kidney Res Clin Pract. 2015 Mar;34(1):4-12
· Clinical Practice Guideline for the Management of Chronic Kidney Disease-Mineral and Bone Disorder, Japanese Society for Dialysis Therapy and Japanese Society of Nephrology, Tokyo, Japan; Therapeutic Apheresis and Dialysis 2013
· 만성콩팥병 진료지침, 2008, 대한신장학회
· Ye H, Ye P et al. A Bayesian network analysis on comparative efficacy of treatment strategies for dialysis patients with secondary hyperparathyroidism. Exp Ther Med. 2019 Jan;17(1):531-540.
· Zhang T, Ju H et al. Comparison of Paricalcitol and Calcitriol in Dialysis Patients With Secondary Hyperparathyroidism: A Meta-Analysis of Randomized Controlled Studies. Ther Apher Dial. 2018 Oct 16.
· Ve·eri·-Haler ·, Romozi K et al. Comparison of the Pharmacological Effects of Paricalcitol Versus Calcitriol on Secondary Hyperparathyroidism in the Dialysis Population. Ther Apher Dial. 2016 Jun;20(3):261-6.
· Abdul Gafor AH, Saidin R et al. Intravenous calcitriol versus paricalcitol in haemodialysis patients with severe secondary hyperparathyroidism. Nephrology (Carlton). 2009 Aug;14(5):488-92.
· Ketteler M, Martin KJ et al. Paricalcitol versus cinacalcet plus low-dose vitamin D therapy for the treatment of secondary hyperparathyroidism in patients receiving haemodialysis: results of the IMPACT SHPT study. Nephrol Dial Transplant. 2012 Aug;27(8):3270-8.
· Taniguchi M, Fukagawa M et, al. Serum Phosphate and Calcium Should Be Primarily and Consistently Controlled in Prevalent Hemodialysis Patients. Therapeutic Apheresis and Dialysis 2013; 17(2):221-228
· Floege J, Kim J et al. Serum iPTH, calcium and phosphate, and the risk of mortality in a European haemodialysis population. Nephrol Dial Transplant. 2011 Jun;26(6):1948-55.
· Naves-Diaz M, Passlick-Deetjen J et al. Calcium, phosphorus, PTH and death rates in a large sample of dialysis patients from Latin America. The CORES Study. Nephrol Dial Transplant. 2011 Jun;26(6):1938-47.
· Teng M et al. Survival of patients undergoing hemodialysis with paricalcitol or calcitriol therapy. N Engl J Med. 2003 Jul 31;349(5):446-56.
· Brancaccio D et al. Secondary hyperparathyroidism in chronic dialysis patients: results of the Italian FARO survey on treatment and mortality. Blood Purif. 2011;32(2):124-32.
· Hosaka K, Kazama JJ et al. Alterations in serum phosphate levels predict the long-term response to intravenous calcitriol therapy in dialysis patients with secondary hyperparathyroidism. J Bone Miner Metab. 2008;26(2):185-90.
변경 전 고시번호(시행일자)
고시 제2013-127호(2013.9.1.)
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