3) 교원성혈관질환과 관련된 폐동맥 고혈압(Pulmonary arterial hypertension associated with collagen vascular disease)
4) 선천성 심장질환과 관련된 폐동맥 고혈압(Pulmonary arterial hypertension associated with congenital heart diseases)
5) 약물 및 독소와 관련된 폐동맥 고혈압 (Pulmonary arterial hypertension associated with drug and toxins)
나. 치료 효과에 대해 정기적인 평가가 이루어져야 하며, 허가사항 중 주의사항(약물상호작용, 부작용 등)을 고려하여 투여하여야 함.
다. 인정 용량
○ 1일 최대 3앰플
2. ‘신생아지속성 폐고혈압(Persistent pulmonary hypertension of the newborn, PPHN)’에 대하여 단독요법으로 투여 시 요양급여를 인정함 (1일 최대 3앰플).
※ 단, ‘환자 상태가 급속도로 악화되고, 동 약제만으로는 임상적 반응이 충분하지 않은 경우’ 에는 sildenafil 경구제와의 병용을 투여소견서 첨부 시 사례별로 인정함.
3. 금기환자
1) 이 약의 구성성분에 과민증이 있는 환자
2) 이 약의 혈소판에 미치는 영향으로 출혈의 위험을 증가시킬 수 있는 조건(예, 활동성 소화 궤양, 외상, 두개골내 출혈)을 가진 환자
3) 심한 관상동맥심장질환 또는 불안정형 협심증 환자, 지난 6개월 이내에 심근 경색증의 병력이 있는 환자, 면밀한 의학적 관찰 하에 있지 않은 대상부전 심부전, 중증의 부정맥, 폐울혈이 의심되는 환자, 지난 3개월 이내에 뇌혈관 질환(예, 일과성 허혈성 발작, 뇌졸중)의 병력이 있는 환자
4) 정맥 폐색성 질환으로 인한 폐고혈압 환자
5) 폐고혈압과는 상관없이 임상적으로 심근기능장애를 지닌 선천성 또는 후천성 판막 결함 환자
6) 임부 또는 임신하고 있을 가능성이 있는 부인 및 수유부
7) 신장애환자 (크레아티닌 클리어런스가 30mL/min 이하인 환자)
■ 고시 개정 고시번호(시행일자)
고시 제2019-93호(2019.6.7.)
■ 고시 개정 사유
투여 요법(단독요법 및 병용요법)의 [일반원칙]화.
■ 관련문헌 등
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· Current Diagnosis & Treatment: Pediatrics, 24e(2018)
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· Kelly LE et al. Sildenafil for pulmonary hypertension in neonates. cochrane review. 4 August 2017.
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· 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension
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