1. The Infectious Diseases Society of Taiwan; The Hematology Society of Taiwan; Taiwan Society of Pulmonary and Critical Care Medicine. Guidelines for the use of antifungal agents in patients with invasive fungal infections in Taiwan--revised 2009. J Microbiol Immunol Infect, 2010; 43(3):258-63.
2. Moore JN, Healy JR, Kraft WK. Pharmacologic and clinical evaluation of posaconazole. Expert Rev Clin Pharmacol. 2015; 8(3):321-34.
3. Tang JL, Kung HC, Lei WC, et al. High Incidences of Invasive Fungal Infections in Acute Myeloid Leukemia Patients Receiving Induction Chemotherapy without Systemic Antifungal Prophylaxis: A Prospective Observational Study in Taiwan. PLoS One. 2015; 10(6):e0128410.
4. Liu YC, Chien SH, Fan NW, et al. Incidence and risk factors of probable and proven invasive fungal infection in adult patients receiving allogeneic
hematopoietic stem cell transplantation. J Microbiol Immunol Infect. 2015;00:
1-8.(article in press)
5. Thompson GR 3rd, Cadena J, Patterson TF, et al. Overview of antifungal agents. Clin Chest Med. 2009. 30(2): 203-15.
6. Guarascio AJ, Slain D. Review of the new delayed-release oral tablet and intravenous dosage forms of posaconazole. Pharmacotherapy. 2015;
35(2):208-19.
7. Walsh TJ, Anaissie EJ, Denning DW, et al. Treatment of aspergillosis: clinical practice guidelines of the Infectious Diseases Society of America. Clin Infect Dis. 2008; 46(3): 327-60.
8. Pappas PG, Kauffman CA, Andes D, et al., Clinical practice guidelines for the management of candidiasis: 2009 update by the Infectious Diseases Society of America. Clin Infect Dis. 2009; 48(5):503-35.
9. Freifeld AG, Bow EJ, Sepkowitz KA, et al. Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the Infectious Diseases Society of America. Clin Infect Dis.
2011;52(4):e56-93.
10. Stevens DL, Bisno AL, Chambers HF, et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis.
2014;59(2):147-59.
11. Perfect JR, Dismukes WE, Dromer F, et al. Clinical practice guidelines for the management of cryptococcal disease: 2010 update by the Infectious Diseases Society of America. Clin Infect Dis. 2010; 50(3):291-322.
12. McKeage K. Posaconazole: a review of the gastro-resistant tablet and intravenous solution in invasive fungal infections. Drugs. 2015; 75(4):
397-406.
13. 財團法人醫藥品查驗中心. 波賽特口服懸液劑 Posanol 40mg/ml oral suspension─財團法人醫藥品查驗中心醫療科技評估報告(2011/4/12).
14. 財團法人醫藥品查驗中心. 波賽特錠劑 Posanol tablet ─財團法人醫藥品查 驗中心醫療科技評估報告(2015/2/16).
15. WHO. WHO ATC/DDD Index 2015. http://www.whocc.no/atc_ddd_index.
16. 行政院衛生福利部. 食品藥物管理署.
http://www.fda.gov.tw/MLMS/HList.aspx. (Accessed 2015/1/7).
17. 行政院衛生福利部, 中央健康保險署. http://www.nhi.gov.tw/.(Accessed 2015/1/7).
18. CADTH. Canadian Agency for Drugs and Technologies in Health:
Posaconazole (Spriafil
TM
) oral suspension, final recommendation: January 30, 2008. https://www.cadth.ca/posaconazole-6 (Accessed 2016/1/8)19. PBAC. Posaconazole, oral suspension, 40 mg per mL, 105 mL, Noxafil® , July 2006. Page last updated: 27 October 2006.
http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2006-07/posaconazole. (Accessed 2016/1/8)
20. PBAC. Posaconazole, oral suspension, 40 mg per mL, 105 mL, Noxafil, March 2008. Page last updated: 04 July 2008
http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2008-03/pbac-psd-posaconazole-mar08. (Accessed 2016/1/8)
21. PBAC. Posaconazole; 100 mg modified release tablet; Noxafil® . March 2015.
Page last updated: 3 July 2015.
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22. NICE. National Institute for Health and Care Excellence.
http://www.nice.org.uk/search?q=posaconazole. (Accessed 2016/1/8)
23. SMC. Scottish Medicines Consortium: Posaconazole concentrate for solution for infusion (Noxafil® ). Date published: 13 July 2015.
http://www.scottishmedicines.org.uk/SMC_Advice/Advice/1067_15_posacona zole_Noxafil_Abbreviated/posaconazole_Noxafil_Abbreviated. (Accessed 2016/1/8)
24. Maertens J, Cornely OA, Ullmann AJ, et al. Phase 1B study of the
pharmacokinetics and safety of posaconazole intravenous solution in patients at risk for invasive fungal disease. Antimicrob Agents Chemother. 2014; 58(7):
3610-7.
25. Kersemaekers WM, van Iersel T, Nassander U, et al. Pharmacokinetics and safety study of posaconazole intravenous solution administered peripherally to healthy subjects. Antimicrob Agents Chemother. 2015; 59(2):1246-51.
26. U.S. FDA. Food and Drug Adminstration: NOXAFIL (Posaconazole), Drug Approval Package (approveal date: 13 March 2014) -Medical Review.
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=S earch.Overview&DrugName=NOXAFIL.(Accessed 2016/1/8)
27. EMA. European Medicines Agency Assessment Report: Noxafil EMA/CHMP/75051/2015. Noxafil, INN-posaconazole. 24 July 2014.
28. Cornely OA, Jaider S, Grigg A, et al. Phase 3 Pharmacokinetics (PK) and Safety Study of Posaconazole (POS) IV in Patients (Pts) at Risk for Invasive Fungal Infection (IFI). Interscience conference of antimicrobial agents chemotherapy. [abstract no. A-292] Denver, CO; 2013.
http://www.icaaconline.com/php/icaac2013abstracts/data/papers/2013/A/2013 _A-292.htm. (Accessed 2016/1/8)
29. Chaftari AM, Hachem RY, Ramos E, et al. Comparison of posaconazole versus weekly amphotericin B lipid complex for the prevention of invasive fungal infections in hematopoietic stem-cell transplantation. Transplantation 2012; 94(3): 302-308.
30. Glockner A. [Innovative antifungals for treatment of invasive fungal infections]. Der Internist 2011; 52(9): 1118-1124, 1126.
31. Krishna G, Vickery D, Ma L, et al. Lack of pharmacokinetic drug interaction between oral posaconazole and caspofungin or micafungin. Journal of clinical pharmacology 2011; 51(1): 84-92.
32. Lazzaro C. [Economic evaluation of posaconazole in prophylaxis of invasive fungal infections in Italian neutropenic patients with acute myeloid leukaemia or myelodysplastic syndrome]. Le infezioni in medicina : rivista periodica di eziologia, epidemiologia, diagnostica, clinica e terapia delle patologie infettive 2010; 18(2): 91-103.
33. Mimouni O, Curto CL, Danvin JB, Thomassin JM, Dessi P. Sinonasal
mucormycosis: case report. European annals of otorhinolaryngology, head and neck diseases 2010; 127(1): 27-29.
34. Muhammed M, Coleman JJ, Carneiro HA, Mylonakis E. The challenge of managing fusariosis. Virulence 2011; 2(2): 91-96.
35. Scheinfeld N. A review of the new antifungals: posaconazole, micafungin, and anidulafungin. Journal of drugs in dermatology : JDD 2007; 6(12): 1249-1251.
36. Yañez L, Fernandez N, Bermudez A, Insunza A, Richard C, Conde E. Efficacy and cost-effectiveness of a different schedule for the prevention of fungal infections during the early phase of stem cell transplantation. Bone Marrow Transplantation 2015; 50: S404-S405.
37. Hamadani M, Craig M, Phillips GS, et al. Higher busulfan dose intensity does not improve outcomes of patients undergoing allogeneic haematopoietic cell transplantation following fludarabine, busulfan-based reduced toxicity conditioning. Hematological Oncology 2011; 29(4): 202-210.
38. von Bonin M, Wermke M, Platzbecker U, et al. Therapy of acute
graft-versus-host disease. Cellular Therapy and Transplantation 2010; 2(6).
39. 衛生福利部國民健康署. 中華民國 101 年癌症登記報告;2015.
40. Chia-Lu Yuan. On the Medical Utilization and Survival Rate of Hematopoietic Stem Cell Transplanation in Taiwan, 臺灣博碩士論文知識加值系統 2009
附錄
附錄一「全民健康保險藥物給付項目及支付標準」藥品給付規定內容(最新版)：
第 10 節 抗微生物劑 Antimicrobial agents (摘錄) 10.6.抗黴菌劑 Antifungal drugs
10.6.1.Fluconazole oral（如 Diflucan oral）：（85/10/1、87/4/1）
限
1.全身黴菌感染之治療。
2.免疫不全病例，治療或預防黴菌感染時使用。
3.非愛滋病隱球菌腦膜炎患者使用，原則上使用 6 到 8 週，視病人臨床反應，
抗原效價及培養結果調整療期，而治黴菌藥物之終止以效價下降四倍及兩 次培養陰性為原則。
4.用於念珠性陰道炎，限頑固性疾病或無性經驗病人無法使用塞劑治療者單一 劑量使用。
10.6.2.Fluconazole Inj（如 Diflucan inj）：（85/10/1）
限
1.已證實為全身性黴菌感染(經組織或培養證實)病例使用。
2.非愛滋病隱球菌腦膜炎患者使用，原則上使用 6 到 8 週，視病人臨床反應，
抗原效價及培養結果調整療期，而治黴菌藥物之終止以效價下降四倍及兩 次培養陰性為原則。
10.6.3.Itraconazole：（85/1/1、91/4/1、91/8/1、96/6/1、96/8/1、96/10/1、98/8/1）
10.6.3.1.Itraconazole 膠囊劑 (如 Sporanox cap)：（85/1/1、91/4/1、91/8/1、98/8/1、
104/1/1）
限
1.甲癬病人使用。使用時，手指甲癬限用 84 顆，每顆 100mg (以 itraconazole 100mg 計算，每日服用 2 顆)，需於 9 週內使用完畢。足趾甲癬限用 168 顆，
需於 17 週內使用完畢。治療結束日起算，並各在 6 及 12 個月內不得重複 使用本品或其他同類口服藥品。(91/4/1、98/8/1)
2.念珠性陰道炎(限頑固性疾病或無性經驗病人無法使用塞劑治療病人)。
3.其他頑固性體癬。
4.全身性或侵入性黴菌感染(經組織切片、微生物或抗原檢測確定之全身性或 侵入性黴菌感染，且經感染症專科醫師或皮膚科專科醫師判定需使用本劑 者，以 12 週至 24 週為原則)。(91/8/1、98/8/1)
5.用於復發性汗斑之治療，每日使用 200mg 治療 7 天為一療程，每月以一療 程為限。(104/1/1)
6.每次門診時，應註明使用日期，目前已使用週數及預定停藥日期。
7.病人接受本品治療期間，不得併用其他同類藥品。
10.6.3.2.Itraconazole 注射劑 (如 Sporanox inj.)：（96/6/1、96/8/1、99/10/1）
1.限用於第一線治療藥物 amphotericin B 治療無效或有嚴重副作用之侵入性麴 菌症、侵入性念珠菌感染症、組織漿病菌之第二線用藥使用，以 14 日為限。
2.限用於第一線治療藥物無法使用或無效的免疫功能不全及中樞神經系統罹 患隱球菌病(包括隱球菌腦膜炎)的病人，並以 14 日為限。
3.因病情需要，經感染症專科醫師會診確認需要使用者(申報費用時需檢附會 診紀錄及相關之病歷資料)。(96/8/1、99/10/1)
10.6.3.3.Itraconazole 內服液劑 (如 Itrazole oral solution)：（96/10/1）
限用於 HIV 陽性反應及其它免疫功能不全病人的口腔念珠菌感染及食道念 珠菌感染者。
10.6.4.Terbinafine (如 Lamisil tab)：(85/1/1、91/4/1、98/8/1) 限
1.手指甲癬及足趾甲癬病例使用，每日 250 mg，手指甲癬限用 42 顆，需於 8 週內使用完畢。足趾甲癬限用 84 顆，需於 16 週內使用完畢。治療結束日 起算，各在 6 及 12 個月內不得重複使用本品或其他同類口服藥品。(98/8/1) 2.其他頑固性體癬及股癬病例使用，每日一次，最長使用 2 週，治療期間不得
併用其他同類藥品。
3.頭癬病例使用，每日一次，最長使用 4 週，若確需延長治療時間，需於病歷 詳細載明備查。(98/8/1)
10.6.5.Amphotericin B Injection colloidal dispersion 及 liposomal complex 劑型（如 Amphocil Injection、AmBisome for Injection）：(91/8/1、93/2/1)
限用於侵入性黴菌感染（invasive fungal infection），且腎功能不全患者 10.6.6.Caspofungin Injection 劑型 (如 Cancidas Injection 50mg)：(92/8/1、94/1/1、
96/7/1、99/10/1)
限符合下列規定之一：
1.限用於其他黴菌藥物治療無效或有嚴重副作用之侵入性麴菌症、侵入性念珠 菌感染症之第二線用藥。
2.經感染症專科醫師認定需使用者，惟治療食道念珠菌感染限用於 fluconazole 無效或有嚴重副作用者。(99/10/1)
10.6.7.Micafungin Injection 劑型(如 Mycamine for Injection)：(96/4/1) (97/10/1) 限用於
1.治療 16 歲以上成人的食道念珠菌感染。
2.預防接受造血幹細胞移植病患的念珠菌感染。
3.治療念珠菌血症與其他侵襲性之念珠菌感染。(97/10/1) 10.6.8.Flucytosine (如 Flusine Tablets)(96/6/1)
限用於 Cryptococcus infection 的病患。
10.6.9.Anidulafungin 注射劑 (如 Eraxis for Injection ) (97/10/1)
限用於治療非白血球低下之成人念珠菌血症、念珠菌腹膜炎及念珠菌腹腔 內膿瘍。
10.6.10. Posaconazole (如 Posanol)：(101/1/1、104/7/1) 1.限下列條件之一使用：
(1)對 amphotericin B 或 itraconazole 或 voriconazole 治療無效或不能忍受之成 人侵入性麴菌病（invasive aspergillosis）的第二線用藥。（無效的定義是 先前用有效抗黴菌劑的治療劑量至少 7 天，感染惡化或未改善）。
(2)對 itraconazole 或 fluconazole 治療無效或不能忍受之成人口咽念珠菌感染
（oropharyngeal candidiasis）的第二線用藥。（無效的定義是先前用有效 抗黴菌劑的治療劑量至少治療一段時間：持續性黴菌血症 3 天，非黴菌 血症型感染 7 天，食道念珠菌病 14 天，感染惡化或未改善）限使用口服 懸液劑劑型。(104/7/1)
(3)用於造血幹細胞移植接受者因發生嚴重(grade Ⅲ、Ⅳ)急性植體宿主反應 (acute graft versus host reaction, GVHD)，而接受高劑量免疫抑制劑
(prednisolone 使用劑量超過 0.8mg/kg/day)治療之 13 歲以上高危險病人，
做為預防侵入性黴菌感染，使用期間以 3 個月為限。
(4)急性骨髓性白血病 (acute myelogenous leukemia)或高危險骨髓化生不良 症候群(myelodysplastic syndrome) 病人接受誘導性化學治療者，給付條 件如下：(104/7/1)
Ⅰ.用於初診斷之誘導性化學治療、誘導失敗進行第二次誘導性化學治 療，或復發病患進行復發後第一次誘導性化學治療者。
Ⅱ.誘導性化學治療需使用「cytarabine(Ara-C)7 天及 anthracycline 類藥物 3 天」、或「高劑量 Ara-C」、或「老年人(＞60 歲)使用 cytarabine (Ara-C)5 天及 anthracycline 類藥物 2 天」、或較上述療法更強的化學治療。
Ⅲ.自化學治療第一天開始使用，當絕對嗜中性白血球數(absolute neutrophil count,ANC)大於 500/mm3，或出現侵入性黴菌感染時應停 止使用。每次療程投予 posaconazole 預防以一個月為限，最多給付 2 次誘導性化學治療療程。
2. 使用本藥須經感染症專科醫師會診確認需要使用，申報費用時需檢附會 診紀錄及相關之病歷資料。
附錄二 療效評估文獻搜尋策略 (Literature search via PubMed/Embase/Cochrane Library)
Cochrane Database of Systematic Reviews : Issue 1 of 12, January 2016.
There is 1 result from 9214 records for your search on 'posaconazole in Title, Abstract, Keywords in Cochrane Reviews'
Cochrane Central Register of Controlled Trials : Issue 12 of 12, December 2015.
There are 2 results from 912712 records for your search on 'posaconazole intravenous solution' in Title, Abstract, Keywords in Trials.
Cochrane Central Register of Controlled Trials : Issue 12 of 12, December 2015.
There are 2 results from 912712 records for your search on 'posaconazole injection' in Title, Abstract, Keywords in Trials.
Health Technology Assessment Database : Issue 4 of 4, October 2015 There are 0 results from 15612 records for your search on 'posaconazole injection' in Title, Abstract, Keywords in Technology Assessments'.
4. Grey Literature search:
Select international regulatory agencies:
Food and Drug Administration (FDA): www.fda.gov European Medicines Agency (EMA):
http://www.ema.europa.eu/ema/index.jsp?curl=/pages/home/Home_Page.jsp
Conference abstract:The American Society for Microbiology (AMS): http://www.asm.org/
Interscience Conference of Antimicrobial Agents Chemotherapy (ICAAC) :
http://www.icaac.org/
附錄三 經濟評估文獻搜尋策略 (Literature search via PubMed/Embase/Cochrane Library)
資料庫 查詢日期 關鍵字 篇數
PubMed 2016/1/7 1 ("posaconazole"[Supplementary Concept] OR "posaconazole"[All Fields]) AND intravenous[All Fields]
AND ("solutions"[MeSH Terms] OR
"solutions"[All Fields] OR
"solution"[All Fields] OR
"pharmaceutical solutions"[MeSH Terms] OR ("pharmaceutical"[All
Fields] AND "solutions"[All Fields]) OR
"pharmaceutical solutions"[All Fields]) 8
2 invasive[All Fields] AND
("aspergillosis"[MeSH Terms] OR
"aspergillosis"[All Fields])
5636
3 "cost-benefit analysis"[MeSH Terms]
OR ("cost-benefit"[All Fields] AND
"analysis"[All Fields]) OR "cost-benefit analysis"[All Fields] OR
("economic"[All Fields] AND
"evaluation"[All Fields]) OR "economic evaluation"[All Fields]
83448
4 #1AND #2 AND#3 0 Embase 2016/1/7 1 'posaconazole'/exp OR posaconazole
AND iv AND ('infusion'/exp OR infusion)
4
2 cost effectiveness analysis 113319
3 #1 AND#2 0
Cochrane 2016/1/7 1 Posaconazole 1