1. G. Bonkat (Co-chair), R. Pickard (Co-chair), R. Bartoletti, T. Cai, F. Bruyère, S.E. Geerlings, B. Köves, F. Wagenlehner Guidelines Associates: A. Pilatz, B.
Pradere, R. Veeratterapillay. EAU Urological Infections Guidelines. Retrieved from: http://uroweb.org/guideline/urological-infections/. Access date July 3, 2018. .
2. Complicated urinary tract infections: ceftolozane/tazobactam. National Institute for Health and Care Excellence (NICE evidence summary: new medicine; no. 74). Available from:
https://www.nice.org.uk/advice/esnm74/chapter/Key-points-from-the-evidence.
Published: June 2016. Accessed June 21, 2018.
3. Gupta K, Hooton TM, Naber KG, et al. International Clinical Practice Guidelines for the Treatment of Acute Uncomplicated Cystitis and
Pyelonephritis in Women: A 2010 Update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clinical Infectious Diseases 2011; 52(5): e103-e120.
4. Hooton TM, Bradley SF, Cardenas DD, et al. Diagnosis, Prevention, and Treatment of Catheter-Associated Urinary Tract Infection in Adults: 2009 International Clinical Practice Guidelines from the Infectious Diseases Society of America. Clinical Infectious Diseases 2010; 50(5): 625-663.
5. 諾倍適乾粉注射劑(ZERBAXA for Injection). 美商默沙東藥廠股份有限 公司台灣分公司. Published July 24, 2017. Accessed June 28, 2018.
6. ATC/DDD Index 2018. WHO Collaborating Centre for Drug Statistics
Methodology. http://www.whocc.no/atc_ddd_index/. Accessed June 28, 2018.
7. 西藥、醫療器材、含藥化粧品許可證查詢. 衛生福利部食品藥物管理署.
http://www.fda.gov.tw/MLMS/H0001.aspx. Accessed June 28, 2018.
8. 藥品給付規定《第十節 抗微生物劑》. 衛生福利部中央健康保險署.
https://www.nhi.gov.tw/Content_List.aspx?n=E70D4F1BD029DC37&topn=3
FC7D09599D25979. Accessed June 28, 2018.
9. 健保用藥品項查詢. 衛生福利部中央健康保險署.
http://www.nhi.gov.tw/query/query1.aspx?n=FC660C5B07007373&sms=36A 0BB334ECB4011&topn=3185A4DF68749BA9&upn=80567D1327F69CB9.
Accessed June 28, 2018.
10. Canadian Agency for Drugs and Technologies in Health (CADTH).
https://www.cadth.ca/about-cadth/what-we-do/products-services/cdr/reports.
Accessed June 21, 2018.
11. Ceftolozane and Tazobactam for the Treatment of Bacterial Infections: A
Review of Clinical Effectiveness, Cost-effectiveness, and Guidelines.
Canadian Agency for Drugs and Technologies in Health. (CADTH Rapid Response; Project Number: RC0819-000). Available from:
https://www.cadth.ca/sites/default/files/pdf/htis/2016/RC0819%20Zerbaxa%2
0Final.pdf. Published November 3, 2016. Accessed June 21, 2018.
12. Pharmaceutical Benefits Advisory Committee (PBAC).
http://www.pbs.gov.au/pbs/industry/listing/elements/pbac-meetings/psd/public -summary-documents-by-product. Accessed June 21, 2018.
13. The National Institute for Health and Care Excellence (NICE).
https://www.nice.org.uk/guidance/published?type=ta. Accessed June 21, 2018.
14. Ceftolozane-tazobactam (Zerbaxa). Scottish Medicines Consortium (SMC).
Available from:
https://www.scottishmedicines.org.uk/media/1443/ceftolozane-tazobactam__z
erbaxa__final_april_2016_for_website.pdf. Published May 9, 2016. Accessed
June 21, 2018.15. Wagenlehner FM, Umeh O, Steenbergen J, Yuan G, Darouiche RO.
Ceftolozane-tazobactam compared with levofloxacin in the treatment of complicated urinary-tract infections, including pyelonephritis: a randomised, double-blind, phase 3 trial (ASPECT-cUTI). Lancet 2015; 385(9981):
1949-1956.
16. Huntington JA, Sakoulas G, Umeh O, et al. Efficacy of
ceftolozane/tazobactam versus levofloxacin in the treatment of complicated urinary tract infections (cUTIs) caused by levofloxacin-resistant pathogens:
results from the ASPECT-cUTI trial. The Journal of antimicrobial chemotherapy 2016; 71(7): 2014-2021.
17. Chen M, Zhang M, Huang P, et al. Novel beta-lactam/beta-lactamase inhibitors versus alternative antibiotics for the treatment of complicated intra-abdominal infection and complicated urinary tract infection: a
meta-analysis of randomized controlled trials. Expert review of anti-infective therapy 2018; 16(2): 111-120.
18. Popejoy MW, Paterson DL, Cloutier D, et al. Efficacy of
ceftolozane/tazobactam against urinary tract and intra-abdominal infections caused by ESBL-producing Escherichia coli and Klebsiella pneumoniae: a pooled analysis of Phase 3 clinical trials. The Journal of antimicrobial chemotherapy 2017; 72(1): 268-272.
19. Popejoy MW, Long J, Huntington JA. Analysis of patients with diabetes and complicated intra-abdominal infection or complicated urinary tract infection in phase 3 trials of ceftolozane/tazobactam. BMC Infectious Diseases 2017;
17(1).
20. Kauf TL, Prabhu VS. Cost-effectiveness of ceftolozane/tazobactam compared with piperacillin/tazobactam as empiric therapy based on the in-vitro
surveillance of bacterial isolates in the United States for the treatment of complicated urinary tract infections. 2017; 17(1): 314.
21. Turner RM, Wu B, Lawrence K, Hackett J, Karve S, Tunceli O. Assessment of Outpatient and Inpatient Antibiotic Treatment Patterns and Health Care Costs of Patients with Complicated Urinary Tract Infections. Clinical therapeutics 2015; 37(9): 2037-2047.
22. 衛生福利部統計處. 全民健康保險醫療統計年報.
https://dep.mohw.gov.tw/DOS/lp-1928-113.html. Published 2015. Accessed Jun 21, 2018.
23. Chen YK, Chen SF, Li HC, Lin HC. No increased risk of adverse pregnancy outcomes in women with urinary tract infections: a nationwide
population-based study. Acta obstetricia et gynecologica Scandinavica 2010;
89(7): 882-888.
附錄
附錄一 Levofloxacin、doripenem、ertapenem、imipenem/cilastatin 及 meropenem 之藥品給付規定[8]
(一) Levofloxacin(如 Cravit
®
)限用於成人(18 歲以上)之慢性支氣管炎的急性惡化、社區性肺炎、複雜 性泌尿道感染。
(二) Doripenem (如 Finibax
®
):1. 經細菌培養證實有意義之致病菌且對其他抗微生物製劑均具抗藥性或對其 他具有感受性抗微生物製劑過敏,而對 carbapenem 具有感受性(sensitivity)
之複雜性泌尿道感染(包括腎盂腎炎)及複雜性腹腔內感染。
2. 臨床上為嚴重之複雜性泌尿道感染(包括腎盂腎炎)及複雜性腹腔內感染,
且經其他廣效性的非第一線抗微生物製劑治療仍無法控制病情者。
3. 經感染症專科醫師會診,確認有感染症需使用者(申報費用時需檢附會診紀 錄及相關之病歷資料)。
(三) Ertapenem(如 Invanz
® inj.)
:1. 臨床上為中、重度細菌感染,且經其他抗微生物製劑治療仍無法控制病情 者,但限用於:
(1) 複雜的腹腔內感染
(2) 感染性肺炎
(3) 急性骨盆感染
2. 經感染症專科醫師會診,確認有感染症需使用者(申報費用時需檢附會診紀 錄及相關之病歷資料)。
(四) Imipenem + cilastatin(如 Tienam
®
);meropenem(如 Mepem®
):1. 經細菌培養證實有意義之致病菌且對其他抗微生物製劑均具抗藥性,而對 carbapenem 具有感受性(sensitivity)。
2. 經細菌培養,發現有意義之致病菌對 carbapenem 及其他抗微生物製劑具有感 受性,但病患對其他抗微生物製劑過敏無其他藥物可供選用時。
3. 臨床上為嚴重之細菌感染,且經其他廣效性的非第一線抗微生物製劑治療仍 無法控制病情者。
4. 經感染症專科醫師會診,確認有感染症需使用者(申報費用時需檢附會診紀 錄及相關之病歷資料)。
附錄二 療效評估文獻搜尋記錄
資料庫 查詢日期 關鍵字 篇數
Cochrane Library
107/6/29 #1 ceftolozane 30 PubMed 107/6/29 #1 "ceftolozane"[Supplementary Concept] OR
"ceftolozane"[All Fields]
258
#2 #1 AND (Meta-Analysis[ptyp] OR systematic[sb])
8
#3 ("random allocation"[MeSH Terms] OR ("random"[All Fields] AND "allocation"[All Fields]) OR "random allocation"[All Fields]
OR "randomized"[All Fields]) OR randomised[All Fields]
842,868
#4 #1 AND (("random allocation"[MeSH Terms] OR ("random"[All Fields] AND
"allocation"[All Fields]) OR "random allocation"[All Fields] OR
"randomized"[All Fields]) OR randomised[All Fields])
17
Embase 107/6/29 #1 ceftolozane 498
#2 #1 AND ([cochrane review]/lim OR [systematic review]/lim OR [meta analysis]/lim)
15
#3 #1 AND [randomized controlled trial]/lim 10
附錄三、經濟評估文獻搜尋紀錄
資料庫 查詢日期 關鍵字 篇數
PubMed 2018.6.13
1 (Complicated urinary tract infections) OR
cUTI 2,130
2 (Ceftolozane) OR tazobactam 4,232
3
(((((((Cost-effectiveness analysis) OR cost-utility analysis) OR cost-minimisation analysis) OR cost-benefit analysis) OR CEA) OR CUA) OR CMA) OR CBA
161,961
4 #1 and #2 and #3 2
Cochrane
Library 2018.6.13 1
'(Complicated urinary tract infections or cUTI) AND (Ceftolozane or tazobactam) AND (Cost-effectiveness analysis or cost-utility analysis or cost-minimisation analysis or cost-benefit analysis or CEA or CUA or CMA or CBA) in Title, Abstract, Keywords '
0
CRD 2018.6.13 1
(Complicated urinary tract infections or cUTI) AND (Ceftolozane or tazobactam) AND (Cost-effectiveness analysis or cost-utility analysis or cost-minimisation analysis or cost-benefit analysis or CEA or CUA or CMA or CBA) IN DARE, NHSEED, HTA
0