1. Hunt R, Armstrong D, Katelaris P, et al. World Gastroenterology Organisation Global Guidelines: GERD Global Perspective on Gastroesophageal Reflux Disease. J Clin Gastroenterol 2017; 51(6): 467-478.
2. Fock KM, Talley N, Goh KL, et al. Asia-Pacific consensus on the management of gastro-oesophageal reflux disease: an update focusing on refractory reflux disease and Barrett's oesophagus. Gut 2016; 65(9): 1402-1415.
3. Fock KM, Talley NJ, Fass R, et al. Asia-Pacific consensus on the management of gastroesophageal reflux disease: update. J Gastroenterol Hepatol 2008;
23(1): 8-22.
4. Fock KM, Talley N, Hunt R, et al. Report of the Asia-Pacific consensus on the management of gastroesophageal reflux disease. J Gastroenterol Hepatol 2004;
19(4): 357-367.
5. Sheu B-S, Chiu C-T, Lee Y-C, et al. Consensus of gastroesophageal reflux disease in Taiwan with endoscopy-based approach covered by National Health Insurance. Advances in Digestive Medicine 2015; 2(3): 85-94.
6. Iwakiri K, Kinoshita Y, Habu Y, et al. Evidence-based clinical practice guidelines for gastroesophageal reflux disease 2015. J Gastroenterol 2016;
51(8): 751-767.
7. Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R, Global Consensus G. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol 2006; 101(8):
1900-1943.
8. Sandhu DS, Fass R. Current Trends in the Management of Gastroesophageal Reflux Disease. Gut Liver 2018; 12(1): 7-16.
9. Dent J, El-Serag HB, Wallander MA, Johansson S. Epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut 2005; 54(5):
710-717.
10. El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut 2014; 63(6):
871-880.
11. Chang F-Y. Variations in the reported prevalence of gastroesophageal reflux disease in Taiwan. J Chin Med Assoc 2012; 75(3): 91-92.
12. Hung L-J, Hsu P-I, Yang C-Y, Wang EM, Lai K-H. Prevalence of gastroesophageal reflux disease in a general population in Taiwan. J Gastroenterol Hepatol 2011; 26(7): 1164-1168.
13. Garnock-Jones KP. Vonoprazan: first global approval. Drugs 2015; 75(4):
439-443.
14. Medical Reviews. U.S. Food & Drug Administration.
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm.
Accessed Feb.12th 2020.
15. European Public Assessment Report. European Medicines Agency.
https://www.ema.europa.eu/en/medicines. Accessed Feb. 13th, 2020.
16. ClinicalTrial.gov. U.S. National Library of Medicine. https://clinicaltrials.gov/.
Accessed Feb. 15th 2020.
17. Hojo M, Nagahara A, Hahm K-B, et al. Management of Gastroesophageal Reflux Disease in Asian Countries: Results of a Questionnaire Survey.
Digestion 2020; 101(1): 66-79.
18. Inatomi N, Matsukawa J, Sakurai Y, Otake K. Potassium-competitive acid blockers: Advanced therapeutic option for acid-related diseases. Pharmacol Ther 2016; 168: 12-22.
19. Oshima T, Miwa H. Potent Potassium-competitive Acid Blockers: A New Era for the Treatment of Acid-related Diseases. J Neurogastroenterol Motil 2018;
24(3): 334-344.
20. Vaezi MF. Diagnosis and Treatment of Gastroesophageal Reflux Disease:
Springer International Publishing; 2016.
21. Kumar S, Sharma S, Norboo T, et al. Population based study to assess prevalence and risk factors of gastroesophageal reflux disease in a high altitude area. Indian J Gastroenterol 2011; 30(3): 135-143.
22. ATC / DDD Index 2020. WHO Collaborating Centre for Drug Statistics Methodology.
https://www.whocc.no/atc_ddd_index/.
Published 2020.Accessed Feb. 17th 2020.
23. 西藥、醫療器材、特定用途化妝品許可證查詢. 衛生福利部食品ˋ藥物管理 署. https://info.fda.gov.tw/MLMS/H0001.aspx. Accessed Feb. 17th 2020.
24. 健 保 藥 品 給 付 規 定 . 衛 生 福 利 部 中 央 健 康 保 險 署 .
https://www.nhi.gov.tw/Content_List.aspx?n=E70D4F1BD029DC37&topn=5 FE8C9FEAE863B46. Published 2020. Accessed Feb. 14th 2020.
25. Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis. ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/show/NCT04124926. Published 2020. Accessed
Feb. 12th 2020.26. Common Drug Review. Canadian Agency for Drugs and Technologies in Health. https://www.cadth.ca/. Published 2020. Accessed Feb. 12th 2020.
27. Public Summary Documents. The Parmaceutical Benefits Scheme, Australian Government Department of Health.
http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/publi c-summary-documents-by-product. Published 2020. Accessed Feb. 12th 2020.
28. Technology appraisal guidance. National Institute for Health and Care Excellence.
https://www.nice.org.uk/. Published 2020. Accessed Feb. 12th
2020.29. Medicines advice. Scottish Medicines Consortium.
https://www.scottishmedicines.org.uk/medicines-advice/.
Published 2020.Accessed Feb. 12th 2020.
30. Miyazaki H, Igarashi A, Takeuchi T, et al. Vonoprazan versus proton-pump inhibitors for healing gastroesophageal reflux disease: A systematic review. J Gastroenterol Hepatol 2019; 34(8): 1316-1328.
31. Miwa H, Igarashi A, Teng L, Uda A, Deguchi H, Tango T. Systematic review with network meta-analysis: indirect comparison of the efficacy of vonoprazan and proton-pump inhibitors for maintenance treatment of gastroesophageal reflux disease. J Gastroenterol 2019; 54(8): 718-729.
32. Ashida K, Sakurai Y, Hori T, et al. Randomised clinical trial: vonoprazan, a novel potassium-competitive acid blocker, vs. lansoprazole for the healing of erosive oesophagitis. Aliment Pharmacol Ther 2016; 43(2): 240-251.
33. Ashida K, Iwakiri K, Hiramatsu N, et al. Maintenance for healed erosive esophagitis: Phase III comparison of vonoprazan with lansoprazole. World J Gastroenterol 2018; 24(14): 1550-1561.
34. Xiao Y, Zhang S, Dai N, et al. Phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis. Gut 2020; 69(2):
224-230.
35. Hoshino S, Kawami N, Takenouchi N, et al. Efficacy of Vonoprazan for Proton Pump Inhibitor-Resistant Reflux Esophagitis. Digestion 2017; 95(2):
156-161.
36. Shinozaki S, Osawa H, Hayashi Y, et al. Vonoprazan 10 mg daily is effective for the treatment of patients with proton pump inhibitor-resistant gastroesophageal reflux disease. Biomed Rep 2017; 7(3): 231-235.
37. Yamashita H, Kanamori A, Kano C, et al. The Effects of Switching to Vonoprazan, a Novel Potassium-Competitive Acid Blocker, on Gastric Acidity and Reflux Patterns in Patients with Erosive Esophagitis Refractory to Proton Pump Inhibitors. Digestion 2017; 96(1): 52-59.
38. Iwakiri K, Sakurai Y, Shiino M, et al. A randomized, double-blind study to evaluate the acid-inhibitory effect of vonoprazan (20 mg and 40 mg) in patients with proton-pump inhibitor-resistant erosive esophagitis. Therap Adv
Gastroenterol 2017; 10(6): 439-451.
39. Oshima T, Arai E, Taki M, et al. Randomised clinical trial: vonoprazan versus lansoprazole for the initial relief of heartburn in patients with erosive oesophagitis. Aliment Pharmacol Ther 2019; 49(2): 140-146.
40. Umezawa M, Kawami N, Hoshino S, et al. Efficacy of On-Demand Therapy Using 20-mg Vonoprazan for Mild Reflux Esophagitis. Digestion 2018; 97(4):
309-315.
41. Kojima Y, Takeuchi T, Sanomura M, et al. Does the Novel Potassium-Competitive Acid Blocker Vonoprazan Cause More Hypergastrinemia than Conventional Proton Pump Inhibitors? A Multicenter Prospective Cross-Sectional Study. Digestion 2018; 97(1): 70-75.
42. Kato M, Ito N, Demura M, Kubo K, Mabe K, Harada N. Study for every other day administration of vonoprazan in maintenance treatment of erosive GERD:
study protocol for a multicentre randomised cross-over study. BMJ Open Gastroenterol 2018; 5(1): e000197-e000197.
43. UMIN-CTR 臨 床 試 験 登 録 情 報 の 閲 覧 . University hospital medical
information network.
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000039563.
Accessed Feb. 24th 2020.
44. Kinoshita Y, Sakurai Y, Shiino M, et al. Evaluation of the Efficacy and Safety of Vonoprazan in Patients with Nonerosive Gastroesophageal Reflux Disease:
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study. Curr Ther Res Clin Exp 2016; 81-82: 1-7.
45. Habu Y. Vonoprazan versus Lansoprazole for the Initial Treatment of Reflux Esophagitis: A Cost-effectiveness Analysis in Japan. Internal medicine (Tokyo, Japan) 2019; 58(17): 2427-2433.
46. Yokoya Y, Igarashi A, Uda A, Deguchi H, Takeuchi T, Higuchi K. Cost-utility analysis of a 'vonoprazan-first' strategy versus 'esomeprazole- or rabeprazole-first' strategy in GERD. Journal of gastroenterology 2019; 54(12):
1083-1095.
47. Wang FW, Tu MS, Chuang HY, Yu HC, Cheng LC, Hsu PI. Erosive esophagitis in asymptomatic subjects: risk factors. Digestive diseases and sciences 2010; 55(5): 1320-1324.
48. Chen MJ, Lee YC, Chiu HM, Wu MS, Wang HP, Lin JT. Time trends of endoscopic and pathological diagnoses related to gastroesophageal reflux disease in a Chinese population: eight years single institution experience.
Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus 2010; 23(3): 201-207.
49. Jung HK. Epidemiology of gastroesophageal reflux disease in Asia: a systematic review. Journal of neurogastroenterology and motility 2011; 17(1):
14-27.
50. 財團法人醫藥品查驗中心. 得喜胃通緩釋膠囊 (Dexilant®)醫療科技評估 報告. Published 2013. Accessed March 3rd, 2020.
附錄
附錄表一、療效評估文獻搜尋紀錄
資料庫 查詢日期 關鍵字 篇數
Cochrane Library 1800-2020
20200212 #1 MeSH descriptor: [Esophagitis] explode all trees
#2 vonoprazan
#3 #1 and #2
777 193 10 PubMed
1950-2020
20200212 "1 5 2 fluorophenyl 1 pyridin 3 ylsulfonyl 1h pyrrol 3 yl n methylmethanamine"[Supplementary Concept] OR "1 5 2 fluorophenyl 1 pyridin 3 ylsulfonyl 1h pyrrol 3 yl n methylmethanamine"[All Fields] OR "vonoprazan"[All Fields
(("1 5 2 fluorophenyl 1 pyridin 3 ylsulfonyl 1h pyrrol 3 yl n methylmethanamine"[Supplementary Concept] OR "1 5 2 fluorophenyl 1 pyridin 3 ylsulfonyl 1h pyrrol 3 yl n methylmethanamine"[All Fields]) OR "vonoprazan"[All Fields]) AND (((((((("esophageal"[All Fields] OR "esophagic"[All Fields]) OR "esophagitis"[MeSH Terms]) OR "esophagitis"[All Fields]) OR "esophagitides"[All Fields]) OR "oesophagal"[All Fields]) OR
"oesophageal"[All Fields]) OR "oesophagic"[All Fields]) OR
"oesophagitis"[All Fields])
127
26
附錄表二、Vonoprazan 之五項第三期隨機分派試驗內容彙整表
95.5%，差異值 3.5% (95%CI 0.362 to 6.732，P< 0.0001)，
達到不劣性標準。治療第 2 週時，兩組的表現差異(8.8%)
試驗號碼 發表年代 執行地區 受試人數 試驗目的 試驗設計與方法 試驗結果
試驗號碼 發表年代 執行地區 受試人數 試驗目的 試驗設計與方法 試驗結果
vs. 91.3%；差異 1.1%；95%CI -3.82%~6.09%)，符合不 劣性標準。試驗第 2 與 4 週時的表現，則兩組差異皆未 受 vonoprazan 10 mg、20 mg 或 lansoprazole 15 mg 24 週做為維持療法。本試驗於 2015 年 4
目前尚未有任何文獻發表。廠商於 2020 年 2 月 21 日在 ClinicalTrials.gov 網頁[25]，上傳初步的試驗數據以供參 考。V 藥 10mg 組納入 235 人、20mg 組 226 人、L 藥 15mg 組 242 人。各組約 75%受試者完成試驗，退出試驗的主
試驗號碼 發表年代 執行地區 受試人數 試驗目的 試驗設計與方法 試驗結果 lansoprazole 。 月 1 日開始進行，直到 2018 年 12 月 31 日結束。
主要療效指標為維持治療 24 週後，受試者經內 視鏡檢測，病灶出現復發的比例，次要療效指 標則為試驗第 12 週時評估的結果以及出現不 良事件的受試者比例。
要 原 因 為 藥 物 副 作 用 或 試 驗 偏 差 (major protocol deviation)。平均年齡 52.8 歲、73.8%為男性、中國人佔 70%、台灣人佔 9% (64 人)、洛杉磯食道炎分級屬 A/B 占 80%、沒有幽門螺旋桿菌感染者占 88.5%，未測量受 試者的 CYP2C19 基因表現。
主次要療效指標結果如下：
V 藥 10mg V 藥 20mg L 藥 15mg
24 週復發(%) (95%CI)
13.3 (8.7-19.1)
12.3 (7.8-18.2)
25.5 (19.4-32.5) 12 週復發(%)
(95%CI)
27.8 (9.7-53.5)
10.0 (1.2-31.7)
35.0 (15.4-59.2)
不良事件(%) 66.8 69.0 65.3
嚴重 AE (%) 4.3 3.5 5.0
附錄表三、經濟評估文獻搜尋紀錄
步驟 搜尋策略 (搜尋時間：2020/2/18) 篇數
PubMed
#1 Gastroesophageal reflux disease 34,554
#2 vonoprazan 226
#3 (((((Cost-consequence analysis) OR cost-effectiveness analysis) OR cost-benefit analysis) OR cost-utility analysis) OR cost studies) OR economic evaluation
277,605
#4 #1 AND #2 AND #3 4
Cochrane
#1 vonoprazan 192
#2 (((((Cost-consequence analysis) OR cost-effectiveness analysis) OR cost-benefit analysis) OR cost-utility analysis) OR cost studies) OR economic evaluation
1,503
#3 #1 AND #2 4
Embase
#1 'vonoprazan'/exp OR vonoprazan 483