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研究生:黃淑芬
研究生(外文):Shu-Fen Huang
論文名稱:比較含Esomeprazole與含Omeprazole三合療法根除幽門桿菌之臨床研究
論文名稱(外文):A Randomized Open Trial for Comparison of Proton Pump Inhibitors, Esomeprazole versus Omeprazole, in Triple Therapy for Helicobacter pylori Infection
指導教授:許博翔許博翔引用關係高雅慧高雅慧引用關係周辰熹周辰熹引用關係
指導教授(外文):Bor-Shyang SheuYea-Huei Kao YangChen-Hsi Chou
學位類別:碩士
校院名稱:國立成功大學
系所名稱:臨床藥學研究所
學門:醫藥衛生學門
學類:藥學學類
論文種類:學術論文
論文出版年:2003
畢業學年度:91
語文別:中文
論文頁數:128
中文關鍵詞:三合療法氫離子幫浦抑制劑幽門桿菌
外文關鍵詞:Helicobacter pyloriProton pump inhibitorsEsomeprazoleTriple therapyOmeprazole
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[研究背景] 幽門桿菌在胃腸道潰瘍的致病原因中,佔有重要地位。一般認為根除幽門桿菌不只使其引致的胃炎能夠恢復,也能加速治癒潰瘍性疾病。最普遍使用的方法是一星期的三合療法(Triple therapy),包含一個胃酸分泌抑制劑及兩個抗生素。Esomeprazole為omeprazole之S-異構物(S-isomer);已知在歐美國家,Esomeprazole用在三合療法,根除幽門桿菌的療效不輸其他氫離子幫浦阻斷劑。但到目前為止,評估東方人使用esomeprazole於三合一療法中之療效、適當劑量、病人服藥順從性、安全性和成本效益的研究,卻明顯缺乏。
[研究目的]
Primary endpoint —
比較esomeprazole 40 mg/天,80 mg/天和omeprazole 40 mg/天,分別合併amoxicillin和clarithromycin的幽門桿菌根除率、病患服藥順從性和副作用發生的情形。
Secondary endpoint —
比較含esomeprazole或omeprazole的三合療法之成本效益。
CYP2C19的基因多形性對三合療法效果的影響。
[研究方法] 於成大醫院胃腸科門診選取幽門桿菌檢驗為陽性的病患,收入研究的每位患者均須已接受內視鏡檢查及可診斷是否有幽門桿菌感染的檢驗,如胃腸道組織切片培養或CLO test。本研究共收入受試者數目為149人,隨機分成三組,分別接受omeprazole 40 mg/天、esomeprazole 40 mg/天、esomeprazole 80 mg/天;各合併amoxicillin 1 g及clarithromycin 500 mg一天兩次 (以下稱之OAC組、E4AC組、E8AC組),一星期的治療,每位受試者在療程結束後的回診,接受服藥順從性、副作用及金錢花費等調查;至少四至六週後再接受是否仍有幽門桿菌感染的檢驗及血液抽樣。
[研究結果] E4AC組的幽門桿菌根除率略低於OAC組 (69.7% vs. 79.5%,p = 0.13);E8AC組的幽門桿菌根除率(84.4%)則高於OAC組及E4AC組 (E8AC vs. OAC,p=0.37; E8AC vs. E4AC,p=0.04) 。E8AC組的成本效益比另兩組高。E4AC組在poor metabolizer的根除率略低於OAC組 (71.4% vs. 100%,p = 0.2);E8AC組在extensive metabolizer的根除率略高於OAC組及E4AC組 (82.4% vs. 75.3%,p = 0.28;82.4% vs. 64.9%,p = 0.081);而含esomeprazole三合療法E4AC組(64.9% vs. 71.4%)及E8AC組(82.4% vs. 90%)在extensive metabolizer和 poor metabolizer間的根除率差異比OAC組(73.5% vs. 100%)小。
[結論] E4AC組的幽門桿菌根除率略低於OAC組,而提高esomeprazole 劑量達兩倍 (如E8AC組) 可顯著增加幽門桿菌根除率。且對extensive metabolizer而言,E8AC組顯比OAC組更具治療優勢。
Background: It is well established that infection with Helicobacter pylori is the important cause of peptic ulcer, and eradication of this organism not only causes regression of the associated gastritis but also enhances curing of the disease. Based on numerous management guidelines, the most proper eradication approach is triple therapy, with one anti-secretory agent in combination with two antibiotics. Esomeprazole is the S-isomer of omeprazole and the first proton pump inhibitor to be developed as an optical isomer. In Europe countries and America, esomeprazole based triple therapy offers comparable efficacy in eradicating H. pylori to omeprazole based triple therapy. But to date, little is known about the efficacy, appropriate dosage, patient’s compliance, tolerability and cost-effectiveness, about esomeprazole based triple therapy in Taiwan.
Aims: The primary efficacy endpoint of the study is to compare the efficacy , patient’s compliance and tolerability of esomeprazole 40 mg/day, 80 mg/day and omeprazole 40 mg/day, in combination with amoxicillin and clarithromycin for eradication of H. pylori. The secondary outcome is to compare the cost-effectiveness of omeprazole and esomeprazole based triple therapy. Another secondary outcome is to investigate whether CYP2C19 genotype status is related to eradication rates of H. pylori by esomeprazole based triple therapy.
Methods: One hundred and forty-nine patients with H. pylori infection proved by CLO test or pathology report are randomized to receive one of the following regimens: amoxicillin 1g bid, clarithromycin 500 mg bid, and PPI (omeprazole 20 mg bid, esomeprazole 40 mg qd or esomeprazole 40 mg bid) for one week. Compliance, adverse event and related cost were recorded after treatment. Four to six weeks after the end of eradication therapy, a UBT or endoscopy is performed to determine H. pylori status. For CYP2C19 genotype analysis, patient’s peripheral blood samples are obtained and determined with polymerase chain reaction —restriction fragment length polymorphism analysis.
Results: Per-protocol based overall cure rate for E4AC、E8AC and OAC regimens are 66.7%,、84.4% and 79.5%. E4AC has a slightly lower eradication rate than OAC (p=0.13), and E8AC has significantly higher eradication rate than E4AC and also for OAC (E8AC vs. OAC, p=0.37; E8AC vs. E4AC, p=0.04). E8AC has the highest average cost effectiveness ratio than OAC and E4AC. Eradication rate in poor metabolizers is slightly lower for E4AC than for OAC. Less variability in eradication rate of different metabolizers for E4AC and E8AC than for OAC. For the extensive metabolizers in CYP2C19, the eradication rate of E8AC is higher than the other two groups.
Conclusions: E4AC has a slightly lower eradication rate than OAC. The increase of esomeprazole dosage to 80 mg/day can potentially improve the eradication rate, especially for the extensive metabolizers of CYP2C19.
中文摘要i
英文摘要iv
表目錄xi
圖目錄xiii
第壹章研究背景 1
第貳章文獻回顧 2
第叁章研究目的 48
第肆章研究材料 49
第伍章研究方法 50
第陸章研究結果 66
第柒章討論 95
參考文獻106
附錄臨床藥事服務 122
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