以氫離子幫浦抑製劑為基礎的三合一療法是目前根除幽門螺旋桿菌感染與治療消化性潰瘍疾病的主流療法。其中以Esomeprazole 為基礎的三合一療法在許多已被發表文章證實了可以達到良好的潰瘍癒合率和幽門螺旋桿菌根除。然而，比較不同劑量及配方的三合一療法根除幽門螺旋桿菌感染則很少被提及。這項臨床試驗的目的是比較兩種不同劑量的Esomeprazole (40 毫克或20 毫克，每天兩次) 和不同的組合的抗生素對於幽門螺桿菌感染根除和消化道潰瘍癒合率的成效。從2003 年2 月至2009 年10 月，我們收集了272 例( 女：42%，平均年齡：53.8±15.2 歲）證實幽門螺旋桿菌相關的消化性潰瘍病( 胃潰瘍或十二指腸潰瘍)，然後將所有的病人隨機分配到四組進行治療。A 組：E 40 毫克，M 500 毫克，C 250毫克；B 組：E 20 毫克，M 500 毫克，C 250 毫克；C 組：E 40 毫克，A 1000 毫克，C 500 毫克；D 組：E 20 毫克，A 1000 毫克，C 500 毫克(E：Esomeprazole，M：Metronidazole，C：Clarithromycin，A：Amoxicillin)。消化性潰瘍病的診斷是經由上消化道內視鏡確認。滅菌成功與否則是經過至少四個月的治療後，經由尿素呼氣試驗 (Urease Breathing Test)、快速尿素酶試驗或組織學確認。所有隨機分組患者再經過治療後，有170 名患者接受第二次上消化道內視鏡來確認潰瘍癒合及加上快速尿素酶試驗確認滅菌成功與否。另外有七名不願意接受第二次上消化道內視鏡的檢查則只用尿素呼氣試驗確認滅菌成功與否。以完成實驗設計流程(perprotocol) 來分析，A 組的幽門螺旋桿菌滅菌成功率為89.6%，B 組86.7%，C 組97.5%，D 組93.2%。在潰瘍癒合率A 組為95.6%，B 組91.1%，C 組97.4%，D 組100%。以完成實驗設計流程的整體滅菌率為91.53% ( 一百七十七分之一百六十二)，而整體的潰瘍癒合率分別為95.88% (170 分之163)。以減半劑量20 毫克的Esomeprazole 為基礎的三合一療法在我們的實驗被證實和原始劑量40 毫克的標準三合一療法是一樣有效的。在這醫療開支高漲的時代，降低治療的成本且不犧牲療效的療法是值得臨床上採用的。

Proton-pump inhibitor-based triple therapy is currently the mainstay for eradication of H. pylori infection and peptic ulcer disease. Esomeprazole-based triple therapy was verified in many publications to achieve
acceptable ulcer healing rate and eradication rate of H. pylori infection. However, comparison of different triple therapy in eradication of H. pylori infection is seldom mentioned. This clinical trial is aimed to compare the effects of two different dosage of esomeprazole (40 mg or 20 mg twice daily) and different antibiotic combination in eradication rate of H. pylori infection and peptic ulcer healing rate. From Feb. 2003 to Oct.
2009, we collected 272 patients (female: 42%; age: 53.8±15.2 yr) with investigated H. pylori related peptic
ulcer disease (gastric ulcer or duodenal ulcer) and then randomly assigned all the patients into four groups
for treatment. Group A: E 40mg, M 500mg, C 250mg; Group B: E 20mg, M 500mg, C 250mg; Group C: E
40mg, A 1000mg, C 500mg; Group D: E 20mg, A 1000mg, C 500mg (E: esomeprazole, M: metronidazole,
C: clarithromycin, A: amoxicillin). Diagnosis of peptic ulcer disease was made via esophagogastroduodenoscopy
(EGD). Eradication was confirmed at least four months after completion of treatment by means
of urea breath test (UBT), rapid urease test or histology. After treatment, repeated EGD was performed
in 170 patients for confirmation of ulcer healing in addition to the rapid urease test or biopsy which is
mandatory for confirmation of eradication. Another seven patients who were reluctant to receive secondary
EGD underwent UBT only. Based on per-protocol analysis, H. pylori eradication among group A is 89.6%,
group B 86.7 %, group C 97.5% and group D 93.2%. Ulcer healing rate among group A is 95.6%, group B
91.1%, group C 97.4% and group D 100%. There was no statistically significant difference in either eradication
or ulcer healing rate among 4 groups. By intention-to-treat analysis, H. pylori eradication rates among
four groups are much lower and reported 63.2%, 57.4%, 57.4% and 60.3% respectively. Moreover, the
per-protocol overall eradication rate was 91.53% (162/177); while overall ulcer healing rate was 95.88%
(163/170). Esomeprazole 20 mg based triple therapy appears to be as effective as standard esomeprazole
40 mg based triple therapy. In the era of high health care expenditure, reducing the cost of treatment but not
sacrificing efficacy may be worthwhile.