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A One-Week Low-Dose New Triple Therapy for Treatment of Duodenal Ulcer with Helicobacter Pylori Infection
以一週低劑量的新三合一療法治療十二指腸潰瘍合併幽門螺旋桿菌感染
摘要
近年來抗生素被廣泛使用在治療十二指腸潰瘍合併幽門螺旋桿菌感染。然而耐受性差，抗藥性，以及藥物的副作用限制了傳統三合一療法（bismuth subcitrate，metronidazole，amoxycillin）的療效。以質子幫浦阻斷劑（PPI）為主的三合一療法提高了幽門螺旋桿菌的根除率但是卻十分昂貴。本研究即在比較新的三合一療法與傳統三合一療法之間的療效，病患的耐受性及價格。共有90位病患經內視鏡，碳-13尿素脢呼吸試驗和CLO試驗證實為活性期之十二指腸潰瘍合併幽門螺旋桿菌感染者，隨機平分為三組接受不同之治療。A組為口服DeN01 120mg，Amoxycillin 500mg和metronidazole 250mg每日四次共14天；B組口服omeprazole 20mg，clarithromycin 500mg每日兩次和amoxycillin 500mg每日四次共14天；C組口服omeprazole 20mg，clarithromycin 250mg，and metronidazole 500mg每日兩次共7天。在三合一療法結束後繼續服用nizatindin 150mg 每日兩次至總計八週為止。兩個月後再以內視鏡，碳-13尿素脢呼吸試驗和CLO試驗評估潰瘍癒合率及幽門螺旋桿菌根除率，同時評估病患的耐受性。共84位病患完成全部之檢查，其中三組之根除率分別為A組75%，B組92.8%，C組為89.3%，潰瘍癒合率分別為A組85.7%，B組89.3%，C組89.3%。治療後，共74位病患（88.1%）完全沒有症狀。對於症狀的緩解以質子幫浦阻斷劑（PPI）為主的三合一療法優於傳統三合一療法，但B組與C組是相同的。在費用方面則C組遠低於A，B兩組，且均無重大之併發症。因此以omeprazole 20mg，clarithromycin 250mg，and metronidazole 500mg每日兩次為期壹週的新三合一療法不但與傳統三合一療法或兩週之質子在幫浦阻斷劑為主的三合一療法具有相同根除率及潰瘍癒合率，而且價格低副作用少，臨床上更提供了一個適當的選擇。
並列摘要
Antimicrobial therapy is the recommended treatment for duodenal ulcer associated Helicobacter pylori infection. The eradication rate of conventional therapy with bismuth subcitrate, metronidazole and amoxycillin is limited with low compliance, drug resistance and side effects. The two-week PPI based triple therapy has a higher eradication rate but is costly. This study was designed to compare the efficacy. Patients' compliance and cost of short-term one-week PPI based triple therapy with those of the conventional therapy. Ninety patients with active duodenal ulcer disease and H. pylori infection proven with 13C-urea breath test and CLO test (Campylobacter Like Organism test) were treated randomly in three therapeutic groups: Group A, DeN01 120mg, Amoxycillin 500mg and metronidazole 250mg four times a day orally for 14 days; Group B, omeprazole 20mg plus clarithromycin 500mg twice a day, and amoxycillin 500mg four times a day for 14 days; Group C, omeprazole 20mg, clarithromycin 250mg, and metronida zole 500mg twice a day for 7 days. Nizatidine 150mg twice a day was given continuously in the days following the end of anti-H. pylori therapy for each group. Two months later, endoscopy, the CLO test and 13C-urea breath test were repeated to access the eradication rate of H. pylori and the ulcer healing rate. Drug tolerance was evaluated by patients themselves via daily recordings. Eighty-four patients completed the entire course of therapy and evaluation of H. pylori infection. The eradication rates of H. pylori infection I group A, B, C were 75% (21/28), 92.8% (26/28),and 89.3% (25/28) respectively. The ulcer healing rate was 85.7% in group A and 89.3% in groups B and C. Totally, seventy-four patients (88.1%) were from symptoms at the end of the triple therapy. The effect of symptom relief was faster in patients with PPI based triple therapy (group B and C)(day 3 and 4) than patients with conventional therapy (day 5). The group C was lower in cost than groups A and B. There were no major side effects in any of the patients. One-week triple therapy with omeprazole, clarithromycin and metronidazole is a highly effective therapy for eradication of H. pylori infection. The therapeutic regimen with lower cost. good compliance and mild side effects of one weed duration may offer a good choice in the treatment of duodenal ulcer associated with H. pylori infection in clinical practice.