One Week of Esomeprazole Triple Therapy vs. 1 Week of Omeprazole Triple Therapy Plus 3 Weeks of Omeprazole for Duodenal Ulcer Healding in <Emphasis Type="Italic">Helicobacter pylori</Emphasis>-Positive Patients

In this randomized, double-blind, multicenter study, H. pylori-positive patients with an active duodenal ulcer (DU) received esomeprazole, 20 mg twice daily (bid), or omeprazole, 20 mg bid, with amoxicillin, 1000 mg bid, and clarithromycin, 500 mg bid, for 1 week (EAC and OAC, respectively). Patients received an additional 3 weeks of either placebo or omeprazole, 20 mg once daily (od), in the EAC and OAC groups, respectively. The intent-to-treat population included 374 patients (EAC, 186; OAC, 188). Four-week DU healing rates were similar in the EAC+placebo and OAC+omeprazole groups: 74% and 76%, respectively. DU healing rates at 8 weeks were 87% for EAC+placebo and 88% for OAC+omeprazole. H. pylori eradication rates were 75% and 79% for EAC and OAC, respectively. Both regimens were well tolerated. A 1-week regimen of esomeprazole-based H. pylori eradication triple therapy was as effective for DU healing and eradication of H. pylori as omeprazole-based triple therapy followed by an additional 3 weeks of monotherapy.     

Esomeprazole versus omeprazole for the eradication of Helicobacter pylori infection: results of a randomized controlled study

BACKGROUND: Esomeprazole has higher oral bioavailability and increased antimicrobial activity against Helicobacter pylori than omeprazole. GOALS: To compare 7 days esomeprazole with 7 days of omeprazole based triple therapies for the eradication of H. pylori, and to assess whether the administration of higher dose of esomeprazole leads to improved eradication rates. STUDY: One hundred and fifty-six dyspeptic patients with H. pylori received either: (1) 1-week treatment including esomeprazole 40 mg once daily, amoxicillin 1 g, and clarithromycin 500 mg, both twice daily (EAC1 group, n = 52); (2) 1-week treatment of omeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg, all administered twice daily (OAC group, n = 52); or (3) 1-week treatment with esomeprazole 40 mg, amoxicillin 1 g, and clarithromycin 500 mg, all given twice daily (EAC2 group, n = 52). RESULTS: H. pylori was eradicated in 37 of 52 patients in the OAC group (Intension to treat [ITT] 71%), and in 42 patients in the EAC1 group (ITT 81%). High eradication rate was achieved by the EAC2 regimen (ITT; 96%), but more patients reported unwanted effects. CONCLUSION: Seven days of esomeprazole based triple therapy is a satisfactory eradication regimen for H. pylori infection. Higher doses of esomeprazole have excellent eradication rates, but they may lead to increased side effects.     

Effect of esomeprazole triple therapy on eradication rates of Helicobacter pylori, gastric ulcer healing and prevention of relapse in gastric ulcer patients

OBJECTIVES: To compare esomeprazole-based triple therapy with esomeprazole alone for the eradication of Helicobacter pylori (H. pylori), healing of ulcer and prevention of relapse in H. pylori-related gastric ulcer (GU) diseases. METHODS: In this double-blind study, 401 H. pylori-positive patients with more than or equal to two GUs were randomized to: esomeprazole (20 mg) twice daily (bid) and amoxicillin (1000 mg) bid and clarithromycin (500 mg) bid (EAC) for 1 week, followed by placebo for 3 weeks (EAC and placebo); EAC for 1 week, followed by esomeprazole (20 mg) once daily (E20) for 3 weeks (EAC and E20); or esomeprazole (20 mg) bid and placebo antimicrobials for 1 week, followed by E20 for 3 weeks (E20 bid and E20). Patients with unhealed GUs at 4 weeks received E20 for an additional 4 weeks. Healed patients were followed up for 12 months. RESULTS: Eradication rates at 4 weeks or 8 weeks were 82% for EAC and E20, 77% for EAC and placebo and 9.5% for E20 bid and E20 (intention-to-treat analysis). Significantly more patients receiving EAC than those receiving esomeprazole alone remained free of GUs during follow-up [EAC and E20, 90%; EAC and placebo, 87%; P=0.0005 for combined group vs. esomeprazole alone [E20 bid and E20 (74%)]. All treatments were well tolerated. CONCLUSION: Esomeprazole-based triple therapy is effective for the eradication of H. pylori, healing of GU and prevention of relapse. Esomeprazole monotherapy for 3 weeks after triple therapy may be beneficial in terms of healing.     

细胞色素P450 2C19基因多态性对埃索美拉唑三联疗法根除幽门螺杆菌疗效的影响

目的 前瞻性对比埃索美拉唑和奥美拉唑三联疗法根除幽门螺杆菌(Hp)的疗效,及细胞色素P450(CYP)2C19基因多态性对根除Hp疗效的影响.方法 240例Hp阳性消化性溃疡患者,随机分为EAC组(埃索美拉唑、阿莫西林和克拉霉素)和OAC组(奥美拉唑、阿莫西林和克拉霉素),每组120例,疗程7 d.继后埃索美拉唑或奥美拉唑巩固治疗3周.胃镜观察2周溃疡愈合情况,结束治疗4周后进行13C尿素呼气试验.利用聚合酶链反应(PCR)及限制片段长度多态性(RFLP)分析技术,测定所有患者的CYP2C19基因型,分为强代谢型(Ems)和弱代谢型(PMs),强代谢型包括纯合子(homEM)和杂合子(hetEM).结果 240例患者中225例完成疗效观察.Hp根除率按意向处理分析(ITT),EAC组为88.3%,OAC组为79.2%(P>0.05);按方案分析(PP)EAC组为91.4%,OAC组为87.2 oA(P>0.05).ITT分析显示,在CYP2C19 homEM基因型中,EAC和OAC组Hp根除率分别为91.9%和71.8%,两组间差异有统计学意义(P=0.037).PP分析显示,在homEM基因型中,EAC组和OAC组Hp根除率分别为97.1%和77.8%,两组间差异也有统计学意义(P=0.028).ITT分析显示,EAC组和OAC组2周溃疡愈合率分别为79.2%和69.2%(P>0.05);PP分析显示分别为81.9%和76.1%(P>0.05).EAC组和OAC组不良反应均较少(分别为3.3%和7.5%,P>0.05).结论 EAC方案Hp根除率较高,尤其在CYP2C19 homEM基因型患者,埃索美拉唑优于奥美拉唑.     

细胞色素P450 2C19基因多态性对埃索美拉唑三联疗法根除幽门螺杆菌疗效的影响

目的 前瞻性对比埃索美拉唑和奥美拉唑三联疗法根除幽门螺杆菌(Hp)的疗效,及细胞色素P450(CYP)2C19基因多态性对根除Hp疗效的影响.方法 240例Hp阳性消化性溃疡患者,随机分为EAC组(埃索美拉唑、阿莫西林和克拉霉素)和OAC组(奥美拉唑、阿莫西林和克拉霉素),每组120例,疗程7 d.继后埃索美拉唑或奥美拉唑巩固治疗3周.胃镜观察2周溃疡愈合情况,结束治疗4周后进行13C尿素呼气试验.利用聚合酶链反应(PCR)及限制片段长度多态性(RFLP)分析技术,测定所有患者的CYP2C19基因型,分为强代谢型(Ems)和弱代谢型(PMs),强代谢型包括纯合子(homEM)和杂合子(hetEM).结果 240例患者中225例完成疗效观察.Hp根除率按意向处理分析(ITT),EAC组为88.3%,OAC组为79.2%(P>0.05);按方案分析(PP)EAC组为91.4%,OAC组为87.2 oA(P>0.05).ITT分析显示,在CYP2C19 homEM基因型中,EAC和OAC组Hp根除率分别为91.9%和71.8%,两组间差异有统计学意义(P=0.037).PP分析显示,在homEM基因型中,EAC组和OAC组Hp根除率分别为97.1%和77.8%,两组间差异也有统计学意义(P=0.028).ITT分析显示,EAC组和OAC组2周溃疡愈合率分别为79.2%和69.2%(P>0.05);PP分析显示分别为81.9%和76.1%(P>0.05).EAC组和OAC组不良反应均较少(分别为3.3%和7.5%,P>0.05).结论 EAC方案Hp根除率较高,尤其在CYP2C19 homEM基因型患者,埃索美拉唑优于奥美拉唑.     

多药耐药基因MDR1 C3435T基因多态性对根除幽门螺杆菌疗效的影响

目的研究多药耐药基因MDR1 C3435T基因多态性对质子泵抑制剂联合阿莫西林与克拉霉素三联1周疗法根除幽门螺杆菌（砀,）治疗的影响。方法选取101例却阳性的慢性胃炎或消化性溃疡患者,分成2组,分别进入埃索美拉唑联合阿莫西林与克拉霉素方案（EAC）或奥美拉唑联合阿莫西林与克拉霉素方案（OAC）进行1周根除治疗。采用聚合酶链反应-限制性内切片段长度多态性（polymerase chain reaction-restriction fragment length polymorphism,PCR-RFLP）的方法检测MDR1 C3435T基因型,比较不同基因型患者之间埤,根除率的差异。结果MDR1 CC3435、C3435T和3435TT的却根除率分别为72．4％、88．2％和81．0％。MDR1 C3435T各基因型组间却根除率比较均元显著性差异。结论MDR1 C3435T基因多态性与却根除疗效无显著相关性。     

Acid suppression therapy is not required after one-week anti-Helicobacter pylori triple therapy for duodenal ulcer healing

AIM: To compare healing of Helicobacter pylori-related non complicated duodenal ulcer after one-week eradication triple therapy alone and after triple therapy with further 3-weeks antisecretory treatment with ranitidine. METHODS: Three hundred and forty three patients with symptomatic H. pylori positive duodenal ulcer were included in this randomized double-blind placebo controlled study. H. pylori infection was established by rapid urease test and histopathology of antral biopsies. All patients were treated for one week with ranitidine 300 mg b.i.d., amoxicillin 1 g b.i.d., clarithromycin 500 mg b.i.d., and then randomly treated for the following 3 weeks either with ranitidine 300 mg once daily (triple therapy + ranitidine, n =180) or placebo (triple therapy alone, n =163). Ulcer healing was assessed by endoscopy 4 weeks after inclusion. H. pylori eradication was established by (13) C-urea breath testing 5 weeks after the end of triple therapy. RESULTS: In intention to treat, duodenal ulcer healed at 4 weeks in 86 % of patients treated with triple therapy + ranitidine and in 83 % of patients treated with triple therapy alone (equivalence: 90 % CI [-3. 8 %; 9.2 %]). The H. pylori eradication rates were 67 % and 69 % respectively. Ulcer healed in 88 % of patients in whom H. pylori eradication was achieved and in 77 % of patients in whom eradication failed. CONCLUSION: These results demonstrate that one-week triple therapy alone is highly effective in healing non complicated H. pylori associated duodenal ulcer without additional antisecretory treatment.     

Clinical evaluation of four one-week triple therapy regimens in eradicating Helicobacter pylori infection

AIM: To evaluate clinical efficacy of four one-week triple therapies in eradicating Helicobacter pylori infection. METHODS: In this clinical trial, 132 patients with duodenal ulcer and chronic gastritis were randomly divided into four groups, and received treatment with OAC (omeprazole 20 mg + amoxicillin 1 000 mg + clarithromycin 250 mg), OFC (omeprazole 20 mg + furazolidone 100 mg + clarithromycin 250 mg), OFA (omeprazole 20 mg + furazolidone 100 mg + amoxicillin 1 000 mg) and OMC (omeprazole 20 mg + metronidazole 200 mg + clarithromycin 250 mg), respectively. Each drug was taken twice daily for one week. The (13)C urea breath test was carried out 4-8 weeks after treatment to determine the success of H pylori eradication. RESULTS: A total of 127 patients completed the treatment. The eradication rate for H pylori infection was 90.3%, 90.9%, 70.9% and 65.6%, respectively in OAC, OFC OMC and OFA groups. CONCLUSION: A high eradication rate can be achieved with one-week OAC or OFC triple therapy. Thus, one-week triple therapies with OAC and OFC are recommended for Chinese patients with duodenal ulcers and chronic gastritis.     

Efficacy of omeprazole and amoxicillin with either clarithromycin or metronidazole on eradication of Helicobacter pylori in Chinese peptic ulcer patients

AIM: One-week triple therapy with proton pump inhibitors, clarithromycin and amoxicillin has recently been proposed as the first-line treatment for Helicobacter pylori (H pylori) infection; however, data regarding the effects of this regimen in China are scarce. The aim of this prospective and randomized study was to compare the efficacy of clarithromycin and metronidazole when they were combined with omeprazole and amoxicillin on eradication of H pylori and ulcer healing in Chinese peptic ulcer patients. METHODS: A total of 103 subjects with Hpylori-positive peptic ulcer were randomly divided into two groups, and accepted triple therapy with omeprazole 20 mg, amoxicillin 1 000 mg and either clarithromycin 500 mg (OAC group, n = 58) or metronidazole 400 mg (0AM group, n - 45). All drugs were given twice daily for 7 d. Patients with active peptic ulcer were treated with omeprazole 20 mg daily for 2-4 wk after anti-H pylori therapy. Six to eight weeks after omeprazole therapy, all patients underwent endoscopies and four biopsies (two from the antrum and two others from the corpus of stomach) were taken for rapid urease test and histological analysis (with modified Giemsa staining) to examine H pylori. Successful eradication was defined as negative results from both examination methods. RESULTS: One hundred patients completed the entire course of therapy and returned for follow-up. The eradication rate of H pylori for the per-protocol analysis was 89.3% (50/56) in OAC group and 84.1% (37/44) in 0AM group. Based on the intention-to-treat analysis, the eradication rate of H pylori was 86.2% (50/58) in OAC group and 82.2% (37/45) in 0AM group. There were no significant differences in eradication rates between the two groups on either analysis. The active ulcer-healing rate was 96.7% (29/30) in OAC group and 100% (21/21) in 0AM group (per-protocol analysis, P>0.05). Six patients in OAC group (10.3%) and five in OAM group (11.1%) reported adverse events (P>0.05). CONCLUSION: One-week triple therapy with omeprazole and amoxicillin in combination with either clarithromycin or metronidazole is effective for the eradication of H pylori. The therapeutic regimen comprising metronidazole with low cost, good compliance and mild adverse events may offer a good choice for the treatment of peptic ulcers associated with H pylori infection in China.     

CYP2C19基因多态性对埃索美拉唑三联疗法根除幽门螺杆菌疗效的影响

目的 研究CYP2C19(cytochrome P450 2C19)基因多态性对以埃索美拉唑为基础三联1周疗法的Hp根除率的影响.方法 选取101例Hp阳性的慢性胃炎或消化性溃疡患者,分成2组,分别进入埃索美拉唑联合阿莫西林与克拉霉素方案(EAC)或奥美拉唑联合阿莫西林与克拉霉素方案(OAC)进行1周根除治疗.治疗前采...     

Comparison of Helicobacter pylori eradication rate according to different PPI-based triple therapy--omeprazole, rabeprazole, esomeprazole and lansoprazole--]

BACKGROUND/AIMS: Helicobacter pylori (H. pylori) is an important cause of various gastrointestinal diseases. H. pylori eradication is essential for the cure and prevention of associated diseases. Nowdays, proton pump inhibitor (PPI)-based triple therapy is the standard eradication regimen. The aims of this study were to compare the H. pylori eradication rate of different PPI-based triple therapies and to find out the factors influencing the eradication rate. METHODS: From May 2002 through February 2004, H. pylori infected patients were treated with the eradication regimen based on one of the four PPIs (omeprazole, rabeprazole, esomeprazole and lansoprazole) for 1 or 2 weeks. After two weeks, drug compliance, adverse effects, and smoking history during the eradication therapy were obtained. The follow-up H. pylori test was performed 4 weeks after the completion of therapy. The data were analyzed by Chi-square test and multiple logistic regression analysis. RESULTS: Overall eradication rate was 83.5%. There was no significant difference in eradication rate among four PPIs (p=0.379). Odds ratio (OR) for omeprazole and rabeprazole was 1.15 (95% CI 0.50-2.68); for omeprazole and esomeprazole, OR 1.63 (95% CI 0.68-3.89); and for omeprazole and lansoprazole, OR 1.13 (95% CI 0.50-2.56). Smoking habit, site of ulcer, and the duration of therapy affected the eradication rate significantly. CONCLUSIONS: The efficacy of four different PPIs for H. pylori eradication is similar to each other. Smoking, site of ulcer, and the duration of treatment have significant effects on eradication rates.     

Helicobacter pylori eradication versus one-year maintenance therapy: effect on relapse and gastritis outcome.

OBJECTIVE: The aim of this study was to determine ulcer healing and H. pylori eradication rates obtained with triple therapy (omeprazole, amoxicillin and clarithromycin). Ulcer relapsing rate one year after eradication was also assessed. Maintenance therapy with placebo was compared with ranitidine therapy and the effect of eradication on histological variables of the gastric mucosa was studied. METHODS: A prospective, double-blind parallel study was performed in 85 patients endoscopically diagnosed of duodenal ulcer H. pylori positive. Patients were randomized to a 7-days triple therapy (group A) or omeprazole plus antibiotic placebo (group B). All patients were treated only with omeprazole for the next three weeks. Patients with ulcer healing after treatment were entered in a one-year follow up phase with ranitidine placebo (group A) or ranitidine (group B). Endoscopy and biopsies were performed at baseline, after treatment (5 weeks) and after 12 months of follow-up or when relapsing symptoms appeared. RESULTS: Healing rate was 90.2% in group A and 85.7% in group B. Eradication rate was 78% in group A and 0% in group B. Out of 37 healed patients in group A, eradication was achieved in 29 and only one relapse was found (3.4%). Three out of eight patients with healing but without eradication relapsed at 12 months (35%) (p < 0.05). Histopathological results showed statistically significant differences (p < 0.05) between eradicated and non eradicated patients in terms of severity of inflammation and intestinal metaplasia, but not in terms of atrophy. CONCLUSIONS: H. pylori eradication is useful to prevent ulcer relapse and to improve gastric mucosa status.     

Twice-daily, 10-day triple therapy with omeprazole, amoxicillin, and clarithromycin for Helicobacter pylori eradication in duodenal ulcer disease: results of three multicenter, double-blind, United States trials

Objective: We assessed the safety and efficacy of 10-day twice-daily triple therapy for Helicobacter pylori ( H. pylori ) in three double-blind, controlled trials in patients with duodenal ulcer disease.
Methods: H. pylori -infected patients with one or more duodenal ulcer(s) at endoscopy (studies 1, 2) or with a documented duodenal ulcer history and no duodenal ulcer or erosions at endoscopy (study 3) were randomly assigned to 10-day courses of omeprazole 20 mg b.i.d . plus amoxicillin 1 g b.i.d . plus clarithromycin 500 mg b.i.d . (OAC) or placebo plus amoxicillin 1 g b.i.d . plus clarithromycin 500 mg b.i.d . (AC). In studies 1 and 2, patients received an additional 18 days of omeprazole 20 mg q.d . (OAC group) or placebo (AC group). Endoscopy was repeated 4 wk after therapy in studies 1 and 2 and 4–6 wk after therapy in study 3. At baseline, H. pylori was diagnosed by CLOtest plus histology, or by culture. Eradication was defined as no positive biopsy test and two or more negative tests. Patients were defined as compliant if they took 75% or more of each study drug and missed ≤ 3 consecutive days of the 10-day therapy.
Results: Intent-to-treat populations of the three studies combined were 241 patients for OAC and 266 for AC. Of all OAC patients combined, 2% stopped study medications due to adverse events, and 93% were compliant. Per-protocol cure rates were 78% to 90% (all studies combined, 84%) for OAC vs 33% to 45% (combined, 39%) for AC (   p < 0.001  , OAC vs AC); intent-to-treat eradication rates were 69% to 83% (combined, 75%) for OAC vs 32% to 37% (combined, 35%) for AC; (   p < 0.001  , OAC vs AC).
Conclusion: Rigorously designed studies indicate that 10 days of twice-daily triple therapy with omeprazole, amoxicillin, and clarithromycin achieves per-protocol eradication rates of approximately 80% to 90% in the U.S.     

雷贝拉唑与奥美拉唑三联疗法根除幽门螺杆菌多中心、随机、双盲、平行对照研究

背景:新一代质子泵抑制剂雷贝拉唑具有较高的解离常数（pKa）,在抑酸方面起效更快,作用更持久稳定。目的:通过与奥美拉唑三联疗法比较,观察雷贝拉唑三联疗法根除幽门螺杆菌（H.pylori）和治疗十二指肠溃疡的疗效。方法:采用多中心、随机、双盲、平行对照研究方法,于2002年1～7月在5家医院进行。109例经胃镜检查确诊为十二指肠溃疡活动期并经快速尿素酶试验和病理学检查确定为H.pylori阳性的患者分为两组:雷贝拉唑（商品名:波利特）试验组（RAC组,53例）和奥美拉唑（商品名:洛赛克）对照组（OAC组,56例）。两组均先给予三联治疗:雷贝拉唑10mg或奥美拉唑20mg+阿莫西林1g+克拉霉素500mg,每日2次,连续7天,然后单独给予雷贝拉唑10mg,每日1次或奥美拉唑20g,每日1次,连续7天,并于用药结束后第28天复查胃镜并检测H.pylori。于用药后第1、2、3、6和42天对患者的上腹痛、反酸以及上腹烧灼感等症状进行评估。结果:101例患者完成全部治疗方案,8例失访。H.pylori根除率:病理学检查结果显示RAC组的H.pylori根除率为86.0％,OAC组为76.5％,两组间差异无显著性（P>0.05）。溃疡愈合率:PAC组的溃疡愈合率为92.0％,OAC组为76.5％,OAC组高于OAC组,两组间差异有显著性（P<0.05）。症状改善情况:两组从用药第1天起均能有效改善     

Comparative study of modified-release clarithromycin and immediate-release clarithromycin in the treatment of Helicobacter pylori-associated peptic ulcer disease

BACKGROUND/AIMS: Proton pump inhibitor-based triple therapy containing immediate-release clarithromycin is an important regimen for the eradication of Helicobacter pylori (H. pylori). However, the efficacy of modified-release clarithromycin for the treatment of H. pylori-associated peptic ulcer disease is still unknown. The aims of the study were to compare the efficacy of modified-release clarithromycin and immediate-release clarithromycin on the rates of ulcer healing and eradication of H. pylori. METHODOLOGY: One hundred and sixty-one patients with Helicobacter pylori-associated peptic ulcer were randomized to receive one-week triple therapy with either modified-release clarithromycin 1000mg once daily (AECMR) or immediate-release clarithromycin 500mg twice daily (AECIR) in combination with amoxicillin 1,000mg twice daily (A) and esomeprazole 40mg once daily (E). Post-treatment ulcer healing status and Helicobacter pylori status was determined by endoscopy and 13C urea-breath test at 16 weeks and 8 weeks after completion of triple therapy, respectively. RESULTS: Helicobacter pylori eradication rates were 87.5% and 87.7% for AECMR and AECIR, respectively, in the intent-to-treat analysis. Eradication rates in the per-protocol groups were 90.3% and 91.4% for AECMR and AECIR, respectively. In both the intent-to-treat and per-protocol analyses, the eradication rates were comparable in the AECMR and AECIR groups (p= 1.0 and 1.0, respectively). Ulcer healing rates in the intention-to-treat analysis were 81.3% and 77.8% for AECMR and AECIR, respectively. Ulcer healing rates in the per-protocol analysis were 90.3% and 90.0% for AECMR and AECIR groups, respectively. In both the intention-to-treat and per-protocol analyses, the ulcer healing rates were comparable in the AECMR and AECIR groups (p=0.645 and 0.584, respectively). CONCLUSIONS: Modified-release clarithromycin 1000mg once daily can be used as an alternative to immediate-release clarithromycin 500mg twice daily for the treatment of Helicobacter pylori-associated peptic ulcer disease.     

Bismuth-based quadruple therapy using a single capsule of bismuth biskalcitrate,metronidazole, and tetracycline given with omeprazole versus omeprazole,amoxicillin, and clarithromycin for eradication of Helicobacter pylori in duodenal ulcer patients: a prospective,randomized, multicenter,North American trial

OBJECTIVES: This multicenter, randomized, active-controlled trial assessed efficacy of bismuth-based quadruple therapy with omeprazole, bismuth biskalcitrate, metronidazole, and tetracycline (OBMT) using a single-triple capsule of BMT compared with triple therapy with omeprazole, amoxicillin, and clarithromycin (OAC) in treatment of patients with Helicobacter pylori infection and duodenal ulcers. METHODS: Patients with active duodenal ulcer or diagnosed within the past 5 yr and with infection documented by (13)C-urea breath test plus histology or culture were randomly assigned to 10-day course of OBMT using a single-triple capsule containing bismuth biskalcitrate 140 mg, metronidazole 125 mg, and tetracycline 125 mg given as three capsules q.i.d. with omeprazole 20 mg b.i.d., or a 10-day course of OAC, omeprazole 20 mg plus amoxicillin 1 g plus clarithromycin 500 mg, all b.i.d. Eradication was confirmed by two negative urea breath tests at >1 month and >2 months after therapy. RESULTS: One hundred thirty-eight patients received OBMT and 137 OAC. Modified intent-to-treat eradication rates were 87.7% for OBMT and 83.2% for OAC (95% CI = -3.9%-12.8%; p = 0.29). OBMT eradicated 91.7% metronidazole-sensitive and 80.4% metronidazole-resistant strains (p = 0.06). OAC eradicated 92.1% clarithromycin sensitive and 21.4% clarithromycin-resistant strains (p < 0.001). Adverse events occurred in 58.5% of OBMT patients and 59.0% of OAC patients. CONCLUSIONS: OBMT regimen using the single-triple capsule is as efficacious and well-tolerated as the widely used OAC regimen for H. pylori eradication. This OBMT therapy largely overcomes H. pylori metronidazole resistance, present in 40% of patients in this study.     

Do Japanese and Swedish peptic ulcer patients respond differently to Helicobacter pylori eradication therapies and what are their histological features?

BACKGROUND: As a consequence of gastric histological differences, Japanese and Swedish peptic ulcer (PU) patients may respond differently to Helicobacter pylori eradication therapies. METHODS: The study was single-blind and compared four eradication therapies in Japanese and Swedish patients with healed gastric (GU) or duodenal (DU) ulcer. Swedish patients received either (a) omeprazole+clarithromycin (OC, where O = 20 mg, C = 500 mg) for 2 weeks, or triple therapy with (b) omeprazole + amoxicillin + clarithromycin (OAC-L where O = 20mg, A = 1 g, C = 250 mg); (c) OAC-H (where O = 20 mg, A-1 g, C-500 mg); or (d) omeprazole + metronidazole + clarithromycin (OMC, where O = 20 mg, M = 400 mg, C = 250 mg) for 1 week. Antibiotic doses were weight-adjusted downwards in Japanese patients. H. pylori was assessed using the urea breath test (UBT), histology and culture pre-entry, with UBT being repeated 4 and 8 weeks after stopping treatment. Histology and culture were repeated if the UBT was positive post-therapy. RESULTS: Recruitment included 120 patients from Japan (43 GU, 61 DU, 16 GU+DU) and 120 from Sweden (119 DU, 1 GU+DU). There were 26 exclusions from a FAS analysis due to H. pylori negativity (14), no drug administration (7) or no data after visit 1 (5). Eradication rates (FAS) from Japan were (a) 63%, (b) 93%, (c) 96% or (d) 96%, and for Sweden (a) 92%, (b) 86%, (c) 93% or (d) 96%. Dual therapy was less effective in patients with gastric atrophy associated with GU disease. Tolerability was good in all treatment groups, with no serious adverse events. CONCLUSION: Triple therapies were safe and effective for H. pylori eradication in Japanese and Swedish peptic ulcer patients. Dual therapy was significantly less effective in the Japanese patients, half of whom had a history of GU and more abnormal histology than in the Swedish patients, all of whom had DU.     

Comparison of 1 and 2 weeks of omeprazole, amoxicillin and clarithromycin treatment for Helicobacter pylori eradication: the HYPER Study

BACKGROUND: Triple therapy is recommended for Helicobacter pylori eradication, yet consensus on the duration of treatment is lacking. AIM: To compare the efficacy and safety of 1- and 2-week regimens of omeprazole, amoxicillin and clarithromycin in a large, multicentre, double-blind and randomised study. METHODS: A total of 909 H pylori-positive patients with duodenal ulcer, enrolled in 81 endoscopy units in Italy, were randomised to receive omeprazole, amoxicillin and clarithromycin for either 1 week (OAC1W) or 2 weeks (OAC2W) or omeprazole and amoxicillin for 2 weeks. H pylori eradication was assessed by histological examination and carbon-13 urea breath test 4 weeks after treatment. RESULTS: Both the intention-to-treat (ITT; n = 907) and per protocol (PP; n = 661) analyses showed no significant differences between the eradication rates of OAC1W (ITT 79.7%; PP 83.6%) and OAC2W (ITT 81.7%; PP 84.9%; ITT p = 0.53; PP p = 0.71). Both triple omeprazole, amoxicillin and clarithromycin regimens gave significantly higher eradication rates compared with omeprazole and amoxicillin treatment (ITT 44.6%; PP 42.8%; p<0.001). Poor compliance was reported in 18.6%, 17.3% and 15.1% (p = 0.51) of patients for OAC2W, OAC1W and omeprazole and amoxicillin, respectively. Adverse events occurred in 9.9% and 9.6% (p = 0.88) of patients for OAC2W and OAC1W, respectively, and in 5.9% for omeprazole and amoxicillin (p = 0.11). CONCLUSIONS: 1-week and 2-week triple treatments for H pylori eradication are similar in terms of efficacy, safety and patient compliance.     

根除幽门螺杆菌三联疗法临床观察

目的　观察以质子泵抑制剂 (PPI)、克拉霉素为中心的三联疗法治疗幽门螺杆菌 (HP)阳性十二指肠溃疡的疗效 ,比较甲硝唑和痢特灵的疗效及副作用 ,筛选理想的三联疗法。方法　胃镜确诊十二指肠溃疡并经病理组织学及 14 C-尿素呼吸试验证实 HP感染者 184例 ,随机分成 2组 ,A组用洛塞克、克拉霉素及甲硝唑 ,B组用洛塞克、克拉霉素及痢特灵 ,每日 2次 ,连续 7d,停药 4周后复查胃镜观察溃疡愈合程度 ,同时经 14 C-尿素呼吸试验及胃镜证实 HP根除情况。结果　溃疡总愈合率 :A组 91.4 % (85 / 93) ,B组 93.4 % (85 / 91) ,2种疗法比较差异无显著意义 (P >0 .0 5 ) ;HP根除率 :A组 90 .3% (84 / 93) ,B组 93.4 % (85 / 91) ,2种疗法比较差异无显著意义 (P >0 .0 5 ) ;轻度不良反应 :A组 16 .1% (15 / 93) ,B组 4 .4 % (4/ 91) ,B组反应明显轻于 A组 (P <0 .0 5 )。结论　 2组三联疗法根除 HP及治疗十二指肠溃疡均有良好疗效 ;痢特灵具有抗 HP作用强、无耐药性、价格低廉、副作用少等优点 ,可替代甲硝唑配伍于洛塞克、克拉霉素的三联疗法中 ,是一种理想的适合国情的根除 HP方案     

Triple therapy for 7 days vs. triple therapy for 7 days plus omeprazole for 21 days in treatment of active duodenal ulcer with Helicobacter pylori infection: A double blind placebo controlled trial

BACKGROUND: The current treatment for active duodenal ulcer implies a 4 weeks course with anti-secretory drugs and two antibiotics for 7 to 10 days in the case of Helicobacter pylori infection. AIM: To establish whether triple therapy with omeprazole given for 7 days with two antibiotics eradicates H. pylori, heals and prevents ulcer recurrence. PATIENTS AND METHODS: A total of 103 patients with active duodenal ulcer and H. pylori were randomly divided into: a group of 50 patients treated with omeprazole, clarithromycin and tinidazole for 7 days followed by omeprazole for 21 days, and a group of 53 patients who received the same treatment as the previous group, followed by placebo for 21 days. Endoscopy with quick urease test, histology and culture was performed at entry and after 4 and 16 weeks. RESULTS: Ulcer healing rate after 16 weeks' treatment was 95% in the former and 96% in the latter group (ns). Eradication after 16 weeks was 84% in the former and 83% in the latter group (ns). At 56 weeks, all patients examined were ulcer free and without H. pylori. CONCLUSION: Omeprazole, clarithromycin and tinidazole for 7 days heals active duodenal ulcer and eradicates H. pylori infection in most patients. Treatment extension with omeprazole, for 3 weeks, after triple therapy does not modify healing and eradication rates.