Results of an open multicenter study of the efficiency of one-week anti-helicobacter therapy using omeprazole, clarithromycin, and amoxicillin in patients with duodenal peptic ulcer

AIM: To study the efficiency of one-week antihelicobacter therapy using omeprazole, clarithromycin, and amoxycillin in patients with duodenal peptic ulcer during its recurrence. MATERIALS AND METHODS: 105 patients with recurrent peptic ulcer and a not less than 0.5-cm ulcer in the duodenal bulb was given triple therapy: omeprazole, 20 mg twice daily, amoxycillin, 1000 mg twice daily, and clarithromycin, 500 mg twice daily for 7 days. Then the patients were allowed to take antacids if they were required to abolish the symptoms of recurrent peptic ulcer. H. pylori was detected in the mucosal biopsy specimens taken from the anthral part and body of the stomach at gastroduodenascopy, by using the rapid urease test and histology. Gastroduodenoscopy was performed before and 4-6 weeks after the triple therapy. RESULTS: The major symptoms of recurrent peptic ulcer were eliminated in 90% of the patients by the end of a course of therapy, i.e. on its day 7. By the control time, the rate of ulcer cicatrization was 99.05% (104/105). The coincidence of results of the two tests has indicated that H. pylori eradication was 81.9% (86/105) 4-6 weeks after termination of treatment. Adverse reactions during therapy were observed in 20% of the patients; however, treatment had to be discontinued only in 2.9% of the patients. CONCLUSION: One-week triple therapy using omeprazole, clarithromycin, and amoxycillin in highly effective in treating duodenal peptic ulcer during its recurrence.     

Eradication effect of lansoprazole-based triple therapy against H. pylori

Eradication of H. pylori provides a potential cure in the majority of patients with gastric ulcer as well as duodenal ulcer. Two proton pump inhibitor(PPI)-based triple therapy, combining with clarithromycin(CAM), amoxicillin(AMPC) or metronidazole have been established as standard regimens worldwide. In Japan, lansoprazole(LPZ)-based triple therapy combined with CAM and AMPC for 1 week was firstly investigated on eradication effect against H. pylori and determination of the optimal dose of CAM in multicenter, double-blind trial. Patients with active gastric ulcer or duodenal ulcer were enrolled in this study. The eradication rate of H. pylori in patients with gastric ulcer were 0%, 87.5% and 89.2% and those in patients with duodenal ulcer were 4.4%, 91.1% and 83.7% in LPZ(60 mg/d) alone, LPZ(60 mg/d) with CAM(400 mg/d) and AMPC(1,500 mg/d), LPZ(60 mg/d) with CAM(800 mg/d) and AMPC(1,500 mg/d), respectively, in the full set analysis. LPZ-based triple therapy demonstrated a high eradication rate and was safe. In addition, the combination regimens with lower or higher dose of CAM were equivalent in Japanese patients.     

阿奇霉素三联疗法根除幽门螺杆菌的疗效观察──附69例报告

目的:观察阿奇霉素三联疗法根除十二指肠球部溃疡病人的幽门螺杆菌(Hp)的临床疗效,对比阿奇霉素三联疗法一周与两周方案的疗效差别。方法:69例经胃镜检查证实为十二指肠球部溃疡并有Hp感染的病人,随机分为两组。A组(35例)口服奥美拉唑40mg每日1次,共2周;阿奇霉素500mg/d,仅疗程开始的头3日口服;阿莫西林500mg口服,每日4次,共2周。B组(34例)奥美拉唑与阿奇霉素的剂量和疗程同A组,阿莫西林500mg口服,每日3次,共1周。疗程结束后停用所有抗生素,4周后胃镜复查溃疡愈合情况,14C-尿素呼气试验复查Hp根除情况。结果:Hp根除率:A组和B组分别为89%(31/35)、85%(29/34),两组比较无显著性差异(P>0.05);溃疡愈合率:A组和B组分别为97%(28/29)、94%(29/31),两组比较无显著性差异(P>0.05);全部病人均完成治疗,仅2例出现恶心,1例轻度腹泻,总不良反应率为4%。结论:①阿奇霉素三联疗法具有Hp根除率高、安全性好、不良反应少及依从性好的优点;②阿奇霉素三联疗法一周方案与两周方案比较疗效相当;③阿奇霉素可作为根除Hp治疗方案中的一个新选择。     

Recurrence rate of H. pylori after successful eradication and second eradication therapy after initial failure of treatment

Three hundred thirty-three patient (116 gastric ulcer, 119 duodenal ulcer, 98 gastritis) who were successfully eradicated were enrolled in the study of H. pylori recurrence rate. H. pylori status was determined by histology, rapid urease test, 13C-urea breath test. The mean of the follow-up period was 13.3 months (2-56 months), and 15 patients showed negative to positive conversion of H. pylori. The recurrence rate was 4.4% for one year and 8.3% for two years using Kaplan-Meier analysis. Second eradication therapy after initial failure is another concern. Nineteen patients were assigned to receive an 1-week new triple therapy (clarithromycin, metronidazole and PPI), in whom a 2-week course of dual therapy (amoxicillin plus PPI) failed (group1). Another 15 patients in whom the 1-week new triple therapy failed were switched to the 2-week course of dual therapy plus ecabet sodium (group2). H. pylori was eradicated in 84.2% (16/19) of patients in group1 and 86.7% (13/15) in group2.     

Evaluation of the efficacy and the cost-effectiveness of proton pump inhibitor-based dual and triple therapy regimens for H. pylori eradication in peptic ulcer disease

To evaluate the efficacy and the cost-effectiveness of H. pylori eradication for the treatment of peptic ulcer disease, a randomized controlled trial to compare the efficacy of proton pump inhibitor-based dual and triple regimens was conducted. A decision analysis was also performed to assess H. pylori eradication compared to the conventional maintenance strategy. Two hundred and thirty-four peptic ulcer patients suffering from H. pylori infection were randomly treated with either omeprazole 20 mg bid + amoxicillin 500 mg qid + clarithromycin 400 mg bid (OAC) or with omeprazole 20 mg bid + clarithromycin 400 mg bid (OC) for 14 days. The eradication rate with OAC was 87.6% (92/105) (95% Confidence Interval (CI): 81-94%), which was significantly higher than that with OC (61.9% (60/97) (95% CI: 52-72%)) (p < 0.001, chi 2 test). Both regimens were safe and well tolerated. H. pylori eradication was more effective and less costly than conventional strategy in a long term perspective. OAC was more cost-effective than OC. In conclusion, H. pylori eradication is a cost-effective alternative to conventional treatment. We recommend 2 weeks triple regimen with omeprazole 20 mg bid + amoxicillin 500 mg qid + clarithromycin 400 mg bid (OAC) as a first-line treatment in all patients with peptic ulcers associated with H. pylori infection.     

Second-line and third-line trial for helicobacter pylori infection in patients with duodenal ulcers: A prospective, crossover, controlled study

Background: Following standard first-line triple therapies for Helicobacter pylori infection, up to 20% of patients require further eradication.Objective: The aim of this study was to assess the effects of second-line triple therapies and third-line quadruple therapies for the eradication of H pylori.Methods: This 7-week, prospective, crossover, controlled, second- and third-line trial was conducted at the Department of Gastroenterology, Ferencváros Health Center (Budapest, Hungary). Patients aged 18 to 80 years with duodenal ulcers and an H pylori infection resistant to first-line triple therapy (pantoprazole 40 mg BID + amoxicillin 1000 mg BID + clarithromycin 500 mg BID [PAC] given as tablets) received a different triple therapy regimen (ranitidine bismuth citrate 400 mg BID + metronidazole 500 mg BID + clarithromycin 500 mg BID [RBC-MC]) for 7 days (group 1A), and nonresponders after RBC + 2 antimicrobials received the pantoprazole-based regimen (group 1B). After secondary failure, patients were randomized to receive quadruple therapies: pantoprazole, amoxicillin, tetracycline, and either nitrofurantoin or bismuth subsalicylate (groups 2A and 2B).Results: One hundred thirty-four patients were enrolled in the second-line study (56 men, 78 women; mean [SD] age, 51.1 [12.4] years; group 1A, 68 patients; group 1B, 66 patients). Subsequently, 41 (30.6%) of these patients were randomized to receive quadruple therapies. Using intent-to-treat (ITT) analysis, the eradication rates did not differ significantly (60.3% and 65.2% in groups 1A and 1B, respectively; 61.9% and 55.0% in groups 2A and 2B, respectively). Perprotocol eradication rates did not differ significantly (66.1% and 68.3% in groups 1A and 1B, respectively); however, the rates were significantly different in group 2A (66.7%) versus group 2B (55.5%) (P = 0.03).     

Eradication of Helicobacter pylori with triple therapy: an epidemiologic analysis of trends in Turkey over 10 years

BACKGROUND: There is increasing concern about the efficacy of current regimens for the eradication of Helicobacter pylori. OBJECTIVES: This study examined rates of H. pylori eradication with a commonly used triple-therapy regimen consisting of a proton pump inhibitor (PPI), clarithromycin, and amoxicillin in trials performed in Turkey from 1996 to 2005. It also investigated the relationship between eradication rates and the duration of treatment (7, 10, or 14 days), choice of PPI, and indication for treatment (dyspepsia or peptic ulcer). METHODS: This was a retrospective epidemiologic analysis. Articles concerning H. pylori eradication in Turkey that were published in peer-reviewed national and international journals were identified through searches of MEDLINE using the terms Helicobacter, eradication, and Turkey, and of the Turkish Medical Index using the terms Helicobacter and eradication. Abstracts from the Turkish Gastroenterology Congress from 1996 through 2005 were searched manually. Open-label trials, controlled trials, treatment arms, and case series that included a triple-therapy regimen consisting of standard doses of any PPI (omeprazole 20 mg BID, lansoprazole 30 mg BID, pantoprazole 40 mg BID, or esomeprazole 40 mg BID) with clarithromycin 500 mg BID and amoxicillin 1 g BID for 7 to 14 days were selected for analysis. Trials including patients who had undergone a previous attempt at eradication of H. pylori were excluded. RESULTS: Of 138 trials or treatment arms identified, 94 met the criteria for inclusion (3637 subjects). The pooled eradication rate was 68.8% (95% CI, 67.3-70.3). A marked decrease in eradication was noted after 2000. Pooled eradication rates each year from 1996 through 2005 were 79.4%, 83.7%, 81.8%, 81.8%, 75.1%, 61.3%, 65.6%, 65.1%, 55.3%, and 61.1%, respectively. Eradication rates were not affected by the duration of treatment, choice of PPI, or indication for treatment. CONCLUSIONS: Rates of H. pylori eradication with the triple-therapy regimen decreased in Turkey over the 10-year period studied. In an era of increasing clarithromycin use, the effectiveness of this regimen for H. pylori eradication appears to require reassessment.     

左氧氟沙星与克拉霉素为基础的三联疗法治疗十二指肠球部溃疡的对比研究

目的比较以左氧氟沙星与克拉霉素为基础的三联疗法对十二指肠球部溃疡（DU）合并幽门螺杆菌（Hp）感染的愈合率及Hp根除率。方法137例Hp阳性的DU（A1期）患者随机分为两组：左氧氟沙星组（A组）69例;克拉霉素组（B组）68例。A组：埃索关拉唑20mg＋阿莫西林1．0g,每天2次1：7服;左氧氟沙星0．5g,每天1次口服。B组：埃索美拉唑20mg＋阿莫西林1．0g＋克拉霉素0．5g,每天2次口服。连续7天,然后两组均继续给予埃索美拉唑20mg,每天1次口服,共21天。用药结束后1～2周再次对患者进行内镜及Hp检查,观察溃疡愈合及HP转阴情况。结果左氧氟沙星组溃疡愈合率为91．3％,克拉霉素组为89．7％,两组之间差异无统计学意义（P〉0．05）。左氧氟沙星组Hp清除率为91．3％,明显高于克拉霉素组的72．1％（P〈0．05）。B组不良反应发生率为17．7％,高于A组的7．2％,但两组间差异无统计学意义（P〉0．05）。两组费用一效果比分别为653．2元和1082．2元,A组远低于B组。结论以左氧氟沙星为基础的三联疗法治疗Hp阳性Du的愈合率与以克拉霉素为基础的三联疗法相似,但Hp清除率显著增加,不良反应发生明显减少且药物经济学效益更优。     

Amoxycillin, clarithromycin and either sucralfate or pantoprazole for eradication of Helicobacter pylori in duodenal ulcer (a randomized controlled trial).

BACKGROUND: Sucralfate enhances the anti-Helicobacter pylori activity of antimicrobials and has an inhibitory effect on H. pylori. AIM: To evaluate the efficacy and safety of one-week sucralfate-based eradication therapy for H. pylori infection in patients with duodenal ulcers, compared with treatment based on pantoprazole, in a randomized controlled multicenter study. METHODS: One hundred and twenty patients with active duodenal ulcers and H. pylori infection were treated with amoxycillin 1 g b.d. plus clarithromycin 500 mg b.d. for the first 7 days. Patients were randomly assigned to receive either sucralfate 1 g t.d.s. for 4 weeks (SAC group; n = 60) or pantoprazole (PAC group; n = 60) 40 mg b.d. for the first 7 days and 40 mg o.d. for the next 3 weeks. The patient's H. pylori status was determined by a urease test and histological investigation before the treatment, and again 4 weeks after cessation of all medication. RESULTS: One hundred and eleven patients completed the study. H. pylori infection was eradicated in 76.4% (42/55) of patients in the SAC group (ITT analysis: 70%, 95% CI: 58-80%) vs. 85.7% (48/56) of patients in the PAC group (ITT analysis: 80%, 95% CI: 70-89) (N.S.). All ulcers had healed. There were no significant differences between the two regimens regarding the occurrence of adverse effects. CONCLUSION: Our study shows that one-week triple therapy with amoxycillin, clarithromycin and either pantoprazole or sucralfate are effective regimens to cure H. pylori infection in patients with duodenal ulcer.     

Supplementing vitamins C and E to standard triple therapy for the eradication of Helicobacter pylori

What is known and Objective: Helicobacter pylori eradication rates of currently accepted triple therapy regimens vary between geographic locations and do not exceed 70–80%. Eradication rates are much lower in locations where uncontrolled antibiotic use is common such as Turkey. In the present study, we aimed to test whether supplementing vitamins C and E to standard triple therapy, including a proton pump inhibitor plus amoxicillin plus clarithromycin, increased the H. pylori eradication rate. Methods: Two hundred patients infected with H. pylori were randomized into two groups in an open‐label trial. In group A, patients (n = 160) were given standard triple therapy, including lansoprazole 30 mg BID plus amoxicillin 1000 mg BID plus clarithromycin 500 mg BID for 14 days, plus vitamin C 500 mg BID plus vitamin E 200 IU BID for 30 days. In group B, patients (n = 40) were given standard triple therapy for 14 days. The success of H. pylori eradication was defined as a negative ¹⁴C‐urea breath test result, 4–6 weeks after the completion of therapy. Comaprisons were by both intention‐to‐treat (ITT) and per‐protocol (PP) analysis. Results and Discussion: Two hundred patients (137 women, 63 men) were analysed using ITT analysis and 195 patients completed the study. In group A, H. pylori eradication was achieved in 132 of the 160 patients (82·5%) included in ITT analysis and 132 of the 157 patients (84%) included in PP analysis. In group B, H. pylori eradication was achieved in 18 of the 40 patients (45%) included in ITT analysis and 18 of the 38 patients (47·4%) included in PP analysis. Eradication rates were significantly higher in group A than in group B (P < 0·005). Eradication rates were not statistically significant between men and women in both groups. What is new and Conclusion: Adding vitamins C and E to standard triple therapy increases the eradication rate of H. pylori. Vitamins C and E may increase the eradication rate via increasing the effectiveness of the antibiotics by decreasing oxidative stress in the gastric mucosa and strengthening the immune system.     

雷贝拉唑三联疗法根除93例Hp的临床疗效观察

目的：观察雷贝拉唑联合克拉霉素和阿莫西林根除幽门螺杆菌（Hp）的临床疗效。方法：将186例Hp阳性的消化性溃疡及慢性胃炎患者随机分为雷贝拉唑治疗组和奥美拉唑对照组，两组联合的抗菌药均为克拉霉素和阿莫西林，疗程1周。各组在治疗前1周内和治疗后4～8周分别检测Hp感染情况，并观察溃疡的愈合情况。结果：雷贝拉唑治疗组Hp根除率（96．8％）明显高于奥美拉唑对照组（89．2％）（P〈0．05），两组溃疡愈合率比较无显著性差异（P〉0．05）。结论：雷贝拉唑联合克拉霉素和阿莫西林是根除Hp比较有效的治疗方案，值得临床进一步推广应用。     

Esomeprazole in treating duodenal ulcer in various modes of anti-Helicobacter therapy

AIM: To assess efficiency of esomeprazole in the treatment of duodenal ulcer (DU) associated with H. pylori in various eradication regimens. MATERIAL AND METHODS: 80 patients with duodenal ulcer at least 0.5 cm in diameter were randomized into three groups. 23 patients of group 1, 28 patients of group 2 received esomeprazole for 7 days in a dose 20 mg twice a day, in a single morning dose 40 mg, respectively. 29 patients of group 3 received omeprazole 20 mg twice a day for 7 days and further 3 weeks 20 mg twice a day. All the patients were also given amoxicillin 1000 mg twice a day and clarithromycin 500 mg twice a day for a week. RESULTS: An antisecretory effect of esomeprazole as shown by 24-h monitoring of gastric secretion was longer and more stable than that of omeprazole: a latent period averaged 1.5 +/- 0.6 h in a pharmacological test with 20 mg esomeprazole, 1.2 +/- 0.4 h in intake of 40 mg esomeprazole and 2.1 +/- 0.3 h in intake of 20 mg omeprazole. Overall duration of the antisecretory effect averaged 16.8 +/- 1.9, 20.3 +/- 1.7 and 12.5 +/- 1.9 h, respectively. The time of intragastric pH > 4 was 13.1 +/- 1.6, 17.2 +/- 1.6 and 9.8 +/- 1.5 hours, respectively. Eradication of H. pylori in group 1, 2 and 3 was 91.3, 89.3 and 89.6%, respectively. Complete epithelization of ulcer occurred in 95.6, 92.8 and 93.1% cases, respectively. In 77 patients who finished the treatment according to the protocol the treatment resulted in eradication in 95.6, 92.5 and 92.8%, respectively; in epithelization--in 100, 96.3 and 96.4% patients of groups 1, 2 and 3, respectively. Side effects were mild or moderate but not causing changes of the regimen or treatment discontinuation. CONCLUSION: Esomeprazole in three-component treatment was highly effective in eradication of H. pylori and epithelisation of duodenal ulcer defects in various regimens of administration. Esomeprazole in combination with amoxicillin and clarithromycin reduces the time of treatment of DU associated with H. pylori to 1 week without further monotherapy with antisecretory drugs.     

Proton pump inhibitor-amoxicillin-clarithromycin versus proton pump inhibitor-amoxicillin-metronidazole as first-line Helicobacter pylori eradication therapy

The aim of this study was to compare the efficacy and tolerability of the first-line Helicobacter pylori (H. pylori) eradication regimen composed of proton pump inhibitor, clarithromycin, and amoxicillin, with those of a regimen composed of proton pump inhibitor, metronidazole, and amoxicillin. Data of patients, who were administered the first-line H. pylori eradication regimen at Tokyo Medical Center between 2008 and 2011, were reviewed. All patients had H. pylori gastritis without peptic ulcer disease. The 7-day triple regimen composed of lansoprazole, clarithromycin, and amoxicillin was administered to 55 patients, and that composed of omeprazole, metronidazole, and amoxicillin was administered to 55 patients. Intention-to-treat and per-protocol eradication rates were 74.5 and 80.4%, respectively, for the regimen of lansoprazole, clarithromycin, and amoxicillin, whereas the corresponding rates were 96.4 and 100%, respectively, for the regimen of omeprazole, metronidazole, and amoxicillin. In conclusion, first-line H. pylori eradication therapy composed of omeprazole, metronidazole, and amoxicillin was significantly more effective than that composed of lansoprazole, clarithromycin, and amoxicillin, without differences in tolerability.     

Eradication rate and side effect from a point of view of Helicobacter pylori eradication of peptic ulcer disease in dual therapy or new triple therapy

Eradication rate of Helicobacter pylori in dual therapy (omeprazole/amoxicillin) are reported in the range of 28-91%, side effect such as loose stool and skin reaction are reported 3.9-16.8%. In our study, eradication rate in dual therapy is 69.6% (lansoprazole/amoxicillin) and 74.0% (lansoprazole/clarithromycin). In triple therapy, eradication rate is 93.8% (lansoprazole/amoxicillin/clarithromycin), 94.4% (lansoprazole/amoxicillin/metronidazole) and 100.0% (lansoprazole/clarithromycin/metronidazole). There is no difference eradication rate between 1 week (89.2%) and 2 weeks (92.9%) regimen. In general, eradication rate of new triple therapy is effective in the range of 80-100%, and side effect are reported in 1.7-49%. However, Suzuki et al reported side effect decreased in new triple therapy adding mucosal protective agent.     

益生菌联合三联疗法根除幽门螺杆菌疗效研究

目的 评价复方嗜酸乳杆菌片与布拉酵母菌(Saccharomyces boulardii,S.Boulardii)散剂联合三联疗法根除幽门螺杆菌(Helicobacter pylori,H.pylori)的有效性和安全性.方法 H.pylori阳性患者240例随机分为3组,A组:埃索美拉唑20 mg+阿莫西林1 000 mg+呋喃唑酮100 mg,口服每日2次,疗程10天;B组:在A组三联10天基础上,加用复方嗜酸乳杆菌片1 000 mg,口服每日3次,总疗程14天;C组:在A组三联10天基础上,加用S.Boulardii散剂500mg,口服每日2次,总疗程14天.治疗期间观察患者不良反应发生情况,疗程结束4周后观察H.pylori根除率.结果 A、B、C组H.pylori根除率按意向性(ITT)分析分别为62.5％、76.2％、83.8％,按方案(PP)分析分别为64.1％、79.2％、85.9％,B组、C组PP根除率明显高于A组(P＜0.05),C组ITT和PP根除率与B组比较差异无统计学意义(P＞0.05).不良反应发生率方面,B、C组明显低于A组(19.5％、7.7％ vs 34.6％,P＜0.05),C组明显低于B组(P＜0.05).B、C组对药物的耐受程度明显高于A组(P＜0.05),B组与C组差异无统计学意义(P＞0.05).结论 复方嗜酸乳杆菌片或S,Boulardii散剂联合三联疗法均可提高H.pylori根除率,后者安全性优于前者.     

Comparison of sequential and standard triple-drug regimen for Helicobacter pylori eradication: a 14-day, open-label, randomized, prospective, parallel-arm study in adult patients with nonulcer dyspepsia

BACKGROUND: The eradication rates of Helicobacter pylori with standard treatments are decreasing worldwide. OBJECTIVES: The primary aim of this study was to compare the eradication success of a 14-day sequential regimen with proton pump inhibitor (PPI)-based triple treatment. The secondary objectives of the study were to evaluate the effect of gastritis score and smoking on eradication rates as well as evaluation of compliance and tolerability of both regimens. METHODS: Consecutive H pylori-positive patients with nonulcer dyspepsia were randomized into 1 of 2 groups in this 14-day, open-label, randomized, prospective, parallel-arm study. An upper endoscopy with biopsy and (14)C-urea breath test ((14)C-UBT) were performed before enrollment. The first group was administered a sequential regimen consisting of pantoprazole 40 mg and amoxicillin 1 g for 7 days, followed by pantoprazole 40 mg, tetracycline 500 mg, and metronidazole 500 mg for the next 7 days. The second group was administered pantoprazole 40 mg, amoxicillin 1 g, and clarithromycin 500 mg (PAC group) for 14 days. All drugs were administered BID, with the exception of tetracycline, which was administered QID. Eradication was confirmed by (14)C-UBT 6 weeks after the end of the treatment. Histologic examination and (14)C-UBT were conducted by investigators blinded to the protocols. Patients were asked to report any adverse events (AEs) during the treatment period. RESULTS: Three hundred white patients were enrolled in the study and evenly randomized into the sequential treatment group (98 males and 52 females; mean age, 40.2 years) and the PAC group (86 males and 64 females; mean age, 41.2 years). A total of 274 patients completed the study per protocol (PP). Twenty-six patients discontinued: lost to follow-up (16), withdrawn due to AEs (9); and noncompliance (1). The intent-to-treat (ITT) and PP H pylori eradication rates were 72.6% and 80.1% in the sequential group, and 58% and 63% in the PAC group, respectively. The eradication rate was significantly higher in the sequential group compared with the PAC group in both the ITT and PP populations (P=0.01 and P=0.002, respectively). The eradication rates were higher in nonsmoking patients compared with smoking patients both in the sequential group (85.8% vs 70.5%) and the PAC group (67.7% vs 53.3%), but the results were not statistically significant when the groups were analyzed separately. Overall, 32 patients (10.7%) reported an AE. Treatment was discontinued in 9 patients because of serious AEs (sequential group--abdominal pain [2 patients], diarrhea [1], chest pain [1], and vaginal pruritus [1]; PAC group--nausea/vomiting [2], chest pain [1], and numbness [1]). There were no significant between-group differences in regard to compliance or AEs. Univariate analyses found no significant effect of sex, age, alcohol consumption, antacid usage, or gastritis score on the eradication rates. CONCLUSIONS: A 14-day sequential treatment regimen achieved a significantly higher eradication rate of H pylori compared with standard PPI-based triple regimen in this small selected population. Large, double-blind, controlled studies are needed to confirm these results.     

High eradication rate of H. pylori with moxifloxacin-based treatment: a randomized controlled trial

INTRODUCTION: Eradication of Helicobacter pylori remains a problematic treatment issue in clinical practice. The intention is to find a treatment that achieves a high rate of eradication at a low price and treatment options that are now used give us the opportunity to achieve this goal. Recently published results showing a low rate of resistance and better compliance with moxifloxacin-based treatment regimens indicate the need to investigate its efficacy in H. pylori eradication. This study is based on proving the efficacy of moxifloxacin in H. pylori eradication within the triple therapy. AIMS AND METHODS: The aim of the study was to compare the efficacy of one week of moxifloxacin-based treatment with the standard treatment for H. pylori eradication. Patients with H. pylori infection and non-ulcer dyspepsia (n = 277) were randomly divided into four groups to receive: moxifloxacin 400 mg/d, metronidazole 400 mg twice daily, lansoprazole 30 mg twice daily (MML group); moxifloxacin 400 mg/d, amoxicillin 1 g twice daily, lansoprazole 30 mg twice daily (MAL group); clarithromycin 500 mg twice daily, metronidazole 400 mg twice daily, lansoprazole 30 mg twice daily (CML group); clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily, lansoprazole 30 mg twice daily (CAL group). The patients were assessed for prevalence of H. pylori using the CLO test, histology and culture on gastric biopsy samples obtained during upper gastrointestinal endoscopy before randomization and 4-6 weeks after completion of treatment. Bacterial sensitivity to clarithromycin and moxifloxacin was determined with the E-test. RESULTS: 265 (95.6%) patients completed the study forming the basis for PP analysis. Eradication rates of H. pylori in ITT and in PP analyses were: in the MML group 93.5% (58/62) and 96.7% (58/60), respectively; in the MAL group 86.4% (57/66) and 90.5% (57/63); in the CML group 70.4% (50/71) and 75.8% (50/66); and in the CAL group 78.2% (61/78) and 80.2% (61/76). Moxifloxacin treatment protocols were significantly more effective on both ITT and PP analyses than the clarithromycin based protocols with only one exception (MAL vs. CAL on ITT analysis). Among 238 patients (86% of the entire study group), strains showing primary resistance to clarithromycin were found in 10.8% and to moxifloxacin in 5.9%. Eradication of moxifloxacin sensitive/resistant strains was 98.1%/75% for MML (p < 0.01) and 91.1%/66.7% for MAL (p = n.s.); comparison of eradication of sensitive strains in MML and MAL regimens was 98.1%/91.1% (p < 0.05), and for resistant strains 75%/66.7% (p = n.s.). CML and CAL protocols did not differ in efficacy of eradication of clarithromycin sensitive or resistant strains. CONCLUSION: Moxifloxacin-based triple therapies showed higher eradication rates with few side effects and good drug compliance when compared with standard H. pylori treatments. Moreover, the increased prevalence of clarithromycin resistance suggests that moxifloxacin-based regimens could be safe and effective options in treatment of H. pylori infection.     

序贯疗法治疗幽门螺杆菌阳性消化性溃疡的疗效分析

目的：比较10d序贯疗法与7d及14d三联疗法根治幽门螺杆菌（Hp）的疗效与安全性。方法：选取113例胃镜证实为消化性溃疡行14C尿素呼气试验Hp阳性患者,随机分为3组：A组（序贯疗法组）前5d给予泮妥拉唑和阿莫西林,后5d给予泮妥拉唑、替硝唑、克拉霉素治疗;B组（7d疗法）给予泮妥拉唑、阿莫西林、克拉霉素治疗,病理为7d;C组（14d疗法）方案同7d疗法,疗程为14d。疗程结束1个月后行^14C尿素呼气试验。结果：A组根除率为87.18%（34/39）,C组根除率为91.43%（34/37）,均高于B组根除率81.08%（30/37）（P〈0.05）,A组与C组根除率比较无显著差别（P〉0.05）。3组不良反应发生率分别为：15.38%、13.51%和18.91%,相互比较均无显著差异,A组费用效益比好于B组和C组。结论：10d序贯疗法疗效与14d三联疗法的疗效均好,序贯疗法费用效益比最低。10d序贯疗法安全、有效、经济。     

序贯疗法与标准三联疗法治疗幽门螺杆菌阳性十二指肠溃疡疗效观察

目的 评价序贯疗法与标准三联疗法对幽门螺杆菌(Hp)阳性十二指肠溃疡的Hp根除和溃疡愈合情况.方法 将95例Hp阳性的十二指肠溃疡活动期患者随机分为2组.序贯治疗组(48例)给予雷贝拉唑10 mg,阿莫西林1 g,连续口服5 d后再给矛雷贝拉唑10 mg,克拉霉素500 mg和替硝唑400 mg,均每天两次,连用10 d.标准三联组(47例)给予雷贝拉唑10 mg,克拉霉素500 mg和替硝唑400mg,均每天两次,连用7 d.所有患者在根治Hp后继续用雷贝拉唑10 mg,每日1次口服,合计总疗程均为4周.停药4周后复查胃镜观察溃疡愈合情况并检测Hp.结果 序贯治疗组Hp根除率89.5%(43/48),标准三联组Hp根除率70.2%(33/47),Hp根除率比较2组差异有统计学意义(P＜0.05).序贯治疗组溃疡愈合率87.5%(42/48),标准三联组溃疡愈合率82.9%(39/47),溃疡愈合率比较2组差异无统计学意义(P＞0.05).结论 序贯治疗对Hp阳性十二指肠溃疡患者Hp根除率高于标准三联疗法,溃疡愈合率近似.

Abstract：

Objective To compare the efficacy of 10-day sequential therapy (including rabeprazole amoxillin clarithromycin tinidazole) and 7-day traditional trigeminy therapy (including rabeprazole amoxillin and clarithromycin) in patients with duodenobulbar ulcer and Hp infection. Methods Ninty-five patients with duodenobulbar ulcer and Hp infection were enrolled into the study and divided into two groups randomly:sequential therapy group and traditional trigeminy therapy group. Patients in the first group received 10-day sequential medications:rabeprazole 10 mg plus amoxillin 1 g for the first 5 days,followed by rabeprazole 10 mg plus clarithromycin 500 mg and tinidazole 500 mg for another 5 days;while in the second group patients received the standard 7-day traditional triple medications:rabeprazole 10 mg plus clarithromycin 500 mg and tinidazole 400 mg. All drugs were given twice daily. All patients received rabeprazole 10 mg daily following the two types of therapys for another four weeks. Hp statuses were assessed by rapid urease test and 14C urea breath test at baseline and 4 weeks after completion of the treatment. Ulcer cicatrization was assessed by gastroscope. Results The eradication rate of Hp infection was significantly higher in sequential group than triple group (89.5%vs. 70. 2%, P ＜ 0. 05 ), but we found no statistically significant difference in the comparison of the ulcer cicatrization rate between sequential group and triple group ( 87.5% vs. 82. 9%, P ＞ 0. 05 ). Conclusion Sequential therapy had a better Hp eradication effect than standard triple therapy, but the eradication rate was very close between the two therapys.     

Efficacy of omeprazole plus two antimicrobials for the eradication of Helicobacter pylori in a Turkish population.

Omeprazole combined with 2 antimicrobials has been suggested as a first-line option for Helicobacter pylori eradication in recent years. However, controversy exists regarding the efficacy of this protocol. This open-label, prospective clinical study investigated the efficacy of omeprazole-based triple therapy for H pylori eradication in 518 patients with H pylori-positive functional dyspepsia with or without duodenal ulcer. Amoxicillin, macrolides (clarithromycin or roxithromycin), and nitroimidazoles (metronidazole, ornidazole, or tinidazole) were the antibiotics used in the study. Nonulcer patients were randomly assigned to 1 of 8 different treatment protocols and duodenal ulcer patients were randomly assigned to 1 of 4 different treatment protocols consisting of omeprazole (20 mg once daily for nonulcer patients, 20 mg twice daily for ulcer patients for 14 days) with a combination of 2 of the above antimicrobials (for 10 days). H pylori infection was assessed by histologic findings and a rapid urease test before therapy and 4 weeks after therapy ended. Four hundred fifty-nine patients completed their regimens; 327 had functional dyspepsia (180 men, 147 women; median age, 39 years; range, 18 to 70 years) and 132 had ulcers (81 men, 51 women; median age, 40 years; range, 18 to 70 years). Eradication of H pylori was achieved in 58.8% (270 of 459) of all patients, 58.1% (190 of 327) of nonulcer dyspeptic patients, and 60.6% (80 of 132) of duodenal ulcer patients. The eradication rate varied from 47.2% to 69.4% in different treatment protocols. There were no statistically significant differences in eradication rates in any treatment group. All drugs were generally well tolerated in all groups, and no patient discontinued treatment because of side effects. Therapy with omeprazole and 2 antimicrobials for H pylori had limited efficacy in a Turkish population. The reason for these results, which conflict with those of other studies, is not clear. Further investigations of regimens for the eradication of H pylori in our population are necessary.