Ranitidine bismuth citrate-based triple therapies as a second-line therapy for Helicobacter pylori in Turkish patients

BACKGROUND: Quadruple therapy with a proton pump inhibitor, bismuth, metronidazole and tetracycline is recommended as the optimal second-line therapy of Helicobacter pylori infection in the Maastricht Consensus Report. The aim of the present paper was to evaluate the efficacy of ranitidine bismuth citrate (RBC)-based regimens as second-line therapies after failure of the standard Maastricht triple therapy. MATERIALS AND METHODS: One hundred and sixteen H. pylori-positive patients were given omeprazole 20 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d for 10 days. Patients remaining H. pylori-positive (n = 29) were combined with 27 patients enrolled after an initial eradication failure from proton-pump inhibitor (PPI), amoxicillin and clarithromycin therapy for at least 7 days and were randomly given one of the following second-line 10-day treatments: RBC 400 mg b.d., amoxicillin 1 g b.d and clarithromycin 500 mg b.d. (RAC group, n = 28) and RBC 400 mg b.d., metronidazole 500 mg b.d and tetracycline 500 mg b.d. (RMT group, n = 28). Eradication was assessed by either histology and rapid urease test or (13)C urea breath test 8 weeks after therapy. RESULTS: The eradication rate of first-line Maastricht therapy was 67% for intention-to-treat analysis (95% confidence interval [CI]: 58-75). Per-protocol and intention-to-treat eradication was achieved in 60.7% of patients (95%CI: 42-79) in the RAC group and in 85.7% of patients (95%CI: 73-98) in the RMT group (P = 0.03). Fifty-three percent of patients in the RAC and 50% of patients in the RMT group experienced at least one slight side-effect (P = 0.6). CONCLUSIONS: RMT is an effective and well-tolerated second-line therapy after H. pylori eradication failure from PPI, amoxicillin, and clarithromycin.     

The efficacy of bismuth containing quadruple therapy as a first-line treatment option for Helicobacter pylori

BACKGROUND: Helicobacter pylori eradication rates have tended to decrease recently, mostly due to increasing antibiotic-resistance. The present study aimed to compare the efficacy of bismuth-based quadruple regimen with proton pump inhibitor-based triple regimen for eradication of H. pylori. METHODS: Consecutive H. pylori-positive patients with non-ulcer dyspepsia were randomized into one of two regimens: (i) bismuth subsalicylate 300 mg q.i.d., lansoprazole 30 mg b.i.d., tetracycline 500 mg q.i.d. and metronidazole 500 mg t.i.d. (BLTM group) for 14 days; (ii) lansoprazole 30 mg b.i.d., amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d. (LAC) for 14 days. Gastroscopy and (14)C-Urea breath test (UBT) were performed before enrollment, and UBT only was repeated for 6 weeks after treatment. RESULTS: A total of 240 patients were randomized into groups and 212 of them completed the protocols. The 'intention-to-treat' (ITT) and 'per protocol' (PP) H. pylori eradication rates were 70% (95%CI 61-78) and 82.3% (95%CI 74-89) in the BLTM group, and 57.5% (95%CI 48-66) and 62.7% (95%CI 53-71) in the LAC group. The BLTM treatment achieved a significantly better eradication rate compared with LAC treatment in PP analysis (82.3% vs. 62.7%, P = 0.002). Mild to severe side-effects, which were more frequent in the BLTM group, were reported in 18.2% of the patients. CONCLUSION: The bismuth-based quadruple regimen achieved a better eradication rate compared with proton pump inhibitor-based triple regimens as a first-line eradication option for H. pylori in our population.     

Eradication of Helicobacter pylori infection with proton pump-based triple therapy in patients in whom bismuth-based triple therapy failed.

To study the effects of treatment of Helicobacter pylori infection in a hyperendemic population, 143 infected patients from the region of Nari?o, Colombia, were treated for 2 weeks with clarithromycin (500 mg twice a day), amoxicillin (1 g twice a day), and either lansoprazole (30 mg twice a day) or omeprazole (30 mg twice a day). All patients belong to a low socioeconomic strata, had multifocal atrophic gastritis documented by gastric biopsies, and had been treated previously and unsuccessfully for 2 weeks with bismuth subsalicylate (262 mg four times a day), amoxicillin (500 mg three times a day), and metronidazole (400 mg three times a day). 13C-urea breath tests were performed 6, 12, 24, and 60 weeks after completing therapy. The 13C-urea breath test was negative in 79.7% of patients 1 month after finishing therapy, and in 69.2% of patients 1 year after finishing treatment. There were no differences in eradication rates between patients treated with omeprazole versus lansoprazole. Dyspepsia symptoms decreased from 74% in patients at baseline to 19% at the time of finishing treatment. In low-socioeconomic status populations with hyperendemic infection, triple therapy using omeprazole or lansoprazole plus clarithromycin and amoxicillin is an effective alternative when previous standard bismuth-based triple therapy has failed.     

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.     

Effects of in vitro antibiotic resistance on treatment: bismuth-containing regimens.

Bismuth compounds remain useful for Helicobacter pylori eradication therapy. These include colloidal bismuth subcitrate (CBS), bismuth subsalicylate (BSS) and, most recently, ranitidine bismuth citrate (RBC). CBS appears to prevent the development of imidazole resistance when coadministered with nitroimidazoles. Traditional triple therapy with bismuth, metronidazole and tetracycline or amoxicillin (BMT/A) only partially overcomes metronidazole resistance. However, the addition of a PPI to bismuth triple therapy largely overcomes established metronidazole resistance if treatment is given for at least one week or more. When RBC rather than PPI is used with clarithromycin, this dual regimen appears to be more effective in preventing the development of secondary clarithromycin resistance. The triple combination of RBC, metronidazole and clarithromycin appears to be effective against metronidazole resistant strains of H pylori. Thus, overall, there is some evidence that bismuth compounds may prevent the development of antibiotic resistance and that existing antibiotic resistance may at least be partially overcome in vitro and in vivo. With the growing emergence of H pylori resistance to metronidazole and clarithromycin, further research to clarify the role of bismuth compounds is required.     

Clarithromycin, Tetracycline, and Bismuth: A New Non-Metronidazole Therapy for Helicobacter pylori Infection

Objective: Metronidazole resistance has become an increasing problem that has limited the usefulness of the original triple therapy. Our objective was to evaluate clarithromycin, a new macrolide compound active against Helicobacter pylori. Methods: We evaluated a new clarithromycin triple therapy for H. pylori infection consisting of the combination of clarithromycin (500 mg t.i.d .), tetracycline (500 mg q.i.d .), and bismuth subsalicylate tablets (2 q.i.d.) for 14 days. Patients with ulcer also received concomitant ranitidine, 300 mg after the evening meal, for 6 wk. Results: Thirty men with documented H. pylori infection were studied; 29 had peptic ulcer disease. Seven had previously failed antimicrobial therapy, including three with metronidazole-based triple therapy. H. pylori status was determined by histology. H. pylori status and ulcer status were evaluated 4 wk after the end of antimicrobial therapy. The ulcer was healed in 90%. The H. pylori infection was cured in 93%, including all three patients who previously failed metronidazole-based triple therapy. Conclusion: We conclude that the combination of clarithromycin, tetracycline, and bismuth is an effective new therapy for treatment of H. pylori infection.     

Beta-lactamase inhibitor enhances Helicobacter pylori eradication rate

OBJECTIVES: One-week triple therapy, a combination of acid suppression with two antibiotics, is the gold standard for anti-Helicobacter pylori treatment. There is increasing evidence of H. pylori resistance to classical triple therapy. Recently, it was reported that the amoxicillin-clavulanate combination had a slightly higher activity than amoxicillin alone against H. pylori, and that beta-lactamase inhibitors had 'in-vitro' antibacterial activity against H. pylori. SETTING: To evaluate the efficacy of 1 week triple therapy omeprazole, clarithromycin and amoxicillin plus clavulanate compared with omeprazole, clarithromycin and amoxicillin for H. pylori eradication. The study was open randomized. SUBJECTS: Sixty dyspeptic patients (36 male, 24 female; mean age 53 +/- 9 years) with Helicobacter pylori infection never treated before, were enrolled and randomly assigned to two different 7-day triple therapies: (i) (n = 30) amoxicillin 875 mg plus clavulanic acid 125 mg b.i.d., clarithromycin 500 mg b.i.d., omeprazole 20 mg b.i.d. (ACCO); (ii) (n = 30) amoxicillin 1 g b.i.d., clarithromycin 500 mg b.i.d., omeprazole 20 mg b.i.d. (ACO). Bacterial eradication was assessed by 13C-urea breath test 4-6 weeks after therapy. Information on gastrointestinal symptoms and antibiotic-related side-effects were recorded using a questionnaire. RESULTS: All patients completed the study. A significantly higher H. pylori eradication rate with ACCO compared with ACO: (26/30) 86.6 vs. (20/30) 66.6%, respectively (P < 0.05) were observed. No major side-effects were reported, whilst 8% patients complained of mild side-effects; no significant differences were noted between the two groups. CONCLUSIONS: Our results suggest that amoxicillin and clavulanate in combination achieve a higher H. pylori eradication rate than amoxicillin alone, without any increase in side-effects. The combination of amoxicillin and clavulanate may represent an alternative therapeutic scheme for the treatment of H. pylori infection.     

Ten-day triple therapy with ranitidine bismuth citrate, amoxicillin, and clarithromycin in eradicating Helicobacter pylori

OBJECTIVE: Fourteen-day therapy with ranitidine bismuth citrate, amoxicillin, and clarithromycin has been shown to have a high Helicobacter pylori eradication rate (> 90%) in U.S. trials. The aim of this study was to determine the H. pylori eradication rate of a ranitidine bismuth citrate-based triple regimen of shorter duration (10 days), which has been shown to be effective in Europe. METHODS: Dyspeptic patients who had a positive baseline 13C-urea breath test and either a positive antral rapid urease test or positive IgG serology were studied. Treatment consisted of ranitidine bismuth citrate 400 mg, clarithromycin 500 mg, and amoxicillin 1 g, all given b.i.d. for 10 days. Eradication was determined >4 wk after completion of therapy by the 13C-urea breath test (enrichment <2.4%). Results are expressed for intent-to-treat (all patients randomized even if they did not take the drug) and per-protocol (major protocol violators excluded) analyses. RESULTS: Seventy-seven patients with a mean age of 48 +/- 1.8 yr were studied. Forty-eight patients had eradication of H. pylori with this regimen (62%), 16 patients (21%) did not have eradication, and 13 patients (17%) did not return for breath testing. By intent-to-treat analysis the eradication rate was 62% (95% confidence intervals [CI], 51%, 73%) and by per-protocol analysis the eradication rate was 75% (95% CI, 63%, 85%). CONCLUSIONS: Ten-day, twice-daily therapy with ranitidine bismuth citrate, amoxicillin, and clarithromycin has an eradication rate that ranges from 62-75%. Fourteen-day therapy may be preferable because of higher eradication rates.     

Ranitidine bismuth citrate-based triple therapy for seven days, with or without further anti-secretory therapy, is highly effective in patients with duodenal ulcer and Helicobacter pylori infection

OBJECTIVE: To compare the efficacy of two protocols for the eradication of Helicobacter pylori infection and the healing of active duodenal ulcer: (i) ranitidine bismuth citrate (RBC) plus two antibiotics for 7 days, and (ii) the same triple therapy followed by 3 weeks of anti-secretory drug treatment. METHODS: The study comprised 102 patients with active duodenal ulcer and H. pylori infection; the patients were randomized to open treatment with either RBC 400 mg b.d. plus amoxycillin 1 g b.d. and clarithromycin 500 mg b.d. for 7 days, or the same treatment followed by 3 weeks of RBC 400 mg b.d. alone. Ulcer healing was confirmed by endoscopy. H. pylori eradication was assessed by endoscopy, rapid urease test and histology. RESULTS: The ulcer healed in 48/50 patients on RBC-based triple therapy alone (96.0%) and in 51/52 patients on triple therapy plus further anti-secretory treatment (98.1%). On an intention-to-treat basis, H. pylori had been successfully eradicated in 42/50 patients on triple therapy (84.0%) and in 44/52 patients on triple therapy plus anti-secretory treatment (84.6%), while by per protocol analysis the H. pylori eradication rates were 91.3% (42/46) and 89.8% (44/49), respectively. CONCLUSIONS: One-week triple therapy with RBC, amoxycillin and clarithromycin is highly effective in eradicating H. pylori and healing duodenal ulcers, even if not followed by anti-secretory drug treatment.     

Poor efficacy of ranitidine bismuth citrate-based triple therapies for Helicobacter pylori eradication.

BACKGROUND: Helicobacter pylori eradication rates have tended to decrease recently possibly related with increasing antibiotic resistance. The present study investigated the efficacy of three different ranitidine bismuth citrate (RBC) based triple regimens in a population with high prevalence of H. pylori. METHODS: 300 consecutive H. pylori positive patients with non-ulcer dyspepsia were randomized into three regimens: (1) RBC 400 mg, amoxicillin 1000 mg and tetracycline 500 mg [RBC-AT], (2) RBC 400 mg, amoxicillin 1000 mg and clarithromycin 500 mg [RBC-AC], (3) RBC 400 mg, metronidazole 500 mg and tetracycline 500 mg [RBC-MT]. Tetracycline was given q.i.d, all other drugs were given b.i.d. for 14 days. Gastroscopy and (14)C-Urea breath test (UBT) were performed before enrollment and UBT only was repeated 6 weeks after the end of treatment. RESULTS: 274 patients completed the protocols. The overall 'intention to treat' and 'per protocol' H. pylori eradication rates in all subjects were 57.6% (95% CI: 52-63) and 63.1% (95% CI: 57-68), respectively. The eradication rates achieved in the groups (RBC-AT, RBC-AC and RBC-MT) were 64.4% (95% CI: 54-74), 66.2% (95% CI: 56-76), and 58.9% (95% CI: 49-68) on 'per protocol' analyses, respectively. There was no difference in eradication rates, compliance and major side effects between the groups. CONCLUSION: The current RBC-based H. pylori eradication therapy is not adequately effective.     

Antimicrobial susceptibility testing before first-line treatment for Helicobacter pylori infection in patients with dual or triple antibiotic resistance

AIM To evaluate the efficacy of antimicrobial susceptibilityguided therapy before first-line treatment for infection in patients with dual or triple antibiotic resistance.METHODS A total of 1034 patients infected by Helicobacter pylori(H. pylori) during 2013-2014 were tested for antimicrobial susceptibility. 157 of 1034(15%) patients showed resistance to two(127/1034; 12%) and to three(30/1034; 3%) antibiotics. Sixty-eight patients with dual H. pylori-resistance(clarithromycin, metronidazole or levofloxacin) were treated for 10 d with triple therapies: OAL(omeprazole 20 mg b.i.d., amoxicillin 1 g b.i.d., and levofloxacin 500 mg b.i.d.) 43cases, OAM(omeprazole 20 mg b.i.d., amoxicillin 1 g b.i.d., and metronidazole 500 mg b.i.d.) 12 cases and OAC(omeprazole 20 mg b.id., amoxicillin 1 g b.i.d., and clarithromycin 500 mg b.i.d.) 13 cases based on the antimicrobial susceptibility testing. Twelve patients showed triple H. pylori-resistance(clarithromycin, metronidazole and levofloxacin) and received for 10 d triple therapy with OAR(omeprazole 20 mg b.id., amoxicillin 1 g b.i.d., and rifabutin 150 mg b.i.d.). Eradication was confirmed by 13C-urea breath test. Adverse effects and compliance were assessed by a questionnaire. RESULTS Intention-to-treat eradication rates were: OAL(97.6%), OAM(91.6%), OAC(92.3%) and OAR(58.3%). Cure rate was significantly higher in na?ve patients treated with OAR-10 compared to patients who had two or three previous treatment failures(83% vs 33%). Adverse events rates for OAL, OAM, OAC and OAR were 22%, 25%, 23% and 17%, respectively, all of them mild-moderate. CONCLUSION Antimicrobial susceptibility-guided triple therapies during 10 d for first-line treatment leads to an eradication rate superior to 90% in patients with dual antibiotic H. pylori resistance.     

One-year follow-up study of Helicobacter pylori eradication rate with 13C-urea breath test after 3-d and 7-d rabeprazole-based triple therapy

AIM: To investigate the long-term role of a 3-d rabeprazole-based triple therapy in patients with Helicobacter pylori (H pylori)-infected active peptic ulcers. METHODS: We prospectively studied 115 consecutive patients with H pylori-infected active peptic ulcers. H pylori infection was confirmed if any two of H pylori DNA, histology, and rapid urease test were positive. Patients were assigned to either an open-labeled 3-d course of oral amoxicillin 1 000 mg b.i.d., clarithromycin 500 mg b.i.d., and rabeprazole 20 mg b.i.d., or 7-d course of oral amoxicillin 1 000 mg b.i.d., clarithromycin 500 mg b.i.d., and rabeprazole 20 mg b.i.d. Subsequently, all patients received oral rabeprazole 20 mg once daily until the 8th wk. Three months after therapy, all patients were followed-up endoscopically for the peptic ulcer, H pylori DNA, histology, and rapid urease test. One year after therapy, H pylori infection was tested using the 13C-urea breath test. RESULTS: The ulcer healing rates 3 mo after therapy were 81.0% vs 75.4% for the 3-d and 7-d groups [intention-to-treat (ITT) analysis, P=0.47] respectively, and 90.4% vs 89.6% for the 3-d and 7-d groups [per-protocol (PP) analysis, P=0.89] respectively. The eradication rates 3 mo after therapy were 75.9% vs 73.7% for the 3-d and 7-d groups (ITT, P=0.79) respectively, and 84.6% vs 87.5% for the 3-d and 7-d groups (PP, P=0.68) respectively. One year after therapy, seventy-five patients returned to receive the 13C-urea breath test, and the eradication rates were 78.4% vs 81.6% in 3-d and 7-d groups (PP, P=0.73) respectively. CONCLUSION: Our study showed the eradication rates against H pylori infection 3 and 12 mo after triple therapy were not different between the 3-d and 7-d rabeprazole-based groups. Therefore, the 3-d rabeprazole-based triple therapy may be an alternative treatment for peptic ulcers with H pylori infection.     

Duodenal ulcer healing rates in a one-year follow-up study with ranitidine bismuth citrate and antibiotics

BACKGROUND/AIMS: The aim of this study was to determine the one-year outcome of an eradication therapy with ranitidine bismuth citrate and antibiotics in Helicobacter pylori-positive duodenal ulcer patients in respect to ulcer and Helicobacter pylori relapse rates. METHODOLOGY: This multicenter, randomized, double-blind study involved 648 duodenal ulcer patients and had been carried out to compare the following regimens: ranitidine bismuth citrate b.i.d. co-prescribed with either clarithromycin 250 mg q.i.d. or clarithromycin 500 mg b.i.d. or clarithromycin 500 mg b.i.d. plus metronidazole 400 mg b.i.d. for 2 weeks, followed by a further 14 days of treatment with ranitidine bismuth citrate 400 mg b.i.d. to facilitate ulcer healing. H. pylori eradication was assessed by 13C-urea breath test and histology at least 4 weeks, 26 weeks and 52 weeks after the end of treatment. Ulcer relapse and H. pylori status were assessed 4 weeks, 26 weeks and 52 weeks post-treatment or if ulcer symptoms recurred. For the remainder of the follow-up period only serious adverse events were collected. RESULTS: At 12 months data of 438 (69%) patients were evaluable. The observed H. pylori eradication rates were 88-91%. H. pylori relapse rates were 2.1% after 26 weeks and 3.9% after 52 weeks. At the week 26 visit 26 patients (5.6%) and at the week 52 visit 25 patients (5.7%) had documented gastroesophageal reflux disease. CONCLUSIONS: Our data confirm the reduction of duodenal ulcer relapses after the cure of Helicobacter pylori infection.     

Moxifloxacine Plus Amoxicillin and Ranitidine Bismuth Citrate or Esomeprazole Triple Therapies for Helicobacter pylori Infection

Up to 20% of patients, or even more, will fail to obtain eradication after a standard triple therapy. The aim of this study is to evaluate the efficacy of moxifloxacine-containing regimens in the first-line treatment of Helicobacter pylori. One hundred and twenty H. pylori-positive patients were randomized into four groups to receive one of the following 14-day treatments: ranitidine bismuth citrate (RBC) 400 mg b.d. plus amoxicillin 1 g b.d. and clarithromycin 500 mg b.d. (RAC group, n = 30); RBC 400 mg b.d. plus moxifloxacine 400 mg o.d. and amoxicillin 1,000 mg b.d. (RAM group, n = 30); esomeprazole 40 mg b.d. plus amoxicillin 1,000 mg b.d. plus clarithromycin 500 mg b.d. (EAC group, n = 30); and esomeprazole 40 mg b.d. plus amoxicillin 1,000 mg b.d. plus moxifloxacine 400 mg o.d. (EAM group, n = 30). Eradication was assessed by ¹³C urea breath test 8 weeks after therapy. Per-protocol and intention-to-treat eradication was achieved in 23 out of 30 patients (76.7%, 95% confidence interval [CI]: 61–92) in the RAC group, in 20 patients (66.7%, 95% CI: 49–84) in the RAM group, in 16 patients in the EAM group (53.3%, 95% CI: 34–71), and in 19 patients in the EAC group (63.3%, 95% CI: 54–72). Mild or moderate side-effects were significantly more common in the EAM group (70%) compared to the RAC (36.6%), RAM (43.3%), and EAC (56.6%) groups (P = 0.03). From our results, we conclude that moxifloxacine-containing triple therapies have neither eradication nor compliance advantages over standard triple therapies. Further studies with new antibiotic associations are needed for the better eradication of H. pylori in developing regions of the world.     

幽门螺杆菌不同治疗方案的疗效评估

目的 对本院门诊患者根除幽门螺杆菌(Hp)的不同治疗方案进行疗效比较.方法 选择2005年1月～2007年7月我院就诊的幽门螺杆菌治疗前后资料完整的患者522例,质子泵抑制剂(PPI) 克拉霉素 硝基咪唑类121例,PPI 克拉霉素 阿莫西林135例,PPI 硝基咪唑类 阿莫西林80例;枸橼酸铋雷尼替丁 克拉霉素 硝基咪唑类63例,枸橼酸铋雷尼替丁(RBC) 克拉霉素 阿莫西林81例,RBC 硝基咪唑类 阿莫西林42例.结果 PPI 两种抗生素的治疗方案中,PPI 克拉霉素 阿莫西林的Hp根除率显著高于PPI 克拉霉素 硝基咪唑组,而与PPI 阿莫西林 硝基咪唑组比较无显著性差异;RBC 两种抗生素的治疗方案中,RBC 克拉霉素 阿莫西林的Hp根除率最高;在使用相同的抗生素的情况下,PPI组与RBC组根除Hp比较无显著性差异.结论 选择PPPI/RBC 克拉霉素 阿莫西林能更有效地根除Hp.     

Effectiveness of ranitidine bismuth citrate, clarithromycin, and metronidazole therapy for treating Helicobacter pylori

OBJECTIVE: There are limited data available from the United States on the effectiveness of ranitidine bismuth citrate (RBC) plus two antibiotics to treat Helicobacter pylori. Therefore, the following study was undertaken to evaluate RBC with two antibiotics, which have been used successfully in combination, to treat H. pylori. METHODS: Adults with and without abdominal symptoms, who had never received H. pylori eradication therapy, were tested for the presence of H. pylori infection either by in-office rapid serology assays or histology. Positive subjects were administered the 13C-urea breath test. Subjects who had a positive urea breath test were then treated with RBC 400 mg b.i.d., clarithromycin 500 mg b.i.d., and metronidazole 500 mg b.i.d. for 10 days. Four to 6 wk after completing antibiotics all subjects were asked to return for a second urea breath test to assess treatment success. RESULTS: Forty-seven of the 50 subjects enrolled into this study completed the antibiotic regimen and returned for a repeat urea breath test. Thirty-seven subjects were negative for H. pylori by urea breath test and 10 were positive, resulting in a 79% eradication rate. Seven subjects (14%) stopped their medication because of side effects. When analysis was performed on the 40 subjects who took > or = 80% of their medication (per-protocol), the eradication rate was 90%. CONCLUSIONS: The combination of RBC with clarithromycin and metronidazole successfully treated H. pylori infection after only 10 days of therapy. The per-protocol eradication rate from this study was similar to that seen with Food and Drug Administration (FDA)-approved regimens. In conclusion, RBC plus clarithromycin and metronidazole should be considered as a first-line treatment regimen for H. pylori infection, and may only need to be taken for a period of 10 days, as opposed to 14 days for FDA-approved regimens.     

A randomized controlled comparison of three quadruple therapy regimens in a population with low Helicobacter pylori eradication rates

BACKGROUND AND AIM: We sought to compare the efficacy and tolerability of an omeprazole/clarithromycin/bismuth/tetracycline-based quadruple therapy to that of a ranitidine/metronidazole/bismuth/tetracycline-based quadruple therapy of 2 or 3 weeks duration in a population with a high prevalence of metronidazole-resistant Helicobacter pylori and low triple therapy eradication rates. METHODS: Two hundred and twenty-one patients who presented endoscopically proven duodenal ulcers and a positive rapid urease test were randomized to receive either: (i) omeprazole 20 mg b.i.d., clarithromycin 250 mg b.i.d., bismuth subcitrate 240 mg b.i.d. and tetracycline 500 mg b.i.d (OCBT) for 2 weeks; (ii) ranitidine 300 mg b.i.d., metronidazole 500 mg b.i.d, bismuth subcitrate 240 mg b.i.d. and tetracycline 500 mg b.i.d. (RMBT2) for 2 weeks; or (iii) ranitidine 300 mg b.i.d., metronidazole 500 mg b.i.d, bismuth subcitrate 240 mg b.i.d. and tetracycline 500 mg b.i.d. (RMBT3) for 3 weeks. Patients were interviewed 2 weeks after the completion of therapy to review compliance and side-effects. Eradication of H. pylori was assessed 8 weeks after the completion of therapy with the use of a 14C-urea breath test. RESULTS: The per-protocol eradication rate was significantly higher with OCBT (88%) than RMBT2 (73%) or RMBT3 (71%) (P<0.05). The intent-to-treat eradication rate was numerically higher with OCBT (80%) than RMBT2 (68%) or RMBT3 (68%), although this difference did not reach statistical significance (P=0.09). Per-protocol or intent-to-treat eradication rates were similar with RMBT2 and RMBT3. There were significantly greater side-effects with the RMBT2 regimen. CONCLUSIONS: The omeprazole/clarithromycin/bismuth/tetracycline-based quadruple therapy provides higher H. pylori eradication rates than the ranitidine/metronidazole/bismuth/tetracycline-based quadruple therapy when administered per protocol. The prolongation of the latter regimen from 2 to 3 weeks did not increase eradication rates.     

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.     

Clarithromycin-based triple therapy for non-resistant Helicobacter pylori infection. How long should it be given?

BACKGROUND: We have previously reported mixed infection with wild-type (sensitive) and mutant (resistant) Helicobacter pylori strains using a PCR-based preferential homo-duplex formation assay (PCR-PHFA) to detect gene mutations associated with clarithromycin resistance. Half of the cases with mixed infection were determined as sensitive by conventional MIC assessment and yet failed to respond to clarithromycin-based therapy. The aim of this study is to assess the efficacy of clarithromycin-based triple therapy in patients infected exclusively with wild-type strains as determined by PCR-PHFA. METHODS: Ninety patients who had pure wild-type H. pylori infection were randomly assigned to receive clarithromycin (200 mg b.i.d.), amoxicillin (500 mg q.i.d.) and lansoprazole (30 mg b.i.d.) for either 5 days or 7 days (n = 48 and n = 42, respectively). The outcome of eradication was assessed by [13C] urea breath test. RESULTS: Eradication was achieved in 36/48 (75%) versus 39/42 (93%) by intention-to-treat analysis (P = 0.02), and in 36/45 (80%) versus 39/40 (98%) by per protocol analysis (P = 0.01), for the 5-day and 7-day protocols, respectively. Compliance and the incidence of untoward effects were similar in both groups. CONCLUSIONS: Seven-day administration is necessary and sufficient for the triple therapy with clarithromycin, amoxicillin and lansoprazole in patients with pure wild-type H. pylori infection.     

Levofloxacin-azithromycin combined triple therapy for Helicobacter pylori eradication]

BACKGROUND/AIMS: Antibiotic resistance and poor compliance are the main causes of Helicobacter pylori (H. pylori) eradication failure. This study evaluated the eradication rate, tolerability, and compliance of levofloxacin- azithromycin combined triple therapy for H. pylori eradication. METHODS: 1) First-line eradication: A total of 78 H. pylori-positive patients were enrolled. Seventeen military men in Armed Forces Capital Hospital were treated with 7 days of levofloxacin-azithromycin combined triple therapy (omeprazole 20 mg bid, levofloxacin 500 mg od, and azithromycin 500 mg od), and 61 patients in Kangbuk Samsung Hospital were treated with standard PPI-based triple therapy (omeprazole 20 mg bid, amoxicillin 1.0 g bid, and clarithromycin 500 mg bid) for 7 days. 2) Second-line eradication: A consecutive series of 59 patients who failed H. pylori eradication with standard PPI-based triple therapy in Kangbuk Samsung Hospital were randomized to two groups. Thirty patients were retreated with 7 days of bismuth-based quadruple therapy (omeprazole 20 mg bid, bismuth 120 mg qid, metronidazole 500 mg tid, and tetracycline 500 mg qid), and remaining 29 patients were retreated with levofloxacin-azithromycin combined triple therapy. Patient's compliance and tolerability were evaluated at the end of treatment. The status of H. pylori infection was assessed 8 weeks later then. The successful eradication of H. pylori was defined as negative results from histology and CLO test, or 13C-urea breath test. RESULTS: First-line eradication rate of levofloxacin-azithromycin triple therapy was lower than that of standard PPI-based triple therapy, but there was no statistically significant difference (70.6% vs. 80.3%, p=0.390). Second-line eradication rate of levofloxacin-azithromycin combined triple therapy was significantly lower than that of bismuth-based quadruple therapy (ITT/PP 65.5%/73.1% vs. 90%/90%, p<0.0001). The compliances of all patients were more than 85%. Two of patients with levofloxacin-azithromycin combined triple therapy complained self-limiting side effects (mild dizziness; mild insomnia with general weakness). CONCLUSIONS: Levofloxacin-azithromycin combined triple therapy should not be recommended as the first-line or second-line H. pylori eradication regimen in Korea.