Second-line treatment for Helicobacter pylori infection: 10-day moxifloxacin-based triple therapy versus 2-week quadruple therapy

BACKGROUND AND AIM: The aim of this study was to test the efficacy of 10-day moxifloxacin-based triple therapy versus 2-week quadruple therapy for the second-line treatment of Helicobacter pylori infection. METHODS: One hundred and ninety-two patients who had failed previous H. pylori eradication on standard triple therapy were randomized to one of two regimens: 1, moxifloxacin (400 mg q.d.), amoxicillin (1000 mg b.i.d.), and esomeprazole (20 mg b.i.d.) for 10 days (the 10MEA group), or 2, esomeprazole (20 mg b.i.d.), tripotassium dicitrate bismuthate (300 mg q.i.d.), metronidazole (500 mg t.i.d.), and tetracycline 500 mg (q.i.d.) for 14 days (the 14EBMT group). The eradication rates, drug compliances, and side-effect rates of these two regimens were compared. RESULTS: Eradication rates by intention-to-treat and per-protocol analyses in the 10MEA and 14EMBT groups were 71.9% and 82.6%, and 71.7% and 90.5% (p = .973 and .321), respectively. The 10MEA group was significantly superior to the 14EMBT group in terms of side-effect rates (12.2% vs. 39.6%, p = .001), and discontinuation rates due to side-effects were lower in the 10MEA group than in the 14EMBT group (0.7% vs. 13.2%, p < .001). Moreover, compliance was higher in the 10MEA group (94.2% (131/139)) than in the 14EBMT group (83.0% (44/53)) (p = .014). CONCLUSION: The 10-day moxifloxacin-based triple therapy was found to have a high eradication rate with few side-effects and good drug compliance. These findings suggest that this regimen is a safe and effective second-line treatment option for H. pylori infection in Korea.     

A pilot study evaluating sequential administration of a PPI-amoxicillin followed by a PPI-metronidazole-tetracycline in Turkey

BACKGROUND: There is no effective regimen for the eradication of Helicobacter pylori in our country. It may be due to the increasing prevalence of resistance to antibiotics used for the treatment of H. pylori. Recently, a study from Turkey has revealed that a new treatment scheme consisting of sequential administration of pantoprazole plus amoxicillin for 7 days followed by pantoprazole plus metronidazole, and tetracycline for the remaining 7 days was effective in the first-line treatment of H. pylori. Therefore, we aimed to confirm efficacy of a new therapy scheme in the first-line H. pylori eradication. MATERIAL AND METHODS: This is a prospective, open label, single center, pilot study and included 32 patients infected with H. pylori diagnosed by both histologic examinations, rapid urease test and (13)C-urea breath test (UBT). The patients received a 14-day sequential regimen (pantoprazole 40 mg b.d. plus amoxicillin 1000 mg b.d. for 7 days and pantoprazole 40 mg b.d., metronidazole 500 mg b.d. and tetracycline 500 mg q.d. for the remaining 7 days). Eradication was assessed with (13)C-UBT 4 weeks after completion of the therapy. Intention-to-treat and per-protocol eradication rates were determined. RESULTS: At intention-to-treat analysis, the eradication rate was 50% (16/32). For the per protocol analysis, the eradication rate was 57% (16/28). There were no significant adverse effects and treatment compliance was good. CONCLUSION: A new therapy consisting of sequentially administered drugs for 14 days yielded unacceptably low eradication rates. This scheme was not efficient for H. pylori eradication in our region. Further investigations are needed to determine the effectiveness of this scheme in other regions of Turkey.     

Efficacy and safety of rabeprazole, amoxicillin, and gatifloxacin after treatment failure of initial Helicobacter pylori eradication

OBJECTIVES: To evaluate the efficacy of a 7-day regimen of gatifloxacin (400 mg daily), amoxicillin (1 g twice a day), and rabeprazole (20 mg twice a day) in the secondary eradication of Helicobacter pylori infection. METHODS: Eligible patients with persistent infection following one or more conventional clarithromycin-containing triple therapies were enrolled in this open-label trial. Eradication of infection was documented by (14)C-urea breath test a minimum of 4 weeks after therapy and 2 weeks off any acid suppressive therapy. Culture of H. pylori and in vitro susceptibility testing to amoxicillin, clarithromycin, and gatifloxacin was done in cases of failed eradication. RESULTS: A total of 45 patients (22 females:23 males; mean age 44.5 +/- 13 years) were enrolled. Eradication occurred in 38 patients [both per-protocol (PP) and intention-to-treat analysis: 84.4%; 95% CI: 74-95%]. No significant adverse effects were reported. In vitro susceptibility testing showed no secondary resistance to gatifloxacin or amoxicillin in any of the seven nonresponders. Smoking, age, and sex were not predictors of potential eradication failure. CONCLUSIONS: A 7-day regimen of gatifloxacin, rabeprazole, and amoxicillin is effective after failed eradication therapy for H. pylori and does not appear to result in secondary resistance. This combination is simple, well tolerated, and may lead to higher compliance and lower costs.     

Low efficacy rate of moxifloxacin-containing Helicobacter pylori eradication treatment: in an observational study in a Turkish population

BACKGROUND: Standard triple therapy for Helicobacter pylori has an eradication rate of about 50% in Turkey. It may be due to an increased resistance of H. pylori to antibiotics. Therefore, we aimed to investigate the effectiveness of a new second-generation fluoroquinolone, moxifloxacin-containing triple therapy in H. pylori eradication. MATERIAL AND METHODS: This is an open-label, prospective, single-center, pilot study. We studied 71 dyspeptic patients infected with H. pylori diagnosed by both histology and rapid urease test. Out of 71 dyspeptic patients, 64 had non-ulcer dyspepsia and seven had peptic ulcer. Patients received pantoprazole (40 mg b.i.d.) plus moxifloxacin (400 mg/day) and amoxicillin (1000 mg b.i.d.) for 14 days. Eradication was assessed 4 weeks after completing the therapy by histology and rapid urease test. Per-protocol and intention-to-treat eradication rates were determined. RESULTS: The eradication rate was 42.2% for the intention-to-treat analysis and 47.6% for the per-protocol analysis. Of all patients included in the study, 29.5% had side-effects and only 2.8% of the patients discontinued the treatment because of side-effects. Most of the complications were mild and self-limiting. CONCLUSION: Triple therapy with pantoprazole, moxifloxacin, and amoxicillin for 14 days yielded unacceptably low eradication rates. However, using tests of susceptibility to antibiotics, further studies with larger sample sizes are needed to judge these eradication rates of moxifloxacin containing eradication treatment.     

Comparative Treatment of Helicobacter pylori–Positive Duodenal Ulcer Using Pantoprazole at Low and High Doses Versus Omeprazole in Triple Therapy

Background. Helicobacter pylori eradication has become the standard treatment for peptic ulcer disease. H. pylori –eradicating triple therapy with omeprazole plus two antibiotics has been used until recently; however, the efficacy of pantoprazole and antibiotics for H. pylori eradication has not been researched thoroughly until now. The aim of this randomized clinical trial was to verify the efficacy of triple oral therapy comparing the effects of pantoprazole using two different doses versus omeprazole twice daily in H. pylori eradication, in ulcer healing and relapses, and in gastritis improvement.
Materials and Methods. We enrolled 243 patients with H. pylori– positive duodenal ulcer and randomized them into three treatment groups: 84 patients (group Ome40) were assigned to receive omeprazole, 20 mg twice daily, plus amoxicillin, 1 gm twice daily, and clarithromycin, 500 mg twice daily for 10 days; 79 patients (group Pan40) were treated with pantoprazole, 40 mg daily, plus amoxicillin and clarithromycin at the same doses as those of group Ome40; and 80 patients (group Pan80) were treated with pantoprazole, 40 mg twice daily, plus amoxicillin and clarithromycin at the same doses as those of group Ome40.
Results. Ulcer healing was observed in 81 of 84 patients (96.4%) in group Ome40; in 66 of 79 patients (83.5%) in group Pan40; and in 77 of 80 patients (96.2%) in group Pan80. H. pylori was eradicated in 79 of 84 patients (94%) in group Ome40; in 63 of 79 patients (79.7%) in group Pan40; and in 75 of 80 patients (93.7%) in group Pan80.
Conclusions. We found that 10-day triple therapy with amoxicillin, clarithromycin, and either pantoprazole, 80 mg daily, or omeprazole, 40 mg daily, is highly effective in ulcer healing and is very well tolerated, achieving the 90% cure recommended for an ideal first-line anti– H. pylori positive duodenal ulcer treatment regimen.     

Open, randomized multicenter comparative trial of rabeprazole, ofloxacin and amoxicillin therapy for Helicobacter pylori eradication: 7 vs. 14 day treatment

BACKGROUND: Because of the increasing resistance to clarithromycin and metronidazole, two of the antibiotics used for the eradication of Helicobacter pylori, new therapeutic alternatives are needed. The aim of this study was to determine the efficacy of a randomized, comparative trial of 7 vs. 14-day triple treatment with rabeprazole, ofloxacin and amoxicillin for H. pylori eradication. MATERIAL AND METHODS: The present authors studied 76 dyspeptic patients infected with H. pylori diagnosed by both histology and a rapid urease test. Patients were randomized to receive rabeprazole (20 mg b.i.d.), plus ofloxacin (400 mg b.i.d.) and amoxicillin (1000 mg b.i.d.) for 7 days (group 1) vs. 14 days (group 2) and were followed by 6 weeks. Eradication was assessed 4 weeks after completing the course of study treatment by the (14)C-urea breath test. Per protocol and intention-to-treat eradication rates were determined. RESULTS: For the intention to treat analysis, the eradication rate was 62.2% for group 1 and 92.3% for group 2 (p =.004). For the per protocol analysis, eradication rate for group 1 was 63.9% and for group 2 was 97.3% (p =.001). CONCLUSIONS: Triple therapy with rabeprazole, amoxicillin and ofloxacin by 14 days was efficient for H. pylori eradication and therefore deserves further study. The same regimen prescribed for 7 days had a significantly lower and unacceptable cure rate and should not be used.     

Impact of Quadruple Regimen of Clarithromycin Added to Metronidazole-Containing Triple Therapy Against Helicobacter pylori Infection Following Clarithromycin-Containing Triple-Therapy Failure

Background: The establishment of an optimal second-line regimen for Helicobacter pylori infection is required. Although quadruple therapy should overcome resistance to either clarithromycin or metronidazole, the effects of a quadruple regimen in second-line therapy are unknown. This study aims to evaluate the efficacy of triple therapy composed of proton pump inhibitor/amoxicillin plus metronidazole with the combined additive effects of clarithromycin as a second-line quadruple therapy against H. pylori infection.
Materials and Methods: Participants were 104 patients in whom first-line therapy containing proton pump inhibitor-amoxicillin-clarithromycin failed. Before starting second-line therapy, patients underwent endoscopy to obtain H. pylori strain for antibiotic susceptibility tests. Patients were randomized to receive rabeprazole (10 mg), amoxicillin (750 mg), and metronidazole (250 mg), either with clarithromycin (200 mg; RAMC group) or without (RAM group); all treatments were administered twice daily for 7 days. H. pylori eradication was confirmed by ¹³C-urea breath tests performed 2 to 3 months post-therapy.
Results: As shown by intention-to-treat/per-protocol analyses, the cure rates for H. pylori infection were 88.5%/93.9% and 82.7%/84.3% for the RAMC and RAM groups. Although the study probably had an insufficient power to show a significant difference between the cure rates of the two regimens, the eradication rates showed a clear trend in favor of the RAMC group. There were no severe side-effects in any group.
Conclusions: In Japan, the RAMC regimen is thought to be a promising alternative strategy for second-line eradication of H. pylori infection.     

Efficacy of two rabeprazole/gatifloxacin-based triple therapies for Helicobacter pylori infection

OBJECTIVES: To evaluate the efficacy of two novel treatment regimens consisting of gatifloxacin (400 mg daily), amoxicillin (1 g twice daily), and rabeprazole 20 mg once (RAG20) or twice daily (RAG40) given for 7 days in the eradication of Helicobacter pylori. METHODS: Eligible patients undergoing endoscopy and having a positive rapid urease assay for H. pylori were enrolled in this open-label trial. Gastric biopsies from a random cohort of patients were cultured for H. pylori and in vitro susceptibility to gatifloxacin and amoxicillin was performed using the E-test. Compliance and side-effects were evaluated by phone calls. (14)C-urea breath tests were performed a minimum of 4 weeks after therapy and 3 weeks after any acid suppressive therapy. RESULTS: A total of 104 patients, 52 in each group (40 females and 64 males; mean age 45.7 years) were enrolled sequentially. Eradication occurred in 43 out of 52 patients in RAG20 group (both per-protocol and intention-to-treat analysis: 83%; 95% CI: 72-93%) and in 48 of 52 patients in the RAG40 group (both per-protocol and intention-to-treat analysis: 92%; 95% CI: 85-99%). Seven patients in the RAG40 group who had previously failed one or more treatment regimens for H. pylori were cured. No significant adverse effects were reported. All 50 recovered H. pylori strains were susceptible to amoxicillin and gatifloxacin in vitro. CONCLUSIONS: A 7-day regimen of gatifloxacin-rabeprazole-amoxicillin is effective eradication therapy for H. pylori. The use of rabeprazole twice daily results in superior eradication rates including cases of failed primary therapy. This new regimen is simple, well-tolerated, and may lead to higher compliance and lower costs.     

Long-term follow-up after eradication of Helicobacter pylori with omeprazole, clarithromycin, and tinidazole (OCT regimen) in a Japanese population

BACKGROUND: The long-term benefit of Helicobacter pylori eradication treatment that includes metronidazole on peptic ulcer disease in Japan is unclear. We investigated the rate of H. pylori re-infection and ulcer relapse after H. pylori eradication. MATERIALS AND METHODS: A total of 266 patients with endoscopically confirmed peptic ulcer disease and H. pylori infection were treated with triple therapy of omeprazole 40 mg (20 mg b.i.d.), clarithromycin 800 mg (400 mg b.i.d.), and tinidazole 1000 mg (500 mg b.i.d.) for 7 days. Endoscopy with gastric biopsy was performed before and 1 month, 6 months, 1.5 years, and 3.5 years after therapy. H. pylori status was determined by H. pylori culture, rapid urease test, and histopathology. 13C-urea breath test was done at 6 months after eradication therapy. Treatment was deemed successful when all tests were negative at 6 months after therapy by endoscopic biopsy. RESULTS: Successful H. pylori eradication was achieved in 262/266 (98.5%) patients with peptic ulcer. Total relapse of peptic ulcer occurred in 8/262 (3%) patients after eradication, with 3/262 (1.1%) occurring within 1.5 years after treatment and 5/262 (1.9%) within 3.5 years. All relapsed patients were found to be H. pylori-positive at the time of relapse. Of the 262 patients who experienced eradication, 20 (7.6%) were subsequently re-infected, six (2.3%) within 1.5 years and 14 (5.3%) within 3.5 years. CONCLUSION: Triple therapy with omeprazole, clarithromycin, and tinidazole (OCT) is useful for H. pylori eradication in Japan, but there is an appreciable re-infection rate in this population.     

Eradication of H. pylori with pantoprazole, clarithromycin, and metronidazole in duodenal ulcer patients: a head-to-head comparison between two regimens of different duration

Background. The study was conducted to compare the efficacy and tolerability of two pantoprazole-based triple therapies of different length in the eradication of H. pylori.
Methods. In this double-blind, multicenter parallel group comparison, H. pylori -positive patients were randomly assigned to either the PCM-7 group (7 days of pantoprazole 40 mg bid, clarithromycin 500 mg bid, metronidazole 500 mg bid) or the PCM-14 m group (modified 14 day therapy of the same regimen with metronidazole only given for 10 days due to labeling reasons). H. pylori status was determined by urease test, histology, culture, and ¹³C-urea breath test. Treatment outcome was assessed 6 weeks after intake of the last study medication.
Results. The following eradication rates were achieved: for PCM-7 in the MITT population 83% (89/107), in the PP population 84% (81/97); for PCM-14 m in MITT 87% (92/106), in PP 88% (91/104). Ulcer healing rates were: for PCM-7 in MITT population 99% (106/107), in the PP population 99% (96/97); for PCM-14 m in MITT 99% (105/106), in PP 99% (103/104). Gastrointestinal symptoms and gastritis scores decreased in both treatment groups. Equivalence of treatment regimens could be proven for all populations. In total, 64 patients reported adverse events. Five serious adverse events occurred, all unrelated to the study medication.
Conclusion. The two pantoprazole-based triple therapies tested in this study are equally effective in H. pylori eradication, ulcer healing and relief from ulcer pain. It is concluded that 7 days of triple therapy are generally sufficient.     

Efficacy of moxifloxacin-based triple therapy as second-line treatment for Helicobacter pylori infection

BACKGROUND AND AIM: Metronidazole and tetracycline-based second-line quadruple therapy, widely used for Helicobacter pylori infection, often ends up in failure due to antibiotic resistance and poor compliance in Korea. Our aim is to evaluate the efficacy and tolerability of moxifloxacin-based triple therapy as an alternative second-line treatment for H. pylori infection. METHODS: The subjects consisted of 85 patients infected with H. pylori, in whom initial proton pump inhibitor triple therapy had failed. They were randomized to receive the following 7-day therapy: 1, moxifloxacin 400 mg q.d., esomeprazole 20 mg b.i.d., and amoxicillin 1 g b.i.d.; and 2, esomeprazole 40 mg b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d., metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d. Eradication rates, drug compliance, and side-effect rates of each group were evaluated. RESULTS: The eradication rates were 75.6 and 83.8% with moxifloxacin triple therapy, and 54.5 and 72.7% with quadruple therapy by intention-to-treat (p = .042) and per-protocol analyses (p = .260), respectively. Moxifloxacin triple therapy was significantly superior to quadruple therapy in terms of side-effect rates (p = .039). Compliance for therapy, i.e., the percentage of tablets taken (> 85%), was 90.2 and 75.0%, numerically higher in moxifloxacin triple therapy group than in quadruple therapy group, but without statistical difference (p = .065). CONCLUSIONS: Moxifloxacin-based triple therapy showed high eradication rates with few side effects and good drug compliance, suggesting this regimen could be a safe and effective option as second-line therapy for H. pylori infection in Korea.     

The results of Helicobacter pylori eradication on repeated bleeding in patients with stomach ulcer

The triple therapy of Helicobacter pylori eradication prevents repeated bleeding from stomach ulcer. The aim of this one-way blind prospective study was to evaluate the efficiency of the two-week triple therapy for Helicobacter pylori eradication in preventing renewed bleeding in patients with stomach ulcer within one year. This research included 60 hospitalized patients with bleeding stomach ulcer and positive Helicobacter pylori infection, 34 men and 26 women (average age 59.7 years). The patients were given therapeutic scheme of omeprazol--amoxicilin--metrodinazol (OAM) eradication for 14 days. Eradication of H. pylori infection was defined as lack of proof of the infection one month or several months after therapy suspension. By applying triple OAM therapy within two weeks the eradication was successful in 72%. In the group of 17 H. pylori positive patients there were 8 patients (47.6%) with repeated stomach ulcer and 3 patients (18%) with bleeding. Within the group of 43 H. pylori negative patients there were only 2 patients (4.65%) with repeated stomach ulcer and 1 patient (2%) with bleeding, during the observed period of 12 months. This research confirms the hypothesis about the necessity of eradication of Helicobacter pylori infection in patients with bleeding stomach ulcer as prevention of repeated bleeding.     

Rabeprazole- versus esomeprazole-based eradication regimens for H. pylori infection

BACKGROUND: Different kinds of proton pump inhibitor-based triple therapies could result in different Helicobacter pylori eradication rates. AIM: The aims of this study were to compare the efficacy and safety of rabeprazole- and esomeprazole-based triple therapy in primary treatment of H. pylori infection in Taiwan. PATIENTS AND METHODS: From June 2005 to March 2007, 420 H. pylori-infected patients were randomly assigned to receive a 7-day eradication therapy with either esomeprazole 40 mg daily (EAC group, n = 209) or rabeprazole 20 mg b.i.d. (RAC group, n = 211) in combination with amoxicillin 1 g b.i.d. and clarithromycin 500 mg b.i.d.. Follow-up endoscopy with biopsy was done 12-16 weeks after completion of eradication therapy. Those who refused endoscopic exams underwent (13)C-urea breath test to assess the treatment response. RESULTS: Intention-to-treat analysis revealed that the eradication rate was 89.4% in the EAC group and 90.5% in RAC groups (p-value = .72). All of the subjects returned for assessment of compliance (100% in EAC group vs. 99.5% in RAC group, p-value = .32) and adverse events (3.83% in EAC group vs. 6.16% in RAC group, p-value = .27). Sixty (28.7%) and 37 (17.6%) patients in EAC and RAC group, respectively, refused endoscopy and underwent a (13)C-urea breath test to determine the treatment effect. CONCLUSION: In conclusion, rabeprazole- and esomeprazole-based primary therapies for H. pylori infection are comparable in efficacy and safety.     

Comparison of amoxicillin-metronidazole plus famotidine or lansoprazole for amoxicillin-clarithromycin-proton pump inhibitor treatment failures for Helicobacter pylori infection

BACKGROUND: Proton pump inhibitor-amoxicillin-metronidazole is recommended as second-line Helicobacter pylori therapy in Japan. The authors assessed the efficacy and safety of second-line eradication using the H2-receptor antagonist famotidine as a substitute for proton pump inhibitor. MATERIALS AND METHODS: Sixty-one patients who failed in first-line H. pylori eradication using proton pump inhibitor-clarithromycin-amoxicillin were randomly assigned to either second-line therapy including metronidazole: a 7-day course of lansoprazole 30 mg, amoxicillin 750 mg, and metronidazole 250 mg, b.i.d. (lansoprazole group); or a 7-day course of famotidine 40 mg, amoxicillin 750 mg, and metronidazole 250 mg, b.i.d. (famotidine group). Eradication was assessed for each group at least 4 weeks after completing eradication therapy. Drug susceptibility test was performed using 57 strains in pretreatment to clarithromycin, metronidazole, and amoxicillin. RESULTS: Prior to second-line H. pylori eradication, the rate of resistance to clarithromycin was high at 84% (48/57). Similarly, resistance to metronidazole was low at 5.3% (3/57); however, no amoxicillin-resistant strains were found. The eradication rates for both lansoprazole and famotidine treatment groups were high at 97% (29/30) and 94% (29/31), respectively. CONCLUSIONS: Famotidine treatment including metronidazole-amoxicillin as second-line therapy provided a high eradication rate similar to lansoprazole therapy. Famotidine is therefore expected to serve as a useful H. pylori eradication regimen in patients with proton pump inhibitor allergy, an economic benefit in terms of reduced health-care costs is also anticipated.     

Double-dose, new-generation proton pump inhibitors do not improve Helicobacter pylori eradication rate

BACKGROUND: Up to present, omeprazole plus two antibiotics are used for Helicobacter pylori eradication therapy . Few studies have compared double-dose new-generation, proton pump inhibitors (PPI) with omeprazole. Therefore, we conducted a randomized, prospective study to evaluate differences in H. pylori eradication rates by PPI type. MATERIAL AND METHODS: Between January 2006 and December 2006, 576 consecutive patients with proven H. pylori infection were enrolled prospectively. Four different PPIs [omeprazole 20 mg b.i.d. (old generation), or pantoprazole 40 mg b.i.d., rabeprazole 20 mg b.i.d., or esomeprazole 40 mg b.i.d. (new generation)] were added to clarithromycin (500 mg b.i.d.) and amoxicillin (1 g b.i.d.) for 1 week. RESULTS: By intention-to-treat analysis, no difference was found between the eradication rates of these four PPIs: 64.9% (omeprazole, n = 148), 69.3% (pantoprazole, n = 140), 69.3% (rabeprazole, n = 140), and 72.9% (esomoprazole, n = 148). When eradication rates were analyzed according to whether patients had an ulcer or not on a per-protocol basis, no difference was found between the eradication rates of the four PPIs. However, side-effects were more common in the esomeprazole-based triple therapy group than in the other groups (p < .05). CONCLUSIONS: No convincing evidence was obtained that double-dose new-generation PPIs have better H. pylori eradication rates and tolerability than omeprazole.     

7-day triple therapy of Helicobacter pylori infection with levofloxacin, amoxicillin, and high-dose esomeprazole in patients with known antimicrobial sensitivity

BACKGROUND AND AIMS: Failed primary anti-Helicobacter pylori therapy results in a high rate of antimicrobial resistance. This necessitates a search for new regimens to cure H. pylori infection. The aim of this study was to evaluate the efficacy and tolerability of a new levofloxacin-containing 7-day triple therapy and to compare it with that of standard French triple therapy in patients with known H. pylori susceptibility to MET (metronidazole) and CLA (clarithromycin). PATIENTS AND METHODS: Sixty-one patients with documented antibiotic sensitivity (E-test) and an indication for anti-H. pylori treatment based on the Maastricht Consensus 2/2000 guidelines were randomized to receive either esomeprazole 2 x 40 mg, levofloxacin 2 x 500 mg, and amoxicillin 2 x 1 g for 7 days (ELA, n = 30), or esomeprazole 2 x 20 mg, clarithromycin 2 x 500 mg, and amoxicillin 2 x 1 g for 7 days (ECA, n = 31). A cure check was performed 4-6 weeks after conclusion of therapy. RESULTS: Sixty-one patients were randomized to the two treatment groups. Twenty-eight of 30 patients of the ELA group were available for per-protocol (PP) analysis, of whom 26 (92.9% CI: 76-99%; intention-to-treat [ITT] analysis 86.7% CI: 68-96%) became H. pylori negative compared with 26 of the 31 patients of the ECA group (83.9%, CI: 66-93% both PP and ITT analyses). Five patients of the ELA group showed CLA resistance, three of whom also showed MET resistance, and all five were treated successfully. Two patients with levofloxacin-resistant strains, one in each group, were cured. Both regimens were generally well tolerated with minor adverse events being seen in 15 patients (51.7%) of the ELA group and in 13 (40.6%) of the ECA group. None of the patients discontinued treatment prematurely due to adverse events. CONCLUSION: The data of this pilot study suggest a better than 80% efficacy of the new 7-day levofloxacin triple therapy, which is within the range of the French triple therapy in patients with MET- and CLA-susceptible strains. The data suggest that the new levofloxacin triple therapy may also be an option in patients with MET- and CLA-resistant H. pylori strains.     

黄连素四联方案补救治疗幽门螺杆菌感染的有效性和安全性

目的:探索黄连素四联方案用于幽门螺杆菌感染根除失败患者补救治疗的有效性及安全性。方法:将经四联方案初次根除治疗失败并自愿接受补救治疗的130例患者按纳入顺序,以1:1的比例分配治疗,随机接受14天黄连素四联(埃索美拉唑20mg+胶体果胶铋200 mg+阿莫西林1000 mg,2/d+黄连素300 mg 3/d)或四环素四联(埃索美拉唑20 mg+胶体果胶铋200 mg+四环素750 mg+呋喃唑酮100 mg,2/d)方案的治疗。所有患者均于治疗14天及治疗结束至少28天后随诊,详细记录患者症状及不良反应情况。治疗结束至少28天后进行13C尿素呼气试验来判断幽门螺杆菌根除情况。结果:65例接受黄连素四联根除治疗,65例接受四环素四联方案治疗。两组分别有6例和4例患者因不良反应服药依从性小于80%,其余患者均完成了14天的治疗。黄连素组和四环素组的幽门螺杆菌根除率ITT分析分别为76.9%(50/65)和81.5%(53/65),P=0.520;PP分析分别为84.7%(50/59)和86.9%(53/61),P=0.739。黄连素组和四环素组不良事件总体发生率分别为49.2%和41.5%,P=0.370。结论:黄连素四联疗法用于幽门螺杆菌感染的二次根除治疗,根除率较高,未明显增加不良事件发生率,是有效及安全的补救治疗方案。     

复方嗜酸乳杆菌片联合三联方案根除幽门螺杆菌的临床研究

目的探讨复方嗜酸乳杆菌片联合三联方案根除幽门螺杆菌(Helicobacter pylori,H.pylori)的疗效及不良反应。方法将143例H.pylori检测阳性的患者随机分为A1组(48例)、A2组(46例)和B组(49例)。B组给予三联方案(埃索美拉唑、阿莫西林、克拉霉素)根除H.pylori治疗,疗程10d。A1组、A2组分别在上述三联方案的基础上同时加用10d、20d的复方嗜酸乳杆菌片。治疗过程中观察并记录上述三组的不良反应发生情况,停药4周后查13 C呼气试验判别H.pylori根除是否成功。结果共133例患者完成治疗和随访,A1组、A2组、B组根除率按方案(PP)分析分别为65.9%、69.8%、63.0%,按意向性(ITT)分析分别为60.4%、65.2%、59.2%,无论按方案分析还是意向性分析三组根除率差异均无统计学意义(P0.05)。纳入三组的共143例患者均完成不良反应的随访,A1组、A2组、B组不良反应发生率分别为10.4%、8.7%、30.6%,三组相比差异有统计学意义(P0.05),其中A1组、A2组分别与B组相比差异有统计学意义(P0.05),A1组与A2组相比差异无统计学意义(P0.05)。结论三联方案加用10d、20d的复方嗜酸乳杆菌片未能提高H.pylori根除率,但可降低不良反应发生率。     

Pantoprazole suppresses Helicobacter pylori without affecting cure

Background. Short-term, low-dose triple regimens composed of proton-pump inhibitors (PPI) and two antibiotics are the current gold standard therapy for cure of Helicobacter pylori infection. To date, the effect of PPI pretreatment on eradication outcome is not known. The aim of this study was to evaluate the influence of pretreatment with pantoprazole on the efficacy of an ensuing triple therapy.
Methods. In this open, randomized, monocenter, parallel group comparison, 107 patients with duodenal ulcer or functional dyspepsia were assigned to receive one of the following treatment regimens: a 7-day triple therapy with pantoprazole, 40 mg bid; clarithromycin, 250 mg bid; and metronidazole, 400 mg bid, which was either preceded or followed by a 7-day therapy with pantoprazole, 40 mg (P-PCM or PCM-P). Assessment of H. pylori status was performed by a biopsy urease test and ¹³C urea breath test at the initial visit and ¹³C urea breath test at all follow-up visits.
Results. The 7-day pantoprazole pretreatment resulted in a significant decline of the δ values of the ¹³C urea breath test. H. pylori infection was cured in 47 of 52 intention-to-treat patients of the P-PCM group (90%; 95% confidence interval, 79–97%) and in 46 of 53 of the PCM-P group (87%; 95% confidence interval, 75–95%).
Conclusions. Pretreatment with pantoprazole suppresses H. pylori but does not impair the efficacy of a consecutive short-term, low-dose triple therapy.     

Evidence that the degree and duration of acid suppression are related to Helicobacter pylori eradication by triple therapy

BACKGROUNDS AND AIMS: Eradication rates of Helicobacter pylori by a proton pump inhibitor-based triple therapy depend on CYP2C19 genotype status. We investigated whether gastric acid inhibition during an eradication therapy would influence the eradication rates attained by the triple therapy. METHODS: Thirty-two patients with H. pylori infection underwent the first-line triple therapy with lansoprazole 30 mg, amoxicillin 750 mg, and clarithromycin 400 mg b.i.d. for 1 week. In all 32 patients, the 24-hour intragastric pH monitoring was performed on day 6 during the treatment period. RESULTS: The intention-to-treat-based eradication rate by the first-line therapy was 75.0% (24/32, 95%CI: 56.60-88.54%). In patients with successful eradication, the median 24-hour pH was 6.4 (range; 5.0-7.6), which was significantly higher than that in patients without eradication [5.2 (2.2-6.2), p = .0131]. The median percentage time of pH < 4.0 during 24-hour postdose in patients with eradication [0.5% (0.0-31.6%)] was significantly shorter than that in patients without eradication [26.7% (6.0-72.2%), p = .0017]. These parameters for acid inhibition significantly differed among the different CYP2C19 genotype groups. When the percentage time of pH < 4.0 and 24-hour pH were attained < 10% and > 6.0, respectively, during the eradication treatment, the majority of patients could eradicate H. pylori infection, irrespective of the bacterial susceptibility to clarithromycin. CONCLUSIONS: The sustained intragastric pH > 4.0 for a longer postdose time appears to be required for a successful eradication of H. pylori with lansoprazole and acid-labile antibiotics.