The effect of Helicobacter pylori retreatment with ranitidine bismuth citrate,clarithromycin, and metronidazole depends on the first-line therapy

BACKGROUND: Helicobacter pylori eradication rates seem to decrease. This study evaluates the effect of retreatment with ranitidine bismuth citrate (RBC) 400 mg B.I.D., clarithromycin (C) 500 mg B.I.D., and metronidazole (M) 500 mg every morning and 1,000 mg every evening for 14 days [RBC.C.M]. STUDY: Nine gastroenterologic units included patients with unsuccessful eradication of H. pylori in a preceding randomized trial. Previous treatment was either omeprazole (O) 20 mg, C 250 mg, and M 500 mg [O.C.M] or RBC 400 mg, tetracycline (T) 1,000 mg, and M 500 mg [RBC x T x M]; all drugs were given twice daily for 7 days. RESULTS: Twenty-six H. pylori-positive patients were included (nine males, 17 females; mean age, 54 years; range, 39-74 years). The eradication rates in the groups previously treated with O.C.M and RBC.T.M were three of nine (33%) (95% CI = 12-65) and 15 of 17 (88%) (95% CI = 66-97) respectively (p = 0.008). The corresponding results in a "per-protocol" analysis were three of eight (38%) (95% CI = 13-69) and 10 of 10 (100%) (95% CI = 72-100), respectively (p = 0.007). A side effect score was 21.8 compared with 8.3 in the previous study (p < 0.001). CONCLUSIONS: The effect of a retreatment regimen depends on the preceding treatment. The RBC x C x M regimen is effective in nonresponders to RBC x T x M, but it seems unsuitable after failure of the O x C x M regimen.     

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.     

Six-day therapy with ranitidine bismuth citrate plus low-dose clarithromycin and tinidazole to cure Helicobacter pylori infection

BACKGROUND/AIMS: Short-term ranitidine bismuth citrate-based triple regimens have been shown to be effective for the eradication of H. pylori. We investigated the efficacy of an eradicating therapy including ranitidine bismuth citrate, low-dose clarithromycin and tinidazole, administered for only 6 days. METHODOLOGY: Forty-five consecutive patients, who underwent gastroscopy for symptoms and were found to be H. pylori-positive, were recruited. They received ranitidine bismuth citrate 400 mg b.i.d. plus clarithromycin 250 mg b.i.d. plus tinidazole 500 mg b.i.d., given for 6 days. The medications given in twice daily doses were taken after meals with an interval of 12 h. The H. pylori status was evaluated by means of histology and rapid urease test on admission, and by 13C-urea breath test alone 8 weeks after treatment. RESULTS: All 45 enrolled patients completed the study. Thirty-nine of 45 patients returned H. pylori-negative (both per protocol and intention-to-treat analysis = 87%; 95% confidence interval = from 73-95%), while 6 of 45 were still H. pylori-positive (13%). Slight or mild side effects occurred in 5/45 patients (11%). CONCLUSIONS: Ranitidine bismuth citrate-based triple therapy, containing low-dose clarithromycin and tinidazole, given for only 6 days, yielded high eradication rates with modest side effects. Regimens based on ranitidine bismuth citrate plus two antibiotics at low dosages, administered for less than 7 days, constitute highly promising strategies for eradication of H. pylori.     

Comparison of ranitidine bismuth citrate, tetracycline and metronidazole with ranitidine bismuth citrate and azithromycin for the eradication of Helicobacter pylori in patients resistant to PPI based triple therapy.

BACKGROUND/AIMS: Helicobacter pylori is the most common infectious disease all over the world. Ten to twenty percent of the patients remain infected despite treatment with proton pump inhibitors (PPIs), amoxicillin and clarithromycin. We compared PPI, bismuth, tetracycline and metronidazole with ranitidine bismuth citrate, tetracycline and metronidazole in cases resistant to PPIs-based triple therapies. METHODS: The study included 52 patients who underwent a triple therapy with PPI, clarithromycin and amoxicillin for 14 days between September 2001 and December 2002, and were found to be resistant to the therapy. They were randomized to take ranitidine bismuth citrate (Rb) 400 mg twice a day, tetracycline (T) 1 g twice a day and metronidazole (M) 500 mg three times a day for 14 days (RbTM), or ranitidine bismuth citrate (Rb) 400 mg twice a day for 14 days and azithromycin (A) 500 mg once a day for 7 days (RbA). Four weeks after the treatment, endoscopies were repeated, and patients were assessed with respect to changes in symptoms. When H. pylori was negative on histological analysis and urease test, eradication was achieved. RESULTS: A total of 52 patients, 32 females and 20 males with a mean age of 49+/-12 years, were included in the study. Eradication was achieved in 15 (28%) out of 52 patients in total. There was a significant difference between RbA and RbTM groups (p=0.01). In fact, H. pylori was eradicated in 3 (12%) out of 25 patients in the RbA group, whereas it was eradicated in 12 (44.4%) out of 27 patients in the RbTM group. Symptom scores significantly improved in both groups after the treatment, though there was not a significant difference between the groups (p=0.705). CONCLUSIONS: Triple therapy including azithromycin does not seem to be a good choice in cases resistant to the first line therapies; however, a similarly lower rate of eradication was achieved with the quadruple therapy proposed. Therefore, different treatment schemes should be applied in resistant patients, and further studies are needed as well.     

A randomized trial comparing seven-day ranitidine bismuth citrate and clarithromycin dual therapy to seven-day omeprazole, clarithromycin and amoxicillin triple therapy for the eradication of Helicobacter pylori.

OBJECTIVE: To assess Helicobacter pylori eradication after one week dual ranitidine bismuth citrate-clarithromycin (RBC-C) or triple omeprazole, clarithromycin and amoxicillin (OCA) therapy. METHODS: In this multicentre Canadian trial, H pylori-positive patients with functional dyspepsia or inactive peptic ulcer disease were randomized to open-label treatment with RBC-C (ranitidine bismuth citrate 400 mg plus clarithromycin 500 mg) or OCA (omezaprole 20 mg, clarithromycin 500 mg and amoxicillin 1000 mg), given twice a day for seven days. Treatment allocation was randomly assigned. H pylori infection was confirmed by positive 13C-urea breath test (13C-UBT). H pylori status was reassessed by UBT at least four and 12 weeks after treatment (negative: d13CO2 below 3.5 per mil). Intention-to-treat (ITT) eradication rates were determined for all patients with confirmed H pylori infection. Per protocol (PP) rate was determined for all patients treated with at least two evaluable follow-up visits. RESULTS: Three hundred five patients were included in the ITT and 222 in the PP analysis. The ITT eradication rates were 66% for RBC-C and 78% for OCA. The PP success rates were 84% for RBC-C and 96% for OCA. The difference for both ITT 12% (95% CI 2 to 22) and PP 12% (95% CI 4 to 19) were statistically significant, P=0.030 and P=0.007, respectively. Treatment was generally well tolerated. CONCLUSION: The eradication rate for the seven-day dual RBC-C regimen was lower than that for OCA.     

Efficacy and tolerability of ranitidine bismuth citrate plus amoxycillin and clarithromycin as first- or second-line therapy to cure Helicobacter pylori infection

BACKGROUND/AIMS: Ranitidine bismuth citrate has recently been introduced for the treatment of H. pylori infection and obtains good eradication rates; however, eradication failures still appear in a considerable proportion of cases. The aim of this study was to compare the efficacy and tolerability of ranitidine bismuth citrate plus amoxycillin and clarithromycin as first- or second-line therapy to cure H. pylori infection. METHODOLOGY: We studied 423 consecutive H. pylori-positive patients. In 210 consecutive patients H. pylori infection was diagnosed for the first time (group A), while 213 consecutive patients were enrolled after failure of a first attempt to eradicate H. pylori (group B). All patients received ranitidine bismuth citrate 400 mg b.d. plus clarithromycin 500 mg b.d. and amoxycillin 1 g b.d. for seven days. H. pylori-status was evaluated by means of histology and rapid urease test at entry and by 13C-urea breath test in all patients one month after treatment. RESULTS: 410/423 patients completed the study (202/210 in group A and 208/213 in group B). Two patients of group A and 1 patient of group B were withdrawn from the study due to poor compliance, 6 group A patients and 4 group B patients were lost to follow-up. In group A, after the end of treatment, 181/202 patients were H. pylori-negative (per-protocol analysis: 89.60% [C.I. 95%: 82-95%]; on intention-to-treat analysis: 86.19% [C.I. 95%; 76-92%]), side-effects occurred in 29 patients (13.80%); they were severe in 2 patients and the patients were withdrawn from the study. In group B, after the end of treatment, 200/208 patients were H. pylori-negative (per-protocol analysis: 95.15% [C.I. 95%; 92-100%], on intention-to-treat analysis: 93.89% [C.I. 95%; 89-98%), side-effects occurred in 11 patients (5.13%); they were slight or mild and did not require discontinuation of the treatment. The results of group B were statistically better than group A, both in eradication rate (P < 0.01) as well as both side-effects provoked (P < 0.01). CONCLUSIONS: Ranitidine bismuth citrate-clarithromycin-amoxycillin is more effective when used as second-line therapy rather than when used as first-line therapy; second, ranitidine bismuth citrate-clarithromycin-amoxycillin shows lower and slighter side-effects when used as second-line therapy rather than when used as first-line therapy; finally, the excellent tolerability of ranitidine bismuth citrate + clarithromycin + amoxycillin influences positively the patients' compliance, both as first- and second-line therapy.     

One-week dual therapy with ranitidine bismuth citrate and clarithromycin for the treatment of Helicobacter pylori infection in Brazilian patients with peptic ulcer

AIM: To assess the efficacy and safety of ranitidine bismuth citrate plus clarithromycin given for 1 wk in Brazilian patients with peptic ulcer. METHODS: One hundred and twenty patients with peptic ulcer were randomized in two treatment groups: (1)1-wk regimen consisting of ranitidine bismuth citrate 400 mg b.i.d. with clarithromycin 500 mg b.i.d. or (2) 2-wk regimen of the same treatment. Eradication of the infection was considered when both the histologic examination and the urease test were negative for the infection 3 mo after treatment. RESULTS: By intention to treat analysis, Helicobacter pylori (H pylori) was eradicated in 73% and 76% of patients, respectively treated for 1 or 2 wk (P>0.05). By per protocol analysis, the eradication rates were 80% and 83%, respectively, in patients treated for 1 or 2 wk (P>0.05). Nine patients (8.2%) reported minor side effects. CONCLUSION: One-week therapy with ranitidine bismuth citrate and clarithromycin is safe, well tolerated and effective for treatment of H pylori infection, and appears to be comparable to the 2-wk regimen in terms of efficacy.x     

One-week therapy with pantoprazole versus ranitidine bismuth citrate plus two antibiotics for Helicobacter pylori eradication

AIM: A combination of omeprazole plus amoxycillin (Amo) and clarithromycin (CIa) for 7 days has been studied extensively. However, the role of other proton pump inhibitors, such as pantoprazole (Pan), in this therapy is not well known. On the other hand, ranitidine bismuth citrate (RBC) also seems to be effective when combined with Amo and CIa. Our aim was to evaluate and to compare these two novel short-term triple therapies (Pan+Amo+Cla and RBC+Amo+Cla) for treatment of Helicobacter pylori. METHODS: In a randomized clinical trial 150 consecutive patients (38 with duodenal ulcer, 112 with non-ulcer dyspepsia) infected by H. pylori were studied prospectively. Exclusion criteria were: previous H. pylori eradication therapy, gastroerosive drug use, gastric surgery, and associated diseases. One of two regimens was given for 7 days: Pan (40 mg b.i.d.), Amo (1 g b.i.d.), Cla (500 mg b.i.d.) (group Pan+Amo+Cla, n = 75); or RBC (400 mg b.i.d.), Amo (1 g b.i.d.), Cla (500 mg b.i.d.) (group RBC+Amo+Cla, n = 75). All drugs were administered together after meals. Compliance was evaluated by return tablet count. Data were analysed by univariate (chi2) and multivariate (multiple logistic regression) analysis. Eradication was defined as a negative 13C-urea breath test 1 month after completing therapy. RESULTS: The distribution of studied variables (age, gender, smoking, duodenal ulcer/non-ulcer dyspepsia) was similar in both therapy groups. Per-protocol eradication was achieved in 48/71 (68%) in group Pan+Amo+Cla, and in 61/70 (87%) in group RBC+Amo+Cla (P= 0.01). Intention-to-treat (ITT) eradication was achieved in, respectively, 48/ 75 (64%) and in 61/75 (81%) (P= 0.03). The RBC+ Amo+Cla regimen was more effective than Pan+Amo+Cla in non-ulcer dyspepsia patients (ITT, 84% vs 58%; P = 0.005), but statistically significant differences were not demonstrated in duodenal ulcer patients (72% vs 80%). In the multivariate analysis the odds ratio for the effect of the type of therapy on H. pylori eradication in patients with non-ulcer dyspepsia was 3.8 (95% Cl, 1.6-9.3; P = 0.003). No relevant adverse effects were reported with any regimen. CONCLUSION: A RBC+Amo+Cla regimen for only 1 week is a promising therapy for H. pylori infection, due to its high efficacy, simple posology, and excellent tolerability. Combination of Pan with Amo and Cla, although effective in duodenal ulcer patients, but in non-ulcer dyspepsia has not achieved the favourable results previously reported with other proton pump inhibitors.     

The efficacy of two-week therapy with ranitidine bismuth citrate, amoxicillin and clarithromycin on Helicobacter pylori eradication in clarithromycinresistant and- sensitive cases.

BACKGROUND/AIMS: Recent studies in Turkey have documented the noticeably low success rates of H. pylori eradication. It has become more important to identify the highly successful therapy regimens since clarithromycin resistance, one of the most important factors affecting the success rate of eradication therapies, continues to increase. The aim of this study was to assess the efficacy of two-week therapy with ranitidine bismuth citrate (RBC), amoxicillin (A), and clarithromycin (C) on H. pylori eradication, and the role of C resistance in eradication. METHODS: The study included 45 dyspeptic patients with H. pylori diagnosed by urease test and histopathological examination. C resistance was studied by real-time PCR method on antral biopsy specimens. All patients were treated with a two-week therapy consisting of RBC: 2x400 mg, A: 2x1000 mg, and C: 2x500 mg, daily. Endoscopy was repeated at least one month after the end of the treatment. Presence of H. pylori was investigated by urease test and histopathological examination on antrum and corpus biopsies. Eradication was considered when both tests were negative for H. pylori in all specimens. RESULTS: Two cases were lost to follow-up. The average age of the remaining 43 patients (22 males, 21 females) was 46.3+/-11.5 years. Mild side effects were encountered in 20 (46.5%) patients. Eradication was achieved in 35 (81.4%) patients. C resistance was studied in 26 patients and was detected in 10 (38.5%) of them. H. pylori eradication rate was 81.3% in C-sensitive (13/16) and 80% in C-resistant patients (8/10) (p>0.05). CONCLUSION: A two-week regimen of RBC-A-C is very effective for H. pylori eradication even in C-resistant patients. These results suggest that RBC-A-C combination should be preferred for H. pylori eradication in Turkey.     

Reduced symptoms and need for antisecretory therapy in veterans 3 years after Helicobacter pylori eradication with ranitidine bismuth citrate/amoxicillin/clarithromycin

OBJECTIVE: The most effective combination therapy to eradicate Helicobacter pylori has not yet been found. The perfect combination would be effective, relatively free of side effects, and easy to comply with. We studied a 14-day course of three medications taken twice daily by H. pylori-infected patients who were enrolled in the outpatient Veterans Affairs (VA) clinics. The two major objectives were 1) to determine the effectiveness of the combination therapy and 2) to determine the compliance of patients in a VA population. METHODS: Fifty-two male patients were identified with H. pylori infection by positive CLO (Rapid Urease Test) test, positive Giemsa stain, or positive serology. Active infection was confirmed by a positive 13C urea breath test (UBT). Patients were treated for 14 days with open-label triple-combination therapy of ranitidine bismuth citrate (RBC; 400 mg b.i.d.), amoxicillin (1000 mg b.i.d.), and clarithromycin (500 mg b.i.d.). Successful eradication of H. pylori was confirmed by repeat UBT at 6-8 wk after the final dose of therapy. RESULTS: Of the 52 enrolled patients, 49 (94.2%) met the criteria for successful completion of the study (per protocol analysis based on compliance with at least 80% of medication and performance of both UBTs). Of the three patients who did not successfully complete, one was cured (after 6 days of treatment), and two remained infected (after 3 days and 9 days of treatment). Of the 49 completed patients, 45 (91.8%) were cured, and four remained infected. Overall, regardless of compliance (intent-to-treat analysis), 46 of the 52 (88.4%) patients had documented cure of H. pylori infection as determined by the posttreatment UBT. By 3 yr after H. pylori eradication, two of 15 (13.3%) patients who were not on baseline medications had developed the need for antisecretory therapy, but 18 of 31 (58.1%) who were on baseline medications were able to stop therapy. Thus, at 3 yr, successful H. pylori eradication decreased the need for antisecretory therapy from 67.4% of the H. pylori-infected population to 43% of the H. pylori-eradicated population. The effect of H. pylori eradication in improving symptoms at 3 yr was statistically significant in both the ulcer population and the nonulcer population. Adverse events were mild, and included diarrhea (26 patients), bad taste in mouth (24 patients), nausea/upset stomach (nine patients), and headache (two patients). The diarrhea was self-limiting in 25 of the 26 patients. Only two patients discontinued medication because of adverse events. CONCLUSION: The RBC/amoxicillin/clarithromycin combination was, in our VA population, an easily complied with, highly effective, and safe triple therapy with a 90% H. pylori eradication rate. Successful eradication of H. pylori leads to a dramatic decrease in upper-gut symptoms and decreased need for antisecretory therapy.     

Comparison of three triple regimens with omeprazole or ranitidine bismuth citrate for Helicobacter pylori eradication

BACKGROUND: Regimens with ranitidine bismuth citrate (RBC) or omeprazole (O) are effective in eradicating Helicobacter pylori. This randomized, open, multicentre trial compares three different regimens with these drugs. METHODS: Consecutive H. pylori +ve outpatients were included. The alternative regimens were: 1) O 20 mg, clarithromycin (C) 250 mg and metronidazole (M) 500 mg (O.C.M), 2) RBC 400 mg, C 250 mg and M 500 mg (RBC.C.M), 3) RBC 400 mg, tetracycline (T) 1000 mg and M 500 mg [RBC.T.M]. All drugs were given twice daily for 7 days. H. pylori infection was assessed with H. pylori urea breath tests. RESULTS: 426 H. pylori +ve patients were included (mean age 58 years [range 18-88], male/female: 244/182). The eradication rates (intention to treat) in the O.C.M, RBC.C.M and RBC.T.M groups were 117/137 (85%), 141/146 (97%) and 117/143 (82%), respectively (P < 0.001, overall assessment). There were no significant differences in side effects between the alternatives. CONCLUSION: In this trial, RBC.C.M was the most effective one, it was well tolerated and compliance was satisfactory. RBC.T.M is an alternative to regimens with clarithromycin.     

Helicobacter pylori infection in childhood: results of management with ranitidine bismuth citrate plus amoxicillin and tinidazole

BACKGROUND AND AIMS: To verify whether a triple therapy bismuth citrate plus amoxicillin and tinidazole eradicates H. pylori infection in pediatric patients. METHODS: Fifty children (30 females; mean age 12.4 +/- 1.1 years, range 10-15 years) suffering from upper abdominal complaints and Helicobacter pylori (H. pylori)-associated gastroduodenal disease were treated with a 4 week course of ranitidine bismuth citrate (400 mg, twice daily) plus oral tinidazole (20 mg/kg) and amoxicillin (50 mg/kg) for the first 2 weeks. RESULTS: The endoscopic diagnoses were: esophagitis (seven cases), gastritis (six cases), gastroduodenitis (43 cases), duodenitis (one case), gastric ulcer (two cases) and duodenal ulcer (13 cases). Helicobacter pylori was eradicated in 40 (80%) patients and clinical improvement was noticed in 39 (78%) of symptomatic subjects. Duodenal ulcers were healed in all the children, but lymphoid nodular hyperplasia was persistent in all patients, independent of the H. pylori status. The potentially drug-related adverse events (blackening of the tongue, six patients; diarrhea, one patient; disturbance of taste, two patients) were registered in seven (14%) patients and dark stools were observed in 48 (96%) patients. No children withdrew from the study because of either side-effects or clinical laboratory changes. No patient had toxic levels of blood bismuth (values ranged between 2.1 and 5.4 microg/L, mean value 3.4 +/- 1.04 microg/L). CONCLUSIONS: Findings suggest that the present treatment regimen is effective enough in the resolution of H. pylori-associated peptic ulcer disease of childhood.     

Resistance to metronidazole, clarithromycin and levofloxacin of Helicobacter pylori before and after clarithromycin-based therapy in Taiwan

Background and Aim:  Clarithromycin-based triple therapy has been commonly applied as the first-line therapy for Helicobacter pylori eradication. Levofloxacin could serve as an alternative in either first-line or second-line regimens. This study surveyed the prevalence of levofloxacin resistance of H. pylori isolates in naive patients and in patients with a failed clarithromycin-based triple therapy.
Methods:  The study collected the H. pylori isolates from 180 naive patients and 47 patients with a failed clarithromycin-based triple therapy. Their in vitro antimicrobial resistance was determined by E -test.
Results:  The naive H. pylori isolates had resistance rates for amoxicillin, levofloxacin, clarithromycin and metronidazole of 0%, 9.4%, 10.6% and 26.7%, respectively. An evolutional increase of the primary levofloxacin resistance was observed in isolates collected after 2004, as compared to isolates collected before 2004 (16.3% vs 3.2%, P  = 0.003). There was no evolutional increment of the primary clarithromycin resistance. The clarithromycin resistance elevated significantly after a failed clarithromycin-based triple therapy (78.7% vs 10.6%, P  < 0.001). The post-treatment isolates remained to have a levofloxacin resistance rate of near 17%, but the levofloxacin-resistant isolates were correlated with a higher incidence of metronidazole resistance ( P  = 0.023). No strain was found to be resistant to amoxicillin even after eradication failure.
Conclusion:  The levofloxacin resistance of naive H. pylori remains less than 10% in Taiwan. With relatively lower resistance to levofloxacin than to metronidazole of the H. pylori isolates collected after a failed clarithromycin-based therapy, proton pump inhibitor–levofloxacin–amoxicillin may be an alternative choice to serve as the second-line therapy.     

以枸橼酸铋雷尼替丁为基础的三联疗法根除幽门螺杆菌的系统评价

目的 评价国产枸橼酸铋雷尼替丁(瑞倍)根除幽门螺杆菌(H.pylori)的疗效.方法 检索1995年1月至2008年10月中国生物医学文献数据库(CBM)、手工检索发表与未发表的中文文献,应用国际Cochrane协作网系统评价方法 收集比较瑞倍为主的三联方案与质子泵抑制剂(PPI)治疗根除H.pylori的随机对照试验(RCT).数据采用RevMan 4.2进行统计分析.结果 12篇文献共1254例患者满足纳入标准.经meta分析显示,瑞倍根除H.pylori疗效和对照组比较差异无统计学意义(OR 1.30,95%CI:0.94～1.81,P=0.12).试验未发现严重副反应.结论 瑞倍为主的三联方案根除H.pylori是一个值得选用的治疗方法 .     

A randomized trial of lansoprazole, amoxycillin, and clarithromycin versus lansoprazole, bismuth, metronidazole and tetracycline in the retreatment of patients failing initial Helicobacter pylori therapy

BACKGROUND/AIM: 10-30% of the patients treated for Helicobacter pylori fail to clear the infection after initial therapy. Little is known as to the efficacy of retreatment regimens in these patients. Proton pump inhibitor (PPI) -based triple and quadruple therapies demonstrate efficacies of 80-90% as initial therapy for H. pylori infection, but whether these regimens are as effective when used for retreatment is unknown. The efficacy of a metronidazole-containing regimen in this situation is also unknown. Our aim was to compare the efficacy of a nonmetronidazole-containing PPI-based triple versus a PPI-based quadruple therapy containing metronidazole in patients failing previous H. pylori therapy. METHODS: 48 patients were enrolled in this study at two sites after failure of previous H. pylori therapy as determined by a positive (14)C-urea breath test. Patients were stratified by prior treatment with a metronidazole-containing regimen and were then randomized to either lansoprazole (L) 30 mg twice daily, amoxycillin (A) 1,000 mg twice daily, and clarithromycin (C) 500 mg twice daily for 14 days (LAC) or L 30 mg four times daily, bismuth subsalicylate (B) 2 tablets four times daily, metronidazole (M) 250 mg four times daily and tetracycline (T) 250 mg four times daily for 14 days (LBMT). Side effects and compliance (pill count) were assessed at the completion of therapy. A repeat (14)C-urea breath test was performed 4 or more weeks after completion of therapy, and cure was defined as a negative test result. RESULTS: 48 patients (16 males and 32 females) were enrolled in this study. 20 patients received LAC (18 prior M), and 28 received LBMT (23 prior M). Per protocol and intention-to-treat efficacies were 82% (95% CI 64-100%) and 75% (95% CI 56-94%) for LAC and 80% (96% CI 64-96%) and 71% (95% CI 54-88%) for LBMT (p = 0.85 per protocol and p = 0.78 intention to treat between LAC and LBMT), respectively. The compliance (> or =80% of pills taken) was found to be 89% in both treatment groups. Side effects were noted in 84% for LAC and in 82% for LBMT, but were mild and did not cause discontinuation of therapy. CONCLUSIONS: PPI-based triple and quadruple therapy with both LAC and LBMT are effective in retreating patients failing initial metronidazole-based H. pylori therapies. LAC was not statistically superior to LBMT as a 'retreatment' regimen in this clinical situation, but the small sample size and wide confidence limits do not preclude the possibility of a smaller but significant difference in efficacy between the regimens. To determine whether LAC or LBMT is as effective for retreating patients failing non-metronidazole-containing regimens requires further study.     

The efficacy of ranitidine bismuth citrate,amoxicillin and doxycycline or tetracycline regimens as a first line treatment for Helicobacter pylori eradication

BackgroundThe eradication rates of Helicobacter pylori (H. pylori) clearly decreased with standard PPI-based triple therapies.AimTo assess the efficacy of two different triple therapies consisting of ranitidine bismuth citrate–amoxicillin–doxycycline and ranitidine bismuth citrate–amoxicillin–tetracycline combinations as a first line treatment option.MethodsOne hundred and fifteen consecutive dyspeptic patients in whom H. pylori infection was diagnosed for the first time were enrolled in this study. The patients were randomized into two groups. Group 1 (n = 57) was assigned to receive a 14-day triple therapy consisting of ranitidine bismuth citrate 400 mg (b.i.d), amoxicillin 1 g (b.i.d) and doxycycline 100 mg (b.i.d). Group 2 (n = 58) was assigned to receive a 14-day triple therapy consisting of ranitidine bismuth citrate 400 mg (b.i.d), amoxicillin 1 g (b.i.d) and tetracycline 500 mg (q.i.d).ResultsThe eradication was achieved in 45.7% (21/46) and 40.8% (20/49) of the patients in group 1 and group 2, according to per protocol analysis. The intention-to-treat eradication rates were 36.8% (21/57) and 34.5% (20/58) in group 1 and group 2, respectively.ConclusionsTwo-week therapy with neither ranitidine bismuth citrate–amoxicillin–doxycycline nor ranitidine bismuth citrate–amoxicillin–tetracycline is adequately effective for H. pylori eradication as a first line therapy.     

Omeprazole once or twice daily with clarithromycin and metronidazole for Helicobacter pylori.

BACKGROUND: Triple therapy for one week with omeprazole, clarithromycin and metronidazole (OCM) is accepted worldwide as a first line therapy for Helicobacter pylori eradication. It is unclear whether omeprazole needs to be given once or twice daily. OBJECTIVES: To assess the efficacy and safety of these regimens in a single-centre, Canadian practice. METHODS: Histologically proven H pylori-positive patients were treated for seven days with clarithromycin 250 mg bid and metronidazole 500 mg bid, and randomly allocated to omeprazole 20 mg either once or twice daily in this open, cohort study. Endoscopy with histology (two antrum and two body biopsies, Giemsa stain) was done four weeks or longer after the pills were completed to assess H pylori eradication. RESULTS: Whether omeprazole was given once or twice daily, eradication was high and the same in both arms. All-patients-treated eradication was 85% (39 of 46 in the omeprazole once daily group and 41 of 48 in the omeprazole twice daily group) and intent-to-treat eradication was 80% (39 of 49 in the omeprazole once daily group and 41 of 51 in the omeprazole twice daily group). Side effects were frequently seen, suffered by 65% to 69% of patients treated. However, these were mild and compliance was high, with 94% of patients taking all of their pills. Mild side effects included loose stools, taste disturbance, nausea, headache and upper or lower gastrointestinal gas. Only one patient (1%) from the omeprazole once daily arm stopped taking metronidazole due to excessive perspiring. CONCLUSIONS: In this community practice, OCM triple therapy was effective whether omeprazole was given once or twice daily. For those with financial constraint, omeprazole 20 mg once daily can be considered. The regimens were well tolerated without serious adverse events.     

Prevalence of primary Helicobacter pylori resistance to metronidazole and clarithromycin in Singapore

INTRODUCTION Eradication of Helicobacter pylori, a bacterium residing in stomach and causing peptic ulcer disease,can be achieved by using combination therapies consisting of one or two antibiotics with a proton pump inhibitor (PPI). The major antibiotics widely used in the regimens to eradicate H. Pylori are metronidazole and clarithromycin[1-3].