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.     

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

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

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 1- and 2-week pantoprazole-based triple therapies in clarithromycin-sensitive and resistant cases

BACKGROUND: The objectives of this prospective study were: (i) to compare the efficacy of 1-week with 2-week pantoprazole-based triple therapy and (ii) to evaluate the impact of clarithromycin resistance on Helicobacter pylori (H. pylori) eradication rates. METHODS: Eighty dyspeptic patients were randomly allocated to two groups. The first group (PAC-1, n=40) received pantoprazole 40 mg, amoxicillin 1000 mg, and clarithromycin 500 mg twice a day for one week, and the second group (PAC-2, n=40) received the same regimen for two weeks. Endoscopy was repeated one month after the end of the treatment. RESULTS: DNA extraction for clarithromycin resistance could not be performed in seven cases. Five cases were lost to follow-up. Clarithromycin resistance was found to be 44.1% (15/34) in the PAC-1 group and 58.8% (20/34) in the PAC-2 group (p>0.05). Eradication was achieved in 16 (PP: 47.1%, ITT: 44.4%) and 25 (PP:73.5%, ITT: 67.6%) patients in the PAC-1 and PAC-2 groups, respectively (p>0.05). H. pylori was eradicated in 4 of 15 (PP: 26.7%, ITT: 26.7%) clarithromycin-resistant patients in the PAC-1 group and in 12 of 20 (PP: 60%, ITT: 60%) clarithromycin-resistant patients in the PAC-2 group (p>0.05). Among the clarithromycin-sensitive ones, eradication was achieved in 12 of 19 (PP: 63.2%, ITT: 57.1%) patients in the PAC-1 group and in 13 of 14 (PP: 92.8%, ITT: 76.5%) patients in the PAC-2 group (p>0.05). CONCLUSION: Although the 2-week regimen of pantoprazole-based triple therapy was effective for H. pylori eradication in clarithromycin-sensitive cases, highly effective H. pylori eradication protocols are needed for clarithromycin-resistant ones.     

含铋剂和克拉霉素的四联根除方案在幽门螺杆菌一线治疗中的作用

背景：近年经典三联方案对幽门螺杆菌（H.pylori）感染的根除疗效明显下降,建立新型、安全和高效的一线标准治疗方案是临床工作的当务之急。目的：评估含铋剂和克拉霉素的四联方案作为H.pylori一线治疗方案的疗效和安全性。方法：120例胃镜诊断为非溃疡性消化不良的H.pylori感染患者随机分为3组：7 d三联组（奥美拉唑20 mgbid＋阿莫西林1000 mg bid＋克拉霉素500 mg bid,疗程7 d）、7 d四联组（7 d三联方案＋枸橼酸铋钾220 mg bid,疗程7 d）和2周四联组（方案同7 d四联组,疗程2周）。治疗结束后至少4周行13C-尿素呼气试验以评估根除疗效。H.pylori分离菌株行克拉霉素、甲硝唑和阿莫西林药敏试验。结果：115例患者按方案完成治疗。7 d三联组、7 d四联组和2周四联组按意向治疗（ITT）分析H.pylori根除率分别为70.0%、75.0%和90.0%,按方案（PP）分析分别为73.7%、76.9%和94.7%。2周四联组ITT和PP根除率均显著高于7 d三联组（P〈0.05）,PP根除率显著高于7 d四联组（P=0.026）,而7 d三联组ITT和PP根除率与7 d四联组相比均无明显差异。H.pylori对克拉霉素、甲硝唑和阿莫西林的耐药率分别为24.2%、48.3%和0%,7 d三联组、7 d四联组和2周四联组对克拉霉素耐药菌株的根除率逐渐升高（37.5%、55.6%、80.0%）,但差异无统计学意义。除2周四联组中1例患者因皮肤过敏而未完成治疗外,其余患者的不良反应相似且轻微,耐受性良好。结论：含铋剂和克拉霉素的2周四联方案可明显提高H.pylori根除疗效,且安全性较高,可作为H.pylori一线治疗的标准方案。     

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.     

Hybrid vs sequential therapy for eradication of Helicobacter pylori in Taiwan: a prospective randomized trial

AIM: To evaluate the efficacy of sequential vs hybrid therapy in patients with Helicobacter pylori(H. pylori) infection.METHODS: From March 2013 to May 2014,one hundred and seventy-five H. pylori infected patients who had not been treated for H. pylori before wererandomized to receive either sequential therapy(rabeprazole 20 mg and amoxicillin 1 g twice daily for 5 d,followed by rabeprazole 20 mg,clarithromycin 500 mg and metronidazole 500 mg twice daily for 5 d) or hybrid therapy(rabeprazole 20 mg and amoxicillin 1 g for 7 d,followed by rabeprazole 20 mg,amoxicillin 1 g,clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 d). H. pylori status was confirmed by positive results of both rapid urease test and histology examination or a positive result of culture. Eradication efficacy was assessed by follow-up endoscopy with rapid urease test and histological examination 8 wk after the end of anti-H. pylori therapy,or 13C-urea breath test at least 4 wk after completion of treatment. The primary outcome was H. pylori eradication by intension-to-treat(ITT) and per-protocol(PP) analyses.RESULTS: One hundred and sixty-seven patients(83 patients in the sequential group and 84 patients in the hybrid group) completed the study. The compliance rates were 97.6% and 97.7% for the two groups,respectively. The eradication rate was 78.2% for the sequential group and 92% for the hybrid group by ITT analysis(P = 0.01). The eradication rate was 81.9% for the sequential group and 96.4% for the hybrid group by PP analysis(P = 0.01). Univariate analysis for the clinical and bacterial factors did not identify any risk factors associated with treatment failure. Severe adverse events were observed in 2.3% of patients in the sequential group and 2.4% of those in the hybrid group.CONCLUSION: Due to a grade A( 95%) success rate for H. pylori eradication by PP analysis,similar compliance and adverse events,hybrid therapy seems to be an appropriate eradication regimen in Taiwan.     

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     

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.     

序贯疗法与标准四联疗法对幽门螺杆菌根除失败后补救治疗的疗效分析

近年经典三联疗法的幽门螺杆菌（11．pylori）根除疗效明显降低,选择有效补救疗法对Hpylori根除失败者有重要意义。目的：比较序贯疗法与标准四联疗法对且pylori根除失败者的疗效。方法：将98例Hpylori根除失败者随机分为序贯疗法组（前5d予奥美拉唑20mg＋阿莫西林1000mgbid,后5d予奥美拉唑20mg＋左氧氟沙星200mg＋克拉霉素500mgbid）和标准四联疗法组（予奥美拉唑20mg＋胶体次枸橼酸铋钾220mg＋阿莫西林1000mg＋克拉霉素500mgbid,疗程7d）。停药4周后复查”C一尿素呼气试验,评估Hpylori根除疗效。结果：共95例患者完成方案,序贯疗法组11Tr和PP分析的Hpylori根除率均显著高于标准四联疗法组（ITF：89．8％对71,4％,PP：91．7％对74。5％,P〈0．05）,序贯疗法组临床症状改善的总有效率亦显著高于标准四联疗法组（95．8％对80．9％,P〈0．05）,两组不良反应发生率无明显差异（P〉0．05）。结论：对Hpylori根除治疗失败的患者,序贯疗法和标准四联疗法均可作为有效的补救治疗方案,但10d序贯疗法的疗效优于7d标准四联疗法。     

根除幽门螺杆菌对功能性消化不良疗效的研究

背景:功能性消化不良(FD)的患病率始终居高不下,目前就幽门螺杆菌(H.pylori)阳性的FD患者是否需根除H.pylori尚存在争议。目的:探讨根除H.pylori对H.pylori阳性FD患者的疗效。方法:200例H.pylori阳性FD患者随机分为治疗组(100例.予以枸橼酸铋雷尼替丁400mg+阿莫西林1000mg+克拉霉素250mg,2次/d,疗程1周)和对照组(100例,予以铝碳酸镁1000mg,3次/d,疗程1周)。随访结束后评估H.pylori根除率和FD症状改善情况。结果:治疗组的H.pylori根除率分别为87.5%(PP分析)和84.0%(ITT分析),对照组H.pylori根除率为0%。H.pylori根除亚组FD症状改善的总有效率显著高于H.pylori未根除亚组和对照组(90.5%对41.7%和45.9%,P0.01)。结论:部分H.pylori阳性FD患者根除H.pylori后,其症状可长期缓解,因此对部分H.pylori阳性FD患者根除H.pylori是一种值得推广的有效治疗手段。     

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.     

Efficacy of levofloxacin-based triple therapy as second-line Helicobacter pylori eradication]

BACKGROUND/AIMS: Bismuth-based quadruple therapy for second-line eradication treatment achieves the eradication rate ranging from 70% to 81% due to antimicrobial resistance and poor compliance. The aim of this study was to compare the eradication rate of levofloxacin-based triple therapy with that of bismuth-based quadruple therapy in second-line Helicobacter pylori (H. pylori) eradication therapy. METHODS: Seventy-six outpatients with persistent H. pylori infection after first-line triple therapy were enrolled in this prospective randomized trial. The subjects were randomized to receive levofloxacin 300 mg, amoxicillin 1 g, and pantoprazole 20 mg, given twice daily for 7 days (LAP group), or metronidazole 500 mg twice, tetracycline 500 mg four times, and pantoprazole 20 mg twice, bismuth subcitrate 600 mg twice daily for 7 days (MTPB group). Eradication was confirmed with (13)C-urea breath test or rapid urease test 4 weeks after the cessation of therapy. RESULTS: Among Seventy-six patients initially included, eleven were lost during follow-up. The eradication rates, expressed as intention to treat (ITT) and per protocol (PP) analyses, were 51.6% and 53.3% in the LAP group, and 48.9% and 62.9% in the MTPB group, respectively. There was no significant difference in H. pylori eradication rates between the two groups (p=0.815 by ITT, p=0.437 by PP). LAP regimen was better tolerated than MTPB regimen with lower incidence of side effects (10.0% versus 31.4%, p=0.03). CONCLUSIONS: H. pylori eradication rates of levofloxacin-based triple therapy and bismuth-based quadruple therapy were not significantly different in second-line H. pylori eradication therapy, and low incidence of side effects was observed in levofloxacin-based triple therapy.     

十二指肠溃疡患者根除幽门螺杆菌后抑酸维持治疗的疗效研究

背景：对感染幽门螺杆菌（H.pylori）的消化性溃疡患者成功根除且H.ylori后,是否应继续行抑酸治疗,目前尚存在争议。目的：探讨合并H.pylori感染的十二指肠溃疡（DU）患者根除H.pylori后抑酸维持治疗的疗效。方法：112例合并H.pylori感染的DU患者随机分为A组和B组,A组给予10d四联疗法：兰索拉唑30mg＋阿莫西林1g＋克拉霉素0．5gbid＋枸橼酸铋钾110mg qid,疗程10d。B组：在A组方案的基础上,疗程结束后再予兰索拉唑30mg,1次／d,维持4周。治疗结束4周后复查胃镜,评估H.pylori根除疗效、溃疡愈合率和腹痛缓解率。结果：109例患者完成方案。A、B两组按意向治疗（ITT）和按方案（PP）分析的H.pylori根除率（ITT：85．7％对87．5％;PP：88．9％对89．1％）和溃疡愈合率（ITT：87．5％对94．6％;PP：90．7％对96．4％）以及腹痛缓解率（95．6％对95．7％）相比差异均无统计学意义（P〉0．05）。结论：以10d四联疗法根除H.pylori后,可使多数DU患者的溃疡愈合,无需进一步行维持抑酸治疗。     

A 10-day levofloxacin-based therapy in patients with resistant Helicobacter pylori infection: a controlled trial.

BACKGROUND & AIMS: Antibiotic resistance is a major issue in anti- Helicobacter pylori treatment. This study was aimed at assessing the efficacy of 2 therapies in patients with resistant H pylori infection. METHODS: Patients who had failed 1 or more eradication regimens underwent upper gastrointestinal endoscopy and 2 antral and 2 corpus biopsy specimens were taken for histology and culture. Metronidazole, clarithromycin, and amoxicillin resistance were determined by E-test. Patients were randomly assigned to 2 therapies: 1 group received pantoprazole 40 mg, amoxicillin 1 g, levofloxacin 250 mg, all twice daily for 10 days, and the other group was treated with omeprazole 20 mg twice daily for the first week and omeprazole 20 mg twice daily, tetracycline 250 mg 4 times daily, metronidazole 500 mg twice daily, and bismuth subcitrate 240 mg twice daily for the second week. Therapeutic success was evaluated by 13C urea breath test after 4 weeks of treatment. RESULTS: We enrolled 44 patients in the levofloxacin-based regimen and 46 patients in the quadruple therapy. The former was successful in 31 of 44 (70%; 95% confidence interval: 53-87) and the latter in 17 of 46 (37%; 95% confidence interval: 23-47) patients, using intention-to-treat (ITT) analysis (P < .001). The rates of H pylori resistance to metronidazole, clarithromycin, and amoxicillin were 46%, 12%, and 0%, respectively. Resistance to both metronidazole and clarithromycin was found in 10% of cases. CONCLUSIONS: Triple therapy containing levofloxacin was better than quadruple therapy. The 70% success rate observed indicates that 10 days of pantoprazole, amoxicillin, and levofloxacin should be considered in patients who had failed 1 or more eradication regimens.     

以泮托拉唑为基础的三联和四联疗法根除幽门螺杆菌疗效比较——一项单中心、随机、开放、平行对照研究

背景：近年质子泵抑制剂（PPI）＋阿莫西林＋克拉霉素标准三联疗法对幽门螺杆菌（H.pylori）的根除率有所降低,PPI＋铋剂＋甲硝唑＋四环素的四联疗法能否成为一线治疗的首选以及适当延长疗程能否提高根除率尚有待明确。目的：比较以泮托拉唑为基础的7d标准三联疗法与7d、10d四联疗法根除H.pylori的疗效。方法：133例非溃疡性消化不良的H.pylori感染患者随机分配至7d三联组（45例,泮托拉唑40mgbid＋阿莫西林1.0gbid＋克拉霉素500mgbid,PAC方案）以及7d、10d四联组（43例和45例,泮托拉唑40mgbid＋枸橼酸铋钾220mgbid＋甲硝唑400mgtid＋四环素750mgbid,PBMT方案）。治疗结束后至少间隔4周行13C-尿素呼气试验复查H.pylori,评估治疗结果。结果：共129例患者按方案完成治疗。三组H.pylori根除率按意图治疗（ITT）分析分别为73.3%、79.1%和88.9%,按方案（PP）分析分别为75.0%、82.9%和90.9%。7dPAC方案的PP根除率显著低于10dPBMT方案（P〈0.05）。除四联组中有2例患者分别因头晕和腹泻而未完成治疗外,其余患者的不良反应相似且均能耐受。结论：在7d标准三联疗法H.pylori根除疗效降低的情况下,含泮托拉唑、铋剂、甲硝唑和四环素的10d四联疗法可考虑作为根除治疗的首选方案。     

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.     

Levofloxacin-based triple therapy in first-line treatment for Helicobacter pylori eradication

BACKGROUND:  The standard first-line therapies for Helicobacter pylori eradication are based on clarithromycin and amoxicillin or metronidazole. Recent studies suggested levofloxacin as an alternative option for both first-and second-line H. pylori eradication treatment.
AIMS:  To compare efficacy and tolerability of two different 7-day standard triple therapies versus 7-day levofloxacin-based triple therapy in first-line treatment for H. pylori infection.
METHODS:  Three hundred consecutive H. pylori positive patients were randomized to receive: clarithromycin, amoxicillin, esomeprazole (Group A: N = 100); clarithromycin, metronidazole, esomeprazole (Group B: N = 100); or clarithromycin, levofloxacin, esomeprazole (Group C: N = 100). H. pylori status was rechecked by ¹³C urea breath test 6 wk after the end of therapy.
RESULTS:  Sixteen out of 300 patients discontinued treatment because of the occurrence of side effects (Group A, 5; Group B, 7; Group C, 4). The eradication rates in intention to treat (ITT) and per protocol (PP) analyses were: Group A, 75% and 79%; Group B, 72% and 77.4%; and Group C, 87% and 90.6%. The eradication rate achieved with levofloxacin-based triple therapy was significantly higher than that with standard therapies in either ITT (87% vs 75%, p <0.05; 87% vs 72%, p <0.01;) or PP analysis (90.6% vs 79%, p <0.05; 90.6 vs 77.4, p <0.05). No difference was found between standard triple therapies. The incidence of side effects was similar among groups.
CONCLUSIONS:  A 7-day levofloxacin-based triple therapy can achieve higher H. pylori eradication rates than standard regimens. These data suggest levofloxacin-based regimens can be the most effective in first-line anti- H. pylori therapy, at least in the Italian population.     

Randomized Comparison of Ranitidine Bismuth Citrate-Based Triple Therapies for Helicobacter pylori

Objectives: In an attempt to increase the efficacy and simplicity of FDA-approved regimens for Helicobacter pylori , we studied (1) addition of an inexpensive antibiotic (amoxicillin) to twice-daily ranitidine bismuth citrate (RBO-clarithromycin dual therapy, and (2) substitution of RBC for bismuth subsalicylate + H2-receptor antagonist in bismuth-based triple therapy. Methods : Subjects with previously untreated Helicobacter pylori infection documented by ¹³C-urea breath test plus either endoscopic biopsy or serology were randomly assigned to a 2-wk course of (1) RBC 400 mg b.i.d. , amoxicillin 1 g b.i.d. , and clarithromycin 500 mg b.i.d. (RAC), or (2) RBC 400 mg b.i.d. , metronidazole 250 mg t.i.d. , and tetracycline 500 mg t.i.d. (RMT). Repeat breath test was performed 4 wk after the completion of therapy. Results : Intent-to-treat and per-protocol cure rates for RAC were 46 of 50 patients (92%) and 45 of 47 patients (96%); for RMT they were 40 of 50 patients (80%) and 37 of 42 patients (88%). Study drugs were stopped due to side effects in three patients (6%) taking RAC and six patients (12%) taking RMT. Conclusions : Twice-daily RBC-based triple therapy with clarithromycin and amoxicillin produces Helicobacter pylori eradication rates over 90%, which is comparable to rates seen with proton pump inhibitor-based triple therapies. RBC also may be substituted for bismuth subsalicylate and an + H2-receptor antagonist in standard bismuth-based triple therapy.     

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.