Effectiveness and pharmaceutical cost of sequential treatment for Helicobacter pylori in patients with non-ulcer dyspepsia

BACKGROUND: A novel 10-day sequential treatment regimen recently achieved a significantly higher eradication rate than standard 7-day therapy in both peptic ulcer disease and non-ulcer dyspepsia. Its higher performance has recently been confirmed using a halved clarithromycin dose in peptic ulcer disease. AIMS: To evaluate whether an acceptable eradication rate could also be obtained by halving the clarithromycin dose in dyspeptic patients and to assess the role of possible factors affecting the outcome of therapy. METHODS: In a prospective, open-label study, 162 patients with non-ulcer dyspepsia and Helicobacter pylori infection, assessed by rapid urease test and histology, were enrolled. Patients were randomized to receive either 10-day sequential therapy, comprising rabeprazole 20 mg b.d. plus amoxicillin 1 g b.d. for the first 5 days, followed by rabeprazole 20 mg b.d., clarithromycin 250 mg b.d. and tinidazole 500 mg b.d. for the remaining 5 days (low-dose therapy), or a similar schedule with clarithromycin 500 mg b.d. (high-dose therapy). Four to six weeks after therapy, H. pylori eradication was assessed by endoscopy/histology. RESULTS: A similar H. pylori eradication rate was observed following low- and high-dose regimens for both per protocol (94% vs. 95%; P = N.S.) and intention-to-treat (93% vs. 94%; P = N.S.) analyses. No major side-effects were reported. Halving the clarithromycin dose leads to a per patient saving in pharmaceutical costs of 24.6 euros. None of the variables examined affected the effectiveness of eradication of the sequential regimen. CONCLUSION: A reduction of the clarithromycin dose does not affect H. pylori eradication with the sequential regimen in non-ulcer dyspepsia and affords lower costs.     

High rate of Helicobacter pylori eradication with sequential therapy in elderly patients with peptic ulcer: a prospective controlled study

BACKGROUND: Helicobacter pylori eradication rates with triple therapies are decreasing, and few data in elderly patients are available. A 10-day sequential regimen succeeded in curing such H. pylori infection in unselected patients. AIM: To compare this sequential regimen and the standard triple therapy for H. pylori eradication in geriatric patients with peptic ulcer. METHODS: Overall, 179 H. pylori-infected patients with peptic ulcer were enrolled (mean age: 69.5 years; range: 65-83). Patients were randomized to 10-day sequential therapy (rabeprazole 20 mg b.d. plus amoxicillin 1 g b.d. for the first 5 days, followed by rabeprazole 20 mg, clarithromycin 500 mg and tinidazole 500 mg, all b.d., for the remaining 5 days) or standard 7-day triple regimen (rabeprazole 20 mg, clarithromycin 500 mg and amoxicillin 1 g, all b.d.). Helicobacter pylori status was assessed by histology and rapid urease test at baseline and 4-6 weeks after completion of treatment. RESULTS: The sequential regimen achieved eradication rates significantly higher in comparison with the standard regimen at both intention-to-treat (94% vs. 80%; P = 0.008) and per-protocol (97% vs. 83%; P = 0.006) analyses. In both treatment groups, compliance to the therapy was high (> 95%), and the rate of mild side-effects was similarly low (< 12%). At repeated upper endoscopy, peptic ulcer lesions were healed in 97% patients, without a statistically significant difference between the sequential regimen and the standard triple therapy. CONCLUSIONS: In elderly patients with peptic ulcer disease, the 10-day sequential treatment regimen achieved significantly higher eradication rates in comparison with standard triple therapy.     

Efficacy of quadruple therapy with pantoprazole,bismuth, tetracycline and metronidazole as rescue treatment for Helicobacter pylori infection

AIM: To study the efficacy of a 7-day quadruple regimen combining pantoprazole, bismuth, tetracycline and metronidazole as rescue treatment for Helicobacter pylori infection after failure of standard triple therapy. METHODS: A prospective study was made of 140 patients infected with H. pylori and diagnosed with peptic ulcer or non-ulcer dyspepsia in whom triple therapy with proton pump inhibitor, clarithromycin and amoxicillin had failed. The patients were treated with quadruple therapy including pantoprazole, 40 mg twice daily, colloidal bismuth subcitrate, 120 mg four times daily, tetracycline, 500 mg four times daily, and metronidazole, 500 mg three times daily, for 7 days. Two months after completion of therapy, a 13C-urea breath test was performed to confirm eradication. RESULTS: With quadruple therapy, the H. pylori eradication rates were 82% (95% confidence interval (CI), 75-88%) by 'intention-to-treat' and 85% (95% CI, 79-91%) by 'per protocol'. No major side-effects were observed. No differences in eradication success were observed in relation to underlying disease (peptic ulcer: 85% (95% CI, 76-91%) vs. non-ulcer dyspepsia: 83% (95% CI, 68-93%)) or smoking habits (smokers: 86% (95% CI, 75-93%) vs. non-smokers: 83% (95% CI, 71-91%)). CONCLUSION: Quadruple therapy with pantoprazole, bismuth, tetracycline and metronidazole for 7 days is an effective H. pylori eradication treatment for patients in whom standard triple therapy has failed.     

Sequential treatment for Helicobacter pylori eradication in duodenal ulcer patients: improving the cost of pharmacotherapy

BACKGROUND: Several studies have shown that Helicobacter pylori eradication rates with standard 7-day triple therapy are unsatisfactory. A novel 10-day sequential treatment regimen recently achieved a significantly higher eradication rate. To improve the pharmacotherapeutic cost, we evaluated whether an acceptable eradication rate could be achieved in peptic ulcer patients by halving the dose of clarithromycin. METHODS: In a prospective, open-label study, 152 duodenal ulcer patients with H. pylori infection, assessed by rapid urease test and histology, were enrolled. Patients were randomized to receive either a 10-day sequential treatment comprising rabeprazole 20 mg b.d. plus amoxicillin 1 g b.d. for the first 5 days, followed by rabeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. for the remaining 5 days (high-dose therapy), or a similar schedule with the clarithromycin doses halved to 250 mg b.d. (low-dose therapy). No further antisecretory drugs were offered. Four to six weeks after therapy, H. pylori eradication and ulcer healing rates were assessed by endoscopy. RESULTS: Similar H. pylori eradication rates were observed following high- and low-dose regimens for both per protocol (97.3% vs. 95.9%; P = N.S.) and intention-to-treat (94.7% vs. 92.2%; P = N.S.) analyses. No major side-effects were reported. At repeat endoscopy, peptic ulcer healing was observed in 93% and 93% of patients following high- and low-dose therapy, respectively. CONCLUSION: The cheaper low-dose sequential regimen may be suggested for H. pylori eradication in duodenal ulcer patients, even without continued proton pump inhibitor therapy after eradication treatment.     

Standard treatment for Helicobacter pylori infection is suboptimal in non-ulcer dyspepsia compared with duodenal ulcer in Chinese

BACKGROUND: Recent studies suggest that the Helicobacter pylori eradication rate in patients with non-ulcer dyspepsia is lower when compared to patients with peptic ulcer diseases. AIM: The aim of this study was to study the efficacy of triple therapy for H. pylori infection in patients with duodenal ulcer vs. patients with non-ulcer dyspepsia. METHODS: A total of 582 Chinese patients with proven H. pylori infection were recruited to receive: omeprazole 20 mg, amoxicillin 1000 mg and clarithromycin 500 mg all given twice daily for 7 days (OCA regime). Endoscopy with rapid urease test, histology and culture were performed before treatment. Post-treatment H. pylori status was determined by (13)C-urea breath test. Metronidazole, clarithromycin and amoxicillin resistance was defined as minimum inhibitory concentration (MIC) of >8 microg/mL, >1 microg/mL and >1 microg/mL, respectively. RESULTS: A significantly higher (intention-to-treat/per-protocol) eradication rate was found in patients with duodenal ulcer than those with non-ulcer dyspepsia (91/94% vs. 84/88% respectively, P = 0.011 and P = 0.016). Clarithromycin resistance rate was higher in patients with non-ulcer dyspepsia than those with duodenal ulcer (14% vs. 6%, P = 0.015). Clarithromycin resistance (40% vs. 5%, P < 0.001, OR 12, 95% CI: 5.7-24.3) and the diagnosis of non-ulcer dyspepsia (91% vs. 84%, P = 0.011, OR 2.0, 95% CI: 1.2-3.3) significantly affected the success of H. pylori eradication. CONCLUSION: Clarithromycin resistance accounts for the significantly lower and suboptimal H. pylori eradication rate of OCA regimen in Chinese patients with non-ulcer dyspepsia compared to those with duodenal ulcer.     

Seven-day therapy for Helicobacter pylori in the United States

BACKGROUND: The ideal duration of Helicobacter pylori treatment in the United States and whether eradication therapy is as successful in nonulcer dyspepsia as in peptic ulcer disease are controversial topics. AIM: This study compared the efficacy of 3-, 7- and 10-day triple therapies with rabeprazole to a 10-day omeprazole control triple therapy for the eradication of Helicobacter pylori in patients with and without peptic ulcer disease in the United States. METHODS: This was a multicentre, double-blind, randomized, parallel-group trial. A total of 803 patients with H. pylori infection (determined by [13C]urea breath test and rapid urease test or culture) received either rabeprazole 20 mg b.d., amoxicillin 1000 mg b.d., and clarithromycin 500 mg b.d. for 3, 7, or 10 days, or 10 days of omeprazole 20 mg b.d. with the same antibiotic regimen (control). H. pylori status was assessed by [13C]urea breath test > or =6 weeks after completing treatment. RESULTS: In intent-to-treat patients, the eradication percentages achieved for the rabeprazole-based treatments were: 3-day, 27% (95% confidence interval: 21%-34%); 7-day, 77% (95% confidence interval: 71%-83%); and 10-day, 78% (95% confidence interval: 72%-84%). The eradication percentage with the 10-day omeprazole-based treatment was 73% (95% confidence interval: 67%-79%). There was no statistically significant difference between the 7-day rabeprazole-based regimen and the 10-day rabeprazole- and omeprazole-based regimens. CONCLUSIONS: Seven-day therapy with rabeprazole, clarithromycin, and amoxicillin is similar in efficacy to 10-day therapies and had similar efficacy in patients with and without ulcer disease.     

Rabeprazole-based 3-day and 7-day triple therapy vs. omeprazole-based 7-day triple therapy for the treatment of Helicobacter pylori infection

BACKGROUND: Rabeprazole is a new proton pump inhibitor with more potent acid suppressive and anti-Helicobacter effects. AIM: To compare two different regimens of rabeprazole-based triple therapy vs. 7-day omeprazole-based triple therapy for the eradication of Helicobacter pylori infection. METHOD: Patients with proven H. pylori infection were randomized to receive: (i) 7-day rabeprazole, 10 mg, amoxicillin, 1000 mg, and clarithromycin, 500 mg, all twice daily; (ii) 3-day rabeprazole, 20 mg, amoxicillin, 1000 mg, and clarithromycin, 500 mg, all twice daily; or (iii) 7-day omeprazole, 20 mg, amoxicillin, 1000 mg, and clarithromycin, 500 mg, all twice daily. Endoscopy (CLO test, histology) was performed before randomization and 6 weeks after drug treatment. RESULTS: One hundred and seventy-three patients were randomized. H. pylori eradication rates (intention-to-treat, n=173/per protocol, n=167) were 88%/91% for 7-day rabeprazole-based therapy, 72%/72% for 3-day rabeprazole-based therapy and 82%/89% for 7-day omeprazole-based therapy, respectively. The per protocol eradication rate was significantly better in the 7-day rabeprazole-based therapy and 7-day omeprazole-based therapy groups when compared to the 3-day rabeprazole-based therapy group (P=0.01 and P=0.04, respectively). Compliance was excellent and all three regimens were well tolerated. CONCLUSIONS: The efficacy of seven-day rabeprazole-based triple therapy is similar to 7-day omeprazole-based triple therapy for the eradication of H. pylori infection.     

Efficacy of low-dose clarithromycin triple therapy and tinidazole-containing triple therapy for Helicobacter pylori eradication

BACKGROUND: Proton pump inhibitor-based triple therapies are recommended as the first-line treatment for Helicobacter pylori eradication. AIM: To evaluate the efficacies of low-dose clarithromycin triple therapy and tinidazole-containing triple therapy in a metronidazole resistance prevalent area and to compare the efficacies with standard triple therapy. METHODS: In a randomized, multicentre, prospective study, a total of 352 patients with duodenal ulcer or non-ulcer dyspepsia were randomly divided into three groups according to the administered regimen: OAC250 group (omeprazole, 20 mg, amoxicillin, 1000 mg, and clarithromycin, 250 mg), OAC500 group (omeprazole, 20 mg, amoxicillin, 1000 mg, and clarithromycin, 500 mg) and OTC group (omeprazole, 20 mg, tinidazole, 500 mg, and clarithromycin, 500 mg). The three groups received each regimen twice daily for 7 days. Upper gastrointestinal endoscopy was performed before and 4 weeks after treatment. H. pylori status was determined by rapid urease test and 13C urea breath test. RESULTS: The eradication rates in the OAC250, OAC500 and OTC groups were 76.2%, 65.7% and 64.8% (95% confidence interval: 67.9-84.4%, 56.7-74.8% and 55.7-73.9%), respectively, by intention-to-treat analysis (P=0.149) and 92.8%, 87.2% and 84.1% (95% confidence interval: 84.4-97.3%, 77.9-93.8% and 73.9-91.2%), respectively, by per protocol analysis (P=0.088). All regimens were well tolerated and compliance was excellent. CONCLUSIONS: Both low-dose clarithromycin triple therapy and tinidazole-containing triple therapy are effective and safe regimens for H. pylori eradication.     

A new highly effective short-term therapy schedule for Helicobacter pylori eradication

BACKGROUND: Although triple therapy regimens suggested in the Current European guidelines give fairly good results, several studies have reported an unsatisfactory Helicobacter pylori eradication rate (< 80%). AIM: To evaluate the efficacy of a new short-term treatment sequence on H. pylori eradication. METHODS: A total of 52 patients with H. pylori infection and either non-ulcer dyspepsia (34 patients) or peptic ulcer (18 patients) were enrolled to receive a 10-day therapy: omeprazole 20 mg b.d. plus amoxycillin 1 g b.d. for the first 5 days, followed by omeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. for the remaining 5 days. H. pylori infection at entry was assessed by rapid urease test and histology on biopsies from the antrum and the corpus. Bacterial eradication was assessed by endoscopy (peptic ulcer patients) or 13C urea breath test (non-ulcer dyspepsia patients) 4-6 weeks after therapy had ended. RESULTS: All patients completed the study. H. pylori eradication was achieved in all but one patient, with an eradication rate of 98% (95% CI: 94.3-100) with intention-to-treat analysis. Patient compliance was good (consumption of prescribed drugs > 95%) for all but one patient, who took the triple therapy regimen for 4 days instead of 5 days. No major side-effects were reported but three (6%) patients complained of mild side-effects. CONCLUSIONS: The use of this 'five plus five' therapy schedule as an initial treatment for H. pylori deserves further investigation.     

含铋剂序贯疗法治疗幽门螺杆菌感染的疗效观察

目的:评价10 d含铋剂序贯疗法与常规序贯疗法及四联疗法对初次根除幽门螺杆菌(H.pylori)失败后补救治疗的疗效。方法:经胃镜下快速尿素酶试验或14C-尿素呼气试验确诊为H.pylori阳性的患者,用标准一线治疗方案进行H.pylori根除治疗,停药4周后行14C-尿素呼气试验,结果仍为阳性者判定为H.pylori根除失败。将初次根除失败的患者随机分为3组,A组:前5 d,雷贝拉唑10 mg、阿莫西林1 g、果胶铋300 mg;后5 d,雷贝拉唑10 mg、克拉霉素0.5 g、奥硝唑0.5 g、果胶铋300 mg。B组:前5 d,雷贝拉唑10 mg、阿莫西林1 g;后5 d,雷贝拉唑10 mg、克拉霉素0.5 g、奥硝唑0.5 g。C组:雷贝拉唑10 mg、果胶铋300 mg、阿莫西林1 g、呋喃唑酮0.1 g,疗程10 d,所有药物均口服,bid。治疗结束4周后复查14C-尿素呼气试验。结果:采用按意向性治疗(intention-to-treat,ITT)分析和按符合方案(per protocol,PP)分析对H.pylori根除率进行评价。A、B、C 3组H.pylori ITT根除率分别为92.3%、74.4%、75.0%,PP根除率分别为94.7%、78.4%、78.9%,2种分析方法均显示A组H.pylori根除率明显高于B、C 2组,差异有统计学意义(P<0.05),而B组与C组间根除率差异无统计学意义(P>0.05)。A组和B组不良反应发生率(5.3%、5.4%)低于C组(21.1%),但差异无统计学意义(P>0.05)。结论:10 d含铋剂序贯疗法可作为H.pylori一线根除治疗失败后安全有效的补救治疗方案。     

Review article: esomeprazole in the treatment of Helicobacter pylori

Proton pump inhibitor-based triple therapy is the most commonly used treatment for eradication of Helicobacter pylori, with pooled eradication rates of approximately 90%. In the USA, per protocol eradication rates with 10-day proton pump inhibitor-based triple therapy are approximately 85%. Esomeprazole, a new proton pump inhibitor that is the S-isomer of omeprazole and produces a greater inhibition of acid secretion than omeprazole, has recently been evaluated in the treatment of H. pylori. Seven-day twice daily triple therapy with esomeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg provided intention-to-treat eradication rates of 86-90% and per protocol eradication rates of 90-91% in duodenal ulcer patients in Europe and Canada. Ten-day triple therapy with esomeprazole 40 mg q.d.s., amoxicillin 1 g b.d. and clarithromycin 500 mg b.d. achieved intention-to-treat eradication rates of 77-78% and per protocol eradication rates of 84-85% in USA duodenal ulcer patients. Thus, esomeprazole triple therapy with amoxicillin and clarithromycin is effective in the treatment of H. pylori, with eradication rates comparable to previously studied proton pump inhibitor-based triple therapies.     

Low-dose lansoprazole and clarithromycin plus metronidazole vs. full-dose lansoprazole and clarithromycin plus amoxicillin for eradication of Helicobacter pylori infection

AIM: To compare, in a randomized controlled trial, the efficacy and tolerability of two 1-week triple therapies for Helicobacter pylori eradication. METHODS: One hundred and thirty-four consecutive patients with non-ulcer dyspepsia and H. pylori infection were randomized to receive lansoprazole 30 mg once daily, clarithromycin 250 mg twice daily, and metronidazole 500 mg twice daily (LCM group), or lansoprazole 30 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1000 mg twice daily (LCA group). H. pylori status was assessed by rapid urease test, histology and 13C-urea breath test before and after therapy. RESULTS: At 3 months, H. pylori eradication (intention- to-treat/per protocol analysis) was 92.4%/93.8% in the LCM group and 83.1%/85.7% in the LCA group (P=N.S.). Side-effects were more frequently reported in the LCA group (37.9%) than in the LCM group (19.7%) (P < 0.05). CONCLUSIONS: In this open, randomized controlled trial, eradication of H. pylori by low-dose lansoprazole and clarithromycin plus metronidazole was higher with significantly less side-effects than by full-dose lansoprazole and clarithromycin plus amoxicillin. This finding may be related to the stronger synergism of clarithromycin plus metronidazole, even at lower doses, than of clarithromycin plus amoxicillin. Considering the lower cost as well, LCM should be preferred to LCA in the eradication of H. pylori.     

Esomeprazole in the treatment of Helicobacter pylori

Proton pump inhibitor-based triple therapy is the most commonly used treatment for eradication of Helicobacter pylori , with pooled eradication rates of approximately 90%. In the USA, per protocol eradication rates with 10-day proton pump inhibitor-based triple therapy are approximately 85%. Esomeprazole, a new proton pump inhibitor that is the S-isomer of omeprazole and produces a greater inhibition of acid secretion than omeprazole, has recently been evaluated in the treatment of H. pylori . Seven-day twice daily triple therapy with esomeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg provided intention-to-treat eradication rates of 86–90% and per protocol eradication rates of 90–91% in duodenal ulcer patients in Europe and Canada. Ten-day triple therapy with esomeprazole 40 mg q.d.s., amoxicillin 1 g b.d. and clarithromycin 500 mg b.d. achieved intention-to-treat eradication rates of 77–78% and per protocol eradication rates of 84–85% in USA duodenal ulcer patients. Thus, esomeprazole triple therapy with amoxicillin and clarithromycin is effective in the treatment of H. pylori , with eradication rates comparable to previously studied proton pump inhibitor-based triple therapies.     

低剂量新三联疗法根除血透患者幽门螺杆菌的疗效及安全性研究

目的研究以低剂量奥美拉唑为基本药物联合低剂量阿莫西林胶囊和克拉霉素片的7日新三联疗法治疗维持性血液透析患者幽门螺杆菌的疗效及安全性。方法选取22例合并幽门螺杆菌感染的血透患者为研究对象,同时选取30例各脏器功能正常的合并幽门螺杆菌患者为对照组,血透患者和对照组的服药剂量为：奥美拉唑胶囊20mg qd、阿莫西林胶囊500mg bid、克拉霉素片250mg qd,疗程均为1周,停药4周后通过组织学及碳呼气试验检测幽门螺杆菌的感染情况,比较两组的幽门螺杆菌根除率。结果血透患者幽门螺杆菌的清除率为81.8%,而非尿毒症患者为80%（P〉0.05）。所有研究对象均未发生严重的不良反应。结论低剂量新三联疗法对根除血透患者幽门螺杆菌是有效及安全的。     

Triple therapy with clarithromycin, omeprazole, and amoxicillin for eradication of Helicobacter pylori in duodenal ulcer patients in Asia and Africa

BACKGROUND: Studies assessing the efficacy of triple therapy containing clarithromycin and amoxicillin for the eradication of Helicobacter pylori infection and healing of duodenal ulcers in Asian and African countries are limited. AIM: To determine the efficacy and safety of 1-week triple therapy with omeprazole, amoxicillin and clarithromycin for eradicating H. pylori infection in patients with active duodenal ulcer living in Asian and African regions. METHODS: This was an open-label, multicentre study in 11 centres in Asia and Africa. Patients with endoscopy-proven duodenal ulcer and who were H. pylori-positive were treated with clarithromycin 500 mg, omeprazole 20 mg, and amoxicillin 1000 mg, all given twice daily for 7 days. Upper endoscopy was repeated at week 6 to check for ulcer healing and H. pylori status. RESULTS: A total of 117 patients were recruited. H. pylori eradication rates were 85% by per protocol analysis and 80% by intention-to-treat analysis. Ulcer healing was found in 94% of subjects (per protocol analysis). Clinical success, measured by change of pre-treatment ulcer symptoms, was strongly supported by complete resolution or improvement in 100% of the evaluable patients (per protocol analysis). Since treatment-related adverse events, when present, were largely mild or moderate, the triple therapy regimen was considered safe. CONCLUSION: Seven-day triple therapy with omeprazole, amoxicillin, and clarithromycin was efficacious for treating Asian and African patients with duodenal ulcer disease associated with H. pylori infection, and the treatment regimen was well-tolerated.     

雷贝拉唑+克拉霉素+左氧氟沙星三联疗法治疗幽门螺杆菌消化道溃疡的观察

目的：观察雷贝拉唑＋克拉霉素＋左氧氟沙星三联疗法治疗幽门螺杆菌消化道溃疡的疗效。方法：60例幽门螺杆菌阳性消化道溃疡患者随机平分为两组,两组患者都采用三联一周疗法,治疗组为雷贝拉唑＋克拉霉素＋左氧氟沙星治疗,对照组为奥美拉唑＋阿莫西林＋甲硝唑治疗。结果：经过治疗,治疗组30例96.7%的总有效率明显高于对照组70.0%的总有效率（P＜0.05）;治疗组90.0%的HP根除率明显高于对照组66.7%的HP根除率（P＜0.05）。结论：雷贝拉唑＋克拉霉素＋左氧氟沙星三联疗法治疗幽门螺杆菌消化道溃疡能提高疗效,提高HP根除率,值得推广应用。     

雷贝拉唑、阿莫西林、加替沙星三联疗法根除幽门螺杆菌的疗效及安全性

目的:评价由加替沙星(400 mg,qd),雷贝拉唑(20 mg,bid),阿莫西林(1 g,bid),疗程7 d的三联方案根除治疗幽门螺杆菌的疗效及安全性。方法:48名幽门螺杆菌感染的患者参与本次研究,受试者均有一次或一次以上含克拉霉素的常规三联治疗史。治疗后四周通过14 C-呼气试验判定根除治疗效果。根除治疗失败的患者通过体外抑菌试验判断幽门螺杆菌对阿莫西林,克拉霉素及加替沙星的药物敏感性。结果:41名患者根除治疗成功[完成治疗分析(PP)和意向治疗分析(ITT)均为85.4%,95%CI:74%～95%]无显著副作用。体外药敏试验显示在7名治疗失败的患者中未出现对加替沙星和阿莫西林的继发耐药。结论:由加替沙星、阿莫西林和雷贝拉唑组成的7 d短程治疗方案,作为根除治疗失败后的补救治疗方案简单有效,耐受性好,依从性高;而且此方案失败后未引起继发耐药性。     

Randomised clinical trial: a comparative study of 10-day sequential therapy with 7-day standard triple therapy for Helicobacter pylori infection in naïve patients

Aliment Pharmacol Ther 2012; 35: 56–65

Summary

Background The eradication rates following standard triple therapy for Helicobacter pylori infection are declining worldwide. Recent studies have shown that sequential therapy for H. pylori infection yields high cure rates. Aim To compare the efficacy and tolerability of a sequential regimen as first‐line treatment of H. pylori infection with a standard triple regimen. Methods A total of 348 naïve H. pylori‐infected patients from six hospitals in Korea were assigned randomly to standard triple or sequential therapy groups. Standard triple therapy consisted of 20 mg of rabeprazole, 1 g of amoxicillin and 500 mg of clarithromycin, twice daily for 7 days. Sequential therapy consisted of a 5‐day dual therapy (20 mg of rabeprazole and 1 g of amoxicillin, twice daily) followed by a 5‐day triple therapy (20 mg of rabeprazole, 500 mg of clarithromycin, and 500 mg of metronidazole, twice daily). Results The intention‐to‐treat (ITT) and per‐protocol (PP) eradication rates were 62.2% (95% CI 54.8–69.6%) and 76.0% (95% CI 68.5–83.5%) in the standard triple group, and 77.8% (95% CI 71.4–84.2%) and 87.9% (95% CI 82.3–93.5%) in the sequential group, respectively. The eradication rate was significantly higher in the sequential group compared with the standard triple group in both the ITT and PP populations (P = 0.002 and P = 0.013 respectively), whereas the incidence of adverse events was similar. Conclusions Ten‐day sequential therapy is more effective and equally tolerated for eradication of H. pylori infection compared with standard triple therapy. Sequential therapy may have a role as first‐line treatment for H. pylori infection.     

雷贝拉唑三联疗法治疗幽门螺杆菌相关性消化性溃疡的疗效观察

目的观察雷贝拉唑三联疗法治疗幽门螺杆菌(Hp)相关性消化性溃疡的临床疗效。方法将胃镜检查经快速尿素检测和病理检查为Hp阳性或14C呼气试验检测阳性患者60例随机分为雷贝拉唑组35例和奥美拉唑组25例。雷贝拉唑组每天口服雷贝拉唑10mg、克拉霉素500mg、甲硝唑400mg,均每天2次,疗程5d;奥美拉唑组每天口服奥美拉唑20mg、克拉霉素500mg、甲硝唑400mg,均每天2次,疗程7d。比较2组治疗总有效率、Hp根除率及溃疡愈合率。结果 2组总有效率及Hp根除率比较差异均无统计学意义(P>0.05)。雷贝拉唑溃疡愈合率为91.4%高于奥美拉唑组的64.0%,差异有统计学意义(P<0.01)。结论雷贝拉唑三联疗法能明显缓解消化性溃疡症状,对溃疡有较高的愈合率及Hp清除率。     

Safety and efficacy of 7-day rabeprazole- and omeprazole-based triple therapy regimens for the eradication of Helicobacter pylori in patients with documented peptic ulcer disease

AIM: A double-blind, randomized study was designed to determine whether rabeprazole- and omeprazole-based triple therapy regimens are therapeutically equivalent in the eradication of Helicobacter pylori. METHODS: Three hundred and forty-five patients with current or previously active peptic ulcer and a positive H. pylori urease test were randomly assigned to receive RCA, OCA, RCM or OCM twice daily for 7 days (R, rabeprazole 20 mg; O, omeprazole 20 mg; C, clarithromycin 500 mg; A, amoxicillin 1000 mg; M, metronidazole 400 mg). H. pylori eradication was documented by negative 13C-urea breath tests at 4 and 12 weeks, and was evaluated using a 2 x 2 factorial design with proton pump inhibitor and antibiotic as factors. RESULTS: Overall eradication rates (per protocol/intention-to-treat) were 87%/77% and 85%/75% with rabeprazole and omeprazole, respectively (not significant). However, a statistical interaction between proton pump inhibitor and antibiotic was identified. RCA produced a somewhat higher eradication rate than OCA (94% vs. 84%; difference, 9.8%; 95% confidence interval, - 0.7% to + 20.4%), whereas RCM produced a lower eradication rate than OCM (79% vs. 86%; difference, 8.1%; 95% confidence interval, - 21.4% to + 5.1%). Ulcer healing rates were > 90% with H. pylori eradication. Each regimen was well tolerated. CONCLUSIONS: Rabeprazole- and omeprazole-based triple therapy regimens are therapeutically equivalent in the eradication of H. pylori and well tolerated. The statistical interaction observed between the proton pump inhibitor and supplementary antibiotic may be due to chance.