Efficacy of ecabet sodium for Helicobacter pylori eradication triple therapy in comparison with a lansoprazole-based regimen

BACKGROUND: The cytoprotective agent, ecabet sodium, inhibits urease activity and growth of Helicobacter pylori. AIM: To evaluate the efficacy and safety of ecabet sodium-based eradication of H. pylori infection, compared with a lansoprazole-based regimen, in a randomized multicentre study. SUBJECTS AND METHODS: A total of 120 H. pylori-positive patients were assigned to one of two treatment regimens for 2 weeks: ecabet sodium 1 g b.d., amoxicillin 500 mg t.d.s. and clarithromycin 400 mg b.d. (EAC: 60 patients); or lansoprazole 30 mg (o.m.) with the same antimicrobial agents (LAC: 60 patients). Cure of infection was assessed by a 13C-urea breath test 1 month after completion of treatment. RESULTS: One patient in the EAC group and two in the LAC group did not complete therapy because of an adverse event, and three did not undergo the 13C-urea breath test. Cure rates for the intention-to-treat, all-patients-treated and per protocol analysis in the EAC group were 85%, 86% and 88%, respectively, whereas those in the LAC group were 85%, 88% and 91%. There were no significant differences in cure rate or adverse events between the two regimens. CONCLUSIONS: Ecabet sodium in combination with amoxicillin and clarithromycin is as effective as lansoprazole-based eradication therapy for H. pylori.     

用三联法根除幽门螺杆菌失败后的补救方案

目的探讨三联疗法(质子泵抑制剂 阿莫西林 克拉霉素)根除幽门螺杆菌(HP)治疗失败后的补救方案。方法将95名HP感染且三联疗法根除HP治疗失败的患者,随机分为试验组与对照组,并分别用新三联法(质子泵抑制剂 阿莫西林 左氧氟沙星)与四联法(质子泵抑制剂 铋剂 四环素 甲硝唑)比较,在治疗结束时和结束后4周,检测HP,并评价耐受性。结果在HP根除率和耐受性,试验组优于对照组。结论以左氧氟沙星为基础的新三联方案是有效的补救方案,优于四联方案。     

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.     

First-line triple therapy with levofloxacin for Helicobacter pylori eradication

BACKGROUND: At present, the efficacy of proton pump inhibitor-clarithromycin-amoxicillin regimen is relatively low. AIM: To evaluate the efficacy and tolerability of a first-line triple clarithromycin-free regimen including ranitidine bismuth citrate, levofloxacin and amoxicillin. METHODS: Design: Prospective study. Patients: Helicobacter pylori-positive patients complaining of dyspeptic symptoms referred for gastroscopy. Intervention: Levofloxacin (500 mg b.d.), amoxicillin (1 g b.d.) and ranitidine bismuth citrate (400 mg b.d.) was prescribed for 10 days. Outcome: Eradication was confirmed by a (13)C-urea breath test 8 weeks after therapy. Compliance with therapy was determined by questioning and the recovery of empty envelopes of medications. Incidence of adverse effects was evaluated by means of a specific questionnaire. RESULTS: Sixty-four patients were included (30% peptic ulcer, 70% functional dyspepsia). Almost all (97%) patients took all the medications correctly. Per-protocol and intention-to-treat eradication rates were 88.5% (95% CI =78-95%) and 84.4 (74-91%). Adverse effects were reported in 9.5% of the patients, mainly including diarrhoea (7.9%); none of them were severe. CONCLUSION: This new 10-day levofloxacin-based combination represents an alternative to clarithromycin-based therapy, as it meets the criteria set for regimens used as primary H. pylori treatment: effectiveness (>80%), simplicity (twice-daily dosing and excellent compliance) and safety (low incidence of adverse effects).     

The sequential therapy regimen for Helicobacter pylori eradication

Importance of the field: Standard triple therapy (STT) is the most used treatment for Helicobater pylori infection. The prevalence of antibiotic resistance has increased substantially in recent years and there has been a corresponding decrease in efficacy.

Areas covered in this review: Bibliographical searches were performed in MEDLINE and international congresses up to 2009 for ‘Helicobacter pylori’ AND ‘sequential regimen/therapy’.

What the reader will gain: Several meta-analyses have demonstrated that sequential therapy (SQT) is more effective than STT. SQT is not affected by bacterial and host factors that have, until now, predicted the outcome of STT. Primary clarithromycin resistance is the only factor reducing the efficacy of SQT; however, even in these patients an acceptable >?75% eradication can be achieved. So far, almost all the studies have been performed in Italy. The advantages of SQT over STT should be confirmed in different countries. Whether it is necessary to provide the drugs sequentially or if the four components of SQT can be given concurrently is unclear.

Take home message: SQT is a promising new treatment approach that deserves consideration as a treatment strategy for H. pylori infection. However, further robust assessment across a much broader range of patients is required before SQT could supplant existing treatment regimens and be generally recommended in clinical practice.     

国产克拉霉素的短程三联疗法根除幽门螺杆菌感染的疗效

目的 :观察国产克拉霉素的短程三联疗法根除幽门螺杆菌 (Hp)感染的疗效及不良反应。方法 :91例Hp阳性的消化性溃疡或糜烂性胃窦炎病人 ,分为A组 ( 4 7例 ,男性 4 0例 ,女性 7例 ,年龄 57a±s14a)和B组 ( 4 4例 ,男性 4 0例 ,女性 4例 ,年龄59a± 15a)。A组以奥美拉唑 2 0mg、替硝唑 50 0mg及国产克拉霉素 2 50mg ,po ,bid ;B组治疗同A组 ,只是将国产克拉霉素改为进口克拉霉素 ,疗程均为 7d。疗程结束 1mo后复查胃镜及Hp。结果 :A ,B 2组Hp根除率分别为 85%和 91% ,不良反应发生率分别为 11%和 14% ,但均能耐受 ,2组比较差异无显著意义 ,P >0 .0 5。每例抗Hp费用A组为 4 70元、B组 550元。结论 :A ,B 2组疗效相近 ,均无严重不良反应 ,但A组费用较低 ,提示国产克拉霉素可替代进口克拉霉素用于Hp根除     

艾司奥美拉唑、克拉霉素、阿莫西林短程三联疗法根除幽门螺杆菌

目的:观察艾司奥美拉唑、克拉霉素、阿莫西林短程三联疗法根除幽门螺杆菌(Hp)的疗效。方法:Hp阳性的活动性十二指肠溃疡病人44例,以艾司奥美拉唑20mg、克拉霉素500mg及阿莫西林1000mg,po,bid治疗,疗程7d,7d之后继服法莫替丁20mg,po,bid×3wk。观察Hp根除率、症状缓解和消失率、溃疡愈合率及不良反应。结果:Hp根除率为88%(按完成试验方案分析)和86%(按意图分析),d7症状缓解率为100%、消失率为72%,wk5溃疡愈合率为100%。不良反应发生率为14%,其中1例因皮疹退出。结论:艾司奥美拉唑、克拉霉素,阿莫西林三联短程疗法并后续法莫替丁治疗3wk,是当前治疗Hp阳性的活动性十二指肠溃疡的满意选择之一。     

标准三联疗法四联疗法及序贯疗法根除幽门螺杆菌的疗效观察

目的比较标准三联疗法、四联疗法及序贯疗法根除幽门螺杆菌(Hp)的疗效及安全性。方法300例非溃疡性消化不良者随机入选三联、四联及序贯疗法组,三联疗法组予兰索拉唑+阿莫西林+克拉霉素治疗10d。四联疗法组予兰索拉唑+胶体次枸橼酸铋+阿莫西林+克拉霉素治疗10d。序贯疗法组前5d予兰索拉唑+阿莫西林治疗,后5d予兰索拉唑+克拉霉素+甲硝唑治疗。治疗结束至少停药4周后复查14 C尿素呼气试验,结果阴性表示根除成功。同时评估疗效及安全性。对Hp根除率进行意向性分析和符合方案分析比较。结果意向性分析显示三联疗法组、四联疗法组及序贯疗法组的Hp根除率分别是66%(66/100)、82%(82/100)及84%(84/100)。符合方案分析显示三联疗法组、四联疗法组及序贯疗法组的Hp根除率分别是72%(66/92)、91%(82/90)及89%(84/94)。意向性分析及符合方案分析均表明三联疗法组Hp根除率明显低于四联疗法组或序贯疗法组,差异有统计学意义(P均<0.05),而四联疗法组与序贯疗法组间差异无统计学意义(P>0.05)。结论四联疗法或序贯疗法可作为临床根治Hp的一线治疗方案。     

One-week clarithromycin triple therapy regimens for eradication of Helicobacter pylori

Background:

One-week triple therapies have been endorsed as the treatment regimens of choice for eradication of Helicobacter pylori infection. Those that include clarithromycin appear to be the most effective.

Aim:

To review reports of triple therapies that include clarithromycin.

Methods:

Reports were identified from the literature to May 1998. The variation between study designs prevents a formal meta-analysis. A measure of the relative efficacies of regimens has, however, been gained by comparison and by pooling of intention-to-treat eradication rates.

Results:

One hundred and ninety-two studies were identified which included 264 treatment arms of a 1-week triple therapy composed of clarithromycin with amoxycillin or a nitroimidazole (metronidazole or tinidazole), and either ranitidine bismuth citrate or a proton pump inhibitor (omeprazole, lansoprazole or pantoprazole). From reports of these studies, an intention-to-treat H. pylori eradication rate could be determined from 210 treatment arms of 151 studies.

Conclusions:

There is little to choose between the efficacies of 1-week clarithromycin-based triple therapy eradication regimens. However, those comprising clarithromycin, a nitroimidazole and either ranitidine bismuth citrate or a high dose of omeprazole are, in general, the most effective. Against antibiotic-resistant strains of H. pylori, regimens including ranitidine bismuth citrate may be more effective than those including a proton pump inhibitor.

     

Bismuth-containing single-antibiotic 1-week triple therapy for Helicobacter pylori eradication

Background:

Although bismuth was both the first drug shown to alter the natural history of peptic ulcer disease and also a constituent of the first very effective eradication regimens, it has been excluded from the newer regimens, despite its safety and low cost, in favour of two antibiotics.

Aim:

To asses a novel 1-week regimen consisting of bismuth, clarithromycin and a proton pump inhibitor in routine clinical practice.

Methods:

One hundred and three consecutive patients with peptic ulcer disease and antral biopsies containing Helicobacter pylori were given a 7-day course of treatment with bismuth (tripotassium dicitrato bismuthate chelate) 120 mg q.d.s., clarithromycin 500 mg t.d.s. and lansoprazole 30 mg o.d. Completeness of eradication was assessed by a ¹³C-urea breath test, in all except three patients, at least 4 months later.

Results:

Of the 100 patients who were assessed in this open treatment study 84 (84%; 95% CI: 77–91%) had a negative breath test. Minor side-effects were reported by 14% and more troublesome side-effects (nausea, vomiting, diarrhoea, hallucinations, nasty taste and body pains) were reported by 10%.

Conclusions:

A 1-week course of triple therapy including bismuth, clarithromycin and a proton pump inhibitor is effective in routine clinical practice and is well tolerated.

     

Randomized comparison of differing periods of twice-a-day triple therapy for the eradication of Helicobacter pylori

Background : We assessed the efficacy, compliance, and tolerability of the twice-a-day triple therapy, amoxycillin, omeprazole, and clarithromycin, for Helicobacter pylori and studied the effect of treatment duration (7, 10 or 14 days) on these factors.
Methods : One-hundred and fifty subjects with H. pylori infection documented by ¹³C-urea breath test were randomly assigned to a 7, 10 or 14-day course of amoxycillin 1 g b.d., omeprazole 20 mg b.d. and clarithromycin 500 mg b.d. Subjects returned at the end of therapy for pill count and assessment of side-effects. Subjects returned for a repeat ¹³C-urea breath test 4 weeks after the end of therapy.
Results : Poor compliance (<80% of medications taken) was seen in 0 subjects at 7 days, 6% at 10 days, and 10% at 14 days ( P =0.03 by χ² test for trend; difference for 7 vs. 14 days=10%; 95% CI, −2% to 18%; P =0.056). Intention-to-treat eradication rates were 86% at 7 days, 90% at 10 days and 92% at 14 days. Per-protocol eradication rates were 86% at 7 days, 91% at 10 days, and 95% at 14 days ( P =0.11; difference for 7 vs. 14 days=9%; 95% CI, −2% to 21%; P =0.17).
Conclusions : One week of twice-a-day amoxycillin, omeprazole and clarithromycin is well tolerated and provides a good rate of H. pylori eradication. Increasing the duration of therapy decreases compliance but has the potential to modestly improve efficacy if the patient takes the full complement of medication.     

10天序贯疗法与传统三联疗法根除幽门螺旋杆菌的疗效观察

目的观察由埃索美拉唑、阿莫西林、克拉霉素、替硝唑组成的10 d序贯疗法根除幽门螺旋杆菌的疗效与安全性。方法选取150例14C尿素呼气试验阳性病例,随机分为2组：治疗组前5 d予埃索美拉唑、阿莫西林,后5 d予埃索美拉唑、替硝唑、克拉霉素治疗;对照组予埃索美拉唑、克拉霉素、阿莫西林治疗10 d。治疗结束后,间隔4周行14C尿素呼气试验,复查Hp,评价治疗效果。结果治疗组Hp根除率为89.74%,对照组为75.0%,两组Hp根除率比较具有统计学意义（P〈0.05）。结论以埃索美拉唑、阿莫西林、克拉霉素、替硝唑组成的10 d序贯疗法根除Hp感染疗效优于传统三联疗法。     

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。     

埃索美拉唑为基础的三联一线治疗幽门螺杆菌的疗效

目的 观察埃索美拉哗联合左氧氟沙星和阿莫西林一线治疗幽门螺杆菌的疗效.方法 163例幽门螺杆菌阳性患者,随机分为3组,分别应用埃索美拉唑20mg每13 2次(A组),埃索美拉唑40 mg每13 2次(B组),埃索美拉唑40 mg每日1次(C组),3组均加用左氧氟沙星500 mg每日1次和阿莫西林1000 mg每日2次,疗程7 d.并且对幽门螺杆菌根除率分别按意愿治疗(ITT)分析和方案(PP)分析进行评估.结果 A、B、C组各治疗方案的根除率:ITT法为82.98%、87.10%、70.37%;PP法为86.67%、88.52%,73.08%.B组明显高于C组(P<0.05).结论 埃索美拉唑联合左氧氟沙星和阿莫西林一线治疗能显著提高幽门螺杆菌根除率.     

Two-week eradication regimen for metronidazole-resistant Helicobacter pylori

At present there is no generally accepted treatment regimen for eradicating metronidazole-resistant Helicobacter pylori. This study determines the eradication rate after treatment with 40 mg omeprazole o.m. and 500 mg amoxycillin q.d.s. for 14 days, with 120 mg tripotassium dicitrato bismuthate q.d.s. for the first week (Days 1–7) and 750 mg ciprofloxacin b.d. for the second week (Days 8–14). Thirty patients (16 male, mean age 45 years, range 16–80 years) with duodenal ulcers (n= 18) or non-ulcer dyspepsia (n= 2) and metronidazole-resistant H. pylori detected by histology, culture, in vitro sensitivity tests and a positive ¹³C-urea breath test entered the study. Follow-up was by ¹³C-urea breath test at the end of treatment and at 1, 3, 6, and 12 months. Eradication was denned as a negative ¹³C-urea breath test at least 1 month after finishing treatment. H. pylori was successfully eradicated in 21/30 (71%) patients (median follow-up 10.2 months, range 4–12 months). A pre-treatment ciprofloxacin-resistant strain was isolated in 1/9 patients in whom eradication failed. Of 30 patients 29 completed the 2-week regimen; one patient experienced dizziness after 3 days of treatment. The most common side-effect was increased stool frequency (n= 6). This 2-week treatment regimen for metronidazole-resistant H. pylori is well tolerated and achieves an eradication rate of 70%.     

A triple therapy regimen after failed Helicobacter pylori treatments

BACKGROUND: Following standard triple therapy, up to 20% of patients require further Helicobacter pylori eradication treatment. Data regarding the efficacy of re-treatment in these patients are scarce. AIM: To evaluate the efficacy of a triple therapy after one or more consecutive treatment failures. METHODS: A total of 51 patients with persistent H. pylori infection after at least one unsuccessful standard 1-week regimen were enrolled in the study. H. pylori infection at entry was assessed by rapid urease test and histology on biopsies from the antrum and the corpus. Patients were given a 2-week triple therapy, comprising ranitidine bismuth citrate 400 mg b.d., tetracycline 500 mg t.d.s., and tinidazole 500 mg b.d. Ranitidine bismuth citrate was given during meals, whilst tetracycline and tinidazole was given after meals. Bacterial eradication was assessed by endoscopy (36 patients) or 13C-urea breath test (15 patients) 4-6 weeks after therapy had ended. RESULTS: All 51 patients completed the study and H. pylori eradication was achieved in 46, with an eradication rate of 90% (95% CI: 82-98). In detail, bacterial eradication was obtained in 96% of patients who had previously failed one course of clarithromycin-amoxicillin based triple therapy, in 88% patients who had failed a clarithromycin-tinidazole based triple therapy, in 83% patients who had failed both treatment schedules, and in the only patient who had failed three consecutive therapeutic attempts. Two patients took the therapy for 9 and 10 days instead of the full 14 day-course. No major side-effects were reported, whilst six (12%) patients complained of mild side-effects. CONCLUSION: This study demonstrates that this triple therapy regimen is effective for re-treatment of H. pylori infection.     

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。     

艾普拉唑7d三联疗法及10d序贯疗法根除幽门螺杆菌的临床疗效

目的观察艾普拉唑7 d三联疗法及10 d序贯疗法根除幽门螺杆菌（Hp）的临床疗效。方法 142例经电子胃镜、RUT检查证实Hp阳性的慢性胃炎患者,随机分成3组。A组予艾普拉唑5 mg+阿莫西林克拉维酸钾0.914 g+呋喃唑酮0.1g,bid,疗程7 d;B组予艾普拉唑5 mg+阿莫西林克拉维酸钾0.914 g,疗程5 d,继之艾普拉唑5 mg+克拉霉素0.5 g+呋喃唑酮0.1g,疗程5 d,共计10 d,每天均给药2次;C组予埃索美拉唑20 mg+阿莫西林克拉维酸钾0.914 g+呋喃唑酮0.1 g,bid,疗程7 d。疗程结束4周后行¹⁴C-尿素呼气试验(¹⁴C-UBT),观察Hp根除率、症状缓解率及不良反应发生情况。结果 A、B、C组患者症状缓解率比较差异无统计学意义（P>0.05）;Hp根除率分别为60%、58.54%和55.26%,经检验P均>0.05。3组患者均无明显不良反应发生。结论 3组用药方案虽能达到良好的症状缓解率,但Hp根除率均未超过60%,低于理想标准。