Evaluation of triple and quadruple Helicobacter pylori eradication therapies in Iranian children: a randomized clinical trial

BACKGROUND: Clinical trials in children concerning Helicobacter pylori eradication treatments are scarce. The purpose of this study was to assess the efficacy of proton pump inhibitor (PPI)-based triple therapy using PPI, amoxicillin and clarithromycin in Iranian children. We also evaluated the efficacy of quadruple therapy with PPI, metronidazole, amoxicilin and bismuth citrate in Iranian children. METHODS: This was a randomized clinical trial performed in Emam Khomeini Hospital between 2003 and 2004. Patients with confirmed H. pylori infection by histology were divided into two groups in a randomized 1:1 scheme: the triple regimen group (omeprazole, clarithromycin and amoxicillin for 10 days) and the quadruple regimen group (omeprazole, amoxicillin, metronidazole and bismuth citrate for 10 days). The eradication was assessed by the C-urea breath test 4 weeks after the end of treatment and analyzed by per-protocol and intention-to-treat approaches. RESULTS: One hundred and twenty-two patients (mean age 12.36+/-3.06 years) were entered into the study. Only 100 patients completed the study (50 patients in each regimen group). The eradication rates by triple therapy were 92% and 75.5% for the "per-protocol" and "intention-to-treat" approaches, respectively. In the quadruple regimen group, the eradication rates were 84% by the per-protocol approach and 68.8% in the intention-to-treat approach. Symptom responses to therapy were reported in all patients with successful eradication (88% of all patients). CONCLUSION: With regard to recent recommendations, we also suggest PPI, amoxicillin and clarithromycin triple therapy as a first-line eradication treatment, and quadruple therapies as a second-line option, in Iranian children.     

含莫西沙星的三联方案补救根除幽门螺杆菌的系统评价

目的系统评价含莫西沙星的三联方案补救根除幽门螺杆菌（Hp）的疗效。方法检索比较含莫西沙星的三联方案和含铋剂的四联方案根除幽门螺杆菌补救治疗的随机对照临床试验,并进行荟萃分析。结果共有6项随机对照试验符合人选标准,共纳入725例患者。基于意向治疗（ITT）分析的结果显示含莫西沙星组Hp根除率为74．8％,含铋剂组为62．3％,差异有显著性（OR1．79,95％CI：1．29～2．49,P=0．0005）。基于按符合方案（PPT）分析的结果显示含莫西沙星组Hp根除率为81．4％,含铋剂组为71．7％,差异有显著性（OR1．61,95％CI：1．10～2．36,P=0．01）。进一步对仅纳入英文或中文研究以及疗程为7天的研究行敏感性分析,基于ITT分析的结果亦显示含莫西沙星组Hp根除率显著高于含铋剂组。结论含莫西沙星的三联补救根除Hp方案明显优于含铋剂的四联方案,应为Hp补救根除的优选方案。     

One-week quadruple therapy is an effective salvage regimen for Helicobacter pylori infection in patients after failure of standard triple therapy

Standard triple therapy remains an important option for eradicating Helicobacter pylori (Hp) in developing countries because of its relatively low cost. However, salvage therapies after failure of this regimen remain undefined. The authors therefore investigate the efficacy of 1-week quadruple therapy as a second-line treatment of Hp infection after failure of standard triple therapy. Seventy-eight patients who failed Hp eradication using a 2-week bismuth-based triple therapy were enrolled and received a course of 1-week quadruple therapy (lansoprazole, 30 mg twice daily; bismuth subcitrate, 120 mg four times daily; clarithromycin, 500 mg twice daily; and amoxicillin, 1,000 mg twice daily) as a salvage regimen. The Hp status was reassessed 7 weeks after cessation of therapy. Among the 78 patients, Hp eradication was achieved in 65 (83%, 95% confidence interval = 75-91%) by intention-to-treat analysis. Only five (6%) patients had side effects, and all (100%) showed good drug compliance. Multivariate analysis disclosed that coffee drinking was an independent factor for treatment failure (odds ratio = 5.3, 95% confidence interval = 1.2-23.6, p = 0.028). The authors therefore conclude that their 1-week quadruple therapy is an effective salvage regimen for Hp infection after failure of standard triple therapy in the population examined. The benefits of this regimen include the high eradication rate, the short duration of treatment, fewer side effects, and good drug compliance. Coffee consumption possibly is an important factor in failure of the rescue regimen. The mechanisms underlying the association between coffee drinking and eradication failure require further research.     

Moxifloxacin-containing triple therapy after non-bismuth quadruple therapy failure for Helicobacter pylori infection

AIM: To assess the efficacy of moxifloxacin-containing triple therapy after non-bismuth quadruple therapy failure for Helicobacter pylori(H. pylori) eradication.METHODS: Between January 2010 and December 2012,we screened individuals who were prescribed non-bismuth quadruple therapy for H. pylori eradication. Among them,a total of 98 patients who failed non-bismuth quadruple therapy received 1-wk or 2-wk moxifloxacin-containing triple therapy(400 mg moxifloxacin once daily,and 20 mg of rabeprazole and 1 g of amoxicillin twice daily). H. pylori status was evaluated using the 13C-urea breath test 4 wk later,after treatment completion. The eradication rates were determined by intention-to-treat and per-protocol analyses.RESULTS: In total,60 and 38 patients received 1-wk and 2-wk moxifloxacin-containing triple therapy,respectively. The intention-to-treat and per-protocol eradication rates were 56.7%(95%CI: 45.0-70.0) and 59.6%(95%CI: 46.6-71.7) in the 1-wk group and 76.3%(95%CI: 63.2-89.5) and 80.6%(95%CI: 66.7-91.9) in the 2-wk group(P = 0.048 and 0.036,respectively). All groups had good compliance(95% vs 94.9%). Neither group showed serious adverse events,and the proportions of patients experiencing mild side effects were not significantly different(21.1% vs 13.9%). Clinical factors such as age,sex,alcohol and smoking habits,comorbidities,and presence of gastric or duodenal ulcer did not influence the eradication therapy efficacy. The efficacy of second-line eradication therapy did not differ significantly according to the firstline regimen.CONCLUSION: Two-week moxifloxacin-containing triple therapy showed better efficacy than a 1-wk regimen after non-bismuth quadruple therapy failure.Key words: Helicobacter pylori; Moxifloxacin-based triple; Non-bismuth quadruple; Second-line; Eradication     

Triple, standard quadruple and ampicillin-sulbactam-based quadruple therapies for H pylori eradication： A comparative three-armed randomized clinical trial

AIM: To compare the effectiveness of triple, standard quadruple and ampicillin-sulbactam-based quadruple therapies for H pylori eradication in a comparative threearmed randomized clinical trial. METHODS: A total of 360 H pylori-positive patients suffering from dyspepsia and aging 24-79 years with a median age of 42 years were enrolled in the study and randomly allocated into the following three groups: group A (n = 120) received a standard 1-wk triple therapy (20 mg omeprazole b.i.d., 1000 mg amoxicillin b.i.d., 500 mg clarithromycin b.i.d.); group B (n = 120) received a 10-d standard quadruple therapy (20 mg omeprazole b.i.d., 1000 mg amoxicillin b.i.d., 240 mg colloidal bismuth subcitrate b.i.d., and 500 mg metronidazole b.i.d.); group C (n = 120) received the new protocol, i.e. 375 mg sultamicillin (225 mg ampicillin plus 150 mg sulbactam) b.i.d. (before breakfast and dinner), instead of amoxicillin in the standard quadruple therapy for the same duration. Chi-square test with the consideration of P < 0.05 as significant was used to compare the eradication rates by intention-to-treat and per-protocol analyses in the three groups. RESULTS: The per-protocol eradication rate was 91.81% (101 patients from a total of 110) in group A, 85.84% (97 patients from a total of 113) in group B, and 92.85% (104 patients from a total of 112) in group C. The intentionto-treat eradication rate was 84.17% in group A, 80.83% in group B, and 86.67% in group C. The new protocol yielded the highest eradication rates by both per-protocol and intention-to-treat analyses followed by the standard triple and quadruple regimens, respectively. However, the differences were not statistically significant between the three groups. CONCLUSION: The results of this study provide further support for the equivalence of triple and quadruple therapies in terms of effectiveness, compliance and side-effect profile when administered as first-line treatment for H pylori infection. Moreover, the new protocol using ampicillin-sulbactam instead of amoxicillin in the quadruple regimen is a suitable first-line alternative to be used in regions with amoxicillin-resistant H pylori strains.     

Triple, standard quadruple and ampicillin-sulbactam-based quadruple therapies for H pylori eradication: A comparative three-armed randomized clinical trial

AIM: To compare the effectiveness of triple, standard quadruple and ampicillin-sulbactam-based quadruple therapies for H pylori eradication in a comparative threearmed randomized clinical trial. METHODS: A total of 360 H pylori-positive patients suffering from dyspepsia and aging 24-79 years with a median age of 42 years were enrolled in the study and randomly allocated into the following three groups: group A (n = 120) received a standard 1-wk triple therapy (20mg omeprazole b.I.d., 1000 mg amoxicillin b.I.d., 500 mg clarithromycin b.I.d.); group B (n = 120) received a 10-d standard quadruple therapy (20 mg omeprazole b.I.d., 1000 mg amoxicillin b.I.d., 240 mg colloidal bismuth subcitrate b.I.d., and 500 mg metronidazole b.I.d.); group C (n = 120) received the new protocol, I.e. 375 mg sultamicillin (225 mg ampicillin plus 150 mg sulbactam) b.I.d. (before breakfast and dinner), instead of amoxicillin in the standard quadruple therapy for the same duration. Chi-square test with the consideration of P ＜ 0.05 as significant was used to compare the eradication rates by intention-to-treat and per-protocol analyses in the three groups. RESULTS: The per-protocol eradication rate was 91.81% (101 patients from a total of 110) in group A, 85.84% (97patients from a total of 113) in group B, and 92.85% (104 patients from a total of 112) in group C. The intentionto-treat eradication rate was 84.17% in group A, 80.83% in group B, and 86.67% in group C. The new protocol yielded the highest eradication rates by both per-protocol and intention-to-treat analyses followed by the standard triple and quadruple regimens, respectively. However, the differences were not statistically significant between the three groups. CONCLUSION: The results of this study provide further support for the equivalence of triple and quadruple therapies in terms of effectiveness, compliance and sideeffect profile when administered as first-line treatmentfor Hpylori infection. Moreover, the new protocol using ampicillin-sulbactam instead of amoxicillin in the quadruple regimen is a suitable first-line alternative to be used in regions with amoxicillin-resistant H pylori strains.     

Comparison of short- and long-term treatment protocols and the results of second-line quadruple therapy in children with <Emphasis Type="Italic">Helicobacter pylori</Emphasis> infection

BACKGROUND: Research regarding the optimal therapeutic approach to Helicobacter pylori infection in children is ongoing. There is no consensus as to duration of treatment or second-line therapy. The purpose of this study was compare the efficacy of 7-day and 14-day triple therapies and report the results of second-line quadruple therapy in children. METHODS: A total of 275 consecutive H. pylori-infected patients were enrolled into two groups. Group 1 (n = 180) received triple therapy with 14 days of amoxicillin and clarithromycin and 21 days of proton pump inhibitor. Group 2 (n = 95) received triple therapy including 7 days of amoxicillin and clarithromycin with 21 days of proton pump inhibitor. Subsequently, 89 patients not responding to the triple therapies received quadruple therapy comprising omeprazole (14 days), bismuth subcitrate (7 days), doxycycline (7 days), and metronidazole (7 days). Eradication was evaluated by 13C-urea breath test. RESULTS: The per-protocol eradication rates in groups 1 and 2 were 60.5% and 55.8%, respectively (P = 0.44). In the second interview with 227 patients, severe symptoms were reported to have disappeared in 59% and decreased notably in 34.8%. Helicobacter pylori was eradicated in 66.7% of patients at the end of the quadruple therapy. In the third interview with 75 patients, severe symptoms had decreased in 38.6% and disappeared in 56%. CONCLUSIONS: The different duration of the two treatment regimens had no impact on eradication rates. Furthermore, quadruple therapy was necessary to achieve H. pylori eradication after triple therapy. However, the eradication rate with quadruple therapy was still insufficient. Consequently, a new therapeutic approach to H. pylori infection in children is needed.     

含莫西沙星的三联疗法作为根除幽门螺杆菌一线方案的Meta分析

目的 综合分析含莫西沙星的三联方案作为根除幽门螺杆菌（Hp）一线方案的疗效.方法 检索比较含莫西沙星的三联方案和标准三联方案根除幽门螺杆菌治疗的随机对照临床试验,进行荟萃分析.结果 共有7项随机对照试验符合人选标准,共纳入899例患者.基于意向治疗分析的结果显示含莫西沙星组Hp根除率为85.7%,标准治疗组为74.7%,差异有显著性（P〈0.0001）.基于按符合方案集分析的结果显示含莫西沙星组Hp根除率为86.5%,标准治疗组为76.1%,差异有显著性（P〈0.0001）.进一步行敏感性分析显示,纳入高质量研究、中文研究、疗程7天的研究和不同疾病谱的研究时结果均未出现变化.结论 含莫西沙星的三联治疗方案有较高的Hp根除率,且优于目前的标准治疗方案,可以作为根除Hp的一线治疗方案.     

含左氧氟沙星的四联方案补救治疗幽门螺杆菌的临床研究

目的 评价含左氧氟沙星的四联方案补救治疗幽门螺杆菌的有效性和安全性。方法 33例幽门螺杆菌初次根除失败的消化性溃疡或慢性萎缩性胃炎患者接受了下述10天含左氧氟沙星的四联方案：质子泵抑制剂（标准剂量）＋枸橼酸铋钾（0．22g）＋左旋氧氟沙星（0．2g）＋阿莫西林（1．0g）b．d，4周后通过^13C-尿素酶呼吸试验判断根除成功与否。结果 2例失访，余31例完成治疗及随访，其中26例补救根除成功，5例补救治疗失败，6例（18．18％）患者发生轻微不良反应，根据意向处理分析（ITT）和完成治疗分析（PP），根除率分别为78．79％和83．87％。结论 含左氧氟沙星的四联方案为安全有效的幽门螺杆菌补救治疗方案。     

瑞倍三联疗法根除幽门螺杆菌的临床研究

目的观察以枸橼酸铋雷尼替丁(Ranitidine Bismuth Citrate,RBC瑞倍)为基础的三联疗法对幽门螺杆菌(Hp)根除疗效及安全性。方法将确诊为Hp阳性147例患者随机分为3组,即瑞倍组、奥美拉唑组和雷尼替丁组,疗程1周,应用14C-尿素呼气试验及荧光定量PCR法检测Hp-DNA判断Hp根除效果。结果根据意图分析治疗(ITT)分析Hp根除率分别为瑞倍组83.7%、奥美拉唑组87.5%、雷尼替丁组70%。根据试验方案分析(PP)Hp根除率分别为87.2%、93.3%及72.9%。瑞倍组Hp根除率与奥美拉唑组相近,但2组均较雷尼替丁组明显升高。瑞倍组和奥美拉唑组较雷尼替丁组消化道症状明显改善,但瑞倍组与奥美拉唑2组间无明显差异。瑞倍组与奥美拉唑组不良反应均较雷尼替丁组轻微。结论瑞倍三联疗法根除Hp的临床疗效优于雷尼替丁三联疗法,但与奥美拉唑三联疗法相当,副反应发生情况也与奥美拉唑三联疗法无显著性差异,且因瑞倍相对价格低廉,值得作为一线药物推广应用。     

Second-line bismuth-containing quadruple therapy for Helicobacter pylori eradication and impact of diabetes

AIM To investigate Helicobacter pylori (H. pylori) eradication rates using second-line bismuth-containing quadruple therapy and to identify predictors of eradication failure.METHODS This study included 636 patients who failed firstline triple therapy and received 7d of bismuthcontaining quadruple therapy between January 2005 and December 2015. We retrospectively demonstrated H. pylori eradication rates with respect to the year of therapy as well as demographic and clinical factors. H. pylori eradication was confirmed by a 13C-urea breath test or a rapid urease test at least 4 wk after the completion of bismuth-based quadruple therapy: proton pump inhibitor, metronidazole, bismuth, and tetracycline.RESULTS The overall eradication rates by intention-to-treat analysis and per-protocol analysis were 73.9%( 95% CI : 70.1 %- 77.4%) and 94.5% (95% CI : 92.4%-96.5%), respectively. Annual eradication rates from 2005 to 2015 were 100.0%, 92.9%, 100.0%, 100.0%, 100.0%, 97.4%, 100.0%, 93.8%, 84.4%, 98.9%, and 92.5%, respectively, by per-protocol analysis. A multivariate analysis showed that diabetes mellitus (OR=3.99, 95%CI: 1.56-10.20, P=0.004)was associated with H. pylori eradication therapy failure.CONCLUSION The second-line bismuth-containing quadruple therapy for H. pylori infection is still effective in Korea, and diabetes mellitus is suggested to be a risk factor for eradication failure.     

根除老年人消化性溃疡合并幽门螺旋杆菌感染的治疗策略

目的对质子泵抑制剂（PPI）或铋剂三联疗法作为初治方案以及序贯疗法或四联疗法作为补救方案根除老年人消化性溃疡（PUA）合并幽门螺旋杆菌（Hp）感染的疗效进行比较。方法2009年7月至2010年7月间261例胃镜下尿素酶法诊断的PUA合并Hp感染患者,随机采用PPI三联疗法、铋剂三联1周疗法进行根除,观察治疗过程中不良反应发生率。PUA患者经上述抗Hp治疗后继续4周抗溃疡治疗,停药1月后复查胃镜并比较两种方法对Hp根除率及溃疡愈合率的疗效差异。对于首次三联疗法根除Hp失败者,随机应用10日序贯疗法和PPI、铋剂四联1周疗法再次行Hp根除。观察疗程中不良反应发生率,停药1个月后采用”C呼气试验观察Hp根除率。统计分析采用符合方案（PP）群组分析和意向治疗（ITT）群组分析。结果相比于铋剂三联疗法,PPI三联疗法Hp根除率（ITT：77．7％vs62．6％;PP：79．5％v564．1％;P〈0．05）及溃疡愈合率（ITT：78．5％vs64．9％;PP：80．3％vs66．4％;P〈0．05）高,不良反应发生率无明显差异（1TT：10．8％vs16．8％：PP：11．0％vs17．2％;P〉0．05）。对于首次三联疗法失败者以10日序贯疗法补救,Hp根除率较高（ITT：84．6％vJ61．5％;PP：86．8％v563．2％;P〈0．05）,且不良反应发生率较四联疗法低（ITT：12．8％VS35．9％;PP：13．2％VS36．8％;P〈0．05）。结论PPI三联1周疗法进行Hp感染根除可作为PUA患者首选,有较高的溃疡愈合率和Hp根除率;首次根除失败者可优先改用10日序贯疗法进行补救。     

基于莫西沙星的三联疗法作为幽门螺杆菌感染二线治疗的研究

目的评价基于莫西沙星的三联疗法作为幽门螺杆菌（Hp）感染二线治疗的疗效和安全性。方法将74例经标准三联疗法治疗失败的Hp感染患者随机分为A组和B组,两组均为37例。A组给予口服雷贝拉唑10mg＋阿莫西林1g＋莫西沙星400mg,均为2次/d;B组给予口服雷贝拉唑10mg（2次/d）＋枸橼酸铋钾300mg（4次/d）＋甲硝唑（400mg,3次/d）＋四环素（500mg,3次/d）。两组均治疗7d,疗程结束后4周复查~（14）C尿素呼气试验。结果按意向治疗分析A组和B组的Hp根除率分别为78.4%和56.8%,差异有统计学意义（P=0.047）;按符合方案分析A组和B组的Hp根除率分别为85.3%和70.0%,差异无统计学意义（P=0.140）。两组的不良反应率分别为10.8%和27.0%,差异无统计学意义（P=0.075）。结论含莫西沙星的三联方案优于含铋剂的四联方案,是一种疗效好且安全性高的Hp根除二线疗法。     

Helicobacter pylori eradication: a randomized prospective study of triple therapy versus triple therapy plus lactoferrin and probiotics

OBJECTIVES: Helicobacter pylori is causally associated with gastritis and peptic ulcer diseases. Recent data (meta-analysis) have demonstrated that triple therapy with amoxicillin, clarithromycin, and a proton pump inhibitor has an eradication rate of only 74-76% and new therapeutic protocols may be necessary. The aim of this study was to examine whether adding bovine lactoferrin (bLf) and probiotics (Pbs) to the standard triple therapy for H. pylori infection could improve the eradication rate and reduce side effects. METHODS: H. pylori infection was diagnosed in 206 patients: in 107 based on an upper endoscopy exam and a rapid urease test, and in 99 by means of the H. pylori stool antigen-test and the C(13) urea breath test (C(13) UBT). The patients were randomized into two groups: 101 patients (group A) underwent standard triple eradication therapy (esomeprazole, clarithromycin, amoxicillin), while 105 patients (group B) underwent a modified eradication therapy (standard triple eradication therapy plus bLf and Pb). Successful eradication therapy was defined as a negative C(13) UBT 8 wk after completion of the treatment. Results were evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis. Data were evaluated and considered positive when P<0.05. RESULTS: At the end of the study 175/206 patients showed negative C(13) UBT results. According to intention-to-treat analysis, the infection was eradicated in 73/101 patients from Group A and in 93/105 from Group B. PP analysis showed 73/96 patients from Group A and 93/101 from Group B to have been successfully treated. More patients from group A than from group B reported side effects from their treatment (P<0.05). CONCLUSIONS: The results of our study suggest that the addition of bLf and Pbs could improve the standard eradication therapy for H. pylori infection--bLf serving to increase the eradication rate and Pbs to reduce the side effects of antibiotic therapy.     

嗜酸乳杆菌联合四联疗法根除幽门螺杆菌的补救治疗

背景:随着抗菌药物广泛应用,标准三联疗法根除幽门螺杆菌(Hp)的疗效呈下降趋势。近来研究显示嗜酸乳杆菌(LA)对Hp具有一定抑制作用。目的:评价LA联合四联疗法对根除Hp补救治疗的疗效。方法:584例经标准三联疗法根除Hp失败的患者随机分为实验组和对照组,实验组前7d口服埃索美拉唑20mgbid+复方铝酸铋1.3gtid+克拉霉素250mgbid+替硝唑1.0gbid+复方嗜酸乳杆菌片1.0gtid,后3个月口服复方嗜酸乳杆菌片1.0gtid。对照组前7d口服埃索美拉唑20mgbid+复方铝酸铋1.3gtid+克拉霉素250mgbid+替硝唑1.0gbid+维生素C片0.1gtid,后3个月口服维生素C片0.1gtid。治疗结束后4周以14C-尿素呼气试验评估根除疗效,试验结果阴性的患者在治疗结束后第3、6、9、12个月复查14C-尿素呼气试验。结果:实验组实际完成方案者259例,对照组实际完成方案者267例。实验组、对照组按意向治疗(ITT)分析Hp根除率分别为84.8%和61.4%,按方案(PP)分析Hp根除率分别为90.3%和70.8%,实验组ITT和PP根除率均显著高于对照组(P<0.05)。实验组Hp累积阴性率为98.8%±0.8%,对照组Hp累积阴性率为96.7%±1.5%,实验组Hp累积阴性率较对照组显著升高(P<0.05)。实验组Hp复发风险为0.007%±0.001%,对照组Hp复发风险为0.501%±0.013%,实验组Hp复发风险较对照组显著降低(P<0.05)。结论:LA联合四联疗法可作为安全有效的Hp根除失败的补救治疗。     

Treatment of Helicobacter pylori in surgical practice： A randomised trial of triple versus quadruple therapy in a rural district general hospital

AIM： To compare a lansoprazole-based triple versus quadruple therapy for Helicobacter pylori （H pylori） eradication with emphasis on side effect profile, patient compliance and eradication rate at a rural district general hospital in Wales, United Kingdom. METHODS： One hundred one patients with H pylori infection were included in the study. Patients were randomised to receive triple therapy comprising of lansoprazole 30 mg, amoxycillin 1 g, clarithromycin 500 mg, all b.d. （LAC）, or quadruple therapy comprising of lansoprazole 30 mg b.d., metronidazole 500 mg t.d.s., bismuth subcitrate 240 mg b.d., and tetracycline chloride 500 mg q.d.s. （LMBT）. Cure was defined as a negative 13C urea breath test 2 mo after treatment. RESULTS： Seven patients were withdrawn after randomisation. Fifty patients were assigned to LAC group and 44 to LMBT group. The intention-to-treat cure rates were 92% and 91%, whereas the perprotocol cure rates were 92% and 97%, respectively. Side effects were common, with 56% experiencingmoderate to severe symptoms in the LAC group and 59% in the LMBT group. Symptoms of vomiting, diarrhoea and black stools were significantly more common in the LMBT group. Patient compliance was 100% for triple therapy and 86% for quadruple therapy （P 〈 0.01）. One-third of patients in both groups were still taking acid-reducing medications at six-month follow-up. CONCLUSION： One-week triple and quadruple therapies have similar intention-to-treat eradication rates. Certain side effects are more common with quadruple therapy, which can compromise patient compliance. Patient education or modifications to the regimen are alternative options to improve compliance of the quadruple regimen.     

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。     

含芦氟沙星四联疗法和含大剂量阿莫西林二联疗法用于幽门螺杆菌根除失败后补救治疗的疗效分析

背景:一线三联疗法根除幽门螺杆菌(Hp)的失败率日益增高。如何选用有效的抗菌药物进行Hp根除失败的补救治疗是临床亟待解决的问题。目的:评估含芦氟沙星四联疗法和含大剂量阿莫西林二联疗法补救根除Hp的有效性和安全性。方法:93例Hp根除失败的患者随机进入含芦氟沙星四联疗法(RBRF)组(雷贝拉唑10 mg bid+枸橼酸铋雷尼替丁220 mg bid+芦氟沙星200 mg qm+呋喃唑酮100 mg bid,疗程14 d)和含大剂量阿莫西林二联疗法(RA)组(雷贝拉唑20 mg bid+阿莫西林1000 mg tid,疗程14 d),治疗结束4周后复查13C-尿素呼气试验,评估Hp根除疗效。结果:共85例患者完成试验,RBRF组按意向治疗(ITT)和按方案(PP)分析根除率分别为83.3%和90.9%,RA组分别为80.0%和87.8%,两组ITT和PP根除率差异均无统计学意义(P>0.05)。按PP分析,RBRF组不良反应发生率显著高于RA组(15.9%对2.4%,P<0.05),所有不良反应均在停药后消失。结论:对Hp根除失败的患者,含芦氟沙星四联疗法和含大剂量阿莫西林二联疗法均可作为安全、有效的补救治疗方案。     

Esomeprazole-based therapy in Helicobacter pylori eradication: a meta-analysis

AIM: To perform a systematic review on the efficacy of esomeprazole-based therapies in Helicobacter pylori eradication, and to conduct a meta-analysis comparing the efficacy of esomeprazole and other proton pump inhibitors when co-prescribed with antibiotics. METHODS: Studies evaluating esomeprazole plus antibiotics were considered. Only randomised trials comparing esomeprazole and other proton pump inhibitors with antibiotics, and differing only in the proton pump inhibitor, were included in the meta-analysis. Electronic and manual bibliographical searches were conducted. The percentage (weighted mean) of eradication success was calculated. Meta-analysis was performed combining the odd ratios of the individual studies. RESULTS: Mean cure rates with dual regimens (esomeprazole plus clarithromycin) were 51 and 54%, respectively, by intention-to-treat and by per-protocol. Corresponding figures with triple regimens (esomeprazole plus clarithromycin and either amoxicillin or metronidazole) were 82% (intention-to-treat) and 86% (per-protocol). Four studies were included in the meta-analysis: mean H. pylori eradication rates (intention-to-treat) with esomeprazole plus antibiotics was 85 and 82% when omeprazole was used (odds ratio = 1.19; 95% confidence interval = 0.81-1.74), results being statistically homogeneous. When subanalysis included only high quality studies, the odds ratio for this comparison was closer to one (1.08; 95% confidence interval = 0.4-1.47) and results were more homogeneous. CONCLUSIONS: Esomeprazole-based triple therapy is highly effective for the eradication of H. pylori infection and offers comparable efficacy to omeprazole-based therapy.     

Rifabutin-based triple therapy after failure of Helicobacter pylori eradication treatment: preliminary experience

Despite continuous improvement of Helicobacter pylori (Hp) eradication therapy, new treatment regimens are necessary if established first-line treatments fail. In the present pilot study, a recently described rifabutin-based triple therapy was evaluated after preceding failure of triple therapy. Rifabutin (150 mg), amoxicillin (1 g), and lansoprazole (30 mg) were administered twice daily for 1 week to 25 patients infected with Hp who had previously failed to respond to eradication treatment and/or who had developed resistance to macrolides and nitroimidazoles. Four patients were lost to follow-up. Eradication rate of rifabutin-based triple therapy was 86% (18/21; per protocol) and 72% (18/25; intention-to-treat). Side effects were minimal. It is concluded that this new drug combination is an effective therapy for Hp strains resistant to clarithromycin or metronidazole; however, rifabutin-based treatment regimens for Hp eradication should be restricted to patients infected with resistant strains.