Efficacy of Different Helicobacter pylori Eradication Regimens in Patients Affected by Insulin-Dependent Diabetes Mellitus

Background: Patients with insulin-dependent diabetes mellitus (IDDM) are often affected by chronic infections; antibiotic absorption, however, may be influenced by the disease. H. pylori eradication appears to be reduced in IDDM patients. The aim of the study was to evaluate the efficacy of the most common H. pylori eradication regimens in a population of IDDM-infected patients. Methods: One hundred and seventy-two IDDM patients were evaluated. H. pylori infection was assessed through the 13C-urea breath test. Infected patients were randomly assigned to three different standard 7-day eradication regimens: 1) amoxicillin, clarithromycin, pantoprazole; 2) tinidazole, clarithromycin, ranitidine bismuth citrate; or 3) tinidazole, clarithromycin, pantoprazole. Patients in whom eradication was not successful in the first cycle were subsequently submitted to a 7-day therapy with tinidazole, tetracycline, bismuth, and pantoprazole. Results: Thirty-seven per cent of IDDM patients were infected. None of the triple therapies used provided an eradication higher than 62%. Conversely, the quadruple regimen was successful in 88% of the patients. Ten per cent of the subjects undergoing the triple therapies showed minor side effects, without significant differences among groups, whereas side effects occurred in 25% of the patients treated with the quadruple therapy (P < 0.05). Conclusions: IDDM patients show a low H. pylori eradication rate with a standard triple therapy regardless of the regimen utilized, the dosage and/or the duration of the therapy used appearing not to be sufficient to eradicate the infection efficiently. The use of a quadruple regimen leads to the cure of a large percentage of the infected patients in whom the eradication was unsuccessful in the first therapy, although it is accompanied by a greater incidence of minor side effects.     

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。     

Quadruple therapy with lactoferrin for Helicobacter pylori eradication: A randomised, multicentre study

BACKGROUND: Helicobacter pylori eradication rate with standard triple therapies is decreasing. Recently, lactoferrin administration has been shown to significantly increase the cure rate of 7-day rabeprazole, clarithromycin and tinidazole triple therapy. We assessed whether lactoferrin also increases the eradication rate of 7-day esomeprazole, clarithromycin and amoxycillin triple therapy as first-line treatment. METHODS: Overall, 133 consecutive patients with non-ulcer dyspepsia and H. pylori infection were randomised to receive either a standard 7-day triple therapy with esomeprazole 20mg b.i.d., clarithromycin 500 mg b.i.d. and amoxycillin 1g b.i.d. (68 patients) or a quadruple therapy comprising of the same regimen plus lactoferrin 200mg b.i.d. (65 patients). H. pylori at entry was assessed by endoscopy, while bacterial eradication was checked by (13)C urea breath test 4-6 weeks after treatment. RESULTS: H. pylori eradication following standard triple therapy was achieved in 53/68 (77.9%; 95% CI = 68-88) and in 53/66 (80.3%; 95% CI = 71-89) patients at ITT and PP analyses, respectively. Following the quadruple regimen, the infection was cured in 50/65 (76.9%; 95% CI = 67-87) and 50/64 (78.1%; 95% CI = 68-88) patients at ITT and PP analyses, respectively. No statistically significant difference emerged between the two therapeutic regimens, both at ITT (p = 0.9) and PP analyses (p = 0.9). Side effects were complained by seven (10.3%) patients and six (9.2%) patients following the triple and quadruple regimens, respectively (p = 0.9), with only one patient in the quadruple group interrupting the treatment due to side effects. CONCLUSIONS: Quadruple therapy with lactoferrin did not significantly increase the H. pylori cure rate of standard 7-day clarithromycin-amoxycillin based triple therapy in non-ulcer dyspepsia patients.     

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。     

3种幽门螺杆菌根除方案和抗生素耐药对其根除率的影响

背景:目前推荐的根除幽门螺杆菌(H.pylori)的治疗方案因H.pylori对大环内酯类和硝基咪唑类抗生素的耐药性快速增加而不能令人满意。目的:评估以质子泵抑制剂(PPI)为基础或以H2受体拮抗剂(H2RA)加铋剂为基础的三联或四联疗法根除H.pylori的疗效和安全性,评估H.pylori的耐药性及其对根除率的影响。方法:120例H.pylori感染的愈合期十二指肠球部溃疡或非溃疡性消化不良患者随机分入3个治疗组,疗程7天。A组:奥美拉唑、克拉霉素和替硝唑;B组:法莫替丁、枸橼酸铋钾、克拉霉素和替硝唑;C组:法莫替丁、枸橼酸铋钾、呋喃唑酮和四环素。根除治疗前取胃窦黏膜活检组织行快速尿素酶试验、H.pylori培养和组织学检查评估H.pylori感染状态。治疗结束后4～6周,采用13C-尿素呼气试验评估H.pylori根除情况。琼脂扩散法药物敏感试验测定抗生素的最小抑菌浓度(MIC)。结果:所有患者均完成治疗和随访。A组、B组和C组的H.pylori根除率分别为80%(32/40)、85％(34/40)和90％(36/40),3组间无显著差异(P>0.05)。耐药菌株与敏感菌株的H.pylori根除率有显著差异。结论:以PPI为基础或以H2RA加铋剂为基础的三联或四联疗法对H.pylori具有较高的根除率。H.py-lori的耐药性是影响根除率的主要因素。     

评估以泮托拉唑为基础的三联和四联疗法根除幽门螺杆菌的疗效

目的 比较以泮托拉唑为基础的7d标准三联疗法与泮托拉唑+铋剂+甲硝唑+四环素的10 d四联疗法根除Hp的疗效和安全性.方法 170例非溃疡性消化不良的Hp感染者随机入选三联、四联治疗组.三联治疗组实行PAC方案:泮托拉唑40 mg(2次/d)+阿莫西林1.0 g(2次/d)+克拉霉素500 mg(2次/d),口服7 d.四联治疗组实行PBMT方案:泮托拉唑40 mg(2次/d)+胶体次枸橼酸铋220 mg(2次/d)+四环素750 mg(2次/d)+甲硝唑400 mg(2次/d),口服10 d.治疗结束后至少停药4周后复查13C-尿素呼气试验,结果≤4%.为Hp阴性,表示根除成功.同时评估疗效及安全性.结果 166例患者按方案完成治疗.三联治疗组按意图治疗分析(ITT)根除率为63.53%(54/85),较四联治疗组低[89.41%(76/85),x2=17.168,P=0.000].三联治疗组按实验方案分析(PP)根除率为65.06%(54/83),亦较四联治疗组低[91.57%(76/83),x2=13.588,P=0.000].从年龄段分析,年龄＞30岁者三联治疗组根除失败率为22.22%(4/18),较四联治疗组高[3.84%(1/26),x2=19.884,P=0.000].三联和四联治疗组不良反应发生率分别为60.00%(51/85)和42.35%(36/85).结论 在7 d标准三联疗法Hp根除疗效降低的情况下,含泮托拉唑、铋剂、四环素和甲硝唑的10 d四联方案可考虑为首选方案.

Abstract：

Objective Compare the efficacy and safety of pantoprazole-based 7-day standard triple therapy with 10-day quadruple therapy including pantoprazole, bismuth, metronidazole and tetracycline in Helicobacter pylori (H.pylori) eradication.Methods A total of 170 H.pylori positive patients with non-ulcer dyspepsia were recruited and randomly assigned into triple and quadruple therapy groups.The triple therapy group was implemented with PAC program which included orally taking pantoprazole 40 mg twice per day, amoxicillin 1.0 g twice per day and clarithromycin 500 mg twice per day for seven days.The quadruple therapy group was implemented with PBMT program which consisted of orally taking pantoprazole 40 mg twice per day, colloidal bismuth subcitrate 220 mg twice per day, metronidazole 400 mg three times per day and tetracycline 750 mg twice per day for ten days.The 13C -urea breathe test was re-examined at least 4 weeks after the completion of treatment, the result lower than 4%.was H.pylori negative which indicated the success of H.pylori eradication.The efficacy and safety were also evaluated.Results A total of 166 patients completed the treatment.With intention-to-treat (ITT) analysis, the H.pylori eradication rate in the triple therapy group was 63.5% (54/85), lower than that of the quadruple therapy group (89.41%(76/85) ,x2= 17.168,P=0.000).With per protocol (PP) analysis, the eradication rate in the triple therapy group was 65.06% (54/83), also lower than that of the quadruple therapy group (91.57 % (76/83) ,x2 = 13.588 ,P=0.000).Through the age analysis, in patients over 30 years old,the eradication failed rate in the triple therapy group was 22.22% (4/18), higher than that of the quadruple therapy group (3.84% (1 / 26), x2 = 19.884, P=0.000).The incidence of adverse reaction rates of the triple and quadruple therapy group were 60.00% (51/85) and 42.35 % (36/85) respectively.Conclusion Since the reduction of eradication rate with seven day standard triple therapy,the 10-day pantoprazole, bismuth, metronidazole and tetracycline quadruple therapy may be considered as the first choice.     

Efficacy and tolerability of antibiotics in patients undergoing H. pylori eradication

BACKGROUND/AIMS: Helicobacter pylori (H. pylori) infection is one of the most common gastrointestinal diseases. An increasing number of people undergo different treatment options. Unfortunately, H. pylori therapy may be troublesome for drug side effects and inefficacious for resistance to antibiotics. METHODOLOGY: One hundred and ninety-three (193) H. pylori-positive patients were randomly assigned to one of the following 7-day treatments: Group A (N = 64): amoxicillin, clarithromycin and rabeprazole; Group B (N = 64): tinidazole, clarithromycin and ranitidine bismuth citrate; Group C (N = 65): tinidazole, clarithromycin and rabeprazole Eradication was assessed by 13C-Urea Breath Test 6-8 weeks after the end of the therapy. Not-eradicated patients underwent a second cycle with tinidazole, tetracycline, bismuth and rabeprazole. All patients were asked to complete a validated questionnaire regarding presence and intensity of drug side effects. RESULTS: One hundred and eighty-eight out of the 193 H. pylori-positive patients (96%) completed therapy. No significant difference in eradication rates was observed among the three groups both in intention to treat analysis and in per protocol analysis. No significant difference in incidence of side effects occurred among groups after the first-line regimens: 48% in group A, 44% in group B and 46% in group C. Twenty-two out of the 193 enrolled subjects (11%) were not eradicated after the first-line therapy. Among them, 86% were successfully eradicated by the tinidazole, tetracycline, bismuth and rabeprazole therapy. Moreover, during quadruple therapy, a higher prevalence and intensity of side effects than in each one of the groups submitted to the first-line triple therapy was observed. CONCLUSIONS: This study shows that triple rabeprazole-based eradicating regimens are effective and safe. Incidence of side effects seems low and similar in different three-drug regimens used. Quadruple therapy, which appear highly efficacious as a second line therapy, is associated with a significantly higher incidence of side effects when compared to first-line treatment.     

Helicobacter pylori eradication with either 7-day or 10-day triple therapies, and with a 10-day sequential regimen.

BACKGROUND: Helicobacter pylori eradication rates achieved by standard seven-day triple therapies are decreasing in several countries, while a novel 10-day sequential regimen has achieved a very high success rate. A longer 10-day triple therapy, similar to the sequential regimen, was tested to see whether it could achieve a better infection cure rate. METHODS: Patients with nonulcer dyspepsia and H pylori infection were randomly assigned to one of the following three therapies: esomeprazole 20 mg, clarithromycin 500 mg and amoxycillin 1 g for seven days or 10 days, or a 10-day sequential regimen including esomeprazole 20 mg plus amoxycillin 1 g for five days and esomeprazole 20 mg, clarithromycin 500 mg and tinidazole 500 mg for the remaining five days. All drugs were given twice daily. H pylori eradication was checked four to six weeks after treatment by using a 13C-urea breath test. RESULTS: Overall, 213 patients were enrolled. H pylori eradication was achieved in 75.7% and 77.9%, in 81.7% and 84.1%, and in 94.4% and 97.1% of patients following seven-day or 10-day triple therapy and the 10-day sequential regimen, at intention-to-treat and per protocol analyses, respectively. The eradication rate following the sequential regimen was higher than either seven-day (P=0.002) or 10-day triple therapy (P=0.02), while no significant difference emerged between the latter two regimens (P=0.6). CONCLUSIONS: The 10-day sequential regimen was significantly more effective than both triple regimens, while 10-day triple therapy failed to significantly increase the H pylori eradication rate achieved by the standard seven-day regimen.     

Comparison of the effectiveness of quadruple salvage regimen for Helicobacter pylori infection according to the duration of treatment]

BACKGROUND/AIMS: At present, triple therapy schemes are recommended by national and international consensus conferences for the treatment of Helicobacter pylori (H. pylori) infection. However, even with the most effective current treatment regimens, about 10-20% of patients fail to eradicate H. pylori, necessitating alternative strategy to eradicate H. pylori in primary treatment failure. Therefore, we performed this study to evaluate the efficacy of quadruple therapy and to compare 1 and 2-week quadruple regimen as a second-line therapy. METHODS: The hospital records of 155 patients who failed to the standard triple therapy (proton pump inhibitor, amoxicillin, clarithromycin) were reviewed retrospectively, and divided the 1 or 2 weeks OBMT regimen (omeprazole 20 mg bid, bismuth salt 120 mg qid, metronidazole 500 mg tid, tetracycline 500 mg qid). Presence of H. pylori infection and side-effects of the treatment regimen were assessed 4 weeks after the cessation of treatment. RESULTS: One hundred and eight male and 47 female (mean age, 52.2+/-15.4) patients were enrolled. The overall eradication rate of H. pylori with quadruple therapy was 83.9% and the eradication rate was similar between 1 and 2 weeks of OBMT regimen (76.8% in OBMT 1 week, 87.9% in OBMT 2 weeks, respectively p=0.110). CONCLUSIONS: Quadruple therapy is an effective salvage regimen for H. pylori eradication after the failure of standard triple therapy. One week quadruple therapy is not significantly different from 2-weeks regimen as the second-line option for H. pylori eradication.     

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.     

The efficacy of levofloxacin based triple therapy for Helicobacter pylori eradication]

BACKGROUND/AIMS: The failure rates of first and second line therapies of Helicobacter pylori (H. pylori) eradication range from 15 to 20%. This study was aimed to evaluate the efficacy and safety of levofloxacin based triple therapy compared with standard triple or quadruple therapy for H. pylori eradication in Korea. METHODS: We enrolled two hundred and sixty seven patients with presence of H. pylori infection. One hundred and forty-one patients were treated with levofloxacin based triple therapy (LAP; levofloxacin, amoxicillin, proton pump inhibitor; PPI), and 126 patients were treated with standard triple therapy (CAP; clarithromycin, amoxicillin, PPI). We retreated the patients who had failed in H. pylori eradication with standard quadruple second-line therapy (MTPB; metronidazole, tetracycline, PPI, bismuth subcitrate) or levofloxacin based therapy (LAP or LCP; levofloxacin, clarithromycin, PPI). RESULTS: In first line therapy of H. pylori eradication, the eradication rates of levofloxacin based triple therapy and standard triple therapy were 69.8% and 74.0% respectively (p=0.52). In second-line therapy, the eradication rate of levofloxacin based triple therapy and standard quadruple therapy were 62.5% and 40.0% respectively (p=0.34). CONCLUSIONS: Levofloxacin based triple therapy is effective as standard regimen to eradicate H. pylori infection and is useful for an alternative rescue therapy as well.     

泮托拉唑四联5d疗法与7d疗法随机对照研究

目的:比较泮妥拉唑四联5d疗法和7d疗法的Hpylori根除率和症状缓解率.方法:H pylori阳性的胃炎、胃溃疡或十二指肠患者70例随机接受5d(34例)或7d(36例)泮妥拉唑四联疗法:泮妥拉唑40mg、克拉霉素250mg、阿莫西林1.0g和胶体枸橼酸铋钾220 mg,均为2次/d.根除治疗后第4周复查H pylori是否根除,了解症状缓解情况.结果:5d组H pylori根除率为84.8%(PP)和82.4%(ITT),7d组H pylori根除率为88.2%(PP)和83.3%(ITT),5d组疼痛缓解率为72.0%(PP)和69.2%(ITT),7d组疼痛缓解率为83.9%(ITT)和89.7%(PP).按PP及ITT组群分析,两组方案H pylori根除率及疼痛缓解率无明显差异,两组患者均未出现严重不良反应.结论:泮妥拉唑四联5d疗法可以获得较高的H pylori根除率和疼痛缓解率,可以作为H pylori根除治疗的一线治疗方案.     

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.     

Rifabutin based triple therapy for eradication of H. pylori primary and secondary resistant to tinidazole and clarithromycin

BACKGROUND: Rifabutin has been empirically used in Helicobacter pylori infections resistant to triple therapy. There are no data on primary and secondary resistance to rifabutin and its use in specific cases. AIM: To analyse the susceptibility and resistance to rifabutin in H. pylori-positive patients with or without previous H. pylori therapy and to test the efficacy of rifabutin in H. pylori resistant to clarithromycin and tinidazole. METHODS: Four hundred and twenty H. pylori-positive patients without previous exposure to triple therapy and 104 patients who had already received one course of triple therapy underwent upper endoscopy for dyspeptic symptoms and H. pylori susceptibility test. Amoxicillin, clarithromycin, tinidazole and rifabutin were evaluated for resistance and susceptibility. Forty patients with primary resistance to both clarithromycin and tinidazole and with susceptibility to amoxicillin and rifabutin, and 65 patients with secondary resistance and susceptibility to the same antibiotics were identified. All these patients received a 10-day triple therapy with pantoprazole amoxicillin and rifabutin. Treatment success was evaluated by the 13C-Urea Breath test. RESULTS: In naive patients 23% of strains were resistant to clarythromycin, 35% to tinidazole, 9% to both antibiotics, and none was resistant to rifabutin In patients already treated the percentages of resistant strains were 76, 64.4, 62.5 and 1%, respectively. With rifabutin based triple therapy eradication rates were (Per Protocol and Intention-to-Treat analysis) 100 and 87.5% in primary resistance to clarithromycin and tinidazole and 82.2 and 78.5% in secondary resistance. CONCLUSION: H. pylori primary and secondary resistances to clarithromycin and tinidazole are high in our geographic area, while resistance to rifabutin is rare. Rifabutin-based triple therapy, can be successfully used in primary and secondary resistance to clarithromycin and tinidazole according to the in vitro susceptibility test.     

幽门螺杆菌根除治疗失败后的补救治疗

幽门螺杆菌（H.pylori)对抗生素的耐药率上升是导致根除治疗失败率上升的主要原因，对经标准方案根除H.pylori失败的患者有必要进行补救治疗。目的：评估铋剂、质子泵抑制剂（PPI）联用呋喃唑酮和四环素组成的7天四联方案用于根除H.pylori治疗失败后补救治疗的疗效，以及H.pylori耐药对疗效的影响。方法：予35例经含克拉霉素根除H.pylori方案治疗、H.pylori仍为阳性的患者以为期7天的四联治疗：枸橼酸铋钾220mg bid 奥美拉唑20mg bid 呋喃唑酮100mg bid 四环素750mg bid。治疗前取胃窦黏膜活检标本进行快速尿素酶试验、组织学检查和培养检测H.pylori。用琼脂扩散法测定克拉霉素、呋喃唑酮和四环素的最低抑菌浓度（MIC）。治疗结束后至少4周，采用^13C-尿素呼气试验进行H.pylori感染状态评估。结果：33例患者完成治疗和随访，2例失访。根据意图治疗（ITT）和试验方案（PP）分析，该补救方案的H.pylori根除率分别为68．6％（24／35）和72．7％（24／33）。10例（28．6％）患者发生轻度副反应（9例发生恶心、中上腹不适，1例发生皮疹）。35例中有27例H.pylori培养成功，克拉霉素的耐药率为51．8％（14／27），呋喃唑酮为3．7％（1／27），四环素为7．4％（2／27）。各药物耐药菌株和敏感菌株的H.pylori根除率无显著差异。结论：铋剂、PPI联用呋喃唑酮和四环素组成的7天联方案作为根除H.pylori治疗失败后的补救治疗可获得较高的H.pylori根除率。     

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.     

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.     

Helicobacter pylori eradication with either quadruple regimen with lactoferrin or levofloxacin-based triple therapy: A multicentre study

BACKGROUND: Helicobacter pylori eradication rate following standard triple therapy is decreasing worldwide. A quadruple therapy with lactoferrin and a levofloxacin-based triple therapy has been found to achieve a very high (>90%) cure rate. This study aimed to confirm these encouraging results. METHODS: This was a prospective, open-label, randomised, multicentre, Italian study enrolling consecutive H. pylori infected patients. The infection at entry was assessed by endoscopy and biopsies (histology plus rapid urease test) in all patients, whilst bacterial eradication was assessed by 13C-urea breath test 4-6 weeks after therapy ended. Patients were randomised to receive either a 7-day, triple therapy with rabeprazole 20mg o.d., levofloxacin 500 mg o.d., and amoxycillin 1g b.i.d. (4 tablets/day) or a 7-day quadruple therapy comprising of rabeprazole 20mg, clarithromycin 500 mg, tinidazole 500 mg plus bovine lactoferrin 200mg, all given twice daily (10 tablets/day). RESULTS: Overall, 144 consecutive patients were enrolled in the study. Following the triple therapy, H. pylori infection was cured in 49 out of 72 (68.1%; 95% CI=57-79) patients and in 49 out of 71 (69.1%; 95% CI=58-80) at intention-to-treat and per protocol analyses, respectively. Following the quadruple regimen, the infection was cured in 52 out of 72 (72.2%; 95% CI=62-83) and in 52 out of 68 (76.5; 95% CI=66-87) patients at intention-to-treat and per protocol analyses, respectively. No statistically significant difference emerged between the two therapy regimens. CONCLUSIONS: H. pylori eradication rate following both quadruple therapy with lactoferrin and a low-dose PPI, triple therapy with levofloxacin is disappointingly low.     

Use of bovine lactoferrin for Helicobacter pylori eradication

BACKGROUND: One-week triple therapy is the most frequently recommended treatment for Helicobacter pylori infection. Eradication rate is satisfactory, nevertheless is advisable to look for more effective therapies. AIM: To test the efficacy of a standard triple therapy plus bovine lactoferrin in the eradication of H. pylori infection. PATIENTS AND METHODS: One hundred and fifty consecutive H. pylori positive patients, suffering from dyspeptic symptoms were recruited in a 7-day triple therapy open randomised single centre study with rabeprazole, clarithromycin, tinidazole, bovine lactoferrin (group A) or rabeprazole, clarithromycin, tinidazole (group B), or a 10-day therapy with rabeprazole, clarithromycin, tinidazole (group C). H. pylori status was assessed 8 weeks after the end of the treatment by means of a 13C-urea breath test or a H. pylori stool antigen-test. RESULTS: Eradication rates (intention to treat/per protocol) were: group A (92.2/95.9%), group B (71.2/72.5%) and group C (70.2/75%). The efficacy of triple therapy added with lactoferrin was significantly higher than other two regimens (p=0.01, intention to treat analysis; p=0.005, per protocol analysis). CONCLUSION: These results suggest that lactoferrin tested in the present study was effective in curing H. pylori and could be a new agent to assist the antimicrobials in the eradication of the bacterium.     

Two new treatment regimens for Helicobacter pylori eradication: a randomised study

BACKGROUND: Several studies have found a fairly low Helicobacter pylori eradication rate using a standard 7-day triple therapy in Italy. Recently, two new therapeutic schedules have been proposed with an eradication rate higher than 90%. This study compared the efficacy of these two treatment regimens. PATIENTS AND METHODS: A total of 131 patients with Helicobacter pylori infection and either non-ulcer dyspepsia (73 patients] or peptic ulcer (58 patients) were enrolled. Helicobacter pylori infection was assessed by rapid urease test and histology on gastric biopsies. Patients were randomised to receive either a 5-day course of ranitidine bismuth citrate 400 mg bid, clarithromycin 500 bid, and tinidazole 500 bid, or a 10-day course of omeprazole 20 mg bid plus amoxycillin 1 g bid for the first 5 days, and omeprazole 20 mg bid, clarithromycin 500 mg bid and tinidazole 500 mg bid for the remaining 5 days. Eradication was assessed by endoscopy 4-6 weeks after therapy. RESULTS: Overall, 4 patients (2 for each treatment group) were lost to follow-up. Helicobacter pylori eradication rates were 67.2% (95% confidence interval: 55.7-78.7) and 65.2% (95% confidence interval: 53.7-76.6) at per protocol and intention-to-treat analyses, respectively, after the 5-day regimen, and 96.8% (95% confidence interval: 92.5-100) and 93.8% (95% confidence interval: 88-99.7) after the 10-day regimen (p<0.05). Both treatments were well tolerated, and no major side-effects were reported. CONCLUSIONS: The 5-day regimen gave disappointing results, while the eradication rate after the 10-day regimen was very high.