Ranitidine bismuth citrate-based triple therapies as a second-line therapy for Helicobacter pylori in Turkish patients

BACKGROUND: Quadruple therapy with a proton pump inhibitor, bismuth, metronidazole and tetracycline is recommended as the optimal second-line therapy of Helicobacter pylori infection in the Maastricht Consensus Report. The aim of the present paper was to evaluate the efficacy of ranitidine bismuth citrate (RBC)-based regimens as second-line therapies after failure of the standard Maastricht triple therapy. MATERIALS AND METHODS: One hundred and sixteen H. pylori-positive patients were given omeprazole 20 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d for 10 days. Patients remaining H. pylori-positive (n = 29) were combined with 27 patients enrolled after an initial eradication failure from proton-pump inhibitor (PPI), amoxicillin and clarithromycin therapy for at least 7 days and were randomly given one of the following second-line 10-day treatments: RBC 400 mg b.d., amoxicillin 1 g b.d and clarithromycin 500 mg b.d. (RAC group, n = 28) and RBC 400 mg b.d., metronidazole 500 mg b.d and tetracycline 500 mg b.d. (RMT group, n = 28). Eradication was assessed by either histology and rapid urease test or (13)C urea breath test 8 weeks after therapy. RESULTS: The eradication rate of first-line Maastricht therapy was 67% for intention-to-treat analysis (95% confidence interval [CI]: 58-75). Per-protocol and intention-to-treat eradication was achieved in 60.7% of patients (95%CI: 42-79) in the RAC group and in 85.7% of patients (95%CI: 73-98) in the RMT group (P = 0.03). Fifty-three percent of patients in the RAC and 50% of patients in the RMT group experienced at least one slight side-effect (P = 0.6). CONCLUSIONS: RMT is an effective and well-tolerated second-line therapy after H. pylori eradication failure from PPI, amoxicillin, and clarithromycin.     

The efficacy of bismuth containing quadruple therapy as a first-line treatment option for Helicobacter pylori

BACKGROUND: Helicobacter pylori eradication rates have tended to decrease recently, mostly due to increasing antibiotic-resistance. The present study aimed to compare the efficacy of bismuth-based quadruple regimen with proton pump inhibitor-based triple regimen for eradication of H. pylori. METHODS: Consecutive H. pylori-positive patients with non-ulcer dyspepsia were randomized into one of two regimens: (i) bismuth subsalicylate 300 mg q.i.d., lansoprazole 30 mg b.i.d., tetracycline 500 mg q.i.d. and metronidazole 500 mg t.i.d. (BLTM group) for 14 days; (ii) lansoprazole 30 mg b.i.d., amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d. (LAC) for 14 days. Gastroscopy and (14)C-Urea breath test (UBT) were performed before enrollment, and UBT only was repeated for 6 weeks after treatment. RESULTS: A total of 240 patients were randomized into groups and 212 of them completed the protocols. The 'intention-to-treat' (ITT) and 'per protocol' (PP) H. pylori eradication rates were 70% (95%CI 61-78) and 82.3% (95%CI 74-89) in the BLTM group, and 57.5% (95%CI 48-66) and 62.7% (95%CI 53-71) in the LAC group. The BLTM treatment achieved a significantly better eradication rate compared with LAC treatment in PP analysis (82.3% vs. 62.7%, P = 0.002). Mild to severe side-effects, which were more frequent in the BLTM group, were reported in 18.2% of the patients. CONCLUSION: The bismuth-based quadruple regimen achieved a better eradication rate compared with proton pump inhibitor-based triple regimens as a first-line eradication option for H. pylori in our population.     

Amoxicillin or tetracycline in bismuth-containing quadruple therapy as first-line treatment for Helicobacter pylori infection

ABSTRACT

Aim

To compare the efficacy and safety between modified quadruple- and bismuth-containing quadruple therapy as first-line eradication regimen for Helicobacter pylori infection.     

Helicobacter pylori eradication with moxifloxacin-containing therapy following failed first-line therapies in South korea

AIM:To investigate moxifloxacin-containing triple therapy as second-line treatment for Helicobacter pylori(H.pylori)infection following failed first-line treatment.METHODS:The sample included 312 patients for whom first-line treatment failed between January 2008and May 2013;27 patients were excluded,and a total of 285 patients received 7-or 14-d moxifloxacincontaining triple therapy as second-line treatment for H.pylori infection.First line regimens included 7-d standard triple(n=172),10-d bismuth-containing quadruple(n=28),14-d concomitant(n=37),or14-d sequential(n=48)therapy.H.pylori status was evaluated using 13C-urea breath testing 4 wk later,aftercompletion of the treatment.The primary outcome was the H.pylori eradication rate analyzed using intentionto-treat(ITT)and per protocol(PP)analyses.The secondary outcome was the occurrence of serious adverse events.Demographic and clinical factors were analyzed using Student’s t-tests and Pearson’sχ2 tests according to first-and second-line regimens.A P value of less than 0.05 was considered statistically significant.RESULTS:The eradication rate of moxifloxacincontaining triple therapy was 68.4%(ITT;95%CI:62.8-73.5)and 73.9%(PP;95%CI:68.3-78.8).The eradication rate was significantly higher with 14 d compared to 7 d of treatment(77.5%vs 62.5%,P=0.017).Peptic ulcer patients had a higher eradication rate than the patients without ulcers(82.9%vs 70.6%,P=0.046).The demographic and clinical characteristics were not significantly different between the groups according to first-line therapies.ITT and PP analyses of the moxifloxacin-containing triple therapy indicated the following eradication rates:70.9%(95%CI:63.8-77.2)and 77.2%(95%CI:70.1-83.1)for standard triple;67.9%(95%CI:51.5-84.2)and 67.9%(95%CI:51.5-84.2)for bismuth-containing quadruple;60.4%(95%CI:46.3-73.0)and 70.7%(95%CI:54.0-80.9)for sequential;and 67.6%(95%CI:51.5-80.4)and67.6%(95%CI:51.5-80.4)for concomitant therapy.There were no statistically significant differences in the efficacy of the first-line regimens(P=0.492).The most common adverse event was diarrhea.There were no serious adverse events and no significant differences in the frequency of side effects between the first-and second-line regimens(28.7%vs 26.1%,respectively).CONCLUSION:Moxifloxacin-containing triple therapy as second-line treatment resulted in low eradication rates.There were no differences in the efficacy between the first-line regimens in South Korea.     

四联疗法与序贯疗法在幽门螺杆菌根除补救治疗中的疗效比较

[目的]比较四联疗法与序贯疗法在幽门螺杆菌(Hp)根除补救治疗中的疗效及安全性,旨在寻找一种有效、安全、经济的补救治疗方案。[方法]将首次根除Hp治疗失败的90例慢性胃炎患者,随机分为四联疗法组和序贯疗法组,每组45例。四联疗法组患者治疗方案为埃索美拉唑、枸橼酸铋钾、阿莫西林、莫西沙星,疗程14d。序贯疗法组患者治疗方案为前5d给予埃索美拉唑、阿莫西林;后5d给予埃索美拉唑、克拉霉素、奥硝唑。所有患者在疗程结束停药4周后行14 C尿素呼气试验检测Hp。比较2组患者治疗前后的不良反应。[结果]四联疗法组Hp根除率(91.1%)显著高于序贯疗法组(75.6%),差异有统计学意义(P<0.05)。2组不良反应均很轻微,组间不良反应发生率比较差异无统计学意义(P>0.05)。[结论]对于Hp补救治疗,四联疗法较序贯疗法疗效更好,且不良反应小,患者依从性好,值得在临床上推广。     

Effects of multistrain probiotic-containing yogurt on second-line triple therapy for Helicobacter pylori infection

Background and Aims: The adjuvant effects of probiotic‐containing yogurt on second‐line triple therapy for Helicobacter pylori (H. pylori) infection have not been evaluated. Methods: A total of 337 patients with persistent H. pylori infection, after first‐line triple therapy, were randomly assigned to receive either triple therapy with (yogurt group, n = 151) or without (control group, n = 186) Will yogurt. Triple therapy consisted of 400 mg moxifloxacin q.d., 1000 mg amoxicillin b.i.d., and 20 mg esomeprazole b.i.d. for 14 days. Will yogurt contains Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium longum, and Streptococcus thermophilus. H. pylori eradication was evaluated by the ¹³C‐urea breath test, histology, or the rapid urease test. Results: The eradication rates by intention‐to‐treat analysis were 66.7% and 68.9% in the control and yogurt groups, respectively (P = 0.667). The eradication rates by per‐protocol analysis were 78.5% and 86% in the control and the yogurt groups, respectively (P = 0.110). The adverse event rates were 25.3% and 28.5% in the control group and yogurt group, respectively (P = 0.508). Conclusions: The addition of yogurt containing probiotics to moxifloxacin‐containing second‐line treatment neither improved H. pylori eradication rates nor reduced the adverse events of treatment.     

10天序贯疗法与标准三联疗法治疗幽门螺杆菌感染荟萃分析

目的系统地评价10天序贯疗法能否获得比标准三联疗法更高的H．pylori根除率，以及两种方案之间发生副反应的差异。方法利用中英文检索词检索相关电子数据库，根据纳入标准入选了比较10天序贯疗法与标准三联疗法的幽门螺杆菌根除率的随机临床试验。提取患者基本资料、研究质量、H．pylori根除率和副作用的发生率等相关数据。针对于10天序贯疗法和7天或10天标准三联疗法的H．pylori根除率和副作用的发生率，计算相应的RR和95％可信区间。运用漏斗图评价出版偏倚。结果Meta分析纳入了10项随机对照研究，共2855例患者。10天序贯疗法明显优于7天或10天标准三联疗法，总的H．pylori根除率分别为93．5％、75．9％和79．4％，RR为1．23（95％CI=1．19—1．28）和1．16（95％CI：1．10—1．23）。无论是溃疡性消化不良患者还是非溃疡性消化不良患者，10天序贯疗法都能获得更高的H．pylori根除率，RR分别为1．16（95％CI=1．10—1．23）和1．26（95％CI=1．19—1．33）；针对克拉霉素耐药患者，10天序贯疗法的有效H．pylori根除率也高于标准三联疗法（75．9％vs32．7％），RR为2．18（95％CI=1．43—3．34）。然而两种方案副作用的发生率无明显差别（RR=1．00，95％CI=0．97—1．03）。结论10天序贯疗法明显优于7天或10天标准三联疗法,副作用无明显增加。     

The long-term efficacy of Helicobacter pylori eradication therapy in patients with idiopathic thrombocytopenic purpura

BACKGROUND AND AIM: A beneficial effect of Helicobacter pylori (H. pylori) eradication in patients with H. pylori-positive idiopathic thrombocytopenic purpura (ITP) has been reported by several investigators; however, it was not clear whether the recovered platelet count after H. pylori eradication was maintained for a long period. METHOD: Thirty-eight ITP patients who were examined for H. pylori infection were assessed. H. pylori-positive patients received a standard antibiotic therapy for H. pylori eradication. We investigated the long-term effect of H. pylori eradication on platelet recovery in patients with H. pylori-positive ITP. RESULTS: Of the 38 ITP patients, 26 (68.4%) were positive for H. pylori. The response rate of platelet recovery was 56.5% (13/23 patients). Twelve patients showed complete response (CR) and one showed partial response (PR). The mean platelet counts 6 months after eradication significantly increased from 31 x 10(9)/L to 129 x 10(9)/L in 23 H. pylori-eradicated patients (P < 0.001). The median platelet counts of responders 1, 2, 3, and 4 years after eradication were 168 x 10(9)/L (n = 10), 193 x 10(9)/L (n = 9), 168 x 10(9)/L (n = 7), and 243 x 10(9)/L (n = 4) after a mean follow-up of 25.8 months. CONCLUSION: Eradication therapy for H. pylori-positive patients with ITP was effective and a favorable effect was maintained for long periods.     

舒肝解郁胶囊联合四联疗法治疗幽门螺杆菌阳性胃溃疡临床观察

[目的]观察舒肝解郁胶囊联合四联疗法(埃索美拉唑、阿莫西林、胶体果胶铋、克拉霉素)对幽门螺杆菌(Hp)阳性胃溃疡的临床疗效与安全性。[方法]89例Hp阳性胃溃疡患者,随机分为观察组(45例)、对照组(44例)。对照组采用四联疗法治疗2周,然后予以埃索美拉唑抑酸治疗4周;观察组在对照组基础上从第1~6周加用舒肝解郁胶囊2片、2次/d进行治疗。观察2组患者胃泌素浓度(GAS)、胃动素浓度(MTL)、临床症状评分、疗效、Hp根除率及用药不良反应。[结果]经过6周治疗,2组患者GAS浓度、MTL浓度及临床症状评分较治疗前均有显著改善;观察组患者GAS浓度、MTL浓度及临床症状评分均显著低于对照组(P<0.05);观察组治疗总有效率为95.56%、Hp根除率为93.33%,显著高于对照组(P<0.05);观察组不良反应发生率显著低于对照组(P<0.05)。[结论]舒肝解郁胶囊联合四联疗法治疗Hp阳性溃疡相对于四联疗法可更有效缓解患者临床症状、提高溃疡愈合率和Hp根除率,不良反应相对较少,值得推广。     

Non-bismuth quadruple therapy for first-line Helicobacter pylori eradication: A randomized study in Japan

AIM:To find the way to improve the eradication rate of first-line therapy in Japanese patients.METHODS:We prospectively compared the effectiveness of 7-d quadruple therapy to standard 7 d triple therapy in Japanese patients infected with Helicobacter pylori(H.pylori).One hundred and nineteen patients were randomly assigned to receive 7-d non-bismuth quadruple therapy with lansoprazole,amoxicillin,clarithromycin and metronidazole(LACM7) or 7-d triple therapy with lansoprazole,amoxicillin and clarithromycin(LAC7).After three months,H.pylori status was analyzed by 13C-urea breath test.Incidence rates of adverse events were evaluated by use of questionnaires.RESULTS:By intention-to-treat(ITT) analysis,the eradication rate in the LACM7 group was 94.9%,which was significantly higher than the LAC7 group(68.3%,P < 0.001).Per protocol analysis also showed a significantly higher eradication rate in the LACM7 group(98.3%) than the LAC7 group(73.2%,P < 0.001).Nevertheless,the incidence of serious adverse events did not differ between the two groups(RR:1.10,95% CI:0.70-1.73,P = 0.67).CONCLUSION:Seven day non-bismuth quadruple therapy(LACM7) was superior to standard 7-d triple therapy(LAC7) for first-line eradication.     

A new quadruple therapy for the eradication of Helicobacter pylori. Effect of pretreatment with omeprazole on the cure rate

To elucidate whether pretreatment with omeprazole decreases the cure rate of Helicobacter pylori infection with a new quadruple therapy, and thus, whether this pretreatment should not be used in clinical practice, we conducted a randomized trial. Ninety patients with chronic peptic ulcer disease and nonulcer dyspepsia, with biopsy-proven H. pylori infection were randomly assigned to the two following regimens: Group 1 (n = 45) received omeprazole 20 mg once daily for 2 weeks (days 1–14), and 500 mg amoxicillin granules and 250 mg metronidazole thrice daily, and roxithromycin 150 mg twice daily for 1 week (days 8–14), Group 2 (n = 45) received the same antibiotic treatment as group 1 for 1 week (days 1–7), in addition to omeprazole treatment for 2 weeks (days 1–14). Four weeks after the treatment ended, endoscopy was repeated, with two biopsy specimens each taken from the antrum and the corpus (total of four specimens) for a urease test, histological analysis, and culture to establish cure of infection. A patient was regarded as cured only if all three methods gave negative results for H. pylori. In the intention-to-treat analysis, 42 of 45 patients (93.3%; 95% confidence intervals [CI], 81.7%–98.6%) in group 1 were cured compared with 43 of 45 patients (95.6%; 95% CI, 84.9%–99.5%) in group 2. In the per-protocol analysis, the corresponding figures were 42/44 (95.5%; 95% CI 84.5%–99.4%) and 43/44 (97.7%; 95% CI, 88.0%–99.9%). There were no significant differences in the cure rate between the two groups on either analysis. All patients, except for one who had an allergic reaction, completed the treatment regimens. Fifty to sixty percent of the patients had no side effects while the rest had mild to moderate side effects. The new quadruple therapy consisting of omeprazole, amoxicillin, metronidazole, and roxithromycin appears suitable for use in clinical practice, as the cure rate was 95% and no severe side effects were observed. Pretreatment with omeprazole did not reduce the cure rate for this new quadruple therapy. (Received Sept. 29, 1997; accepted Jan. 23, 1998)     

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.     

Rabeprazole in a one-week eradication therapy of Helicobacter pylori: comparison of different dosages

AIM: Many data regarding omeprazole-, lanzoprazole- and pantoprazole-based triple therapy for Helicobacter pylori (H. pylori) eradication have been reported, but there is few data present regarding rabeprazole (R). We report the efficacy and tolerability of rabeprazole in different dosages in association with clarithromycin (C)and tinidazole (T) in H. pylori eradication. DESIGN AND METHODS: Ninety-four H. pylori-positive patients with dyspeptic symptoms were enrolled and randomly allocated to eradication therapy in two different one-week regimens. In regimen A, 47 patients received R 20 mg b.i.d, C 500 mg b.i.d and T 500 mg b.i.d, while in regimen B, 47 patients received R 10 mg b.i.d, C 500 mg b.i.d and T 500 mg b.i.d. Eradication of H. pylori was evaluated by a 13C urea breath test (UBT) two months after the end of the therapy. RESULTS: Four patients (two in each regimen) did not complete treatment. The H. pylori eradication rate was 91.4% in group A compared to 89.3% in group B (P-value not significant). Minor side-effects were reported in 4.2% of group A and 6.4% of group B patients. CONCLUSION: Rabeprazole showed good efficacy and tolerability in one-week H. pylori therapy at 20 mg b.i.d and 10 mg b.i.d, suggesting the use of the lower dosage.     

酪酸梭菌活菌片联合四联疗法治疗幽门螺杆菌感染的临床研究

[目的]观察酪酸梭菌活菌片联合四联疗法治疗幽门螺杆菌(Helicobacter pylori,Hp)感染疾病的疗效。[方法]~(14)C尿素呼气试验结果阳性的132例患者随机分为A组、B组。A组给予四联疗法,即雷贝拉唑肠溶片(20mg,2次/d)、枸橼酸铋钾颗粒(2g,2次/d)、阿莫西林胶囊(1g,2次/d)、盐酸左氧氟沙星片(0.2g,2次/d);B组在A组治疗的基础上加用酪酸梭菌活菌片(0.7g,3次/d);2组疗程均为14d。比较2组患者治疗后Hp根除率、症状缓解率及不良反应发生率。[结果]B组Hp根除率明显高于A组,差异有统计学意义(P0.05)。B组药物不良反应的发生率明显低于A组,差异有统计学意义(P0.05)。2组患者治疗后症状缓解率比较差异无统计学意义。[结论]酪酸梭菌活菌片联合四联疗法治疗Hp感染可提高Hp根除率,降低不良反应,值得临床进一步研究。     

枯草杆菌二联活菌联合四联疗法根除幽门螺杆菌临床疗效观察

[目的]观察枯草杆菌二联活菌联合四联疗法对幽门螺杆菌(Hp)的根治效果。[方法]105例诊断为慢性糜烂性胃炎伴有Hp感染的患者随机分为A组(35例)、B组(36例)、C组(34例)。A组用三联疗法(泮托拉唑40mg,bid+阿莫西林1 000mg,bid+克拉霉素500mg,bid),B组用四联疗法(果胶铋+三联疗法),C组用枯草杆菌二联活菌0.5,tid+四联疗法,各组疗程均为14d。疗程结束后至少间隔4周行13 C尿素呼气实验评估治疗结果。记录治疗期间和治疗后不良反应发生情况。[结果]A组、B组、C组患者Hp根除率按意图治疗(ITT)分析分别为62.9%、86.1%、91.2%,按方案(PP)分析分别为68.8%、88.6%和93.9%。B组、C组的疗效明显优于A组(P0.05);A组、B组、C组的不良反应发生率分别为18.7%、20.0%、3.0%。C组的不良反应发生率明显低于A组、B组(P0.05)。[结论]四联疗法对Hp根除率高于三联疗法;四联疗法加枯草杆菌二联活菌尽管不能显著提升Hp根除率,但能有效的减少治疗过程中的不良反应发生率。     

Lactobacillus ruteri compared with placebo as an adjuvant in quadruple therapy for Helicobacter pylori eradication: A randomized,double-blind,controlled trial

Background and study aimsThe aim of this study was to evaluate the efficacy of probiotic as an adjuvant in quadruple therapy for H. pylori eradication compared with placebo.Patients and methodsThis randomized, double-blind, controlled trial was conducted on 450 patients with confirmed H. pylori infection. We randomly allocated patients (1:1) to receive probiotic (Lactobacillus ruteri, 100 mg) or placebo as an adjuvant in quadruple therapy with bismuth subcitrate 240 mg, pantoprazole 40 mg, amoxicillin 1000 mg and clarithromycin 500 mg all twice daily for 14 days. The primary outcome of the study was the H. pylori eradication rate at eight weeks after the end of treatment using ¹⁴C-urea breath test. The secondary endpoint of study was patient-reported side effects of drugs. The study protocol was approved by the Iranian Registry of Clinical Trials (IRCT20080901001155N32).ResultsH. pylori eradication rates were higher in the probiotic group, compared to placebo, but this difference was not statistically significant, according to both intention-to-treat (78.7 % (95 % CI; 71.24–86.16) versus 72 % (95 % CI; 64.9–79.1), respectively) and per-protocol (80.1 % (95 % CI; 73.7 – 86.5) versus 75.2 %(95 % CI; 68.4 – 82), respectively). About 69.7 % of patients in the probiotic group experience side effects compared to 98.6 % in the placebo group that was statistically significant (P-value < 0.001). Headache and all gastrointestinal adverse events except constipation were significantly lower in the probiotic group compared to placebo (P-value < 0.001).ConclusionAdding Lactobacillus ruteri to quadruple therapy did not significantly improve the eradication of H. pylori. However it reduced the frequency of drug-associated side effects.