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。     

5-day vs. 7-day triple therapy with rabeprazole, clarithromycin and amoxicillin for Helicobacter pylori eradication

AIM: To determine whether a 5-day regimen with rabeprazole, clarithromycin and amoxicillin (RCA) was as effective as a 7-day regimen. METHODS: A total of 139 H. pylori-infected patients were randomized to receive either a 5-day or 7-day course of rabeprazole 10 mg b.d., clarithromycin 400 mg b.d. and amoxicillin 750 mg b.d. Eradication was assessed by CLO test, histology and 13C-urea breath test. RESULTS: On the intention-to-treat basis, eradication rates were 66% (46 out of 70) and 84% (58 out of 69) for the 5- and 7-day regimens, respectively (P < 0.05). Using per protocol analysis, eradication rates were 70% (46 out of 66) and 91% (58 out of 64) for the 5- and 7-day regimens, respectively (P < 0.01). Adverse events, which were observed in 14 patients from each group, caused discontinuation of treatment in only two patients, resulting in excellent compliance. CONCLUSIONS: Our 5-day regimen of RCA yielded inferior results, whereas the 7-day regimen achieved an eradication rate exceeding 90% on the per protocol basis. Therefore, treatment regimens of less than 7 days for proton pump inhibitor-clarithromycin-amoxicillin therapies cannot be recommended.     

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.     

艾司奥美拉唑、克拉霉素和阿莫西林三联疗法根除幽门螺杆菌的疗效

目的 :观察艾司奥美拉唑、克拉霉素和阿莫西林三联疗法根除幽门螺杆菌 (Hp)的疗效 ,以期寻找疗程短、疗效高的方案。方法 :10 1例Hp阳性病人随机分为 3组。治疗 1组 (31例 )予艾司奥美拉唑 2 0mg ,克拉霉素0 .5 g,阿莫西林 1.0 g ,疗程3d。治疗 2组 (35例 )予药物 ,剂量同治疗 1组 ,疗程 7d。对照组 (35例 )予奥美拉唑 2 0mg ,克拉霉素 0 .5 g ,阿莫西林 1.0 g ,疗程 7d。均每日 2次口服。停药 4wk查13C 尿素呼气试验。结果 :治疗1,2组 ,对照组Hp的根除率为 81% ,86 % ,83% ,均P >0 .0 5。不良反应发生率为 9% ,19% ,2 1% ,P >0 .0 5。C/E为 2 .5 2 ,5 .75 ,6 .0 1,治疗 1组药费与疗效比值明显低于治疗 2组及对照组。结论 :艾司奥美拉唑三联疗法是一种安全、高效的根除Hp方案。 3d疗法更为短程、经济。     

雷贝拉唑三联疗法治疗幽门螺杆菌阳性消化性溃疡疗效观察

目的探讨雷贝拉唑三联疗法治疗幽门螺旋杆菌阳性消化性溃疡的临床疗效,并与奥美拉唑三联疗法治疗的结果进行对比研究。方法选择幽门螺旋杆菌阳性消化性溃疡患者78例,随机分为观察组40例与对照组38例,观察组患者应用雷贝拉唑联合克拉霉素和阿莫西林三联疗法治疗,对照组患者应用奥美拉唑联合克拉霉素和阿莫西林三联疗法治疗,对比两组患者的临床疗效。结果观察组患者经治疗后总有效率为97．5％,对照组为81．6％,观察组疗效显著优于对照组,差异有统计学意义（P〈0．05）。观察组HP转阴37例,占92．5％,对照组HP转阴35例,占92．1％,两组HP阴转率比较差异无统计学意义（P〉0．05）。结论雷贝拉唑三联疗法治疗幽门螺杆菌阳性消化性溃疡临床效果好,在抑制胃酸分泌及缓解疼痛等方面优于奥美拉唑三联疗法。     

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。     

艾普拉唑、阿莫西林、左氧氟沙星三联法治疗幽门螺杆菌感染的临床观察

目的探讨艾普拉唑+阿莫西林+左氧氟沙星1周疗法根除幽门螺杆菌(HP)的疗效及安全性。方法选择91例HP阳性消化性溃疡患者,随机分为2组。治疗组采用艾普拉唑(5 mg,2次/d)+阿莫西林(1 000 mg,2次/d)+左氧氟沙星(200 mg,2次/d)联合治疗。对照组采用艾普拉唑(5 mg,2次/d)+阿莫西林(1 000 mg,2次/d)+甲硝唑(400 mg,2次/d)联合治疗。两组治疗7 d后继续用艾普拉唑5 mg,1次/d,共3周。疗程结束4周后复查胃镜和HP,观察HP根除率、症状缓解率、溃疡愈合率和不良反应。结果治疗组和对照组的HP根除率分别为91.3%、73.3%(P<0.05),治疗组和对照组症状缓解率、溃疡愈合率和不良反应发生率分别为8.7%vs.6.7%、89.1%vs.84.4%、19.7%vs.17.8%,两组比较,差异均无统计学意义(P>0.05)。结论艾普拉唑+阿莫西林+左氧氟沙星三联1周疗法是根除HP的理想方案。     

One-week ranitidine bismuth citrate,amoxicillin and metronidazole triple therapy for the treatment of Helicobacter pylori infection in Chinese

BACKGROUND: We have previously shown that ranitidine bismuth citrate-based, clarithromycin-containing triple therapy achieves a higher eradication rate than proton pump inhibitor-based regimens in areas with a high prevalence of metronidazole resistance. AIM: To evaluate whether this higher efficacy of ranitidine bismuth citrate over proton pump inhibitor can be extended to non-clarithromycin-containing regimens. METHODS: Helicobacter pylori-positive dyspeptic patients were randomized to receive either ranitidine bismuth citrate, 400 mg, amoxicillin, 1000 mg, and metronidazole, 400 mg, or omeprazole, 20 mg, amoxicillin, 1000 mg, and metronidazole, 400 mg, each given twice daily for 1 week. H. pylori eradication was confirmed by 13C-urea breath test 5 weeks later. The side-effects of the treatments were documented. RESULTS: Two hundred and twenty-nine patients were eligible for analysis. By intention-to-treat and per protocol analysis, the eradication rates were 77% and 79%, respectively, in the ranitidine bismuth citrate-amoxicillin-metronidazole group and 77% and 82%, respectively, in the omeprazole-amoxicillin-metronidazole group (P = 0.58 and P = 0.65). However, patients in the omeprazole-amoxicillin-metronidazole group reported a significantly higher incidence of minor side-effects when compared to those in the ranitidine bismuth citrate-amoxicillin-metronidazole group (P = 0.001). CONCLUSIONS: Ranitidine bismuth citrate-amoxicillin-metronidazole was equally as effective as omeprazole-amoxicillin-metronidazole triple therapy, and may be considered as an alternative non-clarithromycin-based regimen in the Chinese population.     

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     

One-week triple therapy with esomeprazole,clarithromycin and metronidazole provides effective eradication of Helicobacter pylori infection

AIM: To compare the eradication rates of treatment with esomeprazole, metronidazole and clarithromycin (EMC) vs. omeprazole, metronidazole and clarithromycin (OMC), given for 7 days. OMC treatment was followed by 3 weeks of treatment with 20 mg omeprazole alone; the EMC group received placebo. METHODS: A randomized, double-blind, controlled study was conducted in 36 Canadian centres. Patients had a minimum 3-month history of dyspepsia, with or without a previous history of peptic ulcer disease, and were Helicobacter pylori positive by urea breath test. The eradication of H. pylori was determined by two negative breath tests performed at least 4 and 8 weeks following the completion of treatment. RESULTS: The intention-to-treat and per protocol populations consisted of 379 and 339 patients, respectively. The success rates of EMC/placebo were 76% (144/190) by intention-to-treat and 80% (138/172) by per protocol analysis; for OMC/omeprazole, the rates were 72% (137/189) and 75% (125/167), respectively. The difference between the two treatment groups was not significant. Treatment was well tolerated. CONCLUSIONS: A 7-day regimen of esomeprazole, metronidazole and clarithromycin is effective and well tolerated for the eradication of H. pylori infection.     

Lansoprazole, levofloxacin and amoxicillin triple therapy vs. quadruple therapy as second-line treatment of resistant Helicobacter pylori infection

AIM: To test the efficacy of levofloxacin-based second-line therapy for resistant Helicobacter pylori infection. METHODS: One hundred and six patients who failed H. pylori eradication were randomized to receive (i) lansoprazole 30 mg, amoxicillin 1 g, levofloxacin 500 mg, all given twice daily for 7 days (LAL); or (ii) lansoprazole 30 mg twice daily, metronidazole 400 mg thrice daily, bismuth subcitrate 120 mg and tetracycline 500 mg four times daily for 7 days (quadruple). Post-treatment H. pylori status was determined by (13)C-urea breath test. RESULTS: Intention-to-treat and per-protocol H. pylori eradication rates were 57/60% for the LAL group and 71/76% for the quadruple group respectively. Metronidazole, clarithromycin, amoxicillin and levofloxacin resistance were found in 76%, 71%, 0% and 18% of patients, respectively. Levofloxacin resistance led to treatment failure in the LAL group. For patients with dual resistance to metronidazole and clarithromycin, the eradication rates were 79% in the LAL group (levofloxacin-sensitive) and 65% in the quadruple group (P=0.34). CONCLUSION: Lansoprazole, amoxicillin plus levofloxacin second-line therapy is comparable with quadruple therapy in efficacy. Subjects, especially those with dual resistance to metronidazole and clarithromycin, may consider levofloxacin-based therapy for levofloxacin-sensitive strains.     

One-week ranitidine bismuth citrate-based triple therapy for the eradication of Helicobacter pylori in Hong Kong with high prevalence of metronidazole resistance

AIM: To compare 1-week ranitidine bismuth citrate-based (RBC) triple therapy vs. omeprazole-based (O) triple therapy for the eradication of Helicobacter pylori infection in Hong Kong with high prevalence of metronidazole resistance. METHODS: Patients with non-ulcer dyspepsia and H. pylori infection were randomized to receive either: (i) RBCCM: ranitidine bismuth citrate (pylorid) 400 mg, clarithromycin 250 mg and metronidazole 400 mg; or (ii) OCM: omeprazole 20 mg, clarithromycin 250 mg and metronidazole 400 mg, each given twice daily for 1 week. Endoscopy (CLO test, histology and culture) and 13C-urea breath test were performed before randomization and 6 weeks after drug treatment. RESULTS: A total of 180 patients were randomized. H. pylori eradication rates (intention-to-treat, n=180/per protocol, n=166) were 83%/92% for RBCCM and 66%/70% for OCM (P=0.01, intention-to-treat and P=0.001, per protocol, respectively). RBCCM treatment was unaffected by metronidazole susceptibility and achieved a significantly higher eradication rate in metronidazole-resistant cases (89%) than the OCM group (45%, P=0.0064). CONCLUSION: One-week ranitidine bismuth citrate-based triple therapy is significantly better than omeprazole-based triple therapy for the eradication of H. pylori infection, especially in metronidazole-resistant cases. It is an effective regimen for the eradication of H. pylori infection in regions with a high prevalence of metronidazole resistance.     

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。     

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).     

Randomized controlled study of rabeprazole,levofloxacin and rifabutin triple therapy vs. quadruple therapy as second-line treatment for Helicobacter pylori infection

AIM: To test the efficacy of rabeprazole, levofloxacin and rifabutin triple therapy vs. quadruple therapy for the second-line treatment of Helicobacter pylori infection. METHODS: One hundred and nine patients who had failed previous H. pylori eradication were randomized to receive: (i) rabeprazole, 20 mg b.d., rifabutin, 300 mg once daily, and levofloxacin, 500 mg once daily, for 7 days (triple therapy); or (ii) rabeprazole, 20 mg b.d., metronidazole, 400 mg t.d.s., bismuth subcitrate, 120 mg q.d.s., and tetracycline, 500 mg q.d.s., for 7 days (quadruple therapy). Endoscopy and culture were performed before treatment. RESULTS: The clarithromycin (79% vs. 21%, P < 0.001) and metronidazole (89% vs. 40%, P < 0.001) resistance rates were significantly higher in patients with previous exposure than in those with no previous exposure. The intention-to-treat and per protocol eradication rates were 91%/91% for the triple therapy group and 91%/92% for the quadruple therapy group. For patients with double resistance to metronidazole and clarithromycin, the eradication rates were 85% (17/20) in the triple therapy group and 87% (13/15) in the quadruple therapy group. Compliance was greater than 95% for both regimens. CONCLUSION: Rabeprazole, levofloxacin and rifabutin-based triple therapy and quadruple therapy were equally effective as second-line treatments for H. pylori infection.     

以雷贝拉唑与加替沙星为基础的三联疗法作为幽门螺杆菌

目的:研究以雷贝拉唑和加替沙星为基础的三联疗法作为幽门螺杆菌(HP)感染根除2次以上均失败的补救方案的价值。方法:以雷贝拉唑、加替沙星和进口克拉霉素组成方案,分为7 d疗程组(A组)和14 d疗程组(B组)。60例HP感染根除失败患者随机分为A和B组进行前瞻性研究,应用药物经济学分析两组的C/E比。结果:HP的根除方案的应用仍很不规范。A和B组的根除率分别为75.0%和93.3%(P<0.05)。A和B组的不良反应发生率分别为17.9%和23.3%(P>0.05)。A和B组的C/E比分别为7.44和11.96。结论:以雷贝拉唑、加替沙星为基础的三联疗法作为HP根除失败的补救方案有较高的根除率。     

The influence of metronidazole resistance on the efficacy of ranitidine bismuth citrate triple therapy regimens for Helicobacter pylori infection

AIM: To assess the influence of metronidazole resistance on the efficacy of ranitidine bismuth citrate-based triple therapy regimens in two consecutive studies. METHODS: In the first study, patients with a culture-proven Helicobacter pylori infection were treated with ranitidine bismuth citrate 400 mg, metronidazole 500 mg, and clarithromycin 500 mg, all twice daily for 1 week (RMC). In the second study, amoxycillin 1000 mg was substituted for clarithromycin (RMA). Susceptibility testing for metronidazole was performed with the E-test. Follow-up endoscopy was performed after >/= 4 weeks. Antral biopsy samples were taken for histology and urease test, and culture and corpus samples for histology and culture. RESULTS: 112 patients, 53 males, age 55 +/- 14 years (39 duodenal ulcer, 7 gastric ulcer and 66 gastritis) were treated with RMC, and 89 patients, 52 males, age 58 +/- 15 years (23 duodenal ulcer, 7 gastric ulcer and 59 gastritis) were treated with RMA. For RMC, intention-to-treat eradication results were 98% (59/60, 95% CI: 91-100%) and 95% (20/21, 95% CI: 76-100%) for metronidazole susceptible and resistant strains, respectively (P = 0.45). For RMA these figures were 87% (53/61, 95% CI: 76-94%) for metronidazole susceptible strains and 22% (2/9, 95% CI: 3-60%) for resistant strains (P = 0.0001). CONCLUSION: Both regimens are effective in metronidazole susceptible strains. However, in contrast to the amoxycillin-containing regimen, that containing clarithromycin is also effective in resistant strains.