左氧氟沙星四联根除幽门螺杆菌疗效观察

目的：探讨左氧氟沙星在根除幽门螺杆菌（Hp）中的效果。方法：选择242例Hp阳性胃、十二指肠溃疡患者,随机分为观察组和对照组各121例,观察组给予泮托拉唑、阿莫西林、左氧氟沙星、枸橼酸铋钾口服,2次/d。对照组给予泮托拉唑、阿莫西林、甲硝唑、枸橼酸铋钾口服,2次/d。疗程均为7 d。结果：观察组与对照组的Hp根除率分别为92.3%和71.9%,两组有显著性差异（P〈0.05） 溃疡愈合率分别为94.2%和93.4%,两组无显著性差异（P〉0.05）。结论：左氧氟沙星四联根除Hp疗程1周,Hp根除率可达90%以上,疗效好,副作用低,是值得考虑的根除Hp的药物选择。     

泮托拉唑四联疗法加用胃黏膜保护剂对幽门螺杆菌阳性胃溃疡患者愈合质量的影响

目的探讨泮托拉唑为基础的四联疗法加用胃黏膜保护剂对幽门螺杆菌(Hp)阳性的胃溃疡患者愈合质量的影响。方法 240例急诊内镜诊断为胃溃疡的患者,按照随机数字表法分为观察组和对照组各120例,对照组采用泮托拉唑40 mg+阿莫西林1000 mg+克拉霉素500 mg+枸橼酸铋钾220 mg bid,疗程14 d,观察组采用四联方案+替普瑞酮50 mg tid,比较治疗结束后两组Hp根除疗效及愈合质量。结果两组Hp根除率比较,差异无统计学意义(P0.05);观察组总体症状改善优于对照组,S1期愈合率及S2期获得率均明显高于对照组(P0.05)。结论泮托拉唑为基础的四联疗法加用胃黏膜保护剂对于提高Hp的根除率效果不显著,但对于改善患者的总体症状及提高患者有愈合质量具有积极作用,值得推广和应用。     

幽门螺杆菌感染根治方案的对比研究

目的比较不同方案对幽门螺杆菌感染根除治疗的疗效。方法共180例幽门螺杆菌感染患者进行治疗,随机分为A、B、C组。A组(雷尼替丁+胶体果胶铋+阿莫西林+甲硝唑)、B组(泮托拉唑+胶体果胶铋+克拉霉素+甲硝唑)、C组(雷贝拉唑+胶体果胶铋+阿莫西林+呋喃唑酮)分别采用不同方案治疗,疗程7d,停药4周后检测幽门螺杆菌。结果 A、B、C组幽门螺杆菌根除率分别为65.00%、81.66%和91.66%(P0.01),药物不良反应发生率分别为21.66%、25.00%、26.66%(P0.05)。结论雷贝拉唑、胶体果胶铋、阿莫西林和呋喃唑酮四联短程疗法对幽门螺杆菌感染具有较好的根除疗效。     

中药荆花胃康联合质子泵抑制剂三联疗法根除幽门螺杆菌感染的研究

目的 观察中药荆花胃康联合质子泵抑制剂(PPI)三联疗法治疗幽门螺杆菌(Hp)感染的胃炎及十二指肠溃疡的疗效,并与含铋剂四联疗法比较观察其Hp 根除率.方法 80 例经胃镜证实的Hp 阳性的重度胃炎及十二指肠溃疡患者,随机分成荆花胃康组(44 例)和含铋四联组(36例).荆花胃康组:兰索拉唑30 mg +阿莫西林1 g +克拉霉素500 mg +荆花胃康3 粒,bid,疗程7 d(d1 ～7),之后荆花胃康3 粒,bid,14 d(d8 ～21);含铋四联组:兰索拉唑30 mg +阿莫西林1 g +克拉霉素500 mg +枸橼酸铋钾220 mg,bid,疗程7 d(d1 ～7),之后枸橼酸铋钾220 mg,bid,14 d(d8 ～21);各组入选的十二指肠溃疡患者在Hp 根除治疗1 周后继续兰索拉唑30 mg,qd,治疗2 周(d8 ～21).疗程结束4 周后复查Hp,观察Hp 根除率、症状缓解率及不良反应等.结果 荆花胃康组及含铋四联组Hp 根除率分别为72.7%(32/44)和75.0%(27/36),两组比较差异无统计学意义(P ＝0.818);腹痛缓解率治疗1 周后分别为80.6%(29/36)和76.7%(23/30),治疗3 周后分别为94.4%(34/36)和86.7%(26/30),两组比较差异均无统计学意义(P ＞0.05).结论 中药荆花胃康联合PPI 三联疗法治疗Hp 感染的胃炎及十二指肠溃疡的Hp 根除率与含铋剂四联疗法相似,并可获得较高的症状缓解率,荆花胃康联合PPI 三联疗法可用于治疗Hp 感染相关性胃十二指肠疾病.     

3种抗幽门螺杆菌的四联疗法在消化性溃疡中的疗效观察

目的：观察三种不同的抗幽门螺杆菌(Hp)的四联疗法在治疗消化性溃疡中的临床疗效。方法将2011年10月至2013年6月在我院就诊的 HP 阳性消化性溃疡患者120例随机分为三组,A 组：泮托拉唑肠溶胶囊40 mg bid +阿莫西林胶囊1.0 bid +克拉霉素分散片0.5 bid +胶体果胶铋胶囊0.1 tid,疗程7 d, B 组：泮托拉唑肠溶胶囊40 mg bid +阿莫西林胶囊1.0 bid +左氧氟沙星胶囊0.5 qd +胶体果胶铋胶囊0.1 tid,疗程7 d, C 组：泮托拉唑肠溶胶囊40 mg bid +阿莫西林胶囊1.0 bid +左氧氟沙星胶囊0.5 qd +胶体果胶铋胶囊0.1 tid,疗程10 d 。各组疗程结束后继续口服泮托拉唑肠溶胶囊40 mg qd,(胃溃疡6 w,十二指肠溃疡4 w)。治疗结束后4 w 复查胃镜和13 C呼气试验,观察三组患者的临床症状缓解情况、溃疡愈合情况、HP根除及不良反应发生情况,采用按意愿治疗(ITT)和按方案治疗(PP)分析方法对各组的溃疡愈合总体有效率及 HP 根除率进行评价。结果共纳入患者108例,三组治疗临床上均有显著疗效;PP 分析显示,HP 根除率及溃疡愈合总体有效率均为 C 组>B 组>A 组,溃疡愈合总体有效率 C 组>B 组,A 组和 B 组无明显差异。三组中均有少数患者发生不良反应。结论四联疗法治疗 HP 阳性消化性溃疡疗效确定,泮托拉唑肠溶胶囊、阿莫西林胶囊、左氧氟沙星胶囊、胶体果胶铋胶囊四联10 d 方案能获得较高的 HP根除率及溃疡愈合有效率,且不良反应少。     

10d序贯疗法与传统四联疗法根除幽门螺杆菌疗效观察

目的比较10 d序贯疗法与传统四联疗法根治幽门螺杆菌（Hp）的疗效与安全性。方法选取48例14C尿素呼气试验阳性病例,随机分为两组：治疗组前5 d予奥美拉唑或埃索镁拉唑、阿莫西林,后5 d予奥美拉唑、克拉霉素、替硝唑、枸橼酸铋钾治疗;对照组予奥美拉唑、克拉霉素、替硝唑、枸橼酸铋钾治疗10 d。疗程结束1个月后行14C尿素呼气试验检测。结果治疗组14C尿素呼气试验根除率为92.6%,对照组根除率为95%,两组Hp根除率比较差异无统计学意义（P〉0.05）。结论 10 d序贯疗法Hp的根治率较传统四联疗法具有疗效相当,耐受性和依从性好,安全可靠,经济花费减少。     

序贯疗法治疗幽门螺杆菌阳性消化性溃疡的疗效观察及安全性分析

目的探讨序贯疗法治疗幽门螺杆菌(Hp)阳性消化性溃疡(PU)的疗效及安全性。方法 86例Hp阳性PU患者按随机数字表法分为对照组(泮托拉唑+阿莫西林+克拉霉素)和观察组(前5d泮托拉唑+阿莫西林,后5d泮托拉唑+替硝唑+克拉霉素)各43例。以10 d作为1个疗程,疗程结束后一个月,对两组患者Hp转阴情况、疗效及治疗期间的不良反应进行比较。结果对照组Hp根除率76.7%,观察组Hp根除率88.4%,差异有统计学意义(χ~2=4.725,P0.05);对照组总有效率79.1%,观察组总有效率90.7%,差异有统计学意义(χ~2=5.114,P0.05)。两组不良反应比较差异无统计学意义(P0.05)。结论 Hp阳性PU采用序贯疗法治疗具有较高的Hp根除率及治疗有效率,无明显不良反应,值得临床进一步研究与推广运用。     

双歧杆菌联合幽门螺杆菌根除四联疗法治疗青少年人群幽门螺旋杆菌感染的临床研究

目的研究双歧杆菌联合幽门螺杆菌(Hp)根除四联疗法治疗青少年人群Hp感染临床疗效和安全性。方法入选本院门诊或住院Hp感染的青少年患者共180例,随机分为双歧杆菌联合Hp根除四联疗法组(治疗组)及Hp根除四联疗法治疗组(对照组)各90例。对照组四联疗法为泮托拉唑40 mg,早晚餐前0.5 h口服;克拉霉素500 mg,阿莫西林1000 mg,枸橼酸铋钾220 mg,早晚餐后0.5 h口服。治疗组在使用四联疗法基础上加用双歧杆菌三联活菌胶囊630 mg,早晚餐后4 h口服。2组疗程均为14 d。结果双歧杆菌联合四联疗法与单独四联疗法Hp根除率分别为91.11%、62.2%(P0.05)。2组不良反应轻,主要表现为恶心、腹胀、腹泻、便秘、口苦等,治疗组和对照组不良反应发生率分别为6.67%、21.11%(P0.05)。结论双歧杆菌联合Hp根除四联疗法治疗青少年人群幽门螺旋杆菌感染可以提高Hp根除率并减少不良反应的发生。     

含左氧氟沙星三联疗法根除幽门螺杆菌的临床研究

目的观察含左氧氟沙星三联疗法与常规四联疗法根除幽门螺杆菌（Hp）的临床疗效差异,并分析不良反应的差异。方法 260例既往未接受过根除治疗的Hp感染患者,按照分层随机分为A、B组两组,每组130例,A组为泮托拉唑＋克拉霉素干混悬剂＋左氧氟沙星治疗组,B组为泮托拉唑＋胃三联（枸橼酸铋钾＋克拉霉素＋替硝唑）治疗组,各组疗程均为1周,疗程结束4周后行14C-尿素呼气试验判断效果,结果阴性者判断为Hp根除,观察临床疗效及不良反应差异。结果 A组Hp根除103例,根除率83.1%（103/124）,B组Hp根除107例,根除率87.7%（107/122）,差异无显著性（P〉0.05）;A组发生不良反应4例,发生率3.2%（4/126）,B组发生不良反应13例,发生率10.4%（13/125）,差异有显著性（P〈0.05）。结论含左氧氟沙星三联疗法具有与常规四联疗法相似的根除Hp疗效,而且可以降低治疗中的不良反应发生率,依从性更好,可作为根除Hp感染的一线方案。     

序贯疗法与标准三联疗法根除幽门螺杆菌的疗效对比分析——附105例报告

目的：比较由泮托拉唑、阿莫西林、克拉霉素、替硝唑组成的10日序贯疗法与标准的7日三联疗法根除幽门螺杆菌（Hp）的疗效及安全性。方法：将105例消化性溃疡或慢性胃炎且Hp阳性成人患者随机分为两组。治疗组（53例）前5日应用泮托拉唑40mg、阿莫西林1000mg,每日2次口服,后5日用泮托拉唑40mg、克拉霉素500mg、替硝唑500mg,每日2次口服。对照组（52例）采用7日泮托拉唑40mg、阿莫西林1000mg、克拉霉素500mg,每日2次口服。停药4周后复查Hp。结果：治疗组Hp根除率为90.6%,对照组为71.2%,两组比较差异有统计学意义（P〈0.05）;不良反应发生率分别为18.9%和17.3%（P〉0.05）。结论：由泮托拉唑、阿莫西林、克拉霉素、替硝唑组成的10日序贯疗法治疗成人Hp感染的疗效优于标准7日三联疗法。     

不同方案根除幽门螺旋杆菌效果对比分析

目的观察以质子泵抑制剂（PPI）为基础的不同方案根除幽门螺旋杆菌（Hp）的效果。方法选择经内镜下活检病理及快速尿素酶试验确诊的1203例Hp感染患者,根除Hp疗程结束4周以上复查13C-尿素呼气试验,回顾性分析不同根除Hp方案疗效。所有患者均采用PPI为基础（埃索美拉唑、雷贝拉唑、兰索美拉唑、泮托拉唑、奥美拉唑,常规量每日2次）＋不同抗菌药物的三联或四联方案,用药疗程分为7、10、14d。A组421例：阿莫西林1．0g,2次／d,克拉霉素0．5g,2次／d;B组49例：阿莫西林1．0g,2次／d,左氧氟沙星0．2g,2次／d;C组69例：阿莫西林1．0g,2次／d,甲硝唑0．4g,2次／d;D组559例：克拉霉素0．5g,2次／d,左氧氟沙星0．2g,2次／d;E组105例：克拉霉素0．5g,2次／d,甲硝唑0．4g,2次／d。铋剂均为胶体果胶铋200mg,20：／a。结果含阿莫西林组Hp根除率为84．04％（453／539）,不含阿莫西林组为69．12％（459／664）,前者明显优于后者（X。=36．104,P=0．000）,Hp的根除率可提高14．92％。四联疗法根除率76．85％（767／998）,三联疗法根除率70．73％（145／205）,但两组之间疗效比较差异无统计学意义（x。=3．476,P=0．062）。7、10、14d疗程根除率分别为71．07％（199／280）、75．79％（579／764）、84．28％（134／159）,3个疗程疗效差异有统计学意义（X2=9．644,P：0．008）,14d疗程Hp根除率明显优于7、10d疗程,差异均有统计学意义X2值分别为11．719,5．399,P值分别为0．001,0．020）,7、10d两组间根除率差异无统计学意义（X2=2．398,P=0．121）。A组Hp根除率84．80％（357／421）、B组81．63％（40／49）、C组81．16％（56／69）,优于D组69．95％（391／559）、E组64．76％（68／105）,不同抗菌药联合根除Hp疗效对比差异有统计学意义（X2=37．999,P=0．000）。结论根除Hp治疗中应以PPI为基础,首选阿莫西林与克拉霉素联合用药的三联或四联14d疗程治疗方案,其临床疗效值得推广。     

序贯疗法治疗幽门螺杆菌阳性消化性溃疡的疗效分析

目的：比较10d序贯疗法与7d及14d三联疗法根治幽门螺杆菌（Hp）的疗效与安全性。方法：选取113例胃镜证实为消化性溃疡行14C尿素呼气试验Hp阳性患者,随机分为3组：A组（序贯疗法组）前5d给予泮妥拉唑和阿莫西林,后5d给予泮妥拉唑、替硝唑、克拉霉素治疗;B组（7d疗法）给予泮妥拉唑、阿莫西林、克拉霉素治疗,病理为7d;C组（14d疗法）方案同7d疗法,疗程为14d。疗程结束1个月后行^14C尿素呼气试验。结果：A组根除率为87.18%（34/39）,C组根除率为91.43%（34/37）,均高于B组根除率81.08%（30/37）（P〈0.05）,A组与C组根除率比较无显著差别（P〉0.05）。3组不良反应发生率分别为：15.38%、13.51%和18.91%,相互比较均无显著差异,A组费用效益比好于B组和C组。结论：10d序贯疗法疗效与14d三联疗法的疗效均好,序贯疗法费用效益比最低。10d序贯疗法安全、有效、经济。     

雷贝拉唑及雷尼替丁枸橼酸铋的短程四联疗法根除幽门螺杆菌感染

目的观察雷贝拉唑与雷尼替丁枸橼酸铋（Ranitidine bismath citrate，RBC）联合的五天四联疗法根除幽门螺杆菌（Helicobacter pylori，Hp）的疗效及安全性。方法选择Hp感染的活动期溃疡或慢性糜烂性胃窦炎患者，随机分为A、B、C、D四组。分别用雷贝拉唑三联七天疗法、RBC三联七天疗法、雷贝拉唑与三甲二枸橼酸铋联合四联七天疗法和雷贝拉唑与RBC联合四联五天疗法根除Hp治疗，活动期溃疡病例抗Hp治疗后继续服雷贝拉唑10mg，1次／d，疗程2周。观察Hp的根除率、活动期溃疡和糜烂性胃窦炎的愈合率以及副作用的发生率。结果雷贝拉唑与RBC联合五天四联组Hp根除率（97．7％）显著高于雷贝拉唑三联组（72．7％）或RBC三联组（75．6％）（P〈0．05），亦高于雷贝拉唑与三甲二枸橼酸铋联合四联组（88．4％），但差异无统计学意义（P〉0．05）。雷贝拉唑与RBC联合的五天四联组与其他三组对活动期溃疡愈合率较接近；高于其他三组对糜烂性胃窦炎的愈合率，但差异无统计学意义（P〉0．05）。不良反应发生率，雷贝拉唑三联组（8．9％）、RBC三联组（6．7％）和雷贝拉唑与RBC联合四联组（8．9％）较类似。均低于雷贝拉唑与三甲二枸橼酸铋联合四联组（20．0％），但差异无统计学意义（P〉0．05）。结论雷贝拉唑与RBC联合四联疗法可获得高Hp根除率，不良反应少、疗程短，值得进一步试用。     

Randomized Controlled Trial Comparing 7-Day Triple, 10-Day Sequential,and 7-Day Concomitant Therapies for Helicobacter pylori Infection

With the rising prevalence of antimicrobial resistance, the failure rate of the standard triple therapy for Helicobacter pylori infection is increasing. Sequential therapy and concomitant therapy have been recommended to replace standard triple therapy for H. pylori eradication in regions with high clarithromycin resistance. The aim of this prospective, randomized, and controlled study was to simultaneously assess the efficacies of 10-day sequential and 7-day concomitant therapies versus a 7-day standard triple therapy for treating H. pylori infection. Consecutive H. pylori-infected subjects were randomly assigned to a 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin, and metronidazole for a further 5 days), or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin, and metronidazole for 7 days). H. pylori status was confirmed 6 weeks after therapy. Three hundred seven H. pylori-infected participants were randomized to receive triple (n = 103), sequential (n = 102), or concomitant (n = 102) therapies. The eradication rates by an intention-to-treat analysis in the three treatment groups were 81.6% (95% confidence interval [CI], 74.1% to 89.0%), 89.2% (95% CI, 83.2% to 95.2%), and 94.1% (95% CI, 89.5% to 98.7%). The seven-day concomitant therapy had a higher eradication rate than did the 7-day triple therapy (difference, 12.5%; 95% CI, 3.7% to 21.3%). There were no significant differences in the eradication rates between the sequential and standard triple therapies. All three treatments exhibited similar frequencies of adverse events (8.7%, 8.8%, and 13.7%, respectively) and drug compliance (99.0%, 98.0%, and 100.0%, respectively). In conclusion, the seven-day concomitant therapy is superior to the 7-day standard triple therapy for H. pylori eradication. Additionally, it is less complex than the 10-day sequential therapy because the drugs are not changed halfway through the treatment course. (This study has been registered at ClinicalTrials.gov under registration no. NCT1769365.)     

Second-line and third-line trial for helicobacter pylori infection in patients with duodenal ulcers: A prospective, crossover, controlled study

Background: Following standard first-line triple therapies for Helicobacter pylori infection, up to 20% of patients require further eradication.Objective: The aim of this study was to assess the effects of second-line triple therapies and third-line quadruple therapies for the eradication of H pylori.Methods: This 7-week, prospective, crossover, controlled, second- and third-line trial was conducted at the Department of Gastroenterology, Ferencváros Health Center (Budapest, Hungary). Patients aged 18 to 80 years with duodenal ulcers and an H pylori infection resistant to first-line triple therapy (pantoprazole 40 mg BID + amoxicillin 1000 mg BID + clarithromycin 500 mg BID [PAC] given as tablets) received a different triple therapy regimen (ranitidine bismuth citrate 400 mg BID + metronidazole 500 mg BID + clarithromycin 500 mg BID [RBC-MC]) for 7 days (group 1A), and nonresponders after RBC + 2 antimicrobials received the pantoprazole-based regimen (group 1B). After secondary failure, patients were randomized to receive quadruple therapies: pantoprazole, amoxicillin, tetracycline, and either nitrofurantoin or bismuth subsalicylate (groups 2A and 2B).Results: One hundred thirty-four patients were enrolled in the second-line study (56 men, 78 women; mean [SD] age, 51.1 [12.4] years; group 1A, 68 patients; group 1B, 66 patients). Subsequently, 41 (30.6%) of these patients were randomized to receive quadruple therapies. Using intent-to-treat (ITT) analysis, the eradication rates did not differ significantly (60.3% and 65.2% in groups 1A and 1B, respectively; 61.9% and 55.0% in groups 2A and 2B, respectively). Perprotocol eradication rates did not differ significantly (66.1% and 68.3% in groups 1A and 1B, respectively); however, the rates were significantly different in group 2A (66.7%) versus group 2B (55.5%) (P = 0.03).     

雷贝拉唑-替硝唑-克拉霉素-枸橼酸铋钾四联五天疗程能有效根除幽门螺旋杆菌感染

目的　通过与奥美拉唑三联 7天疗法比较 ,观察雷贝拉唑四联 5天疗法根除幽门螺杆菌 (H .pylori)的疗效。方法　采用单中心、随机、平行对照研究法。 96例经快速尿素酶和病理学检查确定为H .pylori阳性患者分为两组 ;雷贝拉唑 (商品名 :波利特 )实验组 (RCTB组 ,50例 )和奥美拉唑 (商品名 :洛赛克 )对照组 (OCT组 ,46例 )。实验组 ;雷贝拉唑 10mg +替硝唑50 0mg +克拉霉素 2 50mg +枸橼酸铋钾 110mg ,每日两次 ,连续 5天 ,对照组 ;奥美拉唑 2 0mg +替硝唑 50 0mg +克拉霉素 2 50mg ,每日两次 ,连续 7天。并于用药后 1月行14C呼气实验检测感染是否治愈。结果　 92例完成全部治疗方案 ,4例失访。H .py lori根除率 :14C呼气实验检测结果示RCTB组 93 .7% ,OCT组 90 .9% ,两组间无显著性差异 (P >0 .0 5)。结论　两组治疗方案均能有效根除H .pylori。     

Quadruple rescue therapy for Helicobacter pylori infection after two treatment failures

Background  A standard third-line therapy for Helicobacter pylori infection is lacking, and antimicrobial sensitivity data for patients who failed eradication therapy are often unavailable in clinical practice. We therefore designed the prospective study to assess the efficacy of levofloxacin, amoxicillin, bismuth and rabeprazole quadruple therapy as a third-line treatment for H. pylori infection.
Patients and methods  From September 2005 to August 2007, 37 consecutive H. pylori -infected patients who had failed standard first-line and second-line treatments underwent a 10-day quadruple therapy comprising rabeprazole (20 mg b.i.d.), bismuth subcitrate (300 mg q.d.s.), amoxicillin (500 mg q.d.s.) and levofloxacin (500 mg o.d.). Follow-up endoscopy with rapid urease test, histological examination and culture was performed at 6 weeks after the end of treatment to evaluate the response to therapy.
Results  Helicobacter pylori was successfully eradicated in 31 out of 37 patients (84% by both intention-to-treat analysis and per-protocol analysis). All patients complied with the eradication therapies, and only seven patients (19%) complained of mild-to-moderate adverse events. Amoxicillin- and levofloxacin-resistant strains were observed in 17% and 22% of the patients, respectively. There were no significant differences between H. pylori eradication rates and antibiotic resistances.
Conclusions  The 10-day levofloxacin- and amoxicillin-based quadruple therapy is well tolerated and achieves a high eradication rate as a third-line empirical treatment for H. pylori infection.     

Effectiveness of antiinfectives

BACKGROUND: Helicobacter pylori is one of the most common infections of mankind, with persistent colonization causing significant morbidity and mortality. TREATMENT: First-line therapy, consisting of 7-day treatment with a proton pump inhibitor or ranitidine bismuth citrate, amoxicillin and clarithromycin, with second-line therapy, consisting of a proton pump inhibitor, bismuth, metronidazole, and tetracycline, in the case of failure, is chosen as the most cost-effective method of H. pylori eradication. CONCLUSION: The effectiveness of these antiinfectives is limited by lack of compliance with treatment regimens, and increasing antibiotic resistance.     

Comparison of sequential and standard triple-drug regimen for Helicobacter pylori eradication: a 14-day, open-label, randomized, prospective, parallel-arm study in adult patients with nonulcer dyspepsia

BACKGROUND: The eradication rates of Helicobacter pylori with standard treatments are decreasing worldwide. OBJECTIVES: The primary aim of this study was to compare the eradication success of a 14-day sequential regimen with proton pump inhibitor (PPI)-based triple treatment. The secondary objectives of the study were to evaluate the effect of gastritis score and smoking on eradication rates as well as evaluation of compliance and tolerability of both regimens. METHODS: Consecutive H pylori-positive patients with nonulcer dyspepsia were randomized into 1 of 2 groups in this 14-day, open-label, randomized, prospective, parallel-arm study. An upper endoscopy with biopsy and (14)C-urea breath test ((14)C-UBT) were performed before enrollment. The first group was administered a sequential regimen consisting of pantoprazole 40 mg and amoxicillin 1 g for 7 days, followed by pantoprazole 40 mg, tetracycline 500 mg, and metronidazole 500 mg for the next 7 days. The second group was administered pantoprazole 40 mg, amoxicillin 1 g, and clarithromycin 500 mg (PAC group) for 14 days. All drugs were administered BID, with the exception of tetracycline, which was administered QID. Eradication was confirmed by (14)C-UBT 6 weeks after the end of the treatment. Histologic examination and (14)C-UBT were conducted by investigators blinded to the protocols. Patients were asked to report any adverse events (AEs) during the treatment period. RESULTS: Three hundred white patients were enrolled in the study and evenly randomized into the sequential treatment group (98 males and 52 females; mean age, 40.2 years) and the PAC group (86 males and 64 females; mean age, 41.2 years). A total of 274 patients completed the study per protocol (PP). Twenty-six patients discontinued: lost to follow-up (16), withdrawn due to AEs (9); and noncompliance (1). The intent-to-treat (ITT) and PP H pylori eradication rates were 72.6% and 80.1% in the sequential group, and 58% and 63% in the PAC group, respectively. The eradication rate was significantly higher in the sequential group compared with the PAC group in both the ITT and PP populations (P=0.01 and P=0.002, respectively). The eradication rates were higher in nonsmoking patients compared with smoking patients both in the sequential group (85.8% vs 70.5%) and the PAC group (67.7% vs 53.3%), but the results were not statistically significant when the groups were analyzed separately. Overall, 32 patients (10.7%) reported an AE. Treatment was discontinued in 9 patients because of serious AEs (sequential group--abdominal pain [2 patients], diarrhea [1], chest pain [1], and vaginal pruritus [1]; PAC group--nausea/vomiting [2], chest pain [1], and numbness [1]). There were no significant between-group differences in regard to compliance or AEs. Univariate analyses found no significant effect of sex, age, alcohol consumption, antacid usage, or gastritis score on the eradication rates. CONCLUSIONS: A 14-day sequential treatment regimen achieved a significantly higher eradication rate of H pylori compared with standard PPI-based triple regimen in this small selected population. Large, double-blind, controlled studies are needed to confirm these results.