Efficacy of omeprazole and amoxicillin with either clarithromycin or metronidazole on eradication of Helicobacter pylori in Chinese peptic ulcer patients

AIM: One-week triple therapy with proton pump inhibitors, clarithromycin and amoxicillin has recently been proposed as the first-line treatment for Helicobacter pylori (H pylori) infection; however, data regarding the effects of this regimen in China are scarce. The aim of this prospective and randomized study was to compare the efficacy of clarithromycin and metronidazole when they were combined with omeprazole and amoxicillin on eradication of H pylori and ulcer healing in Chinese peptic ulcer patients. METHODS: A total of 103 subjects with Hpylori-positive peptic ulcer were randomly divided into two groups, and accepted triple therapy with omeprazole 20 mg, amoxicillin 1 000 mg and either clarithromycin 500 mg (OAC group, n = 58) or metronidazole 400 mg (0AM group, n - 45). All drugs were given twice daily for 7 d. Patients with active peptic ulcer were treated with omeprazole 20 mg daily for 2-4 wk after anti-H pylori therapy. Six to eight weeks after omeprazole therapy, all patients underwent endoscopies and four biopsies (two from the antrum and two others from the corpus of stomach) were taken for rapid urease test and histological analysis (with modified Giemsa staining) to examine H pylori. Successful eradication was defined as negative results from both examination methods. RESULTS: One hundred patients completed the entire course of therapy and returned for follow-up. The eradication rate of H pylori for the per-protocol analysis was 89.3% (50/56) in OAC group and 84.1% (37/44) in 0AM group. Based on the intention-to-treat analysis, the eradication rate of H pylori was 86.2% (50/58) in OAC group and 82.2% (37/45) in 0AM group. There were no significant differences in eradication rates between the two groups on either analysis. The active ulcer-healing rate was 96.7% (29/30) in OAC group and 100% (21/21) in 0AM group (per-protocol analysis, P>0.05). Six patients in OAC group (10.3%) and five in OAM group (11.1%) reported adverse events (P>0.05). CONCLUSION: One-week triple therapy with omeprazole and amoxicillin in combination with either clarithromycin or metronidazole is effective for the eradication of H pylori. The therapeutic regimen comprising metronidazole with low cost, good compliance and mild adverse events may offer a good choice for the treatment of peptic ulcers associated with H pylori infection in China.     

Optimal length of triple therapy for H pylori eradication in a population with high prevalence of infection in Chile

AIM:To compare the efficacy of 7-d versus 14-d triple therapy for the treatment of H pylori infection in Chile,with a prevalence of 73% in general population. METHODS:H pylori-infected patients diagnosed by rapid urease test,with non-ulcer dyspepsia or peptic ulcer disease were randomized to receive omeprazole 20 mg bid,amoxicillin 1 g bid,and clarithromycin 500 mg bid for 7 (OAC7) or 14 (OAC14) d. Primary outcome was eradication rate 6 wk after the treatment. Subgroup analysis was carried out considering the eradication rate among patients with or without peptic ulcer disease and eradication rate among smokers or non-smokers. RESULTS:One hundred and thirty-one patients were randomized to OAC7 (n = 69) or OAC14 (n = 62). The overall eradication rate (intention-to-treat) was 78.3% in OAC7 and 85.5% in OAC14 groups,without a significant difference (P =0.37). No significant difference in the eradication rate was found among the patients with peptic ulcer disease (n = 31) between the OAC7 group (85.7%) and OAC14 group (87.5%). However,smokers had an obviously lower eradication rate compared to non-smokers,particularly in the OAC7 group (57.1% in smokers vs 83.6% in non-smokers; P = 0.06). Adverse effects rate were similar between both groups. CONCLUSION:Short-term efficacy of triple therapy with OAC for 7 d is comparable to 14 d in this high-prevalence population. Longer follow-up,and studies focused to some subgroups of patients (smokers and non-ulcerpatients) are necessary to support widespread use of 7-d instead of 10-14-d triple therapy in a developing country like Chile.     

Eradication of H pylori infection in a rural population： One-day quadruple therapy versus 7-day triple therapy

AIM: To compare the one-day quadruple therapy with a standard 7-d triple therapy for H pylori eradication in a rural population of China. METHODS: A total of 396 patients with 13C-urea breath test positive for H pylori were assigned into two groups: 239 patients received one-day quadruple therapy (amox icillin 2000 mg qid; metronidazole 500 mg qid; bismuth citrate 900 mg qid and lansoprazole 60 mg once daily) and 157 patients received 7-d standard triple therapy (amoxicillin 1000 mg bid; clarithromycin 500 mg bid and lansoprazole 30 mg bid). All the patients underwent a 13C-UBT to assess the eradication of H pylori infection six weeks after treatment. RESULTS: Two hundred and twenty-nine patients completed the one-day therapy (95.8%) and 148 patients completed the 7-d therapy (94.2%). The one day therapy eradicated H pylori infection in 64 patients (27.95%). In contrast, 103 patients (69.59%) were H pylori negative after the 7-d therapy (P < 0.01). CONCLUSION: This pilot study suggests there is no beneficial effect of the one-day therapy in treatment of H pylori infection compared with the 7-d standard therapy.     

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.     

Furazolidone, amoxicillin, bismuth and rabeprazole quadruple rescue therapy for the eradication of Helicobacterpylori

AIM： To compare the efficacy and side effect profiles of three furazolidone and amoxicillin-based quadruple rescue therapies for the eradication of Helicobacter pylori （H pylonS. METHODS： Patients who failed in the Hpylori eradication therapy for at least one course were randomly allocated into three groups. Group A received rebaprazole 10 mg＋ amoxicillin 1 g ＋ furazolidone 100 mg, and bismuth subcitrate 220 mg, twice daily for 1 wk; group B received the same regimen of group A but for 2 wk; and group C received the same regimen of group B, but furazolidone was replaced by furazolidone 100 mg three times daily. To record the side effect profiles at the end of the treatment, Hpylori eradication was assessed with 13C-urea breath test 4 wk after therapy. RESULTS： Sixty patients were enrolled including 28 males, and 20 patients in each group. The average age of the patients was 49.2 years, ranging from 18 to 84 years. H pylori eradication rates with per-protocol analysis were 82%, 89% and 90% in the three groups, respectively. Side effects were found in 11 patients, including mild dizziness, nausea, diarrhea and increased bowel movement. None of the 11 patients needed treatment for their side effects. CONCLUSION： One- or two-week furazolidone and amoxicillin-based quadruple rescue therapy with a low dose furazolidone （100 mg bid） for the eradication of Hpylori is effective. Extending the antibiotic course to 14 d could improve the eradication rates.     

Sofalcone, a mucoprotective agent, increases the cure rate of Helicobacter pylori infection when combined with rabeprazole, amoxicillin and clarithromycin

AIM: The mucoprotective agents, sofalcone and polaprezinc have anti-Helicobacter pylori (H pylori) activities. We determined the therapeutic effects of sofalcone and polaprezinc when combined with rabeprazole, amoxicillin and clarithromycin for Helicobacter pylori infection. METHODS: One hundred and sixty-five consecutive outpatients with peptic ulcer and H pylori infection were randomly assigned to one of the following three groups and medicated for 7 d. Group A: triple therapy with rabeprazole (10 mg twice daily), clarithromycin (200 mg twice daily) and amoxicillin (750 mg twice daily). Group B: sofalcone (100 mg thrice daily) plus the triple therapy. Group C: polaprezinc (150 mg twice daily) plus the triple therapy. Eradication was considered successful if 13C-urea breath test was negative at least 4 wk after cessation of eradication regimens or successive famotidine in the cases of active peptic ulcer. RESULTS: On intention-to-treat basis, H pylori cure was achieved in 43 of 55 (78.2%) patients, 47 of 54 (87.0%) and 45 of 56 (80.4%) for the groups A, B and C respectively. Using per protocol analysis, the eradication rates were 81.1% (43/53), 94.0% (47/50) and 84.9% (45/53) respectively. There was a significant difference in the cure rates between group A and B. Adverse events occurred in 10, 12 and 11 patients, from groups A, B and C respectively, but the events were generally mild. CONCLUSION: The addition of sofalcone, but not polaprezinc, significantly increased the cure rate of H pylori infection when combined with the rabeprazole-amoxicillin-clarithromycin regimen.     

H pylori infection in patients with Behcet''''s disease

AIM:To evaluate endoscopic findings and the prevalence of H pylori in patients with Behcet's disease (BD) who have upper gastrointestinal symptoms. METHODS:The patients with BD diagnosed according to the International Study Group and followed up in the Department of Dermatology and other related departments and who had any upper gastrointestinal complaints,were included in this study. Forty-five patients with BD and 40 patients in the control group were evaluated by upper gastrointestinal endoscopy and two biopsied specimens were taken during endoscopy for H pylori . A two-week triple therapy for H pylori eradication was administered to H pylori positive patients. Two months after the treatment,the patients were evaluated by urea-breath test for eradication control. RESULTS:Patients with BD had a mean age of 36.2 ± 11.4 years (18-67 years). The mean follow-up time was 35 ± 14 mo (16-84 mo). Aphthous or deep ulcer in esophagus,stomach and duodenum had never been confirmed by endoscopic examination. Most gastric lesions were gastric erosion (40%) and the most duodenal lesions were duodenitis (17.5%) in two groups. H pylori was positive in 33 patients (73.3%) with BD. The two-week triple eradication therapy was successful in 75% of the patients. There was no difference between the groups in respect to prevalence of H pylori (73.3% vs 75%,P > 0.05),and eradication rate (75% vs 70%,P > 0.05). CONCLUSION:Endoscopic findings,eradication rate and prevalence of H pylori were similar in patients withBD and control group.     

Modified sequential therapy vs quadruple therapy as initial therapy in patients with Helicobacter infection

AIM: To evaluate the efficacy and safety of modified sequential therapy and to compare modified sequential therapy with standard quadruple therapy for Helicobacter pylori(H. pylori) eradication.METHODS: In total, 200 consecutive patients who were diagnosed with H. pylori-infected chronic gastritis by electronic endoscopy and rapid urease testing from December 2012 to October 2013 were enrolled in this study. The patients had not previously received H. pylori eradication treatment, and were randomized into two groups. The patients in Group A(n = 101) were treated with ilaprazole + bismuth potassium citrate + amoxicillin and clavulanate potassium + levofloxacin, and the patients in Group B(n = 99) were administered a modified sequential therapy composed of ilaprazole at 5 mg bid and amoxicillin and clavulanate potassium at 914 mg for the first five days followed by ilaprazole at 5 mg bid, furazolidone at 100 mg bid and levofloxacin at 500 mg qid for the next five days. Four to six weeks after the end of treatment, a 14C-urea breath test was performed for all the subjects to confirm the eradication of H. pylori. The intention-to-treat and per-protocol eradication rates were determined.RESULTS: A total of 190 of the 200 patients completed the study. All 200 patients were included in the intention-to-treat analysis, whereas 190 patients were included in the per-protocol analysis. In the intentionto-treat analysis, the rates of H. pylori eradication in Groups A and B were 85.15%(86/101) and 81.82%(81/99), respectively. In the per-protocol analysis, the H. pylori eradication rates in Groups A and B were 88.66%(86/97) and 87.09%(81/93), respectively. No significant difference was observed(χ2 = 0.109, P = 0.741) in the eradication rate between Groups A and B. The rates of adverse effects observed in the groups were similar at 6.19%(6/97) for Group A and 7.53%(7/93) for Group B(P 0.05). No mortality or major morbidities were observed in any of the patients. Symptomatic improvements in the presentation of stomachache, acid regurgitation, and burning sensation were not significantly different between the two groups.CONCLUSION: Ilaprazole-based 10-d standard quadruple therapy does not offer an incremental benefit over modified sequential therapy for the treatment of H. pylori infection, as both treatment regimens appear to be effective, safe, and well-tolerated as initial treatment options.     

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.     

Quadruple therapy for eradication of Helicobacter pylori

AIM:To investigate quadruple therapy with rabeprazole,amoxicillin,levofloxacin and furazolidone for the eradication of Helicobacter pylori (H.pylori) infection.METHODS:A total of 147 patients were divided into the experimental treatment group (n=78) and the standard triple treatment group (n=69).The experimental treatment group received rabeprazole 20 mg,amoxicillin 1.0 g,levofloxacin 0.2 g and furazolidone 0.1 g,twice daily.The standard triple treatment group received omeprazole 20 mg,amoxicillin 1.0 g and clarithromycin 0.5 g,twice daily.RESULTS:One month after treatment,the 13 C urea breath test was carried out to detect H.pylori.The eradication rate using per-protocol analysis was 94.3% in the experimental treatment group and 73% in the standard triple treatment group (P < 0.05),and using intention to test analysis,these figures were 86% and 67% in the two groups,respectively.Side effects were observed in 34 patients,and included mild dizziness,nausea,diarrhea and increased bowel movement.Eleven of the 34 patients needed no treatment for their side effects.CONCLUSION:Rabeprazole,amoxicillin,levofloxacinand furazolidone quadruple therapy is a safe method for the eradication of H.pylori with high efficacy and good tolerability.     

十二指肠溃疡患者根除幽门螺杆菌后抑酸维持治疗的疗效研究

背景：对感染幽门螺杆菌（H.pylori）的消化性溃疡患者成功根除且H.ylori后,是否应继续行抑酸治疗,目前尚存在争议。目的：探讨合并H.pylori感染的十二指肠溃疡（DU）患者根除H.pylori后抑酸维持治疗的疗效。方法：112例合并H.pylori感染的DU患者随机分为A组和B组,A组给予10d四联疗法：兰索拉唑30mg＋阿莫西林1g＋克拉霉素0．5gbid＋枸橼酸铋钾110mg qid,疗程10d。B组：在A组方案的基础上,疗程结束后再予兰索拉唑30mg,1次／d,维持4周。治疗结束4周后复查胃镜,评估H.pylori根除疗效、溃疡愈合率和腹痛缓解率。结果：109例患者完成方案。A、B两组按意向治疗（ITT）和按方案（PP）分析的H.pylori根除率（ITT：85．7％对87．5％;PP：88．9％对89．1％）和溃疡愈合率（ITT：87．5％对94．6％;PP：90．7％对96．4％）以及腹痛缓解率（95．6％对95．7％）相比差异均无统计学意义（P〉0．05）。结论：以10d四联疗法根除H.pylori后,可使多数DU患者的溃疡愈合,无需进一步行维持抑酸治疗。     

序贯疗法与标准四联疗法对幽门螺杆菌根除失败后补救治疗的疗效分析

近年经典三联疗法的幽门螺杆菌（11．pylori）根除疗效明显降低,选择有效补救疗法对Hpylori根除失败者有重要意义。目的：比较序贯疗法与标准四联疗法对且pylori根除失败者的疗效。方法：将98例Hpylori根除失败者随机分为序贯疗法组（前5d予奥美拉唑20mg＋阿莫西林1000mgbid,后5d予奥美拉唑20mg＋左氧氟沙星200mg＋克拉霉素500mgbid）和标准四联疗法组（予奥美拉唑20mg＋胶体次枸橼酸铋钾220mg＋阿莫西林1000mg＋克拉霉素500mgbid,疗程7d）。停药4周后复查”C一尿素呼气试验,评估Hpylori根除疗效。结果：共95例患者完成方案,序贯疗法组11Tr和PP分析的Hpylori根除率均显著高于标准四联疗法组（ITF：89．8％对71,4％,PP：91．7％对74。5％,P〈0．05）,序贯疗法组临床症状改善的总有效率亦显著高于标准四联疗法组（95．8％对80．9％,P〈0．05）,两组不良反应发生率无明显差异（P〉0．05）。结论：对Hpylori根除治疗失败的患者,序贯疗法和标准四联疗法均可作为有效的补救治疗方案,但10d序贯疗法的疗效优于7d标准四联疗法。     

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。     

根除幽门螺杆菌对出血性十二指肠溃疡自然病程影响的3年随访研究

目的：探讨根除幽门螺杆菌（Ｈｐ）对出血性十二指肠溃疡自然病程的影响。方法：选择胃镜证实的出血性十二指肠溃疡病人１３６例，均有Ｈｐ感染（胃粘膜Ｇｉｅｍｓａ染色和１４Ｃ尿素呼吸试验二项均阳性）。予奥米拉唑２０ｍｇ，每日２次；羟氨苄青霉素７５０ｍｇ，每日２次；甲硝唑４００ｍｇ，每日３次，疗程２周。疗程结束后４周复查胃镜和Ｈｐ，溃疡愈合者分Ａ组（Ｈｐ根除）和Ｂ组（Ｈｐ未根除）进入随访阶段，随访观察３年。结果：溃疡愈合１２４例（９１２％），Ｈｐ根除１１１例（８１６％）；Ｈｐ根除的溃疡愈合率为９９１％（１１０／１１１），显著高于Ｈｐ未根除的５６％（１４／２５，Ｐ＜０００５）；Ｂ组１年内溃疡复发率达１００％，显著高于Ａ组８３％（Ｐ＜００５）；Ｂ组３年累积再出血率１００％，显著高于同期Ａ组的９０％（Ｐ＜００５）。结论：根除Ｈｐ可提高十二指肠溃疡愈合率和减少溃疡复发率，尤可显著减少溃疡再出血率，提示根除Ｈｐ很可能改变出血性十二指肠溃疡的自然病程。     

含呋喃唑酮短程三联及四联药物治疗幽门螺杆菌感染成本效果分析

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Cure of Helicobacter pylori-positive active duodenal ulcer patients: a double-blind, multicentre, 12-month study comparing a two-week dual vs a one-week triple therapy. GISU (Interdisciplinary Group for Ulcer Study).

AIMS: To compare a two-week dual therapy to a one-week triple therapy for the healing of duodenal ulcer and the eradication of the Helicobacter pylori infection. PATIENTS AND METHODS: A total of 165 patients with active duodenal ulcer were enrolled in the study. At entry, endoscopy, clinical examination and laboratory tests were performed. Histology and the rapid urease test were used to diagnose Helicobacter pylori infection. Patients received either lansoprazole 30 mg plus amoxycillin 1 g bid for two weeks (two-week, dual therapy) or lansoprazole 30 mg plus amoxycillin 1 g plus tinidazole 500 mg bid for one week plus lansoprazole qd for an additional week (one-week, triple therapy). Two and twelve months after cessation of therapy, endoscopy and clinical assessments were repeated. RESULTS: Duodenal ulcer healing and Helicobacter pylori eradication were both significantly greater (p<0.0001) in the triple therapy group (healing: 98.6%; Helicobacter pylori cure rate: 72.6%) than in the dual therapy group (healing: 77.3%; Helicobacter pylori cure rate: 33.3%). Ulcers healed more frequently in Helicobacter pyloricured than in Helicobacter pylori-not cured patients (94.9% vs. 77.2%; p<0.0022). After one year, Helicobacter pylori eradication was re-confirmed in 46/58 patients previously treated with the triple therapy and in 10/40 patients treated with the dual therapy [p<0.0001]. Only three duodenal ulcer relapses were observed throughout follow-up: all were in Helicobacter pylori-not cured patients. CONCLUSIONS: Triple therapy was more effective than dual both in curing Helicobacter pylori infection and healing active duodenal ulcers. The speed of ulcer healing obtained after only 7 days of antibiotics and 14 days of proton pump inhibitors confirmed that longer periods of anti ulcer therapy were not necessary. Helicobacter pylori -not cured patients had more slowly healing ulcers which were more apt to relapse when left untreated.     

雷贝拉唑与奥美拉唑三联疗法根除幽门螺杆菌多中心、随机、双盲、平行对照研究

背景:新一代质子泵抑制剂雷贝拉唑具有较高的解离常数（pKa）,在抑酸方面起效更快,作用更持久稳定。目的:通过与奥美拉唑三联疗法比较,观察雷贝拉唑三联疗法根除幽门螺杆菌（H.pylori）和治疗十二指肠溃疡的疗效。方法:采用多中心、随机、双盲、平行对照研究方法,于2002年1～7月在5家医院进行。109例经胃镜检查确诊为十二指肠溃疡活动期并经快速尿素酶试验和病理学检查确定为H.pylori阳性的患者分为两组:雷贝拉唑（商品名:波利特）试验组（RAC组,53例）和奥美拉唑（商品名:洛赛克）对照组（OAC组,56例）。两组均先给予三联治疗:雷贝拉唑10mg或奥美拉唑20mg+阿莫西林1g+克拉霉素500mg,每日2次,连续7天,然后单独给予雷贝拉唑10mg,每日1次或奥美拉唑20g,每日1次,连续7天,并于用药结束后第28天复查胃镜并检测H.pylori。于用药后第1、2、3、6和42天对患者的上腹痛、反酸以及上腹烧灼感等症状进行评估。结果:101例患者完成全部治疗方案,8例失访。H.pylori根除率:病理学检查结果显示RAC组的H.pylori根除率为86.0％,OAC组为76.5％,两组间差异无显著性（P>0.05）。溃疡愈合率:PAC组的溃疡愈合率为92.0％,OAC组为76.5％,OAC组高于OAC组,两组间差异有显著性（P<0.05）。症状改善情况:两组从用药第1天起均能有效改善     

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。