您的位置:山东大学 -> 科技期刊社 -> 《山东大学学报(医学版)》

山东大学学报(医学版) ›› 2014, Vol. 52 ›› Issue (7): 45-49.doi: 10.6040/j.issn.1671-7554.0.2013.750

• 临床医学 • 上一篇    下一篇

10天伴同、序贯及含铋剂四联方案根除幽门螺杆菌效果的随机对照研究

李月月, 左秀丽, 季锐, 陈飞雪, 赵宏宇, 王晗, 郭婧, 张菁媛, 付姗姗, 刘建伟, 李延青   

  1. 山东大学齐鲁医院消化内科, 山东 济南 250012
  • 收稿日期:2013-12-13 修回日期:2014-06-12 出版日期:2014-07-10 发布日期:2014-07-10
  • 通讯作者: 李延青。E-mail:liyanqing@sdu.edu.cn E-mail:liyanqing@sdu.edu.cn

A randomized clinical trial of ten-day concomitant, sequential and bismuth-based quadruple therapies for Helicobacter pylori

LI Yueyue, ZUO Xiuli, JI Rui, CHEN Feixue, ZHAO Hongyu, WANG Han, GUO Jing, ZHANG Jingyuan, FU Shanshan, LIU Jianwei, LI Yanqing   

  1. Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan 250012, Shandong, China
  • Received:2013-12-13 Revised:2014-06-12 Online:2014-07-10 Published:2014-07-10

摘要: 目的 通过比较10天伴同、序贯及含铋剂四联疗法三种方案对Hp的根除率,以确定最佳的四联治疗方案,进而指导临床实践。方法 经快速尿素酶检查证实Hp的患者随机接受伴同方案(奥美拉唑20 mg、阿莫西林1 000 mg、克拉霉素500 mg、替硝唑500 mg)、序贯方案(前5天为奥美拉唑20 mg、阿莫西林1 000 mg,后5天为奥美拉唑20 mg、克拉霉素500 mg、替硝唑500 mg)或含铋剂方案(奥美拉唑20 mg、阿莫西林1 000 mg、克拉霉素500 mg、胶体果胶铋200 mg)治疗,每日2次用药,疗程均为10 d。患者停药后6周进行13C呼气试验检查,结果阴性者判为根除成功。结果 意向性分析时,伴同方案、序贯方案和含铋剂方案对Hp的根除率分别为85.6%、70.7%、85.3%,伴同方案和含铋剂方案均显著优于序贯方案(P<0.05)。符合方案集分析显示,上述3组对Hp的根除率为87.8%、82.8%和88.9%,各方案之间的根除率均无统计学差异(P>0.05)。结论 在临床工作中,10 d含铋剂四联方案可作为经验性治疗Hp感染的首选方案。

关键词: 幽门螺杆菌, 伴同方案, 含铋剂方案, 序贯方案

Abstract: Objective To determine the best empiric regimens to eradicate Helicobacter pylori (Hp) in daily clinical work by comparing the efficacy of ten-day concomitant, sequential and bismuth-based quadruple therapies. Methods A total of 226 patients with H.pylori infection proved by rapid urease test (RUT) were randomly divided into 3 groups, and received concomitant therapy (omeprazole 20 mg, amoxicillin 1 000 mg, clarithromycin 500 mg and tinidazole 500 mg), sequential therapy (omeprazole 20 mg, amoxicillin 1 000 mg for the first 5 days, followed by omeprazole 20 mg, clarithromycin 500 mg and tinidazole 500 mg for another 5 days), and bismuth-based therapy (omeprazole 20 mg, amoxicillin 1 000 mg, clarithromycin 500 mg and colloidal bismuth pectin 200 mg), respectively. All regimens were taken twice a day for 10 days. Hp status was confirmed by 13C-urea breath test 6 weeks after completion of treatment, and negative result was considered as successful in Hp eradication. Results In intention-to-treat analysis, the eradication rates of concomitant therapy, sequential therapy and bismuth-based therapy were 85.6%, 70.7%, and 85.3%, respectively. Either concomitant therapy or bismuth-based therapy was significantly superior to sequential therapy (P<0.05). In per-protocol analysis, the eradication rates of the 3 regimens were 87.8%, 82.8% and 88.9%, respectively.And there was no statistic significance between any two of the three groups (P>0.05). Conclusion Ten-day bismuth-based therapy can be adopted as the best empiric regimen to cure Hp infection in clinical work.

Key words: Helicobacter pylori, Concomitant therapy, Sequential therapy, Bismuth-based therapy

中图分类号: 

  • R573
[1] McColl K E. Clinical practice. Helicobacter pylori infection[J]. N Engl J Med, 2010, 362(17):1597-1604.
[2] Suerbaum S, Michetti P. Helicobacter pylori infection[J]. N Engl J Med, 2002, 347(15):1175-1186.
[3] Hopkins R J, Girardi L S, Turney E A. Relationship between Helicobacter pylori eradication and reduced duodenal and gastric ulcer recurrence: a review[J]. Gastroenterology, 1996, 110(4):1244-1252.
[4] Graham D Y, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance[J]. Gut, 2010, 59(8):1143-1153.
[5] Malfertheiner P, Megraud F, O'Morain C A, et al. Management of Helicobacter pylori infection-the Maastricht IV/ Florence Consensus Report[J]. Gut, 2012, 61(5):646-664.
[6] Georgopoulos S D, Xirouchakis E, Martinez-Gonzalez B, et al. Clinical evaluation of a ten-day regimen with esomeprazole, metronidazole, amoxicillin, and clarithromycin for the eradication of helicobacter pylori in a high clarithromycin resistance area[J]. Helicobacter, 2013, 18(6):459-467.
[7] Huang Y K, Wu M C, Wang S S, et al. Lansoprazole-based sequential and concomitant therapy for the first-line Helicobacter pylori eradication[J]. J Dig Dis, 2012, 13(4):232-238.
[8] Lim J H, Lee D H, Choi C, et al. Clinical outcomes of two-week sequential and concomitant therapies for Helicobacter pylori eradication: a randomized pilot study[J]. Helicobacter, 2013, 18(3):180-186.
[9] Yang Y J, Sheu B S. Sequential therapy in childhood Helicobacter pylori eradication: emphasis on drug compliance[J]. J Pediatr, 2011, 159(4):700.
[10] Lee M, Kemp J A, Canning A, et al. A randomized controlled trial of an enhanced patient compliance program for Helicobacter pylori therapy[J]. Arch Intern Med, 1999, 159(19):2312-2316.
[11] Manfredi M, Bizzarri B, Sacchero R I, et al. Helicobacter pylori infection in clinical practice: probiotics and a combination of probiotics + lactoferrin improve compliance, but not eradication, in sequential therapy[J]. Helicobacter, 2012, 17(4):254-263.
[12] Kadayifci A, Uygun A, Polat Z, et al. Comparison of bismuth-containing quadruple and concomitant therapies as a first-line treatment option for Helicobacter pylori[J]. Turk J Gastroenterol, 2012, 23(1):8-13.
[13] 刘文忠,谢勇,成虹,等.第四次全国幽门螺杆菌感染处理共识报告[J].胃肠病学, 2012, 51(10):618-625.
[14] Malfenheiner P, Bazzoli F, Delchier J C, et al. Helicobacter pylori eradication with a capsule containing bismuth subcitrate potassium, metronidazole, and tetracycline given with omeprazole versus clarithromycin-based triple therapy: a randomized, open-1abel, non-inferiority, phase 3 trial[J]. Lancet, 2011, 377(9769):905-913.
[15] Zheng Q, Chen W J, Lu H, et al. Comparison of the efficacy of triple versus quadruple therapy on the eradication of Helicobacter pylori and antibiotic resistance[J]. J Dig Dis, 2010,11(5):313-318.
[16] Ford A C, Malfertheiner P, Giguere M, et al. Adverse events with bismuth salts for Helicobacter pylori eradication: systematic review and meta-analysis[J]. World J Gastroenterol, 2008,14(48):7361-7370.
[17] Graham D Y, Lu H, Yamaoka Y. A report card to grade Helicobacter pylori therapy[J]. Helicobacter, 2007, 12(4):275-278.
[18] Gatta L, Vakil N, Vaira D, et al. Global eradication rates for Helicobacter pylori infection: systematic review and meta-analysis of sequential therapy[J]. BMJ, 2013, 347: f4587. doi: 10.1136/bmj.f4587.
[19] Su P, Li Y, Li H, et al. Antibiotic resistance of Helicobacter pylori isolated in the Southeast Coastal Region of China[J]. Helicobacter, 2013, 18(4):274-279.
[20] Gao W, Cheng H, Hu F, et al. The evolution of Helicobacter pylori antibiotics resistance over 10 years in Beijing, China[J]. Helicobacter, 2010, 15(5):460-466.
[21] Toracchio S, Cellini L, Di Campli E, et al. Role of antimicrobial susceptibility testing on efficacy of triple therapy in Helicobacter pylori eradication[J]. Aliment Pharmacol Ther, 2000, 14(12):1639-1643.
[22] Romano M, Iovene M R, Montella F, et al. Pretreatment antimicrobial-susceptibility testing in the eradication of H. pylori infection[J]. Am J Gastroenterol, 2000, 95(11):3317-3318.
[23] Hsu P I, Chen W C, Tsay F W, et al. Ten-day Quadruple therapy comprising proton-pump inhibitor, bismuth, tetracycline, and levofloxacin achieves a high eradication rate for helicobacter pylori infection after failure of sequential therapy[J]. Helicobacter, 2014, 19(1):74-79.
[24] Rodríguez-Torres M, Salgado-Mercado R, Ríos-Bedoya C F, et al. High eradication rates of Helicobacter pylori infection with first- and second-line combination of esomeprazole, tetracycline, and metronidazole in patients allergic to penicillin[J]. Dig Dis Sci, 2005, 50(4):634-639.
[1] 于珍珍,陈慧,杨晓云,吕明. 高尿酸血症、幽门螺杆菌感染与代谢综合征的相关性[J]. 山东大学学报(医学版), 2017, 55(5): 76-80.
[2] 刘正美,姜琼,周建奖,官志忠,赵艳,熊林,谢渊. 幽门螺杆菌对NLRP3炎症小体的活化作用[J]. 山东大学学报(医学版), 2016, 54(3): 9-13.
[3] 徐翠, 王涛, 周平. 儿童幽门螺杆菌免疫组化染色检测分析[J]. 山东大学学报(医学版), 2014, 52(9): 81-84.
[4] 杨雪, 邱春华, 雷蕾, 胡晓. 胃息肉的特点及其与幽门螺杆菌感染的关系[J]. 山东大学学报(医学版), 2014, 52(11): 41-44.
[5] 刘伟,于晗,李玉瑭,刘旭静,李雯,单玉群,孙允东,周亚滨. 二烯丙基三硫醚对幽门螺杆菌生物膜的杀菌作用[J]. 山东大学学报(医学版), 2013, 51(10): 49-53.
[6] 张琪1,2,李延青1,张翠萍2,赵坤2,孙向红3. 活化诱导胞嘧啶核苷脱氨酶在肠型胃癌组织中的表达及与幽门螺杆菌感染的关系[J]. 山东大学学报(医学版), 2012, 50(12): 61-.
[7] . 青年胃癌与老年胃癌临床、内镜、病理特点分析[J]. 山东大学学报(医学版), 2009, 47(10): 83-85.
[8] 高萍,高卫,王薇,黄秀红,孙玉萍. IL-1受体拮抗剂基因多态性与胃癌易感性的相关性研究[J]. 山东大学学报(医学版), 2006, 44(10): 1069-1071.
Viewed
Full text


Abstract

Cited

  Shared   
  Discussed   
No Suggested Reading articles found!