Kale-Pradhan Pramodini B, Mihaescu Anela, Wilhelm Sheila M
Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy & Health Sciences, Wayne State University, Detroit, Michigan.
St. John Hospital and Medical Center, Detroit, Michigan.
Pharmacotherapy. 2015 Aug;35(8):719-30. doi: 10.1002/phar.1614. Epub 2015 Jul 15.
As resistance of Helicobacter pylori to standard first-line therapy is increasing globally, alternative treatment regimens, such as a fluoroquinolone-based sequential regimen, have been explored. The objective of this meta-analysis was to compare the efficacy of fluoroquinolone-based sequential therapy with standard first-line treatment for H. pylori infection.
Meta-analysis of six randomized controlled trials.
A total of 738 H. pylori-infected, treatment-naive adults who received fluoroquinolone-based sequential therapy (5-7 days of a proton pump inhibitor [PPI] and amoxicillin therapy followed by 5-7 days of a PPI, a fluoroquinolone, and metronidazole or tinidazole or furazolidone therapy) and 733 H. pylori-infected, treatment-naive adults who received guideline-recommended, first-line therapy with standard triple therapy (7-14 days of a PPI plus amoxicillin and clarithromycin) or standard sequential therapy (5 days of a PPI plus amoxicillin, followed by an additional 5 days of triple therapy consisting of a PPI, clarithromycin, and metronidazole or tinidazole).
A systematic literature search of the MEDLINE, PubMed, and Cochrane Central Register of Controlled Trials databases (from inception through January 2015) was conducted to identify randomized controlled trials that compared fluoroquinolone-based sequential therapy with guideline-recommended, first-line treatment regimens in H. pylori-infected, treatment-naive adults. All selected trials confirmed H. pylori infection prior to treatment as well as post-treatment eradication. A meta-analysis was performed by using Review Manager 5.2. Treatment effect was determined with a random-effects model by using the Mantel-Haenszel method and was reported as a risk ratio (RR) with 95% confidence interval (CI). In the six randomized controlled trials that met the inclusion criteria, 648 (87.8%) of 738 patients receiving fluoroquinolone-based sequential therapy and 521 (71.1%) of 733 patients receiving standard regimens achieved eradication (RR 1.21, 95% CI 1.09-1.35). The frequencies of adverse effects that were reported in three of the trials were comparable for all treatments (RR 0.99, 95% CI 0.76-1.29). In addition, no statistically significant difference was noted in the number of patients who experienced adverse effects that prompted discontinuation of therapy (RR 1.03, 95% CI 0.34-3.09). The H. pylori eradication rate appeared similar among the six trials with respect to duration of therapy and daily dose of the fluoroquinolone.
Fluoroquinolone-based sequential therapy is a reasonable treatment alternative to first-line eradication therapy for treatment of H. pylori.
由于幽门螺杆菌对标准一线治疗的耐药性在全球范围内不断增加,人们已探索了替代治疗方案,如基于氟喹诺酮的序贯疗法。本荟萃分析的目的是比较基于氟喹诺酮的序贯疗法与幽门螺杆菌感染标准一线治疗的疗效。
六项随机对照试验的荟萃分析。
共有738名未接受过治疗的幽门螺杆菌感染成人接受了基于氟喹诺酮的序贯疗法(质子泵抑制剂[PPI]和阿莫西林治疗5 - 7天,随后是PPI、氟喹诺酮和甲硝唑或替硝唑或呋喃唑酮治疗5 - 7天),以及733名未接受过治疗的幽门螺杆菌感染成人接受了指南推荐的标准三联一线疗法(PPI加阿莫西林和克拉霉素治疗7 - 14天)或标准序贯疗法(PPI加阿莫西林治疗5天,随后是由PPI、克拉霉素和甲硝唑或替硝唑组成的三联疗法再额外治疗5天)。
对MEDLINE、PubMed和Cochrane对照试验中央注册库数据库(从创建至2015年1月)进行系统文献检索,以确定比较基于氟喹诺酮的序贯疗法与幽门螺杆菌感染、未接受过治疗的成人指南推荐一线治疗方案的随机对照试验。所有入选试验在治疗前及治疗后根除时均确认了幽门螺杆菌感染。使用Review Manager 5.2进行荟萃分析。采用Mantel - Haenszel方法通过随机效应模型确定治疗效果,并报告为风险比(RR)及95%置信区间(CI)。在符合纳入标准的六项随机对照试验中,738名接受基于氟喹诺酮序贯疗法的患者中有648名(87.8%)实现根除,733名接受标准方案的患者中有521名(71.1%)实现根除(RR 1.21,95% CI 1.09 - 1.35)。三项试验中报告的所有治疗不良反应发生率相当(RR 0.99,95% CI 0.76 - 1.29)。此外,因不良反应而停药的患者数量无统计学显著差异(RR 1.03,95% CI 0.34 - 3.09)。在六项试验中,基于氟喹诺酮的序贯疗法在治疗持续时间和氟喹诺酮每日剂量方面的幽门螺杆菌根除率似乎相似。
基于氟喹诺酮的序贯疗法是幽门螺杆菌一线根除治疗的合理替代治疗方案。