Sezgin Orhan, Aydın Mehmet Kasım, Özdemir Asena Ayça, Kanık Arzu Emine
Department of Gastroenterology, Mersin University School of Medicine, Mersin, Turkey.
Department of Gastroenterology, Lokman Hekim Hospital, Van, Turkey.
Turk J Gastroenterol. 2019 May;30(5):420-435. doi: 10.5152/tjg.2019.18693.
BACKGROUND/AIMS: This study aims at evaluating the mean eradication rate by a systematic compilation of the studies which involved the standard triple therapy (STT) in first-line Helicobacter pylori (Hp) eradication in Turkey over a period of 10 years between 2004 and 2013 using the meta-analysis method.
The systematic compilation and meta-analysis were carried out according to the PRISMA standards defined in the Cochrane handbook. The results of full-text studies published in national and international journals in English and Turkish languages on Turkish population in a period of 10 years, from 2004 to 2013, are included in this study. The studies include open-label trials, controlled trials, treatment arms, and case series that included a triple therapy regimen consisting of standard doses of a proton pump inhibitor (PPI; omeprazole 20 mg BID, lansoprazole 30 mg BID, pantoprazole 40 mg BID, esomeprazole 40 mg BID, or rabeprazole 20 mg BID) along with clarithromycin 500 mg BID and amoxicillin 1 g BID for 7-14 days. They were scanned electronically via the search engines Google Scholar, PubMed, and the Turkish Medicine Index using specific keywords. The related keywords used were Turkey, Helicobacter pylori, infection, standard triple treatment, first-line therapy, eradication, omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole, clarithromycin, and amoxicillin. Studies carried out with adults were included in the evaluation. The publication year of the studies and the included number of patients, their age, gender, treatment duration (7, 10, and 14 days), and PPIs used were evaluated by two separate gastroenterologists and biostatisticians. Studies that used at least one reliable method (histology, urea breath test (UBT), or Helicobacter pylori stool antigen (HpSA) test) four weeks after completing the treatment for the control of Hp eradication were included. Only naive patients were accepted, and patients who had previously received eradication treatment were excluded. The effectiveness of the Hp eradication was analyzed using an intention-to-treat (ITT) or per-protocol (PP) analysis.
The STT regime of 45 studies complying with the inclusion criteria was evaluated. A total of 3715 patients were included in the study. Of the 3010 patients whose gender information was available, 55% were women and 45% were men; the weighted age average given explicitly in the studies was 42.14±0.67. The treatment lasted for 14 days in 42 studies, for 7 days in six studies, and for 10 days in 1 study. The eradication rates evaluated according to the ITT and PP analyses were 60% (95% CI: 56%-63%) and 57% (95% CI: 51%-62%), respectively. The rates for 7 days of treatment were 57% (95% CI: 46%-68%) and 60% (95% CI: 51%-67%) and for 14 days of treatment were 60% (95% CI: 56%-63%) and 56% (95% CI: 50%-62%), respectively. The ITT eradication rate of the only 10-day study was 78% (95% CI: 66%-86%). In the meta-regression analysis, the treatment duration, PPI, age, and gender ratio (women/men) used for the ITT analysis had no effect. The gender ratio and age were not considered in this analysis because they were not clearly stated in studies using the PP analysis. The duration of treatment and the PPI used had no effect.
A systematic meta-analysis of studies conducted during the period 2004-2013 in Turkey revealed that the rate of first-line Hp eradication using STT was unacceptably low, and the duration of treatment and PPI used made no difference.
背景/目的:本研究旨在通过荟萃分析方法,系统整理2004年至2013年期间土耳其采用标准三联疗法(STT)进行一线幽门螺杆菌(Hp)根除治疗的研究,以评估平均根除率。
根据Cochrane手册中定义的PRISMA标准进行系统整理和荟萃分析。本研究纳入了2004年至2013年期间在国内和国际期刊上以英文和土耳其文发表的关于土耳其人群的全文研究结果。这些研究包括开放标签试验、对照试验、治疗组以及病例系列,其中三联疗法方案包含标准剂量的质子泵抑制剂(PPI;奥美拉唑20 mg,每日两次;兰索拉唑30 mg,每日两次;泮托拉唑40 mg,每日两次;埃索美拉唑40 mg,每日两次;或雷贝拉唑20 mg,每日两次),以及克拉霉素500 mg,每日两次和阿莫西林1 g,每日两次,疗程为7 - 14天。通过搜索引擎谷歌学术、PubMed和土耳其医学索引,使用特定关键词对其进行电子检索。使用的相关关键词为土耳其、幽门螺杆菌、感染、标准三联治疗、一线治疗、根除、奥美拉唑、兰索拉唑、泮托拉唑、雷贝拉唑、埃索美拉唑、克拉霉素和阿莫西林。纳入评估的研究为针对成年人开展的研究。两项独立的胃肠病学家和生物统计学家对研究的发表年份、纳入患者数量、年龄、性别、治疗持续时间(7天、10天和14天)以及使用的PPI进行了评估。纳入的研究为在完成治疗四周后使用至少一种可靠方法(组织学、尿素呼气试验(UBT)或幽门螺杆菌粪便抗原(HpSA)检测)来控制Hp根除情况的研究。仅纳入初治患者,排除既往接受过根除治疗的患者。采用意向性分析(ITT)或符合方案分析(PP)对Hp根除的有效性进行分析。
对符合纳入标准的45项研究的STT方案进行了评估。本研究共纳入3715例患者。在有性别信息的3010例患者中,55%为女性,45%为男性;研究中明确给出的加权平均年龄为42.14±0.67。42项研究的治疗持续时间为14天,6项研究为7天,1项研究为10天。根据ITT分析和PP分析评估的根除率分别为60%(95%CI:56% - 63%)和57%(95%CI:51% - 62%)。7天治疗的根除率分别为57%(95%CI:46% - 68%)和60%(95%CI:51% - 67%),14天治疗的根除率分别为60%(95%CI:56% - 63%)和56%(95%CI:50% - 62%)。唯一一项10天研究的ITT根除率为78%(95%CI:66% - 86%)。在荟萃回归分析中,用于ITT分析的治疗持续时间、PPI、年龄和性别比(女性/男性)均无影响。由于在使用PP分析的研究中未明确说明,因此在该分析中未考虑性别比和年龄。治疗持续时间和使用的PPI均无影响。
对2004 - 2013年期间土耳其开展的研究进行的系统荟萃分析显示,采用STT进行一线Hp根除的率低得令人无法接受,且治疗持续时间和使用的PPI并无差异。