Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
Gastroenterology Unit, Agencia Sanitaria Costa del Sol, Málaga, Spain.
Helicobacter. 2020 Oct;25(5):e12722. doi: 10.1111/hel.12722. Epub 2020 Jul 13.
Different bismuth quadruple therapies containing proton-pump inhibitors, bismuth salts, metronidazole, and a tetracycline have been recommended as third-line Helicobacter pylori eradication treatment after failure with clarithromycin and levofloxacin.
To evaluate the efficacy and safety of third-line treatments with bismuth, metronidazole, and either tetracycline or doxycycline.
Sub-study with Spanish data of the "European Registry on H pylori Management" (Hp-EuReg), international multicenter prospective non-interventional Registry of the routine clinical practice of gastroenterologists. After previous failure with clarithromycin- and levofloxacin-containing therapies, patients receiving a third-line regimen with 10/14-day bismuth salts, metronidazole, and either tetracycline (BQT-Tet) or doxycycline (BQT-Dox), or single capsule (BQT-three-in-one) were included. Data were registered at AEG-REDCap database. Univariate and multivariate analyses were performed.
Four-hundred and fifty-four patients have been treated so far: 85 with BQT-Tet, 94 with BQT-Dox, and 275 with BQT-three-in-one. Average age was 53 years, 68% were women. Overall modified intention-to-treat and per-protocol eradication rates were 81% (BQT-Dox: 65%, BQT-Tet: 76%, BQT-three-in-one: 88%) and 82% (BQT-Dox: 66%, BQT-Tet: 77%, BQT-three-in-one: 88%), respectively. By logistic regression, higher eradication rates were associated with compliance (OR = 2.96; 95% CI = 1.01-8.84) and no prior metronidazole use (OR = 1.96; 95% CI = 1.15-3.33); BQT-three-in-one was superior to BQT-Dox (OR = 4.46; 95% CI = 2.51-8.27), and BQT-Tet was marginally superior to BQT-Dox (OR = 1.67; 95% CI = 0.85-3.29).
Third-line H pylori eradication with bismuth quadruple treatment (after failure with clarithromycin and levofloxacin) offers acceptable efficacy and safety. Highest efficacy was found in compliant patients and those taking 10-day BQT-three-in-one or 14-day BQT-Tet. Doxycycline seems to be less effective and therefore should not be recommended.
在克拉霉素和左氧氟沙星治疗失败后，不同的含质子泵抑制剂、铋盐、甲硝唑和四环素的铋四联疗法已被推荐作为幽门螺杆菌的三线根除治疗。
评估三线铋、甲硝唑和四环素或多西环素治疗的疗效和安全性。
这是西班牙“幽门螺杆菌管理欧洲注册研究”（Hp-EuReg）的子研究，是一项针对胃肠病学家常规临床实践的国际多中心前瞻性非干预性注册研究。在先前含克拉霉素和左氧氟沙星的治疗失败后，接受 10/14 天铋盐、甲硝唑和四环素（BQT-Tet）或多西环素（BQT-Dox）或单胶囊（BQT-三合一）的三线方案治疗的患者被纳入研究。数据在 AEG-REDCap 数据库中注册。进行了单变量和多变量分析。
迄今为止，已有 454 名患者接受了治疗：85 名患者接受了 BQT-Tet 治疗，94 名患者接受了 BQT-Dox 治疗，275 名患者接受了 BQT-三合一治疗。平均年龄为 53 岁，68%为女性。总体改良意向治疗和符合方案根除率分别为 81%（BQT-Dox：65%，BQT-Tet：76%，BQT-三合一：88%）和 82%（BQT-Dox：66%，BQT-Tet：77%，BQT-三合一：88%）。通过逻辑回归，更高的根除率与依从性（比值比[OR] = 2.96；95%置信区间[CI] = 1.01-8.84）和无先前甲硝唑使用（OR = 1.96；95%CI = 1.15-3.33）相关；BQT-三合一优于 BQT-Dox（OR = 4.46；95%CI = 2.51-8.27），BQT-Tet 略优于 BQT-Dox（OR = 1.67；95%CI = 0.85-3.29）。
在克拉霉素和左氧氟沙星治疗失败后，采用铋四联疗法进行三线幽门螺杆菌根除治疗具有可接受的疗效和安全性。在依从性好的患者和接受 10 天 BQT-三合一或 14 天 BQT-Tet 治疗的患者中，疗效最高。多西环素的疗效似乎较低，因此不建议使用。
