Department of Gastroenterology, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Department of Gastroenterology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Helicobacter. 2021 Feb;26(1):e12768. doi: 10.1111/hel.12768. Epub 2020 Oct 21.
This study aimed to investigate whether an increased proton pump inhibitor (PPI) dose enhanced the efficacy of Helicobacter pylori (H. pylori) eradication and determine the appropriate cutoff intragastric pH value that could predict H. pylori eradication with bismuth-based quadruple therapy.
A total of 207 H. pylori infected, treatment naive patients were enrolled in this prospective, open-label, randomized controlled trial. Patients were randomly allocated into Eso40-group (esomeprazole 40 mg bid) and Eso20-group (esomeprazole 20 mg bid), and their CYP2C19 genotyping status was assessed. The 24-h intragastric pH monitoring on day 7 was performed, and percentage of time gastric pH ≥ 3, ≥4, ≥5, and ≥6 (pH holding time ratios; HTRs) were measured. H. pylori eradication was evaluated using C-urea breath test.
No significant difference in the eradication rates was observed between two groups. The median 24-h intragastric pH value was not significant different between two groups but the Eso40 Group had a significant higher pH4 HTRs (91.11% [95%CI: 87.50%-95.83%] vs. 95.83% [95.83%-100%]; p = .002). Additionally, the median 24-h intragastric pH value showed significantly difference between two groups in EM genotype (Eso20 Group 6.00 [95%CI; 5.75-6.15] vs. Eso40 Group 6.30 [6.05-6.30]; p = .019). Similar results were observed in pH4 HTRs. There were significant differences in intragastric pH value (6.10 [95%CI: 4.40-7.00] vs. 5.65 [4.85-5.95], p = .038) and in pH4 HTRs (96% [95%CI: 92.00%-96.00%] vs. 87.5% [67.00%-100.0%], p = .019) between eradication-successful and eradication-failed patients. Statistical analysis suggested that the median intragastric pH = 5.7 could identify the success of H. pylori eradication.
Bismuth-based quadruple therapy resulted in high H. pylori eradication rates either in PPI standard or double doses. Double dose of esomeprazole is associated with better intragastric acid suppression. A median 24-h intragastric pH of 5.7 could be appropriate cutoff value for predicting the successful H. pylori eradication.
本研究旨在探讨质子泵抑制剂（PPI）剂量增加是否能提高幽门螺杆菌（H. pylori）的根除率，并确定适当的胃内 pH 值截断值，以预测铋四联疗法治疗 H. pylori 的疗效。
本前瞻性、开放标签、随机对照试验共纳入 207 例初次治疗的 H. pylori 感染患者。患者被随机分配到 Eso40 组（埃索美拉唑 40mg，bid）和 Eso20 组（埃索美拉唑 20mg，bid），并评估其 CYP2C19 基因型。第 7 天进行 24 小时胃内 pH 监测，测量胃内 pH 值≥3、≥4、≥5 和≥6 的时间百分比（pH 维持时间比；HTRs）。采用 C-尿素呼气试验评估 H. pylori 根除情况。
两组的根除率无显著差异。两组 24 小时胃内 pH 值中位数无显著差异，但 Eso40 组 pH4 HTRs 显著较高（91.11%[95%CI：87.50%-95.83%] vs. 95.83%[95.83%-100%]；p=0.002）。此外，EM 基因型患者的 24 小时胃内 pH 值中位数在两组间有显著差异（Eso20 组 6.00[95%CI；5.75-6.15] vs. Eso40 组 6.30[6.05-6.30]；p=0.019）。pH4 HTRs 也有类似的结果。根除成功和失败患者的胃内 pH 值（6.10[95%CI：4.40-7.00] vs. 5.65[4.85-5.95]，p=0.038）和 pH4 HTRs（96%[95%CI：92.00%-96.00%] vs. 87.5%[67.00%-100.0%]，p=0.019）有显著差异。统计学分析提示胃内 pH 值中位数为 5.7 时可识别 H. pylori 根除的成功。
标准剂量或双倍剂量的质子泵抑制剂铋四联疗法均可获得较高的 H. pylori 根除率。双倍剂量的埃索美拉唑与更好的胃酸抑制相关。胃内 pH 值中位数为 5.7 可能是预测 H. pylori 根除成功的合适截断值。
