10 天铋剂四联疗法与 7 天质子泵抑制剂-克拉霉素三联疗法作为韩国幽门螺杆菌感染的一线经验性治疗：一项随机、开放标签试验。
Ten-day bismuth-containing quadruple therapy versus 7-day proton pump inhibitor-clarithromycin containing triple therapy as first-line empirical therapy for the Helicobacter pylori infection in Korea: a randomized open-label trial.
机构信息
Center for Gastric Cancer, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang, Gyeonggi, 10408, South Korea.
Biostatistics Collaboration Team, Research Core Center, Research Institute, National Cancer Center, Goyang, 10408, Korea.
出版信息
BMC Gastroenterol. 2021 Mar 2;21(1):95. doi: 10.1186/s12876-021-01680-1.
BACKGROUND
This randomized, open-label trial aimed to compare the efficacy of 10-day bismuth-containing quadruple therapy (BQT) with 7-day proton-pump inhibitor-clarithromycin containing standard triple therapy (STT) as an empirical first-line Helicobacter pylori therapy.
METHODS
Participants with H. pylori infection were randomly assigned to either 10-day BQT (daily doses of bismuth 300 mg, four times; lansoprazole 30 mg, twice; metronidazole 500 mg, three times; and tetracycline 500 mg, four times) or 7-day STT (lansoprazole 30 mg; amoxicillin 1,000 mg; and clarithromycin 500 mg; each given twice daily). Participants who failed initial therapy were crossed over to the alternative treatment regimen. Primary outcome was the eradication rates of first-line treatment by intention-to-treat analysis.
RESULTS
Study participants (n = 352) were randomized to receive either 10-day BQT (n = 175) or 7-day STT (n = 177). The BQT-group achieved a significantly higher eradication rate than the STT-group in the intention-to-treat analysis (74.3% vs 57.1%, respectively; P = 0.001), modified intention-to-analysis (87.2% [130/149] vs 68.7% [101/147], respectively; P < 0.001) and per-protocol analysis (92.9% [105/113] vs 70.1% [94/134], respectively; P < 0.001). Although there was no serious adverse event, the compliance was lower with BQT than STT as a higher proportion of participants in the BQT-group discontinued therapy because of adverse events than those in the STT-group (23.1% vs 9.1%, respectively; P = 0.001) CONCLUSIONS: Ten-day BQT had higher eradication rates compared to that of the 7-day STT as an empirical first-line treatment for H. pylori eradication in Korea.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT02557932. Registered 23 September 2015, https://clinicaltrials.gov/ct2/show/NCT02557932?term=NCT02557932&draw=2&rank=1 .
背景
本随机、开放标签试验旨在比较 10 天铋剂四联疗法（BQT）与 7 天质子泵抑制剂-克拉霉素三联标准疗法（STT）作为经验性一线幽门螺杆菌治疗的疗效。
方法
患有幽门螺杆菌感染的参与者被随机分配至 10 天 BQT（每日剂量铋 300mg，四次；兰索拉唑 30mg，两次；甲硝唑 500mg，三次；四环素 500mg，四次）或 7 天 STT（兰索拉唑 30mg；阿莫西林 1000mg；克拉霉素 500mg；均每日两次）。首次治疗失败的参与者交叉至替代治疗方案。主要结局为意向治疗分析的一线治疗根除率。
结果
研究参与者（n=352）被随机分配至接受 10 天 BQT（n=175）或 7 天 STT（n=177）。意向治疗分析中，BQT 组的根除率显著高于 STT 组（分别为 74.3%和 57.1%；P=0.001），改良意向治疗分析（分别为 87.2%[130/149]和 68.7%[101/147]；P<0.001）和方案分析（分别为 92.9%[105/113]和 70.1%[94/134]；P<0.001）。尽管没有严重不良事件，但 BQT 的依从性低于 STT，因为 BQT 组因不良反应而停止治疗的参与者比例高于 STT 组（分别为 23.1%和 9.1%；P=0.001）。
结论
在韩国，10 天 BQT 作为经验性一线幽门螺杆菌根除治疗，其根除率高于 7 天 STT。
试验注册
ClinicalTrials.gov，NCT02557932。2015 年 9 月 23 日注册，https://clinicaltrials.gov/ct2/show/NCT02557932?term=NCT02557932&draw=2&rank=1。
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