Herardi Ryan, Syam Ari Fahrial, Simadibrata Marcellus, Setiati Siti, Darnindro Nikko, Abdullah Murdani, Makmun Dadang
Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia.
Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia.
Asian Pac J Cancer Prev. 2020 Jan 1;21(1):19-24. doi: 10.31557/APJCP.2020.21.1.19.
The aim of this study was to compare the effectiveness of 10-day course of triple therapy versus a 14-day course in the treatment of H.pylori infection in an Indonesian population.
A double-blinded randomized clinical trial was included patients, Indonesian population, with H.pylori infection conducted in Cipto Mangunkusumo Hospital, Jakarta; Cilincing District General Hospital, Jakarta; and West Nusa Tenggara General Hospital, Mataram, during October 2016 - April 2017. Patients were randomized to be given triple therapy as Rabeprazole 20 mg, Amoxicillin 1,000 mg, and Clarithromycin 500 mg twice daily, for 14 days or 10 days plus 4 days placebo. Eradication was evaluated with UBT at least 4 weeks after completion the therapy.
A total of 75 patients (38 in the 14-day group and 37 in the 10-day group) were included to the study. In the intention-to-threat analysis, eradication rate was 67.6% (95% CI. 52.5%-82.6%) for the 10-day group versus 86.8% (95% CI. 76.0%-97.5%) for the 14-day group (p = 0.046), whereas per protocol analysis obtained 73.5% (95% CI. 58.6%-88.3%) for the 10-day versus 91.9% (95% CI. 84.1%-99.6%) in the 14-day group (p = 0.039). Adverse events were not significantly different between the two groups.
A 14-day course was more effective than 10-day course of triple therapy as first-line for eradication of H.pylori infection in an Indonesian population.
本研究旨在比较10天疗程的三联疗法与14天疗程在治疗印度尼西亚人群幽门螺杆菌感染方面的有效性。
一项双盲随机临床试验纳入了2016年10月至2017年4月期间在雅加达的西托·曼古库苏莫医院、雅加达的芝林辛区综合医院和马塔兰的西努沙登加拉综合医院就诊的印度尼西亚幽门螺杆菌感染患者。患者被随机分为两组，一组接受三联疗法，即雷贝拉唑20毫克、阿莫西林1000毫克和克拉霉素500毫克，每日两次，持续14天；另一组接受10天的三联疗法加4天安慰剂。在治疗结束至少4周后，通过尿素呼气试验（UBT）评估根除情况。
共有75名患者（14天疗程组38名，10天疗程组37名）纳入研究。在意向性分析中，10天疗程组的根除率为67.6%（95%置信区间52.5%-82.6%），14天疗程组为86.8%（95%置信区间76.0%-97.5%）（p = 0.046）；而符合方案分析中，10天疗程组为73.5%（95%置信区间58.6%-88.3%），14天疗程组为91.9%（95%置信区间84.1%-99.6%）（p = 0.039）。两组的不良事件无显著差异。
在印度尼西亚人群中，作为根除幽门螺杆菌感染的一线治疗，14天疗程的三联疗法比10天疗程更有效。
