Department of Gastroenterology, Xinqiao Hospital of Army Medical University, Chongqing, China.
Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Hubei, China.
Biomed Pharmacother. 2021 Apr;136:111251. doi: 10.1016/j.biopha.2021.111251. Epub 2021 Jan 12.
Although proton pump inhibitors (PPIs) are widely used in the prevention of gastric bleeding caused by endoscopic submucosal dissection (ESD), there is no consensus on the optimal regimen for these patients. Therefore, we aim to investigate whether intermittent use of low-dose PPI is sufficient to prevent post-ESD bleeding.
This multicenter, non-inferiority, randomized controlled trial was conducted at 9 hospitals in China. Consecutive eligible patients with a diagnosis of gastric mucosal lesions after ESD treatment were randomly assigned (1:1) to receive either intermittent low-dose or continuous high-dose PPIs treatment. After three days, all patients administered orally esomeprazole 40 mg once a day for 8 weeks. The primary endpoint was post-ESD bleeding within 7 days. Analysis was done according to the intention-to-treat principle with the non-inferiority margin (Δ) of 5%.
526 consecutive patients were assessed for eligibility from 30 September 2017 to 30 July 2019, of whom 414 were randomly assigned to low-dose (n = 209) or high-dose (n = 205) esomeprazole treatment group without dropouts within7 days. The total post-ESD bleeding is occurred in 13 (6.2 %, 95 % CI 3.3-9.6) of 209 within 7 days in the intermittent low-dose group, and 12 (5.9 %, 95 % CI 2.9-9.3) of 205 in the continuous high-dose group. The absolute risk reduction (ARR) was 0.4 % (-4.2, 4.9). One month after ESD, There are 44 patients (21.1 %, 95 % CI 15.8, 26.8) and 39 patients (19.0 % 95 % CI 13.7, 24.4) in scar stage respectively in low-dose group and high-dose group (P = 0.875).The hospital costs in the low-dose PPI group was lower than high -dose group (P = 0.005).
The intermittent use of low-dose PPIs is sufficient to prevent post-ESD bleeding. It might be applied in clinical practice to prevent post-ESD bleeding and reduce the costs related to PPIs.
质子泵抑制剂（PPIs）广泛用于预防内镜黏膜下剥离术（ESD）后胃出血，但对于此类患者的最佳方案尚无共识。因此，我们旨在研究间歇使用低剂量 PPI 是否足以预防 ESD 后出血。
这是一项在中国 9 家医院进行的多中心、非劣效性、随机对照试验。连续入选 ESD 治疗后诊断为胃黏膜病变的合格患者，按 1:1 随机分配接受间歇低剂量或连续高剂量 PPI 治疗。3 天后，所有患者均口服艾司奥美拉唑 40mg，每日 1 次，持续 8 周。主要终点是 ESD 后 7 天内出血。根据意向治疗原则进行分析，非劣效性边界（Δ）为 5%。
2017 年 9 月 30 日至 2019 年 7 月 30 日，对 526 例连续患者进行了评估，其中 414 例随机分配至低剂量（n=209）或高剂量（n=205）艾司奥美拉唑治疗组，7 天内无脱落。在间歇低剂量组，ESD 后 7 天内共发生 13 例（6.2%，95%CI 3.3-9.6），在连续高剂量组，共发生 12 例（5.9%，95%CI 2.9-9.3）。绝对风险降低（ARR）为 0.4%（-4.2，4.9）。ESD 后 1 个月，低剂量组和高剂量组分别有 44 例（21.1%，95%CI 15.8，26.8）和 39 例（19.0%，95%CI 13.7，24.4）处于瘢痕期（P=0.875）。低剂量 PPI 组的住院费用低于高剂量组（P=0.005）。
间歇使用低剂量 PPI 足以预防 ESD 后出血。它可能适用于预防 ESD 后出血并降低与 PPI 相关的成本。
