Kim Jae Woo, Kim Hyun Soo, Lee Dong Ki, Suk Ki Tae, Kim Jung Min, Baik Soon Koo, Kwon Sang Ok, Cho Mee Youn
Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju-si, Gangwon-do, Korea.
Korean J Gastroenterol. 2004 Mar;43(3):153-9.
BACKGROUND/AIMS: Proton pump inhibitors (PPI) and H2-receptor antagonists (H2RA) are commonly prescribed for the treatment of mild to moderate reflux esophagitis (MMRE). There remains great controversy in their usefulness as the first choice and the appropriateness. We prospectively compared the efficacy and safety of the 8-week low-dose PPI vs. standard-dose H2RA in MMRE.
One hundred patients with MMRE were randomized to receive either low-dose of omeprazole (L-OMP: 10 mg, q.d.) or standard-dose of ranitidine (S-H2RA: 150 mg, b.i.d.) for 8 weeks. The H. pylori status using rapid urease test, histological examination and culture, reflux esophagitis (RE) grading, gastrointestinal symptoms using 4-point scale, adverse event and the standard laboratory examination were assessed at baseline and 8-week end point of therapy.
Improvement rate of RE [intention to treat (n=82)/per protocol (n=72)] were shown in 69.1%/63.9% for L-OMP and 65.0%/63.9% for S-H2RA group (p=0.697, p=1.000). Complete healing rates of RE were 54.7%/50.0% for L-OMP and 42.5%/41.7% for S-H2RA. No significant difference in healing rate, the rapidity of symptom resolution, adverse events, and laboratory monitoring was found between the two groups.
The low-dose omeprazole therapy produced similar healing rates and safety in the treatment of MMRE. In addition, L-OMP is advantageous in its once-a-day dosing and might be an alternative to S-H2RA, especially in Korean patients with MMRE.
背景/目的：质子泵抑制剂（PPI）和H2受体拮抗剂（H2RA）常用于治疗轻至中度反流性食管炎（MMRE）。它们作为首选药物的有效性和适用性仍存在很大争议。我们前瞻性地比较了低剂量PPI与标准剂量H2RA治疗MMRE 8周的疗效和安全性。
100例MMRE患者被随机分为两组，分别接受低剂量奥美拉唑（L-OMP：10 mg，每日一次）或标准剂量雷尼替丁（S-H2RA：150 mg，每日两次）治疗8周。在基线和治疗8周终点时，通过快速尿素酶试验、组织学检查和培养评估幽门螺杆菌感染状况，采用反流性食管炎（RE）分级，用4分制评估胃肠道症状，记录不良事件并进行标准实验室检查。
L-OMP组和S-H2RA组的RE改善率[意向性分析（n = 82）/符合方案分析（n = 72）]分别为69.1%/63.9%和65.0%/63.9%（p = 0.697，p = 1.000）。RE的完全愈合率L-OMP组为54.7%/50.0%，S-H2RA组为42.5%/41.7%。两组在愈合率、症状缓解速度、不良事件和实验室监测方面均无显著差异。
低剂量奥美拉唑治疗MMRE的愈合率和安全性相似。此外，L-OMP每日一次给药具有优势，可能是S-H2RA的替代药物，尤其是在韩国MMRE患者中。
