Dettmer A, Vogt R, Sielaff F, Lühmann R, Schneider A, Fischer R
Byk Gulden Pharmaceuticals, Konstanz, Germany.
Aliment Pharmacol Ther. 1998 Sep;12(9):865-72. doi: 10.1046/j.1365-2036.1998.00381.x.
To investigate the efficacy of a low dose of pantoprazole, a gastric proton pump inhibitor, for the relief of symptoms and healing of lesions in mild gastro-oesophageal reflux disease (GERD), and to compare it with the efficacy of ranitidine.
Patients with endoscopically established GERD (Stage I, Savary-Miller classification) were enrolled into a randomized, double-blind, parallel-group and multicentre study (intention-to-treat n = 209, age range 19-82 years). They were treated once daily with oral pantoprazole 20 mg or ranitidine 300 mg, for up to 8 weeks. End-point parameters included relief of symptoms (heartburn, acid regurgitation, pain on swallowing) and the healing of GERD lesions. Relief from symptoms was assessed after 2 and 4 weeks, and endoscopically confirmed healing of lesions after 4 and 8 weeks.
The proportion of patients reporting complete relief from symptoms after 2 weeks was greater in the pantoprazole than in the ranitidine group (69 vs. 48%, P < 0.01), with further improvements seen in the pantoprazole group after 4 weeks (80 vs. 65%, P < 0.05, Cochran-Mantel/Haenszel test). Healing of lesions was confirmed in 70/87 (80%) patients after 4 weeks (pantoprazole group), as compared with 55/86 (64%) patients (ranitidine group) (P < 0.05, per protocol population); after 8 weeks the respective results were 78/87 (90%) and 63/86 (73%) patients (P < 0.01). Both study medications were well tolerated.
Low-dose pantoprazole (20 mg) is clinically superior to ranitidine (300 mg) in providing fast relief from symptoms and healing of lesions in patients with mild GERD.
研究低剂量胃质子泵抑制剂泮托拉唑缓解轻度胃食管反流病(GERD)症状及促进病变愈合的疗效,并与雷尼替丁的疗效进行比较。
经内镜确诊为GERD(Savary-Miller分类I期)的患者纳入一项随机、双盲、平行组多中心研究(意向性治疗n = 209,年龄范围19 - 82岁)。他们每日口服一次20 mg泮托拉唑或300 mg雷尼替丁,治疗长达8周。终点参数包括症状缓解(烧心、反酸、吞咽疼痛)及GERD病变愈合情况。在2周和4周后评估症状缓解情况,在4周和8周后通过内镜确认病变愈合情况。
泮托拉唑组在2周后报告症状完全缓解的患者比例高于雷尼替丁组(69%对48%,P < 0.01),4周后泮托拉唑组进一步改善(80%对65%,P < 0.05, Cochr an-Mantel/Haenszel检验)。4周后泮托拉唑组87例患者中有70例(80%)病变愈合,而雷尼替丁组86例患者中有55例(64%)病变愈合(P < 0.05,符合方案人群);8周后相应结果分别为78/87(90%)和63/86(73%)例患者(P < 0.01)。两种研究药物耐受性均良好。
低剂量泮托拉唑(20 mg)在为轻度GERD患者快速缓解症状及促进病变愈合方面在临床上优于雷尼替丁(300 mg)。