Kaspari Suleiman, Kupcinskas Limas, Heinze Hartmut, Berghöfer Peter
Private Practice, Lüneburg, Germany.
Eur J Gastroenterol Hepatol. 2005 Sep;17(9):935-41. doi: 10.1097/00042737-200509000-00009.
A total of 536 patients with endoscopically confirmed GORD grade 0/I were included in this multicentre study. In the acute phase, patients were treated with pantoprazole 20 mg o.d. for 4 weeks to obtain symptom relief. Symptom-free patients were included in the subsequent long-term phase, and were randomly treated on demand with either pantoprazole 20 mg or placebo for 6 months (antacids as rescue medication). After the 4 weeks acute phase, 439 symptom-free patients entered the long-term phase. The perceived average daily symptom load remained significantly lower during the 6-month on-demand treatment with pantoprazole 20 mg as compared to placebo. Both the rates for unwillingness to continue and number of additional antacids taken were also significantly lower with pantoprazole 20 mg than with placebo. Hence, on-demand treatment with pantoprazole 20 mg is safe and effective in maintaining control of the symptoms heartburn, acid regurgitation and pain on swallowing symptoms in patients with GORD grade 0/I with superiority to placebo.
本多中心研究共纳入536例经内镜确诊为0/I级胃食管反流病(GORD)的患者。急性期,患者接受泮托拉唑20 mg每日一次治疗4周以缓解症状。无症状患者进入随后的长期治疗阶段,随机按需接受泮托拉唑20 mg或安慰剂治疗6个月(抗酸剂作为急救药物)。4周急性期后,439例无症状患者进入长期治疗阶段。与安慰剂相比,在6个月按需服用泮托拉唑20 mg治疗期间,患者感知的平均每日症状负荷仍显著更低。泮托拉唑20 mg组的不愿继续治疗率和额外服用抗酸剂的数量也显著低于安慰剂组。因此,按需服用泮托拉唑20 mg对维持0/I级GORD患者烧心、反酸和吞咽痛症状的控制是安全有效的,且优于安慰剂。