Englert E, Freston J W, Graham D Y, Finkelstein W, Kruss D M, Priest R J, Raskin J B, Rhodes J B, Rogers A I, Wenger J, Wilcox L L, Crossley R J
Gastroenterology. 1978 Feb;74(2 Pt 2):416-25.
Two hundred forty patients with benign gastric ulcer were treated in a controlled clinical trial to assess the effect on healing of cimetidine, antacids, and hospitalization. Inpatients and and outpatients were randomly assigned to one of three treatments: cimetidine plus antacid, cimetidine plus dummy antacid, or placebo tablet plus antacid. In 206 patients who met criteria for analysis, ulcer healing as shown by endoscopy occurred by 12 days in 11 to 26 percent and by 42 days in 58 to 76 percent. There were no significant differences in healing between hospitalized and nonhospitalized patients or between treatment subgroups. Symptomatic response was equivalent in all groups. The median antacid consumption was 328 mEq of in vitro buffering capacity per day. Patients taking antacids experienced significant diarrhea compared with those taking no antacid. This investigation suggests that the effect of cimetidine is equivalent to that of large amounts of antacid, but because a true placebo group was not studied it is not possible to conclude from this study alone whether either agent influenced healing. In contrast to widespread belief, initiation of treatment in the hospital did not enhance healing, but because patients were not randomly assigned to inpatient and outpatient status no final conclusion about the effect of hospitalization on healing can be drawn.
对240例良性胃溃疡患者进行了一项对照临床试验,以评估西咪替丁、抗酸剂和住院治疗对溃疡愈合的影响。住院患者和门诊患者被随机分配到三种治疗方法之一:西咪替丁加抗酸剂、西咪替丁加安慰剂抗酸剂或安慰剂片剂加抗酸剂。在206例符合分析标准的患者中,内镜检查显示溃疡愈合情况为:12天时愈合率为11%至26%,42天时愈合率为58%至76%。住院患者和非住院患者之间或治疗亚组之间在愈合方面没有显著差异。所有组的症状反应相当。抗酸剂的日均体外缓冲能力消耗中位数为328毫当量。与未服用抗酸剂的患者相比,服用抗酸剂的患者出现了明显的腹泻。这项研究表明,西咪替丁的效果与大量抗酸剂相当,但由于未研究真正的安慰剂组,仅从这项研究无法得出任何一种药物是否影响愈合的结论。与普遍看法相反,在医院开始治疗并没有促进愈合,但由于患者并非随机分配到住院和门诊状态,因此无法得出关于住院治疗对愈合影响的最终结论。