Bremner C G, Marks I N, Segal I, Simjee A
Department of Surgery, Medical School, University of Witwatersand, Johannesburg, South Africa.
Am J Med. 1991 Aug 8;91(2A):119S-122S. doi: 10.1016/0002-9343(91)90462-7.
Sucralfate (Sc) suspension 6 g/day and ranitidine (Rn) tablets, 150 mg, were compared in 125 patients in a double-blind, multicenter, endoscopically controlled trial in the treatment of reflux esophagitis. Inclusion criteria were symptomatic reflux (number and severity of attacks) and endoscopic evidence of esophagitis (grades 1 to 4). Clinical assessments were performed on entry, and at 4 and at 8 weeks, and endoscopy was repeated at 8 weeks. Sc suspension and Rn placebo or Sc placebo and Rn tablets were taken on waking and immediately before retiring at night. Of the 125 patients, 27 were withdrawn because of default (Rn = 4; Sc = 14), noncompliance (Rn = 1; Sc = 2), or the development of congestive cardiac failure (Rn = 1), diarrhea (Rn = 1; Sc = 1), nausea (Sc = 1), constipation (Sc = 1), and hematemesis (Sc = 1). Analysis was performed on the remaining 98 patients, 43 of whom had been treated with Sc and 55 with Rn. Heartburn, acid regurgitation, epigastric pain, dysphagia, and chest pain were relieved in 34% vs 40%, 67% vs 72%, 71% vs 57%, and 86% vs 63% for Sc and Rn, respectively. There was no significant difference between the two groups. Endoscopic healing occurred in 47% of the Sc- and in 31% of the Rn-treated patients (chi 2 = 2.50), and healing or improvement was noted in 81% of the Sc- and 64% of the Rn-treated patients. This difference approached statistical significance (chi 2 = 3.73). There was no obvious endoscopic benefit in 8 of the 43 and 20 of the 55 patients in the groups treated with Sc and Rn, respectively. Although the findings with sucralfate and ranitidine in patients with reflux esophagitis completing the trial suggest a benefit of these agents, the absence of a placebo control group and the high default rates, particularly for those receiving sucralfate, preclude any firm conclusions as to relative or specific efficacy of these agents in this condition.
在一项双盲、多中心、内镜对照试验中，对125例反流性食管炎患者比较了6克/天的硫糖铝（Sc）混悬液和150毫克的雷尼替丁（Rn）片剂。纳入标准为有症状性反流（发作次数和严重程度）以及食管炎的内镜证据（1至4级）。在入组时、4周和8周时进行临床评估，并在8周时重复内镜检查。Sc混悬液和Rn安慰剂或Sc安慰剂和Rn片剂在醒来时和晚上就寝前服用。125例患者中，27例因未按时就诊（Rn = 4；Sc = 14）、不依从（Rn = 1；Sc = 2）或发生充血性心力衰竭（Rn = 1）、腹泻（Rn = 1；Sc = 1）、恶心（Sc = 1）、便秘（Sc = 1）和呕血（Sc = 1）而退出。对其余98例患者进行分析，其中43例接受Sc治疗，55例接受Rn治疗。Sc和Rn治疗组烧心、反酸、上腹痛、吞咽困难和胸痛缓解的比例分别为34%对40%、67%对72%、71%对57%以及86%对63%。两组之间无显著差异。Sc治疗组47%的患者内镜下愈合，Rn治疗组31%的患者内镜下愈合（χ² = 2.50），Sc治疗组81%的患者愈合或改善，Rn治疗组64%的患者愈合或改善。这种差异接近统计学显著性（χ² = 3.73）。Sc治疗组43例患者中有8例、Rn治疗组55例患者中有20例内镜检查无明显改善。尽管完成试验的反流性食管炎患者使用硫糖铝和雷尼替丁的结果表明这些药物有一定益处，但由于缺乏安慰剂对照组以及高失访率，尤其是接受硫糖铝治疗的患者，因此无法就这些药物在这种情况下的相对或特定疗效得出任何确凿结论。
