Herrerias-Gutierrez J M, Pardo L, Segu J L
Gastroenterology Department, University Hospital of Sevilla, Spain.
Am J Med. 1989 Jun 9;86(6A):94-7. doi: 10.1016/0002-9343(89)90166-6.
This clinical study compared the healing capacities of sucralfate and ranitidine in the treatment of gastric ulcer. Sixty patients were assigned at random to treatment with either sucralfate (1 g four times per day) or ranitidine (150 mg twice per day). The patients underwent endoscopy before inclusion in the study, after four weeks, and after eight weeks if the ulcers had not completely healed after the fourth week (phase I). Patients whose ulcers had healed were invited to participate in phase II, consisting of maintenance treatment for one year. The dosage was 1 g sucralfate twice per day or 150 mg ranitidine before going to bed. The patients underwent a clinical examination every three months and endoscopy every six months, and whenever symptoms suggested a relapse. After four weeks, the ulcers in 53 percent of the sucralfate-treated patients (16 of 30) had healed, compared with 56 percent of the ranitidine-treated patients (17 of 30). After eight weeks, the cumulative healing rates were 83 percent (25 of 30) and 86 percent (26 of 30), respectively. At the six-month follow-up visit, the relapse rates were seven of 21 (33.3 percent) in the sucralfate group and nine of 18 (50 percent) in the ranitidine group. After 12 months, the accumulative relapse rates were eight of 18 (44.4 percent) and nine of 18 (50.0 percent). The only side effects worth noting were mild constipation in four patients treated with sucralfate. One patient in the ranitidine group had myalgia and one reported headache in phase I. In conclusion, sucralfate appears to be as effective as ranitidine in the short-term treatment of gastric ulcers and in relapse prophylaxis.
这项临床研究比较了硫糖铝和雷尼替丁治疗胃溃疡的愈合能力。60名患者被随机分配接受硫糖铝(每日4次,每次1克)或雷尼替丁(每日2次,每次150毫克)治疗。患者在纳入研究前、4周后以及如果溃疡在第4周后未完全愈合则在8周后接受内镜检查(第一阶段)。溃疡已愈合的患者被邀请参加第二阶段,包括为期一年的维持治疗。剂量为硫糖铝每日2次,每次1克,或雷尼替丁睡前150毫克。患者每3个月进行一次临床检查,每6个月进行一次内镜检查,以及每当出现症状提示复发时进行检查。4周后,接受硫糖铝治疗的患者中有53%(30例中的16例)溃疡愈合,而接受雷尼替丁治疗的患者中有56%(30例中的17例)溃疡愈合。8周后,累积愈合率分别为83%(30例中的25例)和86%(30例中的26例)。在6个月的随访中,硫糖铝组21例中有7例(33.3%)复发,雷尼替丁组18例中有9例(50%)复发。12个月后,累积复发率分别为18例中的8例(44.4%)和18例中的9例(50.0%)。唯一值得注意的副作用是4例接受硫糖铝治疗的患者出现轻度便秘。雷尼替丁组1例患者在第一阶段出现肌痛,1例报告头痛。总之,硫糖铝在胃溃疡的短期治疗和预防复发方面似乎与雷尼替丁一样有效。