Tovey F I, Husband E M, Yiu Y C, Baker L, McPhail G, Jayaraj A P, Lewin M R, Clark C G
Department of Surgery, Basingstoke District Hospital, United Kingdom.
Am J Med. 1989 Jun 9;86(6A):141-4. doi: 10.1016/0002-9343(89)90176-9.
A total of 46 patients with duodenal ulcer were randomly assigned, without the knowledge of the investigators, to treatment with cimetidine 200 mg three times daily and 400 mg at night or sucralfate 1 g four times daily followed by one year of maintenance treatment with cimetidine 400 mg at night or sucralfate 1 g twice daily, respectively, in those patients with healed ulcers. The endoscopic healing rates and relapse rates during the maintenance period were similar, four relapses occurring in each group. All four relapses in the sucralfate group occurred at 12 months and only two were symptomatic. All the cimetidine relapses were symptomatic, two occurring at six months, one at nine months, and one at 12 months. Following the one year maintenance period, 13 cimetidine patients and 11 sucralfate patients were followed up for 36 months. During the first two years, nine of 13 (69 percent) cimetidine-treated and two of 11 (18 percent) sucralfate-treated patients had relapses. During the third year, three more sucralfate-treated patients and one more cimetidine-treated patient had relapses, making a total of 10 of 13 (77 percent) and five of 11 (45 percent) in the cimetidine and sucralfate groups, respectively. Duodenal biopsy specimens obtained before and after healing and after one year of maintenance were examined by light and electron microscopy. The sucralfate group showed greater improvement after one year of maintenance therapy than did the cimetidine group, although the appearances in either group were not predictive of subsequent relapse. The results show that relapses are less frequent and occur later after sucralfate therapy and also that the morphologic appearances are more normal after treatment with sucralfate than after treatment with cimetidine.
共有46例十二指肠溃疡患者在研究人员不知情的情况下被随机分配，分别接受西咪替丁治疗（每日三次，每次200毫克，夜间400毫克）或硫糖铝治疗（每日四次，每次1克），溃疡愈合的患者随后分别接受为期一年的维持治疗，西咪替丁组夜间服用400毫克，硫糖铝组每日两次，每次1克。维持期的内镜愈合率和复发率相似，每组均有4例复发。硫糖铝组的4例复发均发生在12个月时，只有2例有症状。西咪替丁组的所有复发均有症状，2例发生在6个月时，1例发生在9个月时，1例发生在12个月时。在为期一年的维持期结束后，对13例接受西咪替丁治疗的患者和11例接受硫糖铝治疗的患者进行了36个月的随访。在头两年中，13例接受西咪替丁治疗的患者中有9例（69%）复发，11例接受硫糖铝治疗的患者中有2例（18%）复发。在第三年，又有3例接受硫糖铝治疗的患者和1例接受西咪替丁治疗的患者复发，西咪替丁组13例中有10例（77%）复发，硫糖铝组11例中有5例（45%）复发。对愈合前后及维持治疗一年后的十二指肠活检标本进行了光镜和电镜检查。尽管两组的表现均不能预测随后的复发，但硫糖铝组在维持治疗一年后的改善程度大于西咪替丁组。结果表明，硫糖铝治疗后复发频率较低且较晚出现，而且硫糖铝治疗后的形态学表现比西咪替丁治疗后更正常。
