Dronfield M W, Batchelor A J, Larkworthy W, Langman M J
Gut. 1979 Jun;20(6):526-30. doi: 10.1136/gut.20.6.526.
Forty-two patients with endoscopically diagnosed duodenal ulcer were studied in a double-blind trial after their ulcers had been healed with cimetidine. Cimetidine was effective in preventing relapse, only five of the 20 patients allocated to cimetidine 400 mg twice daily relapsing during the six months' treatment, compared with 16 of the 22 on placebo treatment (P less than 0.01). Cimetidine was safe in the dosage and duration used, no symptomatic, haematological, or biochemical abnormalities occurring during the trial. Subsequent follow-up at the end of the trial when treatment had been stopped showed that relapse was frequent, particularly in the cimetidine group, making the cumulative relapse rate eight months after completion of the trial similar in the two groups (75% in the cimetidine group, 86% in the placebo group). It seems likely that maintenance cimetidine treatment has to be continued indefinitely in patients with duodenal ulcer, and, until such treatment is shown to be safe and effective, surgical treatment remains a logical option for many patients.
42例经内镜诊断为十二指肠溃疡的患者,在其溃疡用西咪替丁治愈后,进行了一项双盲试验。西咪替丁对预防复发有效,在每日两次服用400毫克西咪替丁的20例患者中,只有5例在6个月的治疗期间复发,而服用安慰剂的22例患者中有16例复发(P<0.01)。试验中所用剂量和疗程的西咪替丁是安全的,试验期间未出现任何症状性、血液学或生化异常。试验结束停止治疗后的后续随访显示复发很常见,尤其是在西咪替丁组,使得试验结束8个月后的累积复发率在两组中相似(西咪替丁组为75%,安慰剂组为86%)。十二指肠溃疡患者似乎可能必须无限期持续进行西咪替丁维持治疗,而且,在这种治疗被证明安全有效之前,手术治疗对许多患者来说仍是一个合理的选择。