Collen M J, Hanan M R, Maher J A, Rent M, Stubrin S E, Arguello J F, Gardner L
Dig Dis Sci. 1980 Oct;25(10):744-9. doi: 10.1007/BF01345292.
We studied the healing efficacy of cimetidine or placebo in 23 endoscopically proven duodenal ulcer outpatients in a randomized, controlled, prospective, double-blind trial. There were 11 patients in the cimetidine (1200 mg daily) treatment group and 12 patients in the placebo-treated group. No antacid was allowed, but a placebo antacid with no neutralizing capacity was given as needed for pain. The incidence of complete endoscopic healing at 2, 4, and 6 weeks was 54%, 63%, and 72% in the cimetidine-treated patients and 8%, 50%, and 67% in the placebo-treated patients. There was a statistically significant difference (P < 0.05) in complete duodenal ulcer healing between both treatment groups after 2 weeks of therapy, but there was no significant difference at the 4- and 6-week observation periods. The incidence of complete pain relief at 2 and 4 weeks was 64% and 82% in the cimetidine-treated patients and 67% and 75% in the placebo-treated patients. At 6 weeks of treatment there was no increase in the number of patients with complete pain relief in either group. There was no significant difference between the two groups in the incidence of ulcer pain relief at any of the three observation periods. Duodenal ulcer healing rates and duodenal ulcer pain relief were compared at 2, 4, and 6 weeks. There was no statistical association between ulcer healing and complete pain relief in the placebo treatment group at the 2-week evaluation period, but there was statistical association (P < 0.05) in the cimetidine treatment group at 2 weeks and both treatment groups at the 4- and 6-week evaluation periods. The results of this study demonstrate that in duodenal ulcer out-patients treated for 6 weeks: (1) cimetidine increases the incidence of duodenal ulcer healing during the first 2 weeks of treatment; (2) more than 50% of duodenal ulcers will spontaneously heal during a 4 to 6-week observation period which is not statistically modified by cimetidine treatment; (3) the complete relief of duodenal ulcer pain is not influenced by treatment with cimetidine when compared to placebo.
我们在一项随机、对照、前瞻性、双盲试验中，研究了西咪替丁或安慰剂对23例经内镜证实的十二指肠溃疡门诊患者的愈合疗效。西咪替丁（每日1200毫克）治疗组有11例患者，安慰剂治疗组有12例患者。试验中不允许使用抗酸剂，但必要时可给予无中和能力的安慰剂抗酸剂以缓解疼痛。在西咪替丁治疗的患者中，2周、4周和6周时内镜完全愈合的发生率分别为54%、63%和72%，而在安慰剂治疗的患者中分别为8%、50%和67%。治疗2周后，两组十二指肠溃疡完全愈合情况存在统计学显著差异（P<0.05），但在4周和6周观察期无显著差异。西咪替丁治疗的患者在2周和4周时完全缓解疼痛的发生率分别为64%和82%，安慰剂治疗的患者分别为67%和75%。治疗6周时，两组中完全缓解疼痛的患者数量均未增加。在三个观察期的任何一个时间点，两组溃疡疼痛缓解的发生率均无显著差异。对2周、4周和6周时的十二指肠溃疡愈合率和十二指肠溃疡疼痛缓解情况进行了比较。在2周评估期，安慰剂治疗组溃疡愈合与完全疼痛缓解之间无统计学关联，但西咪替丁治疗组在2周时以及两个治疗组在4周和6周评估期均存在统计学关联（P<0.05）。本研究结果表明，在接受6周治疗的十二指肠溃疡门诊患者中：（1）西咪替丁在治疗的前2周可提高十二指肠溃疡愈合的发生率；（2）超过50%的十二指肠溃疡在4至6周的观察期内会自发愈合，西咪替丁治疗对此无统计学影响；（3）与安慰剂相比，西咪替丁治疗对十二指肠溃疡疼痛的完全缓解无影响。
