Ström M, Gotthard R, Bodemar G, Walan A
Scand J Gastroenterol. 1981;16(5):593-602. doi: 10.3109/00365528109182017.
Seventy-two patients with duodenal (54) or prepyloric (18) ulcers have taken part in a 12-week double-blind trial. Twenty-four patients received cimetidine, 1 g/day; 24 patients received 10 ml of an antacid suspension (buffering 85 mmol acid) 1 and 3 h after every meal and at bedtime and 0.6 mg L-hyoscyamine in sustained-release tablets twice a day; and 24 patients received placebo. The healing rate after 3 weeks' treatment was 67% (p less than 0.005 compared with placebo) with cimetidine, 50% (p less than 0.01) with antacid/anticholinergic, and 13% with placebo. After 6 weeks' treatment 83% were healed with cimetidine (p less than 0.005 compared with placebo), 96% with antacid/anticholinergic (p less than 0.005), and 33% with placebo. A further 6 weeks' treatment gave healing rates of 96% for cimetidine, of 100% for antacid/anticholinergic, and of 50% for placebo. Compared with placebo, cimetidine but not antacid/anticholinergic caused a faster relief of night-time ulcer pain (p less than 0.05). There was a significant correlation between healed ulcers and complete relief of ulcer symptoms (p less than 0.05). In the placebo group the ulcers of nonsmokers healed to a higher extent than those of smokers (p less than 0.05). During 1 year of follow-up there was no difference between the two actively treated groups in number or severity of symptomatic relapses. Time to relapse was, however, significantly shorter after treatment with cimetidine than after antacid/anticholinergic (p less than 0.05). Recurrences occurred more often (p less than 0.05) after slow healing (6-12 weeks) than after fast healing (3 weeks).
72例十二指肠溃疡（54例）或幽门管溃疡（18例）患者参与了一项为期12周的双盲试验。24例患者接受西咪替丁治疗，每日1克；24例患者在每餐饭后1小时和3小时、睡前服用10毫升抗酸混悬液（缓冲85毫摩尔酸），并每日两次服用0.6毫克长效释放片L-莨菪碱；24例患者接受安慰剂治疗。治疗3周后，西咪替丁组的愈合率为67%（与安慰剂相比，p<0.005），抗酸剂/抗胆碱能药物组为50%（p<0.01），安慰剂组为13%。治疗6周后，西咪替丁组83%愈合（与安慰剂相比，p<0.005），抗酸剂/抗胆碱能药物组96%愈合（p<0.005），安慰剂组33%愈合。再治疗6周后，西咪替丁组愈合率为96%，抗酸剂/抗胆碱能药物组为100%，安慰剂组为50%。与安慰剂相比，西咪替丁能更快缓解夜间溃疡疼痛（p<0.05），而抗酸剂/抗胆碱能药物则不能。溃疡愈合与溃疡症状完全缓解之间存在显著相关性（p<0.05）。在安慰剂组中，不吸烟者的溃疡愈合程度高于吸烟者（p<0.05）。在1年的随访期间，两个积极治疗组在症状复发的数量或严重程度上没有差异。然而，西咪替丁治疗后的复发时间明显短于抗酸剂/抗胆碱能药物治疗后（p<0.05）。愈合缓慢（6 - 12周）后的复发比愈合迅速（3周）后更频繁（p<0.05）。
