Faizallah R, De Haan H A, Krasner N, Walker R J, Morris A I, Calam M J, Budgett D A
Br Med J (Clin Res Ed). 1984 Oct 6;289(6449):869-71. doi: 10.1136/bmj.289.6449.869.
Sixty nine patients with chronic duodenal or juxtapyloric ulceration were studied in a prospective double blind randomised trial to compare the efficacy of antacid and placebo at high (30 ml seven times daily) and low (10 ml as required) doses. After four weeks ulcers had healed in 12 out of 18 patients (67%) receiving "low dose" antacid compared with in six out of 17 patients (35%) receiving low dose placebo; ulcers had also healed in six out of 19 patients (32%) receiving "high dose" antacid compared with in two out of 15 patients (13%) receiving high dose placebo. Overall, the effect of antacid was superior to that of placebo in healing ulcers (p less than 0.05) and the effect of low dose treatment was superior to that of high dose treatment (p less than 0.01). There were no significant differences between antacid and placebo at eight weeks. Antacid was better than placebo in relieving pain, but the difference was not significant. Poor compliance and high incidence of diarrhoea made high dose antacid an impractical treatment. Low dose antacid was associated with a significantly better rate of healing than high dose antacid and was far better tolerated. This low dosage of antacid should be considered to be an active treatment in trials of ulcer healing.
在一项前瞻性双盲随机试验中,对69例患有慢性十二指肠溃疡或幽门旁溃疡的患者进行了研究,以比较高剂量(每日7次,每次30毫升)和低剂量(按需服用10毫升)抗酸剂与安慰剂的疗效。四周后,接受“低剂量”抗酸剂的18例患者中有12例(67%)溃疡愈合,而接受低剂量安慰剂的17例患者中有6例(35%)溃疡愈合;接受“高剂量”抗酸剂的19例患者中有6例(32%)溃疡愈合,而接受高剂量安慰剂的15例患者中有2例(13%)溃疡愈合。总体而言,抗酸剂在溃疡愈合方面的效果优于安慰剂(p<0.05),低剂量治疗的效果优于高剂量治疗(p<0.01)。八周时抗酸剂与安慰剂之间无显著差异。抗酸剂在缓解疼痛方面优于安慰剂,但差异不显著。依从性差和腹泻发生率高使得高剂量抗酸剂成为一种不实用的治疗方法。低剂量抗酸剂的愈合率明显高于高剂量抗酸剂,且耐受性要好得多。在溃疡愈合试验中,这种低剂量抗酸剂应被视为一种有效的治疗方法。