Mach T
Klinika Gastroenterologii Collegium Medicum UJ w Krakowie.
Folia Med Cracov. 1995;36(1-4):3-20.
We carried out the controlled, double-blind clinical study on the effect of antacids containing aluminium on the healing of duodenal ulcer (DU) and the morphology of gastric mucosa in 153 patients with duodenal ulcer disease. The patients were treated for 4 weeks with either dihydroxyaluminium-sodium carbonate (Alugastrin) or aluminium and magnesium hydroxides (Alumag) and for comparison with ranitidine or placebo. The clinical usefulness of antacids were assessed according to the following criteria: ulcer healing ratio, disappearance of ulcer pain, drug tolerance both subjective and objective (biochemical analyses) and drug effect on the gastric mucosa (endoscopy, histology and morphometry). The results were compared with results obtained from ranitidine treated patients. We have shown that both antacids speed up the DU healing similarly to ranitidine (71%, 75% and 79% respectively) and significantly better than placebo (47% of cases). All administered drugs diminished subjective symptoms of patients and were well tolerated. Dihydroxyaluminium-sodium carbonate and aluminium and magnesium hydroxides as well as ranitidine were without any trophic effects on the gastric mucosa. Thus, despite differences in the pharmacological action (antacids are gastroprotective drugs, ranitidine inhibits HCl secretion), antacids are similarly effective to ranitidine in the treatment of DU patients. However, ranitidine is more comfortable for the patients and better accepted in the long-term treatment.
我们对153例十二指肠溃疡病患者开展了一项对照双盲临床研究,以探讨含铝抗酸剂对十二指肠溃疡(DU)愈合及胃黏膜形态的影响。患者分别接受碳酸二羟铝钠(胃舒平)或氢氧化铝镁(胃仙-U)治疗4周,并与雷尼替丁或安慰剂作比较。根据以下标准评估抗酸剂的临床效用:溃疡愈合率、溃疡疼痛消失情况、主观及客观的药物耐受性(生化分析)以及药物对胃黏膜的作用(内镜检查、组织学和形态测量)。将结果与雷尼替丁治疗患者的结果进行比较。我们发现,两种抗酸剂促进DU愈合的速度与雷尼替丁相似(分别为71%、75%和79%),且显著优于安慰剂(47%的病例)。所有给药药物均减轻了患者的主观症状,且耐受性良好。碳酸二羟铝钠、氢氧化铝镁以及雷尼替丁对胃黏膜均无任何营养作用。因此,尽管药理作用存在差异(抗酸剂是胃保护药物,雷尼替丁抑制盐酸分泌),但抗酸剂在治疗DU患者方面与雷尼替丁同样有效。然而,雷尼替丁对患者来说更舒适,在长期治疗中更易被接受。