Schütze K, Hentschel E, Happonen P, Akkila J
1st Medical Department, Hanusch Krankenhaus, Vienna, Austria.
Hepatogastroenterology. 1995 Jul;42(3):240-5.
In a single-centre randomised clinical trial, a new effervescent formulation of sucralfate was compared with the granular formulation of the drug in the treatment of peptic ulcer. The effervescent tablet had not been previously administered to human subjects. Fifty patients with endoscopically verified duodenal (40) and gastric (10) ulcers were treated with 2.0 g sucralfate twice daily, given either as a granular formulation or effervescent tablet. Control endoscopies were performed at weeks 4 and 8 and again at week 12 if gastric ulcers had not healed earlier. The healing rates in the effervescent tablet group were 71% (15/21) and 86% (18/21) after 4 and 8 weeks. In this group one gastric ulcer had to be treated for a further 4 weeks and had not healed at week 12. The corresponding rates in the sucralfate granulate group were 95% (18/19) after 4 and 8 weeks. Serum aluminium concentrations were measured simultaneously before and after treatment. The aluminium concentration almost doubled in both treatment groups during dosing with sucralfate. This effect has not been described previously in the course of therapy with sucralfate in patients with peptic ulcer disease and should be borne in mind when considering treatment with this drug.
在一项单中心随机临床试验中，将一种新的硫糖铝泡腾制剂与该药物的颗粒制剂用于治疗消化性溃疡进行比较。此前尚未对人体受试者使用过该泡腾片。50例经内镜证实为十二指肠溃疡（40例）和胃溃疡（10例）的患者，每日两次服用2.0g硫糖铝，剂型为颗粒制剂或泡腾片。在第4周和第8周进行对照内镜检查，如果胃溃疡未提前愈合，则在第12周再次进行检查。泡腾片组在4周和8周后的愈合率分别为71%（15/21）和86%（18/21）。该组有1例胃溃疡必须再治疗4周，在第12周时仍未愈合。硫糖铝颗粒组在4周和8周后的相应愈合率为95%（18/19）。在治疗前后同时测量血清铝浓度。在服用硫糖铝期间，两个治疗组的铝浓度几乎都增加了一倍。在消化性溃疡疾病患者使用硫糖铝治疗过程中，这种效应此前尚未有过描述，在考虑使用该药物治疗时应予以关注。
