Miglioli M, Bianchi Porro G, Vaira D, Menegatti M, Brunetti G, Petrillo M, Ardizzone S, Frizziero L, Montrone F, Grandinetti G
1st Medical Clinic, University of Bologna, Italy.
Am J Gastroenterol. 1996 Nov;91(11):2367-71.
To evaluate the efficacy of a new formulation of sucralfate as gel (Gastrogel) in the short-term prevention of gastroduodenal lesions in arthritic patients receiving nonsteroidal anti-inflammatory drugs.
One hundred seven patients with arthritis (M/F 18/89, mean age 55.2 +/- 9.7 yr) enrolled in two centers were considered eligible for the study if initial endoscopy showed the absence of any relevant mucosal damage. Patients were randomly allocated to receive diclofenac 200 mg/day or naproxen 1 g/day plus either sucralfate gel 1 g b.i.d. (N = 53) or identical placebo (N = 54) for 14 days in a randomized double-blind study. Repeated assessment of GI symptoms and endoscopy were performed at the end of the study period.
At final endoscopy the incidence of erosion and the mean endoscopic score for both stomach and duodenum were significantly lower in the sucralfate gel group compared with placebo group (p < 0.05). Both heartburn and epigastric pain were significantly less frequent in patients receiving sucralfate gel than placebo (51 vs 30% and 49 vs 28% for heartburn and epigastric pain, respectively, p < 0.05). No differences were observed in the incidence or in the mean score for nausea. An unexplained difference in the incidence of ulcers was found between the two centers, but in both a similar reduction in the incidence of ulcers was observed between patients receiving sucralfate gel compared with those receiving placebo. The overall difference (8% in sucralfate-treated patients, 28% in patients receiving placebo) of gastroduodenal ulcers was statistically significant (p < 0.05).
Sucralfate gel reduces both the incidence of acute gastroduodenal mucosal lesions and symptoms in patients with arthritis receiving short-term nonsteroidal anti-inflammatory drugs.
评估一种新的硫糖铝凝胶制剂（胃凝胶）在短期预防接受非甾体抗炎药治疗的关节炎患者胃十二指肠病变方面的疗效。
在两个中心招募了107例关节炎患者（男18例/女89例，平均年龄55.2±9.7岁），如果初始内镜检查显示无任何相关黏膜损伤，则认为符合研究条件。在一项随机双盲研究中，患者被随机分配接受双氯芬酸200mg/天或萘普生1g/天，加硫糖铝凝胶1g，每日两次（N = 53）或相同的安慰剂（N = 54），持续14天。在研究期结束时对胃肠道症状和内镜检查进行重复评估。
在最终内镜检查时，硫糖铝凝胶组的糜烂发生率以及胃和十二指肠的平均内镜评分均显著低于安慰剂组（p < 0.05）。接受硫糖铝凝胶的患者烧心和上腹痛的发生率均显著低于安慰剂组（烧心分别为51%对30%，上腹痛分别为49%对28%，p < 0.05）。恶心的发生率或平均评分未观察到差异。两个中心之间溃疡发生率存在无法解释的差异，但在接受硫糖铝凝胶的患者与接受安慰剂的患者之间，溃疡发生率均有类似程度的降低。胃十二指肠溃疡的总体差异（硫糖铝治疗患者为8%，接受安慰剂患者为28%）具有统计学意义（p < 0.05）。
硫糖铝凝胶可降低接受短期非甾体抗炎药治疗的关节炎患者急性胃十二指肠黏膜病变的发生率和症状。
