Tytgat G N, Koelz H R, Vosmaer G D
Academic Medical Center, Amsterdam, The Netherlands.
Am J Gastroenterol. 1995 Aug;90(8):1233-7.
to prove in a double-blind placebo-controlled multinational trial the effects of sucralfate suspension 2 g BID and placebo in the prevention of recurrent reflux esophagitis.
One hundred and eighty-four patients from 16 centers with reflux esophagitis Savary grade 1 and 2 were initially healed with antisecretory therapy before entering the study. They were randomly allocated to sucralfate suspension 2 g BID or placebo for 6 months. Symptoms were monitored monthly. Endoscopy was performed at the end of the trial or earlier in case of clinical suspension of relapse.
The two treatment groups were well matched. We were able to analyze 88 sucralfate- and 93 placebo-treated patients. There was a significant reduction in the endoscopic relapse rate (31% in the sucralfate group vs. 65% in the placebo group, p < 0.001). This reduction was especially obvious for symptomatic relapses (10% vs. 34%, respectively, p < 0.001).
This is the first study to show that sucralfate suspension is capable of preventing recurrent reflux esophagitis in patients with solitary or confluent erosions previously healed with antisecretory therapy.
在一项双盲安慰剂对照的多中心试验中，证明2克 bid 的硫糖铝混悬液和安慰剂在预防复发性反流性食管炎方面的效果。
来自16个中心的184例Savary 1级和2级反流性食管炎患者在进入研究前先用抗分泌疗法初步治愈。他们被随机分配接受2克 bid 的硫糖铝混悬液或安慰剂治疗6个月。每月监测症状。试验结束时或在临床复发中止时提前进行内镜检查。
两个治疗组匹配良好。我们能够分析88例接受硫糖铝治疗和93例接受安慰剂治疗的患者。内镜复发率显著降低（硫糖铝组为31%，安慰剂组为65%，p<0.001）。这种降低在有症状的复发中尤为明显（分别为10%和34%，p<0.001）。
这是第一项表明硫糖铝混悬液能够预防先前用抗分泌疗法治愈的单发或融合性糜烂患者复发性反流性食管炎的研究。
