Smart H L, James P D, Atkinson M, Hawkey C J
University Hospital, Nottingham, UK.
Digestion. 1989;44(1):52-6. doi: 10.1159/000199892.
Forty-four patients with symptomatic endoscopically proven mild to moderate reflux oesophagitis were enrolled in a single-centre, double-blind, clinical trial comparing trimoprostil 750 micrograms taken 4 times daily with placebo. Patients treated with trimoprostil but not placebo experienced a significant reduction in the frequency (p less than 0.005) and duration (p less than 0.02) of heartburn. Both groups reported a reduction in the severity of heartburn and resulting sleep disturbance during the trial, but differences between them in these respects at the end of the trial did not reach statistical significance. There was a significant reduction in the severity of oesophagitis seen at endoscopy after treatment with trimoprostil (p less than 0.01) but not placebo. Trimoprostil was well tolerated and appears to be more effective than placebo in the treatment of mild to moderate symptomatic reflux oesophagitis. Although this agent's mode of action was not investigated, we speculate that it may be protective to human squamous oesophageal mucosa.
44例经内镜检查证实为轻至中度反流性食管炎且有症状的患者参与了一项单中心、双盲临床试验,该试验比较了每日4次服用750微克曲莫前列素与安慰剂的效果。接受曲莫前列素治疗而非安慰剂治疗的患者烧心频率(p<0.005)和持续时间(p<0.02)显著降低。两组在试验期间均报告烧心严重程度及由此导致的睡眠障碍有所减轻,但试验结束时两组在这些方面的差异未达到统计学显著性。曲莫前列素治疗后内镜检查可见食管炎严重程度显著降低(p<0.01),而安慰剂则无此效果。曲莫前列素耐受性良好,在治疗轻至中度症状性反流性食管炎方面似乎比安慰剂更有效。尽管未对该药物的作用方式进行研究,但我们推测它可能对人鳞状食管黏膜有保护作用。