Toussaint J, Gossuin A, Deruyttere M, Hublé F, Devis G
Institut Medico-Chirurgical, Tournai, Belgium.
Gut. 1991 Nov;32(11):1280-5. doi: 10.1136/gut.32.11.1280.
Altogether, 138 patients were included in a study aimed at evaluating the effect of cisapride on healing and relapse of oesophagitis shown endoscopically. In the first phase of the study cisapride was given in an open fashion at 10 mg four times a day for 8 to 16 weeks, and healing was obtained in 69% of patients. Healing occurred later in patients with grades II to IV oesophagitis. The total score for reflux symptoms decreased by 67%. Eighty of the healed patients were included in the second phase. They were randomly assigned to double blind treatment with either cisapride 10 mg (n = 37) or placebo (n = 43) twice a day. Control endoscopy was performed when symptoms recurred or at the end of the six month trial. The cumulative percentage of patients in remission was higher (p = 0.06, survival analysis) in the cisapride group than in the placebo group, the relapse rates being 20% and 39%. The duration of remission tended to be longer in patients with a lower initial degree of oesophagitis. Adverse effects were no more frequent with cisapride than with placebo. In conclusion, cisapride is efficacious in healing oesophagitis, and, unlike other gastrointestinal prokinetic drugs or low dose cimetidine (400-800 mg daily) or ranitidine (150 mg daily), it may prevent relapse of oesophagitis.
共有138例患者纳入一项旨在评估西沙必利对内镜下食管炎愈合及复发影响的研究。在研究的第一阶段,西沙必利以开放方式给药,剂量为10毫克,每日4次,持续8至16周,69%的患者实现愈合。II至IV级食管炎患者愈合时间较晚。反流症状总评分下降了67%。80例愈合患者进入第二阶段。他们被随机分为两组,分别接受每日2次、每次10毫克西沙必利(n = 37)或安慰剂(n = 43)的双盲治疗。当症状复发或在6个月试验结束时进行对照内镜检查。西沙必利组缓解患者的累积百分比高于安慰剂组(p = 0.06,生存分析),复发率分别为20%和39%。初始食管炎程度较低的患者缓解期往往更长。西沙必利的不良反应发生率并不高于安慰剂。总之,西沙必利对食管炎愈合有效,与其他胃肠促动力药物或低剂量西咪替丁(每日400 - 800毫克)或雷尼替丁(每日150毫克)不同,它可能预防食管炎复发。