Marks I N, Wright J P, Bank L, Girdwood A H, Kalvaria I, Gilinsky N H, O'Keefe S J, Lucke W
S Afr Med J. 1986 Jul 5;70(1):27-30.
Sixty-seven patients with endoscopically proven duodenal ulceration were entered into a double-blind study and randomized to treatment with pirenzepine (PZ) (Gastrozepin; Boehringer Ingelheim) 50 mg twice daily or cimetidine (CM) (Tagamet; Smith Kline & French Laboratories) 400 mg twice daily, given 30 minutes before breakfast and supper. Patients underwent endoscopic examination before entry, at 4 weeks, and at 8 weeks if unhealed at 4 weeks. Once healing was achieved, 43 patients were entered into a single-blind maintenance study with either PZ 50 mg at night or CM 400 mg at night according to their original randomization. CM had a slight, but not significant, advantage over PZ after 4 weeks, but the 8-week data showed identical healing rates. The relapse rate appeared to be higher in the PZ-treated group, but this difference was also not significant. It is suggested that the evening dose of PZ be amended to 50 or perhaps 100 mg before bed in the short-term treatment of duodenal ulcer, and that a dose of 100 mg at night be considered for maintenance therapy in certain high-risk populations.
67例经内镜证实为十二指肠溃疡的患者进入一项双盲研究，随机分为两组，分别接受哌仑西平（PZ）（胃仙-U；勃林格殷格翰公司）每日两次、每次50 mg或西咪替丁（CM）（泰胃美；史克必成实验室）每日两次、每次400 mg治疗，于早餐和晚餐前30分钟服用。患者在入组前、4周时以及如果4周未愈合则在8周时接受内镜检查。一旦溃疡愈合，43例患者根据其最初的随机分组进入单盲维持治疗研究，分别接受每晚50 mg PZ或每晚400 mg CM治疗。4周后，CM相对于PZ有轻微但不显著的优势，但8周的数据显示愈合率相同。PZ治疗组的复发率似乎较高，但这种差异也不显著。建议在十二指肠溃疡的短期治疗中，将PZ的夜间剂量调整为50 mg或可能100 mg睡前服用，对于某些高危人群，考虑在维持治疗中使用每晚100 mg的剂量。
