Bardhan K D, Singh S, Morris P, Thompson M, Hinchliffe R F, Cary B A, Wall R M, Blakemore C B
Rotherham General Hospital NHS Trust, South Yorkshire, UK.
Ital J Gastroenterol Hepatol. 1997 Apr;29(2):128-34.
To investigate the efficacy and safety of daily low-dose colloidal bismuth subcitrate in reducing duodenal ulcer relapse.
Double-blind, double-dummy group comparative clinical trial with random allocation. Healing Phase: colloidal bismuth subcitrate 240 mg twice daily vs ranitidine 150 mg twice daily for up to 12 weeks. Maintenance Phase: nightly, colloidal bismuth subcitrate 120 mg vs ranitidine 150 mg vs placebo for up to 12 months (high-risk patients received active treatment only).
clinical, endoscopy, random blood bismuth levels (and rapid urease test for Helicobacter pylori in a subgroup).
194 with active duodenal ulcer.
Cumulative healing at 12 weeks was 93% on colloidal bismuth subcitrate (of 92 patients) and 97% on ranitidine (of 102 patients). Relapse at 1 year was significantly less on active treatment as follows: placebo (50 patients) 60%; ranitidine (71 patients) 21%; colloidal bismuth subcitrate (64 patients) 33%. This was independent of the results of the rapid urease test which was positive in 78%, 88% and 76% of the patients respectively. Treatment was well tolerated. The highest median blood bismuth level (mcg/L) was 25 in the healing phase and fluctuated between 6 and 10 in the maintenance phase.
Colloidal bismuth subcitrate, 120 mg nightly, is effective in reducing duodenal ulcer relapse and is well tolerated.
研究每日低剂量枸橼酸铋胶体在减少十二指肠溃疡复发方面的疗效和安全性。
随机分配的双盲、双模拟组对照临床试验。愈合期：枸橼酸铋胶体240毫克，每日两次，与雷尼替丁150毫克，每日两次，治疗长达12周。维持期：每晚服用枸橼酸铋胶体120毫克、雷尼替丁150毫克或安慰剂，治疗长达12个月（高危患者仅接受积极治疗）。
临床、内镜检查、随机血铋水平（以及在一个亚组中进行幽门螺杆菌快速尿素酶试验）。
194例活动性十二指肠溃疡患者。
12周时，服用枸橼酸铋胶体的患者（92例）累积愈合率为93%，服用雷尼替丁的患者（102例）为97%。1年时，积极治疗组的复发率显著降低，如下所示：安慰剂组（50例患者）为60%；雷尼替丁组（71例患者）为21%；枸橼酸铋胶体组（64例患者）为33%。这与快速尿素酶试验结果无关，该试验在患者中的阳性率分别为78%、88%和76%。治疗耐受性良好。愈合期血铋水平中位数最高（微克/升）为25，维持期在6至10之间波动。
每晚服用120毫克枸橼酸铋胶体可有效减少十二指肠溃疡复发，且耐受性良好。
