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枸橼酸铋钾咀嚼片与西咪替丁片治疗十二指肠溃疡的双盲双模拟对照研究。

Tri-potassium di citrato bismuthate chewing tablets and cimetidine tablets in the treatment of duodenal ulcers. A double-blind double-dummy comparative study.

作者信息

Moshal M G, Spitaels J M, Khan F

出版信息

S Afr Med J. 1981 Sep 12;60(11):420-3.

PMID:7025264
Abstract

A randomized, double-blind, double-dummy comparative 6-week study of tri-potassium di-citrato bismuthate (TDB) (Ulcerone; De-Nol) chewing tables and cimetidine was carried out in 60 patients suffering from duodenal ulceration. The data on 51 patients (27 on TDB and 24 on cimetidine) were analysed (9 patients absconded). Both treatments appeared to be highly effective in ulcer healing at the 6-week endoscopic assessment. The healing rate for TDB chewing tablets was 89% and that for cimetidine tablets 92%. Both forms of therapy were comparable in respect of improvement of pain and effect on all other observed symptoms. Neither drug had a statistically significant effect on any of the haematological or clinical chemical parameters tested during the trial, except that the cimetidine-treated group showed a significant linear reduction in white blood cell count. No side-effects were reported. It is suggested that TDB chewing tablets are a safe, effective and cheaper alternative to cimetidine in the treatment of patients with duodenal ulceration.

摘要

对60例十二指肠溃疡患者进行了一项随机、双盲、双模拟的三钾二枸橼酸铋(TDB)(得乐;迪乐)咀嚼片与西咪替丁的为期6周的对比研究。分析了51例患者的数据(27例服用TDB,24例服用西咪替丁)(9例患者潜逃)。在6周的内镜评估中,两种治疗方法在溃疡愈合方面似乎都非常有效。TDB咀嚼片的愈合率为89%,西咪替丁片的愈合率为92%。两种治疗方式在疼痛改善和对所有其他观察到的症状的影响方面具有可比性。在试验期间,两种药物对所检测的任何血液学或临床化学参数均无统计学上的显著影响,只是西咪替丁治疗组的白细胞计数呈显著线性下降。未报告有副作用。建议在治疗十二指肠溃疡患者时,TDB咀嚼片是一种安全、有效且更便宜的西咪替丁替代药物。

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