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双环肽粉与安慰剂治疗十二指肠溃疡。一项双盲内镜对照临床试验。

Bicitropeptide powder and placebo in the treatment of duodenal ulcers. A double-blind endoscopically controlled clinical trial.

作者信息

Moshal M G, Spitaels J M, Bhoola R, van Leenhoff H, Khan F

出版信息

S Afr Med J. 1982 Feb 13;61(7):234-5.

PMID:7036376
Abstract

In a double-blind study comprising 50 patients with endoscopically proven uncomplicated duodenal ulcers a powder formulation of bicitropeptide (BCP-Compound) was found to be superior to placebo. On endoscopic examination 19 patients (76%) treated with bicitropeptide powder had healed, while 3 (12%) showed some degree of healing, a total success rate of 88%. Only 5 patients (20%) on placebo had healed completely while 3 (12%) showed some degree of healing (chi 2 = 17,9667; P less than 0,0005). Blood and urine bismuth levels were measured before and after 6 and 12 weeks of therapy, and showed an increase after the first 6 weeks. By 12 weeks the levels had decreased, although they were still higher than the initial values. The blood levels were, however, significantly lower than postulated toxic levels.

摘要

在一项双盲研究中,纳入了50例经内镜证实为单纯十二指肠溃疡的患者,发现一种比西托肽(BCP复合物)的粉末制剂优于安慰剂。内镜检查显示,接受比西托肽粉末治疗的19例患者(76%)溃疡已愈合,3例(12%)有一定程度的愈合,总成功率为88%。安慰剂组仅有5例患者(20%)完全愈合,3例(12%)有一定程度的愈合(χ2 = 17.9667;P < 0.0005)。在治疗6周和12周前后分别测量血铋和尿铋水平,结果显示在最初6周后有所升高。到12周时,这些水平有所下降,尽管仍高于初始值。然而,血铋水平显著低于假定的中毒水平。

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