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“得乐”治疗十二指肠溃疡的对照试验

Controlled trial of Duogastrone in duodenal ulcer.

作者信息

Davies W A, Reed P I

出版信息

Gut. 1977 Jan;18(1):78-83. doi: 10.1136/gut.18.1.78.

Abstract

A double-blind placebo-controlled trial of carbenoxolone, as 50 mg Duogastrone capsules, and in a dose of 200 mg daily for 12 weeks, was carried out in 40 ambulant subjects with endoscopically diganosed duodenal ulceration, of whom 34 were available for final analysis. Each patient was seen every two weeks and endoscoped at four, eight and 12 weeks. Serum carbenoxolone was measured at each visit. Complete ulcer healing occurred in a significantly greater number of patients receiving Duogastrone than placebo, the significance being greater after four and eight weeks treatment (P less than 0-01) than at 12 weeks (P less than 0-02). While significant symptomatic improvement also was achieved (P less than 0-05), but only after 12 weeks on Duogastrone, there was much closer correlation between ulcer healing and symptom relief, 69% on Duogastrone returning to normal, compared with 22% of controls (P less than 0-02). Rise of systolic blood pressure and reduction in serum potassium levels, especially during the last four treatment weeks, were the most common effects noted in patients taking Duogastrone, and five patients required thiazide diuretics and potassium supplements. Higher serum carbenoxolone levels were found in patients with healed ulcers as well as in those with more marked side-effects.

摘要

对40例经内镜诊断为十二指肠溃疡的门诊患者进行了一项双盲安慰剂对照试验,使用50毫克甘珀酸钠胶囊(商品名:Duogastrone),每日剂量为200毫克,疗程12周,最终有34例患者可供分析。每两周对每位患者进行一次检查,并在第4、8和12周进行内镜检查。每次就诊时测量血清甘珀酸钠水平。接受Duogastrone治疗的患者中溃疡完全愈合的人数明显多于接受安慰剂的患者,治疗4周和8周后的差异比12周时更显著(P<0.01),12周时差异为P<0.02。虽然也实现了显著的症状改善(P<0.05),但仅在服用Duogastrone 12周后出现,溃疡愈合与症状缓解之间的相关性更强,服用Duogastrone的患者中有69%恢复正常,而对照组为22%(P<0.02)。服用Duogastrone的患者中最常见的效应是收缩压升高和血清钾水平降低,尤其是在治疗的最后四周,有5例患者需要噻嗪类利尿剂和钾补充剂。溃疡愈合的患者以及副作用更明显的患者血清甘珀酸钠水平更高。

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