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羧苄索钠胶囊治疗十二指肠溃疡的双盲试验。

A double-blind trial of carbenoxolone sodium capsules in the treatment of duodenal ulcer.

作者信息

Cliff J M, Milton-Thompson G J

出版信息

Gut. 1970 Feb;11(2):167-70. doi: 10.1136/gut.11.2.167.

DOI:10.1136/gut.11.2.167
PMID:4909817
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1411351/
Abstract

A controlled trial of carbenoxolone sodium positioned-release capsules (Duogastrone) was carried out on a randomized series of 100 unselected male Service personnel with symptoms of active duodenal ulceration and supporting radiological evidence. Fifty-seven patients completed the trial, 29 in the carbenoxolone group and 28 in the control group. The carbenoxolone group was given capsules containing 50 mg carbenoxolone four times a day for 12 weeks while the controls received a capsule identical in every respect except that it did not contain carbenoxolone. All patients were assessed at fortnightly intervals and had clinical and radiological reassessments three and six months after commencing treatment. Review at three months and at six months revealed a slight but clinically insignificant trend in favour of the carbenoxolone group. As a corollary to this controlled trial, those patients (38 in all) who did not have an early remission of symptoms were removed from the trial and placed on capsules known to contain carbenoxolone. Subsequently these patients did not show an advantage for carbenoxolone.

摘要

对100名出现活动性十二指肠溃疡症状且有相应放射学证据的未经过挑选的男性军人进行了一项关于甘珀酸钠定位释放胶囊(商品名:胃溃宁)的对照试验。100名患者随机分组,57名患者完成了试验,其中甘珀酸钠组29人,对照组28人。甘珀酸钠组患者每日服用4次含50毫克甘珀酸钠的胶囊,持续12周,而对照组服用的胶囊在各方面均与试验组相同,但不含甘珀酸钠。所有患者每两周接受一次评估,并在开始治疗后的3个月和6个月进行临床和放射学重新评估。3个月和6个月时的复查显示,有轻微但临床上无显著意义的趋势表明甘珀酸钠组更具优势。作为这项对照试验的一个推论,那些(总共38名)症状未早期缓解的患者被排除在试验之外,并给予已知含有甘珀酸钠的胶囊。随后,这些患者并未显示出甘珀酸钠的优势。

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本文引用的文献

1
TREATMENT OF GASTRIC ULCER WITH CARBENOXOLONE SODIUM AND OESTROGENS.用甘珀酸钠和雌激素治疗胃溃疡
Gut. 1965 Feb;6(1):19-24. doi: 10.1136/gut.6.1.19.
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Metabolic studies, aldosterone secretion rate, and plasma renin after carbenoxolone sodium.服用甘珀酸钠后的代谢研究、醛固酮分泌率及血浆肾素
Br Med J. 1969 Jun 28;2(5660):793-5. doi: 10.1136/bmj.2.5660.793.
3
Muscle paresis and hypokalemia after treatment with duogastrone.使用双层片治疗后出现肌肉轻瘫和低钾血症。
Br Med J. 1969 Jun 14;2(5658):674. doi: 10.1136/bmj.2.5658.674.
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Carbenoxolone in the treatment of duodenal ulcer.生胃酮治疗十二指肠溃疡
Practitioner. 1967 Jul;199(189):109-11.
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A trial of carbenoxolone sodium in the treatment of gastric ulceration.
S Afr Med J. 1967 Mar 25;41(12):297-300.
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Carbenoxolone sodium in the treatment of gastric ulcer with special reference to side-effects.生胃酮钠治疗胃溃疡——特别提及副作用
Gut. 1965 Dec;6(6):591-4. doi: 10.1136/gut.6.6.591.
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Treatment of gastric ulceration with carbenoxolone sodium: clinical and radiological evaluation.用甘珀酸钠治疗胃溃疡:临床与放射学评估
Br Med J. 1965 Nov 27;2(5473):1274-7. doi: 10.1136/bmj.2.5473.1274.
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A controlled trial of carbenoxolone sodium capsules in the treatment of duodenal ulcer.甘珀酸钠胶囊治疗十二指肠溃疡的对照试验。
Gut. 1968 Dec;9(6):704-6. doi: 10.1136/gut.9.6.704.