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铝镁加治疗有无内镜下可证实十二指肠溃疡患者的胃灼热。一项多中心临床试验。

Treatment of gastric pyrosis with almagate in patients with and without endoscopically demonstrable duodenal ulcer. A multicentre clinical trial.

作者信息

Suau A, Dominguez Martin A, Ferrando Cucarella J, Juncosa Iglesias L, Muñoz Benitez J, Nieto Calvet M, Pérez Gieb J, Pérez Mota A, Pineda Garcia A, Rodriguez Sanchez E

出版信息

Arzneimittelforschung. 1984;34(10A):1380-3.

PMID:6548926
Abstract

An open multicentre trial of a new clinical antacid, almagate (hydrated aluminium-magnesium hydroxycarbonate, Al2Mg6(OH)14(CO3)2 X 4H2O, Almax) has been made in 169 patients suffering from gastric pyrosis (heartburn). Clinical and endoscopical exploration revealed that 104 of the patients had an active duodenal ulcer and 60 of these (group II) were treated with antisecretory drugs (cimetidine or ranitidine) plus Almax and 44 (group III) with Almax alone. Endoscopic exploration in the remaining 65 patients (group I) failed to reveal the presence of an ulcer and they were also treated with Almax alone. In all groups Almax proved to be very effective and the majority of patients were symptom free by the end of the two week trial. 79.5% of the ulcer patients in group III required doses of 6-8 g/d whereas only 21.7% of those in group II with concomitant treatment with antisecretory drugs took more than 4 g/d. The nonulcer patients of group I also used lower doses and only 29.3% needed to reach 6-8 g/d. There was a significant increase in daily bowel movements in all groups which was considered to be advantageous by most patients. Overall tolerance was excellent and side effects (diarrhoea 7 cases, nauseas 5 cases and constipation 1 case) were few and transient and 84.2% of the patients expressed a clear preference for Almax over their previous antacid treatment.

摘要

对一种新型临床抗酸剂铝镁加(水合铝镁羟基碳酸盐,Al2Mg6(OH)14(CO3)2·4H2O,Almax)进行了一项开放性多中心试验,研究对象为169例患有胃灼热的患者。临床和内镜检查显示,其中104例患者患有活动性十二指肠溃疡,其中60例(第二组)接受了抗分泌药物(西咪替丁或雷尼替丁)加Almax治疗,44例(第三组)仅接受Almax治疗。其余65例患者(第一组)的内镜检查未发现溃疡,他们也仅接受Almax治疗。在所有组中,Almax都被证明非常有效,在为期两周的试验结束时,大多数患者症状消失。第三组中79.5%的溃疡患者需要6 - 8克/天的剂量,而第二组中同时接受抗分泌药物治疗的患者只有21.7%服用超过4克/天。第一组的非溃疡患者使用的剂量也较低,只有29.3%的患者需要达到6 - 8克/天。所有组的每日排便次数都有显著增加,大多数患者认为这是有利的。总体耐受性良好,副作用(腹泻7例、恶心5例和便秘1例)很少且短暂,84.2%的患者表示明显更喜欢Almax而不是他们之前使用的抗酸剂。

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