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一种新型高效抗酸产品的开放型使用安全性试验。

Open safety-in-use trial of a new high-potency antacid product.

作者信息

Pawlowski G J, Krondl A, Darke A C

出版信息

J Int Med Res. 1983;11(4):239-42. doi: 10.1177/030006058301100408.

DOI:10.1177/030006058301100408
PMID:6617982
Abstract

In an open safety-in-use study, the subjective effectiveness and taste acceptability of a new high-potency antacid product were compared to previous treatment in 109 patients presenting with upper gastro-intestinal disorders of functional origin. Severity of the dominant symptoms prior to treatment was compared with that of symptoms present during treatment. Sixty-seven per cent to 73% of upper gastro-intestinal tract symptoms were completely relieved. Eighty-three per cent versus 48% of patients seen in a private practice setting, as compared with the speciality practice, reported good to excellent results, with 92% versus 56% describing good to excellent taste acceptability. When compared with previous antacid therapy, 70% of the patients preferred the new high-potency formulation to the regular-strength products, for both effectiveness and taste. The incidence of product-related side-effects was low, with only 6.7% experiencing the diarrhoea or loose stools commonly associated with conventional products containing magnesium hydroxide.

摘要

在一项开放性使用安全性研究中,将一种新型高效抗酸产品的主观疗效和口味接受度与之前对109例患有功能性上消化道疾病患者的治疗情况进行了比较。将治疗前主要症状的严重程度与治疗期间出现的症状严重程度进行了比较。67%至73%的上消化道症状得到完全缓解。在私人诊所就诊的患者中,有83%报告疗效良好至极佳,而在专科诊所这一比例为48%;在口味接受度方面,分别有92%和56%的患者表示良好至极佳。与之前的抗酸治疗相比,70%的患者在疗效和口味方面都更青睐新型高效制剂而非常规强度产品。与产品相关的副作用发生率较低,只有6.7%的患者出现了与含氢氧化镁的传统产品常见的腹泻或大便稀溏症状。

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