Porsio A, Borgia M
Int J Clin Pharmacol Biopharm. 1976 Jul;14(1):40-3.
A controlled double-blind clinical trial was carried out to compare the effects of a new combination FZ. 560 in the symptomatic treatment of digestive disorders including a wide variety of symptoms. The combination contained fentonium bromide, 10 mg, dehydrocholic acid, 25 mg, pancreatin 3FU, 50 mg, and lactulose, 200 mg; it was compared with fentonium bromide 10 mg, and the other components. The three treatment groups included 37 patients, treated for a maximum of 14 days. The severity of the painful and dyspeptic symptoms was recorded daily; the overall daily scores were analyzed using persistence curves. A 50% reduction of the initial overall scores was observed in all the 12 patients in the combination groups by the third treatment day, but not until the 13th day in the fentonium group, while a 50% reduction in symptom intensity was not achieved during the trial in 7.7% of the group treated with the other components. Statistical comparison with the Wilcoxon test showed in fact that the effects of FZ. 560 were significantly superior to those of the two control preparations which did not differ significantly. These results, therefore, demonstrate clearly the advantages of the new combination FZ. 560.
开展了一项对照双盲临床试验，以比较新型复方制剂FZ. 560对包括多种症状在内的消化系统疾病进行对症治疗的效果。该复方制剂含有10毫克溴芬铵、25毫克去氢胆酸、50毫克3FU胰酶和200毫克乳果糖；将其与10毫克溴芬铵及其他成分进行比较。三个治疗组各有37名患者，治疗最长时间为14天。每天记录疼痛和消化不良症状的严重程度；使用持续曲线分析每日总分。复方制剂组的所有12名患者在治疗第3天时初始总分均降低了50%，而溴芬铵组直到第13天才降低50%，使用其他成分治疗的组中有7.7%在试验期间症状强度未降低50%。事实上，通过威尔科克森检验进行的统计学比较表明，FZ. 560的效果明显优于两种对照制剂，而这两种对照制剂之间无显著差异。因此，这些结果清楚地证明了新型复方制剂FZ. 560的优势。
