World M J, Aps E J, Shaw G K, Thomson A D
Alcohol Alcohol. 1984;19(1):23-9.
A prospective randomized double-blind trial of (+)-cyanidanol-3 at a dose of 2 g daily (500 mg qds) for six months versus placebo has failed to demonstrate statistically significant clinical, biochemical or histological benefit in patients with biopsy-proven alcoholic liver disease although certain trends were identified. The group receiving the active drug tended to drink more both before and during the trial and had mean serum aspartate aminotransferase (AsT) and gamma-glutamyltranspeptidase (gamma-GT) levels which were higher on admission to the trial. After the fourth week of treatment, the mean serum levels of these enzymes remained consistently lower in the group receiving the active drug. In order to reproduce the beneficial effects of the drug observed in the rat, it is suggested that further trials be conducted with the dosage so far used in man (ca. 20-40 mg/kg daily) increased toward that successfully employed in animal experiments (200 mg/kg daily).
一项前瞻性随机双盲试验，将每日剂量为2克（500毫克，每日四次）的（+）-花青定醇-3与安慰剂进行为期六个月的对比，结果显示，对于经活检证实患有酒精性肝病的患者，在临床、生化或组织学方面未显示出具有统计学意义的益处，尽管发现了某些趋势。接受活性药物的组在试验前和试验期间饮酒量往往更多，且在进入试验时血清天冬氨酸转氨酶（AsT）和γ-谷氨酰转肽酶（γ-GT）的平均水平更高。治疗第四周后，接受活性药物的组中这些酶的平均血清水平持续较低。为了重现该药物在大鼠身上观察到的有益效果，建议进一步试验，将目前在人体中使用的剂量（约每日20-40毫克/千克）提高至动物实验中成功使用的剂量（每日200毫克/千克）。
