Poupon R, Chrétien Y, Poupon R E, Ballet F, Calmus Y, Darnis F
Lancet. 1987 Apr 11;1(8537):834-6. doi: 10.1016/s0140-6736(87)91610-2.
The effects of ursodeoxycholic acid (UDCA, 13-15 mg/kg body weight daily) were prospectively evaluated in fifteen patients with primary biliary cirrhosis (PBC). The mean concentration of UDCA in serum expressed as the percentage of total bile acids rose from 0% at baseline to 58% (SEM 9%) after 2 years' treatment, whereas total serum bile acid levels did not change significantly. The proportion of patients with pruritus necessitating the use of cholestyramine was significantly lower at 2 years than at baseline. Standard liver function tests improved in all the patients. At 2 years the average activities of gamma-glutamyltranspeptidase, alkaline phosphatases, and alanine aminotransferase and bilirubin levels were reduced (respectively 78%, 65%, 68%, and 36% of pretreatment values). In three patients who agreed to interrupt the ingestion of UDCA for 3 months after 2 years' treatment there was clear deterioration in liver function tests, which again improved after reinstitution of UDCA. These results suggest that long-term UDCA might be a safe and effective treatment for PBC, but a randomised, controlled, double-blind trial is urgently needed.
对15例原发性胆汁性肝硬化（PBC）患者前瞻性评估了熊去氧胆酸（UDCA，每日13 - 15mg/kg体重）的疗效。以总胆汁酸百分比表示的血清中UDCA平均浓度在治疗2年后从基线时的0%升至58%（标准误9%），而血清总胆汁酸水平无显著变化。2年后因瘙痒而需要使用考来烯胺的患者比例显著低于基线。所有患者的标准肝功能检查均有改善。2年后，γ-谷氨酰转肽酶、碱性磷酸酶、丙氨酸氨基转移酶的平均活性及胆红素水平均降低（分别为治疗前值的78%、65%、68%和36%）。在3例同意在治疗2年后中断服用UDCA 3个月的患者中，肝功能检查明显恶化，重新服用UDCA后又再次改善。这些结果表明，长期使用UDCA可能是治疗PBC的一种安全有效的方法，但迫切需要进行一项随机、对照、双盲试验。
