URSODEOXYCHOLIC ACID FOR TREATMENT OF PRIMARY SCLEROSING CHOLANGITIS - A PLACEBO-CONTROLLED TRIAL
URSODEOXYCHOLIC ACID FOR TREATMENT OF PRIMARY SCLEROSING CHOLANGITIS - A PLACEBO-CONTROLLED TRIAL
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DOI：
10.1002/hep.1840160315
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发表时间：
1992-09-01
期刊：
影响因子：
13.5
通讯作者：
PAUMGARTNER, G
中科院分区：
文献类型：
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作者：
BEUERS, U;SPENGLER, U;PAUMGARTNER, G
熊去氧胆酸治疗原发性硬化性胆管炎的有效性和安全性在一项前瞻性、随机、双盲、安慰剂对照试验中进行了评估。14例原发性硬化性胆管炎患者均经胆汁淤积型血清酶谱、肝组织学检查和内窥镜逆行胆管造影术证实。6名患者接受熊去氧胆酸(13至15 mg/kg体重/天)，8名患者接受安慰剂治疗。两名患者不得不退出研究，一名患者是因为UDCA相关的腹泻，另一名患者是因为在安慰剂治疗期间病情恶化。与安慰剂组相比，熊去氧胆酸组患者的血清胆红素(中位数=-50%)、碱性磷酸酶(中位数=-67%)、γ-谷氨酰转移酶(中位数=-53%)、天冬氨酸转氨酶(中位数=-54%)和丙氨酸氨基转移酶(中位数=-36%)水平显著改善，但疏水性胆汁酸水平没有改善。在熊去氧胆酸治疗期间，组织病理学特征也有显著改善，通过多参数评分进行评估。熊去氧胆酸处理后，肝细胞上人类白细胞抗原I类分子的表达明显减少。我们得出结论，熊去氧胆酸对降低原发性硬化性胆管炎患者的疾病活动性是有益的。
The efficacy and safety of ursodeoxycholic acid for the treatment of primary sclerosing cholangitis were evaluated in a prospective, randomized, double-blind, placebo-controlled trial. Fourteen patients with primary sclerosing cholangitis documented by cholestatic serum enzyme pattern, liver histological appearance and endoscopic retrograde cholangiography were included in the trial. Six patients received ursodeoxycholic acid (13 to 15 mg/kg body wt/day), and eight patients received placebo. Two patients had to be withdrawn from the study, one because of UDCA-related diarrhea and the other because of worsening of the disease during placebo treatment. Patients in the ursodeoxycholic acid group improved significantly during 1 yr of treatment with respect to serum levels of bilirubin (median = - 50%), alkaline phosphatase (median = -67%), gamma-glutamyltransferase (median = - 53%), AST (median = - 54%) and ALT (median = - 36%) compared with the placebo group, but not with respect to serum levels of hydrophobic bile acids. During ursodeoxycholic acid treatment, histopathological features also improved significantly, as evaluated by multiparametric score. Expression of human leukocyte antigen class I molecules appeared to be markedly reduced on liver cells after ursodeoxycholic acid treatment. We conclude that ursodeoxycholic acid is beneficial in reducing disease activity in patients with primary sclerosing cholangitis.