Oral budesonide in the treatment of primary sclerosing cholangitis.
Oral budesonide in the treatment of primary sclerosing cholangitis.
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口服布地奈德治疗原发性硬化性胆管炎。
DOI：
10.1111/j.1572-0241.2000.02323.x
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发表时间：
2000
期刊：
影响因子：
--
通讯作者：
Lindor,KD
中科院分区：
文献类型：
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作者：
Angulo,P;Batts,KP;Jorgensen,RA;LaRusso,NA;Lindor,KD
目的：本研究旨在评估原发性硬化性胆管炎 (PSC) 患者口服布地奈德的安全性并评估其疗效。方法：21 名 PSC 患者接受每日 9 mg 口服布地奈德治疗，为期 1 年。结果：血清碱性磷酸酶显着但不太重要（1235±190 vs 951±206） 在治疗期结束时记录 U/L，p= 0.003）和 AST 水平（119±14 vs 103±19 U/L，p= 0.02）。完成 1 年治疗的 18 名患者的血清胆红素水平显着升高（1.1±0.1 vs 1.4±0.3，p = 0.01），并且在布地奈德停药 3 个月后肝脏检查没有显着变化。 Mayo风险评分没有显着变化，尽管在治疗结束时发现门脉炎症程度显着改善，但纤维化程度和疾病阶段没有显着影响。布地奈德治疗1年时，股骨颈（0.851±0.02 vs 0.826±0.02 g/cm 2，p= 0.002）和腰椎（1.042±0.02 vs 1.029±0.02 g/cm 2，p= 0.09）骨量明显减少。两名患者在治疗期间需要进行肝移植评估，两名患者出现了美容副作用。结论：口服布地奈德似乎没有任何益处（如果有的话），并且与 PSC 患者骨质疏松症的显着恶化有关。
OBJECTIVE:This study was designed to evaluate the safety and estimate the efficacy of oral budesonide in patients with primary sclerosing cholangitis (PSC).METHODS:Twenty-one patients with PSC were treated with 9 mg daily of oral budesonide for 1 yr.RESULTS:Significant, but marginally important, improvement in serum alkaline phosphatase (1235±190 vs 951±206 U/L, p= 0.003) and AST levels (119±14 vs 103±19 U/L, p= 0.02) was noted at the end of the treatment period. Serum bilirubin levels increased significantly in the 18 patients who completed 1 yr of treatment (1.1±0.1 vs 1.4±0.3, p= 0.01) and no significant changes in liver tests were noted 3 months after budesonide was discontinued. The Mayo risk score did not change significantly, and although a significant improvement in the degree of portal inflammation was noted at the end of the treatment period, the degree of fibrosis and stage of disease were not significantly affected. There was a marked loss of bone mass of the femoral neck (0.851±0.02 vs 0.826±0.02 g/cm 2, p= 0.002) and lumbar spine (1.042±0.02 vs 1.029±0.02 g/cm 2, p= 0.09) at 1 yr of treatment with budesonide. Two patients required evaluation for liver transplantation during treatment, and two patients developed cosmetic side effects.CONCLUSIONS:Oral budesonide appears to be of minimal, if any, benefit and it is associated with a significant worsening of osteoporosis in patients with PSC.