Osteoporosis in primary biliary cirrhosis: A randomized trial of the efficacy and feasibility of estrogen/progestin
Osteoporosis in primary biliary cirrhosis: A randomized trial of the efficacy and feasibility of estrogen/progestin
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DOI：
10.1007/s10620-006-8015-x
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发表时间：
2006-06-01
影响因子：
3.1
通讯作者：
Heathcote, E. Jenny
中科院分区：
文献类型：
--
作者：
Boone, Robert H.;Cheung, Angela M.;Heathcote, E. Jenny
预防和治疗原发性胆汁性肝硬化（PBC）骨质疏松症的最佳治疗方法尚不清楚。激素替代疗法（HRT）可预防骨质疏松症，但可能促进胆汁淤积。我们进行了一项双盲、随机、安慰剂对照试验，在绝经后PBC妇女中进行经皮雌激素/孕激素治疗。这项为期24个月的研究招募了31名患者，但试验吸收有限，治疗组脱落率显著。安慰剂治疗患者的股骨颈骨密度丢失百分比高于活性治疗患者（分别为-3.76 +/- 1.37% vs 0.21 +/-1.01%，P = 0.058）。安慰剂组2例患者发生新骨折，治疗组无患者发生新骨折。两组间胆红素的平均每月增加无显著差异，但个体数据表明HRT可能会加重胆汁淤积。总之，PBC妇女对HRT有强烈的感受，这种干预措施的招聘是困难的。经皮雌激素/孕激素可能对PBC患者的骨丢失提供保护，但可能使胆汁淤积恶化。
The optimal therapy for the prevention and treatment of osteoporosis in primary biliary cirrhosis (PBC) is unknown. Hormone replacement therapy (HRT) prevents osteoporosis, but may promote cholestasis. We performed a double-blind, randomized, placebo-controlled trial of transdermal estrogen/progestin in postmenopausal women with PBC. The 24-month study enrolled 31 patients, but trial uptake was limited and treatment arm dropout was significant. Placebo-treated patients had a higher percentage loss in femoral neck bone mineral density than actively treated patients (-3.76 +/- 1.37% versus 0.21 +/- 1.01%, respectively, P = .058). New fractures occurred in 2 patients on placebo, and in no patients on treatment. The mean monthly increase in bilirubin was not significantly different between groups, but individual data suggest HRT may worsen cholestasis. In conclusion, women with PBC have strong feelings about HRT, and recruitment for this intervention is difficult. Transdermal estrogen/progestin likely provides protection against bone loss in PBC patients, but may worsen cholestasis.