Department of Gastroenterology, University Hospital of Patras, Patras, Greece.
Aliment Pharmacol Ther. 2011 Oct;34(8):901-10. doi: 10.1111/j.1365-2036.2011.04822.x. Epub 2011 Aug 22.
There is no satisfactory medical treatment for patients with primary sclerosing cholangitis. There are conflicting data regarding the clinical benefit of high doses of ursodeoxycholic acid (UDCA) in primary sclerosing cholangitis.
To evaluate using meta-analysis, if UDCA (standard or high-dose) is useful in primary sclerosing cholangitis.
We searched MEDLINE using the textwords 'PSC', 'treatment', 'UDCA' and retrieved all abstracts from the major Gastroenterology and Liver meetings. We included randomised clinical trials comparing standard or high-dose of UDCA (>15 mg/kg body weight per day) vs. placebo or no intervention. End-points: mortality or liver transplantation, pruritus, fatigue, cholangiocarcinoma and histological progression.
We identified eight randomised clinical trials comprising 567 patients. Five used standard doses and three high doses of UDCA. There was no significant difference in mortality [OR, 0.6 (95% CI, 0.4-1.4)], in pruritus [OR, 1.5 (95% CI, 0.3-7.2)], in fatigue [OR, 0.0 (95% CI, 0.1-7.7)], in cholangiocarcinoma [OR, 1.7 (95% CI, 0.6-5.1)] and in histology stage progression [OR, 0.9 (95% CI, 0.34-2.44)]. No differences were found in the subgroup analyses.
Neither standard nor high-dose UDCA influence favourably the progression of primary sclerosing cholangitis.
原发性硬化性胆管炎患者目前尚无满意的治疗方法。熊去氧胆酸(UDCA)高剂量治疗原发性硬化性胆管炎的临床获益存在争议数据。
通过荟萃分析评估 UDCA(标准剂量或高剂量)是否对原发性硬化性胆管炎有效。
我们使用“PSC”、“治疗”、“UDCA”等词在 MEDLINE 上进行检索,并从主要的胃肠病学和肝脏会议中检索所有摘要。我们纳入了比较标准剂量或高剂量 UDCA(>15mg/kg 体重/天)与安慰剂或不干预的随机临床试验。终点:死亡率或肝移植、瘙痒、疲劳、胆管癌和组织学进展。
我们确定了八项随机临床试验,共纳入 567 名患者。其中五项使用标准剂量,三项使用高剂量 UDCA。死亡率[比值比(OR),0.6(95%置信区间,0.4-1.4)]、瘙痒[OR,1.5(95%置信区间,0.3-7.2)]、疲劳[OR,0.0(95%置信区间,0.1-7.7)]、胆管癌[OR,1.7(95%置信区间,0.6-5.1)]和组织学分期进展[OR,0.9(95%置信区间,0.34-2.44)]均无显著差异。亚组分析也未发现差异。
标准剂量或高剂量 UDCA 均不能改善原发性硬化性胆管炎的进展。