De Lédinghen V, Person B, Legoux J L, Le Sidaner A, Desaint B, Greef M, Moesch C, Grollier G, Ingrand P, Sautereau D, Beauchant M
Centre Hospitalier Universitaire, Poitiers, France.
Dig Dis Sci. 2000 Jan;45(1):145-50. doi: 10.1023/a:1005429914955.
We report a prospective randomized multicenter trial that tested the efficacy of combining ursodeoxycholic acid and norfloxacin in the prevention of polyethylene stent clogging in patients with obstructive jaundice due to an unresectable malignancy at the level of the common bile duct. After insertion of a 10-Fr straight polyethylene stent, patients were allocated to receive oral treatment with ursodeoxycholic acid and norfloxacin, or conservative treatment. The primary outcome measure was stent blockage within six months. Thirty-three patients (group I) received ursodeoxycholic acid and norfloxacin, and 29 received conservative treatment (group II). At six months, cumulative stent patency rate did not differ significantly between group I (47+/-11%, mean +/- SE, median 149 days) and group II patients (24+/-10%, mean +/- SE, median 100 days, P = 0.23, log-rank test). Four stents were clogged by ursodeoxycholic acid. Survival did not differ between the two groups. Combined therapy with ursodeoxycholic acid and norfloxacin failed to improve stent patency. Moreover, ursodeoxycholic acid can cause stent obstruction.
我们报告了一项前瞻性随机多中心试验，该试验测试了熊去氧胆酸和诺氟沙星联合使用在预防因不可切除的胆总管恶性肿瘤导致梗阻性黄疸患者的聚乙烯支架堵塞方面的疗效。在插入10F直型聚乙烯支架后，患者被分配接受熊去氧胆酸和诺氟沙星的口服治疗或保守治疗。主要结局指标是6个月内支架堵塞情况。33例患者（I组）接受了熊去氧胆酸和诺氟沙星治疗，29例接受了保守治疗（II组）。6个月时，I组患者（47±11%，均值±标准误，中位数149天）和II组患者（24±10%，均值±标准误，中位数100天）的累积支架通畅率差异无统计学意义（P = 0.23，对数秩检验）。有4个支架被熊去氧胆酸堵塞。两组患者的生存率无差异。熊去氧胆酸和诺氟沙星联合治疗未能提高支架通畅率。此外，熊去氧胆酸可导致支架阻塞。
