Galandi D, Schwarzer G, Bassler D, Allgaier H P
Department for Gastroenterology and Hepatology, University Hospital Freiburg, Hugstetter Strasse 55, Freiburg, Germany.
Cochrane Database Syst Rev. 2002;2002(3):CD003043. doi: 10.1002/14651858.CD003043.
Malignant biliary obstruction, which requires endoscopic stenting as palliative therapy, is often complicated by clogging of the stent with subsequent jaundice and/or cholangitis. Stent clogging may be caused by microbiological adhesion and biliary stasis. Therefore, antibiotics and choleretic agents like ursodeoxycholic acid (UDCA) have been investigated to see whether they prolong stent patency.
To evaluate if UDCA and/or antibiotics may prolong stent patency and survival in patients with strictures of the biliary tract and endoscopically inserted stents.
The Trials Register of The Cochrane Hepato-Biliary Group, The Cochrane Library, MEDLINE, Current Contents, EMBASE, and CancerLit were searched until June 2001. Reference lists of the identified articles were checked for further trials.
All randomised or quasi-randomised clinical trials investigating UDCA and/or antibiotics in patients with biliary stents were considered for inclusion, regardless of blinding, language, and publication status.
Trial inclusion, quality assessment, and data extraction were performed independently by two reviewers. Principal investigators were contacted for further information. Survival data were combined by using hazard ratios (with 95% confidence interval (95% CI)).
Five non-blinded randomised trials with 258 patients with malignant strictures treated with polyethylene stents were included. Three trials, including 152 patients, investigated a combination of UDCA and antibiotics versus no treatment. The meta-analysis of these three trials does not show a significant treatment effect on the duration of stent patency (hazard ratio (random effects model) 0.58, 95% CI 0.22 to 1.54) or mortality (hazard ratio (fixed effect model) 0.99, 95% CI 0.68 to 1.43). Two trials with 106 patients compared antibiotics with no treatment, one of these trials used a combination of antibiotics and rowachol (an 'alternative' drug of the 'mint' family). The pooled results of these two trials do not show significant effects of antibiotics on the duration of stent patency (hazard ratio (fixed effect model) 0.69 (95% CI 0.37 to 1.30)) or mortality (hazard ratio (fixed effect model) 1.23 (95% CI 0.72 to 2.08). Data concerning duration of hospital stay, frequency of cholangitis, and rate of infectious complications due to selection of antibiotic resistant bacteria strains were not available.
REVIEWER'S CONCLUSIONS: Treatment with UDCA and/or antibiotics to prevent clogging of biliary stents in patients with malignant stricture of the biliary tract cannot be recommended routinely on the basis of the existing randomised clinical trials. Further trials are needed with rigorous methodology and sufficient statistical power.
恶性胆管梗阻常需内镜下支架置入作为姑息治疗，其常因支架堵塞继而出现黄疸和/或胆管炎等并发症。支架堵塞可能由微生物黏附和胆汁淤积引起。因此，已对抗生素和熊去氧胆酸（UDCA）等利胆剂进行研究，以观察它们是否能延长支架通畅时间。
评估UDCA和/或抗生素能否延长胆管狭窄且内镜置入支架患者的支架通畅时间和生存期。
检索了Cochrane肝胆组试验注册库、Cochrane图书馆、医学索引在线数据库（MEDLINE）、《现刊目次》、荷兰医学文摘数据库（EMBASE）和癌症文献数据库（CancerLit），检索截至2001年6月。对已识别文章的参考文献列表进行检查以查找更多试验。
纳入所有调查UDCA和/或抗生素用于胆管支架置入患者的随机或半随机临床试验，无论是否设盲、语言及发表状态如何。
两名评价者独立进行试验纳入、质量评估和数据提取。与主要研究者联系以获取更多信息。生存数据采用风险比（及95%置信区间（95%CI））进行合并。
纳入了5项非设盲随机试验，共258例接受聚乙烯支架治疗的恶性狭窄患者。3项试验（共152例患者）研究了UDCA与抗生素联合治疗对比未治疗的情况。这3项试验的Meta分析未显示对支架通畅持续时间（风险比（随机效应模型）0.58，95%CI 0.22至1.54）或死亡率（风险比（固定效应模型）0.99，95%CI 0.68至1.43）有显著治疗效果。2项试验（共106例患者）对比了抗生素治疗与未治疗的情况，其中1项试验使用了抗生素与消胆胺（薄荷家族的一种“替代”药物）的联合治疗。这2项试验的汇总结果未显示抗生素对支架通畅持续时间（风险比（固定效应模型）0.69（95%CI 0.37至1.30））或死亡率（风险比（固定效应模型）1.23（95%CI 0.72至2.08））有显著影响。关于住院时间、胆管炎发生频率以及因选择抗生素耐药菌株导致的感染并发症发生率的数据不可得。
基于现有随机临床试验，不建议常规使用UDCA和/或抗生素治疗来预防胆管恶性狭窄患者的胆管支架堵塞。需要采用严格方法和足够统计学效力进行进一步试验。
