Ursodeoxycholic acid and/or antibiotics for prevention of biliary stent occlusion

Abstract

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 Cochrane Hepato‐Biliary Group Controlled Trials Register, 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. 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. Ursodeoxycholic acid 和/或抗生素治療以預防膽道支架閉塞 惡性膽管阻塞時，需要在內視鏡下置入支架，作為緩和療法，但經常造成支架閉塞，後續黃疸和/或膽管炎等併發症。支架閉塞可能是因為微生物粘附和膽管淤積而造成的。因此，人們研究抗生素和利膽劑，譬如ursodeoxycholic acid (UDCA)是否可以延長支架的通暢性。 評估對於有膽道狹窄及內視鏡置入支架的患者，UDCA和/或抗生素是否能夠延長支架的通暢性以及病人的存活率。 搜尋截至2001年6月的The Cochrane HepatoBiliary Group Controlled Trials Register ，CochraneLibrary、MEDLINE、Current Contents、EMBASE和CancerLit。檢查已找出之的文章的參考文獻列表，以獲取更多試驗。 考慮收納所有研究UDCA和/或抗生素治療置入膽道支架的病人的隨機或准隨機臨床試驗。 不受盲法、語言和發表狀態的限制。 兩位回顧作者獨立收那試驗，評估品質，摘錄數據。 我們聯繫主要的研究人員，獲取更多的資訊。 使用hazard ratio合併存活率資料 (以及95% 信賴區間 (95% CI))。 共包括5個非盲法隨機試驗，包括惡性膽管狹窄而有聚乙烯支架的258位病人。3個試驗研究UDCA合併抗生素治療比照無藥物治療，包括152 位病人參加。3個試驗的統合分析指出，在支架通暢性的持續時間(hazard ratio (隨機效果模式) 0.58, 95% CI 0.22 1.54)和死亡率 (hazard ratio (固定效果模式) 0.99, 95% CI 0.68 1.43)等方面，該療法沒有明顯治療效果。共有2個針對抗生素比照無藥物治療的試驗，包括106位病人，其中一個試驗合併抗生素和rowachol (薄荷“家族的一種“替代性”藥物)。 合併2個試驗的結果之後，顯示抗生素對於支架通暢性的持續時間(hazard ratio (固定效果模式) 0.69 (95% CI 0.37 1.30))或死亡率(hazard ratio (固定效果模式) 1.23 (95% CI 0.72 2.08)沒有顯著作用。沒有獲取住院日、膽管炎發生頻率、感染併發症的機率，抗生素抗性細菌菌株的選擇等相關資料。 根據已有的隨機臨床試驗UDCA和/或抗生素治療無法被建議用於避免膽道支架在膽道惡性狹窄的病人中發生閉塞。需要進一步採用穩健方法和有充分的統計學檢力(power)的試驗來求證。 此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。 ursodeoxycholic acid和/或抗生素避免膽道支架閉塞的作用還有待證據支持。 膽道惡性閉塞可以透過插入一個支架來緩和症狀，使膽汁通行。但是，支架通常會閉塞。本次文獻回顧是否ursodeoxycholic acid和/或抗生素可以避免膽道支架閉塞。目前沒有充足的證據建議ursodeoxycholic acid和/或抗生素用於治療置入膽道支架的病人。