秋水仙碱用于治疗酒精性和非酒精性肝纤维化及肝硬化。
Colchicine for alcoholic and non-alcoholic liver fibrosis and cirrhosis.
作者信息
Rambaldi A, Gluud C
机构信息
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7102, H:S Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark, DK-2100.
出版信息
Cochrane Database Syst Rev. 2005 Apr 18;2005(2):CD002148. doi: 10.1002/14651858.CD002148.pub2.
BACKGROUND
Alcohol and hepatotropic viruses cause the majority of liver cirrhosis cases in the Western World. Colchicine is an anti-inflammatory and anti-fibrotic medication. Several randomised clinical trials have addressed the question whether colchicine has any efficacy in patients with alcoholic or non-alcoholic fibrosis and cirrhosis.
OBJECTIVES
To assess the beneficial and harmful effects of colchicine in patients with alcoholic or non-alcoholic fibrosis or cirrhosis, excluding primary biliary cirrhosis.
SEARCH STRATEGY
The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Controlled Trials Register on The Cochrane Library, MEDLINE, EMBASE, Web of Science, and full text searches were combined (September 2004). Manufacturers and researchers in the field were also contacted.
SELECTION CRITERIA
We included randomised trials irrespective of blinding, language, or publication status comparing per oral colchicine with placebo or no intervention for patients with fibrosis or cirrhosis induced by either alcohol, virus, or unknown factors (cryptogenic).
DATA COLLECTION AND ANALYSIS
The statistical package (RevMan Analyses) provided by The Cochrane Collaboration was used. The methodological quality of the randomised clinical trials was evaluated.
MAIN RESULTS
We could include fifteen randomised clinical trials in which 1714 patients were randomised. We found no significant effects of colchicine on mortality (relative risks (RR) 1.00, 95% confidence interval (CI) 0.87 to 1.16), liver-related mortality (RR 1.08, 95% CI 0.88 to 1.33), complications (RR 1.01, 95% CI 0.74 to 1.38), liver biochemistry, liver histology, and alcohol consumption (RR 1.03, 95% CI 0.77 to 1.39). Colchicine was associated with a significantly increased risk of adverse events (RR 4.35, 95% CI 2.16 to 8.77).
AUTHORS' CONCLUSIONS: Colchicine should not be used for alcoholic, viral, or cryptogenic liver fibrosis or liver cirrhosis outside randomised clinical trials.
背景
在西方世界，酒精和嗜肝病毒是导致大多数肝硬化病例的原因。秋水仙碱是一种抗炎和抗纤维化药物。多项随机临床试验探讨了秋水仙碱对酒精性或非酒精性纤维化及肝硬化患者是否有疗效这一问题。
目的
评估秋水仙碱对酒精性或非酒精性纤维化或肝硬化患者（不包括原发性胆汁性肝硬化）的有益和有害影响。
检索策略
Cochrane肝胆组对照试验注册库、Cochrane图书馆中的Cochrane对照试验注册库、MEDLINE、EMBASE、科学引文索引以及全文检索相结合（2004年9月）。还联系了该领域的制造商和研究人员。
选择标准
我们纳入了随机试验，无论其是否采用盲法、语言或发表状态，比较口服秋水仙碱与安慰剂或不干预措施对酒精、病毒或未知因素（隐源性）引起的纤维化或肝硬化患者的疗效。
数据收集与分析
使用Cochrane协作网提供的统计软件包（RevMan Analyses）。对随机临床试验的方法学质量进行评估。
主要结果
我们纳入了15项随机临床试验，共1714例患者被随机分组。我们发现秋水仙碱对死亡率（相对危险度（RR）1.00，95%置信区间（CI）0.87至1.16）、肝脏相关死亡率（RR 1.08，95%CI 0.88至1.33）、并发症（RR 1.01，95%CI 0.74至1.38）、肝脏生化指标、肝脏组织学以及酒精摄入量（RR 1.03，95%CI 0.77至1.39）均无显著影响。秋水仙碱与不良事件风险显著增加相关（RR 4.35，95%CI 2.16至8.77）。
作者结论
在随机临床试验之外，秋水仙碱不应被用于治疗酒精性、病毒性或隐源性肝纤维化或肝硬化。
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