D'Amico Gennaro, Pagliaro Luigi, Pietrosi Giada, Tarantino Ilaria
Gastroenterology Unit, Ospedale V Cervello, Via Trabucco 180, Palermo, Italy, 90146.
Cochrane Database Syst Rev. 2010 Mar 17;2010(3):CD002233. doi: 10.1002/14651858.CD002233.pub2.
Emergency sclerotherapy is still widely used as a first line therapy for variceal bleeding in patients with cirrhosis, particularly when banding ligation is not available or feasible. However, pharmacological treatment may stop bleeding in the majority of these patients.
To assess the benefits and harms of emergency sclerotherapy versus vasoactive drugs for variceal bleeding in cirrhosis.
Search of trials was based on The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded through January 2010.
Randomised clinical trials comparing sclerotherapy with vasoactive drugs (vasopressin (with or without nitroglycerin), terlipressin, somatostatin, or octreotide) for acute variceal bleeding in cirrhotic patients.
Outcome measures were failure to control bleeding, five-day treatment failure, rebleeding, mortality, number of blood transfusions, and adverse events. Data were analysed by a random-effects model according to the vasoactive treatment. Sensitivity analyses included combined analysis of all the trials irrespective of the vasoactive drug, type of publication, and risk of bias.
Seventeen trials including 1817 patients were identified. Vasoactive drugs were vasopressin (one trial), terlipressin (one trial), somatostatin (five trials), and octreotide (ten trials). No significant differences were found comparing sclerotherapy with each vasoactive drug for any outcome. Combining all the trials irrespective of the vasoactive drug, the risk differences (95% confidence intervals) were failure to control bleeding -0.02 (-0.06 to 0.02), five-day failure rate -0.05 (-0.10 to 0.01), rebleeding 0.01 (-0.03 to 0.05), mortality (17 randomised trials, 1817 patients) -0.02 (-0.06 to 0.02), and transfused blood units (8 randomised trials, 849 patients) (weighted mean difference) -0.24 (-0.54 to 0.07). Adverse events 0.08 (0.03 to 0.14) and serious adverse events 0.05 (0.02 to 0.08) were significantly more frequent with sclerotherapy.
AUTHORS' CONCLUSIONS: We found no convincing evidence to support the use of emergency sclerotherapy for variceal bleeding in cirrhosis as the first, single treatment when compared with vasoactive drugs. Vasoactive drugs may be safe and effective whenever endoscopic therapy is not promptly available and seems to be associated with less adverse events than emergency sclerotherapy. Other meta-analyses and guidelines advocate that combined vasoactive drugs and endoscopic therapy is superior to either intervention alone.
紧急硬化疗法仍然广泛用作肝硬化患者静脉曲张出血的一线治疗方法,尤其是在无法进行或不可行套扎结扎术时。然而,药物治疗可能使这些患者中的大多数止血。
评估紧急硬化疗法与血管活性药物治疗肝硬化静脉曲张出血的利弊。
检索试验的依据是截至2010年1月的Cochrane肝胆组对照试验注册库、Cochrane图书馆中的Cochrane系统评价数据库(CENTRAL)、MEDLINE、EMBASE和科学引文索引扩展版。
比较硬化疗法与血管活性药物(加压素(加或不加硝酸甘油)、特利加压素、生长抑素或奥曲肽)治疗肝硬化患者急性静脉曲张出血的随机临床试验。
结局指标为出血控制失败、五日治疗失败、再出血、死亡率、输血量和不良事件。根据血管活性治疗,采用随机效应模型分析数据。敏感性分析包括对所有试验进行综合分析,而不考虑血管活性药物、出版物类型和偏倚风险。
共纳入17项试验,涉及1817例患者。血管活性药物有加压素(1项试验)、特利加压素(1项试验)、生长抑素(5项试验)和奥曲肽(10项试验)。硬化疗法与每种血管活性药物在任何结局方面均未发现显著差异。综合所有试验,不考虑血管活性药物,风险差异(95%置信区间)为出血控制失败-0.02(-0.06至0.02)、五日失败率-0.05(-0.10至0.01)、再出血0.01(-0.03至0.05)、死亡率(17项随机试验,1817例患者)-0.02(-0.06至0.02)以及输血量(8项随机试验,849例患者)(加权均数差)-0.24(-0.54至0.07)。硬化疗法的不良事件0.08(0.03至0.14)和严重不良事件0.05(0.02至0.08)明显更常见。
我们没有找到令人信服的证据支持在肝硬化静脉曲张出血时将紧急硬化疗法作为首选单一治疗方法,与血管活性药物相比。当无法及时进行内镜治疗时,血管活性药物可能安全有效,而且似乎比紧急硬化疗法的不良事件更少。其他荟萃分析和指南主张血管活性药物与内镜治疗联合使用优于单独任何一种干预措施。