Terlipressin for acute esophageal variceal hemorrhage

Abstract
Terlipressin (triglycyl lysine vasopressin) is a synthetic analogue of vasopressin, which has been used in the treatment of acute variceal haemorrhage. In contrast to vasopressin, terlipressin can be administered as intermittent injections instead of continuous intravenous infusion and it has a safer adverse reactions profile. However, its effectiveness remains uncertain. To determine if treatment with terlipressin improves outcome in acute oesophageal variceal haemorrhage and is safe. Randomized clinical trials were identified by searching the following databases (November 1999): The Cochrane Hepato‐Biliary Group Controlled Trials Register, The Cochrane Controlled Trials Register on The Cochrane Library (Issue 3, 1999), MEDLINE, EMBASE, Biosis, and Current Contents. The bibliographies of identified publications were checked. Experts in the field and the manufacturers of terlipressin were contacted. For the update of this review, no new randomised clinical trials were identified on any of the databases (October 2002). All randomised clinical trials, which compared terlipressin with: (a) placebo or no treatment, (b) balloon tamponade, (c) endoscopic treatment, (d) octreotide, (e) somatostatin and (f) vasopressin, in the setting of acute variceal haemorrhage. Eligibility, trial quality assessment and data extraction were done independently by two reviewers. The primary outcome measure was mortality. Secondary outcomes were failure of initial haemostasis, rebleeding, procedures required for uncontrolled bleeding or rebleeding, transfusion requirements and length of hospitalisation. Twenty studies were identified for all the comparison groups, involving 1609 patients. There were seven studies (with 443 patients) comparing terlipressin to placebo, five of which were considered to be high quality studies based on the Jadad scale. The meta‐analysis indicates that terlipressin was associated with a statistically significant reduction in all cause mortality compared to placebo (relative risk 0.66, 95% confidence interval 0.49 to 0.88). Three studies (with 302 patients) were identified comparing terlipressin to somatostatin, two of which were high quality studies; only one high quality study (219 patients) comparing terlipressin to endoscopic treatment was identified. Within the limited power provided by these small numbers of patients, no statistically significant difference was demonstrated between terlipressin and either somatostatin or endoscopic treatment in any of the outcomes. For the remaining comparison groups (terlipressin versus balloon tamponade, terlipressin versus octreotide, and terlipressin versus vasopressin) only small, low quality studies were identified and no difference was demonstrated in any of the major outcomes. There was no significant difference between the terlipressin group and any of the comparison groups in the number of adverse events that caused death or withdrawal of medication. On the basis of a 34% relative risk reduction in mortality, terlipressin should be considered to be effective in the treatment of acute variceal hemorrhage. Further, since no other vasoactive agent has been shown to reduce mortality in single studies or meta‐analyses, terlipressin might be the vasoactive agent of choice in acute variceal bleeding. 以Terlipressin治療急性食管靜脈曲張出血 Terlipressin(triglycyl lysine vasopressin)是垂體後葉荷爾蒙(vasopressin)的合成物,用來治療急性靜脈曲張出血。相較於垂體後葉荷爾蒙,Terlipressin可以通過間歇性注射的方法給與,代替持續性靜脈內灌注,具有較安全的不良反應,但是,該藥物的有效性還不是非常明確。 判定Terlipressin是否改善急性食管靜脈曲張出血的結果(outcome)及其安全性。 透過研究下列資料庫(1999年9月),確定隨機臨床試驗:The Cochrane HepatoBiliary Group Controlled Trials Register, Cochrane Library的The Cochrane HepatoBiliary Group Controlled Trials Register (1999年第3期)、MEDLINE、EMBASE、Biosis和Current Contents。檢閱已找出之的發表文章的書目。 聯繫該領域的專家和Terlipressin廠商。 為了更新本次文獻回顧,直到2002年10月為止沒有從任何的資料庫找到新的隨機臨床試驗。 所有在急性靜脈曲張出血的情況下使用Terlipressin對照下列療法的隨機臨床試驗: (a) 安慰劑或無治療、(b) 氣囊填塞法、(c)內視鏡治療、(d) octreotide、(e) 生長激素抑制素(somatostatin)、(f) 垂體後葉荷爾蒙。 兩位回顧作者獨立評估試驗的合格性、試驗品質、並且摘錄數據。主要結果測量值是死亡率。次要結果是初步止血失敗、再出血、無法控制的出血或再出血所需的進一步治療,輸血需求和住院天數。 所有控制組一共找到20個研究,共1609 位病人。有7個研究 (443位病人)比較Terlipressin和安慰劑,根據Jadad量表,5個研究被認為屬於品質較高。統合分析指出,和安慰劑相比,Terlipressin可以明顯降低所有原因造成的死亡率 ((relative risk 0.66, 95% CI 0.49 0.88)。有3個研究比較Terlipressin和生長激素抑制素 (302位病人),其中2個研究具有較高的品質;只有一個品質較高的研究比較(219 位病人)Terlipressin和內視鏡治療。在病人數量較少的有限檢力(power)範圍內,Terlipressin和生長激素抑制素或內視鏡治療沒有在任何結果上顯示有統計上顯著的差異。其餘對照組被確定為研究規模小、品質低,包括Terlipressin對照氣囊填塞法,Terlipressin對照octreotideTerlipressin對照垂體後葉荷爾蒙,在所有主要結果方面沒有顯示有差異。 Terlipressin組和所有對照組在引起死亡或治療中斷等不良事件的數量方面,沒有顯著差異。...

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