Intervention Review

Pharmacological interventions to decrease blood loss and blood transfusion requirements for liver resection

  1. Kurinchi Selvan Gurusamy*,
  2. Jun Li,
  3. Dinesh Sharma,
  4. Brian R Davidson

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 7 OCT 2009

Assessed as up-to-date: 7 NOV 2008

DOI: 10.1002/14651858.CD008085


How to Cite

Gurusamy KS, Li J, Sharma D, Davidson BR. Pharmacological interventions to decrease blood loss and blood transfusion requirements for liver resection. Cochrane Database of Systematic Reviews 2009, Issue 4. Art. No.: CD008085. DOI: 10.1002/14651858.CD008085.

Author Information

  1. Royal Free Hospital and University College School of Medicine, University Department of Surgery, London, UK

*Kurinchi Selvan Gurusamy, University Department of Surgery, Royal Free Hospital and University College School of Medicine, 9th Floor, Royal Free Hospital, Pond Street, London, NW3 2QG, UK. kurinchi2k@hotmail.com.

Publication History

  1. Publication Status: New
  2. Published Online: 7 OCT 2009

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Blood loss during liver resection is one of the most important factors affecting the peri-operative outcomes of patients undergoing liver resection.

Objectives

To determine the benefits and harms of pharmacological interventions to decrease blood loss and to decrease allogeneic blood transfusion requirements in patients undergoing liver resections.

Search methods

We searched 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 until November 2008 for identifying the randomised trials.

Selection criteria

We included all randomised clinical trials comparing various pharmacological interventions aimed at decreasing blood loss and allogeneic blood transfusion requirements in liver resection. Trials were included irrespective of whether they included major or minor liver resections, normal or cirrhotic livers, vascular occlusion was used or not, and irrespective of the reason for liver resection.

Data collection and analysis

Two authors independently identified trials for inclusion and independently extracted data. We analysed the data with both the fixed-effect and the random-effects models using RevMan Analysis. For each outcome we calculated the risk ratio (RR), mean difference (MD), or standardised mean difference with 95% confidence intervals (CI) based on intention-to-treat analysis or available case-analysis. For dichotomous outcomes with only one trial included under the outcome, we performed the Fisher's exact test.

Main results

Six trials involving 849 patients satisfied the inclusion criteria. Pharmacological interventions included aprotinin, desmopressin, recombinant factor VIIa, antithrombin III, and tranexamic acid. One or two trials could be included under most comparisons. All trials had a high risk of bias. There was no significant difference in the peri-operative mortality, survival at maximal follow-up, liver failure, or other peri-operative morbidity. The risk ratio of requiring allogeneic blood transfusion was significantly lower in the aprotinin and tranexamic acid groups than the respective control groups. Other interventions did not show significant decreases of allogeneic transfusion requirements.

Authors' conclusions

None of the interventions seem to decrease peri-operative morbidity or offer any long-term survival benefit. Aprotinin and tranexamic acid show promise in the reduction of blood transfusion requirements in liver resection surgery. However, there is a high risk of type I (erroneously concluding that an intervention is beneficial when it is actually not beneficial) and type II errors (erroneously concluding that an intervention is not beneficial when it is actually beneficial) because of the few trials included, the small sample size in each trial, and the high risk of bias. Further randomised clinical trials with low risk of bias and random errors assessing clinically important outcomes such as peri-operative mortality are necessary to assess any pharmacological interventions aimed at decreasing blood loss and blood transfusion requirements in liver resections. Trials need to be designed to assess the effect of a combination of different interventions in liver resections.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Aptrotinin and tranexamic acid may show promise in decreasing blood loss and blood transfusion requirements

Blood loss during liver resection (partial removal of liver) is one of the important factors affecting the post-operative complications of patients. Allogeneic blood transfusion (using blood donated by a different individual) is associated with increased morbidity and lower survival in patients with liver cancer. This systematic review was aimed at determining whether any medical treatment decreased blood loss and decreased allogeneic blood transfusion requirements in patients undergoing liver resections. This systematic review included six trials with 849 patients. All trials had high risk of bias ('systematic error') as well of play of chance ('random error'). The trials included comparison of medicines (such as aprotinin, desmopressin, recombinant factor VIIa, antithrombin III, and tranexamic acid) with controls (no medicines). There was no difference in the death or complications due to surgery or long-term survival in any of the comparisons. Fewer patients required transfusion of blood donated by others when aprotinin or tranexamic acid were compared to controls not receiving the interventions. The other comparisons did not decrease the transfusion requirements. However, there is a high risk of type I errors (erroneously concluding that an intervention is beneficial when it is actually not beneficial) and type II errors (erroneously concluding that an intervention is not beneficial when it is actually beneficial) because of the few trials included and the small sample size in each trial as well as the inherent risk of bias (systematic errors). Aprotinin and tranexamic acid show promise in the reduction of blood transfusion requirements in liver resections. Further randomised clinical trials with low risk of bias (systematic errors) and low risk of play of chance (random errors) which assess clinically important outcomes (such as death and complications due to operation) are necessary to assess any pharmacological interventions aimed at decreasing blood transfusion and blood transfusion requirements in liver resections. Trials need to be designed to assess the effect of a combination of different interventions in liver resections.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

減少肝切除時的失血和輸血需求的藥物處置

肝切除時失血量是影響患者肝切除前後結果最重要因素之一。

目標

確定以藥物減少患者接受肝切除術失血量及異體輸血需求的利弊。

搜尋策略

我們搜尋Cochrane Library資料庫中的Cochrane HepatoBiliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials及MEDLINE、EMBASE,Science Citation Index Expanded等資料庫2008年11月前的隨機試驗。

選擇標準

我們收納所有比較不同藥物減少肝切除時的失血和異體輸血需求的隨機臨床實驗。而肝臟切除的大小、是否肝硬化、是否使用血管閉合,以及肝切除的原因都不在考量範圍。

資料收集與分析

由兩位作者獨立決定欲收納的試驗及擷取數據資料。我們使用RevMan分析軟體以固定效果模型和隨機效果模型分析這些數據。對於每個結果,我們依治療意向分析或可獲得觀察體分析,計算95%信賴區間(CI)的風險比(RR)、平均差(MD)或標準平均差。對於歧異性的分析結果,我們則使用費氏精確檢定。

主要結論

共6項符合收案條件的試驗,有849位患者參與。使用藥物包括aprotinin、desmopressin、recombinant factor VIIa、antithrombin III及tranexamic acid。其中有一項或兩項試驗可用於大部份的比較。所有的試驗都有高度偏差風險。這些試驗的週術期死亡率、最長追蹤期的存活率、肝衰竭或其它週術期發病率並無重大差異性。使用Aprotin及tranexamic acid患者之異體輸血需求的風險率遠比各自的對照組來得低。而其它藥物並不能有效減少患者對異體輸血的需求。

作者結論

這些藥物似乎都無法減少週術期的發病率或增加患者長期存活率。不過Aprotinin及tranexamic acid顯示可有效減少進行肝切除術患者的異體輸血需求。不過,因所包含的試驗數量太少、試驗樣本數量太少及高偏差風險,會產生第一型誤差(誤以為某一藥物介入是有益的而實際上卻是無益的)及第二型誤差(誤以為某一藥物介入是無益的而實際上卻是有益)的高風險。所以還是需要進行具低偏差風險及低隨機錯誤的隨機臨床試驗,以評估重要的臨床結果,像是週術期死亡率,來估計所施用之藥物是否能減少肝切除時的失血和異體輸血需求。還需要另行設計試驗,以評估不同藥物的結合所可能產生的結果。

翻譯人

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

Aprotinin及tranexamic acid顯示可有效減少失血及異體輸血需求 進行肝切除術(切除部份的肝臟)時的失血情況是影響患者術後是否產生併發症的重要因素之一。異體輸血(使用別人捐贈的血液)會增加肝癌患者的發病率及降低其存活率。此系統性文獻回顧旨在測定任何的診療是否能減少接受肝切除術患者失血的情況並且減少其異體輸血的需求。此系統性文獻回顧包括有849位患者參與的6項試驗。所有的試驗都有偏差(系統誤差)及機率(隨機誤差)的高風險。這些試驗包括了有服用藥物的實驗組(像是服用aprotinin,desmopressin 、recombinant factor VIIa、antithrombin III及tranexamic acid)與對照組(沒有服用藥物)的比較。這兩組在手術的致死率或併發症或長期存活率上並無差異。與對照組相較,服用aprotinin或tranexamic acid的患者較少需要進行異體輸血。而服用其它藥物的患者其輸血的需求與對照組相較並沒有差別。因所包含的試驗數量太少、每項試驗的樣本數量太少及偏差的固有風險(系統誤差),所以會產生第一型誤差(誤以為某一藥物介入是有益的而實際上卻是無益的)及第二型誤差(誤以為某一藥物介入是無益的而實際上卻是有益)的高風險。Aprotinin和tranexamic acid顯示可有效減少肝切除患者的輸血需求。而進一步進行低偏差風險(系統錯誤)及低機率風險(隨機錯誤)的隨機臨床試驗,以評估重要的臨床結果(像是手術的致死率及併發症)是必要的,以便估計所施用之藥物是否能有效減少肝切除時的失血和異體輸血需求。需要另行設計可評估不同藥物的結合所可能產生之結果的試驗。