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肝切除术中减少失血的方法:一项网状Meta分析

Methods to decrease blood loss during liver resection: a network meta-analysis.

作者信息

Simillis Constantinos, Li Tianjing, Vaughan Jessica, Becker Lorne A, Davidson Brian R, Gurusamy Kurinchi Selvan

机构信息

Department of Surgery, Royal Free Campus, UCL Medical School, Royal Free Hospital, Rowland Hill Street, London, UK, NW3 2PF.

出版信息

Cochrane Database Syst Rev. 2014 Apr 2(4):CD010683. doi: 10.1002/14651858.CD010683.pub2.

Abstract

BACKGROUND

Liver resection is a major surgery with significant mortality and morbidity. Various methods have been attempted to decrease blood loss and morbidity during elective liver resection. These methods include different methods of vascular occlusion, parenchymal transection, and management of the cut surface of the liver. A surgeon typically uses only one of the methods from each of these three categories. Together, one can consider this combination as a treatment strategy. The optimal treatment strategy for liver resection is unknown.

OBJECTIVES

To assess the comparative benefits and harms of different treatment strategies that aim to decrease blood loss during elective liver resection.

SEARCH METHODS

We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and Science Citation Index Expanded to July 2012 to identify randomised clinical trials. We also handsearched the references lists of identified trials.

SELECTION CRITERIA

We included only randomised clinical trials (irrespective of language, blinding, or publication status) where the method of vascular occlusion, parenchymal transection, and management of the cut surface were clearly reported, and where people were randomly assigned to different treatment strategies based on different combinations of the three categories (vascular occlusion, parenchymal transection, cut surface).

DATA COLLECTION AND ANALYSIS

Two review authors identified trials and collected data independently. We assessed the risk of bias using The Cochrane Collaboration's methodology. We conducted a Bayesian network meta-analysis using the Markov chain Monte Carlo method in WinBUGS 1.4 following the guidelines of the National Institute for Health and Care Excellence Decision Support Unit guidance documents. We calculated the odds ratios (OR) with 95% credible intervals (CrI) (which are similar to confidence intervals in the frequentist approach for meta-analysis) for the binary outcomes and mean differences (MD) with 95% CrI for continuous outcomes using a fixed-effect model or random-effects model according to model-fit.

MAIN RESULTS

We identified nine trials with 617 participants that met our inclusion criteria. Interventions in the trials included three different options for vascular occlusion, four for parenchymal transection, and two for management of the cut liver surface. These interventions were combined in different ways in the trials giving 11 different treatment strategies. However, we were only able to include 496 participants randomised to seven different treatment strategies from seven trials in our network meta-analysis, because the treatment strategies from the trials that used fibrin sealant for management of the raw liver surface could not be connected to the network for any outcomes. Thus, the trials included in the network meta-analysis varied only in their approaches to vascular exclusion and parenchymal transection and none used fibrin sealant. All the trials were of high risk of bias and the quality of evidence was very low for all the outcomes. The differences in mortality between the different strategies was imprecise (seven trials; seven treatment strategies; 496 participants). Five trials (six strategies; 406 participants) reported serious adverse events. There was an increase in the proportion of people with serious adverse events when surgery was performed using radiofrequency dissecting sealer compared with the standard clamp-crush method in the absence of vascular occlusion and fibrin sealant. The OR for the difference in proportion was 7.13 (95% CrI 1.77 to 28.65; 15/49 (adjusted proportion 24.9%) in radiofrequency dissecting sealer group compared with 6/89 (6.7%) in the clamp-crush method). The differences in serious adverse events between the other groups were imprecise. There was a high probability that 'no vascular occlusion with clamp-crush method and no fibrin' and 'intermittent vascular occlusion with Cavitron ultrasonic surgical aspirator and no fibrin' are better than other treatments with regards to serious adverse events. Quality of life was not reported in any of the trials.The differences in the proportion of people requiring blood transfusion was imprecise (six trials; seven treatments; 446 participants). Two trials (three treatments; 155 participants) provided data for quantity of blood transfused. People undergoing liver resection by intermittent vascular occlusion had higher amounts of blood transfused than people with continuous vascular occlusion when the parenchymal transection was carried out with the clamp-crush method and no fibrin sealant was used for the cut surface (MD 1.2 units; 95% CrI 0.08 to 2.32). The differences in the other comparisons were imprecise (very low quality evidence). Three trials (four treatments; 281 participants) provided data for operative blood loss. People undergoing liver resection using continuous vascular occlusion had lower blood loss than people with no vascular occlusion when the parenchymal transection was carried out with clamp-crush method and no fibrin sealant was used for the cut surface (MD -130.9 mL; 95% CrI -255.9 to -5.9). None of the trials reported the proportion of people with major blood loss.The differences in the length of hospital stay (six trials; seven treatments; 446 participants) and intensive therapy unit stay (four trials; six treatments; 261 participants) were imprecise. Four trials (four treatments; 245 participants) provided data for operating time. Liver resection by intermittent vascular occlusion took longer than liver resection performed with no vascular occlusion when the parenchymal transection was carried out with Cavitron ultrasonic surgical aspirator and no fibrin sealant was used for the cut surface (MD 49.6 minutes; 95% CrI 29.8 to 69.4). The differences in the operating time between the other comparisons were imprecise. None of the trials reported the time needed to return to work.

AUTHORS' CONCLUSIONS: Very low quality evidence suggested that liver resection using a radiofrequency dissecting sealer without vascular occlusion or fibrin sealant may increase serious adverse events and this should be evaluated in further randomised clinical trials. The risk of serious adverse events with liver resection using no special equipment compared with more complex methods requiring special equipment was uncertain due to the very low quality of the evidence. The credible intervals were wide and considerable benefit or harm with a specific method of liver resection cannot be ruled out.

摘要

背景

肝切除术是一项具有较高死亡率和发病率的大型手术。人们尝试了各种方法来减少择期肝切除术中的失血和发病率。这些方法包括不同的血管阻断、实质离断以及肝切面处理方法。外科医生通常在这三类方法中各仅使用一种。综合起来,可以将这种组合视为一种治疗策略。肝切除术的最佳治疗策略尚不清楚。

目的

评估旨在减少择期肝切除术中失血的不同治疗策略的相对益处和危害。

检索方法

我们检索了截至2012年7月的Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、EMBASE和科学引文索引扩展版,以识别随机临床试验。我们还手工检索了已识别试验的参考文献列表。

选择标准

我们仅纳入随机临床试验(无论语言、盲法或发表状态如何),其中血管阻断、实质离断和肝切面处理方法均有明确报告,且根据这三类(血管阻断、实质离断、肝切面)的不同组合将患者随机分配至不同治疗策略。

数据收集与分析

两位综述作者独立识别试验并收集数据。我们使用Cochrane协作网的方法评估偏倚风险。我们按照英国国家卫生与临床优化研究所决策支持单位指南文件的指导方针,在WinBUGS 1.4中使用马尔可夫链蒙特卡罗方法进行贝叶斯网络荟萃分析。对于二分类结局,我们计算了比值比(OR)及其95%可信区间(CrI)(类似于频率学派荟萃分析中的置信区间),对于连续结局,我们使用固定效应模型或随机效应模型根据模型拟合情况计算了平均差(MD)及其95% CrI。

主要结果

我们识别出9项试验,共617名参与者符合我们的纳入标准。试验中的干预措施包括血管阻断的3种不同选择、实质离断的4种选择以及肝切面处理的2种选择。这些干预措施在试验中以不同方式组合,产生了11种不同的治疗策略。然而,在我们的网络荟萃分析中,我们仅能纳入来自7项试验的随机分配至7种不同治疗策略的496名参与者,因为使用纤维蛋白封闭剂处理肝创面的试验中的治疗策略在任何结局方面均无法与网络相连。因此,纳入网络荟萃分析的试验仅在血管阻断和实质离断方法上存在差异,且均未使用纤维蛋白封闭剂。所有试验的偏倚风险均较高,所有结局的证据质量均非常低。不同策略之间的死亡率差异不精确(7项试验;7种治疗策略;496名参与者)。5项试验(6种策略;406名参与者)报告了严重不良事件。在未进行血管阻断且未使用纤维蛋白封闭剂的情况下,与标准钳夹压榨法相比,使用射频解剖密封器进行手术时严重不良事件的发生率有所增加。差异的OR为7.13(95% CrI 1.77至28.65;射频解剖密封器组为15/49(调整比例24.9%),钳夹压榨法组为6/89(6.7%))。其他组之间严重不良事件的差异不精确。就严重不良事件而言,“钳夹压榨法且无纤维蛋白且无血管阻断”和“Cavitron超声手术吸引器间歇性血管阻断且无纤维蛋白”极有可能优于其他治疗方法。所有试验均未报告生活质量。需要输血的人群比例差异不精确(6项试验;7种治疗;446名参与者)。2项试验(3种治疗;155名参与者)提供了输血量数据。当使用钳夹压榨法进行实质离断且未使用纤维蛋白封闭剂处理肝切面时,间歇性血管阻断进行肝切除的患者输血量高于持续性血管阻断的患者(MD 1.2单位;95% CrI 0.08至2.32)。其他比较中的差异不精确(证据质量非常低)。3项试验(4种治疗;281名参与者)提供了术中失血量数据。当使用钳夹压榨法进行实质离断且未使用纤维蛋白封闭剂处理肝切面时,持续性血管阻断进行肝切除的患者失血量低于未进行血管阻断的患者(MD -130.9 mL;95% CrI -255.9至-5.9)。所有试验均未报告大出血患者的比例。住院时间(6项试验;7种治疗;446名参与者)和重症监护病房住院时间(4项试验;6种治疗;261名参与者)的差异不精确。4项试验(4种治疗;245名参与者)提供了手术时间数据。当使用Cavitron超声手术吸引器进行实质离断且未使用纤维蛋白封闭剂处理肝切面时,间歇性血管阻断进行肝切除的时间长于未进行血管阻断的肝切除(MD 49.6分钟;95% CrI 29.8至69.4)。其他比较中的手术时间差异不精确。所有试验均未报告恢复工作所需时间。

作者结论

质量极低的证据表明,在未进行血管阻断或未使用纤维蛋白封闭剂的情况下使用射频解剖密封器进行肝切除可能会增加严重不良事件,这应在进一步的随机临床试验中进行评估。由于证据质量极低,与使用需要特殊设备的更复杂方法相比,不使用特殊设备进行肝切除的严重不良事件风险尚不确定。可信区间较宽,并不能排除特定肝切除方法有显著益处或危害的可能性。

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