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巴曲酶制剂对胸外科手术围手术期出血是否有效?一项随机对照试验的系统评价。

Are batroxobin agents effective for perioperative hemorrhage in thoracic surgery? A systematic review of randomized controlled trials.

作者信息

Zeng Zhiyong, Xiao Pingping, Chen Junmin, Wei Yisheng

机构信息

Department of Hematology and Rheumatology, The First Affiliated Hospital of Fujian Medical University, Chating, Fuzhou, China.

出版信息

Blood Coagul Fibrinolysis. 2009 Mar;20(2):101-7. doi: 10.1097/MBC.0b013e3283254532.

Abstract

The objective of the present study was to evaluate the effect of batroxobin agents on perioperative hemorrhage in thoracic surgery.We systematically searched Cochrane Library, Pubmed, EMBASE and the China Biological Medicine CD-ROM Databases up to August 2007. Reference lists of all included studies and of reviews related to the topic of the present systematic review were manually searched. Two reviewers independently identified the eligible studies, assessed their methodological quality and extracted data. Results of relevant outcomes were pooled together whenever possible, using RevMan software.Five randomized controlled trials involving 678 patients were included. Three trials were for pneumonectomy and two for cardiac surgery with cardiopulmonary bypass. The quality of the identified studies was generally poor. All the trials claimed randomized allocation, but allocation concealment was unclear. Blinding was not mentioned. Two trials found that batroxobin agents decreased intraoperative blood loss for pneumonectomy. Mean differences between the batroxobin agents group and the no-treatment group were -182.20 ml [95% confidence interval (CI), -207.48 to -156.92] and -131.32 ml (95% CI, -142.95 to -119.69), respectively, for these two trials. All included trials reported less drainage volume favoring the batroxobin agents group. Mean differences at different time points after operation ranged from -15 ml (95% CI, -31.77 to 1.77) to -150.60 ml (95% CI, -179.26 to -121.94). Although most of the differences between the batroxobin agents group and the no treatment group were statistically significant, clinical value was limited.There is not enough evidence supporting any benefit of batroxobin agents for hemorrhage during thoracic surgery.

摘要

本研究的目的是评估巴曲酶制剂对胸外科手术围手术期出血的影响。我们系统检索了截至2007年8月的Cochrane图书馆、PubMed、EMBASE和中国生物医学光盘数据库。对所有纳入研究以及与本系统评价主题相关的综述的参考文献列表进行了手工检索。两名评价员独立识别符合条件的研究,评估其方法学质量并提取数据。尽可能使用RevMan软件将相关结局的结果合并在一起。纳入了5项涉及678例患者的随机对照试验。3项试验用于肺切除术,2项用于体外循环心脏手术。所识别研究的质量普遍较差。所有试验均声称采用随机分配,但分配隐藏情况不明。未提及盲法。两项试验发现巴曲酶制剂可减少肺切除术的术中失血量。这两项试验中巴曲酶制剂组与未治疗组之间的平均差异分别为-182.20 ml [95%置信区间(CI),-207.48至-156.92]和-131.32 ml(95%CI,-142.95至-119.69)。所有纳入试验均报告巴曲酶制剂组的引流量较少。术后不同时间点的平均差异范围为-15 ml(95%CI,-31.77至1.77)至-150.60 ml(95%CI,-179.26至-121.94)。尽管巴曲酶制剂组与未治疗组之间的大多数差异具有统计学意义,但其临床价值有限。没有足够的证据支持巴曲酶制剂对胸外科手术出血有任何益处。

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