中国组织工程研究 ›› 2016, Vol. 20 ›› Issue (9): 1336-1344.doi: 10.3969/j.issn.2095-4344.2016.09.018

• 骨与关节循证医学 evidence-based medicine of the bone and joint • 上一篇    下一篇

全膝关节置换后应用自体血回输器是否必要:一项Meta分析

罗明辉1,洪坤豪2,潘建科2,刘 军1,杨伟毅1,郭 达1   

  1. 1广东省中医院骨科,广东省广州市 510120;2广州中医药大学第二临床医学院,广东省广州市 510405
  • 出版日期:2016-02-19 发布日期:2016-02-19
  • 通讯作者: 刘军,硕士,主任医师,广东省中医院骨科,广东省广州市 510120
  • 作者简介:罗明辉,男,1981年生,广东省人,汉族,2007年广州中医药大学毕业,硕士,主治医师。
  • 基金资助:
    国家自然科学基金项目(81473698,81273781),教育部高等学校博士点科研基金项目(20124425110004),国家中医药管理局中医药标准化项目(SATCM -2015-BZ115, SATCM-2015-BZ173),广东省科技计划项目 (2011B031700027),广东省财政厅项目([2014]157号),广东省中医院中医药科学技术研究专项(YK2013B2N19)

Is autologous blood transfusion drainage necessary after total knee arthroplasty: a meta-analysis

Luo Ming-hui1, Hong Kun-hao2, Pan Jian-ke2, Liu Jun1, Yang Wei-yi1, Guo Da1
  

  1. 1 Department of Orthopedics, Traditional Chinese Medicine Hospital of Guangdong Province, Guangzhou 510120, Guangdong Province, China
    2 the Second Clinical Medical College, Guangzhou University of Traditional Chinese Medicine, Guangzhou 510405, Guangdong Province, China
  • Online:2016-02-19 Published:2016-02-19
  • Contact: Liu Jun, Master, Chief physician, Department of Orthopedics, Traditional Chinese Medicine Hospital of Guangdong Province, Guangzhou 510120, Guangdong Province, China
  • About author:Luo Ming-hui, Master, Attending physician, Department of Orthopedics, Traditional Chinese Medicine Hospital of Guangdong Province, Guangzhou 510120, Guangdong Province, China
  • Supported by:
    the National Natural Science Foundation of China, No. 81473698, No. 81273781; Research Fund of Doctor Station of Ministry of Education of China, No. 20124425110004; TCM Standardization Projects of State Administration of Traditional Chinese Medicine of China,  No. SATCM-2015-BZ115, SATCM-2015-BZ173; Science and Technology Planning Project of Guangdong Province, China, No. 2011B031700027; Project funded by Guangdong Provincial Department of Finance, No. [2014]157; Science and Technology Research Project of Guangdong Provincial Hospital of Chinese Medicine, No. YK2013B2N19

摘要:

文章快速阅读:

文题释义:

自体血回输器:是术后采集、过滤和自体血回输的全封闭式血液回收系统,包括引流管、排液管、带滤过器的储血罐、血袋等,理论上是一种简便易行、有效安全、可缓解血源紧张的新技术设备。

人工膝关节:完全参照了正常人膝关节的解剖形状,是一种仿生设计制品。模仿人体膝关节的结构及活动方式,人工膝关节由四个部件组成:股骨部分、胫骨部分、髌骨部分以及聚乙垫。

 

背景:全膝关节置换是治疗膝骨性关节炎标准化、技术成熟、效果肯定的手术,但术后易发生显性失血过多,血红蛋白水平下降,术口感染及其他并发症。而自体血回输器作为一项新技术,通过回输术后不洗涤、过滤的引流血,可有效降低输血率。目前,国内外尚无系统评价提供直接循证证据比较全膝关节置换后使用自体血回输器与不引流。
目的:基于Meta分析研究全膝关节置换后应用自体血回输器/不引流的有效性、安全性及潜在优势。
方法:计算机系统全面检索国内外数据库PubMed,Embase,Cochrane Library,CBMdisc,中国知网,维普及万方数据库,以主题词结合自由词的方式制定检索策略:“total knee replacement” OR “total knee arthroplasty” OR “total knee prosthesis” OR“unicompartmental” OR “unicondylar” OR “unicompartmenta” OR” arthroplasty,replacement,knee “[MeSH term] AND (“autologous blood transfusion” OR “Autotransfusion” OR “blood transfusion,autologous”[MeSH Terms] OR “Intraoperative Blood Salvage” OR“ Intraoperative Blood” OR “Postoperative Blood Salvage”OR “Intraoperative Blood Cell Salvage” OR “Operative Blood Salvage”[MeSH Terms],最终纳入文献的数据应用 Cochrane推荐的 RevMan 5.3.5软件进行Meta 分析,主要结局指标是输血率,次要结局指标有血红蛋白平均变化、第3天血红蛋白水平、住院时间、术口感染率。

结果与结论:共纳入随机对照试验5篇,共计667例患者。Meta分析结果显示,术后使用自体血回输器与不引流相比,在输血率(OR=0.7,95%CI:0.47-1.13;Z=1.41,P=0.16)、血红蛋白平均变化(WMD=0.20,95%CI-0.28-0.68;Z= 0.82,P=0.41)、第3天血红蛋白水平(WMD=0.41,95%CI:-0.26-1.09;Z=1.20,P=0.23)、住院时间(OR=1.01,95%CI:0.06-16.27;Z =0.01,P=1.00)、术口感染率(OR=1.01,95%CI:0.06- 16.27;Z=0.01,P=1.00)上差异都无显著性意义。结果提示,文章结局指标的Meta分析并未为自体血回输器的临床有效性(包括输血率、血红蛋白平均变化、第3天血红蛋白平均变化和住院时间)提供循证医学证据支持。由于文章存在纳入文献质量和发表偏倚等局限性,此结论尚需开展更多高质量、大样本、多中心的随机对照试验来验证或更新文章的结论。 

ORCID: 0000-0002-1943-3880 (Liu Jun)

关键词: 骨科植入物, 人工假体, 膝关节置换, 自体血回输, 不引流, Meta分析, 系统评价, 输血率, 血红蛋白平均变化, 第3天血红蛋白水平, 住院时间, 循证, 国家自然科学基金

Abstract:

BACKGROUND: Total knee arthroplasty is a procedure for treatment of knee osteoarthritisa with standardized, mature technology and affirmative efficacy. Total knee arthroplasty can result in overt excessive bleeding, decreased hemoglobin levels, patient mouth infection and other complications. As a new technology, autologous blood transfusion device can effectively reduce the rate of blood transfusion through reinfusing the unwashed and filterable drainage blood after operation. Up to now, no systematic reviews incorporating meta-analyses have found directly sufficient evidence to compare autologous blood transfusion drainage and no drainage after primary total knee arthroplasty.
OBJECTIVE: To study the clinical efficacy, safety and potential advantages of the application of autologous blood transfusion device/no drainage based on the meta-analysis.
METHODS: PubMed, Embase, the Cochrane Library, CBMdisc, China HowNet, VIP, Wanfang database were searched comprehensively by computer. The search strategies were developed by the way of MeSH terms combining with free words: “total knee replacement” OR “total knee arthroplasty” OR “total knee prosthesis” OR “unicompartmental” OR “unicondylar” OR “unicompartmenta” OR “arthroplasty, replacement, knee” [MeSH terms] AND “autologous blood transfusion” OR “Autotransfusion” OR “blood transfusion, autologous” [MeSH Terms] OR “Intraoperative Blood Salvage” OR “Intraoperative Blood” OR “Postoperative Blood Salvage” OR “Intraoperative Blood Cell Salvage” OR “Operative Blood Salvage” [MeSH Terms]. Data included in the final literature were analyzed using RevMan 5.3.5 software recommended by Cochrane. The main outcome measure was the rate of transfusion. The secondary outcome measures were the average change in hemoglobin, hemoglobin levels at the 3rd day, hospitalization time and intraoperative mouth infection rate.
RESULTS AND CONCLUSION: Five randomized controlled trials, a total of 667 patients were enrolled. Meta-analysis results showed that there were no significant differences in the transfusion rate (OR=0.73, 95%CI: 0.47-1.13; Z=1.41, P=0.16), average change in hemoglobin (WMD=0.20, 95%CI: -0.28-0.68; Z=0.82, P=0.41), the hemoglobin levels at the 3rd day (WMD=0.41, 95%CI: -0.26-1.09; Z=1.20, P=0.23), hospitalization time (OR=1.01, 95%CI: 0.06-16.27; Z= 0.01, P=1.00), intraoperative mouth infection rate (OR=1.01, 95%CI: 0.06-16.27; Z=0.01, P=1.00) between the postoperative use of autologous blood transfusion and no drainage. These results suggest that the meta-analysis of outcome measures has not provided the evidence-based medical support for the clinical efficacy of autologous blood transfusion device (including blood transfusion rate, the average change in hemoglobin, average hemoglobin change at the 3rd day, hospitalization time). Given the inherent limitations of the quality of the included studies and the publication bias, future high-quality, large-volume, multi-center randomized controlled trials are awaited to confirm and update the findings of this analysis.