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 Cel 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。
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 Cel 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 enroled. 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 3rdday (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 controled trials are awaited to confirm and update the findings of this analysis.