全膝关节置换后应用自体血回输器是否必要：一项Meta分析

doi:10.3969/j.issn.2095-4344.2016.09.018

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 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/Abstract

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。

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

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 3^rd 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 3^rdday (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 3^rd 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.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

罗明辉，洪坤豪，潘建科，刘军，杨伟毅，郭达. 全膝关节置换后应用自体血回输器是否必要：一项Meta分析[J]. 中国组织工程研究, 2016, 20(9): 1336-1344.

Luo Ming-hui, Hong Kun-hao, Pan Jian-ke, Liu Jun, Yang Wei-yi, Guo Da. Is autologous blood transfusion drainage necessary after total knee arthroplasty: a meta-analysis[J]. Chinese Journal of Tissue Engineering Research, 2016, 20(9): 1336-1344.

图/表（结果） 6

The results of literature retrieval

Five RCTs^[22-26] which were full-text articles in English including 674 patients (involving 337 people in ABT drainage group and 337 people in no drainage group) fulfilled the predefined inclusion criteria and were selected for final analysis (Figure 1). Agreement between the two authors reached to 92% for study selection and quality assessment of trials.

Characteristics of eligible studies

The demographic characteristics of 5 studies were presented in Table 1, Figures 2, 3. The quality of eligible studies was medium. The majority of the RCTs reviewed in this meta-analysis were moderate-quality studies. Among the eligible studies, there were 3 RCTs^{[22-23, 25]} with 1b level of evidence; two RCTs^{[24, 26]}with 2b level of evidence. Figure 2 and Figure 3 showed the methodological quality of RCTs assessed by the Cochrane risk of bias tool. True randomization was reported in only 3 RCTs^{[22, 24, 26]}, 2 RCTs^{[23, 25]}not eterogeneity was detected between studies without clinicmentioned. Four studies mention the method of allocation concealment. Because the difficulty of blinding for the intervention measures, no studies provided information about blinding for participants^[22-25]. One study mentioned the blinding of outcome assessment^[23]. Three studies^{[23, 25-26]}reported the complete analysis.

Meta-analysis results

Homologous blood transfusion rate

The homologous blood transfusion rate was compared in these five studies between ABT drainage and no drainage according to changes in the number of patients requiring homologous blood transfusion^[22-26]. Meta-analysis showed that no heterogeneity in the consistency of the results (chi²= 1.22, P=0.87; I²=0%). The random effects model of meta-analysis showed no significant difference between the ABT drainage and no drainage groups (13.05% and 16.91%, OR=0.73, 95%CI: 0.47-1.13;Z=1.41, P=0.16) (Figure 4).

Comparison on the average change in Hb levels

Three trials^[23-25] including 223 patients were enrolled in the meta-analysis regarding the comparison of Hb levels between preoperation and postoperation (Figure 5). The post-operative Hb levels in two RCTs^{[23, 25]} were combined for the mean post-operative according to the combined methods described in the Cochrane Reviewer’s Handbook 5.3. The mean change in ABT drainage and no drainage groups could be obtained by subtracting the final mean from the baseline mean. A change-from- baseline standard deviations were imputed using a correlation coefficient^[21]. The Hb change from baseline was more accurate to show the benefit of ABT drainage compared with no drainage. Three trials showed high statistical heterogeneity in the consistency of the trial results (chi²= 9.16, P=0.01; I²=78%). Sensitivity analysis was conducted by excluding one study^[24] with the result showed no heterogeneity (I²=0%, P=0.09), but no clinical diversity was identified. Therefore, a random effects model was used for statistical analysis. Pooling the data of the 223 patients showed no significant difference between ABT drainage and no drainage groups (WMD=0.20, 95%CI: -0.28-0.68; Z=0.82, P=0.41) (Figure 5).

Post-operative hemoglobin levels at the third day after surgery

Two studies^{[23, 25]}including 175 patients were enrolled in the meta-analysis regarding Hb levels between ABT drainage and no drainage groups at the third day after surgery. These three studies^{[18, 28, 34]} showed moderate heterogeneity in the consistency of the trial results (chi²=2.50, P=0.11; I²=60%). As for the two included studies, sensitivity analyses were not necessary with no clinical diversity. The random effects model of meta-analysis showed no significant difference between ABT drainage and no drainage groups (WMD=0.41, 95%CI: -0.26-1.09; Z=1.20, P =0.23) (Figure 6).

Length of hospital stay

Pooling the data from two studies^{[23, 25]} illustrated that assessed length of hospital stay in 175 patients showed no significant difference between ABT drainage and no drainage groups (WMD=0.07, 95%CI: -0.67-0.81; Z=0.19, P=0.85). No significant heterogeneity was detected (Chi²=0.01, P=0.90, I²= 0%). The random effects model of meta-analysis showed no significant difference between ABT drainage and no drainage groups (WMD: -0.07, 95%CI:-0.67-0.81; Z=0.19, P=0.85) (Figure 7).

Wound infection

One study^[26] reported the complication of wound infection. Pooling the data of the 275 patients in ABT versus no drainage groups showed no significant difference (OR=1.01, 95%CI:0.06-16.27; Z=0.01, P=1.00; Figure 8).

参考文献

[1] Neogi T. The epidemiology and impact of pain in osteoarthritis. Osteoarthritis and Cartilage. 2013;21(9): 1145-1153.

[2] Visser AW, de Mutsert R, Bloem JL, et al. Knee osteoarthritis and fat free mass interact in their impact on health-related quality of life in men: the Netherlands Epidemiology of Obesity study. Arthritis Care Res. 2015.

[3] Alkan B M, Fidan F, Tosun A, et al. Quality of life and self-reported disability in patients with knee osteoarthritis. Mod Rheumatol. 2014;24(1):166-171.

[4] Torres-Claramunt R, Hinarejos P, Pérez-Prieto D, et al. Sealing of the intramedullar femoral canal in a TKA does not reduce postoperative blood loss: a randomized prospective study. Knee. 2014;21(4):853-857.

[5] Keating EM, Meding JB, Faris PM, et al. Predictors of transfusion risk in elective knee surgery. Clin Orthop Relat Res. 1998;(357):50-59.

[6] Tsumara N, Yoshiya S, Chin T, et al. A prospective comparison of clamping the drain or post-operative salvage of blood in reducing blood loss after total knee arthroplasty. J Bone Joint Surg Br. 2006;88(1):49-53.

[7] Friederichs MG, Mariani EM, Bourne MH. Perioperative blood salvage as an alternative to predonating blood for primary total knee and hip arthroplasty. J Arthrop. 2002;17(3):298-303.

[8] Steinberg EL, Ben-Galim P, Yaniv Y, et al. Comparative analysis of the benefits of autotransfusion of blood by a shed blood collector after total knee replacement. Arch Orthop Trauma Surg. 2004;124(2):114-118.

[9] Abuzakuk T, Senthil Kumar V, Shenava Y, et al. Autotransfusion drains in total knee replacement. Are they alternatives to homologous transfusion? Int Orthop. 2007;31(2):235-239.

[10] Amin A, Watson A, Mangwani J, et al. A prospective randomised controlled trial of autologous retransfusion in total knee replacement. J Bone Joint Surg Br. 2008;90(4):451-454.

[11] Strümper D, Weber EWG, Gielen Wijffels S, et al. Clinical efficacy of postoperative autologous transfusion of filtered shed blood in hip and knee arthroplasty. Transfusion. 2004;44(11):1567-1571.

[12] So-Osman C, Nelissen RGHH, Eikenboom HCJ, et al. Efficacy, safety and user-friendliness of two devices for postoperative autologous shed red blood cell re-infusion in elective orthopaedic surgery patients: a randomized pilot study. Transfusion Med. 2006;16(5): 321-328.

[13] Markar SR, Jones GG, Karthikesalingam A, et al. Transfusion drains versus suction drains in total knee replacement: meta-analysis. Knee Surg Sports Traumatol Arthroscopy. 2012;20(9):1766-1772.

[14] Quinn M, Bowe A, Galvin R, et al. The use of postoperative suction drainage in total knee arthroplasty: a systematic review. Int Orthop. 2015;39(4):653-658.

[15] Haien Z, Yong J, Baoan M, et al. Post-operative auto-transfusion in total hip or knee arthroplasty: a meta-analysis of randomized controlled trials. PLoS One. 2013;8(1):e55073.

[16] Bafeta A, Trinquart L, Seror R, et al. Reporting of results from network meta-analyses: methodological systematic review. BMJ. 2014;348:g1741.

[17] Hutton B, Salanti G, Chaimani A, Caldwell DM, et al. The quality of reporting methods and results in network meta-analyses: an overview of reviews and suggestions for improvement. PLoS One. 2014;9(3):e92508.

[18] Cipriani A, Higgins JP, Geddes JR, et al. Conceptual and technical challenges in network meta-analysis. Ann Intern Med. 2013;159(2):130-137.

[19] Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta- analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ. 2009; 339:b2700.

[20] Phillips B, Ball C, Sackett D, et al. Levels of evidence and grades of recommendation. Oxford Centre for Evidence-based Medicine. 2015.

[21] J H, S G. Cochrane Handbook for Systematic Reviews of Interventions. New York, NY: Cochrane Collaboration, John Wiley and Sons. 2008.

[22] Thomassen BJ, den Hollander PH, Kaptijn HH, ety al. Autologous wound drains have no effect on allogeneic blood transfusions in primary total hip and knee replacement: a three-arm randomised trial. Bone Joint J. 2014;96-B(6):765-771.

[23] Horstmann W, Kuipers B, Ohanis D, et al. Autologous re-transfusion drain compared with no drain in total knee arthroplasty: a randomised controlled trial. Blood Transfus. 2014;12 Suppl 1:S176-S181.

[24] Dutton T, De-Souza R, Parsons N, et al. The timing of tourniquet release and ‘retransfusion’ drains in total knee arthroplasty: a stratified randomised pilot investigation. Knee. 2012;19(3):190-192.

[25] Adalberth G, Bystrom S, Kolstad K, et al. Postoperative drainage of knee arthroplasty is not necessary: a randomized study of 90 patients. Acta Orthop Scand. 1998;69(5):475-478.

[26] Ritter MA, Keating EM, Faris PM. Closed wound drainage in total hip or total knee replacement. A prospective, randomized study. J Bone Joint Surg Am. 1994;76(1):35-38.

[27] Esler CNA, Blakeway C, Fiddian NJ. The use of a closed-suction drain in total knee arthroplasty. J Bone Joint Surg. 2003;85(2):215-217.

[28] Holt BT, Parks NL, Engh GA, Lawrence JM. Comparison of closed-suction drainage and no drainage after primary total knee arthroplasty. Orthopedics. 1997;20(12):1121-1124, 1124-1125.

[29] Muñoz M, Ariza D, Garcerán MJ, et al. Benefits of postoperative shed blood reinfusion in patients undergoing unilateral total knee replacement. Arch Orthop Trauma Surg. 2005;125(6):385-389.

[30] Carless P, Moxey AO, Connell D, et al. Autologous transfusion techniques: a systematic review of their efficacy. Transfusion Med. 2004;14(2):123-144.

[31] Thomas D, Wareham K, Cohen D, et al. Autologous blood transfusion in total knee replacement surgery. Br J Anaesth. 2001;86(5):669-673.

[32] Hansen E, Hansen MP. Reasons against the retransfusion of unwashed wound blood. Transfusion. 2004;44(12 Suppl):45S-53S.

[33] Kim YH, Cho SH, Kim RS. Drainage versus nondrainage in simultaneous bilateral total knee arthroplasties. Clin Orthop Relat Res. 1998, (347):188-193.

[34] Saleh K, Olson M, Resig S, et al. Predictors of wound infection in hip and knee joint replacement: results from a 20 year surveillance program. J Orthop Res. 2002;20(3): 506-515.

[35] Zamora-Navas P, Collado-Torres F, de la Torre-Solis F. Closed suction drainage after knee arthroplasty. A prospective study of the effectiveness of the operation and of bacterial contamination. Acta Orthop Belg. 1999; 65(1):44-47.

[36] Greidanus NV, Peterson RC, Masri BA, et al. Quality of Life Outcomes in Revision Versus Primary Total Knee Arthroplasty. J Arthrop. 2011;26(4):615-620.

引言

Osteoarthritis (OA) is the most common form of arthritis disease worldwide and one of the important reasons of disability and economic burden^[1]. Knee osteoarthritis (Knee OA), associated with an impaired health-related quality of life, has been shown to account for 83% of disability in OA^[2-3]. Total knee arthroplasty (TKA) is a standardized highly successful procedure for this urgent knee OA. TKA can result in significant blood loss, Hb reduction, introperative month infection and other clinical risks^[4-5]. To avoid symptomatic anaemia and subsequent delays in postoperative rehabilitation, blood transfusion may be considered necessary in some patients. As a new technology, autologous blood transfusion (ABT) device can effectively reduce the rate of blood transfusion through reinfusing the unwashed and filterable drainage blood after operation. However, it is still controversial to use ABT drainage due to its limited role of reinfusion. Some studies have shown that the application of vacuum-assisted device can effectively reduce allogeneic blood transfusion rate after clinical surgery^[6-8]. Therefore, using autologous blood transfusion device, suction drainage or no drainage after TKA is still in dispute stage^[11-12].

Up to now, no systematic reviews incorporating meta-analyses (SRMA) have found directly suf?cient evidence to compare autologous blood transfusion drainage and no drainage after primary TKA. This is the first SRMA to systematically compare the clinical results of ABT drainage with no drainage in patients undergoing total knee arthroplasty. Some SRMA compared ABT drainage versus closed suction drainage, closed suction drainage versus no drainage, were published as standard in evidence based medicine^[13-15]. On the basis of a common comparator between pairwise meta-analyses, network meta-analyses were used to evaluate healthcare interventions. But the conduct of network meta-analyses poses multiple challenges and controversies^[16-18]. The aim of this systematic review and meta-analysis was to pool the data from available literature of randomized controlled trials, in order to provide a directly substantiated judgment regarding the use of ABT drainage following TKA surgery.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

材料方法

Evidence acquisition
A prospective protocol of objectives, literature-search strategies, inclusion and exclusion criteria, outcome measures, and methods of statistical analysis were prepared a priority according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis^[19].

Literature-search strategy
A systematic literature search of PubMed (1950-March 2015), Embase (1974-March 2015), Cochrane Library (March 2015 Issue 3), CNKI (March 2015), WANFANG (March 2015), VIP (March 2015) databases was undertaken. The following MeSH terms and their combinations were searched in [Title/Abstract]: “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]. We also searched the reference lists of related reviews and original articles identified for any relevant studies including randomized controlled trials (RCTs) involving adult humans. Only articles originally written in English/Chinese or translated into English/Chinese were considered. When multiple reports describing the same situation were published, the most recent or complete reports were used.

Inclusion and exclusion criteria
Two independent researchers identified studies that met the defined inclusion criteria with disagreements resolved by consensus.

Inclusion criteria: (1) the comparison was between ABT drainage and no drainage after TKA (2) at least one of the quantitative outcomes mentioned in the next section of this paper was reported (3) a RCT was designed (4) full text was published in English/Chinese.

Excluded criteria: editorials, letters to the editor, review articles, retrospective comparative studies, case reports, and animal experimental studies were excluded.

Data extraction and outcomes of interest

The data from eligible studies were extracted by 2 researchers independently to minimize errors and reduce potential biases. In cases of disagreement, a consensus was reached by the adjudicating senior authors. The extracted data were inputted into a computerized spreadsheet including sample size, study design, patient age, gender, preoperative/postoperative Hb levels, number of patients transfused with homologous blood, length of hospital stay, wound infection. The primary outcome was the number of patients requiring homologous blood transfusions. The secondary outcomes were Hb reduction between pre-operative Hb levels and mean postoperative Hb levels at the 3^rd day, length of hospital stay and wound infection.

Quality assessment and statistical analysis

Studies were rated for the level of evidence according to criteria provided by the Centre for Evidence-Based Medicine in Oxford, UK^[20]. The methodological quality of RCTs was assessed by the Cochrane risk of bias tool^[21].

Outcome measures

The main outcome measures were allogeneic blood transfusion rate; secondary outcome measures were the average change in Hb levels, Hb levels at the third day after surgery, hospitalization time and intraoperative mouth infection.

Statistical analysis

The statistical analysis was conducted with Cochrane Collaboration Review Manager 5.3.5 (Cochrane Collaboration, Oxford, UK). Our analyses were based on intent-to-treat (ITT) or modified ITT data. Odds risk (OR) with 95% confidence intervals (CIs) was calculated for dichotomous data and weight mean differences (WMD) with 95%CI for continuous data. Statistical heterogeneity was assessed by using the chi-square test and I-square statistic. A random-effect model was used when significant diversity was found

(P < 0.10; I² > 50%). Otherwise, a fixed-effect model was used^[21]. In cases with I² values greater than 50% for outcome measures, sensitivity analyses were conducted for heterogeneity. When overall results and conclusion are not affected by the different decisions that could be made during the review process, the results of the review can be regarded as a higher degree of certainty^[21].

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

讨论

This meta-analysis of 5 RCTs including 674 patients about the comparison of efficacy of ABT drainage and no drainage showed no significant differences in the homologous blood transfusion rate, Hb reduction between mean pre-operative Hb levels and mean postoperative, post-operative Hb levels at the third day after surgery, length of hospital stay and wound infection after TKA surgery. Our findings do not support the routine use of postoperative ABT drainage in TKA.

ABT drainage after TKA with recent techniques and attractive concept of retransfusing collected blood in the drain continues to be a controversial topic in the orthopedic literature, and many studies have reported considerable doubt with respect to its benefits^[27-28]. Contrary to the advantageous results included reducing homologous blood transfusion rate with a ABT drainage system was shown in some studies^[29-31], some authors have suggested insufficient efficiency for ABT^{[9, 32]}. In spite of the paucity of consistent evidence for their use, for many years the majority of major orthopaedic procedures were followed by the use of ABT drainage after TKA to reduce the blood transfusion rate. However, the present systematic review and meta-analysis demonstrated that compared with no drainage, ABT drainage has no significant beneficial effect on reducing the blood transfusion rate.

As for the secondary outcomes, such as Hb reduction, post-operative Hb levels at the third day after surgery and wound infection, ABT drainage was not superior in clinical efficacy compared with no drainage in TKA. The comparison in the Hb levels between preoperation and postoperation was also an important indicator to evaluate which way of drainage had the best clinical efficacy for TKA. According the pooled results, ABT drainage had increased wound infection rate with no statistical differences. Because of the low incidence of wound infection and small sample size, this systematic analysis was not sufficiently powered to compare the ABT drainage groups with respect to postoperative wound infection rate. Acting as a channel for the introduction of infection, drainage may increase infection by impairing host resistance and allowing pathogens access to a sterile field^{[28, 33-35]}. Furthermore, the demands on nursing care and physiotherapy are increase to accommodate the presence of drainage. In the orthopedic surgery, wound infection is a devastating complication.

Some possible limitations of this present meta-analysis and future research directions should be pointed out. The primary limitation is that the selected RCTs in this meta-analysis were moderate-quality studies, and with small sample sizes. In consideration of small number of included study in outcome analysis, the statistical heterogeneity assessments included I² text that was able to make false negative errors. Future systematic reviews should evaluate the indications with enough and larger multi-centre clinical literature being available. In addition, this meta-analysis limited the included articles published in English/Chinese. There might be selection bias in language. Finally, no outcome measures assessed in this study are long-term measures which is most pertinent to patients^[36]. Therefore, other outcomes such as range of movement, deep joint infection and component loosening, which were manifested in many years, should be considered.

To our knowledge, this is the first meta-analysis of randomized controlled trials to systematically compare the clinical results of ABT drainage and no drainage in patients undergoing TKA. The pooled results demonstrate that ABT drainage and no drainage have similar clinical efficacy and safety with regard to reducing blood transfusion rate, Hb reduction, hemoglobin levels at the third day after surgery, length of hospital stay and wound infection. Nevertheless, in spite of our rigorous methodology, the inherent limitations of eligible studies prevent us from reaching definitive conclusions. Future large-volume, well-designed RCTs with long-term measures and extensive follow-up are awaited to confirm and update the findings of this analysis.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

全膝关节置换后应用自体血回输器是否必要：一项Meta分析

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

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