比较全膝关节置换应用自体血回输引流与传统负压引流：随机对照试验的Meta分析

doi:10.3969/j.issn.2095-4344.2016.53.018

中国组织工程研究 ›› 2016, Vol. 20 ›› Issue (53): 8032-8042.doi: 10.3969/j.issn.2095-4344.2016.53.018

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

比较全膝关节置换应用自体血回输引流与传统负压引流：随机对照试验的Meta分析

刘军¹，潘建科¹，洪坤豪²，谢辉¹，郭达¹，许树柴¹

¹广州中医药大学第二附属医院(广东省中医院)骨科，广东省广州市 510120；²广东省第二中医院骨科，广东省广州市 510095

修回日期:2016-08-07 出版日期:2016-12-23 发布日期:2016-12-23
通讯作者: 许树柴，主任医师，硕士生导师，广州中医药大学第二附属医院(广东省中医院)骨科，广东省广州市 510120
作者简介:刘军，男，汉族，主任医师，教授，博士生导师，博士后合作导师，主要从事骨与关节退变及损伤的基础、临床和循证医学研究。
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，YN2015MS15)

Autologous blood transfusion drainage versus conventional suction drainage in total knee arthroplasty: a meta-analysis of randomized controlled trials

Liu Jun¹, Pan Jian-ke¹, Hong Kun-hao², Xie Hui¹, Guo Da¹, Xu Shu-chai¹

¹ Department of Orthopedics, Second Affiliated Hospital, Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Traditional Chinese Medicine), Guangzhou 510120, Guangdong Province, China;²Department of Orthopedics, Guangdong Second Traditional Chinese Medicine Hospital, Guangzhou 510095, Guangdong Province, China

Revised:2016-08-07 Online:2016-12-23 Published:2016-12-23
Contact: Xu Shu-chai, Chief physician, Master’s supervisor, Department of Orthopedics, Second Affiliated Hospital, Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Traditional Chinese Medicine), Guangzhou 510120, Guangdong Province, China
About author:Liu Jun, Chief physician, Professor, Doctoral supervisor, Department of Orthopedics, Second Affiliated Hospital, Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Traditional Chinese Medicine), Guangzhou 510120, Guangdong Province, China
Supported by:
the National Natural Science Foundation of China, No. 81473698, 81273781; the Doctoral Scientific Research Fund Project of Higher Learning Schools of Education Ministry of China, No. 20124425110004; the Chinese Medicine Standardization Project of State Administration of Traditional Chinese Medicine, No. SATCM-2015-BZ115, SATCM-2015-BZ173; the Science and Technology Plan Program of Guangdong Province, No. 2011B031700027; a grant from Guangdong Provincial Department of Finance, No. [2014]157; the Science and Technology Research Program of Traditional Chinese Medicine of Guangdong Province Hospital of Traditional Chinese Medicine, No. YK2013B2N19, YN2015MS15

摘要/Abstract

摘要：

文章快速阅读：

文题释义：

平均输血单位数：是在一组研究对象中，统计一定时间组内输血治疗患者的总输血单位数，然后除于整组研究对象的总人数，为平均输血单位数。

血液回收：是指用血液回收装置，将患者体腔积血、手术中失血及术后引流血液进行回收、抗凝、滤过、洗涤等处理，然后回输给患者。血液回收必须采用合格的设备，回收处理的血必须达到一定的质量标准.

摘要

背景：目前，与常规负压引流比较，全膝关节置换后使用自体血回输引流的优势尚未得到明确，有待循证医学证据的进一步支持。

目的：基于现有的循证医学证据，与常规负压引流比较，评价全膝关节置换中应用自体血回输引流的有效性、安全性及潜在优势。

方法：系统检索PubMed，Embase和Cochrane Library数据库，将所有在全膝关节置换中比较自体血回输引流与传统负压引流疗效的随机对照试验纳入进行Meta分析。

结果与结论：共纳入随机对照试验12篇，共计1 119例患者，其中自体血回输引流556例，传统负压引流563例。Meta分析结果显示，术后使用自体血回输引流的患者与传统负压引流的患者相比，有更低的输血率(OR=0.28，95%CI：0.14-0.55，Z=3.67，P=0.000 2) 和更少的平均输血单位数(WMD= -0.56，95%CI：-0.79至-0.33，Z=4.71, P < 0.000 01)。两组患者在伤口并发症发生率、深静脉血栓发生率、术后发热发生率、术后第5-8天血红蛋白水平、伤口引流量和住院时间比较均差异无显著性意义(P > 0.05)。结果说明，自体血回输引流可降低全膝关节置换后患者的输血率和平均输血单位数，是一种可替代传统负压引流的安全、有效的治疗手段。

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: 0000-0001-5425-8785(Xu Shu-chai)

关键词: 骨科植入物, 人工关节, 自体血回输引流, 传统负压引流, 全膝关节置换, meta分析, 随机对照试验, 循证医学, 输血, 并发症

Abstract:

BACKGROUND: At present, when compared with the conventional suction drainage, the advantages of autologous blood transfusion drainage after total knee arthroplasty have not been clear yet and need evidence of evidence-based medicine to support.

OBJECTIVE: Based on the existing evidence of evidence-based medicine, compared with the conventional suction drainage, we evaluated the efficiency, safety, and potential advantages of autologous blood transfusion drainage in total knee arthroplasty.

METHODS: We performed a systematic literature search of PubMed, Embase, and the Cochrane Library; all randomized controlled trials that compared the effects of autologous blood transfusion drainage and conventional suction drainage in total knee arthroplasty were included for meta-analysis.

RESULTS AND CONCLUSION: Twelve randomized controlled trials, including 1 119 cases (556 cases for autologous blood transfusion drainage and 563 cases for conventional suction drainage), were identified. Meta-analysis results demonstrated that patients in the autologous blood transfusion drainage group benefitted from a lower blood transfusion rate (OR=0.28, 95%CI: 0.14-0.55, Z=3.67, P=0.000 2) and a lower number of units transfused per patient (weighted mean difference=-0.56, 95%CI: -0.79- -0.33, Z=4.71, P < 0.000 01). Wound complications, deep vein thrombosis, febrile complications, post-operative hemoglobin on days 5–8, drainage volume, and hospital stay length did not significantly differ between autologous blood transfusion drainage and conventional suction drainage groups (P > 0.05). This meta-analysis suggests that autologous blood transfusion drainage offers a safe and efficient alternative to conventional suction drainage with a lower blood transfusion rate and a smaller number of units transfused per patient.

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

Key words: Tissue Engineering, Knee Joint, Complications

刘军，潘建科，洪坤豪，谢辉，郭达，许树柴. 比较全膝关节置换应用自体血回输引流与传统负压引流：随机对照试验的Meta分析[J]. 中国组织工程研究, 2016, 20(53): 8032-8042.

Liu Jun, Pan Jian-ke, Hong Kun-hao, Xie Hui, Guo Da, Xu Shu-chai. Autologous blood transfusion drainage versus conventional suction drainage in total knee arthroplasty: a meta-analysis of randomized controlled trials[J]. Chinese Journal of Tissue Engineering Research, 2016, 20(53): 8032-8042.

图/表（结果） 7

Study selection

One hundred and eighty-one articles were retrieved in the study. Twelve studies^[24-35], including 1 119 cases (556 cases for ABTD and 563 cases for CSD), met the inclusion criteria (Figure 1). We examined the references listed in these studies and in review articles, but did not find additional studies for evaluation.

Characteristics of included studies

The characteristics of the 12 included studies are summarized in Table 1. Among the included studies, there were 7 RCTs^{[24, 26, 29-30, 32, 34-35]} with a 1b level of evidence and 5 RCTs^{[25, 27-28, 31, 33]}with a 2b level of evidence. Patients in 11 studies^{[24-30, 32-35]}underwent selective unilateral total knee replacement, while in the other study^[31] they underwent bilateral total knee replacement.

The methodological quality of all the included studies was evaluated by using the Cochrane risk of bias criteria (Figures 2, 3). Six studies^{[24, 26, 29, 32-34]} mentioned the method of randomization. One study^[27]used a quasi-randomization method. Five studies did not mention the method of randomization^{[25, 28, 30-31, 35]}. Two studies^{[29, 32]} mentioned the method of allocation concealment. One study^[29] provided information about the blinding method. None of the 12 studies^[24-35] mentioned the method of blinding the outcome assessment. Eleven studies^{[24-30, 32-35]} reported the complete analysis. One study^[33] was at high risk of selective reporting. The majority of the RCTs reviewed in this meta-analysis were moderate-quality studies. All the included studies claimed that the baseline data were comparable, including age, gender and pre-operative hemoglobin, as shown in Table 1.

Primary outcomes of meta-analysis

Blood transfusion rate

Ten trials^{[24-26, 28-30, 32-35]}compared the effects of ABTD and CSD according to changes in the number of patients requiring homologous blood transfusion. Because of the substantial heterogeneity (chi-square=34.04, P < 0.000 1; I²=74%), a random-effect model was used. The meta-analysis showed a significant beneficial effect of ABTD compared to CSD in reducing the blood transfusion rate (16.59% versus 37.47%, OR=0.28, 95%CI: 0.14-0.55, Z=3.67, P=0.000 2; Figure 4). Due to the marked heterogeneity within the evaluated blood transfusion rate, sensitivity analyses were conducted by excluding one study^[33]with lower quality. This operation reduced the heterogeneity in the consistency of the trial results (I²=59%, P=0.01). The random-effects model of the meta-analysis also showed a significant beneficial effect of ABTD compared to CSD in reducing the blood transfusion rate (17.25% versus 34.03%, OR=0.37, 95%CI: 0.21-0.65, Z=3.42, P=0.000 6). Dropping any one of the studies did not alter the results that favored ABTD.

Mean number of units transfused per patient

Three trials^{[27, 32, 34]}, including 294 patients, reported the mean number of units transfused per patient (Figure 5). Because of the moderate heterogeneity (chi-square=3.40, P=0.18; I²=41%), a fixed-effects model was used. The meta-analysis showed a significant beneficial effect of ABTD compared to CSD in reducing the mean number of units transfused per patient (WMD=-0.56, 95%CI: -0.79- -0.33, Z=4.71, P < 0.000 01).

Wound complications

Data extracted from three studies^{[24, 30, 35]}that assessed wound complications in 449 patients showed no significant difference between the ABTD and CSD groups (OR=0.98, 95%CI: 0.40-2.38; Z = 0.04, P=0.97). No significant heterogeneity was detected (P=0.66, I²=0%; Figure 6).

Deep vein thrombosis

Data extracted from four studies^{[24, 30, 32, 35]}that assessed deep vein thrombosis in 509 patients showed no significant difference between the ABTD and CSD groups (OR=0.69, 95%CI: 0.21-2.24, Z=0.61, P=0.54). No significant heterogeneity was detected (P=0.64, I²=0%;Figure 7).

Secondary outcomes of meta-analysis

Febrile complications

Six trials^{[26-27, 29, 31, 33, 34]} compared the effects of ABTD versus CSD with respect to changes in febrile complications. Because of the substantial heterogeneity (chi-square=11.28, P=0.05; I²=56%), a random-effects model was used. The meta-analysis showed no significant difference between the ABTD and CSD groups (OR=0.78, 95%CI: 0.25-2.40, Z=0.43, P=0.67; Figure 8). Due to the marked heterogeneity within the evaluated febrile complications, sensitivity analyses were conducted by excluding one study^[33] with lower quality. This operation reduced the heterogeneity in the consistency of the trial results (I²=30%, P=0.22). The random-effects model of the meta-analysis also showed no significant difference between the ABTD and CSD groups (OR=1.21, 95%CI: 0.39-3.68, Z=0.33, P=0.74). Dropping any one of the studies did not alter the result that there was no significant difference between the two groups.

Post-operative hemoglobin on days 5-8

Three studies^{[26, 32-33]} reported post-operative hemoglobin on days 5-8. Among them, one study^[26] reported hemoglobin on the fifth day post-operation, another study^[32] reported hemoglobin on the eighth day post-operation, and the final study^[33] reported hemoglobin on the seventh day post-operation. Because of the substantial heterogeneity (chi-square=5.74, P=0.06; I²=65%), a random-effects model was used. Pooling the data for the 234 patients in these three studies revealed no significant difference between the ABTD and CSD groups (WMD=0.20: -0.38-0.79, Z=0.68, P=0.50;Figure 9). Due to the marked heterogeneity within the evaluated post-operative hemoglobin at days 5-8, sensitivity analyses were conducted by excluding one study^[32] with a high weight. No significant heterogeneity was then detected (P=1.00, I²=0%). The random-effects model of the meta-analysis showed a significant beneficial effect of CSD compared to ABTD in post-operative hemoglobin on days 5-8 (WMD=0.50, 95%CI: 0.08-0.92, Z=2.35, P=0.02).

Drainage volume

Five studies^{[26, 32-35]} reported the post-operative drainage volume. Because of the moderate heterogeneity (chi-square=7.37, P=0.12; I²=46%), a fixed-effects model was used. The pooled data for the 353 patients in the five studies showed no significant difference between the ABTD and CSD groups (WMD=-52.68, 95%CI: -145.79-40.44, Z=1.11, P=0.27; Figure 10).

Length of hospital stay

Three trials^{[26, 32-33]} compared the effects of ABTD and CSD with respect to changes in the length of hospital stay. Because of the substantial heterogeneity (chi-square=4.14, P=0.13; I²=52%), a random-effects model was used. The meta-analysis showed no significant difference between the ABTD and CSD groups for the length of hospital stay (WMD=-0.96, 95%CI: -2.09-0.17, Z=1.67, P=0.10; Figure 11). Due to the marked heterogeneity within the evaluated length of hospital stay, sensitivity analyses were conducted by excluding one study^[33]with lower quality. After this operation, no significant heterogeneity was detected (P=0.32, I²=0%). The random-effects model of the meta-analysis also showed no significant difference between the ABTD and CSD groups for the hospital stay length (WMD=-0.52, 95%CI: -1.30-0.25, Z=1.33, P=0.18).

Publication bias

The distribution, visualized using a funnel plot, of the studies in this meta-analysis that reported blood transfusion rates (Figure 12) showed an asymmetrical distribution of the effect estimate, which indicated the presence of publication bias.

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引言

材料方法

Data sources and search strategies

In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis^[20], we created a prospective protocol of objectives, literature-search strategies, inclusion and exclusion criteria, outcome measurements, and methods of statistical analysis before the research began.

A systematic literature search of the PubMed (1950/March 2015), Embase (1974/March 2015) and Cochrane Library (March 2015 Issue 3) databases was undertaken. The following MeSH terms or Emtree terms and their combinations were searched in [Title/Abstract]: “drainage”, “suction”, “blood transfusion, autologous”, “operative blood salvage”, “arthroplasty, replacement, knee”, “wound drainage”, “closed drainage”, “drainage catheter”, “drainage tube”, “suction drain”, “surgical drainage”, “drain”, “wound drain”, “blood autotransfusion”, “autotransfusion unit”, “blood salvage”, and “knee arthroplasty”. Only articles originally written in English or translated into English were considered. Only the most recent or complete published report was included when duplicate publications from the same study were identified.

Inclusion and exclusion criteria

Inclusion criteria

All available RCTs that compared ABTD with CSD in all age groups and that reported at least one of the quantitative outcomes, presented as the mean and standard deviations or as 95% confidence intervals (95%CI), mentioned in the next section of this paper were included.

Exclusion criteria

Non-original research (e.g., review articles, editorials, and letters to the editor), case reports, animal experimental studies, and duplicate publications were excluded.

Data extraction and analysis

The extraction of data was conducted by two authors (Hong and Xie) working independently. Any disagreement was resolved by the consensus of senior authors (Pan and Liu). The primary outcomes were the blood transfusion rate, mean number of units transfused per patient, wound complications, and deep vein thrombosis. The secondary outcomes were febrile complications, post-operative hemoglobin on days 5-8, drainage volume, and length of hospital stay.

Quality assessment

Studies were graded according to the criteria of the Center for Evidence-Based Medicine in Oxford, UK^[21]. The methodological quality of the included RCTs was evaluated using the Cochrane risk of bias tool^[22-23].

Data synthesis and analysis

Our analyses were based on intention-to-treat or on modified intention-to-treat data. Review Manager 5.3.5 software (Cochrane Collaboration, Oxford, UK) was employed for all the meta-analyses. Odds ratio (OR) and 95%CI were calculated for the blood transfusion rate, wound complications, deep vein thrombosis and febrile complications. Weighted mean difference (WMD) and 95%CI were calculated for the mean number of units transfused per patient, post-operative hemoglobin days 5-8, drainage volume, and length of hospital stay. For studies that presented continuous data as means and 95%CI, the standard deviations were calculated using the calculator in Review Manager 5.3.5 software.

Heterogeneity was assessed using the I-square test. If there was heterogeneity in the studies (I² > 50%), the random-effects model was applied; otherwise, the fixed-effects model was applied^[22]. In cases with I² values of greater than 50% for outcome measures, we conducted sensitivity analyses to determine the reasons for the heterogeneity. Funnel plots were inspected visually to assess the possibility of publication bias.

讨论

The results suggested that ABTD was safe, with a significantly reduced blood transfusion rate and a smaller number of units transfused per patient. We found no significant differences in wound complications, deep vein thrombosis, febrile complications, post-operative hemoglobin on days 5-8, drainage volume, or length of hospital stay.

The requirement for post-operative allogenic blood transfusion in TKA patients was reduced significantly by using ABTD. Although allogenic transfusion is still the most popular method of compensating for blood loss in TKA patients, it may have potential deleterious effects, including transfusion-related infection, incompatibility-related transfusion reaction, immune modulatory effects, and febrile complications^[29]. These risks have led to the use of autologous predonation blood, which itself has drawbacks in terms of difficulty in organizing patients for predonation and adherence to iron or erythropoietin therapy^[36]. Studies have reported that nearly half of autologous blood donated by patients for surgery is discarded^[37-38]. Compared to autologous predonation blood, ABTD is easier to perform and more cost-effective, and it also helps to avoid the risks associated with allogenic blood^[39]. Because ABTD significantly reduced the blood transfusion rate and the number of units transfused per patient, TKA patients who used ABTD have a cost savings of 20% to 70% over allogenic blood transfusion despite the greater cost of the ABTD device compared to the CSD device^{[25, 27, 29-31]}.

Data extracted from post-operative outcomes indicate that the ABTD equipment is safe and effective for TKA. There were no significant differences in wound complications, deep vein thrombosis, or febrile complications. In all the studies included in this meta-analysis, reinfusion was completed within 6 hours of the operation. A lower rate of allogenic blood transfusion may prevent febrile complications. Post-operative febrile complications are generally seen in the context of major orthopedic surgery. It has been suggested that the rise in temperature is a response to the surgical procedure^[40]. Some studies indicated no differences between ABTD and CSD in terms of febrile complications^[41-43]. The absence of significant differences between ABTD and CSD with respect to wound complications, deep vein thrombosis, or febrile complications indicates that ABTD is as safe as CSD.

The pooled results indicated no significant difference in drainage volume, which indicates that the ABTD system does not increase wound bleeding and that ABTD is safe. We found no significant differences in post-operative hemoglobin on days 5-8. This meta-analysis showed that ABTD was effective in reducing allogeneic blood transfusions, but was not successful in achieving high post-operative hemoglobin levels.

Due to the limited number of included articles and insufficient detail in the descriptions of the study methods of the included articles, subgroup analyses of the outcomes could not be performed.

To assess the impact of individual studies on the effect estimates, we performed sensitivity analyses by excluding one study with high weight or lower quality. The results of sensitivity analyses for the blood transfusion rate, febrile complications, and hospital stay length were similar to those of the analyses before exclusion. However, the result for post-operative hemoglobin at days 5-8 favored CSD, and the heterogeneity decreased from 65% to 0% when the study performed by Adalberth et al.^[32] was excluded. There were no significant differences among the three included studies^{[26, 32-33]}with respect to pre-operative hemoglobin. One study^[26] found that ABTD could prevent a rapid fall in hemoglobin level during the early post-operative period, whereas this benefit disappeared by day 5. Because only 3 studies^{[26, 32-33]} were included in the meta-analysis of post-operative hemoglobin, additional studies are needed to confirm any benefit with respect to post-operative hemoglobin.

Limitations

The shortcoming of this meta-analysis was that the majority of the RCTs reviewed in this meta-analysis were moderate-quality studies with small sample sizes. Inadequate random sequence generation and blinding tended to increase the risk of bias. Nine of the included studies did not provide complete information for each endpoint. In addition, the original meta-analysis was based on the assumption that the surgical treatments (selective unilateral total knee arthroplasty and bilateral total knee arthroplasty) were similar enough to be assessed together. Fortunately, the result of the sensitivity analysis was similar to that of the original analysis. Another limitation was that there were heterogeneities among the included studies. The heterogeneities are related to methodological differences, different surgical methods (selective unilateral total knee arthroplasty and bilateral total knee arthroplasty), and the fact that the studies were conducted in different countries with patients of different races.

Conclusions

The evidence from the meta-analysis of the included studies shows that ABTD is more effective than CSD for reducing the blood transfusion rate and the number of units transfused per patient in TKA patients. The two types of drainage are equivalent in terms of wound complications, deep vein thrombosis, febrile complications, post-operative hemoglobin on days 5-8, drainage volume, and hospital stay length. The results of this meta-analysis will help expert TKA surgeons to make clinical decisions. As additional large-volume, well-designed RCTs with extensive clinical follow-ups become available, the conclusions of this study will become more credible.

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

比较全膝关节置换应用自体血回输引流与传统负压引流：随机对照试验的Meta分析

Autologous blood transfusion drainage versus conventional suction drainage in total knee arthroplasty: a meta-analysis of randomized controlled trials

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