比較全膝關(guān)節(jié)置換應(yīng)用自體血回輸引流與傳統(tǒng)負(fù)壓引流：隨機(jī)對(duì)照試驗(yàn)的Meta分析.doc

www.CRTER.org莊，等.黃芩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-chai11 Department of Orthopedics, Second Affiliated Hospital, Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Traditional Chinese Medicine), Guangzhou 510120, Guangdong Province, China2 Department of Orthopedics, Guangdong Second Traditional Chinese Medicine Hospital, Guangzhou 510095, Guangdong Province, ChinaCite this article: Liu J, Pan JK, Hong KH, Xie H, Guo D, Xu SC. Autologous blood transfusion drainage versus conventional suction drainage in total knee arthroplasty: a meta-analysis of randomized controlled trials. Zhongguo Zuzhi Gongcheng Yanjiu. 2016;20(53):8032-8042. DOI:10.3969/j.issn.2095-4344.2016.53.018 ORCID: 0000-0001-5425-8785(Xu Shu-chai)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, ChinaCorresponding author: Xu Shu-chai, Chief physician, Masters supervisor, Department of Orthopedics, Second Affiliated Hospital, Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Traditional Chinese Medicine), Guangzhou 510120, Guangdong Province, ChinaAccepted: 2016-08-07 AbstractBACKGROUND: 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 0.05). 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. Subject headings: Tissue Engineering; Knee Joint; Complications Funding: 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. 2014157; the Science and Technology Research Program of Traditional Chinese Medicine of Guangdong Province Hospital of Traditional Chinese Medicine, No. YK2013B2N19, YN2015MS153 P.O.Box 1200,Shenyang 110004 www.CRTER.orgLiu J, et al. Autologous blood transfusion drainage versus conventional suction drainageISSN 2095-4344 CN 21-1581/R CODEN: ZLKHAH 8041INTRODUCTIONTotal knee arthroplasty (TKA) can result in significant blood loss of up to 1 500 mL1-3. The average reduction in hemoglobin concentration after TKA has been estimated4. Blood transfusion may be considered necessary for some patients to avoid symptomatic anemia and subsequent delays in post-operative rehabilitation5. A blood transfusion rate of up to 39% for these surgeries has been reported2, 6-7. Conventional suction drainage (CSD) used for post-operative wound blood collection after TKA has gained worldwide acceptance8. CSD is believed to be effective in decreasing hematoma formation and has in theory been thought to decrease post-operative pain, swelling, and incidence of infection9-12. However, CSD inevitably increases bleeding8. Surgeons also use adjunctive measures, such as autologous blood transfusion drainage (ABTD), to reduce excessive blood loss from the drain13. Studies published in recent years have shown a decrease in the rate of blood transfusion when using ABTD14-16. In recent years, several studies comparing ABTD and CSD have been reported but with contradictory outcomes1, 17-19. It remains uncertain whether the benefits of ABTD are restricted to reducing the blood transfusion rate. We therefore comprehensively searched and analyzed the available literature for randomized controlled trials (RCTs) to evaluate the efficiency, safety, and potential advantages of ABTD compared with CSD.MATERIALS AND METHODSData sources and search strategies In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis20, 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 criteriaInclusion 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 analysisThe 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, UK21. The methodological quality of the included RCTs was evaluated using the Cochrane risk of bias tool22-23. Data synthesis and analysisOur 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 (I 50%), the random-effects model was applied; otherwise, the fixed-effects model was applied22. In cases with I 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.RESULTS Study selection One hundred and eighty-one articles were retrieved in the study. Twelve studies24-35, 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. ScreeningIncludedEligibilityIdentificationRecords identified through database searching PubMed, Embase, Cochrane (n=181)Records after duplicates removed (n=88)Records screened (n=88)Records excluded by identified titles or abstracts (n=54)Full-text articles assessed for eligibility (n=34)Full-text articles excluded, with reasons (n=22):Non-randomized controlled trial(n=8);Duplicate reports (n=2);Studies data not extractable (n=12)Studies included in qualitative synthesis (n=12)Studies included in quantitative synthesis (meta-analysis) (n=12)Figure 1 PRISMA 2009 flow diagram of studies identified, included, and excludedCharacteristics of included studiesThe characteristics of the 12 included studies are summarized in Table 1. Among the included studies, there were 7 RCTs24, 26, 29-30, 32, 34-35 with a 1b level of evidence and 5 RCTs25, 27-28, 31, 33 with a 2b level of evidence. Patients in 11 studies24-30, 32-35 underwent selective unilateral total knee replacement, while in the other study31 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 studies24, 26, 29, 32-34 mentioned the method of randomization. One study27 used a quasi-randomization method. Five studies did not mention the method of randomization25, 28, 30-31, 35. Two studies29, 32 mentioned the method of allocation concealment. One study29 provided information about the blinding method. None of the 12 studies24-35 mentioned the method of blinding the outcome assessment. Eleven studies24-30, 32-35 reported the complete analysis. One study33 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.Figure 2 Risk of bias summaryPrimary outcomes of meta-analysisBlood transfusion rateTen trials24-26, 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; I=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 bloodTable 1 Characteristics of the included studiesStudyLevel ofevidencePatients (n)Surgical methodAge (year)Sex Male:Female, (n)Pre-op Hb(10 g/L)ABTDCSDABTDCSDABTDCSDABTDCSDAmin et al., 2008241 b9286SU-TKA70.370.443:4939:471.3Zacharopoulos et al., 2007252 b3030SU-TKA69.270.26:247:23NANAAbuzakuk et al., 2007261 b5252SU-TKANANA21:3122:3013.61.513.51.2Kirkos et al., 2006272 b7877SU-TKA69.15.568.95.118:6010:6713.01.413.11.4Dramis et al., 2006282 b2524SU-TKANANANANANANACheng et al., 2005291 b2634SU-TKA7269.66:2012:2212.412.8Thomas et al., 2001301 b115116SU-TKANANA44:7155:61NANABreakwell et al., 2000312 b1419B-TKA66.873.78:68:1112.912.8Adalberth et al., 1998321 b3030SU-TKA715.4728.0NANA13.8 Newman et al., 1997332 b3535SU-TKANANANANA13.4 Heddle et al., 1992341 b3940SU-TKA69.36.971.09.025:1426:14NANAMajkowski et al., 1991351 b2020SU-TKA71.370.36:146:1413.212.7Note: SU-TKA: Selective unilateral total knee arthroplasty; B-TKA: bilateral total knee arthroplasty; ABTD: autologous blood transfusion drainage; CSD: conventional suction drain; NA: data not available. *: mean or meanSD; M:F: male:female; Pre-op Hb: pre-operative hemoglobin.Figure 3 Risk of bias assessmenttransfusion rate, sensitivity analyses were conducted by excluding one study33 with lower quality. This operation reduced the heterogeneity in the consistency of the trial results (I=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 patientThree trials27, 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; I=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 complicationsData extracted from three studies24, 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, I=0%; Figure 6).Deep vein thrombosis Data extracted from four studies24, 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 Figure 4 Forest plot and meta-analysis of the blood transfusion rateFigure 5 Forest plot and meta-analysis of the mean number of units transfused per patientFigure 6 Forest plot and meta-analysis of wound complicationsFigure 7 Forest plot and meta-analysis of deep vein thrombosisFigure 8 Forest plot and meta-analysis of febrile complicationsFigure 9 Forest plot and meta-analysis of post-operative hemoglobin on days 58Figure 10 Forest plot and meta-analysis of the drainage volumeFigure 11 Forest plot and meta-analysis of the length of hospital staydetected (P=0.64, I=0%; Figure 7). Secondary outcomes of meta-analysisFebrile complicationsSix trials26-27, 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; I=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 study33 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 5-8Three studies26, 32-33 reported post-operative hemoglobin on days 5-8. Among them, one study26 reported hemoglobin on the fifth day post-operation, another study32 reported hemoglobin on the eighth day post-operation, and the final study33 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 bet