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Flapless osteotome-mediated sinus floor elevation using platelet-rich fibrin versus lateral approach using deproteinised bovine bone mineral for residual bone height of 2-6 mm: a randomised trial
Lv H, Sun X, Wang J, Wang H, Wang L, Zhou Y
Clinical oral implants research. 2022
Abstract
OBJECTIVES To evaluate patient-reported outcomes and radiographic results of simultaneous implant placement in severely atrophic maxilla using flapless endoscope-assisted osteotome sinus floor elevation with platelet-rich fibrin (PRF), also defined as PESS, and to compare the results with those of lateral sinus floor elevation (LSFE). METHODS Patients with a residual bone height (RBH) of 2-6 mm were included in a randomised controlled trial. PESS was performed with PRF as the sole grafting material. LSFE was performed using deproteinised bovine bone matrix. Patient-reported outcomes were recorded on a visual analogue scale (VAS-pain) and visual rating scale (VRS-swelling and VRS-willingness). Peri-implant bone height (PBH), bone mineral density (BMD), and sinus grafting remodelling index were measured using CBCT immediately postoperatively and 3(rd) , 6(th) and 18(th) months post-surgery. RESULTS The study population consisted of 20 patients in each group. The RBH of two groups averaged 3.35±0.79 mm and 2.92±0.63 mm with no significant difference (p > 0.05). VAS-pain was 18.0 (IR 15.0-22.5) and 35.0 (IR 32.5-37.0) in the PESS and LSFE groups, respectively (p < 0.01). VAS-pain decreased with time in both groups. VRS-swelling was lower in the PESS group than LSFE group. VRS-willingness was higher in the PESS group than LSFE group (p < 0.01). At 18 months post-surgery, the marginal bone loss was 0.60±0.25 mm and 0.69±0.35 mm in the two groups with no significant difference (p = 0.52). CONCLUSIONS Within the limitations of this study, PESS was associated with lower postoperative morbidity and was more tolerable than LSFE. PESS could be a reliable procedure for sinus floor elevation in patients with insufficient RBH.
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Effect of ulinastatin on post-operative blood loss and allogeneic transfusion in patients receiving cardiac surgery with cardiopulmonary bypass: a prospective randomized controlled study with 10-year follow-up
Zhang P, Lv H, Qi X, Xiao W, Xue Q, Zhang L, Li L, Shi J
J Cardiothorac Surg. 2020;15(1):98
Abstract
BACKGROUND Major bleeding and allogeneic transfusion leads to negative outcomes in patients receiving cardiac surgery with cardiopulmonary bypass (CPB). Ulinastatin, a urine trypsin inhibitor, relieves systemic inflammation and improves coagulation profiles with however sparse evidence of its effects on blood loss and allogeneic transfusion in this specific population. METHODS In this prospective randomized controlled trial, 426 consecutive patients receiving open heart surgery with CPB were randomly assigned into three groups to receive ulinastatin (group U, n = 142), tranexamic acid (group T, n = 143) or normal saline (group C, n = 141). The primary outcome was the total volume of post-operative bleeding and the secondary outcome included the volume and exposure of allogeneic transfusion, the incidence of stroke, post-operative myocardial infarction, renal failure, respiratory failure and all-cause mortality. A ten-year follow-up was carried on to evaluate long-term safety. RESULTS Compared with placebo, ulinastatin significantly reduced the volume of post-operative blood loss within 24 h (688.39 +/- 393.55 ml vs 854.33 +/- 434.03 ml MD - 165.95 ml, 95%CI - 262.88 ml to - 69.01 ml, p < 0.001) and the volume of allogeneic erythrocyte transfusion (2.57 +/- 3.15 unit vs 3.73 +/- 4.21 unit, MD-1.16 unit, 95%CI - 2.06 units to - 0.26 units, p = 0.002). The bleeding and transfusion outcomes were comparable between the ulinastatin group and the tranexamic acid group. In-hospital outcomes and 10-year follow-up showed no statistical difference in mortality and major morbidity among groups. CONCLUSIONS Ulinastatin reduced post-operative blood loss and allogeneic erythrocyte transfusion in heart surgery with CPB. The mortality and major morbidity was comparable among the groups shown by the 10-year follow-up. TRIAL REGISTRATION The trial was retrospectively registered on February 2, 2010. TRIAL REGISTRATION NUMBER https://www.clinicaltrials.gov Identifier: NCT01060189.
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Different dose regimes and administration methods of tranexamic acid in cardiac surgery: a meta-analysis of randomized trials
Guo J, Gao X, Ma Y, Lv H, Hu W, Zhang S, Ji H, Wang G, Shi J
BMC anesthesiology. 2019;19(1):129
Abstract
BACKGROUND The efficacy of tranexamic acid (TXA) to reduce perioperative blood loss and allogeneic blood transfusion in cardiac surgeries has been proved in previous studies, but its adverse effects especially seizure has always been a problem of concern. This meta-analysis aims to provide information on the optimal dosage and delivery method which is effective with the least adverse outcomes. METHODS We searched Cochrane Central Register of Controlled Trials, MEDLINE and EMBASE for all relevant articles published before 2018/12/31. Inclusion criteria were adult patients undergoing elective heart surgeries, and only randomized control trials comparing TXA with placebo were considered. Two authors independently assessed trial quality and extracted relevant data. RESULTS We included 49 studies with 10,591 patients into analysis. TXA significantly reduced transfusion rate (RR 0.71, 95% CI 0.65 to 0.78, P<0.00001). The overall transfusion rate was 35%(1573/4477) for patients using TXA and 49%(2190/4408) for patients in the control group. Peri-operative blood loss (MD - 246.98 ml, 95% CI - 287.89 to - 206.06 ml, P<0.00001) and re-operation rate (RR 0.62, 95% CI 0.49 to 0.79, P<0.0001) were also reduced significantly. TXA usage did not increase risk of mortality, myocardial infarction, stroke, pulmonary embolism and renal dysfunction, but was associated with a significantly increase in seizure attack (RR 3.21, 95% CI 1.04 to 9.90, P = 0.04).The overall rate of seizure attack was 0.62%(21/3378) for patients using TXA and 0.15%(5/3406) for patients in the control group. In subgroup analysis, TXA was effective for both on-pump and off-pump surgeries. Topical application didn't reduce the need for transfusion requirement, while intravenous delivery no matter as bolus injection alone or bolus plus continuous infusion were effective. Intravenous high-dose TXA didn't further decrease transfusion rate compared with low-dose regimen, and increased the risk of seizure by 4.83 times. No patients in the low-dose group had seizure attack. CONCLUSIONS TXA was effective in reducing transfusion requirement in all kinds of cardiac surgeries. Low-dose intravenous infusion was the most preferable delivery method which was as effective as high-dose regimen in reducing transfusion rate without increasing the risk of seizure.
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Effects of Tranexamic Acid on Short-term and Long-term Outcomes of On-pump Coronary Artery Bypass Grafting: Randomized Trial and 7-Year Follow-Up
Zhang Y, Gao X, Yuan S, Guo J, Lv H, Zhou Y, Wang Y, Ji H, Wang G, Li L, et al
Cardiovascular Therapeutics. 2018;:e12472.
Abstract
AIMS: Safety evaluations of tranexamic acid (TXA) remain sparse, especially with respect to its impact on long-term outcomes in patients undergoing on-pump coronary artery bypass grafting (CABG). We hypothesized that the effects of TXA on perioperative bleeding and allogeneic transfusion and its impact on long-term clinical outcomes of patients receiving on-pump CABG are superior to those in the control group. METHODS In this prospective, randomized, placebo-controlled trial, 210 patients undergoing primary and isolated on-pump CABG were randomly assigned to receive TXA or a corresponding volume of saline solution. Randomly assigned patients were followed up at 1, 3, 5, and 7 years after hospital discharge. Finally, 163 patients fulfilled the 7-year follow-up. The primary outcome was allogeneic red blood cell (RBC) transfusion. Long-term mortality and morbidity were also evaluated. RESULTS Compared with placebo, TXA reduced the allogeneic RBC requirement in terms of the volume transfused (4.20+/-4.06 vs. 6.25+/-4.86 units; p<0.01), ratio exposed (52.0% vs. 71.6%; p<0.01), and blood loss volume (879.0+/-392.5 vs. 1154.0+/-582.8 mL; p<0.01). Except for myocardial infarction, there were no significant differences in mortality or morbidity between the two groups during the 7-year follow-up. The TXA group had a lower rate of myocardial infarction than did the placebo group (0.0% vs. 4.9% at 84 months; p=0.03). CONCLUSIONS TXA significantly decreased postoperative bleeding and allogeneic transfusion in patients undergoing on-pump CABG. The 7-year follow-up suggested that the use of TXA was safe and might play a potential role in the prevention of long-term myocardial infarction. This article is protected by copyright. All rights reserved.
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A meta-analysis and systematic review evaluating the use of erythropoietin in total hip and knee arthroplasty
Li Y, Yin P, Lv H, Meng Y, Zhang L, Tang P
Therapeutics and Clinical Risk Management. 2018;14:1191-1204.
Abstract
Purpose: The debate is still ongoing on the effectiveness and safety of erythropoietin (EPO) treatment in orthopedic surgeries. Specifically, previous studies have not compared the dynamic change of hemoglobin (Hb) levels between different transfusion methods. Besides, complications or side effects of this alternative have not been quantitatively analyzed. We conducted a meta-analysis and systemic review to evaluate the efficacy of EPO on Hb levels observed during the whole perioperative period as well as the volume of allogeneic blood transfusion (ABT), the risk of venous thromboembolism, and application frequency of ABT in hip and knee surgery. Materials and methods: PubMed, Embase, Web of Science, and the Cochrane library were systematically searched from inception to November 2017. The data from randomized controlled trials were extracted and the risk of bias assessed using Cochrane's Collaboration's tool. Results: Twenty-five randomized controlled trials involving 4,159 patients were included in this meta-analysis. EPO could reduce exposure to allogeneic blood transfused (odds ratio [OR] =0.42, P=0.001) and reduce the average volume of allogeneic blood transfused (OR = -0.28, P=0.002). When EPO and preoperative autologous blood donation (PABD) were compared, the use of EPO was associated with lower exposure to ABT (OR =0.48, P=0.03), but no significant decrease in the average volume of allogeneic blood transfused (OR = -0.23, P=0.32). The use of EPO was associated with a higher level of Hb with or without use of PABD at all the 4 time points (preoperation, 24-48 hours postoperation, 3-5 days postoperation, discharge of last observation) (P<0.0001), which means EPO could increase the level of Hb significantly during the perioperative period. The results also indicated EPO does not increase the risk of a venous thromboembolism event. Conclusion: Preoperative administration of EPO was shown to generally increase Hb levels during the whole perioperative period; however, the extent of the positive effects varies with time points. Additionally, EPO minimizes the need for transfusion significantly in patients undergoing hip or knee surgery without increasing the chance of developing thrombotic complications. Therefore, EPO offers an alternative blood management strategy in total hip arthroplasty and total knee arthroplasty.
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Intra-articular versus intravenous tranexamic acid application in total knee arthroplasty: a meta-analysis of randomized controlled trials
Mi B, Liu G, Zhou W, Lv H, Liu Y, Zha K, Wu Q, Liu J
Archives of Orthopaedic and Trauma Surgery. 2017;137((7):):997-1009
Abstract
BACKGROUND The purpose of this meta-analysis was to compare the blood loss and complications of intra-articular (IA) with intravenous (IV) tranexamic acid (TXA) for total knee arthroplasty (TKA). METHODS A comprehensive search of studies was conducted to identify related articles in Pubmed, Embase, Cochrane central Register of Controlled Trials, springerLink, OVID and the Research published from January 1980 to September 2016. All studies that compared IA TXA with IV TXA application on TKA were included. Main outcomes of the two methods were collected and analyzed by using Review Manager 5.3. RESULTS There were 16 randomized controlled trials with 1308 cases met the criteria. Compared with IV TXA, IA TXA had similar blood volume of drainage, hidden blood loss, transfusion rate and complications (P > 0.05). IA TXA had lower total blood loss than IV TXA, and there was significant difference (P < 0.05). Subgroup analysis of total blood loss based on times of IV TXA administration showed that repeat dose of IV TXA had a higher total blood loss and postoperative hemoglobin drop (P < 0.05) than IA TXA. However, single dose of IV TXA had a similar efficacy on total blood loss and postoperative hemoglobin drop (P > 0.05) when compared with IA TXA. CONCLUSIONS Both IA TXA and single dose of IV TXA are effective in reducing total blood loss and postoperative hemoglobin drop without increasing complications of DVT or PE. The current meta-analysis suggests that 1.5 g TXA by IA administration or 1 g TXA by IV administration 10 min before tourniquet deflation is effective and safe in patients undergoing TKA.
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Is combined use of intravenous and intraarticular tranexamic acid superior to intravenous or intraarticular tranexamic acid alone in total knee arthroplasty? A meta-analysis of randomized controlled trials
Mi B, Liu G, Lv H, Liu Y, Zha K, Wu Q, Liu J
Journal of Orthopaedic Surgery and Research. 2017;12((1)):61.
Abstract
BACKGROUND Tranexamic acid (TXA) has been proven to be effective in reducing blood loss and transfusion rate after total knee arthroplasty (TKA) without increasing the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE). Recently, an increasing number of studies have been interested in applying combined intravenous (IV) with intraarticular (IA) tranexamic acid in total knee arthroplasty. The purpose of this meta-analysis was to compare the blood loss and complications of combined TXA with IV TXA or IA TXA on TKA. METHODS Systematic search of literatures were conducted to identify related articles that were published in PubMed, MEDLINE, Embase, the Cochrane Library, SpringerLink, ClinicalTrials.gov, and Ovid from their inception to September 2016. All studies that compare blood loss and complications of combined TXA and IV TXA or IA TXA on TKA were included. Main outcomes were collected and analyzed by the Review Manager 5.3. RESULTS Five studies were included in the present meta-analysis. There was significant difference in total blood loss and blood volume of drainage when compared combined TXA group with IV TXA group or IA TXA group (P < 0.05). There was no difference in transfusion rate and thromboembolic complications when comparing combined TXA with IV TXA or IA TXA alone (P > 0.05). CONCLUSIONS Compared with administration of IA TXA or IV TXA alone on TKA, combined use of TXA has advantages in reducing total blood loss and blood volume of drainage without increasing the incidence of thromboembolic complications. We recommend combined TXA as the preferred option for patients undergoing TKA.
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Tranexamic acid in on-pump coronary artery bypass grafting without clopidogrel and aspirin cessation: randomized trial and 1-year follow-up
Shi J, Wang G, Lv H, Yuan S, Wang Y, Ji H, Li L
Annals of Thoracic Surgery. 2013;95((3):):795-802.
Abstract
BACKGROUND Dual antiplatelet therapy is widely used in patients with coronary artery disease and increases the risk of excessive bleeding and transfusion in those undergoing coronary artery bypass grafting (CABG). METHODS The study was a prospective, randomized, double-blinded and placebo-controlled trial. Patients undergoing primary and isolated on-pump CABG with their last dose of clopidogrel and aspirin less than 7 days preoperatively were randomly assigned to receive tranexamic acid (15 mg/kg before surgical incision and 15 mg/kg after protamine neutralization) or a corresponding volume of saline solution. The primary outcome was allogeneic erythrocyte transfusion. RESULTS Randomly assigned participants were 120 adults among whom 117 were analyzed, 58 in the tranexamic acid group and 59 in the placebo group. As compared with placebo, tranexamic acid reduced allogeneic erythrocyte requirement-both the volume transfused (4.84 +/- 5.85 versus 9.36 +/- 11.41 units; mean difference -4.52 units; 95% interval confidence [CI], -7.85 to -1.19 units; p < 0.001) and the ratio exposed (72.4% versus 91.5%; risk difference in percentage point, -19.1; 95% CI, -32.6 to -5.59; relative risk, 0.79; 95% CI, 0.66 to 0.94; p = 0.007)-blood loss (1069.1 +/- 565.5 mL versus 1449.8 +/- 899.8 mL; mean difference, -380.7 mL; 95% CI, -656.4 to -104.9 mL; p = 0.005), major bleeding (50.0% versus 78.0%; risk difference, -28.0; 95% CI, -44.6 to -11.3; relative risk, 0.64; 95% CI, 0.48 to 0.86; p = 0.002), and reoperation (0.0% versus 10.2%; risk difference, -10.2; 95% CI, -17.9 to -2.46; relative risk, 0.08; 95% CI, 0.00 to 1.36; p = 0.01). CONCLUSIONS Tranexamic acid significantly reduced blood loss, major bleeding, reoperation, and allogeneic transfusion in patients undergoing primary and isolated on-pump CABG without clopidogrel and aspirin cessation. Copyright 2013 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.