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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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Hypertension management in elderly with severe intracerebral hemorrhage
Zhao J, Yuan F, Fu F, Liu Y, Xue C, Wang K, Yuan X, Li D, Liu Q, Zhang W, et al
Annals of clinical and translational neurology. 2021;8(10):2059–2069
Abstract
OBJECTIVE To explore the effect of individualized blood pressure (BP)-lowering treatment on the outcomes of elderly patients with severe intracerebral hemorrhage (ICH). METHODS We performed an exploratory analysis of Controlling Hypertension After Severe Cerebrovascular Event (CHASE) trial, which was a multicenter, randomized, controlled clinical trial. Patients with severe ischemic or hemorrhagic stroke (defined as GCS ≤ 12 or NIHSS ≥ 11) were randomized into individualized versus standard BP-lowering treatment in CHASE trial. In this exploratory analysis, patients with severe ICH were included. The primary outcome was the percentage of patients with 90-day functional independence defined as modified Rankin Scale (mRS) ≤2. RESULTS We included 242 patients with severe ICH in the present analysis, consisting of 142 patients aged <65 years and 100 patients aged ≥65 years. There were significant differences between patients aged ≥65 years and <65 years in the proportion of functional independence (47.9% vs. 15.0%, P < 0.001) and good outcome (73.9% vs. 50.0%, P < 0.001) at day 90. In patients aged ≥65 years, the adjusted individualized BP-lowering treatment had an unequivocal effect on the functional independence at day 90 (21.6% vs. 8.2%, odds ratio [OR]: 4.309, 95% confidence interval [CI]: 1.040-17.859, P = 0.044) and improved the neurological deficits at discharge (∆ NIHSS ≥ 4: 64.7% vs. 34.7%, OR: 4.300, 95% CI: 1.599-11.563, P = 0.004). INTERPRETATION Compared with the younger counterparts, the elderly patients (≥65 years) with acute severe ICH might benefit more from individualized BP-lowering treatment.
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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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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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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.