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Efficacy, safety and bioequivalence of the human-derived B-domain-deleted recombinant factor VIII TQG202 for prophylaxis in severe haemophilia A patients
Xi Y, Jin C, Liu W, Zhou H, Wang Z, Zhou R, Lou S, Zhao X, Chen F, Cheng P, et al
Haemophilia : the official journal of the World Federation of Hemophilia. 2022
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Abstract
INTRODUCTION Current treatment of severe haemophilia A includes prophylaxis with factor VIII (FVIII) replacement. The supply of plasma-derived FVIII is short in China. PURPOSE To evaluate the efficacy and safety of a new B-domain deleted (BDD) recombinant FVIII (TQG202) produced by human-derived cells for prophylaxis in severe haemophilia A patients and compare the bioequivalence with Xyntha. METHODS This multicentre, clinical trial consisted of an open-label, randomized, two-period cross-over trial assessing single-dose pharmacokinetics (PK), and a single-arm clinical trial evaluating the efficacy and safety of 24 weeks of TQG202 prophylaxis, and repeated PK were assessed after prophylaxis phase. The single-dose was 50 IU/kg in PK assessment, and the initial dose was 30 ± 5 IU/kg for prophylaxis. The primary endpoints of prophylaxis were the annualized bleeding rate (ABR) and the incremental recovery rate of the first administration. Adverse events (AEs) were recorded. RESULTS Twenty-six participants were enrolled in the PK assessment and 81 participants in the prophylaxis phase. Mean age was 25.9 ± 10.8 years and all participants were male. The results of PK assessment showed TQG202 is bioequivalent to Xyntha. The total ABR was 2.0 (95% CI: 1.2-2.9) in prophylaxis phase. The mean incremental recovery rate of the first administration was .027 (95% CI: .026-.028) (IU/ml)/(IU/kg). AEs occurred in 42 participants, with an incidence of 51.9%. One severe AE not related to TQG202 occurred. No participants developed FVIII inhibitors. CONCLUSION TQG202 shows bioequivalence with Xyntha. The promising efficacy and tolerability in the severe haemophilia A prophylaxis support the use of TQG202in clinical practice.
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Efficacy and safety of perioperative tranexamic acid in elderly patients undergoing trochanteric fracture surgery: a randomised controlled trial
Chen F, Jiang Z, Li M, Zhu X
Hong Kong medical journal = Xianggang yi xue za zhi. 2019
Abstract
INTRODUCTION Trochanteric fractures result in a high frequency of considerable blood loss, a high incidence of blood transfusions, and a high risk of perioperative morbidity and mortality in elderly patients. This study aimed to evaluate the efficacy and safety of a three-dose regimen of tranexamic acid on blood loss and transfusion rate in elderly patients with trochanteric fractures. METHODS Eligible patients with trochanteric fractures surgically treated by dynamic hip screw and proximal anti-rotating intramedullary nail between March 2016 and October 2017 were enrolled in the study. Patients were randomly assigned to receive 15 mg/kg intravenous tranexamic acid dissolved in 100 mL of saline (TXA group) or 100 mL of saline solution (placebo group) over 10 minutes before, during, and after surgery. Perioperative blood loss, obvious blood loss, and hidden blood loss in the two groups were calculated separately. Vascular events and patient mortality over 6 months' follow-up were noted. RESULTS In total, 176 patients were included. Compared with the placebo group (n=88), patients in the TXA group (n=88) had less blood loss: perioperative blood loss was 205.5 mL (P<0.001), obvious blood loss was 125 mL (P<0.001), and hidden blood loss was 76.5 mL (P<0.001); reduced incidence of blood transfusion (17% vs 35%, P=0.007); and shorter hospital stays (median [interquartile range], 7 [6-8] vs 8.5 [7.5-9] days, P<0.001). CONCLUSION Tranexamic acid significantly lowered perioperative blood loss and blood transfusion rate without an increased risk of venous thromboembolism or mortality in elderly patients with trochanteric fractures treated with dynamic hip screw or proximal anti-rotating intramedullary nail.
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Minimally invasive surgery is superior to conventional craniotomy in patients with spontaneous supratentorial Intracerebral hemorrhage:a systematic review and meta-analysis
Xia Z, Wu X, Li J, Liu Z, Chen F, Zhang L, Zhang H, Wan X, Cheng Q
World Neurosurgery. 2018;115:266-273
Abstract
BACKGROUND Outcomes of minimally invasive surgery (MIS) versus conventional craniotomy (CC) for patients with spontaneous supratentorial intracerebral hemorrhage(SICH) have not been previously compared. We reviewed the current evidence regarding the safety and efficacy of MIS as compared with conventional craniotomy, in patients with SICH. METHODS We conducted a meta-analysis of studies that comparing MIS and CC in patients with computed tomography confirmed SICH, published from January 2000 to April 2018 in Medline, Embase, and Cochrane Controlled Trials Register (CCTR) based on PRISMA inclusion and exclusion criteria. Binary outcomes comparisons between MIS and CC were described using odds ratios (ORs). RESULTS Five randomized controlled trials (RCTs) and nine prospective controlled studies (non-RCTs) met the included criteria, involving 2466 patients. There was statistically significant difference in mortality rates between MIS and CC (OR, 0.76; 95% confidence interval [CI], 0.60-0.97). MIS associated with lower rates of complications in rebleeding (OR, 0.42; 95% CI, 0.28-0.64), and higher rates of good recovery compared with CC (OR, 2.27; 95% CI, 1.34-3.83). CONCLUSIONS Patients with SICH may benefit more from MIS than CC. Our study could help clinicians to optimize treatment strategies in SICH.
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The effect of tranexamic acid on blood loss and use of blood products in total knee arthroplasty: a meta-analysis
Zhang H, Chen J, Chen F, Que W
Knee Surgery, Sports Traumatology, Arthroscopy. 2012;20((9):):1742-52.
Abstract
PURPOSE Studies have shown that tranexamic acid (TXA) reduces blood loss and transfusion need in patients undergoing total knee arthroplasty (TKA). However, no single study has been large enough to definitively determine whether the drug is safe and effective. We report a systematic review and meta-analysis of randomised controlled trials evaluating the efficacy and safety of TXA in reducing blood loss and transfusion in TKA. METHODS A comprehensive literature search was done in Cochrane Library, MEDLINE, EMBASE, and CNKI. Two reviewers independently identified the eligible studies, assessed their methodological quality, and extracted data. The data were evaluated using the generic evaluation tool designed by the Cochrane Bone, Joint and Muscle Trauma Group. The relevant data were analyzed using RevMan 5.0. RESULTS Fifteen randomized controlled trials involving 842 patients were included. The use of TXA reduced total blood loss by a mean of 487ml [95% confidence interval (CI) -629 to -344], intra-operative blood loss by a mean of 127ml (95% CI -313-59), and post-operative blood loss by a mean of 245ml (95% CI -410 to -80). TXA led to a significant reduction in the proportion of patients requiring blood transfusion (risk difference -0.4). There were no significant differences in deep-vein thrombosis (DVT), pulmonary embolism, or other complications among the study groups. CONCLUSION Meta-analysis indicates that TXA may reduce post-operative, total blood loss and transfusion in patients undergoing TKA. TXA led to a significant reduction in the proportion of patients requiring blood transfusion. LEVEL OF EVIDENCE Therapeutic study (Systematic review of Level I studies with inconsistent results), Level II.