Low-dose PPI to prevent bleeding after ESD: A multicenter randomized controlled study
Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie. 2021;136:111251
BACKGROUND Although proton pump inhibitors (PPIs) are widely used in the prevention of gastric bleeding caused by endoscopic submucosal dissection (ESD), there is no consensus on the optimal regimen for these patients. Therefore, we aim to investigate whether intermittent use of low-dose PPI is sufficient to prevent post-ESD bleeding. METHODS This multicenter, non-inferiority, randomized controlled trial was conducted at 9 hospitals in China. Consecutive eligible patients with a diagnosis of gastric mucosal lesions after ESD treatment were randomly assigned (1:1) to receive either intermittent low-dose or continuous high-dose PPIs treatment. After three days, all patients administered orally esomeprazole 40 mg once a day for 8 weeks. The primary endpoint was post-ESD bleeding within 7 days. Analysis was done according to the intention-to-treat principle with the non-inferiority margin (Δ) of 5%. RESULTS 526 consecutive patients were assessed for eligibility from 30 September 2017 to 30 July 2019, of whom 414 were randomly assigned to low-dose (n = 209) or high-dose (n = 205) esomeprazole treatment group without dropouts within7 days. The total post-ESD bleeding is occurred in 13 (6.2 %, 95 % CI 3.3-9.6) of 209 within 7 days in the intermittent low-dose group, and 12 (5.9 %, 95 % CI 2.9-9.3) of 205 in the continuous high-dose group. The absolute risk reduction (ARR) was 0.4 % (-4.2, 4.9). One month after ESD, There are 44 patients (21.1 %, 95 % CI 15.8, 26.8) and 39 patients (19.0 % 95 % CI 13.7, 24.4) in scar stage respectively in low-dose group and high-dose group (P = 0.875).The hospital costs in the low-dose PPI group was lower than high -dose group (P = 0.005). CONCLUSION The intermittent use of low-dose PPIs is sufficient to prevent post-ESD bleeding. It might be applied in clinical practice to prevent post-ESD bleeding and reduce the costs related to PPIs.
Low-dose, Early Fresh frozen plasma Transfusion therapy after severe trauma brain injury: a clinical, prospective, randomized, controlled study (LEFT)
World neurosurgery. 2019
BACKGROUND To investigate the role of Low-dose, Early Fresh frozen plasma Transfusion (LEFT) therapy in preventing peri-operative coagulopathy and improving long-term outcome after severe traumatic brain injury (TBI). METHODS A prospected, single-centre, parallel-group, randomized trial was designed. Patients with severe TBI were eligible. We used a computer-generated randomization list, and closed opaque envelopes to randomly allocate patients to treatment with FFP (5mL/kg of body weight) as LEFT treatment or normal saline (5mL/kg of body weight) as no LEFT treatment once admitting to operation room. RESULTS Between 1 January 2018 and 31 November 2018, 63 patients were included and randomly allocated to LEFT (n=28) and NO LEFT (n=35) groups. 20 patients in the LEFT group and 32 patients in the NO LEFT group were included in the final interim analysis. The study was terminated early for futility and safety reasons because of the high proportion of patients (7 of 20, 35.0 %) in the LEFT group developing new delayed traumatic intracranial hematoma (DTICH) after surgery as compared with 3 of 32 in the NO LEFT group (9.4 %) (relative risk, 5.205; 95% CI, 1.159 to 23.384; P=0.023). Demographic characteristics and indexes of severity of brain injury were similar at baseline. CONCLUSION Low-dose, early fresh frozen plasma transfusion therapy was associated with higher incidence of DTICH than normal FFP transfusion in patients with severe TBI. A restricted FFP transfusion protocol, in the right clinical setting, may be more appropriate in patients with TBIs. (Current Controlled Trials number, ChiCTR-INR-17013901).
Efficacy and safety of tranexamic acid usage in patients undergoing posterior lumbar fusion: a meta-analysis
BMC musculoskeletal disorders. 2019;20(1):390
BACKGROUND The purpose of this meta-analysis is to evaluate the efficacy and safety of tranexamic acid (TXA) for patients with degenerative lumbar disc herniation, stenosis or instability undergoing posterior lumbar fusion (PLF) surgery. METHODS We searched PubMed, Embase, and Cochrane Library until May 1, 2018. Two reviewers selected studies, assessed quality, extracted data, and evaluated the risk of bias independently. Weighted mean difference (WMD) and relative risk (RR) were calculated as the summary statistics for continuous data and dichotomous data, respectively. We chose fixed-effects or random-effects models based on I(2) statistics. RevMan 5.0 and STATA 14.0 software were used for data analysis. RESULTS Nine studies enrolling 713 patients for the study. The pooled outcomes demonstrated that TXA can decrease total blood loss (TBL) in patients underwent PLF surgery [WMD = -250.68, 95% CI (- 325.06, - 176.29), P<0.001], intraoperative blood loss (IBL) [WMD = -72.57, 95% CI (- 103.94, - 41.20), P<0.001], postoperative blood loss (PBL) [WMD = -127.57, 95% CI (- 149.39, - 105.75), P<0.001], and the loss of hemoglobin (Hb) in postoperative 24 h [WMD = -0.31, 95% CI (- 0.44, - 0.18), P<0.001]. However, there is no significant difference between two groups in transfusion rate [RR =0.34, 95% CI (0.09, 1.28), P = 0.11], and none thrombotic event was happened in the two groups. CONCLUSION Our meta-analysis demonstrated that TXA can decrease the Hb loss, TBL, IBL, PBL, and without increasing the risk of thrombotic event in patients with degenerative lumbar disc herniation, stenosis or instability underwent PLF surgery. However, there was no significant difference in blood transfusion rates between the two groups.
Effect of allogeneic blood transfusion on levels of IL-6 and sIL-R2 in peripheral blood of children with acute lymphocytic leukemia
Oncology Letters. 2018;16((1)):849-852.
Effect of allogeneic blood transfusion on the expression of interleukin-6 (IL-6) and soluble interleukin-2 receptor (sIL-2R) in peripheral blood of children with acute lymphoblastic leukemia (ALL) was investigated. A total of 91 ALL children admitted to Nanfang Hospital from June 2014 to January 2017 were selected as the study group. Patients were randomly divided into allogeneic blood transfusion group (n=38) and non-transfusion group (n=53). In addition, a total of 64 healthy children were also selected from June 2014 to January 2017 as the control group. Patients in allogeneic blood transfusion group were transfused with red blood cell suspension and machine-collected platelets, while patients in non-transfusion group were not treated with blood transfusion. Peripheral venous blood was collected before and at 4, 8 and 12 weeks after blood transfusion to prepare serum. Serum IL-6 and sIL-2R levels were measured by enzyme-linked immunosorbent assay (ELISA). Before transfusion, serum levels of IL-6 and sIL-2R were significantly lower in the study group than those in control group (p<0.05), and no significant differences in serum levels of IL-6 and sIL-2R were found between the allogeneic blood transfusion and non-transfusion group. After transfusion, serum levels of IL-6 and sIL-2R were stable for 12 weeks in the non-transfusion group, while IL-6 and sIL-2R levels were significantly increased in the allogeneic blood transfusion group. The results showed that serum level of IL-6 and sIL-2R was increased in ALL patients with allogeneic blood transfusion, which resulted in reduced antibody production and decreased cellular immunity. The patients had low immunity, and attention should be paid on the pathogen infection prevention.
A systematic review of tranexamic acid usage in patients undergoing femoral fracture surgery
Clinical Interventions in Aging. 2018;13:1579-1591.
Background: Patients undergoing femoral fracture surgery frequently require blood transfusion. Tranexamic acid (TXA) has been widely used to decrease transfusion rate in joint replacement surgery. Therefore, we conducted a systematic review to evaluate the efficacy and safety of TXA usage in femoral fracture surgery. Materials and methods: Studies involving TXA usage in femoral fracture surgery were searched through four electronic databases. The end points included total blood loss, postoperative hemoglobin decline, transfusion rate, thromboembolic events, 90-day mortality, and operative time. The present study was performed following Cochrane Reviewers' Handbook and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and was carried out by using Stata 14.0 software. Results: Eleven studies concerning intravenous (IV) application of TXA and three studies concerning topical administration of TXA were included. Twelve studies were randomized controlled trials (RCTs), and one was a retrospective cohort study. Regarding IV TXA, our paper indicated that the IV TXA group had less total blood loss (weighted mean difference [WMD] = -319.282, P = 0.000), lower postoperative hemoglobin decline (WMD = -1.14, P = 0.000) and lower transfusion rate (risk difference [RD] = -0.172, P = 0.000). No significant differences were found in thromboembolic events (RD = 0.008, P = 0.507), 90-day mortality (RD = 0.009, P = 0.732) and operative time (WMD = -2.227, P = 0.103). Regarding topical TXA, no significant differences were found in the transfusion rate (RD = -0.098, P = 0.129), postoperative hemoglobin decline (WMD = -1.137, P = 0.231), thromboembolic events (RD = -0.017, P = 0.660) and operative time (WMD = -4.842, P = 0.136). Conclusion: Our meta-analysis demonstrated that both IV and topical application of TXA reduced transfusion rate in femoral fracture surgery. However, still further studies are needed to identify the optimal route of administration, TXA dosage and timing. In addition, high-quality RCTs with a large sample size are required to figure out the safety of TXA application, especially in the elderly, before its wide recommendation.