Metabolomics-Based Clinical Efficacy of Compound Shenlu Granule, a Chinese Patent Medicine, in the Supportive Management of Aplastic Anemia Patients: A Randomized Controlled Pilot Trial
Evidence-based complementary and alternative medicine : eCAM. 2021;2021:6655848
OBJECTIVE To explore the clinical efficacy and mechanism of compound Shenlu granule (SLG) treatment in patients with aplastic anemia (AA). METHODS A total of 89 AA patients were randomly divided into an SLG supportive group (group A, n = 44) and a control group (group B, n = 45) while continuing Western medical management. After 6 months, hemograms, traditional Chinese medicine (TCM) syndrome scores, and overall clinical efficacy rate were assessed. Serum metabolomics characteristics were observed using ultraperformance liquid chromatography-mass spectrometry after SLG intervention. RESULTS The levels of red blood cell (RBC), hemoglobin (Hb), and platelet (PLT) were increased in both groups after treatment for 6 months (P < 0.05), and in group A, the elevation of PLT became much more significant (P < 0.01). The TCM syndrome score was lower in group A than in group B after treatment (P < 0.05). Metabolomics data showed a significant difference in the patients using SLG after 6 months, and 14 biomarkers were identified. CONCLUSION SLG supportive treatment showed positive results in patients with AA, and metabolomics data indicated that SLG influenced aminoacyl-tRNA biosynthesis and glycerophospholipid metabolism to gradually return to normal.
Use of recombinant activated factor VII for the treatment of perioperative bleeding in noncardiac surgery patients without hemophilia: A systematic review and meta-analysis of randomized controlled trials
Journal of critical care. 2020;62:164-171
PURPOSE To evaluate the efficacy and safety of perioperative use of recombinant activated factor VII (rFVIIa) in noncardiac patients. MATERIALS AND METHODS We searched electronic databases for randomized controlled trials (RCTs) that involved the use of rFVIIa through December 13, 2019 in noncardiac patients without hemophilia. Two investigators extracted the related data and assessed the quality of the included trials. RESULTS Eleven RCTs examining 993 perioperative patients were ultimately included. The use of rFVIIa did not decrease all-cause mortality (RR:0.90; 95% CI:0.50,1.64; I(2) = 0.0%; P = 0.738), shorten the length of ICU (SMD:-0.15; 95% CI:-0.47,0.17; I(2) = 0.0%; P = 0.346) or hospital (SMD:0.42; 95% CI:-0.05,0.89; I(2) = 0.0%; P = 0.078) stay, or increase incidence of the thromboembolic events (RR:1.30; 95% CI:0.70,2.41; I(2) = 0.0%; P = 0.403) among perioperative patients. However, individual RCT analyses showed that the use of rFVIIa could reduce the volume of blood loss (including prostatic cancer, severe acute pancreatitis (SAP), and spinal disease) and the transfusion of RBCs (including prostatic cancer, SAP, and spinal disease) and FFP (SAP) in a subset of perioperative patients. Publication bias was not present. CONCLUSIONS For perioperative hemorrhagic patients, rFVIIa-based hemostatic therapy showed no effect on mortality, ICU or hospital LOS, or the rate of thromboembolic events, although it appears to decrease blood loss and reduce the need for blood product transfusion in a subset of patients.
Effect of Two Different Colloid Priming Strategies in Infants Weighing Less Than 5 kg Undergoing On-pump Cardiac Surgeries
Artificial organs. 2019
OBJECTIVES To explore the effect of two different priming strategies (artificial colloid only vs. artificial colloid combined with human serum albumin) on the prognosis of children weighing less than 5 kg undergoing on-pump congenital heart disease (CHD) surgery. METHODS A total of 65 children weighing less than 5 kg who underwent on-pump CHD surgery in our hospital from September 2016 to December 2017 were enrolled in this study. The children were randomly divided into two groups: artificial colloid priming group (AC group, n=33) and artificial colloid combined albumin priming group (ACA group, n=32). The primary clinical endpoint was the peri-CPB colloid osmotic pressure (COP). Secondary clinical endpoints included perioperative blood product & hemostatic drug consumption, postoperative renal function, coagulation function, postoperative renal function and postoperative recovery parameters. RESULTS COP values were not significant in the priming system as well as peri-CPB time points between the two groups (P>0.05). Platelet consumption in the AC group was significantly lower than that in the ACA group (P<0.05). There were no significant differences in the use of other blood products and hemostatic drugs as well as perioperative coagulation parameters between the two groups (P>0.05). Postoperative length of stay in the AC group was significantly lower than that in the ACA group (P<0.05). There were no significant differences in mortality, postoperative mechanical ventilation time, ICU time and perioperative adverse event (including postoperative AKI) occurrences between the two groups (P>0.05). CONCLUSIONS In the on-pump cardiac surgeries of patients weighting less than 5kg, total colloidal priming would not affect peri-CPB COP values, postoperative coagulation function and blood products consumption. Total artificial colloidal priming strategy is feasible in low-weight patients.
Evidence-based use of FFP: the influence of a priming strategy without FFP during CPB on postoperative coagulation and recovery in pediatric patients
OBJECTIVE Although fresh frozen plasma (FFP) is one of the most commonly used hemostatic agents in clinical specialties today, there is little evidence available supporting its administration. Our present study observed the effects of a priming strategy without FFP during cardiopulmonary bypass (CPB) on postoperative coagulation and clinical recovery in pediatric patients, aiming to supply new evidence for evidence-based use of FFP. METHOD Eighty pediatric patients with congenital heart disease undergoing cardiac surgery with CPB were randomized to receive either 10-20 ml/kg 4% succinylated gelatin (Gelofusine, GEL group, n = 40) or 1-2 units FFP (FFP group, n = 40) in the pump prime. Rapid-thromboelastography (r-TEG) and functional fibrinogen level were measured before skin incision and 15 minutes after heparin reversal. We recorded the volume of chest tube drainage, transfusion requirements and the dosage of pharmacological agents. The ventilation time, ICU length of stay and hospitalization time after surgery were also collected. RESULTS After heparin neutralization, there were significantly elevated levels of fibrinogen in the FFP group, which were manifested by r-TEG parameters MAf and FLEV. No significant differences were observed between the two groups in postoperative bleeding, transfusion requirements and the usage of pharmacological agents. Recovery time was also comparable between the two groups. CONCLUSION In conclusion, prophylactic use of FFP in the priming solution does not provide clinical benefits as presumed. Artificial colloids, such as Gelofusine, can be used safely and effectively as a substitute for FFP in the pump prime. TEG is an effective assessment tool to evaluate postoperative coagulation function in pediatric patients.Copyright © The Author(s) 2014.
Hemostatic agents used for nephrostomy tract closure after tubeless PCNL: a systematic review and meta-analysis
To evaluate the role of hemostatic agents used for nephrostomy tract closure after tubeless percutaneous nephrolithotomy (PCNL). A systematic review of Pubmed, Embase and Cochrane was performed. All studies that compared hemostatic agents with common methods (silk stitch or pressure dressing) were included. The analyzed outcomes were hospital stay, operative time, blood loss, transfusion rate, fever rate, and complication rate. A total of eight articles including six RCTs met our criteria. Hemostatic agents showed short hospital stay (MD -4.54, 95 % CI -6.78 to -2.36, p < 0.0001). There was no difference between hemostatic agents and common methods on operative time (MD 2.00, 95 % CI -17.32 to 21.33, p = 0.84), blood loss (MD -0.19, 95 % CI -0.41 to 0.03, p = 0.08), transfusion rate (OR 1.42, 95 % CI 0.34-5.96, p = 0.63), fever rate (OR 1.02, 95 % CI 0.33-3.12, p = 0.97) and complication rate (OR 1.02, 95 % CI 0.33-3.12, p = 0.97). Eight studies including six RCTs showed that use of hemostatic agents was safe. Hemostatic agents showed short hospital stay. There were no difference between hemostatic agents and common methods on blood loss, transfusion rate, fever rate, and complication rate.
The influence of cardiopulmonary bypass priming without FFP on postoperative coagulation and recovery in pediatric patients with cyanotic congenital heart disease
European Journal of Pediatrics. 2014;173((11):):1437-43.
UNLABELLED Transfusion guidelines have been produced for the evidence-based use of fresh frozen plasma (FFP). However, the inappropriate use of FFP is still a worldwide problem, especially in the prophylactic settings. In the present study, 100 cyanotic pediatric patients (age 6 months to 3 years) undergoing cardiac surgery with cardiopulmonary bypass (CPB) were randomized to receive either 10-20 ml/kg FFP (FFP group, n=50) or 10-20 ml/kg 4 % succinylated gelatin (Gelofusine, GEL group, n=50) in the priming solution. Rapid thromboelastography (r-TEG) was measured before skin incision and 15 min after heparin neutralization. Postoperative renal and hepatic function, mediastinal chest tube drainage, transfusion requirements, and recovery time were observed. The relationships between hematologic and demographic data and postoperative bleeding volume were also analyzed. The results showed that there were significantly elevated levels of fibrinogen (r-TEG parameters: fibrinogen contribution to maximal amplitude (MAf) and fibrinogen level (FLEV)) in the FFP group compared to the GEL group. The postoperative blood loss, total transfusion requirements, and recovery time were not significantly different between the two groups, indicating that there were no obvious clinical benefits of using FFP in the priming. The maximal amplitude (MA) of r-TEG measured after heparin neutralization was correlated with the 6-h postoperative bleeding volume. In addition, preoperative fibrinogen level rather than FFP priming was an independent predictor of postoperative blood loss. CONCLUSION Prophylactic use of FFP in the priming solution does not have obvious clinical benefits in cyanotic congenital heart disease (CCHD) patients. Gelofusine, an artificial colloid, is a safe and effective substitute of FFP in the priming solution. Furthermore, r-TEG can be used as a "real-time" assessment tool to evaluate postoperative bleeding and guide transfusion after cardiac surgery in pediatric patients.
Perioperative monitoring of thromboelastograph on blood protection and recovery for severely cyanotic patients undergoing complex cardiac surgery
Artificial Organs. 2010;34((11):):955-60.
In this study, we assessed the clinical effect of a new transfusion therapy guided by thromboelastograph (TEG) on blood protection. Thirty-one children with severe cyanosis (hematocrit ≥ 54%), who were diagnosed as having transposition of the great arteries or double outlet right ventricle with or without pulmonary valve stenosis, and underwent arterial switch operation or double roots transplantation, were involved and were divided into two groups. In group F (n=17), the transfusion therapy after cardiopulmonary bypass was performed with fibrinogen administration combined with traditional transfusion, guided by TEG. In group C (n=14), traditional transfusion guided by clinical experiences only was performed. We observed the blood protection effects and recovery conditions of these patients. In surgery, compared with group C, the chest closure time, fresh-frozen plasma (FFP), and platelet (PLT) volume used at closure time had no significant reductions in group F (P>0. 05, respectively), and the patients in group F had no significant reductions in the amount of chest drainage (P>0. 05). The total PLT and total red blood cells usage were also the same (P>0. 05). But during the first 24h, FFP usage in the intensive care unit (ICU) and total perioperative FFP usage had significantly dropped in group F (P<0. 05); the mechanical ventilator time, ICU stay, and hospitalization time in group F were much shorter than those in group C (P<0. 05). So, TEG was effective in perioperative blood protection. Fibrinogen could be a substitute for FFP to restore hemostasis and improve the prognosis for these patients.
The effect of preprocessing stored red blood cells on neonates undergoing corrective cardiac surgery
ASAIO Journal (American Society for Artificial Internal Organs : 1992). 2007;53((6):):680-3.
This study compared the effect of unprocessed and processed packed red blood cells (PRBCs) with the continuous autotransfusion system (CATS) during neonate heart surgery. Sixteen neonatal patients undergoing cardiac surgery were randomly divided into two groups: unprocessed PRBC (C group, n = 8); processed PRBC (P group, n = 8). The CATS was employed perioperatively. Series laboratory and clinical parameters, including levels of hematocrit, blood potassium, blood glucose, blood lactate, acid-base, and total priming volume of PRBC, were used to compare the effect between the two groups. Before CPB, the hematocrit of processed PRBCs in P group was significantly higher than those in C group (p < 0. 01), and the concentrations of potassium, blood glucose, and lactate of processed PRBCs in P group were significantly lower than those in C group (p < 0. 01). At the beginning and the end of CPB, the hematocrit levels in P group were all higher than those in C group (p < 0. 05); lactate levels in P group were significantly lower than those in C group at the beginning of CPB (p < 0. 01), and lower than that of C group at the end of CPB (p < 0. 05). The total priming of PRBCs in P group was significantly less than that in C group (p < 0. 01). Perioperative processing with CATS provided a high-quality RBC concentration, decreased the total priming of PRBCs, providing increased high-quality blood salvage during neonatal CPB procedure.