High-dose dexamethasone plus recombinant human thrombopoietin versus high-dose dexamethasone alone as frontline treatment for newly diagnosed adult primary immune thrombocytopenia:a prospective, multicenter, randomized trial
American journal of hematology. 2020
We conducted a prospective, multicenter, randomized, controlled clinical trial to compare the efficacy and safety of high-dose dexamethasone (HD-DXM) plus recombinant human thrombopoietin (rhTPO) versus HD-DXM alone in newly diagnosed adult immune thrombocytopenia (ITP) patients. Enrolled patients were randomly assigned to receive DXM plus rhTPO or DXM monotherapy. Another 4-day course of DXM was repeated if response was not achieved by day 10 in both arms. One hundred patients in the HD-DXM plus rhTPO arm and 96 patients in the HD-DXM monotherapy arm were included in the full analysis set. HD-DXM plus rhTPO resulted in a higher incidence of initial response (89.0% vs. 66.7%, P < 0.001) and complete response (CR, 75.0% vs. 42.7%, P < 0.001) compared with HD-DXM monotherapy. Response rate at 6 months was also higher in the HD-DXM plus rhTPO arm than that in the HD-DXM monotherapy arm (51.0% vs. 36.5%, P = 0.02; sustained CR: 46.0% vs. 32.3%, P = 0.043). Throughout the follow-up period, the overall duration of response was greater in the HD-DXM plus rhTPO arm compared to the HD-DXM monotherapy arm (P = 0.04), as estimated by the Kaplan-Meier analysis. The study drugs were generally well tolerated. In conclusion, the combination of HD-DXM with rhTPO significantly improved the initial response and yielded favorable SR in newly diagnosed ITP patients, thus could be further validated as a frontline treatment for ITP. This study is registered as clinicaltrials.gov identifier: NCT01734044. This article is protected by copyright. All rights reserved.
The Additional Effect of Autologous Platelet Concentrates to Coronally Advanced Flap in the Treatment of Gingival Recessions: A Systematic Review and Meta-Analysis
BioMed research international. 2019;2019:2587245
Background: To improve the efficacy of regenerative treatment for gingival recessions, the autologous platelet concentrates (APCs) combined with coronally advanced flap (CAF) have been investigated. However, few studies systematically assess the complementary effect of APCs in periodontal regeneration. The present study aims to evaluate the additional effect of different types of APCs to CAF in the treatment of gingival recessions. Methods: Electronic databases (EMBASE, MEDLINE, and Cochrane Central Register of Controlled Trails) and relevant journals were searched until May 15, 2019. Only randomized controlled trials (RCTs) in English were included. Outcome variables include root coverage (RC), recession depth (RD), clinical attachment level (CAL), keratinized tissue width (KTW), and gingival thickness (GT). Data were analyzed with Revman5.3. The estimate of effect sizes was expressed as the mean differences and the 95% confidence interval. Results: 8 RCTs involving 170 patients (328 sites) were included. Our meta-analysis indicated RC, RD, CAL, KTW, and GT were better improved in the CAF plus APCs groups than the CAF alone. The subgroup analyses revealed that platelet-rich fibrin (PRF) brought significant improvement in RC, RD, CAL, and GT. Concentrated growth factors (CGF) lead clinic beneficial in CAL, KTW, and GT. No significant effect of platelet-rich plasma (PRP) could be found in any clinical parameters when combined with CAF. Conclusions: PRF could exert additional effect to CAF; the preferred treatment for gingival recessions was considered. Based on the limited studies, it seemed that PRP failed to show any additional effect and it was not suggested for gingival recessions. Given the limited research and high risk of bias, it is still needed to confirm the additional effect of CGF by more high-quality studies.
Comprehensive assessment of tranexamic acid during orthognathic surgery: A systematic review and meta-analysis of randomized, controlled trials
Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery. 2019
The objective of this study was to comprehensively assess the use of tranexamic acid (TXA) during orthognathic surgery. A systematic review and meta-analysis of randomized controlled trials addressing these issues were carried out. Three electronic databases, included PubMed, Web of Science, and Cochrane Library, were searched until April 30, 2018. Eligible studies were restricted to randomized, controlled trials (RCTs). Weighted mean differences (WMD) for blood loss, operation time, haematocrit, quality of surgical field, and odds ratio (OR) for transfusion rates were pooled for the included studies. Eight randomized, controlled trials were included for analysis. Compared with the control group, the TXA group showed a reduction in intraoperative blood loss of 165.03 ml (p < 0.00001; 95% CI, -200.93 to -129.13 ml), a reduction in the drop of haematocrit of 2.32 g/dl (p < 0.00001; 95% CI, -3.38 to -1.26 g/dl), and an improved quality of surgical field (p < 0.00001; MD, -1.01; 95% CI, -1.23 to -0.80). Tranexamic acid has a limited effect on reducing operative time (p < 0.00001; MD, -16.18 min; 95% CI, -19.60 to -12.75 min) and on decreasing the transfusion rates (p = 0.02; OR = 0.33; 95% CI, 0.13 to 0.83).
Efficacy of oral tranexamic acid on blood loss in primary total hip arthroplasty using a direct anterior approach: a prospective randomized controlled trial
International Orthopaedics. 2018;42((11):):2535-2542
BACKGROUND Tranexamic acid (TXA), delivered intravenously or topically, has been shown to reduce blood loss, the need for transfusion, and relevant healthcare costs when administered in primary standard total hip arthroplasty (THA). Whether the same is true of oral TXA is unclear, the purpose of this study was to determine if oral tranexamic acid is equivalent to intravenous TXA in the case of patients undergoing THA via the direct anterior approach. METHODS In this prospective randomized controlled trial, 120 patients undergoing primary THA by the direct anterior approach were randomized to receive oral TXA (two doses of 20 mg/kg), intravenous TXA (two doses of 15 mg/kg), or no TXA. Primary outcomes were haemoglobin drop, haematocrit levels, total blood loss, intra-operative blood loss, need for transfusion, and volume transfused. Secondary outcomes included thromboembolic events, wound complications, the length of post-operative hospital stay, and 30-day readmission. RESULTS Demographic characteristics were similar among the three patient groups (p > 0.05, n = 40 per group). Haemoglobin drop, haematocrit levels, total blood loss, and intra-operative blood loss were similar in the oral and intravenous groups (p > 0.05), and significantly smaller than in the control group (p < 0.05). Transfusions were given to significantly fewer patients in the oral group (3%) and intravenous group (6%) than in the control group (27%, p = 0.01). Costs of TXA and transfusions were significantly lower in the oral group than the intravenous group (p < 0.05). The three groups were similar in thromboembolic events, wound complications, the length of post-operative hospital stay, and 30-day readmission (p > 0.05). CONCLUSION Oral TXA shows similar efficacy and safety as intravenous TXA for reducing haemoglobin drop, haematocrit levels, total blood loss, and transfusion rate following THA by the direct anterior approach. Therefore, the much less-expensive oral formulation may be superior to the intravenous form.
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.
Application of autologous blood cell salvage in off-pump coronary artery bypass graft operation
The Heart Surgery Forum. 2017;20((3)):E107-E110.
OBJECTIVE To analyze whether application of autologous blood cell salvage can reduce the transfusion volume of allogeneic blood and complications of blood transfusion in off-pump coronary artery bypass operations. Methods: We randomly divided 120 patients into autologous blood cell salvage group (experimental group, n = 60) and non-autologous blood cell salvage group (control group, n = 60). Volume of perioperative allogeneic blood transfusion of each patient was recorded. Moreover, complications and ICU retention times (H) of each patient were also recorded. The data were analyzed using t tests. Results: The volume of allogeneic blood transfusion was significantly less in the experimental group than in the control group. Conclusion: Application of autologous blood cell salvage in off-pump coronary artery bypass graft operation can reduce the volume of allogeneic blood transfusion, alleviate blood shortage, and reduce the incidence of postoperative complications, leading to medical, economic, and social benefits.
Combined use of intravenous and topical versus intravenous tranexamic acid in primary total knee and hip arthroplasty: a meta-analysis of randomised controlled trials
Journal of Orthopaedic Surgery and Research. 2017;12((1)):22.
BACKGROUND This meta-analysis aimed to evaluate the efficiency and safety of combined intravenous and topical methods of application versus single intravenous of tranexamic acid in primary total knee and hip arthroplasty. METHODS A systematic search was carried out in MEDLINE (from 1966 to 25 September 2016), PubMed (from 1966 to 25 September 2016), Embase (from 1980 to 25 September 2016), ScienceDirect (from 1985 to 25 September 2016) and the Cochrane Library. Only high-quality randomised controlled trials (RCT) were identified. Two authors independently performed data extraction and quality assessment of included studies. Meta-analysis was conducted using Review Manager 5.1 software. RESULTS Six RCTs that included 687 patients met the inclusion criteria. The present meta-analysis indicated that there were significant differences in terms of total blood loss (MD = -193.59, 95% CI -338.06 to -49.13, P = 0.009), transfusion rate (RD = -0.07, 95% CI -0.12 to -0.03, P = 0.001), haemoglobin decline (MD = -0.51, 95% CI -0.83 to -0.18, P = 0.01) and length of stay (MD = -0.20, 95% CI -0.38 to -0.02, P = 0.03) between groups. CONCLUSIONS Combined administration of tranexamic acid (TXA) in patients with total knee and hip arthroplasty was associated with significantly reduced total blood loss, transfusion requirements, postoperative haemoglobin decline and length of stay compared to single application alone but was not associated with prolonged operation time. Moreover, no adverse effects, such as superficial infection, deep vein thrombus (DVT) or pulmonary embolism (PE), were associated with TXA. We suggest that combined administration of TXA demonstrated excellent clinical efficacy and safety in patients with total knee and hip arthroplasty. More importantly, well-designed studies with larger sample size are needed to provide further reliable evidence for the combined use of TXA.
Covered TIPS for secondary prophylaxis of variceal bleeding in liver cirrhosis: A systematic review and meta-analysis of randomized controlled trials
BACKGROUND In the era of bare stents, transjugular intrahepatic portosystemic shunt (TIPS) is the second-line choice of therapy for the prevention of variceal rebleeding in liver cirrhosis. In the era of covered stents, the role of TIPS should be re-evaluated. AIM: The aim of the study was to compare the outcomes of covered TIPS versus the traditional first-line therapy (i.e, drug plus endoscopic therapy) for the prevention of variceal rebleeding in liver cirrhosis. METHODS All relevant randomized controlled trials were searched via the PubMed, EMBASE, and Cochrane Library databases. Hazard ratios (HRs) and odds ratios (ORs) with 95% confidence intervals (CIs) and P values were calculated for the cumulative risk and overall risk, respectively. Heterogeneity among studies was also calculated. RESULTS Three of 111 retrieved papers were eligible. Among them, the proportion of patients who were switched from drug plus endoscopic therapy to TIPS was 16% to 25%. The risk of bias was relatively low in all included randomized controlled trials. Meta-analyses demonstrated that the covered TIPS group had a similar overall survival (HR = 0.84, 95% CI = 0.55-1.28, P = 0.41; OR = 1.00, 95% CI = 0.59-1.69, P = 0.99), a significantly lower risk of variceal rebleeding (HR = 0.30, 95% CI = 0.18-0.48, P < 0.00001; OR = 0.24, 95% CI = 0.12-0.46, P < 0.0001), and a similar risk of hepatic encephalopathy (HR = 1.35, 95% CI = 0.72-2.53, P = 0.36; OR = 1.28, 95% CI = 0.54-3.04, P = 0.57). In most of meta-analyses, the heterogeneity among studies was not statistically significant. CONCLUSIONS Compared with drug plus endoscopic therapy, covered TIPS had a significant benefit of preventing from variceal rebleeding, but did not increase the overall survival or risk of hepatic encephalopathy.
Using tranexamic acid soaked absorbable gelatin sponge following complex posterior lumbar spine surgery: a randomized control trial
Clinical Neurology and Neurosurgery. 2016;147:110-114.
OBJECTIVES This paper aims to determine whether the use of Tranexemic Acid (TXA) - soaked absorbable gelatin sponge could more effectively reduce post-operative blood loss and blood transfusion requirements among low-risk adult patients undergoing lumbar spine surgery. METHODS A total of 90 consecutive patients undergoing surgery for multilevel posterior lumbar degenerative procedures were prospectively randomized into one of three groups: - TXA Soaked Gelfoam group, absorbable gelatin sponge group or control group. Demographic distribution, total drain output, blood transfusion requirement, length of hospital stay, the number of readmissions, and postoperative complications were analyzed. RESULTS In the TXA Soaked Gelfoam, Gelfoam, and control groups, the respective hemovac drainage at the first 8h postoperatively was 81.06+/-61.21, 166.73+/-76.76, and 155.67+/-92.94ml respectively. The second 8h period drainage for the same groups postoperatively was 46.67+/-40.09, 55.10+/-43.43, and 82.50+/-56.67ml and 23.73+/-25.56, 32.43+/-25.81 and 44.20+/-32.44ml for the third 8h period postoperatively. The duration of the post-operative drain left in the TXA Soaked Gelfoam group was significantly shorter than the Gelfoam and control groups (p=0.019 and 0.000, respectively). The TXA Soaked Gelfoam and Gelfoam also had a significantly shorter hospital stay than the control group (p=0.014, and 0.036, respectively). No patient developed adverse reactions attributable to the tranexamic acid soaked absorbable gelatin sponge. CONCLUSIONS TXA-soaked absorbable gelatin sponge is a safe, effective treatment for reduction of post-operative blood loss and blood transfusions among low-risk adult patients undergoing lumbar spine surgery.
The effect of tourniquet use on hidden blood loss in total knee arthroplasty
International Orthopaedics. 2009;33((5):):1263-8.
The objective of this study was to examine the characteristics of hidden blood loss and assess the effects of using a tourniquet on postoperative hidden loss in patients undergoing primary total knee arthroplasty. Eighty patients were randomised into two groups: one group underwent operation with a tourniquet and one without. Operating time, perioperative blood loss, hidden blood loss, free haemoglobin, swelling, ecchymosis, straight leg raising action and knee flexion were measured. There were significant differences in the hidden blood loss, free haemoglobin, postoperative swelling, extent of ecchymosis, straight leg raising and postoperative knee flexion in the early period after operation between the two groups. Our results indicate that knee arthroplasty operations with a tourniquet might promote postoperative hidden blood loss and hinder patients' in early postoperative rehabilitation exercises.