Abstract

BACKGROUND Platelet-rich plasma (PRP) and corticosteroids are used to treat rotator cuff diseases. However, few reviews have compared the effects of these two treatments. In this study, we compared the effects of PRP and corticosteroid injection on the prognosis of rotator cuff diseases. METHODS According to the Cochrane Manual of Systematic Review of Interventions, the PubMed, Embase, and Cochrane databases were searched comprehensively. Two independent authors screened suitable studies and performed data extraction and risk of bias assessment. Only randomized controlled trials (RCTs) comparing the effects of PRP and corticosteroid in the treatment of rotator cuff injuries were included, as measured by clinical function and pain during different follow-up periods. RESULTS Nine studies with 469 patients were included in this review. In short-term treatment, corticosteroids were superior to PRP in the improvement of constant, SST, and ASES scores (MD -5.08, 95%CI -10.26, 0.06; P = .05 and MD -0.97, 95%CI -1.68, -0.07; P = .03 and MD -6.67, 95%CI -12.85, -0.49; P = .03, respectively). No statistically difference was observed between the two groups at mid-term (P> .05), and the recovery of the SST and ASES scores in PRP treatment was significantly better than that in corticosteroid treatment in the long-term (MD 1.21, 95%CI 0.68, 1.74; P < .00001 and MD 6.96, 95%CI 3.90, 9.61; P < .00001, respectively). In pain reduction based on VAS score, corticosteroids led to better pain reduction (MD 0.84, 95%CI 0.03, 1.64; P = .04), but no significant difference was observed in pain reduction between the two groups in the any term (P> .05). However, these differences did not reach the minimum clinically important difference. CONCLUSION Current analysis showed that corticosteroids have better efficacy in short-term, whereas PRP is more beneficial for long-term recovery. However, no difference was observed in the mid-term efficacy between the two groups. RCTs with longer follow-up periods and larger sample sizes are also needed to determine the optimal treatment.

Abstract

OBJECTIVE The optimal dose and efficacy of tranexamic acid (TXA) and epsilon-aminocaproic acid (EACA) in total knee arthroplasty (TKA) were under controversial, and we aimed to make comparisons between different doses of TXA and EACA in intravenous (IV) or intra-articular (IA) applications in patients undergoing TKA. METHODS This network meta-analysis was guided by the Priority Reporting Initiative for Systematic Assessment and Meta-Analysis (PRISMA). According to the administrations of antifibrinolytic agents, patients in eligible studies were divided into three subgroups: (i) IA applications of TXA and EACA; (ii) IV applications (g) of TXA and EACA; (iii) IV applications (mg/kg) of TXA and EACA. Total blood loss (TBL), hemoglobin (HB) drops and transfusion rates were the primary outcomes, while drainage volume, pulmonary embolism (PE) or deep vein thrombosis (DVT) risk were the secondary outcomes. A multivariate Bayesian random-effects model was adopted in the network analysis. RESULTS A total of 38 eligible trials with different regimens were assessed. Overall inconsistency and heterogeneity were acceptable. Taking all primary outcomes into account, 1.0-3.0 g TXA were most effective in IA applications, 1-6 g TXA and 10-14 g EACA were most effective in IV applications (g), while 30 mg/kg TXA and 150 mg/kg EACA were most effective in IV applications (mg/kg). None of the regimens showed increasing risk for pulmonary embolism (PE) or deep vein thrombosis (DVT) compared with placebo. CONCLUSION 0 g IA TXA, 1.0 g IV TXA or 10.0 g IV EACA, as well as 30 mg/kg IV TXA or 150 mg/kg IV EACA were most effective and enough to control bleeding for patients after TKA. TXA was at least 5 times more potent than EACA.

Abstract

To systematically review of randomized controlled trials(RCTs) to compared the effects of leukocyte-rich and leukocyte-poor platelet-rich plasma in arthroscopic rotator cuff repair. Two independent reviewers comprehensively searched PubMed, Embase, and Cochrane library databases according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Comparison of leukocyte-rich platelet-rich plasma or leukocyte-poor platelet-rich plasma in rotator cuff repair in a level I RCTs. Methodological quality assessment was carried out using Cochrane Review Manager 5.3 software. P<0.05 was considered statistically significant. Nine RCTs with 540 patients were included in this review. Meta-analysis showed that leukocyte-poor platelet-rich plasma in significantly reduced retear rate in rotator cuff repair [RR=0.56 95%CI (0.42,0.75); P＜0.05), and in clinical results, the constant score [MD=3.67, 95%CI (1.62,5.73); P=0.0005], UCLA score [MD=1.60, 95%CI (0.79,2.42); P=0.0001], ASES score [MD=2.16, 95%CI(0.12,4.20);P=0.04] were significantly improved. There was a significant result in favor of PRP for the Constant score [MD=-1.24, 95%CI(-1.50,-0.99); P＜0.00001], while SST scores were not significantly different among all groups [MD=0.21, 95%CI(-0.21,0.64); P=0.32]. In conclusion, leukocyte-poor platelet-rich plasma can improved the clinical function and reduced retear rate in arthroscopic rotator cuff repair. In contrast, the efficacy of leukocyte-rich platelet-rich plasma was not significantly improved with the exception of VAS score.

Abstract

OBJECTIVE There were limited randomized controlled trials (RCTs) of epsilon-aminocaproic acid (EACA) versus tranexamic acid (TXA) in total knee arthroplasty (TKA). The aim of the study was to compare the efficacy and safety of TXA and EACA in the combination of intravenous (IV) and intra-articular (IA) administration on reducing blood loss in patients following primary TKA. METHODS From January 2020 to January 2021, a total of 181 patients undergoing a primary unilateral TKA were enrolled in this prospective randomized controlled trial. Patients in the TXA group (n = 90) received 20 mg/kg of intravenous TXA preoperatively, 1 g of intra-articular TXA intraoperatively, and three doses of 20 mg/kg intravenous TXA at 0, 3, 6 h postoperatively. Patients in the EACA group (n = 91) received 120 mg/kg of intravenous EACA preoperatively, 2 g of intra-articular EACA intraoperatively, and three doses of 40 mg/kg intravenous EACA at 0, 3, 6 h postoperatively. The primary outcomes were total blood loss (TBL), transfusion rates and drop of hemoglobin (HB) level. The secondary outcomes included postoperative hospital stays and postoperative complications. The chi-square tests and Fisher's exact tests were utilized to compare categorical variables, while the independent-samples t-tests and Mann-Whitney tests were used to compare continuous variables. RESULTS The patients who received TXA averaged less TBL than the patients who received EACA (831.83 ml vs 1065.49 ml, P = 0.015), and HB drop in TXA group was generally less than that of EACA group on postoperative day 1 and 3 (20.84 ± 9.48 g/L vs 24.99 ± 9.40 g/L, P = 0.004; 31.28 ± 11.19 vs 35.46 ± 12.26 g/L, P = 0.047). The length of postoperative stays in EACA group was 3.66 ± 0.81 day, which is longer than 2.62 ± 0.68 day in TXA group (P < 0.001). No transfusions were required in either group. The risk of nausea and vomiting in TXA group was significantly higher than that in EACA group (11/90 vs 0/91, P < 0.01). CONCLUSION Although the TBL and HB drop were slightly greater in EACA group, these results were not clinically important, given that no transfusions were required. EACA could be an alternative to TXA, especially for patients with severe nausea and vomiting after using TXA postoperatively. Further studies are needed to adjust dosage of EACA to make better comparison of the two drugs.

Abstract

OBJECTIVES We aimed to evaluate the optimal regimen, efficacy and safety of tranexamic acid (TXA) and aminocaproic acid (EACA) for patients after total hip arthroplasty (THA). METHODS The network meta-analysis was guided by the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guideline. The outcomes were total blood loss, transfusion rates, hemoglobin (HB) drop, and risk for pulmonary embolism (PE) or deep vein thrombosis (DVT). Subgroup analyses were performed among most effective regimens to determine the influences of timing and number of doses. RESULTS A total of 56 eligible RCTs with different regimens were assessed. For reducing total blood loss, all high doses of TXA and EACA except high dose of intra-articular (IA) TXA, as well as medium dose of combination of intravenous and intra-articular (combined IV/IA) TXA were most effective. All high doses of TXA, as well as medium dose of combined IV/IA TXA did not show inferiority in reducing transfusion rates and HB drop compared with other regimens. No regimens showed higher risk for PE or DVT compared with placebo, and no statistical differences were seen among most effective regimens in subgroup analyses. CONCLUSIONS As effective as high doses of EACA and TXA, medium dose (20-40 mg/kg or 1.5-3.0 g) of combined IV/IA TXA was enough to control bleeding for patients after THA without increasing risk for PE/DVT. TXA was at least 5 times more potent than EACA. Timing and number of doses had few influences on blood conserving efficacy. LEVEL OF EVIDENCE Level I.

Abstract

BACKGROUND Hetrombopag, a novel thrombopoietin receptor agonist, has been found in phase I studies to increase platelet counts and reduce bleeding risks in adults with immune thrombocytopenia (ITP). This phase III study aimed to evaluate the efficacy and safety of hetrombopag in ITP patients. METHODS Patients who had not responded to or had relapsed after previous treatment were treated with an initial dosage of once-daily 2.5 or 5 mg hetrombopag (defined as the HETROM-2.5 or HETROM-5 group) or with matching placebo in a randomized, double-blind, 10-week treatment period. Patients who received placebo and completed 10 weeks of treatment switched to receive eltrombopag, and patients treated with hetrombopag in the double-blind period continued hetrombopag during the following open-label 14-week treatment. The primary endpoint was the proportion of responders (defined as those achieving a platelet count of ≥ 50 × 10(9)/L) after 8 weeks of treatment. RESULTS The primary endpoint was achieved by significantly more patients in the HETROM-2.5 (58.9%; odds ratio [OR] 25.97, 95% confidence interval [CI] 9.83-68.63; p < 0.0001) and HETROM-5 (64.3%; OR 32.81, 95% CI 12.39-86.87; p < 0.0001) group than in the Placebo group (5.9%). Hetrombopag was also superior to placebo in achieving a platelet response and in reducing the bleeding risk and use of rescue therapy throughout 8 weeks of treatment. The durable platelet response to hetrombopag was maintained throughout 24 weeks. The most common adverse events were upper respiratory tract infection (42.2%), urinary tract infection (17.1%), immune thrombocytopenic purpura (17.1%) and hematuria (15%) with 24-week hetrombopag treatment. CONCLUSIONS In ITP patients, hetrombopag is efficacious and well tolerated with a manageable safety profile. Trial registration Clinical trials.gov NCT03222843 , registered July 19, 2017, retrospectively registered.

Abstract

Background: Blood for transfusion is lifesaving and essential to many elements of modern medical practice. The global blood supply relies on volunteer blood donors. Apheresis is increasingly used to collect blood and requires anticoagulant to prevent extracorporeal coagulation. Citrate, the standard apheresis anticoagulant, chelates ionized calcium with consequent perturbations of serum calcium, parathyroid hormone, vitamin D, and markers of bone remodeling in donors. Cross-sectional studies of bone mineral density (BMD) among apheresis donors exhibit conflicting results. Methods: The longitudinal, randomized, controlled ALTRUYST trial (NCT02655055) was undertaken to determine whether BMD declined following high frequency apheresis blood donation over 1year. The study was powered at 80% to detect the primary outcome of a 3% decline in BMD. Subjects new to apheresis agreed to make ≥20 apheresis donations in a one-year period and were randomized to treatment (high frequency apheresis) or control (no apheresis). Dual-energy x-ray absorptiometry was performed before and after participation. Two-sided t-test and multivariable logistic regression were used to assess outcomes. Findings: Mean lumbar spine BMD did not change during the study among control donors (-0.002g/cm(2), 95%CI [-0.020, 0.016], p=0.78), or among donors in the apheresis arm (mean change=0.007g/cm(2), 95%CI [-0.005, 0.018], p=0.24). Mean total hip BMD did not change for control donors (mean change=0.002g/cm(2), 95%CI [-0.006, 0.009], p=0.63) or apheresis donors (-0.004g/cm(2), 95%CI [-0.10, 0.002], p=0.16). Tests for differences in proportions of donors with change in BMD exceeding the least significant change at the lumbar spine in either a positive [8 apheresis (31%), 4 control (27%), p=0.78] or negative direction [4 apheresis (15%), 5 control (33%)] were statistically non-significant (p=0.18). Proportional increases [0 apheresis (0%), 1 control (7%), p=0.18] and decreases [3 apheresis (12%), 1 control (14%)] were also not significantly different at the total hip (p=0.61). Interpretation: ALTRUYST is the first longitudinal trial to demonstrate that apheresis blood collection guidelines in the United States adequately protect the skeletal health of male volunteer blood donors. Funding: Marquette University and the BloodCenter Research Foundation.

Abstract

OBJECTIVE This study aimed to compare the effects of intravenous, topical and combined routes of tranexamic acid (TXA) administration on blood loss and transfusion requirements in patients undergoing total knee arthroplasty (TKA) and total hip arthroplasty (THA). DESIGN This was a meta-analysis of randomised controlled trials (RCT) wherein the weighted mean difference (WMD) and relative risk (RR) were used for data synthesis applied in the random effects model. Stratified analyses based on the surgery type, region, intravenous and topical TXA dose and transfusion protocol were also conducted. The main outcomes included intraoperative and total blood loss volume, transfusion rate, low postoperative haemoglobin (Hb) level and postoperative Hb decline. However, the secondary outcomes included length of hospital stay (LOS) and/or occurrence of venous thromboembolism (VTE). SETTING We searched the PubMed, Embase and Cochrane CENTRAL databases for RCTs that compared different routes of TXA administration. PARTICIPANTS Patients undergoing TKA or THA. INTERVENTIONS Intravenous, topical or combined intravenous and topical TXA. RESULTS Twenty-six RCTs were selected, and the intravenous route did not differ substantially from the topical route with respect to the total blood loss volume (WMD=30.92, p=0.31), drain blood loss (WMD=-34.53, p=0.50), postoperative Hb levels (WMD=-0.01, p=0.96), Hb decline (WMD=-0.39, p=0.08), LOS (WMD=0.15, p=0.38), transfusion rate (RR=1.08, p=0.75) and VTE occurrence (RR=1.89, p=0.15). Compared with the combined-delivery group, the single-route group had significantly increased total blood loss volume (WMD=198.07, p<0.05), greater Hb decline (WMD=0.56, p<0.05) and higher transfusion rates (RR=2.51, p<0.05). However, no significant difference was noted in the drain blood loss, postoperative Hb levels and VTE events between the two groups. The intravenous and topical routes had comparable efficacy and safety profiles. CONCLUSIONS The combination of intravenous and topical TXA was relatively more effective in controlling bleeding without increased risk of VTE.

Abstract

BACKGROUND Erythropoiesis-stimulating agents (ESAs) are widely used in the management of anemia in cancer patients. Despite their apparent effectiveness, recent studies have suggested that ESAs could result in serious adverse events and even higher mortality. The aim of the current study was to evaluate the benefits and risks of ESAs in the management of cancer patients with anemia using a meta-analysis. METHODS The initial literature search covered Medline, PubMed, Embase, and the Cochrane Center Register of Controlled Trials, and identified 1,569 articles. The final meta-analysis included eight randomized controlled trials (n=2,387) in cancer patients with <11 g/dL hemoglobin (Hb) at the baseline and target Hb (for stopping ESA treatment) at no more than 13 g/dL. The assessment measures included Hb response, blood transfusion rate and adverse events that included venous thromboemblism (VTE), hypertension, and on-study mortality. The results are expressed as pooled odds ratio (OR). Publication bias was assessed using funnel plot analysis. RESULTS ESAs significantly increased the Hb concentration [OR 7.85, 95% confidence interval (CI): 5.85 to 10.53, P<0.001] and reduced the red blood cell (RBC) transfusion rate (OR 0.52, 95% CI: 0.42 to 0.65, P<0.001). ESAs did not increase the accumulated adverse events (OR 0.95, P=0.82), or the on-study mortality (OR 1.09, P=0.47). CONCLUSIONS ESAs are not associated with increased frequency of severe adverse events in anemic cancer patients when the target Hb value is no more than 13 g/dL.