Abstract

OBJECTIVE To evaluate the efficacy and safety of roxadustat in the treatment of anemia in non-dialysis-dependent chronic kidney disease (NDD-CKD) patients. MATERIALS AND METHODS For this systematic review and meta-analysis, we searched for randomized controlled trials (RCTs) of anemia in NDD-CKD patients to assess the efficacy and safety of roxadustat. The primary efficacy endpoint was the proportion of patients who achieved a hemoglobin (Hb) response. Secondary efficacy endpoints were hepcidin, serum iron, serum ferritin (SF), total iron-binding capacity (TIBC), transferrin saturation (TAST), and low-density lipoprotein (LDL). In addition, adverse events (AEs) were compared. Meta-analyses were performed using Revman 5.4 software. The quality of the evidence was assessed using the Cochrane risk of bias tool. This study was conducted under a pre-established protocol registered with PROSPERO (registration number: CRD42021252331). RESULTS Seven studies enrolled 4,764 patients, of whom 2,730 received roxadustat and 2,034 received placebo. The results of this meta-analysis showed that roxadustat increased Hb levels [weighted mean difference (WMD) = 1.43, 95% CI: 1.17 to 1.68, P < 0.001, I (2) = 95%], and Hb response [relative ratio (RR) = 8.12, 95% CI: 5.80 to 11.37, P < 0.001, I (2) = 61%]. In addition, roxadustat significantly increased transferrin TAST. During the treatment period in patients with anemia, the AEs of roxadustat compared with placebo was not statistically significant. CONCLUSION Roxadustat can improve anemia in NDD-CKD patients by increasing Hb levels and regulating iron metabolism, but does not increase the incidence of AEs. SYSTEMATIC REVIEW REGISTRATION [https://www.crd.york.ac.uk/prospero/], identifier [CRD42021252331].

Abstract

OBJECTIVE Recent studies suggest that the clinical course and outcomes of patients with coronavirus disease 2019 (COVID-19) and myasthenia gravis (MG) are highly variable. We performed a systematic review of the relevant literature with a key aim to assess the outcomes of invasive ventilation, mortality, and hospital length of stay (HLoS) for patients presenting with MG and COVID-19. METHODS We searched the PubMed, Scopus, Web of Science, and MedRxiv databases for original articles that reported patients with MG and COVID-19. We included all clinical studies that reported MG in patients with confirmed COVID-19 cases via RT-PCR tests. We collected data on patient background characteristics, symptoms, time between MG and COVID-19 diagnosis, MG and COVID-19 treatments, HLoS, and mortality at last available follow-up. We reported summary statistics as counts and percentages or mean±SD. When necessary, inverse variance weighting was used to aggregate patient-level data and summary statistics. RESULTS Nineteen studies with 152 patients (mean age 54.4 ± 12.7 years; 79/152 [52.0%] female) were included. Hypertension (62/141, 44.0%) and diabetes (30/141, 21.3%) were the most common comorbidities. The mean time between the diagnosis of MG and COVID-19 was7.0 ± 6.3 years. Diagnosis of COVID-19 was confirmed in all patients via RT-PCR tests. Fever (40/59, 67.8%) and ptosis (9/55, 16.4%) were the most frequent COVID-19 and MG symptoms, respectively. Azithromycin and ceftriaxone were the most common COVID-19 treatments, while prednisone and intravenous immunoglobulin were the most common MG treatments. Invasive ventilation treatment was required for 25/59 (42.4%) of patients. The mean HLoS was 18.2 ± 9.9 days. The mortality rate was 18/152 (11.8%). CONCLUSION This report provides an overview of the characteristics, treatment, and outcomes of MG in COVID-19 patients. Although COVID-19 may exaggerate the neurological symptoms and worsens the outcome in MG patients, we did not find enough evidence to support this notion. Further studies with larger numbers of patients with MG and COVID-19 are needed to better assess the clinical outcomes in these patients.

Abstract

This study aimed to evaluate the efficiency and safety of tranexamic acid for blood management during high tibial osteotomy (HTO). A systematic search was conducted in Medline, Embase, and the Cochrane library database. Six studies and 208 patients were included in this meta-analysis using Review Manager V.5.3 and Stata 15.1 software. For primary outcomes, tranexamic acid lowered the total blood loss (WMD = -219.47, 95% CI [-355.61, -83.33], P = 0.002). For secondary outcomes, a significant reduction was found for decreased hemoglobin (POD1: WMD = -9.86, 95% CI [-13.45, -6.28], P < 0.05; POD2: WMD = -8.41, 95% CI [-11.50, -5.32], P < 0.05; POD5: WMD = -11.48, 95% CI [-14.56, -8.39], P < 0.05) and drainage (total: WMD = -105.93, 95% CI [-187.08, -24.78], P < 0.05; POD1: WMD = -122.195, 95% CI [-168.902, -75.488], P < 0.05). The sex difference (male/female ratio) was determined (total blood loss: P = 0.025; total drainage amount: p = 0.018) using meta-regression analysis. Females benefited more from tranexamic acid in terms of total blood loss (M/F > 40%: WMD = -53.11, 95% CI [-100.16, -6.05], P = 0.03; 40% ≥ M/F ≥ 20%: WMD = -362.20, 95% CI [-423.96, -300.45], P < 0.05; M/F < 20%: WMD = -263.00, 95% CI [-277.17, -248.83], P < 0.05) and total drainage (M/F > 40%: WMD = -7.11, 95% CI [-10.75, -3.47], P < 0.05; 40% ≥ M/F ≥ 20%: WMD = -104.72, 95% CI [-155.36, -54.08], P < 0.05; M/F < 20%: WMD = -222.00, 95% CI [-297.42, -146.58], P < 0.05). No significant differences were found for drainage on POD2 and POD3, wound complications, orthromboembolic events. In conclusion, tranexamic acid is effective and safe for blood management during HTO. Females appeared to benefit more from it, and an additional postoperative dose is suggested fora better effect.

Abstract

The purpose of this systematic review is to evaluate the efficacy and safety of using potential drugs: remdesivir and glucocorticoid in treating children and adolescents with COVID-19 and intravenous immunoglobulin (IVIG) in treating MIS-C. We searched seven databases, three preprint platform, ClinicalTrials.gov, and Google from December 1, 2019, to August 5, 2021, to collect evidence of remdesivir, glucocorticoid, and IVIG which were used in children and adolescents with COVID-19 or MIS-C. A total of nine cohort studies and one case series study were included in this systematic review. In terms of remdesivir, the meta-analysis of single-arm cohort studies have shown that after the treatment, 54.7% (95%CI, 10.3 to 99.1%) experienced adverse events, 5.6% (95%CI, 1.2 to 10.1%) died, and 27.0% (95%CI, 0 to 73.0%) needed extracorporeal membrane oxygenation or invasive mechanical ventilation. As for glucocorticoids, the results of the meta-analysis showed that the fixed-effect summary odds ratio for the association with mortality was 2.79 (95%CI, 0.13 to 60.87), and the mechanical ventilation rate was 3.12 (95%CI, 0.80 to 12.08) for glucocorticoids compared with the control group. In terms of IVIG, most of the included cohort studies showed that for MIS-C patients with more severe clinical symptoms, IVIG combined with methylprednisolone could achieve better clinical efficacy than IVIG alone.Conclusions: Overall, the current evidence in the included studies is insignificant and of low quality. It is recommended to conduct high-quality randomized controlled trials of remdesivir, glucocorticoids, and IVIG in children and adolescents with COVID-19 or MIS-C to provide substantial evidence for the development of guidelines. What is Known: • The efficacy and safety of using potential drugs such as remdesivir, glucocorticoid, and intravenous immunoglobulin (IVIG) in treating children and adolescents with COVID-19/MIS-C are unclear. What is New: • Overall, the current evidence cannot adequately demonstrate the effectiveness and safety of using remdesivir, glucocorticoids, and IVIG in treating children and adolescents with COVID-19 or MIS-C. • We are calling for the publication of high-quality clinical trials and provide substantial evidence for the development of guidelines.

Abstract

Thrombocytopenia is a tough complication after hematopoietic stem cell transplantation (HSCT) with elusive pathogenesis and lack of well-established therapies. Thrombopoietin receptor agonists (TPO-RAs) have been used for thrombocytopenia post HSCT in recent years, but the outcomes remain debatable. We conducted this meta-analysis and systematic-review to evaluate the efficacy and safety of TPO-RAs for platelet recovery after HSCT. We searched PubMed, EMBASE, and Cochrane databases for studies on the application of TPO-RAs (eltrombopag and romiplostim) in the settings of primary or secondary thrombocytopenia after HSCT by 17 March 2021. Efficacy outcomes included response rate and survival rate, and adverse events were also evaluated. A total of 19 studies involving 378 patients were included. The pooled response rate was 73% (95%CI: 68-78%), which was significantly higher than recombinant human thrombopoietin (rhTPO) (27.8%). The pooled survival rate was 66% (95%CI: 54-77%), and infection was found to be the main cause of death. In addition, the pooled rate of adverse events was 3% (95%CI: 1-7%), with no severe adverse events reported. TPO-RAs could effectively and safely promote the recovery of platelets in patients after HSCT.

Abstract

This meta-analysis evaluated the efficacy and safety of infliximab as initial therapy for patients with Kawasaki disease (KD) and intravenous immunoglobulin (IVIG) resistant KD.Studies of infliximab in KD, published between January 2004 and December 2019, were curated from PubMed, MEDLINE, and Cochrane Library. Data were analyzed using STATA Version 12.0. Of the 8 studies considered, 4 evaluated the effect of infliximab combined with IVIG as primary therapy in KD, and the remaining investigated the effect of infliximab in IVIG resistant patients. Infliximab was more effective than the control group, with the total summary odds ratio (OR) of 0.34 (95% confidence interval (CI): 0.19-0.62). The treatment resistance of the infliximab group was lower than the IVIG group (0.36 [95% CI: 0.14-0.92]) when infliximab was combined with IVIG as the initial treatment. However, infliximab treatment for IVIG resistant KD was more effective than the IVIG group (0.28 [95% CI: 0.12-0.66]). There was no significant increase in the incidence of coronary artery lesions. The total summary OR for the incidence of coronary artery lesions and infliximab treatment was 0.88 (95% CI: 0.48-1.62). There was no statistically significant difference in adverse events (AEs) when compared between the groups (0.71 [95% CI: 0.44-1.16]).Infliximab combined with IVIG reduced treatment resistance in KD patients vs. conventional IVIG therapy. Infliximab improved clinical course in IVIG resistant KD patients. Infliximab treatment did not reduce the incidence of coronary artery lesions and did not show any significant increase in the incidence of AEs. PROSPERO REGISTRATION NUMBER CRD42020218554.

Abstract

Background: Minimally invasive surgery for intracerebral hemorrhage (ICH) has been evaluated in clinical trials. Although meta-analyses on this topic have been performed in the past, recent trials have added important information to the results of the comparison. However, little work has been done to compare the effect of MIS and conventional treatment on patient prognosis, especially mortality. Methods: PubMed, EMBASE, Web of Science, Ovid, China National Knowledge Infrastructure, and ClinicalTrials.gov were searched on May 1, 2021, for randomized controlled trials of MIS for spontaneous ICH. The primary outcome was defined as death at follow-up, while the secondary outcome was defined as death in different comparisons between MIS and craniotomy (CT) or medication (Me). Results: The initial search yielded 12 high-quality randomized controlled trials involving 2,100 patients. We analyzed the odds ratios (ORs) for MIS compared with conventional treatment, including Me and conventional CT. The OR and confidence intervals (CIs) of the primary and secondary outcomes were 0.62 (0.45-0.85) for MIS vs. conventional treatment. We also conducted subgroup analyses and found that the ORs and CIs for MIS compared with that of conventional treatment in the short-term follow-up were 0.58 (0.42-0.80), and, in the long-term follow-up, was 0.67 (0.46-0.98); and found that ORs were 0.68 (0.48-0.98) for MIS vs. CT and 0.57 (0.41-0.79) for MIS vs. Me. Conclusions: This meta-analysis demonstrates that certain patients with ICH benefit in short- and long-term follow-up from MIS over other treatments, including open surgery and conventional Me. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/.

Abstract

BACKGROUND Human parvovirus B19 (B19V) infection exhibits a broad range of clinical outcomes. Blood transfusion is a common route of B19V transmission. However, information about the overall prevalence of B19V infection and B19V genotypes among blood donors in mainland China is lacking. METHODS This meta-analysis was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A literature search for studies reporting the B19V prevalence among blood donors in mainland China from 2000 to 2018 was performed. The prevalence of B19V was estimated through a meta-analysis of the relevant literature. A comprehensive meta-analysis program was used for data processing and statistical analysis. RESULTS Twenty-one eligible articles were included, involving 48,923 participants assessed for B19V-DNA, 12,948 participants assessed for anti-B19V immunoglobulin M (IgM), and 8244 participants assessed for anti-B19V immunoglobulin G (IgG). The analysis revealed the pooled estimates of the prevalence rates of B19V-DNA, anti-B19V IgM, and anti-B19V IgG among blood donors to be 0.7% (95% confidence interval [CI] 0.2-2.4%), 2.7% (95% CI 1.7-4.3%), and 33.6% (95% CI 28.2-39.4%), respectively. Moreover, phylogenetic analyses indicated that 142 of 169 (84.0%) B19V isolates belonged to Genotype 1. CONCLUSIONS The overall prevalence of B19V among blood donors is not high in mainland China, and most isolates belong to Genotype 1.

Abstract

BACKGROUND Prothrombin complex concentrate (PCC) is the treatment of choice in vitamin K antagonist-associated intracranial hemorrhage (VKA-ICH). However, the efficiency and safety associated with their use remain unclear. AIMS This study aimed to assess the current evidence of the clinical outcomes in patients with VKA-ICH treated with or without PCC. A meta-analysis was conducted. Two randomized controlled trials and 19 observational studies were included. PCC use demonstrated a significant increased likelihood of international normalized ratio (INR) normalization (OR = 3.76; 95% CI 1.74-8.12), shortened time to INR correction (MD = - 1.30; 95% CI - 2.08 to - 0.53) and reduction of hematoma expansion (HE) rate (OR = 0.37; 95% CI 0.23-0.60). Although PCC use revealed a statistical reduction at 30-day mortality (OR = 0.62; 95% CI 0.50-0.78), the result was inconsistent with mortality at discharge (OR = 1.03; 95% CI 0.68-1.57) and 90-day follow-up (OR = 0.50; 95% CI 0.24-1.07), both of which yielded no significant difference. When subgroup analyses were performed focus on PCC only treatment with FFP, no statistically significant difference was observed in 30-day mortality (OR = 0.43; 95% CI 0.11-1.71) as well. Besides, significant difference was not found in neurologic improvement at discharge (OR = 1.85; 95% CI 0.32-10.75), 30-day follow-up (OR = 3.00; 95% CI 0.93-9.70), or 90-day follow-up (OR = 1.55; 95% CI 0.84-2.86). No statistically significant difference was noted in the risk of thromboembolism following PCC administration (OR = 0.61; 95% CI 0.23-1.63). CONCLUSIONS PCC use for VKA-ICH reversal was associated with a significant reduction in INR and HE rate, without an increased risk of thromboembolic events. However, this reduction was not associated with improvement in neurologic deficits or overall survival. Well-designed randomized trials with special considerations to the aspect are necessary.

Abstract

BACKGROUND The aim of the study was to identify the efficacy and safety of multiple doses of oral tranexamic acid (TXA) on reducing blood loss and minimizing the postoperative inflammatory and fibrinolytic responses following primary total knee arthroplasty (TKA). MATERIALS AND METHODS In this prospective, double-blinded, randomized trial, we randomly assigned a total of 151 patients into three groups to receive 2g of oral TXA 2h preoperatively (group A); an additional dose of 2g of oral TXA 4h postoperatively (group B); or additional doses of 2g of oral TXA at 4, 10, and 16h postoperatively (group C). The primary outcome was total blood loss (TBL). The secondary outcomes were maximum drop in hemoglobin (Hb) and hematocrit (Hct), level of inflammatory and fibrinolytic parameters, transfusion rate, and the incidence of complications. RESULTS The results were represented as mean+/-standard deviation. The mean TBL was 607+/-254mL in group C, 743+/-347mL in group B (p=0.027 vs group C), and 978+/-335mL in group A (p<0.001 vs group C). The maximum Hb and Hct drop was 18.3+/-7.7g/L and 0.051+/-0.025 in group C, 22.3+/-9.7g/L and 0.070+/-0.028 in group B (p=0.022 and p=0.001 vs group C), 29.6+/-11.7g/L and 0.090+/-0.034 in group A (p<0.001 and p<0.001 vs group C). In addition, C-reactive protein and interleukin-6 in group C were lower than in group A (p<0.001 and p=0.003) and in group B (p=0.031 and p<0.001) on postoperative day (POD) 3. Moreover, fibrin degradation products and D-dimer in group C were lower than in groups A and B on both POD 1 and POD 3. The incidence of complications did not differ significantly between the three groups (p>0.05). CONCLUSION Multiple postoperative doses of oral TXA could further reduced blood loss and the drop in Hb and Hct, and diminished the postoperative inflammatory and fibrinolytic responses in primary TKA with no apparent increase in the incidence of complications. LEVEL OF EVIDENCE Level , therapeutic study.