Abstract

INTRODUCTION The treatment of COVID-19 is still challenge. So convalescent plasma can be an important alternative of treatment. Protocols with nursing care during infusion is very important to guide an effective and safety care. OBJECTIVE to analyze the evidence in the literature on the action of convalescent plasma, of the use of protocols with nursing care to use convalescent plasma and build a nursing care protocol for transfusion in patients with COVID-19. METHODS Methodological study carried out in two stages: scoping review. The search was done using the descriptors: convalescent plasma transfusion, convalescent plasma, and acute respiratory syndromes or COVID-19, to found protocols and effectiveness of convalescent plasm. Beside was done a specialist panel to build the protocol. RESULTS Low-evidence studies have shown improvement in the clinical signs of COVID-19 using Convalescent Plasma, reduction or elimination of viral load, benefits in the production of lymphocytes, decreases C-reactive protein, increases titers of anti-SARS-CoV-2 antibodies, positive evolution in lung involvement identified by X-rays, decrease in hospitalization. No studies were found in the databases on the protocol for clinical nursing care in plasma transfusion. Therefore, a protocol was developed with the description of clinical nursing care to be performed before, during and after the transfusion by plasma: checking of vital signs and indicative signs of transfusion reaction, measurement of oxygen saturation, assessment of venous access and checking of the level of consciousness. CONCLUSION There are no evidence studies to support the use of plasma, nor anything related to bundles.

Abstract

BACKGROUND Platelet-rich plasma is considered an effective modality to promote bone regeneration, improve hard and soft tissue healing in surgical procedures including sinus augmentation. However, the survival of dental implants in sinus augmented sites with platelet-rich plasma has shown equivocal results in recent studies. PURPOSE In this systematic review, data on dental implants' survival in sinus augmentation sites with platelet-rich plasma were examined. MATERIALS AND METHODS Randomized controlled trials on the topic with a minimum mean follow-up of 6 months with no language restriction were considered. Other study designs on the topic were excluded. Accordingly, relevant articles were searched in Clinicaltrials.gov, Cochrane databases, PubMed/Medline, and Scopus up to April 2021. Using the Cochrane risk of bias assessment tool, the listed studies' risk of bias was evaluated. From the included studies, the pertinent information was taken and pooled for qualitative and quantitative analysis using R software 4.1.1. RESULTS Six randomized controlled trials involving 188 patients who underwent sinus augmentation with and without platelet-rich plasma, and 781 implants were included for qualitative and quantitative analysis. Four hundred and eleven implants were placed in the intervention group (with platelet-rich plasma) and 370 implants were placed in the control group (without platelet-rich plasma). The pooled estimate (OR 0.84, 95% CI 0.37 to 1.91; I(2) = 0%) indicated that there was no statistically significant difference observed between the groups. The test for subgroup differences showed no statistically significant differences between the subgroups (p = 0.45) with no heterogeneity (I(2) = 0%). CONCLUSION The bias associated with selective reporting of outcome data was considered as some concern for bias. This systematic review revealed that the effect of platelet-rich plasma is uncertain on the survival of dental implants.

Abstract

Background: Many studies demonstrated that roxadustat (FG-4592) could increase hemoglobin (Hb) levels effectively in anemia patients with chronic kidney disease (CKD). However, its safety remains controversial. This study aims to explore the risk of infection for CKD patients treated with roxadustat, especially focused on sepsis. Methods: We thoroughly searched for the randomized controlled trials (RCTs) comparing treatment with roxadustat versus erythropoiesis stimulating agents (ESAs) or placebo in PubMed, Embase, Cochrane Library, ClinicalTrials.gov, European Union Clinical Trials Register. Both on and not on dialysis anemia patients with CKD were included. Primary outcomes contained the incidence rates of sepsis. Secondary outcomes included infection-related consequences (septic shock and other infection events), general safety outcomes [all-cause mortality, treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)] and iron parameters. Moreover, a trial sequential analysis (TSA) was conducted to assess if the results were supposed to be a robust conclusion. Results: Eighteen RCTs (n = 11,305) were included. Overall, the incidence of sepsis (RR: 2.42, 95% CI [1.50, 3.89], p = 0.0003) and cellulitis (RR: 2.07, 95% CI [1.24, 3.44], p = 0.005) were increased in the roxadustat group compared with placebo group. In non-dialysis-dependent (NDD) CKD patients, the incidence of cellulitis (RR 2.01, 95% CI [1.23, 3.28], p = 0.005) was significantly higher in roxadustat group than that in the ESAs or placebo group. Both groups showed similar results in the incidence of septic shock (RR 1.29, 95% CI [0.86, 1.94], p = 0.22). A significant increased risk of all-cause mortality [risk ratios (RR): 1.15, 95% confidence interval (CI) [1.05, 1.26], p = 0.002] was found in roxadustat treatment, and TSA confirmed the result. Compared with ESAs or placebo, both the incident rates of TEAEs (RR:1.03, 95% CI [1.01, 1.04], p = 0.008) and TESAEs (RR: 1.06, 95% CI [1.02, 1.11], p = 0.002) were significantly increased in roxadustat group. As for iron parameters, changes from baseline (Δ) of hepcidin (MD: -26.46, 95% CI [-39.83, -13.09], p = 0.0001), Δ ferritin and Δ TSAT were remarkably lower in the roxadustat group, while Δ Hb, Δ iron and Δ TIBC increased significantly versus those in ESAs or placebo group. Conclusion: We found evidence that incidence rates of sepsis and cellulitis are higher in roxadustat group compared with placebo. This may be the result of improved iron homeostasis. The risk of all-cause mortality, TEAEs and TESAEs in CKD patients also increased in patients treated with roxadustat. We need more clinical and mechanistic studies to confirm whether roxadustat really causes infection.

Abstract

INTRODUCTION To compare efficacy and safety of the levonorgestrel-releasing intrauterine system (LNG-IUS) with medical treatments for women with heavy menstrual bleeding. MATERIALS AND METHODS We searched PubMed, Embase, the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure (CNKI), and Wanfang databases for relevant randomized controlled trials (RCTs) in November 2021. All meta-analyses were performed using the random-effects model. PROSPERO registration number: CRD42021295379. RESULTS A total of trials (with 14 references) reporting on 1,677 women were included in this systematic review. The majority of the included RCTs were rated with low-to-unclear risk of bias in selection, detection, attrition, reporting, and other bias. All RCTs were rated as high risk in performance bias because blinding was difficult to ensure in the compared groups. Results of meta-analyses revealed that the number of clinical responders was greater in the LNG-IUS group than that in the medical treatments group at both 6-month (steroidal: five RCTs; n = 490; risk ratio [RR]: 1.72 [1.13, 2.62]; I (2) = 92%; nonsteroidal: one RCT; n = 42; RR: 2.34 [1.31, 4.19]) and 12-month (steroidal: three RCTs; n = 261; RR: 1.31 [1.01, 1.71]; I (2) = 74%) endpoints, with no clear differences on number of dropouts, and the incidence of adverse events. CONCLUSION Evidence indicates that LNG-IUS is superior to the medical treatments in short-term and medium-term clinical responses, blood loss control, compliance, and satisfaction. Meanwhile, frequency of adverse events related to LNG-IUS is acceptable. SYSTEMATIC REVIEW REGISTRATION PROSPERO, identifier CRD42021259335, https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021295379.

Abstract

OBJECTIVE COVID-19 is associated with an increased risk of venous thromboembolic events (VTE). Recent studies have characterized racial disparities in the incidence of VTE. The aim of our study was to present a systematic review and meta-analysis to assess the association between race and VTE in hospitalized COVID-19 patients. METHODS We performed a systematic literature review to evaluate the number of deep vein thrombosis (DVT) and pulmonary embolism (PE) events reported by racial groups in COVID-19 hospitalized patients. For qualitative analysis, independent reviewers extracted data from eligible studies, and we utilized the Newcastle-Ottawa Scale to assess the quality of design and content for accurate interpretation. For the quantitative analysis, we pooled the ORs with Der Simonian and Laird random effects models. RESULTS The qualitative analysis included 11 studies, and the meta-analysis had six of them. All studies were observational, retrospective cohort studies, except for one retrospective case-control study. Six studies were eligible for the meta-analysis due to high interstudy heterogeneity; thus, variable reports of racial groups reduced the cohort to Black/African American and White patients (n = 9723) in the analysis. The estimated proportion for DVT/PE for Black/African American and Whites was 0.07 (95% CI [0.00, 0.10]) and 0.04 (95% CI [0.00, 0.07]), respectively. The p value of 0.13 suggest non-significant difference in VTE rates between Black/African American and White patients. CONCLUSION In our study, the proportion of DVT/PE events between Black/African American and White COVID-19 patients were comparable. Future COVID-19 studies should include systematic racial group reporting to identify disparities in the setting of thromboembolic events.

Abstract

BACKGROUND The pathophysiology of cancer-related anemia is multifactorial, including that of chemotherapy-induced anemia (CIA). The guidelines are not consistent in their approach to the use of intravenous (IV) iron in patients with cancer as part of the clinical practice. MATERIALS AND METHODS All randomized controlled trials that compared IV iron with either no iron or iron taken orally for the treatment of CIA were included. We excluded trials if erythropoiesis-stimulating agents (ESAs) were used. The primary outcome was the percentage of patients requiring a red blood cell (RBC) transfusion during the study period. The secondary outcomes included the hematopoietic response (an increase in the Hb level by more than 1 g/dL or an increase above 11 g/dL), the iron parameters and adverse events. For the dichotomous data, risk ratios (RRs) with 95% confidence intervals (Cis) were estimated and pooled. For the continuous data, the mean differences were calculated. A fixed effect model was used, except in the event of significant heterogeneity between the trials (p < 0.10; I(2) > 40%), in which we used a random effects model. RESULTS A total of 8 trials published between January 1990 and July 2021 that randomized 1015 patients fulfilled the inclusion criteria. Of these, 553 patients were randomized to IV iron and were compared with 271 patients randomized to oral iron and 191 to no iron. IV iron decreased the percentage of patients requiring a blood transfusion compared with oral iron (RR 0.72; 95% CI 0.55-0.95) with a number needed to treat of 20 (95% CI 11-100). IV iron increased the hematopoietic response (RR 1.23; 95% CI 1.01-1.5). There was no difference with respect to the risk of adverse events (RR 0.97; 95% CI 0.88-1.07; 8 trials) or severe adverse events (RR 1.09; 95% CI 0.76-1.57; 8 trials). CONCLUSIONS IV iron resulted in a decrease in the need for RBC transfusions, with no difference in adverse events in patients with CIA. IV iron for the treatment of CIA should be considered in clinical practice.

Abstract

PURPOSE Aim of this systematic review was to evaluate the literature regarding the effect of tranexamic acid (TXA) on the outcome after knee osteotomy. METHODS A systematic literature search was carried out in various databases on studies on the use of tranexamic acid in osteotomies around the knee. Primary outcome criterion was the hemoglobin (drop). Secondary outcome criteria were total blood loss, drainage volume, adverse effects such as thromboembolic events, blood transfusions, wound complications and clinical scores. A meta-analysis was performed for quantitative measures. The present study was registered prospectively ( www.crd.york.ac.uk/PROSPERO ; no.: CRD42021229624). RESULTS Seven studies with 584 patients (TXA group: 282 patients, non TXA group: 302 patients) Hemoglobin decrease (1.54 g/dl vs. 2.28 g/dl), blood loss (394.49 ml vs. 595.54 ml) and drainage volume (266.5 ml vs. 359.05 ml) were significantly less in the TXA group compared to the non TXA group. No thromboembolic event was noted in any study. In the non TXA group four blood transfusions were given. Eleven wound complications occurred in the non TXA group in comparison to two wound complications in the TXA group. CONCLUSIONS The results of the present study show that the application of TXA reduces hemoglobin drop, blood loss and drainage volume. These effects could be responsible for the lesser rate of side effects after administration of TXA during knee osteotomy.

Abstract

Background - The new severe acute respiratory syndrome coronavirus 2 have emerged as a global pandemic that threatens thousands around the world. Observational cohort studies have demonstrated that cancer patients have inferior outcomes due to underlying malignancy, treatment-related immunosuppression, or increased comorbidities. We aimed to examine the representation of cancer patients (hematological malignancies and solid tumors) in COVID-19 therapeutic and prophylactic interventional trials. Methods- In this review, all randomized controlled trials (RCTs) published between December 2019 and August 2021 were included. We included only trials evaluating medications that were recommended by NIH guidelines: steroids, Tocilizumab, Remdesivir and REGN-COV2. Results- The search yielded 540 potentially relevant RCTs, 22 of which were considered suitable. All trials included patients with solid cancer and hematological malignancies in the formal reported inclusion criteria. However, only two trials reported the accurate number of cancer patients included. Ten trials excluded neutropenic patients and seven trials excluded thrombocytopenic patients. Eleven trials excluded patients that were treated with any immunosuppression treatment. None of the two trials that included cancer patients reported separate outcomes for this population. Conclusion- Our systematic review shows that cancer patients are under-represented in COVID-19 interventional therapeutic trials, and evidence regarding outcomes are lacking.

Abstract

OBJECTIVE To conduct a systematic review and meta-analysis of randomized controlled trials on the clinical efficacy and safety of prophylactic tranexamic acid (TXA) versus control (normal saline/no treatment) during myomectomy. METHODS Six databases were screened from inception until 21-February-2022. The eligible studies were assessed for risk of bias. The outcomes were summarized as mean difference (MD) and risk ratio (RR) with 95% confidence intervals (CI) in a random-effects model. RESULTS Seven studies, comprising eight arms and 571 patients (TXA = 304 patients, control = 267 patients) were analyzed. The included studies had an overall low risk of bias. The mean intraoperative blood loss (MD = -224.34 ml, 95% CI [-303.06, -145.61], p < 0.001), mean postoperative blood loss, and mean total blood loss were significantly reduced in favor of the prophylactic TXA group. Additionally, the mean postoperative hemoglobin (MD = 0.4 mg/dl, 95% CI [0.11, 0.68], p = 0.006) and mean postoperative hematocrit levels were significantly higher in favor of the prophylactic TXA group. While the mean hospital stay was significantly reduced in favor of the prophylactic TXA group (MD = -0.39 d, 95% [-0.74, -0.04], p = 0.03), there was no significant difference between both groups regarding the mean operation time and rate of blood transfusion. None of the participants in both groups developed any incidence of thromboembolic events. The rate of nausea was significantly higher in disfavor of the prophylactic TXA group (RR = 2.68, 95% CI [1.11, 6.43], p = 0.03). CONCLUSION Among patients undergoing myomectomy, prophylactic TXA was largely safe and linked to substantial reductions in perioperative blood loss and related morbidities.

Abstract

Intra-articular (IA) hyaluronic acid (HA) and platelet-rich plasma (PRP) injections are increasingly being prescribed for knee osteoarthritis (KOA). However, failure of the medical treatment may result in total knee arthroplasty (TKA). We wondered if IA HA or PRP injections (intervention) may delay the time to TKA (outcome) among KOA patients (population), compared to KOA patients not receiving these injections (comparator). For this systematic literature review (SLR) and meta-analysis, we selected observational studies with at least one group of patients receiving IA HA or PRP and with TKA data available. The main outcome was time from the diagnosis of KOA to TKA. We included 25 articles in the SLR (2,824,401 patients) and four in the meta-analysis. The mean strengthening the reporting of observational studies in epidemiology (STROBE) score was 63%. For patients receiving versus not receiving HA injections, the delay between a declared diagnosis of KOA to TKA was increased by 9.8 months (95% CI (8.2-11.4)). As compared with standard of care, the effect size of HA injections for this outcome was 0.57 (95% CI (0.36-0.76)). Only one study described a median time from PRP injections to TKA of 4.1 years (range 0.3-14.7). IA HA injections were associated with increased time to TKA. Causality cannot be concluded because of missing confounder factors as comorbidities. Data were insufficient to conclude any effect of PRP injections on TKA delay.