Abstract

PURPOSE Cancer patients with COVID-19 likely express biomarker changes in circulation. However, the biomarkers used in SARS-CoV-2 infected cancer patients for COVID-19 severity and prognosis are largely unclear. Therefore, this systematic review aims to determine what biomarkers were measured in cancer patients with COVID-19 and their prognostic utility. METHODS A systematic literature review in PubMed, Embase, and Scopus was performed on June 16th, 2021. The search keywords coronavirus, neoplasm, biomarkers, and disease progression were used to filter out 17 eligible studies, which were then carefully evaluated. RESULTS A total of 4,168 patients, 16 types of cancer, and 60 biomarkers were included. Seven up-regulated markers, including CRP, d-dimer, ferritin, IL-2R, IL-6, LDH, and PCT, were identified in eligible studies. Albumin and hemoglobin were significantly down-regulated in cancer patients with COVID-19. Moreover, we observed that the SARS-CoV-2 infected cancer patients with lower CRP, ferritin, and LDH levels successfully survived from COVID-19 treatments. CONCLUSION Several important clinical biomarkers, such as CRP, ferritin, and LDH, may serve as the prognostic markers to predict the outcomes following COVID-19 treatment and monitor the deterioration of COVID-19 in cancer patients.

Abstract

OBJECTIVE To evaluate the safety and efficacy of using ergometrine maleate injection combined with oxytocin injection, with oxytocin injection as the control, to prevent postpartum hemorrhage after vaginal delivery. METHODS A total of 305 cases who underwent vaginal delivery between December 2018 and November 2019 in 16 hospitals across China were enrolled and included in the full analysis set (FAS) and the safety analysis set (SS). Among the 299 subjects who completed the trial, 277 were included in the per protocol set (PPS). The subjects were randomly assigned by 1∶1 ratio to two groups, 152 cases in Group A, the experimental group receiving oxytocin injection plus ergometrine injection, and 153 cases in Group B, the control group, receiving oxytocin injection. The difference in total bleeding volume at 2 h, 6 h and 24 h postpartum in the two groups was documented and compared. Other measures were also compared between the two groups, including the proportion of additional use of uterotonics and hemostatic drugs or other hemostatic measures 2 h and 24 h postpartum, the proportion of subjects needing blood transfusion, the time of placenta retention, proportion of subjects with prolonged hospital stay due to uterine asthenia, the vital signs, lab test indicators and the incidence of adverse reactions in the two groups. RESULTS The total bleeding volume at 2 h, 6 h and 24 h after delivery was significantly lower in the experimental group (P<0.05). There was no significant difference between the two groups in the proportion of additional use of uterotonics and hemostatic drugs or other hemostatic measures 2 h and 24 h postpartum, the proportion of subjects needing blood transfusion and the time of placenta retention, heart rate, respiration, lab test indicators, or the incidence of adverse reaction (P>0.05). CONCLUSION Ergometrine maleate injection showed evident therapeutic efficacy in preventing hemorrhage after vaginal delivery, causing fewer adverse reactions and ensuring greater safety, and therefore, presenting promising prospects for clinical application.

Abstract

AIM: The ideal route of tranexamic acid (TXA) administration in total hip arthroplasty (THA) or total knee arthroplasty (TKA) remains controversial. This study aims to identify the optima route of TXA administration in THA or TKA. METHODS PUBMED, EMBASE, MEDLINE and CENTRAL database were systematically searched until 4 August 2021 for randomised studies that compared intravenous (IV) or intra-articular (IA) administration of TXA in THA or TKA. RESULTS Sixty-seven studies enrolling 8335 patients (IA: 4162; IV: 4173) were eligible for quantitative and qualitative analysis. Comparable results were demonstrated in the incidence of venous thromboembolisation (OR:0.96, p = 0.84), total blood loss (MD: - 9.05, p = 0.36), drain output (MD: - 7.36, p = 0.54), hidden blood loss (MD: - 6.85, p = 0.47), postoperative haemoglobin level (MD: 0.01, p = 0.91), haemoglobin drop (MD: - 0.10, p = 0.22), blood transfusion rate (OR: 0.99, p = 0.87), total adverse events (OR: 1.12, p = 0.28), postoperative range of motion (MD: 1.08, p = 0.36), postoperative VAS pain score (MD: 0.13, p = 0.24) and postoperative D-dimer level (MD: 0.61, p = 0.64). IV route of TXA administration was associated with significantly longer length of hospital stay compared to IA route of administration (MD: - 0.22, p = 0.01). CONCLUSION In this meta-analysis, both IV and IA route of TXA administration were equally effective in managing blood loss and postoperative outcomes in lower limb joints arthroplasty. LEVEL OF EVIDENCE Level 1. PROSPERO Registration CRD42021271355.

Abstract

BACKGROUND Many studies have documented the use of platelet-rich plasma (PRP) alongside anterior cruciate ligament (ACL) reconstruction (ACLR) in the management of ACL injury, but evidence on the benefits of PRP in improving the clinical outcomes of ACLR is inconsistent. PURPOSE To help in our understanding, we undertook a systematic review and meta-analysis of randomized controlled trials (RCTs) that evaluated the effects of PRP on patient-reported functional scores, the clinical assessments of knee function and structure, and complications. STUDY DESIGN Systematic review; Level of evidence, 1. METHODS We searched 9 online databases for RCTs published in English or Chinese that examined the effects of PRP on ACLR. The primary outcome measures were visual analog scale (VAS) for pain and International Knee Documentation Committee (IKDC) scores. The secondary outcomes included KT-1000 arthrometer, pivot-shift test, Lysholm and Tegner scores, tunnel widening, graft characterization, and complications. Subgroup analyses were performed according to time of assessments. Fixed- and random-effects models were selected for data analysis. RESULTS A total of 14 studies were included. When PRP was injected to graft tunnels, the pooled VAS scores of the 2 groups were similar (P = .31), and the subgroup analysis found that VAS and IKDC only improved at 3 months postoperatively (P = .0003 and P < .00001, respectively). When PRP was used at the bone-patellar tendon-bone harvest sites, VAS was decreased in the first 6 months postoperatively (P < .00001), whereas IKDC score was not remarkably different (P = .07). After PRP injection, Lysholm scores at 3 months postoperatively was different between the 2 groups (P < .00001), but the Tegner scores (P = .86), KT-1000 measurements (P = .12), the positive rate of pivot-shift test (P = .64), the enlargement of tunnels (femoral, P = .91; tibial, P = .80), and the characterization of grafts (P = .05) were not different. No difference in complications was found in either group. CONCLUSION PRP applied alongside ACLR could reduce postoperative pain and improve knee function in the short and medium terms but is ineffective in the long term. PRP does not improve knee stability and the enlargement of tunnels and does not accelerate the healing of grafts. Further studies would be required.

Abstract

BACKGROUND The aim of this trial was to assess the effectiveness of quality improvement collaboratives to implement large-scale change in the National Health Service (NHS) in the UK, specifically for improving outcomes in patients undergoing primary, elective total hip or knee replacement. METHODS We undertook a two-arm, cluster randomised controlled trial comparing the roll-out of two preoperative pathways: methicillin-sensitive Staphylococcus aureus (MSSA) decolonisation (infection arm) and anaemia screening and treatment (anaemia arm). NHS Trusts are public sector organisations that provide healthcare within a geographical area. NHS Trusts (n = 41) in England providing primary, elective total hip and knee replacements, but that did not have a preoperative anaemia screening or MSSA decolonisation pathway in place, were randomised to one of the two parallel collaboratives. Collaboratives took place from May 2018 to November 2019. Twenty-seven Trusts completed the trial (11 anaemia, 16 infection). Outcome data were collected for procedures performed between November 2018 and November 2019. Co-primary outcomes were perioperative blood transfusion (within 7 days of surgery) and deep surgical site infection (SSI) caused by MSSA (within 90 days post-surgery) for the anaemia and infection trial arms, respectively. Secondary outcomes were deep and superficial SSIs (any organism), length of hospital stay, critical care admissions and unplanned readmissions. Process measures included the proportion of eligible patients receiving each preoperative initiative. RESULTS There were 19,254 procedures from 27 NHS Trusts included in the results (6324 from 11 Trusts in the anaemia arm, 12,930 from 16 Trusts in the infection arm). There were no improvements observed for blood transfusion (anaemia arm 183 (2.9%); infection arm 302 (2.3%) transfusions; adjusted odds ratio 1.20, 95% CI 0.52-2.75, p = 0.67) or MSSA deep SSI (anaemia arm 8 (0.13%); infection arm 18 (0.14%); adjusted odds ratio 1.01, 95% CI 0.42-2.46, p = 0.98). There were no significant improvements in any secondary outcome. This is despite process measures showing the preoperative pathways were implemented for 73.7% and 61.1% of eligible procedures in the infection and anaemia arms, respectively. CONCLUSIONS Quality improvement collaboratives did not result in improved patient outcomes in this trial; however, there was some evidence they may support successful implementation of new preoperative pathways in the NHS. TRIAL REGISTRATION Prospectively registered on 15 February 2018, ISRCTN11085475.

Abstract

IMPORTANCE COVID-19 convalescent plasma (CCP) is a potentially beneficial treatment for COVID-19 that requires rigorous testing. OBJECTIVE To compile individual patient data from randomized clinical trials of CCP and to monitor the data until completion or until accumulated evidence enables reliable conclusions regarding the clinical outcomes associated with CCP. DATA SOURCES From May to August 2020, a systematic search was performed for trials of CCP in the literature, clinical trial registry sites, and medRxiv. Domain experts at local, national, and international organizations were consulted regularly. STUDY SELECTION Eligible trials enrolled hospitalized patients with confirmed COVID-19, not receiving mechanical ventilation, and randomized them to CCP or control. The administered CCP was required to have measurable antibodies assessed locally. DATA EXTRACTION AND SYNTHESIS A minimal data set was submitted regularly via a secure portal, analyzed using a prespecified bayesian statistical plan, and reviewed frequently by a collective data and safety monitoring board. MAIN OUTCOMES AND MEASURES Prespecified coprimary end points-the World Health Organization (WHO) 11-point ordinal scale analyzed using a proportional odds model and a binary indicator of WHO score of 7 or higher capturing the most severe outcomes including mechanical ventilation through death and analyzed using a logistic model-were assessed clinically at 14 days after randomization. RESULTS Eight international trials collectively enrolled 2369 participants (1138 randomized to control and 1231 randomized to CCP). A total of 2341 participants (median [IQR] age, 60 [50-72] years; 845 women [35.7%]) had primary outcome data as of April 2021. The median (IQR) of the ordinal WHO scale was 3 (3-6); the cumulative OR was 0.94 (95% credible interval [CrI], 0.74-1.19; posterior probability of OR <1 of 71%). A total of 352 patients (15%) had WHO score greater than or equal to 7; the OR was 0.94 (95% CrI, 0.69-1.30; posterior probability of OR <1 of 65%). Adjusted for baseline covariates, the ORs for mortality were 0.88 at day 14 (95% CrI, 0.61-1.26; posterior probability of OR <1 of 77%) and 0.85 at day 28 (95% CrI, 0.62-1.18; posterior probability of OR <1 of 84%). Heterogeneity of treatment effect sizes was observed across an array of baseline characteristics. CONCLUSIONS AND RELEVANCE This meta-analysis found no association of CCP with better clinical outcomes for the typical patient. These findings suggest that real-time individual patient data pooling and meta-analysis during a pandemic are feasible, offering a model for future research and providing a rich data resource.

Abstract

The purpose of this systematic review was to analyze sinus lifting procedures and to compare the efficiency of this treatment associated with the second generation of platelet-rich fibrin related to its effects on bone gain and to clarify the regenerative efficacy in sinus lift procedure, whether alone or as a coadjutant to other bone graft materials. The PICOT question was, "In clinical studies with patients needing a maxillary sinus lift (P), does the use of PRF either alone (I) or in conjunction with other biomaterials (C) improve the clinical outcome associated with bone gain and density (O), with at least three months of follow-up (T)?" An electronic search was conducted in the MEDLINE (PubMed), Science Direct, and Scopus databases through a search strategy. A total of 443 articles were obtained from the electronic database search. Sixteen articles met all criteria and were included in this review. Within the limitation of this study and interpreting the results carefully, it was suggested that a higher risk for implant failure after a sinus elevation might be seen in patients with residual bone ≤4 mm, and PRF application was effective, suggesting reducing the time needed for new bone formation.

Abstract

INTRODUCTION There are two treatment modalities for aneurysmal subarachnoid hemorrhage: endovascular treatment and neurosurgical clipping. Results of economic evaluations are needed to gain insight into the relationship between clinical effectiveness and costs of these treatment modalities. This important information can inform both clinical decision-making processes and policymakers in facilitating Value-Based Healthcare. EVIDENCE ACQUISITION Databases (PubMed, Embase, Cochrane Library, the Centre for Reviews and Dissemination, EBSCO, and Web of Science) were searched for studies published until October 2020 that had performed economic evaluations in aneurysmal subarachnoid hemorrhage patients by comparing endovascular treatment with neurosurgical clipping. The quality of reporting and methodology of these evaluations was assessed using the associated instruments (i.e. CHEERS statement and CHEC-list, respectively). EVIDENCE SYNTHESIS A total of six studies met the inclusion criteria. All included studies reported both effects and costs, however five did not relate effects to costs. Only one study related effects directly to costs, thus conducted a full economic evaluation. The reporting quality scored 81% and the methodological quality scored 30%. CONCLUSIONS The quality of published cost-effectiveness studies on the treatment of aneurysmal subarachnoid hemorrhage is poor. Six studies reported both outcomes and costs, however only one study performed a full economic evaluation comparing endovascular treatment to neurosurgical clipping. Although the reporting quality was sufficient, the methodological quality was poor. Further research that relates health-related quality of life measures to costs of endovascular treatment and neurosurgical clipping is required-specifically focusing on both reporting and methodological quality. Different subgroup analyses and modeling could also enhance the findings.

Abstract

PURPOSE To investigate whether local administration of epsilon-aminocaproic acid (EACA) is effective and safe in reducing the post-operative blood loss in surgery for Sanders III-IV calcaneal fractures. METHODS Patients with Sanders III-IV calcaneal fractures who were hospitalized in our hospital from January 2016 to February 2021 and underwent open reduction internal fixation (ORIF) via lateral approach with an L-shaped incision were included in the current study. Eighty five patients were randomly divided into two groups, EACA group (43) and control group (42). Twenty milliliters of 5% EACA solution or normal saline was perfused into the incision of patients in EACA group and control group, respectively. The volume of post-operative drainage was investigated as the primary outcome. Post-operative blood test, coagulation test, and wound complications were analyzed as the secondary outcomes. RESULTS The volume of post-operative drainage at 24 and 48 h was 164.8 ± 51.4 ml, 18.9 ± 3.8 ml for patients in EACA group, and 373.0 ± 88.1 ml, 21.2 ± 4.4 ml for patients in the control group, respectively. EACA greatly reduced the post-operative blood loss compared to the control (normal saline). The difference between the two groups was statistically significant. No statistically significant difference was found between EACA group and control group with regard to the pre-operative, baseline characteristics. Post-operative blood test results demonstrated that haemoglobin and hematocrit were significantly higher in EACA compared to those of control group. No significant difference was found between EACA group and control group in terms of the platelet counts, prothrombin time (P.T.), activated partial prothrombin time (APTT), and wound complications. CONCLUSION Local administration of EACA is effective in post-operative blood loss reduction in ORIF surgeries for Sanders III-IV types of calcaneal fractures without increasing the incidence of periwound complication.