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.

Abstract

BACKGROUND The apheresis technique is increasingly used in patients with hypertriglyceridemia-induced pancreatitis (HTGP), while its role in this context is still not well established. Thus, we aimed to evaluate the clinical outcomes of an apheresis therapy compared to usual care in such a patient population. METHODS We searched PubMed, Embase, and Cochrane library databases up to July 10, 2021. Studies were included if they focused on HTGP treated with or without apheresis technique. We used the Newcastle-Ottawa Scale to assess the quality of the included studies. The primary outcome was the mortality rate. We also explored the heterogeneity, sensitivity analysis, subgroup analysis, and publication bias. RESULTS Sixteen observational studies with 1476 adults were included. The overall quality of included studies was moderate. Despite better TG level reduction with apheresis therapy (mean difference [MD], 12.27 mmol/L, 95% CI, 3.74 to 20.81; I(2) = 78%; P = 0.005), use of apheresis did not reduce the mortality (odds ratio [OR], 1.01; 95% CI, 0.65 to 1.59; P = 0.95) compared with usual care. This result was further confirmed by sensitivity analysis, subgroup analysis. The length of stay in hospital (MD, 0.96 days; 95% CI, - 1.22 to 3.14; I(2) = 70%; P = 0.39) and most complications were similar between the groups, while hospital cost was significantly higher in the apheresis group. CONCLUSIONS The apheresis technique did not decrease the mortality in HTGP patients compared with usual care. Until the results of high-quality RCTs are known, these findings do not support the routine use of the apheresis technique in such a patient population.

Abstract

Artificial liver support system (ALSS) therapy is widely used in patients with hepatitis B virus-related acute-on-chronic liver failure (HBV-ACLF). We aimed to develop a predictive score to identify the subgroups who may benefit from plasma exchange (PE)-centered ALSS therapy. A total of 601 patients were retrospectively enrolled and randomly divided into a derivation cohort of 303 patients and a validation cohort of 298 patients for logistic regression analysis, respectively. Five baseline variables, including liver cirrhosis, total bilirubin, international normalized ratio of prothrombin time, infection and hepatic encephalopathy, were found independently associated with 3-month mortality. A predictive PALS model and the simplified PALS score were developed. The predicative value of PALS score (AUROC = 0.818) to 3-month prognosis was as capable as PALS model (AUROC = 0.839), R score (AUROC = 0.824) and Yue-Meng' score (AUROC = 0.810) (all p > 0.05), and superior to CART model (AUROC = 0.760) and MELD score (AUROC = 0.765) (all p < 0.05). The PALS score had significant linear correlation with 3-month mortality (R(2) = 0.970, p = 0.000). PALS score of 0-2 had both sensitivity and negative predictive value of > 90% for 3-month mortality, while PALS score of 6-9 had both specificity and positive predictive value of > 90%. Patients with PALS score of 3-5 who received 3-5 sessions of ALSS therapy had much lower 3-month mortality than those who received 1-2 sessions (32.8% vs. 59.2%, p < 0.05). The more severe patients with PALS score of 6-9 could still benefit from ≥ 6 sessions of ALSS therapy compared to ≤ 2 sessions (63.6% vs. 97.0%, p < 0.05). The PALS score could predict prognosis reliably and conveniently. It could identify the subgroups who could benefit from PE-centered ALSS therapy, and suggest the reasonable sessions.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000032055. Registered 19th April 2020, http://www.chictr.org.cn/showproj.aspx?proj=52471 .

Abstract

BACKGROUND The safety of perioperative intravenous hydroxyethyl starch (HES) products, specifically HES 130/0.4, continues to be the source of much debate. The aim of this meta-analysis was to update the existing evidence and gain further insight into the clinical effects of HES 130/0.4 on postoperative outcomes for volume replacement therapy in surgical patients. METHODS MEDLINE, EMBASE, and Cochrane Library databases were searched from inception to March 2020 for relevant randomized controlled trials (RCTs) on perioperative use of HES 130/0.4 in adult surgical patients. The primary outcome was postoperative mortality and secondary outcomes were the incidence of acute kidney injury (AKI) and requirement for renal replacement therapy (RRT). The analysis was performed using the random-effects method and the risk ratio (RR) with a 95% confidence interval (CI). We performed the risk-of-bias assessment of eligible studies and assessed the overall quality of evidence for each outcome. RESULTS Twenty-five RCTs with 4111 participants were finally included. There were no statistical differences between HES 130/0.4 and other fluids in mortality at 30 days (RR 1.28, 95% CI 0.88 to 1.86, p = 0.20), the incidence of AKI (RR 1.23, 95% CI 0.99 to 1.53, p = 0.07), or requirement for RRT (RR 0.75, 95% CI 0.37 to 1.53, p = 0.43). Overall, there was a moderate certainty of evidence for all the outcomes. There was no subgroup difference related to the type of surgery (p = 0.17) in the incidence of AKI. As for the type of comparator fluids, however, there was a trend that was not statistically significant (p = 0.06) towards the increased incidence of AKI in the HES 130/0.4 group (RR 1.22, 95% CI 0.97 to 1.54) compared with the crystalloid group (RR 1.21, 95% CI 0.27 to 3.91). Subgroup analyses according to the type of surgery demonstrated consistent findings. CONCLUSIONS This systematic review and meta-analysis suggests that the use of HES 130/0.4 for volume replacement therapy compared with other fluids resulted in no significant difference in postoperative mortality or kidney dysfunction among surgical patients. Given the absent evidence of confirmed benefit and the potential trend of increased kidney injury, we cannot recommend the routine clinical use of HES 130/0.4 for volume replacement therapy in surgical patients from the perspective of benefit/risk profile. However, the results need to be interpreted with caution due to the limited sample size, and further well-powered RCTs are warranted. TRIAL REGISTRATION PROSPERO registry reference: CRD42020173058.

Abstract

BACKGROUND Convalescent plasma (CP) has been used successfully to treat many types of infectious diseases, and it has shown initial effects in the treatment of the emerging 2019 coronavirus disease (COVID-19). However, its curative effect and feasibility have yet to be confirmed by formal evaluation and well-designed clinical trials. To explore the effectiveness of treatment and predict the potential effect of CP for COVID-19, studies of different types of infectious diseases treated with CP were included in this systematic review and meta-analysis. METHODS Related studies were obtained from databases and screened based on the inclusion criteria. The data quality was assessed, and the data were extracted and pooled for analysis. RESULTS We included 40 studies on CP treatment for infectious diseases We found that CP treatment could reduce the risk of mortality with a low incidence of adverse events, promote the production of antibodies, show the decline in viral load, and shorten the disease course. A meta-analysis of 15 controlled studies showed that there was a significantly lower mortality rate in the group treated with CP (pooled OR = 0.32, 95% CI: 0.19-0.52, P < 0.001, I(2) = 54%) than in the control groups. Studies were mostly of low or very low quality with a moderate or high risk of bias. The sources of clinical and methodological heterogeneity were identified. The exclusion of heterogeneity indicated that the results were stable. CONCLUSIONS CP therapy has some curative effect and is well tolerated to treat infectious diseases. It is a potentially effective treatment for COVID-19.

Abstract

There is a growing interest in precision medicine where individual heterogeneity is incorporated into decision-making and treatments are tailored to individuals to provide better healthcare. One important aspect of precision medicine is the estimation of the optimal individualized treatment rule (ITR) that optimizes the expected outcome. Most methods developed for this purpose are restricted to the setting with two treatments, while clinical studies with more than two treatments are common in practice. In this work, we summarize methods to estimate the optimal ITR in the multi-arm setting and compare their performance in large-scale clinical trials via simulation studies. We then illustrate their utilities with a case study using the data from the INTERVAL trial, which randomly assigned over 20,000 male blood donors from England to one of the three inter-donation intervals (12-week, 10-week, and eight-week) over two years. We estimate the optimal individualized donation strategies under three different objectives. Our findings are fairly consistent across five different approaches that are applied: when we target the maximization of the total units of blood collected, almost all donors are assigned to the eight-week inter-donation interval, whereas if we aim at minimizing the low hemoglobin deferral rates, almost all donors are assigned to donate every 12 weeks. However, when the goal is to maximize the utility score that "discounts" the total units of blood collected by the incidences of low hemoglobin deferrals, we observe some heterogeneity in the optimal inter-donation interval across donors and the optimal donor assignment strategy is highly dependent on the trade-off parameter in the utility function.

Abstract

INTRODUCTION The most common complication of post-colorectal endoscopic resection is delayed bleeding. The assessment of risk factors for delayed bleeding provide important and useful information in standard clinical operations. The risk factors have been previously reported, however they remain inconsistent across different studies. AREAS COVERED In this meta-analysis the patient conditions, lesion-related factors, and operation-related factors were compared between delayed bleeding and no bleeding. PubMed, Cochrane, Embase, China National Knowledge Infrastructure (CNKI), and Wanfang Database were searched to identify eligible studies. Pooled odds ratio (OR) and 95% confidence intervals (CI) were calculated along with heterogeneity. EXPERT OPINION This study is the first meta-analysis to investigate risk factors for colorectal delayed bleeding. We found several risk factors contributing to this condition: colorectal tumors located in the proximal colon, a history of antithrombotic drug use, high-grade intraepithelial neoplasia or early cancer, piecemeal resection, intraoperative hemorrhage, no clip placement, and severe submucosal fibrosis. Despite our findings, we also conclude that more high-quality, large-scale clinical randomized controlled studies are needed due to limited retrospective studies at present. Future therapeutic colonoscopies should focus on precise diagnosis, treatment safety, and management during the perioperative period.

Abstract

BACKGROUND Convalescent plasma administration may be of clinical benefit in patients with severe influenza, but reports on the efficacy of this therapy vary. METHODS We conducted a systematic review and meta-analysis assessing randomized controlled trials (RCTs) involving the administration of convalescent plasma to treat severe influenza. Healthcare databases were searched in February 2020. All records were screened against eligibility criteria, and the risks of bias were assessed. The primary outcome was the fatality rate. RESULTS A total of 2861 studies were retrieved and screened. Five eligible RCTs were identified. Pooled analyses yielded no evidence that using convalescent plasma to treat severe influenza resulted in significant reductions in mortality (odds ratio, 1.06; 95% CI, 0.51-2·23; P = 0.87; I(2) = 35%), number of days in the intensive care unit, or number of days on mechanical ventilation. This treatment may have the possible benefits of increasing hemagglutination inhibition titers and reducing influenza B viral loads and cytokine levels. No serious adverse events were reported. The included studies were generally of high quality with a low risk of bias. CONCLUSIONS The administration of convalescent plasma appears safe but may not reduce the mortality, number of days in the intensive care unit, or number of days on mechanical ventilation in patients with severe influenza.

Abstract

BACKGROUND No consensus on the superiority between neuroendoscopy (NE) and craniotomy (CT) for the treatment of supratentorial hypertensive intracerebral hemorrhage (HICH) has been achieved. The purpose of this study is to analyze the efficacy and safety of NE versus CT for supratentorial HICH. METHOD A systematic search of English databases (PubMed, Embase, the Cochrane Library, Web of Science) was performed to identify related studies published from September 1994 to June 2019. The Newcastle-Ottawa Scale (NOS) and the Cochrane Reviewer's Handbook 5.0.0 were separately used to evaluate the quality of the included observational studies (OSs) and randomized controlled trials (RCTs). RevMan 5.3 software was adopted to conduct the meta-analysis. The outcome measures included the primary and secondary outcomes. Subgroup analysis was performed to explore the impact of year of publication, initial Glasgow Coma Scale (GCS), age, time to surgery, hematoma volume and surgical methods on the outcome measures. RESULTS Fifteen studies (three RCTs and twelve OSs), containing 1859 supratentorial HICH patients, were included in this meta-analysis. The pooled results showed that NE could increase the good functional outcome (GFO) (P <0.0003) and hematoma evacuation rate (P = 0.0007); reduce the mortality (P <0.00001), blood loss (P = 0.004), operation time (P <0.00001), hospital stays (P = 0.006), and ICU stays (P <0.0001) when compared with CT. In addition, NE could also have a positive effect on preventing postoperative infection (P <0.00001) and total complications (P <0.00001). However, in the aspect of postoperative rebleeding incidence (P = 0.12), no obvious difference was found between the two group. Publication bias was low regarding GFO, mortality, and hematoma evacuation rate. Subgroup analysis suggested year of publication, initial GCS, age, hematoma volume and surgical methods did not affect the hematoma evacuation rate significantly. The difference in mortality was not statistically significant in the subgroup of hematoma volume < 50ml (P = 0.44) and initial GCS > 8 (P = 0.09). In addition, the data suggested that time to surgery and surgical methods might be the important factors affecting the GFO and mortality. CONCLUSION NE might be a safer and more effective surgical method than CT in the treatment of patients with supratentorial HICH. However, due to the existence of some limitations, the safety and validity of NE was weakened. More high-quality trials should be included to verify our conclusion.

Abstract

BACKGROUND Intravenous (IV), topical and combination of both application of tranexamic acid (TXA) can reduce blood loss, hemoglobin drop, and transfusion rate in patients following total hip arthroplasty (THA). Lately, published articles reported that oral TXA had as similar blood-saving as IV and topical TXA in THA. The purpose of this meta-analysis is to investigate the efficiency and safety of oral TXA in THA. METHODS We systematically searched articles about oral administration of TXA in THA from PubMed, Embase, Scopus, Web of Science, the Cochrane Library, and the Chinese Wanfang database. STUDY ELIGIBILITY CRITERIA The outcomes were collected and analyzed by the Review Manager 5.3. RESULTS Nine RCTs and 1 CCT, containing 1305 patients, were ultimately included according to the inclusion criteria and exclusion criteria in the meta-analysis. The effectiveness of oral TXA was as similar as the IV or topical TXA in regard to hemoglobin drop (SMD = -0.14; 95% CI, [-0.28, 0.01]; P = .06), total blood loss (SMD = 0.01; 95% CI, [-0.13, 0.16]; P = .84), transfusion rate (OR = 0.76; 95% CI, [0.38, 1.55]; P = .37). Compared with single oral TXA or blank group, multiple oral TXA effectively reduced hemoglobin drop (SMD = -1.06; 95% CI, [-1.36, -0.77]; P < .05), total blood loss (SMD = -1.30; 95% CI, [-1.66, -0.94]; P < .05), transfusion rate (OR = 0.53; 95% CI, [0.29, 0.95]; P = .03). There were no significant difference in terms of length of stay and complication among all of enrolled studies. CONCLUSION Oral TXA has favorable effect of blood-saving and do not increase risk of complication in patients following THA. Oral TXA may have no effect in the length of stay. More high quality RCTs are necessary.