Sirolimus plus prednisolone vs sirolimus monotherapy for kaposiform hemangioendothelioma: a randomized clinical trial
The Kasabach-Merritt phenomenon (KMP) in kaposiform hemangioendothelioma (KHE) is characterized by life-threatening thrombocytopenia and consumptive coagulopathy. This study compared the efficacy and safety of sirolimus plus prednisolone versus sirolimus monotherapy as treatment strategies for KHE with KMP in the largest cohort to date. Participants were randomized to receive either sirolimus in combination with a short course of prednisolone or sirolimus monotherapy for at least 12 months. The primary outcome was defined as achievement of a durable platelet response (platelet count >100×109/L) at week 4. Participants completed efficacy assessments 2 years after the initial treatment. At week 4, a durable platelet response was achieved by 35 of 37 patients given sirolimus and prednisolone compared with 24 of 36 patients given sirolimus monotherapy (difference 27.9%; 95% CI, 10.0% to 44.7%). Compared with the sirolimus monotherapy group, the combination treatment group showed improvements in terms of measures of durable platelet responses at all points during the initial 3-week treatment period, median platelet counts during weeks 1 to 4, increased numbers of patients achieving fibrinogen stabilization at week 4, and objective lesion responses at month 12. Patients receiving combination therapy had fewer blood transfusions and a lower total incidence of disease sequelae than patients receiving sirolimus alone. The frequencies of total adverse events and grade 3-4 adverse events during treatment were similar in both groups. The responses seen in patients with KHE with KMP were profound and encouraging, suggesting that sirolimus plus prednisolone should be considered a valid treatment for KHE with KMP. ClinicalTrial.gov, number NCT03188068.
Effectiveness of intravenous immunoglobulin for children with severe COVID-19: A rapid review
Annals of Translational Medicine. 2020
Background: Intravenous immunoglobulin (IVIG) is usually used as supportive therapy, but the treatment of COVID-19 by IVIG is controversial This rapid review aims to explore the clinical effectiveness and safety of IVIG in the treatment of children with severe COVID-19 Methods: We systematically searched the literature on the use of IVIG in patients with COVID-19, severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS), including both adults and children We assessed the risk of bias and quality of evidence and reported the main findings descriptively Results: A total of 1,519 articles were identified by initial literature search, and finally six studies met our inclusion criteria, included one randomized controlled trial (RCT), four case series and one case report involving 198 patients One case series showed the survival of COVID-19 patients with acute respiratory distress syndrome (ARDS) was not improved by IVIG One case report showed high-dose IVIG could improve the outcome of COVID-19 adults Three observational studies showed inconsistent results of the effect of IVIG on SARS patients One RCT showed that IVIG did not reduce mortality or the incidence of nosocomial infection in adults with severe SARS The quality of evidence was between low and very low Conclusions: The existing evidence is insufficient to support the efficacy or safety of IVIG in the treatment of COVID-19
Thromboelastography or rotational thromboelastometry for bleeding management in adults undergoing cardiac surgery: a systematic review with meta-analysis and trial sequential analysis
Journal of thoracic disease. 2019;11(4):1170-1181
Background: Severe bleeding and massive transfusion of blood products may be associated with increased morbidity and mortality of cardiac surgery. A transfusion algorithm incorporating thromboelastography (TEG) or rotational thromboelastometry (ROTEM) can help to determine the appropriate time and target for the use of hemostatic blood products, which may thus reduce the quantity of blood loss as well as blood products transfused. Methods: We conducted meta-analysis and trial sequential analysis to evaluate the effects of TEG or ROTEM-guided transfusion algorithms vs. standard treatments for patients undergoing cardiac surgery with cardiac pulmonary bypass. Results: Nineteen studies with a total of 15,320 participants, including 13 randomized controlled trials (RCTs), were included. All-cause mortality was not reduced either in overall studies or in RCTs. Blood loss volume was reduced by 132 mL in overall studies [mean difference (MD): -132.46, 95% CI: -207.49, -57.43; I(2) =53%, P<0.01], and by 103 mL in RCTs (MD: -103.50, 95% CI: -156.52, -50.48; I(2) =0%, P<0.01). The relative risks (RRs) in RCTs were 0.89 (95% CI: 0.80-0.98; I(2) =0%, P=0.02) for red blood cells transfusion, 0.59 (95% CI: 0.42-0.82; I(2) =55%, P<0.01) for fresh frozen plasma transfusion, and 0.81 (95% CI: 0.74-0.90; I(2) =0%, P<0.01) for platelet transfusion, respectively. Trial sequential analysis of continuous data on blood loss and dichotomous outcomes on transfusion of blood products suggested the benefits of a TEG/ROTEM-guided algorithm. Conclusions: TEG or ROTEM-guided transfusion strategies may reduce blood loss volume and the transfusion rates in adult patients undergoing cardiac surgery.
Autologous peripheral blood mononuclear cells intrauterine instillation to improve pregnancy outcomes after recurrent implantation failure: a systematic review and meta-analysis
Archives of gynecology and obstetrics. 2019
PURPOSE Recurrent implantation failure (RIF) is a common cause of disappointment and a big challenge after assisted reproduction technology treatments. The objective of this study was to evaluate the existing literature to explore whether peripheral blood mononuclear cells' (PBMCs) instillation could improve pregnancy outcomes among patients with RIF. METHODS We conducted a comprehensive search including PubMed, EMBASE, Cochrane library and various databases in China. Three randomized controlled trials (RCTs) and three non-randomized controlled trials (non-RCTs) were included. We included subgroup and sensitivity analyses using Stata 12.0. RESULTS The results of the three RCTs showed that PBMC improved outcomes in all patients compared with placebo or no-treatment [clinical pregnancy rate (CPR): odds ratio (OR) 2.45, 95% confidence interval (CI) 1.53-3.91; implantation rate (IR): OR 2.46, 95% CI 1.48-4.09; live birth rate (LBR): OR 2.43, 95% CI 1.32-4.49]. However, the results of the three non-RCTs indicated that there were no statistically significant differences in the outcomes and that the heterogeneity was higher (I(2) > 0%). Subgroup analysis further suggested that PBMCs treatment significantly increased the CPR, IR and LBR in the three or more implantation failure subgroups (CPR: OR 2.83, 95% CI 1.29-6.22; IR: OR 3.74, 95% CI 1.71-8.19; LBR: OR 3.03, 95% CI 1.15-7.98). CONCLUSIONS Among patients with three or more implantation failures, this treatment improved IR, LBR, and CPR compared to that in controls, due to the limited data available, PBMCs' intrauterine instillation should only be used in the context of clinical trials.
The impact of perioperative allogeneic blood transfusion on prognosis of hepatocellular carcinoma after radical hepatectomy: A systematic review and meta-analysis of cohort studies
This meta-analysis aims to clarify the clinical impacts of allogeneic blood transfusion (ABT) on hepatectomy outcome in hepatocellular carcinoma (HCC) patients. A systematic literature search was performed for relevant articles in international and Chinese databases up to May 2018. Random- or fixed-effect meta-analysis was used to pool the effect estimates. Publication bias was assessed by Egger's and Peters's test. Heterogeneity was assessed using the I statistic. The strength of evidence was rated by the Grading of Recommendations Assessment, Development, and Evaluation system. A total of 29 studies met the eligibility criteria. Meta-analysis showed HCC patients in ABT group had lower survival rate at 1, 3, 5, and 10 years after radical hepatectomy than those in no blood transfusion (NBT) group (RR = 0.9, 95%CI: 0.87-0.93, P < .05; RR = 0.83, 95%CI: 0.77-0.89, P < .05; RR = 0.7, 95%CI: 0.65-0.74, P < .05; RR = 0.64, 95%CI: 0.54-0.75, P < .05). Similar results were observed in disease-free survival (DFS) (respectively: RR = 0.86, 95%CI: 0.82-0.91, P < .05; RR = 0.77, 95%CI: 0.67-0.79, P < .05; RR = 0.71, 95%CI: 0.64-0.79, P < .05; RR = 0.62, 95%CI: 0.48-0.8, P < .05). Cancer recurrence rate was higher for the patients in ABT group at 1 and 3 years (RR = 1.5, 95%CI: 1-2.24, P < .05; RR = 1.27, 95%CI: 1.09-1.49, P < .05, respectively), but not statistically significant at 5years (RR = 1.08, 95%CI: 0.98-1.19, P = .512). The HCC patients in ABT group increased postoperative complications occurrence compared with those in NBT group (RR = 1.87, 95%CI: 1.42-2.45, P < .05). This meta-analysis demonstrated that ABT was associated with adverse clinical outcomes for HCC patients undergoing radical hepatectomy, including poor survival, DFS, and complications. Surgeons should reduce blood loss during hepatectomy and avoid perioperative allogenic blood transfusion.
Cell salvage in emergency trauma surgery
Cochrane Database of Systematic Reviews. 2015;((1):):CD007379.
BACKGROUND Trauma is the leading cause of death in people under the age of 45 years. Over the past 20 years, intraoperative autologous transfusions (obtained by cell salvage, also known as intraoperative blood salvage (IBS)) have been used as an alternative to blood products from other individuals during surgery because of the risk of transfusion-related infections such as hepatitis and human immunodeficiency virus (HIV). In this review, we sought to assess the effects and cost of cell salvage in individuals undergoing abdominal or thoracic surgery. OBJECTIVES To compare the effect and cost of cell salvage with those of standard care in individuals undergoing abdominal or thoracic trauma surgery. SEARCH METHODS We ran the search on 25 November 2014. We searched the Cochrane Injuries Group's Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), Ovid MEDLINE, Ovid MEDLINE In-Process & Other Non-Indexed Citations, Ovid MEDLINE Daily and Ovid OLDMEDLINE, EMBASE Classic + EMBASE (OvidSP), PubMed, and ISI Web of Science (SCI-Expanded & CPSI-SSH). We also screened reference lists and contacted principal investigators. SELECTION CRITERIA Randomised controlled trials comparing cell salvage with no cell salvage (standard care) in individuals undergoing abdominal or thoracic trauma surgery. DATA COLLECTION AND ANALYSIS Two authors independently extracted data from the trial reports. We used the standard methodological procedures expected by The Cochrane Collaboration. MAIN RESULTS Only one small study (n = 44) fulfilled the inclusion criteria. Results suggested that cell salvage did not affect mortality overall (death rates were 67% (14/21 participants) in the cell salvage group and 65% (15/23) in the control group) (odds ratio (OR) 1.07, 95% confidence interval (CI) 0.31 to 3.72). For individuals with abdominal injury, mortality was also similar in both groups (OR 0.48, 95% CI 0.11 to 2.10).Less donor blood was needed for transfusion within the first 24 hours postinjury in the cell salvage group compared with the control group (mean difference (MD) -4.70 units, 95% CI -8.09 to -1.31). Adverse events, notably postoperative sepsis, did not differ between groups (OR 0.54, 95% CI 0.11 to 2.55). Cost did not notably differ between groups (MD -177.81, 95% CI -452.85 to 97.23, measured in GBP in 2002). AUTHORS' CONCLUSIONS Evidence for the use of cell salvage in individuals undergoing abdominal or thoracic trauma surgery remains equivocal. Large, multicentre, methodologically rigorous trials are needed to assess the relative efficacy, safety and cost-effectiveness of cell salvage in different surgical procedures in the emergency context.