1.
Efficacy and safety of blood purification in the treatment of deep burns: A systematic review and meta-analysis
Zhang G, Liu W, Li J, Wang D, Duan J, Luo H
Medicine. 2021;100(5):e23968
Abstract
INTRODUCTION This meta-analysis aimed to systematically review and evaluate randomized controlled trials (RCTs) and cohort studies examining the efficacy and safety of blood purification in the treatment of patients with deep burns. METHODS The PubMed, Cochrane Library, and Embase databases and relevant references were systematically searched for RCTs and cohort studies published until the end of September 2020 to investigate the potential of blood purification in improving the prognosis of severely burned patients. The primary outcome of this systematic review was overall patient mortality; secondary outcomes included the incidence of sepsis and infection prevention (vital signs and routine blood tests). RESULTS A total of 6 RCTs and 1 cohort study were included, with a total of 538 burn patients (274 patients who received blood purification and 264 control patients). Compared with patients who received conventional treatment, those treated with blood purification displayed significant 2-day reduction in mortality and sepsis with relative risks of 0.62 and 0.41, respectively (95% confidence intervals [CIs], 0.74-0.82 and 0.25-0.67, respectively; P < .05). In terms of vital signs and blood biochemistry, the respiratory rates and blood urea nitrogen levels of patients in the blood purification group 3 days post-treatment were significantly higher than those in the control group (randomized standard deviations (SMDs), 0.78 and 0.77, respectively; 95% CIs, 0.33-1.23 and 1.22-0.31, respectively; P < .05). However, there were no significant differences between groups on day 3 with regard to temperature (P = .32), heart rate (P = .26), white blood cell count (P = .54), or neutrophil count (P = .74), potentially owing to the small sample size or the relatively short intervention time. Heterogeneous differences existed between the groups with respect to blood urea nitrogen (SMD = -1.22; 95% CI, -2.16 to -0.40; P < .00001) and Cr (SMD = -3.13; 95% CI, -4.92 to -1.33; P < .00001) on day 7. No systematic adverse events occurred. CONCLUSIONS Blood purification treatment for deep burn patients can significantly reduce the mortality rate and the incidence of complications.
2.
Drotrecogin alfa (activated) in children with severe sepsis: a multicentre phase III randomised controlled trial
Nadel S, Goldstein B, Williams MD, Dalton H, Peters M, Macias WL, Abd-Allah SA, Levy H, Angle R, Wang D, et al
Lancet. 2007;369((9564):):836-43.
Abstract
BACKGROUND Drotrecogin alfa (activated) (DrotAA) is used for the treatment of adults with severe sepsis who have a high risk of dying. A phase 1b open-label study has indicated that the pharmacokinetics and pharmacodynamics of DrotAA are similar in children and adults. We initiated the RESOLVE (REsearching severe Sepsis and Organ dysfunction in children: a gLobal perspectiVE) trial to investigate the efficacy and safety of the drug in children. METHODS Children aged between 38 weeks' corrected gestational age and 17 years with sepsis-induced cardiovascular and respiratory failure were randomly assigned to receive placebo or DrotAA (24 microg/kg/h) for 96 h. We used a prospectively defined, novel primary endpoint of Composite Time to Complete Organ Failure Resolution (CTCOFR) score. Secondary endpoints were 28-day mortality, major amputations, and safety. Analysis was by intention-to-treat. This trial is registered with clinicaltrials. gov, number NCT00049764. FINDINGS 477 patients were enrolled; 237 received placebo, and 240 DrotAA. Our results showed no significant difference between groups in CTCOFR score (p=0. 72) or in 28-day mortality (placebo 17. 5%; DrotAA, 17. 2%; p=0. 93). Although there was no difference in overall serious bleeding events during the 28-day study period (placebo 6. 8%; DrotAA 6. 7%; p=0. 97), there were numerically more instances of CNS bleeding in the DrotAA group (11 [4. 6%], vs 5 [2. 1%] in placebo, p=0. 13), particularly in children younger than 60 days. For CTCOFR score days 1-14, correlation coefficient was -0. 016 (95% CI -0. 106 to 0. 74); relative risk for 28-day mortality was 1. 06 (95% CI 0. 66 to 1. 46) for DrotAA compared with placebo. INTERPRETATION Although we did not record any efficacy of DrotAA in children with severe sepsis, serious bleeding events were similar between groups and the overall safety profile acceptable, except in children younger than 60 days. However, we gained important insights into clinical and laboratory characteristics of childhood severe sepsis, and have identified issues that need to be addressed in future trials in critically ill children.