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1.
Comparison of anticoagulation monitoring strategies for adults supported on extracorporeal membrane oxygenation: A systematic review
Sun J, Ma Y, Su W, Miao H, Guo Z, Chen Q, Zhang Y, Ma X, Chen S, Ding R
Heart & lung : the journal of critical care. 2023;61:72-83
Abstract
BACKGROUND Anticoagulation is critical in patients supported on extracorporeal membrane oxygenation (ECMO). The appropriate monitoring strategies for heparin remain unclear. OBJECTIVES This systematic review aimed to compare the accuracy and safety of various monitoring strategies for patients supported on ECMO. METHODS The PubMed and Web of Science databases were searched for articles in March 2023 without restrictions on publication date. Anticoagulation monitoring strategies for adults supported on ECMO were compared across all included studies. The incidence of bleeding, thrombosis, mortality, blood transfusion, correlation between tests and heparin dose, and the discordance between different tests were discussed in the included studies. The risk of bias was assessed using the Newcastle-Ottawa Scale and Cochrane Collaboration's tool. RESULTS Twenty-six studies, including a total of 1,684 patients, met the inclusion criteria. The monitoring of anticoagulation by activated partial thromboplastin time (aPTT) resulted in less blood product transfusion than that by activated clotting time (ACT). Moreover, the monitoring of anticoagulation by anti-factor Xa (Anti-Xa) resulted in a more stable anticoagulation than that by aPTT. Anti-Xa and aPTT correlated with heparin dose better than ACT, and the discordance between different monitoring tests was common. Finally, combined monitoring showed some advantages in reducing mortality and blood product transfusion. CONCLUSION Anti-Xa and aPTT are more suitable for anticoagulation monitoring for patients supported on ECMO than ACT. Thromboelastography and combination strategies are less applied. Most of the studies were retrospective, and their sample sizes were relatively small; thus, more appropriate monitoring strategies and higher quality research are needed.
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LNG-IUS vs. medical treatments for women with heavy menstrual bleeding: A systematic review and meta-analysis
Chen S, Liu J, Peng S, Zheng Y
Frontiers in medicine. 2022;9:948709
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.
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Sirolimus plus prednisolone vs sirolimus monotherapy for kaposiform hemangioendothelioma: a randomized clinical trial
Ji Y, Chen S, Zhou J, Yang K, Zhang X, Xiang B, Qiu T, Gong X, Zhang Z, Lan Y, et al
Blood. 2022
Abstract
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.
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Oral eltrombopag versus subcutaneous recombinant human thrombopoietin for promoting platelet engraftment after allogeneic stem cell transplantation: A PROSPECTIVE, NON-INFERIORITY, RANDOMIZED CONTROLLED TRIAL
Wen B, Zhang X, Chen S, Fan J, Yang S, Cai Y, Wang P, Zhang Q, Gu Q, Du X
Hematological oncology. 2022
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Abstract
Delayed platelet engraftment (DPE) is associated with poor survival and increased transplantation-related mortality after allogeneic haematopoietic stem cell transplantation (allo-HSCT). Therefore, treatments are needed to improve platelet engraftment and prevent DPE. We performed a phase 3, non-inferior, randomized controlled study of eltrombopag or recombinant human thrombopoietin (rhTPO) to promot platelet engraftment after allo-HSCT. Candidates for allo-HSCT were randomly assigned to receive oral eltrombopag (50mg daily) or subcutaneous rhTPO (15000U daily ) from the first-day post-transplantation. The primary endpoint was the cumulative numbers of platelet engraftment (platelet recovery ≥ 20 × 10(9) /L, without transfusion, for seven consecutive days) on day 60 after transplantation. We performed intention-to-treat analyses with a non-inferior margin of -15%. A total of 92 participants underwent randomization. 44 and 48 patients were randomized to the eltrombopag and rhTPO groups, respectively. The median duration of follow-up was 360 days (range: 12-960 days). The cumulative incidence of platelet engraftment on day 60 after transplantation in eltrombopag group was 86.4% (38/44) compared with 85.4% (41/48) in the rhTPO group (absolute risk difference [ARD] 1%, one-sided lower limit of 95% confidence interval [CI] -13.28%, P(non-inferirioty) =0.014). The rate of DPE in the eltrombopag group was 6.8% (3/44) compared with 12.5% (6/ 48) in the rhTPO group (ARD -5.7%, one-sided higher limit of 95% CI 6.28%, P(non-inferirioty) =0.063). Approximately, 3/4 of non-haematologic adverse events were not observed in the eltrombopag group but three patients (3/48, 6%) experienecd them in the rhTPO group. In addtion, platelet transfusions unite from day 0 to day 21, or from day 22 to day 60, progression-free survival, overall survival were not significantly different between both groups. Eltrombopag was non-inferior to rhTPO in promoting platelet engraftment post allo-HSCT for patients with haematological malignancy. Oral eltrombopag was more convenient for patients than subcutaneous rhTPO (NCT03515096). This article is protected by copyright. All rights reserved.
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Randomized and dose-escalation trials of recombinant human serum albumin /granulocyte colony-stimulating factor in patients with breast cancer receiving anthracycline-containing chemotherapy
Chen S, Han Y, Ouyang Q, Lu J, Zhang Q, Yang S, Wang J, Huang H, Liu H, Shao Z, et al
BMC cancer. 2021;21(1):341
Abstract
BACKGROUND To evaluate the efficacy and safety of recombinant human serum albumin /granulocyte colony-stimulating factor (rHSA/G-CSF) in breast cancer following receipt of cytotoxic agents. METHODS The phase 1b trial assessed the pharmacokinetics, pharmacodynamics, and safety of dose-escalation, ranging from rHSA/G-CSF 1800 μg, 2100 μg, and 2400 μg. Randomized controlled phase 2b trial was further conducted to ensure the comparative efficacy and safety of rHSA/G-CSF 2400 μg and rhG-CSF 5 μg/kg. In multicenter, randomized, open-label, parallel, phase 2 study, participants treated with anthracycline-containing chemotherapy were assigned in a ratio 1:1:1 to receive double delivery of rHSA/G-CSF 1200 μg, 1500 μg, and continuous rhG-CSF 5 μg/kg. RESULTS Between December 16, 2014, to July 23, 2018, a total of 320 patients were enrolled, including 25 individuals in phase 1b trial, 80 patients in phase 2b trial, and 215 participants in phase 2 study. The mean duration of agranulocytosis during the first chemotherapeutic intermission was observed as 1.14 ± 1.35 days in rHSA/G-CSF 1500 μg, which was comparable with that of 1.07 ± 0.97 days obtained in rhG-CSF control (P = 0.71). Safety profiles were assessed to be acceptable ranging from rHSA/G-CSF 1800 μg to 2400 μg, while the double delivery of HSA/G-CSF 2400 μg failed to meet the noninferiority in comparison with rhG-CSF. CONCLUSION The prospective randomized controlled trials demonstrated that rHSA/G-CSF was efficacious and well-tolerated with an approachable frequency and expense of application for prophylactic management of agranulocytosis. The double delivery of rHSA/G-CSF 1500 μg in comparisons with paralleling G-CSF preparations is warranted in the phase 3 trial. TRIAL REGISTRATION ClinicalTrials.gov identifiers: NCT02465801 (11/17/2014), NCT03246009 (08/08/2017), NCT03251768 (08/07/2017).
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Intravenous tranexamic acid reduce postoperative drainage and pain after open elbow arthrolysis: A randomized controlled trial
Cui H, Yu S, Ruan J, Sun Z, Li J, Chen S, Fan C
Journal of shoulder and elbow surgery. 2021
Abstract
BACKGROUND Open elbow arthrolysis (OEA), which has become an established treatment for post-traumatic elbow stiffness (PTES), requires complete release of contracture tissue and wide excision of ectopic bone, which results in extensive bleeding. The aim of the present study is to evaluate the efficacy of intravenous tranexamic acid (TXA) on postoperative drainage, calculated blood loss and early clinical outcomes in patients undergoing OEA. METHODS A double-blind, randomized, placebo-controlled trial including 96 patients undergoing OEA was undertaken. Patients received intravenously either 100 mL saline (placebo group, n = 48), or 100 mL saline plus 1 g TXA (TXA group, n = 48) before skin incision. The primary outcome was the drainage volume on postoperative day (POD) 1 to 3. Secondary outcomes included the calculated blood loss, elbow pain score measured by Visual Analog Scale (VAS), elbow function valued by Mayo Elbow Performance Score (MEPS), and rate of complications after OEA. RESULTS Mean total postoperative drainage volume (TXA group: 182 mL vs. placebo group: 214 mL, p = 0.003) and mean calculated total blood loss (TXA group: 582 mL vs. placebo group: 657 mL, p = 0.004) were significantly lower in the TXA group. No transfusions were necessary in either group. Mean VAS pain scores in elbow motion showed marked differences between both groups on POD 1 (TXA: 5 vs. placebo: 6, p = 0.003) and POD 2 (TXA: 4 vs. placebo: 5, p = 0.023), but not in other postoperative time points. No differences were detected in complications, such as pin-related infection, hematoma, new or exacerbation of ulnar nerve symptoms, and recurrent heterotopic ossification. At the 6-month follow-up, no statistical differences were found between the two groups with respect to the elbow functions including range of motion, VAS score and MEPS. CONCLUSION Intravenous administration of TXA significantly decreased the postoperative drainage volume and the total estimated blood loss, and alleviated the elbow pain with motion during early postoperative days in patients undergoing OEA. LEVEL OF EVIDENCE Level I; Randomized Controlled Trial; Treatment Study.
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Diagnostic accuracy of dual-energy computed tomography to differentiate intracerebral hemorrhage from contrast extravasation after endovascular thrombectomy for acute ischemic stroke: systematic review and meta-analysis
Chen S, Zhang J, Quan X, Xie Y, Deng X, Zhang Y, Shi S, Liang Z
European radiology. 2021
Abstract
OBJECTIVES To assess whether dual-energy computed tomography (DECT), using conventional computed tomography or magnetic resonance imaging as a reference standard, is sufficiently accurate to differentiate intracerebral hemorrhage from contrast extravasation after endovascular thrombectomy for acute ischemic stroke. METHODS On January 20, 2021, we searched the PubMed Medline, Embase, Web of Science, and Cochrane Library databases. QUADAS-2 was used to assess the risk of bias and applicability. Meta-analyses were performed using a bivariate random-effects model. To explore sources of heterogeneity, meta-regression analyses were performed. Deeks' funnel plot asymmetry test was used to assess publication bias. RESULTS A total of 7 studies (269 patients, 269 focal areas) were included. The pooled mean sensitivity, specificity, and accuracy of DECT in identifying intracerebral hemorrhage from contrast extravasation after mechanical thrombectomy for acute ischemic stroke were 0.77 (95% confidence interval (CI) 0.29 to 0.96), 1 (95% CI 0.86 to 1), and 0.99 (95% CI 0.98 to 1), respectively. This evidence was of moderate certainty due to the risk of bias. Higgin's I-squared for study heterogeneity was observed for the pooled sensitivity (I(2) = 78.88%) and pooled specificity (I(2) = 82.12%). Moreover, Deeks' funnel plot asymmetry test revealed no publication bias (p = 0.38). CONCLUSION DECT shows excellent accuracy and specificity in differentiating intracerebral hemorrhage from contrast extravasation after endovascular thrombectomy for acute ischemic stroke. Nevertheless, there was substantial and moderate heterogeneity among the studies. Future large-scale, prospective cohort studies are warranted to validate our findings. KEY POINTS • Dual-energy computed tomography shows excellent accuracy and specificity in differentiating intracerebral hemorrhage from contrast extravasation after endovascular thrombectomy for acute ischemic stroke. • Via meta-regression analysis, we found various possible covariates, including the publication date, image analysis, index test time, time of follow-up imaging, and reference standard judgment, that had an important effect on the heterogeneity. • There were no concerns regarding applicability in any of the included studies.
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Comparison of the curative effect and prognosis of stereotactic drainage and conservative treatment for moderate and small basal ganglia haemorrhage
Huang X, Jiang L, Chen S, Li G, Pan W, Peng L, Yan Z
BMC neurology. 2021;21(1):268
Abstract
BACKGROUND Minimally invasive surgery has achieved good results in the treatment of cerebral haemorrhage.However, no large-scale clinical study has demonstrated that surgical treatment of cerebral haemorrhages less than 30 ml can improve the curative effect. Our study explored the efficacy and complication of stereotactic drainage based on the amount of cerebral hemorrhage (15-30 ml) in hypertensive basal ganglia. METHOD Sixty patients with hypertensive basal ganglia haemorrhages were divided into a control group and an experimental group with 30 patients in each group. Patients in the control group were treated conservatively. In contrast, those in the experimental group received stereotactic drainage, and urokinase was injected into the haematoma cavity after the operation. The haematoma volume at admission and 1, 3, 7 and 30 days after treatment and National Institute of Health stroke scale(NIHSS) score data were recorded. Complications after treatment in the two groups of data were compared and analysed. RESULT No significant differences in age, sex, time of treatment after onset, admission blood pressure, admission haematoma volume or admission NIHSS score were noted between these two groups (P > 0.05). After treatment, significant differences in haematoma volume were noted between the two groups on the 1st, 3rd, 7th and 30th days after treatment (P < 0.05). The amount of hematoma of patients in the experimental group was significantly reduced compared with that in the control group, and the NIHSS scores were significantly different on the 3rd, 7th and 30th days after treatment. The neurological deficit scores of patients in the experimental group were significantly reduced compared with those in the control group, and the incidence of pulmonary infection and venous thrombosis in the lower limbs of patients in the experimental group were significantly reduced (P < 0.05). ROC curve analysis showed that stereotactic drainage affected the early neurological function of patients with small and medium basal ganglia haemorrhages. CONCLUSION For patients with small and medium basal ganglia haemorrhages, stereotactic drainage can be used due to the faster drainage speed of haematomas after operation, which is beneficial to the recovery of neurological function and reduce complications.
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The Function of Tranexamic Acid to Prevent Hematoma Expansion After Intracerebral Hemorrhage: A Systematic Review and Meta-Analysis From Randomized Controlled Trials
Yan Z, Chen S, Xue T, Wu X, Song Z, Wang Z, Chen Z, Wang Z
Frontiers in neurology. 2021;12:710568
Abstract
Objectives: The clinical results caused by spontaneous intracerebral hemorrhage (ICH) are disastrous to most patient. As tranexamic acid (TXA) has been proved to decrease the influence of ICH, we conducted this research to explore the function of TXA for the prognosis of ICH compared with placebo. Methods: We searched MEDLINE, Embase, Cochrane Library, and Clinicaltrials.gov for randomized controlled trials (RCTs) that were performed to evaluate TXA vs. placebo for ICH up to February 2021. The data were assessed by Review Manager 5.3 software. The risk ratio (RR) and mean difference were analyzed using dichotomous outcomes and continuous outcomes, respectively, with a fixed effect model. Results: We collected 2,479 patients from four RCTs. Then, we took the change of hematoma volume, modified Rankin Scale (mRS), and adverse events as evaluation standard of the treatment for ICH. Through statistical analysis, we found that there is no obvious hematoma expansion effect after the application of TXA (RR = 1.05), and we proceeded the quantitative analysis of percentage change in hematoma volume from baseline, indicating that TXA could inhibit the expansion of hematoma volume (RR = -2.02) compared with placebo. However, according to the outcomes of mRS (0-1, RR = 1.04; 0-2, RR = 0.96), TXA cannot improve neurological functional prognosis. As for the security outcomes-mortality (RR = 1.02), thromboembolic events (RR = 0.99), neurological deterioration (RR = 0.92), infection (RR = 0.86), and craniotomy (RR = 0.41), there seems exist no statistical difference between TXA and placebo. Conclusions: TXA has an advantage in the aspect of preventing hematoma expansion compared with placebo for ICH, but cannot illustrate the efficacy of TXA in improving neurological functional prognosis, which still needs more researches with large sample sizes. Moreover, for safety, we did not find obvious statistical difference between TXA and placebo.
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Assessment of Bone Formation After Secondary Alveolar Bone Grafting With and Without Platelet-Rich Plasma Using Computer-Aided Engineering Techniques
Chen S, Liu B, Yin N, Wang Y, Li H
The Journal of craniofacial surgery. 2020
Abstract
The aim of this study was to analyze the newly formed bone volume (FV), 6 months after secondary alveoloplasty using iliac cancellous bone graft, with and without platelet-rich plasma (PRP). Forty patients with unilateral alveolar cleft were involved in this randomized, prospective, comparative study, with 20 patients each forming the control (group A) and PRP (group B) groups, respectively. The preoperative alveolar defect volume (DV) and the postoperative FV were automatically calculated by the computer-aided engineering software using the patients' pre and postsurgical computed tomography data. The volume of the actual bone graft (AV) was identical to the DV calculated before surgery. The bone formation ratio (BF%) was calculated as follows: BF% = (FV/AV) x 100%. The mean BF% was 42.54 +/- 9.32% in group A and 46.97 +/- 18.49% in group B. There was no statistically significant difference between the 2 groups for BF% (P > 0.05). The study presents a fast and accurate method for assessing the effect of PRP in alveolar grafting. However, the study found no conclusive evidence on the effect of PRP on bone growth.