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Recombinant human thrombopoietin promotes platelet recovery in DCAG-treated patients with intermediate-high-risk MDS/hypoproliferative AML
Chen X, Wang Y, Zang Y, Wei Z, Zhang W, Wei X, Luo G, Chen L, Zhang Y, Xu Z
Medicine. 2023;102(13):e33373
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Abstract
BACKGROUND This study aimed to explore the effects of recombinant human thrombopoietin (rhTPO) on platelet recovery in decitabine, cytarabine, aclarubicin, and G-CSF (DCAG)-treated patients with intermediate-high-risk myelodysplastic syndrome/hypo proliferative acute myeloid leukemia. METHODS Recruited patients were at a ratio of 1:1 into 2 groups: the rhTPO group (DCAG + rhTPO) and control group (DCAG). The primary endpoint was the time for platelets to recover to ≥ 20 × 109/L. The secondary endpoints were the time for platelets to recover to ≥ 30 × 109/L and ≥ 50 × 109/L, overall survival (OS), and progression-free survival (PFS). RESULTS The time required for platelet recovery to ≥ 20 × 109/L, ≥30 × 109/L, and ≥ 50 × 109/L in the rhTPO group was significantly shorter (6.5 ± 2.2 vs 8.4 ± 3.1 days, 9.0 ± 2.7 vs 12.2 ± 3.9 days, 12.4 ± 4.7 vs 15.5 ± 9.3 days, respectively; all P < .05 vs controls). The amount of platelet transfusion in the rhTPO group was smaller (4.4 ± 3.1 vs 6.1 ± 4.0 U, P = .047 vs controls). The bleeding score was lower (P = .045 vs controls). The OS and PFS were significantly different (P = .009 and P = .004). The multivariable analysis showed that age, karyotype, and time for PLT recovery to ≥ 20 × 109/L were independently associated with OS. Adverse events were similar. CONCLUSIONS This study suggests that rhTPO leads to a faster platelet recovery after DCAG treatment, reduces the risk of bleeding, reduces the number of platelet transfusions, and prolongs the OS and PFS.
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Association of Use of Tourniquets During Total Knee Arthroplasty in the Elderly Patients With Post-operative Pain and Return to Function
Zhao J, Dong X, Zhang Z, Gao Q, Zhang Y, Song J, Niu S, Li T, Chen J, Wei FL
Frontiers in public health. 2022;10:825408
Abstract
OBJECTIVE During total knee arthroplasty (TKA), tourniquet may negatively impact post-operative functional recovery. This study aimed at investigating the effects of tourniquet on pain and return to function. METHODS Pubmed, Embase, and Cochrane Library were comprehensively searched for randomized controlled trials (RCTs) published up to February 15th, 2020. Search terms included; total knee arthroplasty, tourniquet, and randomized controlled trial. RCTs evaluating the efficacies of tourniquet during and after operation were selected. Two reviewers independently extracted the data. Effect estimates with 95% CIs were pooled using the random-effects model. Dichotomous data were calculated as relative risks (RR) with 95% confidence intervals (CI). Mean differences (MD) with 95% CI were used to measure the impact of consecutive results. Primary outcomes were the range of motion (ROM) and visual analog scale (VAS) pain scores. RESULTS Thirty-three RCTs involving a total of 2,393 patients were included in this study. The mean age is 65.58 years old. Compared to no tourniquet group, the use of a tourniquet resulted in suppressed ROM on the 3rd post-operative day [MD, -4.67; (95% CI, -8.00 to -1.35)] and the 1st post-operative month [MD, -3.18; (95% CI, -5.92 to -0.44)]. Pain increased significantly when using tourniquets on the third day after surgery [MD, 0.39; (95% CI, -0.19 to 0.59)]. Moreover, tourniquets can reduce intra-operative blood loss [MD, -127.67; (95% CI, -186.83 to -68.50)], shorter operation time [MD, -3.73; (95% CI, -5.98 to -1.48)], lower transfusion rate [RR, 0.85; (95% CI, 0.73-1.00)], higher superficial wound infection rates RR, 2.43; [(5% CI, 1.04-5.67)] and higher all complication rates [RR, 1.98; (95% CI, 1.22-3.22)]. CONCLUSION Moderate certainty evidence shows that the use of a tourniquet was associated with an increased risk of higher superficial wound infection rates and all complication rates. Therefore, the findings did not support the routine use of a tourniquet during TKA.
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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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Side-effects of carbetocin to prevent postpartum hemorrhage: A systematic review and meta-analysis of randomized controlled trials
Ai W, Zeng Y, Ma Y, Liu L, Fan D, Wu S, Zhang Y
Pharmacology research & perspectives. 2021;9(2):e00745
Abstract
Postpartum hemorrhage (PPH) increases the risk of maternal death worldwide. Heat-stable carbetocin, a long-acting oxytocin analog, is a newer uterotonic agent. Clinicians do not fully understand its side-effects, particularly the unanticipated side-effects. The aim of this study is to investigate the side-effects of carbetocin to PPH. The Cochrane Library, Web of Science, PubMed, Elsevier ScienceDirect, Embase, and ClinicalTrials.gov were searched from the inception to September 2020. Randomized controlled trials (RCTs) that considered pregnant women who received carbetocin before delivery and provided at least one adverse event were included. Statistical analysis included random or fixed-effect meta-analyses using relative risk. Stratified analyses and sensitivity analyses were also performed. Begger's and Egger's test and funnel plots were used to assess the publication bias. Seventeen RCTs involving 32,702 women were included, and all these studies ranked as medium- to high-quality. Twenty-four side-effects were reported. The use of carbetocin had a lower risk of vomiting in intravenously (0.53, 0.30 to 0.93) and cesarean birth (0.51, 0.32 to 0.81) women, and had a slightly higher risk of diarrhea (8.00, 1.02 to 62.79) compared with oxytocin intervention. No significant difference was found among other side-effects. Evidence from our systematic review and meta-analysis of 17 RCTs suggested that the risk of vomiting decreased with carbetocin use in the prevention of PPH after delivery.
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Preradiosurgery embolization in reducing the postoperative hemorrhage rate for patients with cerebral arteriovenous malformations: a systematic review and meta-analysis
Jiang X, Zhao Z, Zhang Y, Wang Y, Lai L
Neurosurgical review. 2021
Abstract
Few studies have examined the postoperative hemorrhage rate of cerebral arteriovenous malformations (AVMs) treated by embolization prior to stereotactic radiosurgery. The objective of this analysis was to compare the postoperative hemorrhage rate between AVMs treated with and those treated without preradiosurgery embolization. A systematic search of the PubMed and Embase databases was performed with no restriction on the publication period. Based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we included studies with sufficient baseline and outcome data. The analysis was performed using Comprehensive Meta-Analysis (CMA) 2.0. Eleven studies comprising 2591 patients were eligible for analysis. There was no significant difference in the postoperative hemorrhage rate between patients who had undergone embolization followed by SRS and those who had undergone SRS alone (OR 1.140, 95% CI 0.851-1.526, p = 0.38). The obliteration rate was significantly lower in the E + SRS group than in the SRS group (OR 0.586, 95% CI 0.398-0.863, p = 0.007). No significant difference in permanent neurological deficits was identified between patients who had undergone embolization followed by SRS and those who had undergone SRS alone (OR 1.175, 95% CI 0.626-2.206, p = 0.616). Available data suggested that preradiosurgery embolization did not reduce the postoperative hemorrhage rate and resulted in a significantly lower obliteration rate than treatment with SRS alone.
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The rule of brain hematoma pressure gradient and its influence on hypertensive cerebral hemorrhage operation
Sun G, Fu T, Liu Z, Zhang Y, Chen X, Jin S, Chi F
Scientific reports. 2021;11(1):4599
Abstract
To comparatively study the size of and variation in the 'brain-haematoma' pressure gradient for different surgical methods for hypertensive intracerebral haemorrhage (HICH) and analyse the gradient's influence on surgical procedures and effects of the haemorrhage. Seventy-two patients with HICH treated from 1/2019 to 12/2019 were randomly divided into two groups, namely, the keyhole endoscopy and large trauma craniotomy groups, according to different operative methods. Intraoperative changes in intracranial pressure (ICP) were monitored to calculate intraoperative alterations in the 'brain-haematoma' pressure gradient. Intraoperative characteristics (operative time, bleeding volume, volume of blood transfusion, and haematoma clearance rate) and postoperative characteristics (oedema, postoperative activities of daily living (ADL) scores, mortality rate and rebleeding rate) were compared between the two groups. In the keyhole endoscopy group, ICP decreased slowly; the 'brain-haematoma' pressure gradient was large, averaging 251.1 ± 20.6 mmH(2)O, and slowly decreased. The mean operative time was 83.6 ± 4.3 min, the mean bleeding volume was 181.2 ± 13.6 ml, no blood transfusions were given, the average postoperative haematoma clearance rate was 95.6%, the rate of severe oedema was 10.9%, and the average postoperative ADL score was 85.2%. In the large trauma craniotomy group, ICP rapidly decreased after craniotomy. When the haematoma was removed, the 'brain-haematoma' pressure gradient was small, averaging 132.3 ± 10.5 mmH2O, and slowly decreased. The mean operative time was 232 ± 26.1 min, the mean bleeding volume was 412.6 ± 35.2 ml, the average volume of blood transfusion was 281.3 ± 13.6 ml, and the average postoperative haematoma clearance rate was 82.3%; moreover, the rate of severe oedema was 72.1%, and the average postoperative ADL score was 39.0%. These differences were statistically significant (P < 0.05). Neither the death rate (P > 0.05, 2.7% VS 2.8%) nor rebleeding rate (P > 0.05, 2.7% VS 2.8%) showed any obvious changes. The magnitude and variation in the 'brain-haematoma' pressure gradient for different surgical methods significantly influence surgical procedures and effects of HICH. During keyhole endoscopy surgery, this gradient was relatively large and slowly decreased; the haematoma was therefore easier to remove. Advantages of this approach include a high haematoma clearance rate, decreased bleeding volume, decreased operative time, reduced trauma, decreased postoperative brain oedema and improved postoperative recovery of neurological function.Chinese Clinical Trial Register: ChiCTR1900020655 registration in 12/01/02,019 registration in 28/02/02,020 Number: NCOMMS-20-08,091.
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Incidence of venous thromboembolism and hemorrhage in Chinese patients after pulmonary lobectomy: mechanical prophylaxis or mechanical prophylaxis combined with pharmacological prophylaxis: a randomized controlled trial
Hong Y, Zhang Y, Xiang Y, Ye Z, Lu X
Annals of translational medicine. 2021;9(18):1478
Abstract
BACKGROUND Venous thromboembolism (VTE) and postoperative bleeding are important complications of lung resection surgery. We investigated the preventive effect of mechanical prophylaxis versus pharmacological prophylaxis after lobectomy, and evaluated the effect of both on the incidence of hemorrhagic events. METHODS A prospective study of 424 lobectomies with moderate to high risk of VTE (Caprini risk score <5) in a single center was performed from April 2020 to March 2021. Patients were 1:1 randomly allocated to mechanical prophylaxis or to the low-molecular-weight heparin (LMWH)-combination-prophylaxis. The incidence of postoperative thrombotic and bleeding events and relevant factors of the two groups were analyzed. RESULTS A total of 410 participants, with 202 and 208 in the mechanical prophylaxis and LMWH-combination-prophylaxis groups respectively, were selected for analysis. Both groups had similar baseline and clinical characteristics. There were no cases of VTE or major bleeding during the study, but the incidence rate of minor bleeding in the LMWH-combination-prophylaxis group was significantly higher than mechanical prophylaxis group [odds ratio (OR) 0.035, 95% confidence interval (CI): 0.011-0.113]. CONCLUSIONS A case-by-case risk assessment of VTE and hemorrhage remains necessary to determine the most appropriate method of thrombosis prophylaxis for patients undergoing pulmonary surgery. Mechanical prophylaxis may be preferable for lung cancer patients with moderate to high risk of VTE (Caprini risk score <5) undergoing lobectomy. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR2100051073.
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Erythropoietin Improves Poor Outcomes in Preterm Infants with Intraventricular Hemorrhage
Song J, Wang Y, Xu F, Sun H, Zhang X, Xia L, Zhang S, Li K, Peng X, Li B, et al
CNS drugs. 2021
Abstract
BACKGROUND Intraventricular hemorrhage (IVH) is a common complication in preterm infants that has poor outcomes, especially in severe cases, and there are currently no widely accepted effective treatments. Erythropoietin has been shown to be neuroprotective in neonatal brain injury. OBJECTIVE The objective of this study was to evaluate the protective effect of repeated low-dose recombinant human erythropoietin (rhEPO) in preterm infants with IVH. METHODS This was a single-blinded prospective randomized controlled trial. Preterm infants ≤ 32 weeks gestational age who were diagnosed with IVH within 72 h after birth were randomized to receive rhEPO 500 IU/kg or placebo (equivalent volume of saline) every other day for 2 weeks. The primary outcome was death or neurological disability assessed at 18 months of corrected age. RESULTS A total of 316 eligible infants were included in the study, with 157 in the rhEPO group and 159 in the placebo group. Although no significant differences in mortality (p = 0.176) or incidence of neurological disability (p = 0.055) separately at 18 months of corrected age were seen between the rhEPO and placebo groups, significantly fewer infants had poor outcomes (death and neurological disability) in the rhEPO group: 14.9 vs. 26.4%; odds ratio (OR) 0.398; 95% confidence interval (CI) 0.199-0.796; p = 0.009. In addition, the incidence of Mental Development Index scores of < 70 was lower in the rhEPO group than in the placebo group: 7.2 vs. 15.3%; OR 0.326; 95% CI 0.122-0.875; p = 0.026. CONCLUSIONS Treatment with repeated low-dose rhEPO improved outcomes in preterm infants with IVH. TRIAL REGISTRATION The study was retrospectively registered on ClinicalTrials.gov on 16 April 2019 (NCT03914690).
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Effects of Tranexamic Acid on Bleeding in Pediatric Surgeries: A Systematic Review and Meta-Analysis
Wei Y, Zhang Y, Jin T, Wang H, Li J, Zhang D
Frontiers in surgery. 2021;8:759937
Abstract
Background: Major pediatric surgeries can cause severe intraoperative blood loss. This meta-analysis aims to evaluate the efficacy of tranexamic acid (TXA) in pediatric surgeries. Methods: We searched PubMed, Embase, Web of Science, and Cochrane Library from the conception to March 31, 2021 to identify eligible randomized controlled trials (RCTs) that evaluated the efficacy of TXA in pediatric surgeries. Two reviewers choosed studies, evaluated quality, extracted data, and assessed the risk of bias independently. Mean difference (MD) was calculated as the summary statistic for continuous data. We used a random-effects model to measure mean effects. Data were generated from the corresponding 95% confidence interval (CI) using RevMan 5.3 software. Primary outcomes included intraoperative and postoperative blood loss, red blood cell (RBC) transfusion as well as fresh frozen plasma (FFP) transfusion. Results: Fifteen studies enrolling 1,332 patients were included in this study. The pooled outcomes demonstrated that TXA was associated with a decreased intraoperative (MD = -1.57 mL/kg, 95% CI, -2.54 to -0.60, P = 0.002) and postoperative (MD = -7.85 mL/kg, 95% CI, -10.52 to -5.19, P < 0.001) blood loss, a decreased intraoperative (MD = -7.08 mL/kg, 95% CI, -8.01 to -6.16, P < 0.001) and postoperative (MD = -5.30 mL/kg, 95% CI, -6.89 to -3.70, P < 0.001) RBC transfusion, as well as a decreased intraoperative (MD = -2.74 mL/kg, 95% CI, -4.54 to -0.94, P = 0.003) and postoperative (MD = -6.09 mL/kg, 95% CI, -8.26 to -3.91, P < 0.001) FFP transfusion in pediatric surgeries. However, no significant difference was noted between two groups in duration of surgery (MD = -12.51 min, 95% CI -36.65 to 11.63, P = 0.31). Outcomes of intraoperative and postoperative blood loss and the duration of surgery in included studies were not pooled due to the high heterogeneity. Conclusion: This meta-analysis demonstrated that TXA was beneficial for bleeding in pediatric surgeries.
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Erythropoietin prevents necrotizing enterocolitis in very preterm infants: a randomized controlled trial
Wang Y, Song J, Sun H, Xu F, Li K, Nie C, Zhang X, Peng X, Xia L, Shen Z, et al
Journal of translational medicine. 2020;18(1):308
Abstract
BACKGROUND Necrotizing enterocolitis (NEC) is one of the most severe complications in very preterm infants, but there are currently no accepted methods to prevent NEC. Studies have shown that erythropoietin (EPO) has the potential to prevent NEC or improve outcomes of preterm NEC. This study aimed to determine whether recombinant human EPO (rhEPO) could protect against NEC in very preterm infants. METHODS The study was a prospective randomized clinical trial performed among four NICU centers. A total of 1327 preterm infants with gestational age ≤ 32 weeks were admitted to the centers, and 42 infants were excluded leaving 1285 eligible infants to be randomized to the rhEPO or control group. Infants in the rhEPO group were given 500 IU/kg rhEPO intravenously every other day for 2 weeks, while the control group was given the same volume of saline. The primary outcome was the incidence of NEC in very preterm infants at 36 weeks of corrected gestational age. RESULTS A total of 1285 infants were analyzed at 36 weeks of corrected age for the incidence of NEC. rhEPO treatment significantly decreased the incidence of NEC (stage I, II and III) (12.0% vs. 17.1%, p = 0.010), especially confirmed NEC (stage II and III) (3.0% vs. 5.4%, p = 0.027). Meanwhile, rhEPO treatment significantly reduced the number of red blood cells transfusion in the confirmed NEC cases (1.2 ± 0.4 vs. 2.7 ± 1.0, p = 0.004). Subgroup analyses showed that rhEPO treatment significantly decreased the incidence of confirmed NEC at gestational age < 28 weeks (p = 0.019), and the incidence of all stages NEC in preterm infants with hemoglobin < 90 g/l (p = 0.000) and 5 min Apgar score > 5 (p = 0.028). CONCLUSION Repeated low-dose rhEPO treatment is beneficial against NEC in very preterm infants. Trial registration The protocol was registered retrospectively at ClinicalTrials.gov (NCT03919500) on April 18, 2019. https://clinicaltrials.gov/ct2/show/NCT03919500.