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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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Safety and efficacy of double plasma molecular adsorption system with sequential low-volume plasma exchange in intermediate-stage hepatitis B virus-related acute-on-chronic liver failure
Xu W, Zhu S, Yang L, Li Z, Wu L, Zhang Y, Chen J, Deng Z, Luo Q, Peng L
Journal of medical virology. 2023
Abstract
BACKGROUND Current evidence suggests that the mortality rate of intermediate-stage hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) remains high. We aimed to investigate the safety and efficacy of double plasma molecular adsorption system (DPMAS) with sequential low-volume plasma exchange (LPE) treatment in intermediate-stage HBV-related ACLF. METHODS This prospective study recruited intermediate-stage HBV-related ACLF patients and was registered on ClinicalTrials.gov (NCT04597164). Eligible patients were randomly divided into a trial group and a control group. Patients in both groups received comprehensive medical treatment. Patients in the trial group further received DPMAS with sequential LPE. Data were recorded from baseline to week 12. RESULTS 50 patients with intermediate-stage HBV-related ACLF were included in this study. The incidence of bleeding events and allergic reactions in the trial group was 12% and 4%, respectively, with no other treatment-related adverse events. The levels of TBIL and PT-INR, and MELD scores after each session of DPMAS with sequential LPE were significantly lower than those before treatment (all p<0.05). The 12-week cumulative liver transplantation-free survival rates in the trial and control groups were 52% and 24%, respectively (p=0.041). The 12-week cumulative overall survival rates in the trial and control groups were 64% and 36%, respectively (p=0.048). The Kaplan-Meier survival analysis revealed significant differences in liver transplantation-free survival (p=0.047) and overall survival (p=0.038) between the trial and control groups. COX regression analysis indicated that BUN (p=0.038), DPMAS with sequential LPE (p=0.048) and COSSH-ACLF II score (p<0.001) were significant risk factors for mortality. CONCLUSION DPMAS with sequential LPE treatment is safe and effective for patients with intermediate-stage HBV-related ACLF. This article is protected by copyright. All rights reserved.
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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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Effects of emergency treatment mode of damage-control orthopedics in pelvic fracture complicated with multiple fractures
Fan H, Fei R, Guo C, Li Y, Yan C, Chen F, Zhang Y
American journal of translational research. 2021;13(6):6817-6826
Abstract
OBJECTIVE This study aimed to observe the application effect of emergency treatment mode of damage-control orthopedics (DCO) in pelvic fracture complicated with multiple fractures. METHODS Ninety-four patients with pelvic fracture complicated with multiple fractures in our hospital were recruited and divided into two groups according to the random number table method, with 47 cases in each group. Patients in the control group received traditional methods for emergency treatment (early complete treatment), and patients in the research group received DCO for emergency treatment (treatment performed in stages according to patient's physiological tolerance, with simplified initial surgery, followed by ICU resuscitation, and finally definitive surgery). The two groups were compared in terms of mortality, the incidence of acidosis and hypothermia three days after the first surgery, surgery-related indexes (time of the first surgery, blood transfusion volume, intraoperative blood loss, recovery time of temperature, and length of hospital stay), coagulation function indexes (activated partial thromboplastin time (APTT), thrombin time (TT), prothrombin time (PT) and fibrinogen (FIB)), postoperative reduction of fracture, complication rate, and quality of life. RESULTS The incidences of acidosis, hypothermia, and mortality three days after the first surgery in the research group were lower than those in the control group (P<0.05). Compared with the control group, the research group experienced shorter time of the first surgery, less intraoperative blood transfusion volume, less intraoperative blood loss, shorter recovery time of body temperature, and shorter length of hospital stay (P<0.05). Seven days after surgery, PT, TT and APTT decreased and FIB increased in both groups (P<0.05), PT, TT and APTT in the research group were lower than those in the control group (P<0.05), while FIB was higher (P<0.05). The good rate of reduction in the research group was higher than that in the control group (P=0.025). The incidence of complications in the research group was lower than that in the control group (P=0.049). Six months after surgery, the scores of physiological function (PF), body pain (BP), role physical (RP), emotional function (EF), social function (SF), vitality, and general health (GH) of the research group were higher than those of the control group (P<0.05), but there was no significant difference in mental health (MH) between the two groups (P>0.05). CONCLUSION The emergency treatment mode of DCO is effective in pelvic fracture complicated with multiple fractures, which can effectively improve postoperative reduction of patients, improve the coagulation function, reduce complications, and improve the quality of life.
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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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[Application of goal-oriented fluid replacement therapy in volume management of postpartum hemorrhage during cesarean section]
Yu Y, Zhang Y, Zhu X, Zhang C, Tong C, Zhao Y
Zhonghua wei zhong bing ji jiu yi xue. 2021;33(3):305-310
Abstract
OBJECTIVE To observe the effect of fluid therapy on volume and coagulation function in patients with severe postpartum hemorrhage during cesarean section of placenta accreta under the guidance of inferior vena cava diameter (IVCD) and inferior vena cava collapse index (IVC-CI). METHODS A prospective randomized controlled study was conducted in 60 pregnant women with severe postpartum hemorrhage (blood loss ≥ 1 000 mL) who were hospitalized for delivery or referred for delivery in the Peking University Third Hospital from December 2018 to July 2019. The patients were divided into routine fluid replacement group and goal-oriented fluid resuscitation group (goal-oriented fluid replacement therapy was given) according to the different ways of fluid replacement. The hemodynamics, blood gas analysis, coagulation function, total fluid replacement, urine volume, prognosis, intraoperative vasoactive drugs utilization rate and postoperative adverse events were recorded before skin incision, after the fetus delivered, postpartum hemorrhage and at the end of operation, and the differences of these indices between the two groups were compared. RESULTS (1) Hemodynamics: the heart rate (HR) of the two groups were reached the peak during postpartum hemorrhage, but there was no significant difference in HR at each time point between the two groups. The mean arterial pressure (MAP) was decreased at first and then increased in both groups, and reached the trough at postpartum hemorrhage, but the MAP in the goal-oriented fluid resuscitation group was significantly higher than that in the routine fluid replacement group [mmHg (1 mmHg = 0.133 kPa): 75.6±10.7 vs. 69.2±8.9, P < 0.05]. In the goal-oriented fluid resuscitation group, the central venous pressure (CVP) was increased slightly after the fetus delivered and then stabilized, while in the routine fluid replacement group, the CVP was increased at first and then decreased, and reached the peak in postpartum hemorrhage. During postpartum hemorrhage, CVP in the goal-oriented fluid resuscitation group was significantly lower than that in the routine fluid replacement group [cmH(2)O (1 cmH(2)O = 0.098 kPa): 9.5±3.9 vs. 11.4±3.4, P < 0.05]. (2) Arterial blood gas: partial pressure of oxygen (PaO(2)) and partial pressure of carbon dioxide (PaCO(2)) in arterial blood at the end of operation in both groups were higher than those in postpartum hemorrhage. There was no significant difference in PaO(2) at the end of operation between the goal-oriented fluid resuscitation group and routine fluid replacement group (mmHg: 189.3±100.5 vs. 240.2±126.3, P > 0.05). The PaCO(2) in the goal-oriented fluid resuscitation group was significantly lower than that in the routine fluid replacement group (mmHg: 34.6±4.6 vs. 36.8±4.1, P < 0.05). The lactic acid (Lac) at the end of operation of the goal-oriented fluid resuscitation group was significantly lower than that of the routine fluid replacement group (mmol/L: 2.2±0.6 vs. 2.6±1.1, P < 0.05). (3) Liquid intake and output volume: the total infusion volume, crystal fluid infusion volume and suspended red blood cell infusion volume in the goal-oriented fluid resuscitation group were significantly less than those in the routine fluid replacement group [total infusion volume (mL): 3 385.9±1 144.1 vs. 4 448.3±1 194.4, crystal infusion volume (mL): 2 635.6±789.7 vs. 3 160.0±860.3, suspended red blood cell input volume (mL): 695.6±366.2 vs. 911.1±284.7, all P < 0.05], and the utilization rate of vasoactive drugs in the goal-oriented fluid resuscitation group was decreased significantly during operation [13.3% (4/30) vs. 60.0% (18/30), P < 0.05]. The amount of bleeding in the goal-oriented fluid resuscitation group was also significantly less than that in the routine fluid replacement group (mL: 1 451.7±373.8 vs. 1 725.9±372.8, P < 0.05), but there was no significant difference in urine volume between the goal-oriented fluid resuscitation group and the routine fluid replacement group (mL: 369.0±262.7 vs. 485.0±286.8, P > 0.05). (4) Coagulation function: at the end of operation, the prothrombin time (PT) in the goal-oriented fluid resuscitation group was significantly shorter than that in the routine fluid replacement group (s: 10.9±0.6 vs. 11.2±0.6), and the fibrinogen (Fib) in the goal-oriented fluid resuscitation group was significantly higher than that in the routine fluid replacement group (g/L: 3.7±0.5 vs. 2.9±0.8), and the differences were statistically significant (both P < 0.05). (5) Prognostic index: compared with the routine fluid replacement group, the proportion of patients transferred to intensive care unit (ICU) at the end of operation in the goal-oriented fluid resuscitation group was significantly lower [16.7% (5/30) vs. 66.7% (20/30), P < 0.05], and ICU length-of-stay was significantly shorter [hours: 0 (0, 24) vs. 24 (0, 24), P < 0.05], but there was no significant difference in the incidence of disseminated intravascular coagulation (DIC), acute renal injury (AKI) or hysterectomy between the goal-oriented fluid resuscitation group and the routine fluid replacement group [the incidence of DIC: 0% (0/30) vs. 6.7% (2/30), the incidence of AKI: 0% (0/30) vs. 3.3% (1/30), the hysterectomy rate: 10.0% (3/30) vs. 26.7% (8/30), all P > 0.05]. CONCLUSIONS Fluid resuscitation guided by IVC-CI can effectively reduce the volume of blood and fluid transfusion and blood loss in patients with severe postpartum hemorrhage and improve their blood coagulation function.
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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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A randomised controlled trial of fibrinogen concentrate during scoliosis surgery
Chen W, Shen J, Zhang Y, Hu A, Liang J, Ma L, Yu X, Huang Y
Anaesthesia. 2020
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Abstract
Bleeding and blood transfusion are common after scoliosis surgery. Fibrinogen is essential for blood clot formation and depletes quickly during haemorrhage. We randomly allocated 102 children 12-18 years old having surgery for idiopathic scoliosis, 51 to intra-operative fibrinogen concentrate 30 mg.kg(-1) (maximum 2 g) and 51 to saline placebo. Fibrinogen reduced peri-operative blood loss by a median (95%CI) volume of 155 (5-320) ml, from a median (IQR [range]) of 1035 (818-1420 [400-3030]) ml to 885 (755-1155 [270-2645]) ml, p = 0.04. Seven and four children received allogeneic red blood cell transfusion after fibrinogen and placebo, respectively, p = 0.34. There were no side-effects.
PICO Summary
Population
Patients between 12 to 18 years old having surgery for idiopathic scoliosis (n= 102).
Intervention
Intraoperative fibrinogen concentrate (30 mg.kg−1, maximum 2 g), (n= 51).
Comparison
Saline placebo (n= 51).
Outcome
Fibrinogen concentrate infusion reduced median perioperative bleeding by about 155ml compared with placebo. Fibrinogen did not reduce postoperative blood transfusion or increase postoperative haemoglobin concentration.
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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.