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1.
N Engl J Med ; 385(10): 885-895, 2021 09 02.
Artigo em Inglês | MEDLINE | ID: mdl-34469646

RESUMO

BACKGROUND: Immune thrombocytopenia is a rare autoimmune disorder with associated bleeding risk and fatigue. Recommended first-line treatment for immune thrombocytopenia is high-dose glucocorticoids, but side effects, variable responses, and high relapse rates are serious drawbacks. METHODS: In this multicenter, open-label, randomized, controlled trial conducted in the United Kingdom, we assigned adult patients with immune thrombocytopenia, in a 1:1 ratio, to first-line treatment with a glucocorticoid only (standard care) or combined glucocorticoid and mycophenolate mofetil. The primary efficacy outcome was treatment failure, defined as a platelet count of less than 30×109 per liter and initiation of a second-line treatment, assessed in a time-to-event analysis. Secondary outcomes were response rates, side effects, occurrence of bleeding, patient-reported quality-of-life measures, and serious adverse events. RESULTS: A total of 120 patients with immune thrombocytopenia underwent randomization (52.4% male; mean age, 54 years [range 17 to 87]; mean platelet level, 7×109 per liter) and were followed for up to 2 years after beginning trial treatment. The mycophenolate mofetil group had fewer treatment failures than the glucocorticoid-only group (22% [13 of 59 patients] vs. 44% [27 of 61 patients]; hazard ratio, 0.41; range, 0.21 to 0.80; P = 0.008) and greater response (91.5% of patients having platelet counts greater than 100×109 per liter vs. 63.9%; P<0.001). We found no evidence of a difference between the groups in the occurrence of bleeding, rescue treatments, or treatment side effects, including infection. However, patients in the mycophenolate mofetil group reported worse quality-of-life outcomes regarding physical function and fatigue than those in the glucocorticoid-only group. CONCLUSIONS: The addition of mycophenolate mofetil to a glucocorticoid for first-line treatment of immune thrombocytopenia resulted in greater response and a lower risk of refractory or relapsed immune thrombocytopenia, but with somewhat decreased quality of life. (Funded by the U.K. National Institute for Health Research; FLIGHT ClinicalTrials.gov number, NCT03156452; EudraCT number, 2017-001171-23.).


Assuntos
Glucocorticoides/uso terapêutico , Imunossupressores/uso terapêutico , Ácido Micofenólico/uso terapêutico , Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Adolescente , Adulto , Idoso , Quimioterapia Combinada , Fadiga/induzido quimicamente , Feminino , Glucocorticoides/efeitos adversos , Hemorragia/etiologia , Hemorragia/prevenção & controle , Humanos , Imunossupressores/efeitos adversos , Masculino , Pessoa de Meia-Idade , Ácido Micofenólico/efeitos adversos , Contagem de Plaquetas , Púrpura Trombocitopênica Idiopática/complicações , Qualidade de Vida , Adulto Jovem
2.
Adv Ther ; 38(9): 4872-4884, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34368918

RESUMO

INTRODUCTION: Given the relatively small number of patients with haemophilia A, head-to-head comparisons between recombinant FVIII (rFVIII) products are difficult to conduct. This study compared the efficacy and consumption of rVIII-SingleChain (lonoctocog alfa, AFSTYLA®) with rAHF-PFM (octocog alfa, Advate®) and rFVIIIFc (efmoroctocog alfa, Elocta®), for the prophylaxis and treatment of bleeding episodes in previously treated adolescents/adults with severe haemophilia A, through a matching-adjusted indirect comparison (MAIC). METHODS: A systematic literature review identified published clinical trials for rAHF-PFM and rFVIIIFc. Individual patient data for rVIII-SingleChain were used to match baseline patient characteristics to those from published trials, using an approach similar to propensity score weighting. After matching, annualized bleeding rates (ABR), percentage of patients with zero bleeds, and rFVIII consumption were compared across trial populations. RESULTS: Published data were identified from two rAHF-PFM trials and one rFVIIIFc trial. rVIII-SingleChain had similar ABR (risk ratio [RR]: 0.74 [0.16; 3.48]; RR: 1.18 [0.85; 1.65]) and percentage of patients with zero bleeds (odds ratio [OR]: 1.34 [0.56; 3.22]; OR: 0.78 [0.47; 1.31]) versus rAHF-PFM and rFVIIIFc, respectively. Annual rVIII-SingleChain consumption was significantly lower than rAHF-PFM (mean difference: - 1507.66 IU/kg/year [- 2011.71; - 1003.61]) and equivalent to rFVIIIFc (RR: 0.96 [0.62; 1.49]). CONCLUSION: Although limited to published information for comparator trials, these results suggest that with an annualized rFVIII consumption comparable to rFVIIIFc, but significantly lower than rAHF-PFM, routine prophylaxis with rVIII-SingleChain is able to maintain a similar ABR and percentage of patients with zero bleeds, attesting to the long-acting nature of rVIII-SingleChain.


Assuntos
Hemofilia A , Adolescente , Adulto , Fator VIII , Hemofilia A/tratamento farmacológico , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Humanos , Imunoterapia Adotiva , Pontuação de Propensão , Proteínas Recombinantes
4.
Expert Opin Drug Metab Toxicol ; 17(9): 1091-1102, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34357838

RESUMO

INTRODUCTION: Although dabigatran is safer than vitamin K antagonists, bleeding still occurs. Bleeding is an important cause of short-term morbidity and rarely mortality and can also have long-term consequences that are often under-appreciated. After bleeding, patients often do not restart treatment or are poorly adherent, which is associated with increased thromboembolism and mortality. Consequently, we need strategies to prevent and treat bleeding in patients with atrial fibrillation treated with dabigatran. AREAS COVERED: We review a) relevant dabigatran pharmacology, b) the burden and consequences of bleeding, c) how to identify patients at high risk of bleeding; and d) existing and novel approaches to prevent and treat bleeding in dabigatran-treated patients. EXPERT OPINION: Concerns about the risk of bleeding associated with anticoagulant therapy and emerging evidence of increased risk of thromboembolism and mortality after bleeding highlight the need for improved approaches to prevention and treatment of bleeding. Future research priorities should focus on improving our ability to prevent bleeding by identifying modifiable risk factors and the development of safer agents. The current front runners include drugs that selectively target the contact pathway of coagulation (e.g. factor XI). Targeting upstream drivers of thrombosis (e.g. inflammation) could help to further reduce the risk of thromboembolism.


Assuntos
Antitrombinas/efeitos adversos , Dabigatrana/efeitos adversos , Hemorragia/induzido quimicamente , Antitrombinas/administração & dosagem , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Dabigatrana/administração & dosagem , Hemorragia/prevenção & controle , Humanos , Fatores de Risco , Tromboembolia/etiologia , Tromboembolia/prevenção & controle
5.
Rev Infirm ; 70(273): 21-22, 2021.
Artigo em Francês | MEDLINE | ID: mdl-34446229

RESUMO

Uncontrolled bleeding is the leading cause of preventable death. After rapid diagnosis of the injury, early stoppage of the bleeding and maintenance of effective coagulation are, in the pre-hospital setting, the two mainstays of treatment of hemorrhagic shock. The latter requires a trained and experienced medical and paramedical team to prevent patient morbidity and mortality.


Assuntos
Choque Hemorrágico , Torniquetes , Hemorragia/prevenção & controle , Humanos
6.
Rev Infirm ; 70(273): 23-26, 2021.
Artigo em Francês | MEDLINE | ID: mdl-34446230

RESUMO

When faced with a hemorrhage, there are many ways to achieve hemostasis. War medicine and terrorist attacks have taught us the wide use of the tactical tourniquet since hemorrhagic injury is the leading cause of death, mainly in pre-hospital care. The existence of hemorrhagic areas not accessible to tourniquets and the possibility of conversion of a tourniquet by other non-ischemic local hemostasis means have demonstrated the relevance of compression by internal or external packing. Procoagulant hemostatic dressings have progressed in their efficacy over four generations. History and development.


Assuntos
Hemostáticos , Bandagens , Hemorragia/prevenção & controle , Hemostasia , Humanos , Torniquetes
7.
BMC Neurol ; 21(1): 247, 2021 Jun 28.
Artigo em Inglês | MEDLINE | ID: mdl-34182941

RESUMO

BACKGROUND: Dual antiplatelet therapy (DAPT) is necessary for stent assisted coiling. However, long term use of DAPT has a potential risk of hemorrhagic events. We aimed to examine the relationship between clopidogrel reactivity and complications. METHODS: Patients who underwent stent assisted coiling for unruptured aneurysms or previously treated aneurysms and received periprocedural DAPT in our institution between August 2011 to March 2020 were included. Platelet reactivity for clopidogrel was measured by VerifyNow assay system, and we defined the cut off value of P2Y12 Reaction Units (PRU) at 208 and classified patients as hypo-responders (PRU≧208) or responders (PRU<208). The rates of hemorrhagic and thrombotic events within 30 days (acute phase) and 30 days after the procedure (delayed phase) were compared between the two groups. Furthermore, changes in hemoglobin levels were measured before and after the procedure and at chronic stages (1 to 6 months thereafter). RESULTS: From 61 patients included in this study, 36 patients were hypo-responders and 25 patients were responders. Hemorrhagic events occurred 8.0% only in responders in the acute phase (p = 0.16), and 2.78% in hypo-responders and 20.0% in responders in the delayed phase (p = 0.037). Changes in hemoglobin levels before and after the procedure were 1.22 g/dl in hypo-responders and 1.74 g/dl in responders (p = 0.032) while before the procedure and chronic stages they were 0.39 g/dl in hypo-responders and 1.39 g/dl in responders (p <  0.01). Thrombotic events were not significantly different between the two groups. CONCLUSION: Long term use of DAPT after stent assisted coiling is related to hemorrhagic events in the delayed phase. Preventing for hemorrhagic events, the duration of DAPT should be carefully considered in clopidogrel responders.


Assuntos
Clopidogrel/efeitos adversos , Hemorragia , Inibidores da Agregação Plaquetária/efeitos adversos , Stents , Plaquetas/efeitos dos fármacos , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Hemorragia/prevenção & controle , Humanos
8.
Clin Immunol ; 229: 108764, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34089860

RESUMO

C57BL/6 mice with pristane-induced lupus develop macrophage-dependent diffuse alveolar hemorrhage (DAH), which is blocked by treatment with liver X receptor (LXR) agonists and is exacerbated by low IL-10 levels. Serp-1, a myxomavirus-encoded serpin that impairs macrophage activation and plasminogen activation, blocks DAH caused by MHV68 infection. We investigated whether Serp-1 also could block DAH in pristane-induced lupus. Pristane-induced DAH was prevented by treatment with recombinant Serp-1 and macrophages from Serp1-treated mice exhibited an anti-inflammatory M2-like phenotype. Therapy activated LXR, promoting M2 polarization and expression of Kruppel-like factor-4 (KLH4), which upregulates IL-10. In contrast, deficiency of tissue plasminogen activator or plasminogen activator inhibitor had little effect on DAH. We conclude that Serp-1 blocks pristane-induced lung hemorrhage by enhancing LXR-regulated M2 macrophage polarization and KLH4-regulated IL-10 production. In view of the similarities between DAH in pristane-treated mice and SLE patients, Serp-1 may represent a potential new therapy for this severe complication of SLE.


Assuntos
Lúpus Eritematoso Sistêmico/terapia , Macrófagos/efeitos dos fármacos , Serpinas/farmacologia , Proteínas Virais/farmacologia , Animais , Coagulação Sanguínea , Feminino , Hemorragia/sangue , Hemorragia/patologia , Hemorragia/prevenção & controle , Interleucina-10/biossíntese , Receptores X do Fígado/metabolismo , Pneumopatias/sangue , Pneumopatias/patologia , Pneumopatias/prevenção & controle , Lúpus Eritematoso Sistêmico/induzido quimicamente , Lúpus Eritematoso Sistêmico/imunologia , Macrófagos/classificação , Macrófagos/imunologia , Camundongos , Camundongos Endogâmicos C57BL , Camundongos Transgênicos , Myxoma virus/genética , Células RAW 264.7 , Serpinas/genética , Terpenos/toxicidade , Proteínas Virais/genética
9.
J Interv Cardiol ; 2021: 9934535, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34035674

RESUMO

Introduction: This network meta-analysis aimed to evaluate the efficacy and safety of different dual antiplatelet therapies (DAPTs) after percutaneous coronary intervention (PCI) with drug-eluting stents (DESs). Methods: Randomized controlled trials (RCTs) comparing longer-term (>12 months) DAPT (L-DAPT), 12-month DAPT (DAPT 12Mo), 6-month DAPT (DAPT 6Mo), 3-month DAPT followed by aspirin monotherapy (DAPT 3Mo + ASA), 3-month DAPT followed by a P2Y12 receptor inhibitor monotherapy (DAPT 3Mo + P2Y12), or 1-month DAPT with a P2Y12 receptor inhibitor monotherapy (DAPT 1Mo + P2Y12) were searched. Primary endpoints were all-cause mortality, cardiac death, myocardial infarction (MI), major bleeding, any bleeding, definite or probable stent thrombosis (ST), and net adverse clinical events (NACE). This Bayesian network meta-analysis was performed with the random-effects model. Results: Twenty-four RCTs (n = 81339) were included. In comparison with L-DAPT, DAPT 6Mo (OR: 0.50, 95% CI: 0.29-0.83), DAPT 3Mo + P2Y12 (OR: 0.38, 95% CI: 0.18-0.82), DAPT 3Mo + ASA (OR: 0.44, 95% CI: 0.17-0.98), and DAPT 1Mo + P2Y12 (OR: 0.45, 95% CI: 0.14-0.93) were associated with a lower risk of major bleeding. DAPT 3Mo + P2Y12 (OR: 0.58, 95% CI: 0.38-0.88) reduced the risk of any bleeding when compared with DAPT 12Mo. L-DAPT decreased the risk of MI and definite or probable stent ST when compared with DAPT 6Mo. DAPT 3Mo + P2Y12 decreased the risk of NACE in comparison with DAPT 6Mo and DAPT 12Mo. No significant difference in all-cause mortality and cardiac death was observed. In patients with acute coronary syndrome, DAPT 6Mo was comparable to DAPT 12Mo. Conclusion: Short-term (1-3 months) DAPT is noninferior to DAPT 6Mo after DESs implantation, while L-DAPT reduces MI and definite or probable ST rates. DAPT 3Mo + P2Y12 might be a reasonable trade-off in patients with high risk of bleeding accompanied by ischemia.


Assuntos
Reestenose Coronária/prevenção & controle , Quimioterapia Combinada , Stents Farmacológicos , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/farmacologia , Quimioterapia Combinada/efeitos adversos , Quimioterapia Combinada/métodos , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Humanos , Metanálise em Rede , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Risco Ajustado/métodos
10.
PLoS Med ; 18(5): e1003601, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33939696

RESUMO

BACKGROUND: Oral bleeding after dental extraction in patients on non-vitamin K oral anticoagulants (NOACs) is a frequent problem. We investigated whether 10% tranexamic acid (TXA) mouthwash decreases post-extraction bleeding in patients treated with NOACs. METHODS AND FINDINGS: The EXTRACT-NOAC study is a randomized, double-blind, placebo-controlled, multicenter, clinical trial. Patients were randomly assigned to 10% TXA or placebo mouthwash and were instructed to use the mouthwash once prior to dental extraction, and thereafter for 3 times a day for 3 days. The primary outcome was the number of patients with any post-extraction oral bleeding up to day 7. Secondary outcomes included periprocedural, early, and delayed bleeding, and the safety outcomes included all thrombotic events. The first patient was randomized on February 9, 2018 and the last patient on March 12, 2020. Of 222 randomized patients, 218 patients were included in the full analysis set, of which 106 patients were assigned to TXA (74.8 (±8.8) years; 81 men) and 112 to placebo (72.7 (±10.7) years; 64 men). Post-extraction bleeding occurred in 28 (26.4%) patients in the TXA group and in 32 (28.6%) patients in the placebo group (relative risk, 0.92; 95% confidence interval [CI], 0.60 to 1.42; P = 0.72). There were 46 bleeds in the TXA group and 85 bleeds in the placebo group (rate ratio, 0.57; 95% CI, 0.31 to 1.05; P = 0.07). TXA did not reduce the rate of periprocedural bleeding (bleeding score 4 ± 1.78 versus 4 ± 1.82, P = 0.80) and early bleeding (rate ratio, 0.76; 95% CI, 0.42 to 1.37). Delayed bleeding (rate ratio, 0.32; 95% CI, 0.12 to 0.89) and bleeding after multiple extractions (rate ratio, 0.40; 95% CI, 0.20 to 0.78) were lower in the TXA group. One patient in the placebo group had a transient ischemic attack while interrupting the NOAC therapy in preparation for the dental extraction. Two of the study limitations were the premature interruption of the trial following a futility analysis and the assessment of the patients' compliance that was based on self-reported information during follow-up. CONCLUSIONS: In patients on NOACs undergoing dental extraction, TXA does not seem to reduce the rate of periprocedural or early postoperative oral bleeding compared to placebo. TXA appears to reduce delayed bleeds and postoperative oral bleeding if multiple teeth are extracted. TRIAL REGISTRATION: ClinicalTrials.gov NCT03413891 EudraCT; EudraCT number:2017-001426-17; EudraCT Public website: eudract.ema.europa.eu.


Assuntos
Anticoagulantes/administração & dosagem , Antifibrinolíticos/uso terapêutico , Hemorragia/prevenção & controle , Hemorragia Pós-Operatória/tratamento farmacológico , Extração Dentária/efeitos adversos , Ácido Tranexâmico/uso terapêutico , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Bélgica , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Hemorragia Pós-Operatória/etiologia , Estudos Prospectivos
11.
Eur J Epidemiol ; 36(8): 793-812, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33993379

RESUMO

PURPOSE: To systematically review available evidence of indirect comparisons from RCTs and direct comparisons from observational studies regarding the comparative effectiveness and safety of DOACs in patients with AF. METHODS: Electronic databases including EMBASE, MEDLINE, and PUBMED were searched up to June 5th, 2020. Primary endpoints included effectiveness (stroke or systemic embolism [SE]) and safety (major bleeding) outcomes. Bucher methods and random-effects models were conducted for indirect and direct comparisons among DOACs, respectively. Ranking probability analyses and the number needed to treat for net effect (NNTnet) were applied. RESULTS: A total of 36 studies, involving 7 RCTs (n = 60,292 patients) and 29 observational studies (n = 1,164,821 patients), were included for analyses. Regarding the risk of stroke/SE, no significant differences were found from indirect comparisons of RCTs among the DOACs. For major bleeding, apixaban tended to be safer than rivaroxaban and dabigatran based on both direct and indirect comparisons (all p < 0.05; evidence quality: very low to moderate). Ranking probability analysis showed that apixaban had a high probability of being the best treatment in decreased risk of stroke/SE and major bleeding (80.30% and 91.30%, respectively). Likewise, apixaban was found to have the highest net clinical benefit (0.02, 95% CI: 0.014-0.029) and smallest NNTnet (48, 95% CI: 35-74). CONCLUSIONS: Apixaban appeared to have a favorable effectiveness-safety profile compared with the other DOACs in AF for stroke prevention, based on evidence from both direct and indirect comparisons. However, additional high-quality evidence is needed to support firm recommendations on clinical decision-making.


Assuntos
Anticoagulantes/administração & dosagem , Fibrilação Atrial/tratamento farmacológico , Hemorragia/prevenção & controle , Acidente Vascular Cerebral/prevenção & controle , Administração Oral , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Inibidores do Fator Xa/administração & dosagem , Inibidores do Fator Xa/efeitos adversos , Humanos , Pirazóis/administração & dosagem , Pirazóis/efeitos adversos , Piridonas/administração & dosagem , Piridonas/efeitos adversos , Resultado do Tratamento
12.
Blood Coagul Fibrinolysis ; 32(4): 259-265, 2021 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-33955860

RESUMO

Patients with haemophilia A who have similar FVIII levels show clinical heterogeneity, and 10-15% of patients with severe haemophilia do not have a severe bleeding phenotype. The aim of this study was to assess whether global haemostasis tests, such as thrombin generation assay (TGA) and thromboelastography (TEG), can predict the bleeding pattern of severe haemophilia better than trough levels and pharmacokinetic profiles, particularly in the prophylactic setting. The study group consisted of 39 patients with haemophilia A and 75 healthy controls. The annual bleeding rate (ABR) and Hemophilia Joint Health Score 2.1 (HJHS) of the patients were determined. Basal factor FVIII, inhibitor levels, TEG and TGA of participants with prophylaxis were performed after a washout period. Then, a recombinant FVIII product was administered to patients. After factor replacement, the above tests were repeated at 30 min, 6 and 48 h. There was a significant difference in the ABR and HJHS between the groups according to the basal factor VIII activity of patients after wash-out. TEG and TGA parameters of patients with factor activity above 1% were significantly better than those of patients with factor activity below 1%. After factor concentrate administration, factor activities, TEG and TGA parameters at 30 min, 6 and 48 h were similar in the two groups. We showed that the 1% trough level but not for the 3% trough level is critical for both clinical phenotypes and thrombin generation for haemophilia patients in the prophylactic setting.


Assuntos
Hemofilia A/sangue , Hemofilia A/prevenção & controle , Adolescente , Testes de Coagulação Sanguínea , Criança , Fator VIII/uso terapêutico , Hemofilia A/diagnóstico , Hemorragia/sangue , Hemorragia/diagnóstico , Hemorragia/prevenção & controle , Humanos , Sacarose/sangue , Sacarose/uso terapêutico , Tromboelastografia , Trombina/análise
14.
Medicine (Baltimore) ; 100(21): e26077, 2021 May 28.
Artigo em Inglês | MEDLINE | ID: mdl-34032739

RESUMO

BACKGROUND: Nonacog alfa (recombinant factor IX [FIX]) is approved in China for the control and prevention of bleeding events in patients with hemophilia B. This was the first study to assess prophylaxis and on-demand therapy with recombinant FIX replacement in a real-world setting in China. This study aimed to evaluate the safety and efficacy of nonacog alfa in Chinese patients with hemophilia B. METHODS: In this open-label, multicenter study (clinicaltrials.gov identifier NCT02336178), patients received on-demand or prophylactic treatment with intravenous nonacog alfa for approximately 6 months or 50 exposure days, whichever occurred first. The primary safety outcome was medically important events (i.e., development of FIX inhibitors, allergic reactions, and thrombotic events). Key secondary efficacy outcomes included the annualized bleeding rate for on-demand treatment and prophylaxis, response to on-demand treatment, the number of infusions per bleeding event, and the number of breakthrough bleeding events within 48 hours of prophylaxis. RESULTS: Seventy male patients (mean [standard deviation] age 7.8 [7.2] years) were enrolled (on-demand, n = 37; prophylaxis, n = 57 [24 patients were included in both groups]). Thirty-eight (54%) patients had up to 50 FIX exposure days before the study. The only medically important event was a transient low-titer FIX inhibitor (incidence 1.4%, 95% confidence interval, 0-7.7). The mean annualized bleeding rate was 26.3 for on-demand treatment and 6.5 for prophylaxis. A mean (standard deviation) of 1.5 (1.7) nonacog alfa infusions were given per bleeding episode; 78.8% of episodes resolved with 1 infusion. Response was "excellent" or "good" for 88% of the on-demand infusions. Twenty-three bleeding events (n = 11 patients) occurred within 48 hours of 2032 prophylaxis doses (1.13%). CONCLUSION: In the real-world setting, nonacog alfa is safe and effective for on-demand treatment and for prophylaxis for patients with hemophilia B in China.


Assuntos
Terapia de Reposição de Enzimas/efeitos adversos , Fator IX/efeitos adversos , Hemofilia B/tratamento farmacológico , Hemorragia/epidemiologia , Adolescente , Criança , Pré-Escolar , China , Terapia de Reposição de Enzimas/métodos , Fator IX/administração & dosagem , Hemofilia B/complicações , Hemorragia/etiologia , Hemorragia/prevenção & controle , Humanos , Lactente , Infusões Intravenosas , Masculino , Estudos Prospectivos , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/efeitos adversos , Resultado do Tratamento
15.
Blood Coagul Fibrinolysis ; 32(5): 349-351, 2021 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-33878047

RESUMO

Glanzmann thrombasthenia is an inherited disease causing bleeding episodes due to platelet dysfunction. The standard treatment for moderate-severe bleeding is platelet transfusion. Recombinant factor VIIa (rFVIIa) is successfully used in bleeding episodes and invasive procedures. Here, we present a patient with Glanzmann thrombasthenia, whose bleeding episodes could only be controlled by rFVIIa. The patient is a 28 years old male, who has had frequent bleeding episodes unresponsive to local hemostatic agents and tranexamic acid and had an anaphylactoid reaction to platelet transfusion. We started the patient on a low-dose (20 µg/kg) rFVIIa once a week. The patient has no spontaneous bleeding since then. This is the first case report of a Glanzmann thrombasthenia patient on routine prophylaxis with low-dose rFVIIa.


Assuntos
Fator VIIa/uso terapêutico , Hemorragia/etiologia , Hemorragia/prevenção & controle , Trombastenia/complicações , Adulto , Relação Dose-Resposta a Droga , Fator VIIa/administração & dosagem , Humanos , Masculino , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/uso terapêutico
16.
J Thromb Thrombolysis ; 52(1): 354-362, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33900522

RESUMO

American Society of Hematology conducts an annual meeting, where investigators from around the globe presented ground-breaking research in the fields of malignant and non-malignant hematology. We provide a summary of non-malignant hematology abstracts from the 2020 meeting. Topics included range from those related to thrombosis, including thrombotic complications of COVID-19, bleeding and novel therapies such as gene therapies. Readers are encouraged to access meeting materials for a more detailed coverage of the event.


Assuntos
Pesquisa Biomédica , Hematologia , Animais , Anticoagulantes/uso terapêutico , Antifibrinolíticos/uso terapêutico , COVID-19/sangue , COVID-19/complicações , COVID-19/tratamento farmacológico , Congressos como Assunto , Terapia Genética , Doenças Hematológicas/sangue , Doenças Hematológicas/genética , Doenças Hematológicas/terapia , Hemorragia/etiologia , Hemorragia/prevenção & controle , Humanos , Trombose/sangue , Trombose/etiologia , Trombose/prevenção & controle
17.
Acta Biomater ; 128: 305-313, 2021 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-33894348

RESUMO

INTRODUCTION: Incomplete hemostasis after vascular cannulation can cause a hematoma or pseudoaneurysm. We hypothesized that a hydrogel-coated needle would effectively and rapidly stop bleeding after vascular cannulation. METHODS: A hydrogel composed of sodium alginate, hyaluronic acid, and calcium carbonate was coated onto the surface of suture needles. Needles were observed using scanning electronic microscopy (SEM) and immunofluorescence. Cannulation was performed in both mouse and rat models; the liver, kidney, jugular vein, inferior vena cava and aorta were punctured using uncoated and hydrogel-coated needles. Needles coated with a hydrogel with and without CD34 antibody were used to puncture the rat jugular vein and aorta. Tissues were examined by histology and immunofluorescence. RESULTS: The hydrogel was successfully coated onto the surface of 22G and 30G needles and confirmed by SEM. Hydrogel-coated needles rapidly stopped bleeding after cannulation of the liver, kidney, jugular vein, inferior vena cava and aorta. Hydrogel-coated needles that contained CD34 antibody attracted vascular progenitor cells near the puncture site; there were fewer M1-type macrophages and more M2-type macrophages. CONCLUSION: Hydrogel-coated needles can effectively and rapidly stop puncture-site bleeding. The hydrogel that contains CD34 antibody attracted vascular progenitor cells, potentially promoting healing of the site after cannulation. STATEMENT OF SIGNIFICANCE: Incomplete hemostasis after vascular cannulation can cause a hematoma or pseudoaneurysm and remains a significant clinical problem. We developed a hydrogel composed of sodium alginate, hyaluronic acid, and calcium carbonate; hydrogel-coated needles effectively and rapidly stopped bleeding after vascular cannulation. Interestingly, the hydrogel can also serve as a carrier for drugs that are delivered to the puncture site during the short time of cannulation that could additionally promote puncture site healing. Hydrogel-coated needles may be a new method for rapid hemostasis with application to patients especially at risk for bleeding.


Assuntos
Hidrogéis , Agulhas , Animais , Hemorragia/etiologia , Hemorragia/prevenção & controle , Humanos , Veias Jugulares , Camundongos , Punções/efeitos adversos , Ratos
19.
Scand J Trauma Resusc Emerg Med ; 29(1): 56, 2021 Apr 06.
Artigo em Inglês | MEDLINE | ID: mdl-33823884

RESUMO

BACKGROUND: Falls from standing are common in the elderly and are associated with a significant risk of bleeding. We have compared the proportional incidence of bleeding complications in patients on either direct oral anticoagulants (DOAC) or vitamin K antagonists (VKA). METHODS: Our retrospective cohort study compared elderly patients (≥65 years) on DOAC or VKA oral anticoagulation who presented at the study site - a Swiss university emergency department (ED) - between 01.06.2012 and 01.07.2017 after a fall. The outcomes were the proportional incidence of any bleeding complication and its components (e.g. intracranial haemorrhage), as well as procedural and clinical parameters (length of hospital stay, admission to intensive care unit, in-hospital-mortality). Uni- and multivariable analyses were used to compare the studied outcomes. RESULTS: In total, 1447 anticoagulated patients were included - on either VKA (n = 1021) or DOAC (n = 426). There were relatively more bleeding complications in the VKA group (n = 237, 23.2%) than in the DOAC group (n = 69, 16.2%, p = 0.003). The difference persisted in multivariable analysis with 0.7-fold (95% CI: 0.5-0.9, p = 0.014) lower odds for patients under DOAC than under VKA for presenting with any bleeding complications, and 0.6-fold (95% 0.4-0.9, p = 0.013) lower odds for presenting with intracranial haemorrhage. There were no significant differences in the other studied outcomes. CONCLUSIONS: Among elderly, anticoagulated patients who had fallen from standing, those under DOACs had a lower proportional incidence of bleeding complications in general and an even lower incidence of intracranial haemorrhage than in patients under VKAs.


Assuntos
Anticoagulantes/administração & dosagem , Serviço Hospitalar de Emergência/estatística & dados numéricos , Fibrinolíticos/administração & dosagem , Hemorragia/epidemiologia , Vitamina K/antagonistas & inibidores , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Feminino , Hemorragia/prevenção & controle , Mortalidade Hospitalar/tendências , Humanos , Incidência , Tempo de Internação , Masculino , Estudos Retrospectivos , Suíça/epidemiologia
20.
Medicine (Baltimore) ; 100(16): e25601, 2021 Apr 23.
Artigo em Inglês | MEDLINE | ID: mdl-33879725

RESUMO

ABSTRACT: There is controversy in clinical application of antiplatelet drugs by monitoring platelet function. Therefore, we explored whether early and dynamic medication could bring better clinical outcomes for patients under the guidance of platelet function tests (PFT).In this retrospective cohort study, we analyzed the prognostic events of 1550 patients with acute coronary syndrome (ACS) at Tianjin People's Hospital in China. They received dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) from January 2017 to December 2018. The primary endpoint was based on the Bleeding Academic Research Consortium (BARC) 3 or 5 major bleeding. Secondary endpoints included MACCE (all-cause death, nonfatal myocardial infarction, stroke, stent thrombosis, and unplanned target vessel reconstruction) and BARC 1 to 2 minor bleeding. The endpoint events within 1 year after PCI were recorded. Patients were divided into a guided group and a control group according to the drug adjustment by PFT results. After the propensity scores matched, the end points of 2 groups were compared, and subgroup analysis was performed on major bleeding events.After propensity score matching, there were 511 cases in the guided group and the control group, respectively. The primary endpoint events occurred in 10 patients (1.96%) in the guided group and 23 patients (4.5%) in the control group (HR: 0.45; 95% CI, 0.21-0.95; P = .037). After the guided group adjusted drug doses, the risk of major bleeding was lower than standard DAPT of the control group. Although some patients in the guided group reduced doses earlier, the incidence of MACCE events did not increase in the guided group compared with the control group (4.89% vs 6.07%; P = .41). There was no statistical difference in BARC 1 to 2 minor bleeding (P = .22). Subgroup analysis showed that PFT was more effective in patients with diabetes and multivessel disease.Early observation of dynamic PFT in ACS patients after PCI can guide individualized antiplatelet therapy to reduce the risk of major bleeding without increasing the risk of ischemia.


Assuntos
Síndrome Coronariana Aguda/terapia , Monitoramento de Medicamentos/métodos , Hemorragia/prevenção & controle , Inibidores da Agregação Plaquetária/uso terapêutico , Testes de Função Plaquetária/estatística & dados numéricos , Síndrome Coronariana Aguda/complicações , Idoso , China , Terapia Antiplaquetária Dupla , Feminino , Hemorragia/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Período Pós-Operatório , Prognóstico , Pontuação de Propensão , Estudos Retrospectivos , Resultado do Tratamento
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