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1.
Medicine (Baltimore) ; 99(44): e22999, 2020 Oct 30.
Artigo em Inglês | MEDLINE | ID: mdl-33126380

RESUMO

BACKGROUND: The efficacy and safety of oral tranexamic acid (TXA) remain controversial because of the small number of clinical studies. The aim of the present study was to compare the efficacy and safety of oral TXA with intravenous TXA in patients undergoing total hip arthroplasty and total knee arthroplasty in a systematic review and meta-analysis. METHODS: We conducted a meta-analysis to identify randomized controlled trials (RCTs) involving oral and intravenous TXA in total hip arthroplasty and total knee arthroplasty up to December 2019 by searching databases including PubMed, Web of Science, Embase, the Cochrane Controlled Trials Register, the Cochrane Library China Biology Medicine, China National Knowledge Infrastructure, China Science and Technology Journal Database and Wanfang. The mean difference or standard mean difference was used to assess continuous outcomes such as hemoglobin (Hb) drop, total blood loss, drain blood loss, and length of hospital stay, with a 95% confidence interval. Relative risks with a 95% confidence interval were used to assess dichotomous outcomes such as transfusion rate and the incidence of deep venous thrombosis and calf muscular vein thrombosis. Review Manager was used for the meta-analysis. RESULTS: Ten RCTs containing 1080 participants met the inclusion criteria. We found no significant differences in terms of the average Hb drop (P = .60), total blood loss (P = .60), transfusion rate (P = .99), drain blood loss (P = .91), length of hospital stay (P = .95), and the incidence of deep venous thrombosis (P = .55) and calf muscular vein thrombosis (P = .19) between oral and IV TXA. CONCLUSIONS: Compared with the IV TXA, oral TXA has similar effects on reducing the Hb drop, total blood loss, transfusion rate, drain blood loss, and length of hospital stay without increasing the risk of calf muscular vein thrombosis and deep venous thrombosis. Furthermore, oral TXA is easy to access and administer, which decreases the workload of nurses and even delivers cost-saving benefits to the health care system. We thus conclude that oral TXA may be an optimal approach in total joint arthroplasty. However, more high-quality and multicenter RCTs are still needed to confirm our conclusions. REGISTRATION: The current meta-analysis was registered on PROSPERO (International Prospective Register of Systematic Reviews), and the registration number was CRD42018111291.


Assuntos
Antifibrinolíticos/uso terapêutico , Artroplastia de Quadril , Artroplastia do Joelho , Ácido Tranexâmico/uso terapêutico , Trombose Venosa/prevenção & controle , Administração Oral , Antifibrinolíticos/administração & dosagem , Humanos , Infusões Intravenosas , Complicações Pós-Operatórias/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto , Ácido Tranexâmico/administração & dosagem
2.
J Stroke Cerebrovasc Dis ; 29(10): 105136, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32912508

RESUMO

BACKGROUND: Hematoma expansion (HE) and peri-hematomal edema (PHE) are associated with adverse outcomes of patients with acute spontaneous intracerebral hemorrhage (sICH). Due to a lack of proven treatments, it is critical to explore novel treatments for HE and PHE to improve functional recovery after sICH. METHODS: This is a prospective, multicenter, placebo-controlled, double-blind, and randomized clinical study of approximately 2400 patients with sICH. Patients within 4.5 h of sICH onset that fulfilling the clinical criteria for diagnosis (e.g. age more than 18 years old, the Glasgow Coma Scal>7, and no planned surgery) will randomly receive either intravenous tranexamic acid (TXA) 1 g 10-min bolus followed by 1 g eight-hour infusion or placebo (sodium chloride 0.9%). Clinical data including the ICH score and the Glasgow Coma Scale score will be collected on admission. After assessment of HE and PHE expansion, follow-up will be conducted with enrolled patients for 90 days. RESULTS: Primary outcome metrics are HE (defined as either >33% or >6 ml increase from baseline) and PHE expansion rate at 24 ± 3 h and 72 ± 3 h post-sICH. Secondary outcome metrics include mortality and the modified Rankin Scale on day 90 after sICH. Appropriate statistic methods will be used to evaluate the efficacy of TXA on patients with sICH within 4.5 h of symptom onset. CONCLUSIONS: HE usually occurs within the first few hours after onset of symptoms. It is essential to evaluate the efficacy of TXA on HE within a narrow window of time. This will be the first trial to evaluate the efficacy of TXA on HE and PHE expansion in sICH patients within 4.5 h after symptom onset. This trial is registered as ChiCTR1900027065 at http://www.chictr.org.cn.


Assuntos
Antifibrinolíticos/administração & dosagem , Edema Encefálico/prevenção & controle , Hemorragia Cerebral/tratamento farmacológico , Hematoma/prevenção & controle , Ácido Tranexâmico/administração & dosagem , Antifibrinolíticos/efeitos adversos , Edema Encefálico/etiologia , Hemorragia Cerebral/complicações , China , Progressão da Doença , Método Duplo-Cego , Hematoma/etiologia , Humanos , Infusões Intravenosas , Estudos Multicêntricos como Assunto , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Ácido Tranexâmico/efeitos adversos , Resultado do Tratamento
3.
Bone Joint J ; 102-B(9): 1151-1157, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32862676

RESUMO

AIMS: Tranexamic acid (TXA) has been shown to reduce blood loss and transfusion requirements in patients undergoing orthopaedic surgery. There remains a lack of prospective evidence for the use of TXA in patients undergoing periacetabular osteotomy (PAO). The purpose of this study was to determine if intravenous (IV) TXA is effective in reducing calculated blood loss and transfusions after PAO. METHODS: This was a single-centre prospective double-blind placebo-controlled randomized trial of 81 patients aged 12 to 45 years undergoing elective PAO by a single surgeon. The intervention group (n = 40) received two doses of IV TXA of a maximum 1 g in each dose; the control group (n = 41) received two doses of 50 ml 0.9% saline IV. The primary outcome was perioperative calculated blood loss. Secondary outcomes included allogenic transfusions and six-week postoperative complications. RESULTS: There were no differences in demographics or intraoperative variables between study groups. The TXA group demonstrated lower mean calculated blood loss (1,265 ml, (SD 321) vs 1,515 ml, (SD 394); p = 0.002) and lower frequency of allogenic transfusion (10%/n = 4 vs 37%/n = 15; p = 0.008). Regression analyses associated TXA use with significant reductions in calculated blood loss (p < 0.001) and transfusion (p = 0.007) after adjusting for age, sex, body mass index, preoperative haemoglobin, cell-saver volume, intraoperative mean arterial blood pressure, and operating time. No patients suffered venous thromboembolic complications. CONCLUSION: In this trial, IV TXA decreased postoperative calculated blood loss by 293 ml and reduced the frequency of allogenic transfusions by 73% (37% vs 10%) following PAO. TXA may be safe and effective for reducing blood loss in patients undergoing PAO. Cite this article: Bone Joint J 2020;102-B(9):1151-1157.


Assuntos
Acetábulo/cirurgia , Antifibrinolíticos/administração & dosagem , Perda Sanguínea Cirúrgica/prevenção & controle , Transfusão de Sangue/estatística & dados numéricos , Osteotomia , Hemorragia Pós-Operatória/prevenção & controle , Ácido Tranexâmico/administração & dosagem , Administração Intravenosa , Adolescente , Adulto , Criança , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Adulto Jovem
4.
JAMA ; 324(10): 961-974, 2020 09 08.
Artigo em Inglês | MEDLINE | ID: mdl-32897344

RESUMO

Importance: Traumatic brain injury (TBI) is the leading cause of death and disability due to trauma. Early administration of tranexamic acid may benefit patients with TBI. Objective: To determine whether tranexamic acid treatment initiated in the out-of-hospital setting within 2 hours of injury improves neurologic outcome in patients with moderate or severe TBI. Design, Setting, and Participants: Multicenter, double-blinded, randomized clinical trial at 20 trauma centers and 39 emergency medical services agencies in the US and Canada from May 2015 to November 2017. Eligible participants (N = 1280) included out-of-hospital patients with TBI aged 15 years or older with Glasgow Coma Scale score of 12 or less and systolic blood pressure of 90 mm Hg or higher. Interventions: Three interventions were evaluated, with treatment initiated within 2 hours of TBI: out-of-hospital tranexamic acid (1 g) bolus and in-hospital tranexamic acid (1 g) 8-hour infusion (bolus maintenance group; n = 312), out-of-hospital tranexamic acid (2 g) bolus and in-hospital placebo 8-hour infusion (bolus only group; n = 345), and out-of-hospital placebo bolus and in-hospital placebo 8-hour infusion (placebo group; n = 309). Main Outcomes and Measures: The primary outcome was favorable neurologic function at 6 months (Glasgow Outcome Scale-Extended score >4 [moderate disability or good recovery]) in the combined tranexamic acid group vs the placebo group. Asymmetric significance thresholds were set at 0.1 for benefit and 0.025 for harm. There were 18 secondary end points, of which 5 are reported in this article: 28-day mortality, 6-month Disability Rating Scale score (range, 0 [no disability] to 30 [death]), progression of intracranial hemorrhage, incidence of seizures, and incidence of thromboembolic events. Results: Among 1063 participants, a study drug was not administered to 96 randomized participants and 1 participant was excluded, resulting in 966 participants in the analysis population (mean age, 42 years; 255 [74%] male participants; mean Glasgow Coma Scale score, 8). Of these participants, 819 (84.8%) were available for primary outcome analysis at 6-month follow-up. The primary outcome occurred in 65% of patients in the tranexamic acid groups vs 62% in the placebo group (difference, 3.5%; [90% 1-sided confidence limit for benefit, -0.9%]; P = .16; [97.5% 1-sided confidence limit for harm, 10.2%]; P = .84). There was no statistically significant difference in 28-day mortality between the tranexamic acid groups vs the placebo group (14% vs 17%; difference, -2.9% [95% CI, -7.9% to 2.1%]; P = .26), 6-month Disability Rating Scale score (6.8 vs 7.6; difference, -0.9 [95% CI, -2.5 to 0.7]; P = .29), or progression of intracranial hemorrhage (16% vs 20%; difference, -5.4% [95% CI, -12.8% to 2.1%]; P = .16). Conclusions and Relevance: Among patients with moderate to severe TBI, out-of-hospital tranexamic acid administration within 2 hours of injury compared with placebo did not significantly improve 6-month neurologic outcome as measured by the Glasgow Outcome Scale-Extended. Trial Registration: ClinicalTrials.gov Identifier: NCT01990768.


Assuntos
Antifibrinolíticos/administração & dosagem , Lesões Encefálicas Traumáticas/tratamento farmacológico , Ácido Tranexâmico/administração & dosagem , Adulto , Antifibrinolíticos/efeitos adversos , Encefalopatias/etiologia , Lesões Encefálicas Traumáticas/complicações , Lesões Encefálicas Traumáticas/mortalidade , Método Duplo-Cego , Serviços Médicos de Emergência , Feminino , Seguimentos , Escala de Coma de Glasgow , Humanos , Infusões Intravenosas , Masculino , Pessoa de Meia-Idade , Testes Neuropsicológicos , Gravidade do Paciente , Análise de Sobrevida , Tempo para o Tratamento , Ácido Tranexâmico/efeitos adversos
5.
Medicine (Baltimore) ; 99(36): e22028, 2020 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-32899057

RESUMO

Comparison of different anticoagulants in blood management and complications with tranexamic acid (TXA) in total hip arthroplasty (THA) is unclear. Our aim was to compare the efficacy and safety among receiving nadroparin calcium, enoxaparin sodium or rivaroxaban after TXA in THA.150 patients undergoing primary unilateral THA were received 15 mg/kg intravenous TXA (IV-TXA) before skin incision, followed by 1 of nadroparin calcium (Group A), enoxaparin sodium (Group B), or rivaroxaban (Group C) randomly during hospitalization. The primary outcome was hidden blood loss (HBL). Other outcomes such as the maximum hemoglobin (Hb) drop, total blood loss (TBL), the volume of drainage, transfusion rate, length of hospital stay (LOS), and complications were also compared.There were no statistically significant differences in HBL, the maximum hemoglobin (Hb) drop, transfusion rate, and complications among 3 groups. LOS was significantly higher for patients in Group B than Group A (P = .026). Neither deep venous thrombosis (DVT) nor pulmonary embolism (PE) occurred in any group.There were no differences in efficacy and safety in patients undergoing THA receiving nadroparin calcium, enoxaparin sodium, or rivaroxaban after anti-fibrinolysis with TXA.


Assuntos
Anticoagulantes/efeitos adversos , Antifibrinolíticos/efeitos adversos , Perda Sanguínea Cirúrgica/prevenção & controle , Ácido Tranexâmico/efeitos adversos , Administração Intravenosa , Idoso , Anticoagulantes/administração & dosagem , Antifibrinolíticos/administração & dosagem , Artroplastia de Quadril/efeitos adversos , Transfusão de Sangue/estatística & dados numéricos , China/epidemiologia , Enoxaparina/administração & dosagem , Enoxaparina/efeitos adversos , Feminino , Hemoglobinas/análise , Hospitalização , Humanos , Tempo de Internação/tendências , Masculino , Pessoa de Meia-Idade , Nadroparina/administração & dosagem , Nadroparina/efeitos adversos , Sangue Oculto , Estudos Retrospectivos , Rivaroxabana/administração & dosagem , Rivaroxabana/efeitos adversos , Segurança , Ácido Tranexâmico/administração & dosagem , Resultado do Tratamento
6.
Medicine (Baltimore) ; 99(34): e21747, 2020 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-32846798

RESUMO

BACKGROUND: The safety and efficacy of intravenous tranexamic acid (TXA) in the anterior cruciate ligament (ACL) reconstruction remains controversial. There is an urgent need of studies that efficiently control for confounding, conduct comprehensive and consecutive observation of potential risks of the TXA administration, and investigate its clinical applicability. The purpose of this work is to assess the safety and efficacy of the intravenous TXA in decreasing perioperative blood loss in the patients undergoing ACL reconstruction. METHODS: This randomized, controlled, prospective research was carried out between January 2017 and January 2018. All the patients and their family members signed the informed consent forms, and this current work was authorized via the ethics committee of Nanjing first hospital (registration No.: NJU1003586). A total of 100 patients were divided randomly into 2 group: the control group (n = 50) and study group (n = 50). The study group receives intravenous TXA administration [1 g] before skin incision. The control group receives equivalent normal saline. Primary outcome measures including blood loss, hemoglobin decline, transfusion rate, C-reactive protein, D-dimer value, fibrinogen, prothrombin time, activated partial thromboplastin time, thrombin time, international normalized ratio and erythrocyte sedimentation rate were recorded. The measures of secondary outcomes refer to the clinical data involving the range of motion and postoperative pain score. The pain score was quantified by utilizing the 10-cm scale of visual analog. The pain strength was in the range of 0-10, where 0 is totally no pain and 10 represents the most severe pain. RESULTS: This experiment had strict inclusive criteria and exclusive criteria and a well- regulated intervention. CONCLUSION: Our results can bring a new perspective on the use of TXA after arthroscopically assisted ACL surgery. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5798).


Assuntos
Reconstrução do Ligamento Cruzado Anterior/métodos , Antifibrinolíticos/uso terapêutico , Ácido Tranexâmico/uso terapêutico , Antifibrinolíticos/administração & dosagem , Antifibrinolíticos/efeitos adversos , Perda Sanguínea Cirúrgica/estatística & dados numéricos , Transfusão de Sangue/estatística & dados numéricos , Feminino , Humanos , Masculino , Dor Pós-Operatória , Estudos Prospectivos , Amplitude de Movimento Articular , Projetos de Pesquisa , Ácido Tranexâmico/administração & dosagem , Ácido Tranexâmico/efeitos adversos
7.
Plast Reconstr Surg ; 146(2): 238-245, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32740567

RESUMO

BACKGROUND: Antifibrinolytic medications, such as tranexamic acid, have recently garnered increased attention. Despite its ability to mitigate intraoperative blood loss and need for blood transfusion, there remains a paucity of research in breast reconstruction. The authors investigate whether intravenous tranexamic acid safely reduces the risk of hematoma following implant-based breast reconstruction. METHODS: A single-center retrospective cohort study was performed to analyze all consecutive patients undergoing immediate two-stage implant-based breast reconstruction following mastectomy between 2015 and 2016. The incidence of postoperative hematomas and thromboembolic events among all patients was reviewed. The patients in the intervention group received 1000 mg of intravenous tranexamic acid before mastectomy incision and 1000 mg at the conclusion of the procedure. Fisher's exact test and the Mann-Whitney-Wilcoxon test were used. Multivariate logistic regression models were performed to study the impact of intravenous tranexamic acid after adjusting for possible confounders. RESULTS: A total of 868 consecutive breast reconstructions (499 women) were reviewed. Overall, 116 patients (217 breasts) received intravenous tranexamic acid, whereas 383 patients (651 breasts) did not. Patient characteristics and comorbidities were similar between the two the groups. Patients who received tranexamic acid were less likely to develop hematomas [n = 1 (0.46 percent)] than patients who did not [n = 19 (2.9 percent)] after controlling for age, hypertension, and type of reconstruction (prepectoral and subpectoral) (p = 0.018). Adverse effects of intravenous tranexamic acid, including thromboembolic phenomena were not observed. Multivariate analysis demonstrated that age and hypertension independently increase risk for hematoma. CONCLUSIONS: Intravenous tranexamic acid safely reduces risk of hematoma in implant-based breast reconstruction. Further prospective randomized studies are warranted to further corroborate these findings. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.


Assuntos
Implantes de Mama/efeitos adversos , Mama/irrigação sanguínea , Hematoma/prevenção & controle , Mamoplastia/efeitos adversos , Complicações Pós-Operatórias/prevenção & controle , Tromboembolia/prevenção & controle , Ácido Tranexâmico/administração & dosagem , Adulto , Antifibrinolíticos/administração & dosagem , Neoplasias da Mama/cirurgia , Relação Dose-Resposta a Droga , Feminino , Seguimentos , Hematoma/etiologia , Humanos , Injeções Intravenosas , Mastectomia , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Tromboembolia/etiologia , Resultado do Tratamento
8.
J Card Surg ; 35(10): 2835-2837, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32668053

RESUMO

Polycytemia vera (PV) is a rare myeloproliferative neoplasm associated with microcirculatory disturbances, thrombosis and bleeding. Patients suffering from PV have a high risk of perioperative adverse events, but the literature regarding on-pump procedures in PV patients is scarce. We report two cases of acute and severe oxygenator failure during cardiopulmonary bypass and present valid exit scenarios.


Assuntos
Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Oxigenadores/efeitos adversos , Policitemia/complicações , Trombose/etiologia , Trombose/prevenção & controle , Substituição da Valva Aórtica Transcateter/métodos , Doença Aguda , Coagulação Sanguínea , Feminino , Heparina/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Policitemia/sangue , Cuidados Pré-Operatórios , Reoperação , Ácido Tranexâmico/administração & dosagem , Resultado do Tratamento
9.
Medicine (Baltimore) ; 99(24): e20619, 2020 Jun 12.
Artigo em Inglês | MEDLINE | ID: mdl-32541498

RESUMO

BACKGROUND: Questions still remain about the safest and most effective route of administration for tranexamic acid (TXA) in lumbar interbody fusion. As such, the goal of this randomized clinical trial was to assess the efficacy and safety of topical TXA compared with intravenous TXA in lumbar interbody fusion. METHODS: This was a prospectively randomized trial that investigated the effectiveness and safety of the intravenous and topical administrations of TXA with regard to lumbar interbody fusion. Approval from Clinical Studies Ethical Committee in our hospital was obtained. The patients were randomized to 1 of 2 treatment options:Patients, surgeons, anesthesiologists, nurses, and research assistants collecting data were blinded to group allocation. The primary outcome measures were perioperative calculated blood loss, total drain output at 24 hours, and perioperative blood transfusion rate. Secondary outcomes included an analysis of complications, namely symptomatic venous thromboembolism, cerebrovascular accident, and arterio-occlusive events. Data were analyzed using the statistical software package SPSS version 25.0 (Chicago, IL). RESULTS: There are several limitations to this study. We did not include a group of patients who did not receive TXA. Another potential limitation is that the study population contains heterogeneity such as varying patient diagnosis and surgical technique/approach. Despite these limitations, the validity of our results should be maintained, as the same methodology was applied to both treatment arms. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5564).


Assuntos
Antifibrinolíticos/administração & dosagem , Perda Sanguínea Cirúrgica/prevenção & controle , Fusão Vertebral , Ácido Tranexâmico/administração & dosagem , Administração Intravenosa , Administração Tópica , Antifibrinolíticos/efeitos adversos , Método Duplo-Cego , Humanos , Estudos Prospectivos , Ácido Tranexâmico/efeitos adversos , Resultado do Tratamento
10.
Lancet ; 395(10241): 1927-1936, 2020 06 20.
Artigo em Inglês | MEDLINE | ID: mdl-32563378

RESUMO

BACKGROUND: Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding. METHODS: We did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0·9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and ClinicalTrials.gov, NCT01658124. FINDINGS: Between July 4, 2013, and June 21, 2019, we randomly allocated 12 009 patients to receive tranexamic acid (5994, 49·9%) or matching placebo (6015, 50·1%), of whom 11 952 (99·5%) received the first dose of the allocated treatment. Death due to bleeding within 5 days of randomisation occurred in 222 (4%) of 5956 patients in the tranexamic acid group and in 226 (4%) of 5981 patients in the placebo group (risk ratio [RR] 0·99, 95% CI 0·82-1·18). Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (42 [0·7%] of 5952 vs 46 [0·8%] of 5977; 0·92; 0·60 to 1·39). Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977; RR 1·85; 95% CI 1·15 to 2·98). INTERPRETATION: We found that tranexamic acid did not reduce death from gastrointestinal bleeding. On the basis of our results, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a randomised trial. FUNDING: UK National Institute for Health Research Health Technology Assessment Programme.


Assuntos
Antifibrinolíticos/efeitos adversos , Hemorragia Gastrointestinal/tratamento farmacológico , Tromboembolia/induzido quimicamente , Ácido Tranexâmico/efeitos adversos , Doença Aguda , Adulto , Idoso , Antifibrinolíticos/administração & dosagem , Antifibrinolíticos/uso terapêutico , Estudos de Casos e Controles , Método Duplo-Cego , Feminino , Hemorragia Gastrointestinal/mortalidade , Hemorragia Gastrointestinal/prevenção & controle , Humanos , Injeções Intravenosas , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Razão de Chances , Avaliação de Resultados em Cuidados de Saúde , Placebos/administração & dosagem , Valor Preditivo dos Testes , Embolia Pulmonar/epidemiologia , Acidente Vascular Cerebral/epidemiologia , Tromboembolia/epidemiologia , Ácido Tranexâmico/administração & dosagem , Ácido Tranexâmico/uso terapêutico , Trombose Venosa/epidemiologia
11.
Cochrane Database Syst Rev ; 6: CD002126, 2020 06 12.
Artigo em Inglês | MEDLINE | ID: mdl-32529637

RESUMO

BACKGROUND: Heavy menstrual bleeding (HMB) impacts the quality of life of otherwise healthy women. The perception of HMB is subjective and management depends upon, among other factors, the severity of the symptoms, a woman's age, her wish to get pregnant, and the presence of other pathologies. Heavy menstrual bleeding was classically defined as greater than or equal to 80 mL of blood loss per menstrual cycle. Currently the definition is based on the woman's perception of excessive bleeding which is affecting her quality of life. The intrauterine device was originally developed as a contraceptive but the addition of progestogens to these devices resulted in a large reduction in menstrual blood loss: users of the levonorgestrel-releasing intrauterine system (LNG-IUS) reported reductions of up to 90%. Insertion may, however, be regarded as invasive by some women, which affects its acceptability. OBJECTIVES: To determine the effectiveness, acceptability and safety of progestogen-releasing intrauterine devices in reducing heavy menstrual bleeding. SEARCH METHODS: We searched the Cochrane Gynaecology and Fertility Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO and CINAHL (from inception to June 2019); and we searched grey literature and for unpublished trials in trial registers. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in women of reproductive age treated with LNG-IUS devices versus no treatment, placebo, or other medical or surgical therapy for heavy menstrual bleeding. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data, assessed risk of bias and conducted GRADE assessments of the certainty of evidence. MAIN RESULTS: We included 25 RCTs (2511 women). Limitations in the evidence included risk of attrition bias and low numbers of participants. The studies compared the following interventions. LNG-IUS versus other medical therapy The other medical therapies were norethisterone acetate, medroxyprogesterone acetate, oral contraceptive pill, mefenamic acid, tranexamic acid or usual medical treatment (where participants could choose the oral treatment that was most suitable). The LNG-IUS may improve HMB, lowering menstrual blood loss according to the alkaline haematin method (mean difference (MD) 66.91 mL, 95% confidence interval (CI) 42.61 to 91.20; 2 studies, 170 women; low-certainty evidence); and the Pictorial Bleeding Assessment Chart (MD 55.05, 95% CI 27.83 to 82.28; 3 studies, 335 women; low-certainty evidence). We are uncertain whether the LNG-IUS may have any effect on women's satisfaction up to one year (RR 1.28, 95% CI 1.01 to 1.63; 3 studies, 141 women; I² = 0%, very low-certainty evidence). The LNG-IUS probably leads to slightly higher quality of life measured with the SF-36 compared with other medical therapy if (MD 2.90, 95% CI 0.06 to 5.74; 1 study: 571 women; moderate-certainty evidence) or with the Menorrhagia Multi-Attribute Scale (MD 13.40, 95% CI 9.89 to 16.91; 1 trial, 571 women; moderate-certainty evidence). The LNG-IUS and other medical therapies probably give rise to similar numbers of women with serious adverse events (RR 0.91, 95% CI 0.63 to 1.30; 1 study, 571 women; moderate-certainty evidence). Women using other medical therapy are probably more likely to withdraw from treatment for any reason (RR 0.49, 95% CI 0.39 to 0.60; 1 study, 571 women, moderate-certainty evidence) and to experience treatment failure than women with LNG-IUS (RR 0.34, 95% CI 0.26 to 0.44; 6 studies, 535 women; moderate-certainty evidence). LNG-IUS versus endometrial resection or ablation (EA) Bleeding outcome results are inconsistent. We are uncertain of the effect of the LNG-IUS compared to EA on rates of amenorrhoea (RR 1.21, 95% CI 0.85 to 1.72; 8 studies, 431 women; I² = 21%; low-certainty evidence) and hypomenorrhoea (RR 0.98, 95% CI 0.73 to 1.33; 4 studies, 200 women; low-certainty evidence) and eumenorrhoea (RR 0.55, 95% CI 0.30 to 1.00; 3 studies, 160 women; very low-certainty evidence). We are uncertain whether both treatments may have similar rates of satisfaction with treatment at 12 months (RR 0.95, 95% CI 0.85 to 1.07; 5 studies, 317 women; low-certainty evidence). We are uncertain if the LNG-IUS compared to EA has any effect on quality of life, measured with SF-36 (MD -14.40, 95% CI -22.63 to -6.17; 1 study, 33 women; very low-certainty evidence). Women with the LNG-IUS compared with EA are probably more likely to have any adverse event (RR 2.06, 95% CI 1.44 to 2.94; 3 studies, 201 women; moderate-certainty evidence). Women with the LNG-IUS may experience more treatment failure compared to EA at one year follow up (persistent HMB or requirement of additional treatment) (RR 1.78, 95% CI 1.09 to 2.90; 5 studies, 320 women; low-certainty evidence); or requirement of hysterectomy may be higher at one year follow up (RR 2.56, 95% CI 1.48 to 4.42; 3 studies, 400 women; low-certainty evidence). LNG-IUS versus hysterectomy We are uncertain whether the LNG-IUS has any effect on HMB compared with hysterectomy (RR for amenorrhoea 0.52, 95% CI 0.39 to 0.70; 1 study, 75 women; very low-certainty evidence). We are uncertain whether there is difference between LNG-IUS and hysterectomy in satisfaction at five years (RR 1.01, 95% CI 0.94 to 1.08; 1 study, 232 women; low-certainty evidence) and quality of life (SF-36 MD 2.20, 95% CI -2.93 to 7.33; 1 study, 221 women; low-certainty evidence). Women in the LNG-IUS group may be more likely to have treatment failure requiring hysterectomy for HMB at 1-year follow-up compared to the hysterectomy group (RR 48.18, 95% CI 2.96 to 783.22; 1 study, 236 women; low-certainty evidence). None of the studies reported cost data suitable for meta-analysis. AUTHORS' CONCLUSIONS: The LNG-IUS may improve HMB and quality of life compared to other medical therapy; the LNG-IUS is probably similar for HMB compared to endometrial destruction techniques; and we are uncertain if it is better or worse than hysterectomy. The LNG-IUS probably has similar serious adverse events to other medical therapy and it is more likely to have any adverse events than EA.


Assuntos
Dispositivos Intrauterinos Medicados , Levanogestrel/uso terapêutico , Menorragia/tratamento farmacológico , Noretindrona/uso terapêutico , Progesterona/uso terapêutico , Antifibrinolíticos/administração & dosagem , Antifibrinolíticos/uso terapêutico , Anticoncepcionais Orais/administração & dosagem , Anticoncepcionais Orais/uso terapêutico , Endométrio/cirurgia , Feminino , Humanos , Histerectomia , Levanogestrel/administração & dosagem , Ácido Mefenâmico/administração & dosagem , Ácido Mefenâmico/uso terapêutico , Menorragia/cirurgia , Noretindrona/administração & dosagem , Progesterona/administração & dosagem , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Ácido Tranexâmico/administração & dosagem , Ácido Tranexâmico/uso terapêutico , Resultado do Tratamento
12.
J Shoulder Elbow Surg ; 29(7): 1375-1379, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32418856

RESUMO

BACKGROUND: Elbow joint open arthrolysis is an effective method to release contracted tissue and débride heterotopic ossification in cases of post-traumatic elbow stiffness. Recurrence remains one of the most common concerns for surgeons. Soft tissue contracture may result from intra- and/or extra-articular bleeding, edema, effusion, and granulation. The increasing incidence of intraoperative and postoperative bleeding has caused uncertainty about surgical outcomes. Tranexamic acid (TXA) is effective for reducing surgery-related bleeding and effusions in total hip or knee arthroplasty. PURPOSE: To investigate whether topical TXA can decrease blood loss and effusions in patients treated with elbow joint open arthrolysis and whether it affects final function. PATIENTS AND METHOD: A prospective comparative study was conducted. Sixty-one patients with joint stiffness were enrolled and randomly divided into 2 groups: one consisting of 31 patients treated with topical TXA intraoperatively after open arthrolysis (experimental group) and the other consisting of 30 patients who received saline administration (control group). The operation time, tourniquet time, and intraoperative blood loss were recorded. Drainage volume, elbow rotation, elbow motion arc, Mayo Elbow Performance Score, and operation-related complications were followed up and recorded, whereas hematoma volume remaining in the joint space after drainage tube removal was assessed on ultrasonography. RESULTS: Tourniquet time, intraoperative blood loss, and postoperative drainage were significantly lower in the TXA group than in the control group. However, no significant intergroup differences were found in the incidence of related complications and final function evaluated at the final follow-up. CONCLUSION: Topical TXA improves surgical quality by controlling intraoperative bleeding, decreases the amount of blood loss soon after surgery, and could become a routine procedure in elbow joint open arthrolysis.


Assuntos
Antifibrinolíticos/administração & dosagem , Articulação do Cotovelo/cirurgia , Cotovelo/cirurgia , Hemorragia Pós-Operatória/prevenção & controle , Ácido Tranexâmico/administração & dosagem , Adulto , Perda Sanguínea Cirúrgica , Drenagem , Cotovelo/patologia , Feminino , Humanos , Artropatias/cirurgia , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Procedimentos Ortopédicos/efeitos adversos , Procedimentos Ortopédicos/métodos , Estudos Prospectivos , Adulto Jovem
13.
J Shoulder Elbow Surg ; 29(6): 1087-1095, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32423576

RESUMO

BACKGROUND: The ideal method of administering tranexamic acid (TXA) for reverse total shoulder arthroplasty (RTSA) remains unknown. We aimed to evaluate TXA efficacy according to 3 administration methods after RTSA. METHODS: Overall, 102 patients who underwent RTSA using a single implant between September 2016 and November 2018 were randomized to the following groups according to the TXA administration method: intravenous (n = 34; 1 g + 0.9% normal saline 100 mL), topical (n = 33; 2 g + 0.9% normal saline 50 mL), and combined groups (n = 34). Patients were enrolled in 4 tertial referral hospitals for prospective multicenter studies. The primary outcome was a hemoglobin decrease in 24 hours postoperatively; secondary outcomes were total drain volume, transfusion rate, and calculated total blood loss. RESULTS: Demographic data, including preoperative hemoglobin levels, were not different among the 3 groups, but the average age was higher in the combined group (P = .038). Hemoglobin decrease (1.8 ± 1.1 vs. 1.8 ± 1.0 vs. 2.0 ± 1.1 g/dL, P = .769), total drain volume (209.2 ± 147.6 vs. 167.2 ± 102.0 vs. 166.0 ± 118.7, P = .270), and total blood loss (701.1 ± 352.3 vs. 656.5 ± 285.6 vs. 699.0 ± 248.7 mL, P = .810) were not significantly different among the 3 groups (all P > .05). The transfusion rate was higher in the intravenous group (n = 4), whereas only 1 patient had transfusion in the topical group and none in the combined group, although the difference was not statistically significant (P = .084). CONCLUSION: Blood loss did not differ among TXA administration methods after RTSA. However, considering the risk of complication in intravenous TXA, topical TXA after RTSA may be safer, even for patients with normal risk for venous thromboembolic complication.


Assuntos
Antifibrinolíticos/administração & dosagem , Artrite/cirurgia , Artroplastia do Ombro/efeitos adversos , Perda Sanguínea Cirúrgica/prevenção & controle , Ácido Tranexâmico/administração & dosagem , Administração Intravenosa , Administração Tópica , Idoso , Artrite/diagnóstico , Artrite/etiologia , Artroplastia do Ombro/métodos , Transfusão de Sangue , Drenagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
14.
J Nippon Med Sch ; 87(4): 227-232, 2020 Sep 09.
Artigo em Inglês | MEDLINE | ID: mdl-32350188

RESUMO

Traumatic brain injury (TBI) often results in coagulopathy, which increases mortality risk. The Clinical Randomization of an Antifibrinolytic in Significant Head injury (CRASH)-2 and CRASH-3 trials confirmed that tranexamic acid (TXA) was effective after trauma. Herein, we report a unique coagulation change in a patient with TBI given TXA after point-of-care assessment. Coagulation functions were impaired on admission. At 1 hour after TXA administration, clotting time was further prolonged in the extrinsic coagulation pathway but shortened in the intrinsic coagulation system. The results of a test of the total thrombus-formation analysis system showed improved blood clot formation ability. Intrinsic coagulation and clot formation improved after TXA administration in a TBI patient with coagulopathy.


Assuntos
Antifibrinolíticos/administração & dosagem , Transtornos da Coagulação Sanguínea/tratamento farmacológico , Transtornos da Coagulação Sanguínea/etiologia , Lesões Encefálicas Traumáticas/complicações , Ácido Tranexâmico/administração & dosagem , Idoso de 80 Anos ou mais , Coagulação Sanguínea/efeitos dos fármacos , Transtornos da Coagulação Sanguínea/sangue , Humanos , Masculino , Trombose/etiologia , Trombose/prevenção & controle , Ácido Tranexâmico/farmacologia , Resultado do Tratamento
15.
Am J Health Syst Pharm ; 77(Supplement_2): S46-S53, 2020 May 19.
Artigo em Inglês | MEDLINE | ID: mdl-32426833

RESUMO

PURPOSE: To evaluate the effect of time to tranexamic acid administration on blood product usage in trauma patients and to assess the potential benefit of initiating a protocol for field administration by ground ambulance personnel. METHODS: Adult patients with traumatic injuries who received 1 g of tranexamic acid during the period January 2014 through June 2016 were retrospectively identified via review of automated dispensing cabinet and electronic medical record data and cross-referencing with the New Mexico Trauma Registry. Exclusion criteria included tranexamic acid use for nontrauma indications, previous admission for trauma during the study period, and a lack of pertinent information regarding the time, type, or severity of trauma in available records. The primary outcome was blood product use (aggregate of units of platelets, packed red blood cells [pRBCs], and fresh frozen plasma [FFP]) in the first 24 hours of hospital admission. RESULTS: The analysis included 107 patient cases, with a median transport time of 20 minutes (range, 7-103 minutes); 73% of reported transport times were less than 30 minutes. All patients received a loading dose of tranexamic acid in the hospital, with the exception of 2 patients who received tranexamic acid in the field. Administration of a tranexamic acid loading dose was documented within 3 hours for 90.7% of patients, with a mean time to administration of 91.9 minutes. A mean (SD) total of 14.8 (16.0) units of blood products (range, 0-91 units) were administered, consisting of a mean (SD) of 8.0 (8.4) units of pRBCs (range, 0-48 units), 5.6 (7.5) units of FFP (range, 0-38 units), and 1.2 (1.7) units of platelets (range, 0-7 units). Time to tranexamic acid administration did not affect blood product usage in the first 24 hours of admission after adjusting for potential confounders. CONCLUSION: Earlier administration of tranexamic acid was not associated with a decrease in use of blood products. This finding, paired with the relatively short ground transport times typical for our institution, makes it unlikely that field administration of tranexamic acid would benefit the evaluated patient population.


Assuntos
Antifibrinolíticos/administração & dosagem , Transfusão de Sangue/estatística & dados numéricos , Ácido Tranexâmico/administração & dosagem , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Tempo , População Urbana , Adulto Jovem
16.
Am J Obstet Gynecol ; 223(3): 413.e1-413.e7, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32229194

RESUMO

BACKGROUND: Myomectomy is associated with a significant risk of hemorrhage. Tranexamic acid is a synthetic lysine derivative with antifibrinolytic activity used in other surgical disciplines to reduce blood loss during surgery. However, its utility in gynecologic surgery is not well understood. OBJECTIVE: This study aimed to determine the effect of early administration of intravenous tranexamic acid on perioperative bleeding and blood transfusion requirements in women undergoing myomectomy. STUDY DESIGN: This study was a double-blinded, randomized, placebo-controlled trial conducted in an academic teaching hospital. Women with symptomatic fibroids thought to be at risk for large intraoperative blood loss who met the following criteria were included in the study: (1) at least 1 fibroid ≥10 cm, (2) any intramural or broad ligament fibroid ≥6 cm, and/or (3) at least 5 total fibroids based on preoperative imaging. Patients were randomized to receive a single intravenous bolus injection of tranexamic acid 15 mg/kg (intervention group) versus an intravenous bolus injection of saline of equivalent volume (placebo group) 20 minutes before the initial surgical incision. Perioperative bleeding was defined by measuring intraoperative estimated blood loss, change between pre- and postoperative hemoglobin, and frequency of blood transfusions. Estimated blood loss was calculated by combining the blood volume collected within the suction canister and the weight of used sponges. The 2 groups were compared for age; body mass index; perioperative hemoglobin and hematocrit; perioperative blood loss; duration of surgery; blood transfusion requirements; and the number, total weight, and volume of myomas removed. RESULTS: A total of 60 patients (30 per arm) were enrolled into the study between March 1, 2015, and January 29, 2018. Age, body mass index, baseline hemoglobin and/or hematocrit, number and total weight of myomas removed, and size of myomas did not differ between arms. Of 60 patients, 32 (53%) had laparoscopic myomectomy, 24 (40%) had robotic myomectomy, and 4 (7%) had laparotomy. Median estimated blood loss was 200 mL for the tranexamic acid group and 240 mL for the placebo group (P=.88). There was no difference in median duration of surgery (165 vs 164 minutes; P=.64) or change in perioperative hemoglobin (1.00 vs 1.1 g/dL; P=.64). Patients in the tranexamic acid group did not require blood transfusions; however, 4 patients (13.3%) in the placebo group (P=.11) required blood transfusions. CONCLUSION: Intravenous administration of tranexamic acid in patients undergoing laparoscopic or robotic myomectomies was not associated with decreased blood loss.


Assuntos
Antifibrinolíticos/uso terapêutico , Ácido Tranexâmico/uso terapêutico , Hemorragia Uterina/prevenção & controle , Miomectomia Uterina/efeitos adversos , Adulto , Antifibrinolíticos/administração & dosagem , Perda Sanguínea Cirúrgica , Método Duplo-Cego , Feminino , Humanos , Injeções Intravenosas , Complicações Intraoperatórias/prevenção & controle , Ácido Tranexâmico/administração & dosagem , Resultado do Tratamento , Hemorragia Uterina/etiologia
17.
Arch Orthop Trauma Surg ; 140(8): 1087-1095, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32253548

RESUMO

BACKGROUND: Consensus is lacking regarding the dose and timing of tranexamic acid (TXA). The aim of this study was to determine whether multiple-dose intravenous TXA further reduced blood loss and attenuated inflammation after total knee arthroplasty (TKA). MATERIALS AND METHODS: We prospectively studied four regimens on TXA: no TXA (A), before incision, 3, 6, and 12 h later (B), before incision, 3, 6, 12, and 18 h later (C) and before incision, 3, 6, 12, 18, and 24 h later (D). The primary outcome was hidden blood loss (HBL). Other outcome measurements such as total blood loss (TBL), intraoperative blood loss (IBL), fibrinolysis parameters [fibrin(-ogen) degradation products, D-dimer], inflammatory factors (C-reactive protein, interleukin-6), visual analog scale (VAS) score, transfusion rate, length of stay (LOS) and complications were also compared. RESULTS: The mean HBL and TBL were significantly lower in Group D than in Groups C, B and A. The level of inflammatory factors and fibrinolysis parameters were significantly lower in Group D than in Groups C, B and A at 24 and 72 h postoperatively. The VAS score on postoperative days 1 and 3 (POD1 and POD3) was significantly lower in Group D than in Groups C, B and A. There was no significant difference in LOS among groups. No patient underwent blood transfusion. No episodes of deep venous thrombosis or pulmonary embolism occurred in all the groups. CONCLUSION: The repeated doses of TXA up to 24 h can further diminish HBL, provide additional fibrinolysis and inflammation control and ameliorate postoperative pain following TKA. LEVEL OF EVIDENCE: I.


Assuntos
Anti-Inflamatórios , Antifibrinolíticos , Artroplastia do Joelho , Ácido Tranexâmico , Anti-Inflamatórios/administração & dosagem , Anti-Inflamatórios/uso terapêutico , Antifibrinolíticos/administração & dosagem , Antifibrinolíticos/uso terapêutico , Artroplastia do Joelho/efeitos adversos , Artroplastia do Joelho/métodos , Artroplastia do Joelho/estatística & dados numéricos , Perda Sanguínea Cirúrgica/estatística & dados numéricos , Humanos , Inflamação/epidemiologia , Ácido Tranexâmico/administração & dosagem , Ácido Tranexâmico/uso terapêutico
18.
Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi ; 34(4): 463-468, 2020 Apr 15.
Artigo em Chinês | MEDLINE | ID: mdl-32291982

RESUMO

Objective: To explore the efficacy and safety of intravenous injection of tranexamic acid (TXA) combined with local use of TXA cocktail in intertrochanteric fracture fixation with proximal femoral nail antirotation (PFNA). Methods: Patients with intertrochanteric fractures who underwent close reduction and internal fixation with PFNA between February 2018 and March 2019 were enrolled in the study. Among them, 45 patients who met the selection criteria were included in the study and randomly allocated into 3 groups ( n=15). The patients in group A were not received TXA during perioperative period. The patients were intravenously injected of 1.0 g TXA before operation in group B and combined with local use of TXA cocktail during operation in group C. There was no significant difference in the age, gender, body mass index, fracture classification, disease duration, and complications between groups ( P>0.05). The perioperative blood loss and blood transfusion rate, the visual analogue scale (VAS) score before operation and at 12, 24, and 48 hours after operation, the levels of prostaglandin E2 (PGE2) and bradykinin (BK) before operation and at 1 and 3 days after operation, postoperative complications, and the maximum amplitude (MA) of thromboelastogram were recorded and compared between groups. Results: The total blood loss, hidden blood loss, and visible blood loss were significantly lower in groups B and C than those in group A ( P<0.05), and the total blood loss and hidden blood loss were significantly lower in group C than those in group B ( P<0.05). There was no significant difference in the blood transfusion rate, preoperative VAS scores and the levels of PGE2 and BK between groups ( P>0.05). The postoperative VAS scores and the levels of PGE2 and BK were significantly lower in group C than in groups A and B ( P<0.05). There was no significant difference in pre- and post-operative MA of thromboelastogram between groups ( P>0.05). The incidences of postoperative complications were 33.33% (5/15), 20.00% (3/15), and 13.33% (2/15) in groups A, B, and C, respectively, with no significant difference between groups ( χ 2=1.721, P=0.550). Conclusion: For intertrochanteric fractures, application of intravenous injection of TXA combined with local use of TXA cocktail in PFNA fixation can reduce perioperative blood loss, relieve pain after operation, and do not increase the risk of complications.


Assuntos
Fixação Interna de Fraturas , Fraturas do Quadril/cirurgia , Ácido Tranexâmico/administração & dosagem , Perda Sanguínea Cirúrgica/prevenção & controle , Humanos , Injeções Intravenosas , Medição da Dor , Dor Pós-Operatória/prevenção & controle , Hemorragia Pós-Operatória , Resultado do Tratamento
19.
Orthop Surg ; 12(2): 582-588, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32347005

RESUMO

OBJECTIVE: To evaluate the efficacy and safety of combined use of tranexamic acid (TXA) and dexamethasone (DEX) for anti-inflammatory and clinical outcomes after total hip arthroplasty (THA). METHODS: A total of 100 patients were included in this randomized, controlled study. Patients in the TXA + DEX group were administered TXA at a dose of 15 mg/kg, which was repeated 3 h after THA, and received 20 mg DEX. In contrast, patients in the TXA group were administered TXA at a dose of 15 mg/kg, which was repeated at 3 h postoperatively. C-reactive protein (CRP), interleukin-6 (IL-6) and pain levels, incidence of postoperative nausea and vomiting (PONV), total blood loss and transfusion rates, postoperative fatigue, range of motion (ROM), length of hospital stay (LOS), analgesic rescue and antiemetic rescue consumption, and complications were compared in both groups. RESULTS: The CRP and IL-6 levels were lower in the TXA + DEX group than in the TXA group (all P < 0.001) at 24 h, 48 h, and 72 h postoperatively. Patients in the TXA + DEX group had lower pain scores at rest and walking at 24 h postoperatively (all P < 0.001). In the TXA + DEX group, the incidence of PONV was lower (P = 0.005), postoperative fatigue (P < 0.001) was reduced, and analgesia and antiemetic rescue consumption were also reduced. The total blood loss, transfusion rate, LOS and hip ROM were similar in the two groups. There was no thrombosis, infection, or gastrointestinal bleeding in either group. CONCLUSION: Compared to TXA alone, the combination of TXA + DEX can reduce postoperative inflammatory response, relieve pain, and reduce PONV and fatigue, without increasing the risk of complications. Therefore, the present study suggested that the combination of TXA + DEX is an effective and safe accelerated rehabilitation strategy for patients receiving primary unilateral THA.


Assuntos
Artroplastia de Quadril , Dexametasona/administração & dosagem , Inflamação/prevenção & controle , Ácido Tranexâmico/administração & dosagem , Idoso , Anti-Inflamatórios/administração & dosagem , Antifibrinolíticos/administração & dosagem , Proteína C-Reativa/análise , Quimioterapia Combinada , Feminino , Humanos , Interleucina-6/sangue , Masculino , Pessoa de Meia-Idade , Medição da Dor , Complicações Pós-Operatórias/prevenção & controle , Período Pós-Operatório , Amplitude de Movimento Articular
20.
Acta Orthop Traumatol Turc ; 54(2): 132-137, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32254027

RESUMO

OBJECTIVE: This study aimed to determine whether the local administration of tranexamic acid (TXA) combined with diluted epinephrine (DEP) reduces blood loss and the need for transfusions compared with the administration of TXA alone following surgery for trochanteric femoral fractures. METHODS: Hundred patients were enrolled in this study. In the target group (TXA/DEP group: n=50; 19 men and 31 women, mean age 72.5±11.1 years), the surgical sites were injected with 35 mL normal saline mixed with 3 g of TXA with 0.2 mg of DEP at a 1:200,000 dilution (TXA/DEP) immediately after musculoaponeurotic closure. In the control group (TXA group: n=50; 22 men and 28 women; mean age: 70.5±12.2 years), the surgical site was injected with 35 mL normal saline containing 3 g of TXA alone. The main outcome measures were postoperative hemoglobin (Hb) levels, hematocrit, drainage volume, and total blood loss (TBL); the secondary measures included transfusion requirements and perioperative complications. RESULTS: The mean Hb levels among patients in theTXA/DEP group were significantly lower than among those in the TXA group, measured on postoperative day 1 at 101.0±14.1 g/L vs. 106.9±10.5 g/L and day 3 as 104.2±8.2 g/L vs. 108.5±9.1 g/L, respectively (p<0.05). Drainage volume from the surgical site and TBL measured on postoperative day 2 were also significantly reduced in the TXA/DEP group vs. the TXA group, measured at 71.4±26.0 mL vs. 82.5±24.6 mL and 343.6±148.0 mL vs. 419.6±165.4 mL, respectively (p<0.05). Furthermore, 11 patients (22%) from the TXA group and 15 (30%) from the TXA/DEP group received blood transfusions; the mean number of transfusion events (1.2±0.4 vs. 1.9±0.7) and the amount of blood transfused (1.7±0.5 Units vs. 2.9±1.0 Units) was also markedly reduced in the TXA/DEP group (p<0.05). Two cases in the TXA/DEP group and three in the TXA group were diagnosed with deep vein thrombosis, a difference that did not reach statistical significance (p>0.05). CONCLUSION: Local administration of TXA with DEP reduced blood loss and limited the need for blood transfusions after surgery for trochanteric femoral fracture without increasing the risk of perioperative complications. Our study indicates that the local administration of TXA/DEP is safe and more effective than the administration of TXA alone in treating trochanteric femoral fractures. LEVEL OF EVIDENCE: Level III, Therapeutic study.


Assuntos
Perda Sanguínea Cirúrgica/prevenção & controle , Epinefrina/administração & dosagem , Fixação de Fratura/efeitos adversos , Fraturas do Quadril/cirurgia , Hemorragia Pós-Operatória/prevenção & controle , Ácido Tranexâmico/administração & dosagem , Idoso , Antifibrinolíticos/administração & dosagem , Transfusão de Sangue/estatística & dados numéricos , Feminino , Fixação de Fratura/métodos , Humanos , Masculino , Resultado do Tratamento , Vasoconstritores/administração & dosagem
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