tranexamic acid

氨甲环酸
  • 文章类型: Journal Article
    本研究旨在评估氨甲环酸(TXA)在预防产后出血(PPH)的效果,这些产后出血(PPH)的风险因素已确定在中国进行阴道分娩的妇女。
    这个前景,随机化,开放标签,盲法终点(PROBE)试验纳入了2258名接受阴道分娩的具有一种或多种PPH危险因素的女性.参与者以1:1的比例随机分配,在婴儿分娩后立即接受1gTXA或安慰剂的血管内输注。评估的主要结果是PPH的发生率,定义为分娩后24小时内失血≥500mL,而重度PPH被认为是次要结局,并定义为24小时内总失血≥1000mL。
    2245个人(99.4%)可以随访他们的主要结果。TXA组1128名妇女中有186名发生PPH,安慰剂组1117名妇女中有215名发生PPH(16.5%vs.19.2%;RR,0.86;95%CI,0.72至1.02;p=0.088)。关于与疗效相关的次要结果,TXA组的女性重度PPH的发生率明显低于安慰剂组(2.7%vs.5.6%;RR,0.49;95%CI,0.32至0.74;p=0.001;调整后p=0.002)。同样,使用额外的子宫收缩剂显著减少(7.8%vs.15.6%;RR,0.50;95%CI,0.39至0.63;p<0.001;调整后p=0.001)。两组在分娩后30天内均未发生血栓栓塞事件和孕产妇死亡。
    在有PPH危险因素的总人口中,与安慰剂相比,阴道分娩后给予TXA并未导致PPH发生率的统计学显著降低;它与重度PPH的发生率显著降低相关.
    在阴道分娩中有危险因素的妇女中,预防性给予TXA并没有显著降低PPH的发生率。预防性使用TXA可能有助于降低严重PPH的发生率。
    UNASSIGNED: This study aimed to evaluate the effects of tranexamic acid (TXA) in preventing postpartum haemorrhage (PPH) among women with identified risk factors for PPH undergoing vaginal delivery in China.
    UNASSIGNED: This prospective, randomized, open-label, blinded endpoint (PROBE) trial enrolled 2258 women with one or more risk factors for PPH who underwent vaginal delivery. Participants were randomly assigned in a 1:1 ratio to receive an intravascular infusion of 1 g TXA or a placebo immediately after the delivery of the infant. The primary outcome assessed was the incidence of PPH, defined as blood loss ≥500 mL within 24 h after delivery, while severe PPH was considered as a secondary outcome and defined by total blood loss ≥1000 mL within 24 h.
    UNASSIGNED: 2245 individuals (99.4%) could be followed up to their primary outcome. PPH occurred in 186 of 1128 women in the TXA group and in 215 of 1117 women in the placebo group (16.5% vs. 19.2%; RR, 0.86; 95% CI, 0.72 to 1.02; p = 0.088). Regarding secondary outcomes related to efficacy, women in the TXA group had a significant lower rate of severe PPH than those in the placebo group (2.7% vs. 5.6%; RR, 0.49; 95% CI, 0.32 to 0.74; p = 0.001; adjusted p = 0.002). Similarly, there was a significant reduction in the use of additional uterotonic agents (7.8% vs. 15.6%; RR, 0.50; 95% CI, 0.39 to 0.63; p < 0.001; adjusted p = 0.001). No occurrence of thromboembolic events and maternal deaths were reported in both groups within 30 days after delivery.
    UNASSIGNED: In total population with risk factors for PPH, the administration of TXA following vaginal delivery did not result in a statistically significant reduction in the incidence of PPH compared to placebo; however, it was associated with a significantly lower incidence of severe PPH.
    Prophylactic administration of TXA did not yield a statistically significant reduction in the incidence of PPH among women with risk factors in vaginal deliveries.Prophylactic use of TXA may help to reduce the incidence of severe PPH.
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  • 文章类型: Journal Article
    本研究旨在研究口服氨甲环酸(TXA)对减少脊柱手术中术中出血的影响。
    这项研究是一个单中心,双盲,随机化,安慰剂对照临床试验。参与者是20岁以上接受脊柱手术的个体。患者口服1.5gTXA,手术前2h。术中出血量,手术后引流管的血容量,手术后住院时间,恶心或呕吐的发生率,血红蛋白(Hb)水平降低,并对各组术后凝血检测结果进行评价。
    在这项研究中,根据纳入和排除标准将患者分配到每个研究组.患者平均年龄为69.6±6.47岁,65%是男性。在年龄上没有显著差异,性别,术前术后Hb水平,凝血酶原时间(PT),或研究组之间的国际标准化比率(INR)。TXA组术中出血量和术后引流管的血容量明显降低。此外,TXA组术后住院时间明显缩短.TXA组恶心或呕吐的发生率明显较高。此外,TXA组术后部分凝血活酶时间(PTT)明显高于安慰剂组.
    脊柱手术前口服TXA可显著减少术中和术后出血,且无明显不良反应,还可缩短住院时间。
    UNASSIGNED: This study aimed to investigate the effect of oral administration of tranexamic acid (TXA) on reducing intraoperative bleeding during spinal surgeries.
    UNASSIGNED: The study was a single-center, double-blind, randomized, placebo-controlled clinical trial. Participants were individuals over 20 years old who underwent spinal surgery. Patients received 1.5 g of TXA orally, 2 h before surgery. Intraoperative bleeding volume, blood volume in the drain after surgery, length of hospital stays after surgery, incidence of nausea or vomiting, decrease in hemoglobin (Hb) level, and postoperative coagulation test results were evaluated in each group.
    UNASSIGNED: In this study, patients were assigned to each study group based on inclusion and exclusion criteria. The mean age of patients was 69.6±6.47 years, and 65% were male. There was no significant difference in age, sex, pre and postoperative Hb levels, prothrombin time (PT), or international normalized ratio (INR) between the study groups. Intraoperative bleeding volume and blood volume in the drain after surgery were significantly lower in the TXA group. Additionally, the length of hospital stay after surgery was significantly shorter in the TXA group. The incidence of nausea or vomiting was significantly higher in the TXA group. Furthermore, postoperative partial thromboplastin time (PTT) was significantly higher in the TXA group compared to the placebo group.
    UNASSIGNED: Oral administration of TXA before spinal surgery leads to a significant reduction in intraoperative and postoperative bleeding without significant adverse effects and also reduces the length of hospital stay.
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  • 文章类型: Journal Article
    背景:需要拔牙的华法林患者面临出血的问题,没有足够的止血会导致干窝和术后疼痛。这项研究旨在评估和比较局部应用氨甲环酸浸泡的可吸收明胶(TXA-Gel)和盐水浸泡的可吸收明胶(盐水-Gel)在缓解双侧简单拔除永久性下颌磨牙后的术后疼痛华法林患者。
    方法:这是一个随机的,三盲,裂口,主动对照临床试验。它是在口腔颌面外科进行的,牙科学院,大马士革大学,2021年11月至2023年10月。60颗双侧下颌永久磨牙,在30例华法林患者中,根据提取后使用的局部止血剂随机分为两组:第1组:对照组,盐水凝胶(n=30)。组2:TXA-凝胶(n=30)。通过掷硬币进行简单的随机化方法。主要结果指标是视觉模拟量表(VAS)。在基线(t0)评估疼痛的强度,在1号(t1),第二(t2),3rd(t3),第四(t4),5th(t5),6th(t6),和提取后第7天(t7)。进行了Kolmogorov-Smirnov检验和Mann-WhitneyU检验。显著性水平设定为0.05(p<0.05)。
    结果:在TXA-Gel组中,t1时的平均vas评分为4.17±1.76,在t7时下降至0.73±0.78。然而,在明胶组,t1时平均vas评分为4.83±2.18,t7时下降至1.80±1.00。Mann-WhitneyU检验结果显示,两组在t1(p=0.236)和t2(p=0.155)时差异无统计学意义。然而,其余时间点差异有统计学意义(p<0.05)。
    结论:TXA-Gel在缓解华法林患者拔牙后疼痛方面发挥了重要作用。
    背景:该试验在ISRCTN注册中心(ISRCTN71901901)进行回顾性注册。
    BACKGROUND: Warfarin patients who need dental extraction face the problem of bleeding and no sufficient hemostasis results in dry socket and postoperative pain. This study aimed to evaluate and compare the efficacy of the topical application of tranexamic acid-soaked absorbable Gelfoam (TXA-Gel) and saline-soaked absorbable Gelfoam (saline-Gel) in relieving postoperative pain following bilateral simple extraction of permanent mandibular molars in warfarin patients.
    METHODS: This was a randomized, triple-blinded, split-mouth, active-controlled clinical trial. It was performed at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Damascus University, between November 2021 and October 2023. 60 bilateral permanent mandibular molars, which were indicated for simple extraction in 30 warfarin patients randomly assigned into two groups according to the topical hemostatic agents after extraction used: Group 1: control group, saline-Gel (n = 30). Group 2: TXA-Gel (n = 30). A simple randomization method was performed by flipping a coin. The primary outcome measure was the visual analogue scale (VAS). The intensity of pain was evaluated at the baseline (t0), and on the 1st (t1), 2nd (t2), 3rd (t3), 4th (t4), 5th (t5), 6th (t6), and 7th (t7) days following extraction. The Kolmogorov-Smirnov test and the Mann-Whitney U test were performed. The level of significance was set at 0.05 (p < 0.05).
    RESULTS: The mean vas scores was 4.17 ± 1.76 at t1 and decreased to 0.73 ± 0.78 at t7 in the TXA-Gel group. However, in the Gelfoam group, the mean vas scores was 4.83 ± 2.18 at t1 and decreased to 1.80 ± 1.00 at t7. The results of the Mann-Whitney U test showed that there was no statistically significant difference between the two groups at t1 (p = 0.236) and t2 (p = 0.155). However, there was a statistically significance difference at the rest time points (p < 0.05).
    CONCLUSIONS: TXA-Gel played a prominent role in alleviating post-extraction pain in warfarin patients.
    BACKGROUND: The trail was retrospectively registered at the ISRCTN registry (ISRCTN71901901).
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  • 文章类型: Journal Article
    背景:氨甲环酸(TXA)在减轻创伤内皮病中的抗炎作用可能对急性肺损伤有保护作用。缺乏在创伤患者中显示这种益处的临床数据。我们假设TXA治疗可减轻穿透性创伤患者的肺部并发症。
    方法:这是对多中心的事后分析,prospective,在25个城市创伤中心出现穿透性躯干和/或近端肢体损伤的成年人(18岁以上)的观察性研究。检查院前环境或入院三小时内的氨甲环酸给药。参与者倾向匹配,以比较类似受伤的患者。主要结果是肺部并发症(ARDS和/或肺炎)的发展。
    结果:共纳入2382例患者,206人(8.6%)接受TXA。在206人中,93人(45%)在院前接受了TXA,113人(55%)在入院后三小时内接受了TXA。年龄,性别,大量输血的发生率没有差异。TXA组伤势更重,更常见于休克(SBP<90mmHg),出现了更多的肺部并发症,生存率较低(均P<0.01)。在倾向匹配之后,仍有410名患者(每个队列205名),年龄无差异,性别,或休克率。在逻辑回归中,急诊科心率增加与肺部并发症相关。氨甲环酸与肺部并发症的不同发生率或Logistic回归分析的生存率无关。在逻辑回归或倾向得分匹配分析中,两组之间的生存率没有差异。
    结论:氨甲环酸对穿透性创伤患者的肺部并发症没有保护作用。
    BACKGROUND: Anti-inflammatory effects of tranexamic acid (TXA) in reducing trauma endotheliopathy may protect from acute lung injury. Clinical data showing this benefit in trauma patients is lacking. We hypothesized that TXA administration mitigates pulmonary complications in penetrating trauma patients.
    METHODS: This is a post-hoc analysis of a multicenter, prospective, observational study of adults (18+ years) with penetrating torso and/or proximal extremity injury presenting at 25 urban trauma centers. Tranexamic acid administration in the prehospital setting or within three hours of admission was examined. Participants were propensity matched to compare similarly injured patients. The primary outcome was development of pulmonary complication (ARDS and/or pneumonia).
    RESULTS: A total of 2382 patients were included, and 206 (8.6%) received TXA. Of the 206, 93 (45%) received TXA prehospital and 113 (55%) received it within three hours of hospital admission. Age, sex, and incidence of massive transfusion did not differ. The TXA group was more severely injured, more frequently presented in shock (SBP < 90 mmHg), developed more pulmonary complications, and had lower survival (P < 0.01 for all). After propensity matching, 410 patients remained (205 in each cohort) with no difference in age, sex, or rate of shock. On logistic regression, increased emergency department heart rate was associated with pulmonary complications. Tranexamic acid was not associated with different rate of pulmonary complications or survival on logistic regression. Survival was not different between the groups on logistic regression or propensity score-matched analysis.
    CONCLUSIONS: Tranexamic acid administration is not protective against pulmonary complications in penetrating trauma patients.
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  • 文章类型: Journal Article
    背景:全髋关节置换术(THA)围手术期出血可导致各种问题,因此需要有效管理失血。这个未来,单盲,随机对照试验旨在比较SURGICEL®(一种氧化再生纤维素的止血剂)粉末(SP)和氨甲环酸(TXA)局部给药在THA期间控制围手术期出血的疗效.
    方法:总共,114例接受THA治疗的骨关节炎患者被随机分为S组(THA伴SP)或T组(THA伴TXA)。包括患者人口统计在内的数据,实验室数据(C反应蛋白[CRP],血红蛋白,和血细胞比容),手术时间,分析术中出血量。使用WOMAC评估临床结果,JOA,FJS分数,和视觉模拟量表(VAS)评分。主要结果是估计的总失血量和术后失血量,次要结局包括血液学检查结果和各种临床评分.
    结果:每组分配57例患者,最终将S组55例和T组56例纳入分析。S组(788.2±350.1ml)和T组(714.1±318.4ml)之间的估计总失血量没有显着差异(p=0.141)。血红蛋白和血细胞比容水平和WOMAC,两组在任何时间点的FJS评分均无显著差异。术后第4天和第7天CRP水平差异有统计学意义,术前和术后JOA评分差异有统计学意义。然而,CRP和JOA评分值本身的差异相对较小,且没有临床差异.
    结论:在减少THA患者围手术期出血方面,局部给予SP与TXA一样有效。此外,SP和TXA术后早期临床结局无显著差异。
    方法:治疗级别I
    背景:大学医院医学信息网络(UMIN)注册号UMIN000047607。
    BACKGROUND: Perioperative bleeding in total hip arthroplasty (THA) can lead to various problems, so effective management of blood loss is needed. This prospective, single-blind, randomized controlled trial aimed to compare the efficacy of topical administration of SURGICEL® (a hemostatic agent of oxidized regenerated cellulose) powder (SP) and tranexamic acid (TXA) in controlling perioperative bleeding during THA.
    METHODS: In total, 114 patients undergoing THA for osteoarthritis were randomized to either group S (THA with SP) or group T (THA with TXA). Data including patient demographics, laboratory data (C-reactive protein [CRP], hemoglobin, and hematocrit), operative time, and intraoperative blood loss were analyzed. Clinical outcomes were assessed using WOMAC, JOA, FJS scores, and visual analog scale (VAS) scores. Primary outcomes were estimated total and postoperative blood loss, while secondary outcomes included hematological test results and various clinical scores.
    RESULTS: 57 patients were allocated to each group, with 55 in group S and 56 in group T were finally included in the analysis. There was no significant difference (p = 0.141) in estimated total blood loss between group S (788.2 ± 350.1 ml) and group T (714.1 ± 318.4 ml). Hemoglobin and hematocrit levels and WOMAC, and FJS scores were not significantly different between the two groups at any time point. CRP levels were significantly different on postoperative days 4 and 7, and JOA score was significantly different on preoperative and postoperative period. However, the differences in CRP and JOA score values themselves were relatively small and not clinically different.
    CONCLUSIONS: Topical administration of SP is as effective as TXA in reducing perioperative bleeding in patients undergoing THA. Additionally, no significant difference was observed in early postoperative clinical outcomes between SP and TXA.
    METHODS: Therapeutic Level I.
    BACKGROUND: The University Hospital Medical Information Network (UMIN) registration number UMIN000047607.
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  • 文章类型: Journal Article
    Introduction: Drain placement is commonplace after many plastic surgery procedures to evacuate excess blood and fluid. Tranexamic acid (TXA) is an antifibrinolytic that has been shown to decrease bleeding and fluid production at surgical sites and can be administered orally, intravenously, and topically. The purpose of this study is to evaluate the effect of topical TXA on drain removal in abdominally based autologous breast reconstruction (ABABR). Methods: A retrospective chart review was performed on patients who underwent ABABR from August 2018 to November 2019. In 1 cohort, a 2.5% TXA solution was topically applied to the abdominal wall prior to closure. Drains were removed when output was less than 30 mL/day for 2 consecutive days. The primary outcome was days to drain removal. Secondary outcomes include daily inpatient drain output, postoperative hemoglobin levels, blood transfusions, and complications within 30 days postoperatively. Results: Eighty-three patients were included, with 47 in the control group and 36 in the TXA group. Drains were removed significantly earlier in patients who received TXA (16 days vs 23 days, P = .02). Additionally, significantly fewer patients required postoperative blood transfusions in the TXA group (2 vs 14, P = .005). Abdominal complications were fewer in the TXA group with significantly less wound healing complications (22% vs 49%, P = .01). There was no difference in flap loss or systemic thromboembolic events. Conclusion: Topical TXA use in ABABR results in earlier abdominal drain removal, less blood transfusions, and lower abdominal wound complications without an increased risk of flap loss or adverse patient outcomes.
    Introduction : La mise en place d\'un drain est habituelle après de nombreuses procédures de chirurgie plastique pour l\'évacuation des excès de sang et de liquide. L\'acide tranexamique (TXA) est un agent antifibrinolytique qui a une efficacité démontrée sur la réduction des saignements et de la production de fluides au niveau des sites chirurgicaux; il peut être administré par voie orale, par voie intraveineuse ou en application locale. L\'objectif de cette étude était d\'évaluer l\'effet du TXA topique sur le retrait du drain après reconstruction mammaire autologue à base abdominale (ABABR). Méthodes : Un examen rétrospectif des dossiers des patients ayant subi une ABABR entre août 2018 et novembre 2019 a été effectué. Dans une cohorte, une solution de TXA à 2,5 % a été appliquée localement sur la paroi abdominale avant sa fermeture. Les drains ont été retirés quand la production est devenue inférieure à 30 mL/jour pendant 2 jours consécutifs. Le critère d\'évaluation principal était le nombre de jours jusqu\'au retrait du drain. Les critères de jugement secondaires étaient notamment : la production quotidienne du drain chez les patients hospitalisés, les taux d\'hémoglobine postopératoires, les transfusions sanguines et les complications survenues dans les 30 jours postopératoires. Résultats : Quatre-vingt-trois patients ont été inclus, dont 47 dans le groupe contrôle et 36 dans le groupe TXA. Les drains ont été retirés significativement plus tôt chez les patients qui avaient reçu du TXA (16 jours contre 23 jours, P = 0,02). De plus, un nombre significativement inférieur de patients a nécessité des transfusions sanguines postopératoires dans le groupe TXA (2 contre 14, P = 0,005). Les complications abdominales ont été moins nombreuses dans le groupe TXA avec significativement moins de complications de cicatrisation (22 % contre 49 %, P = 0,01). Il n\'y a pas eu de différence concernant la perte du lambeau cutané ou les événements thromboemboliques systémiques. Conclusion : L\'utilisation topique de TXA dans l\'ABABR permet un retrait plus précoce du drain abdominal, moins de transfusions sanguines et moins de complications de la plaie abdominale inférieure sans augmentation du risque de perte du lambeau cutané ou d\'événements indésirables pour le patient.
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  • 文章类型: Journal Article
    背景:氨甲环酸(TXA)可降低开放性肘关节松解术中的出血和血肿发生率。然而,其对关节镜下肘关节松解术的影响尚不清楚。这项研究旨在评估TXA对肘关节镜手术的影响,并比较出血量,关节积血,疼痛的视觉模拟量表(VAS),运动范围(ROM),术后早期接受关节内TXA和未接受关节内TXA的患者之间的Mayo肘关节性能评分(MEPS)。
    方法:前瞻性,双盲,在2021年1月至2022年12月期间,我们进行了80例接受关节镜下关节松解术的肘部僵硬患者的随机对照试验.关节内,根据随机分组,关节镜手术后给予100ml盐水或安慰剂(对照组)中的1gTXA。记录并比较各组参数,包括引流的出血量,血红蛋白(Hgb)水平,手术侧与对侧的手臂和前臂周长的比率,血肿分级,VAS,术后一周内ROM和MEPS。在一年的随访中,记录ROM和MEPS。
    结果:参加本研究的所有患者在术后一周表现出ROM(屈伸)和MEPS的显着改善,两组之间没有显着差异。与对照组相比,TXA组引流出血量差异有统计学意义(61.45±47.7ml与89.8±47.0ml,p=0.030)和术后24小时更高的Hgb水平(13.5±1.5g/dLvs.12.6±1.8g/dLp=0.049)。而TXA组术后24小时手臂和前臂周度的比值与术前相比明显增加(1.05±0.06vs.1.02±0.04和1.02±0.06vs.0.98±0.04,分别为p=0.019和p=0.005),这种差异在术后一周的臂围比率消失。然而,对于前臂周长的比率(1.02±0.07vs.0.98±0.04,p=0.003)。此外,MEPS没有显着差异,术后1周两组间VAS或ROM。
    结论:肘部僵硬的患者接受关节镜下关节松解术后很早就取得了令人满意的临床结果。与对照组相比,接受关节镜下肘关节松解术并关节内给予TXA的患者术后引流出血量明显减少,Hgb水平略高.术后一周,与TXA组相比,对照组上臂区域的肿胀稍多。这些发现表明,关节镜下松解术后关节内注射TXA治疗肘关节僵硬可在统计学上减少与术后出血相关的并发症。然而,它的临床相关性需要进一步研究。
    BACKGROUND: Tranexamic acid (TXA) reduces bleeding and hematoma rates in open elbow arthrolysis. However, its effects on arthroscopic elbow arthrolysis remain unclear. This study aims to evaluate the effect of TXA on elbow arthroscopic procedures and compare bleeding volume, hemarthrosis, visual analog scale (VAS) for pain, range of motion (ROM), and Mayo Elbow Performance Score (MEPS) in the early postoperative period between patients who received intra-articular TXA and those who did not.
    METHODS: A prospective, double-blind, randomized controlled trial enrolling 80 patients with stiff elbows who underwent arthroscopic arthrolysis was performed from January 2021 to December 2022. Intra-articularly, 1 g of TXA in 100 ml of saline or placebo (control group) was administered after the arthroscopic operation according to randomization. Parameters were recorded and compared between the groups, including bleeding volume of drainage, hemoglobin (Hgb) level, ratio of arm and forearm circumference of the surgical side to the contralateral side, grading of hematoma, VAS, ROM and MEPS within one week postoperatively. And during one year follow-up, ROM and MEPS were recorded.
    RESULTS: All patients enrolled in this study demonstrated significant improvements in ROM (flexion-extension) and MEPS one week postoperatively, with no significant differences observed between the two groups. Compared to the control group, the TXA group exhibited significant differences in the bleeding volume of drainage (61.45±47.7 ml vs. 89.8±47.0 ml, p=0.030) and a higher Hgb level 24 hours postoperatively (13.5±1.5 g/dL vs. 12.6±1.8 g/dL p=0.049). While the ratio of arm and forearm circumferences significantly increased 24 hours postoperatively compared to preoperative values in TXA group (1.05±0.06 vs. 1.02±0.04 and 1.02±0.06 vs. 0.98±0.04, with p=0.019 and p=0.005, respectively), this difference vanished one week postoperatively for the ratio of arm circumference. However, it persisted for the ratio of forearm circumference (1.02±0.07 vs. 0.98±0.04, p=0.003). Furthermore, there was no significant difference in MEPS, VAS or ROM between the two groups one week postoperatively.
    CONCLUSIONS: Patients with stiff elbows who underwent arthroscopic arthrolysis achieved satisfactory clinical outcomes very early postoperatively. Compared to the control group, patients who underwent arthroscopic elbow arthrolysis with intra-articular administration of TXA exhibited significantly less bleeding volume of drainage and slightly higher Hgb levels postoperatively. One week postoperatively, slightly more swelling in the upper arm region was noted in the control group compared to the TXA group. These findings suggest that the intra-articular injection of TXA after arthroscopic release for elbow stiffness may statistically reduce complications related to postoperative bleeding. However, it\'s clinical relevance needs further investigation.
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  • 文章类型: Journal Article
    目的:评估预防性氨甲环酸(1g)在减少阴道分娩后产后失血量和PPH发生率方面的作用,除了积极管理第三产程。
    方法:在这项随机对照试验中,纳入650名接受阴道分娩的单胎妊娠≥34周的妇女。除了积极管理第三产程外,符合条件的妇女还被随机分配接受1g氨甲环酸或静脉注射安慰剂。在第三和第四分娩阶段,使用校准的采血袋测量产后失血量。
    结果:在886名接受研究的女性中,650名符合入选标准的人被纳入,分析A组320例和B组321例。两组产妇的特征相似。平均失血量在干预组和安慰剂组之间没有显着差异(378.5±261.2ml与383±258.9ml;p=0.93)。两组的原发性产后出血发生率相当(A组:15.9%,B组:15.3%,p=0.814)。A组分娩后12-24小时内血红蛋白的中位数(四分位数间)定量下降为0.60g%(0.40-0.90),B组为0.60g%(0.40-0.80),两组具有可比性(p=0.95)。报告的最常见的不良反应是头晕,两组随访3个月时均无血栓栓塞事件。
    结论:使用氨甲环酸作为预防措施,同时积极管理第三产程,在减少产后失血以及阴道分娩后PPH的发生率方面没有额外的益处。
    OBJECTIVE: To assess the effect of prophylactic tranexamic acid (1 g) in reducing postpartum blood loss and the incidence of PPH after vaginal delivery, in addition to active management of third stage of labour.
    METHODS: In this randomized controlled trial, 650 women with singleton pregnancies of ≥ 34 weeks gestation who were undergoing vaginal delivery were included. Eligible women were randomly assigned to receive either 1 g of tranexamic acid or placebo intravenously in addition to active management of third stage of labour. Calibrated blood collection bags were used to measure postpartum blood loss during the third and fourth stage of labour.
    RESULTS: Out of 886 women who were approached for the study, 650 who met the inclusion criteria were enrolled, and 320 in group A and 321 in group B were analysed. Maternal characteristics were similar in both groups. Mean blood loss did not differ significantly among the intervention and placebo groups (378.5±261.2 ml vs. 383±258.9 ml; p = 0.93). The incidence of primary postpartum hemorrhage was comparable in both groups (Group A: 15.9%, Group B: 15.3%, p = 0.814). The median (interquartile) quantitative fall in haemoglobin within 12-24 hours following delivery in group A was 0.60 g% (0.40-0.90) and group B was 0.60 g% (0.40-0.80) which were comparable in both groups (p=0.95). The most common adverse effect reported was dizziness and there were no thromboembolic events at three months follow-up in both groups.
    CONCLUSIONS: The use of tranexamic acid as a prophylactic measure along with active management of third stage of labour does not provide additional benefit in reducing the postpartum blood loss as well as incidence of PPH after vaginal delivery.
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  • 文章类型: Journal Article
    背景:尽管知识有所增加,烧伤切除手术期间的失血量仍然是一项重大挑战,也是死亡率的独立预测指标.在烧伤手术期间,控制出血的措施有限。纤维蛋白溶解增加可能是烧伤切除手术中失血的因素之一。氨甲环酸抑制纤溶反应,少量证据表明氨甲环酸对失血量有积极影响。
    方法:本研究的主要目标是双重的,(1)研究氨甲环酸是否减少失血;(2)研究烧伤创伤后和烧伤切除手术中凝血功能的变化。这项研究是一项针对荷兰烧伤中心计划进行烧伤切除手术的患者的多中心双盲随机临床试验。所有计划进行烧伤手术的预期失血≥250的成年患者均符合纳入本研究的条件。该研究支持干预组减少25%的失血量。总的来说,将包括95个主题。干预组将接受1500mg氨甲环酸,而另一组则接受安慰剂。主要终点是减少失血。次要终点包括手术期间纤维蛋白溶解的发生,裂开的皮肤移植物的移植物,以及凝血和血凝块形成的差异。
    结论:该随机对照试验方案旨在研究氨甲环酸在减少烧伤切除手术中失血的效果。此外,本研究旨在阐明烧伤后和手术过程中的凝血状态。
    背景:EudraCT:2020-005405-10;ClinicalTrial.gov:NCT05507983(于2022年8月回顾性注册,于2021年12月开始纳入)。
    BACKGROUND: Despite an increase in knowledge, blood loss during burn excisional surgery remains a major challenge and is an independent predictor of mortality. During burn surgery, limited measures are available to control the bleeding. Increased fibrinolysis could be one of the contributing factors of blood loss during burn excisional surgery. Tranexamic acid inhibits the fibrinolytic response, and a small body of evidence shows positive effects of tranexamic acid on the volume of blood loss.
    METHODS: The main objectives of this study are twofold, (1) to investigate whether tranexamic acid reduces blood loss and (2) to investigate the changes in coagulation after burn trauma and during burn excisional surgery. This study is a multicenter double-blind randomized clinical trial in patients scheduled for burn excisional surgery within the Dutch burn centers. All adult patients scheduled for burn surgery with an expected blood loss of ≥ 250 are eligible for inclusion in this study. The study is powered on a blood loss reduction of 25% in the intervention group. In total, 95 subjects will be included. The intervention group will receive 1500 mg tranexamic acid versus placebo in the other group. Primary endpoint is reduction of blood loss. Secondary endpoints include occurrence of fibrinolysis during surgery, graft take of the split skin graft, and differences in coagulation and blood clot formation.
    CONCLUSIONS: This protocol of a randomized controlled trial aims to investigate the efficacy of tranexamic acid in reducing blood loss during burn excisional surgery. Furthermore, this study aims to clarify the coagulation status after burn trauma and during the surgical process.
    BACKGROUND: EudraCT: 2020-005405-10; ClinicalTrial.gov: NCT05507983 (retrospectively registered in August 2022, inclusion started in December 2021).
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  • 文章类型: Journal Article
    目标:死亡率和术后副作用的风险增加导致抑肽酶(Trasylol®)在2008年退出市场,但自2018年以来,抑肽酶再次在法国使用。法国回顾性多中心APACHE研究(在有过度出血风险的心脏手术患者中,阿普汀与氨甲环酸)比较了氨甲环酸与半剂量抑肽酶的疗效。本研究的目的,辅助APACHE研究,是对APACHE亚群使用这两种抗纤维蛋白溶解剂进行医学经济学分析。
    方法:从医疗信息数据处理程序中提取法国医疗保险系统报销的经济数据,和医疗产品成本的定量数据是从医院药房软件获得的。
    结果:对人群成本的主要分析表明,两个治疗组之间的全球评估没有显着差异(p=0.60),但血液制品的费用包括在相关的住院组(GroupeHomogènedeséjour[GHS](全血,氨甲环酸组的血小板和血浆)较高(p=0.007)。在对出院时还活着的病人的亚分析中,对于氨甲环酸组,除GHS(血液衍生药物)外的血液制品成本和GHS中的血液制品成本较高(分别为p=0.04和0.001).
    结论:购买抑肽酶时的额外费用被氨甲环酸组血液制品的额外费用所抵消。
    OBJECTIVE: An increased risk of mortality and postoperative side effects led to aprotinin (Trasylol®) withdrawal from the market in 2008, but since 2018 aprotinin has again been used in France. The French retrospective multicentre APACHE study (AProtinin versus tranexamic Acid in Cardiac surgery patients with High-risk for Excessive bleeding) compared the efficacy of tranexamic acid versus half-dose aprotinin. The aim of this study, ancillary to the APACHE study, is to carry out a medico-economic analysis of the use of these two antifibrinolytics on an APACHE subpopulation.
    METHODS: Economic data on reimbursement by the French health insurance system were extracted from the program for the data processing of medical information, and quantitative data on the cost of healthcare products were obtained from the hospital pharmacy software.
    RESULTS: The main analysis of costs for the population shows that the global valuation was not significantly different between the two treatment groups (P=0.60), but the costs of blood products included in the related hospital stay group (Groupe Homogène de séjour [GHS]) (whole blood, platelets and plasma) were higher for the tranexamic acid group (P=0.007). In a sub-analysis of patients alive at discharge, the costs of blood products in addition to GHS (blood-derived medicines) and the costs of blood products in the GHS were higher for the tranexamic acid group (P=0.04 and 0.001, respectively).
    CONCLUSIONS: The additional cost of aprotinin at the time of purchase is offset by the additional costs of blood products in the tranexamic acid group.
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