-
Frontiers in Pharmacology 2024In recent years, with the continuous expansion of the application scope of Tranexamic acid (TXA), its usage has surged. Despite numerous studies demonstrating its...
BACKGROUND
In recent years, with the continuous expansion of the application scope of Tranexamic acid (TXA), its usage has surged. Despite numerous studies demonstrating its powerful efficacy, concerns regarding its adverse reactions persist, necessitating comprehensive safety assessment. This study analyzed real-world data from the U.S. Food and Drug Administration to investigate TXA-related adverse events, aiming to elucidate its safety and optimize patient treatment.
METHODS
The adverse drug event data concerning TXA from 2004 Q1 to 2023 Q3 were collected. Following data standardization, a variety of signal quantification techniques, including the reporting odds ratios, proportional reporting ratios, Bayesian confidence propagation neural network, and empirical Bayes geometric mean were used for analysis.
RESULTS
After analyzing 16,692,026 adverse event reports, a total of 1,574 cases of adverse events related to TXA were identified, spanning 23 system organ classes and 307 preferred terms. In addition to the common thrombosis-related Vascular disorders ( = 386) and Cardiac disorders ( = 377), adverse reactions in the Nervous system disorders category were also observed ( = 785), including Myoclonus ( = 70), Status epilepticus ( = 43), and Myoclonic epilepsy ( = 17). Furthermore, this study uncovered adverse effects such as Renal cortical necrosis, Hepatic cyst rupture, and Vascular stent stenosis, which were not previously mentioned in the instructions. Although these occurred infrequently, they exhibited high signal strength. Both Retinal artery occlusion and Vascular stent thrombosis disorder were frequent and exhibited high signal strength as well. It is worth noting that 78 cases of adverse reactions were caused by confusion between incorrect product administration.
CONCLUSION
Our research suggests that TXA has some adverse reactions that are being overlooked. As a cornerstone medication in hemorrhage treatment, it's crucial to monitor, identify, and address these adverse reactions effectively.
PubMed: 38863974
DOI: 10.3389/fphar.2024.1388138 -
MedRxiv : the Preprint Server For... May 2024Identifying risk protein targets and their therapeutic drugs is crucial for effective cancer prevention. Here, we conduct integrative and fine-mapping analyses of large...
Identifying risk protein targets and their therapeutic drugs is crucial for effective cancer prevention. Here, we conduct integrative and fine-mapping analyses of large genome-wide association studies data for breast, colorectal, lung, ovarian, pancreatic, and prostate cancers, and characterize 710 lead variants independently associated with cancer risk. Through mapping protein quantitative trait loci (pQTL) for these variants using plasma proteomics data from over 75,000 participants, we identify 365 proteins associated with cancer risk. Subsequent colocalization analysis identifies 101 proteins, including 74 not reported in previous studies. We further characterize 36 potential druggable proteins for cancers or other disease indications. Analyzing >3.5 million electronic health records, we uncover five drugs (Haloperidol, Trazodone, Tranexamic Acid, Haloperidol, and Captopril) associated with increased cancer risk and two drugs (Caffeine and Acetazolamide) linked to reduced colorectal cancer risk. This study offers novel insights into therapeutic drugs targeting risk proteins for cancer prevention and intervention.
PubMed: 38853880
DOI: 10.1101/2024.05.29.24308170 -
Clinical and Experimental Dermatology Jun 2024Melasma is a skin pigmentation disorder that lacks consistent treatment success despite various methods used. Tranexamic Acid (TXA) has shown hypopigmentation...
INTRODUCTION
Melasma is a skin pigmentation disorder that lacks consistent treatment success despite various methods used. Tranexamic Acid (TXA) has shown hypopigmentation properties, but whether TXA administration should be combined with standard treatment or not, is still not clarified. We aimed to perform an investigation of oral TXA effectiveness and safety as an adjuvant of Triple Combination Cream (TCC) Therapy in melasma.
METHODS
We searched PubMed, EMBASE and Cochrane Central for studies comparing TCC plus adjuvant TXA to TCC therapy alone in patients with melasma. Outcomes of interest included change from the baseline of Melasma Area Severity Index (MASI) score, recurrence of melasma and adverse events. Statistical analysis was performed using R Studio 4.3.2.
RESULTS
Four trials, involving 480 patients were included. In the pooled analysis, the decrease from baseline in the MASI score (mean difference [MD] -3.10; 95% confidence interval [CI] -5.85 to -0.35) was significantly higher in patients treated with oral tranexamic acid as an adjuvant to TCC compared to TCC alone. Melasma recurrence (RR 0.28; 95% CI 0.16-0.49) was significantly lower in the group treated with TCC and TXA. Regarding erythema (RR 0.63; 95% CI 0.34-1.17) and burning (RR 0.59; 95% CI 0.30-1.17), there was no significant difference.
CONCLUSION
This meta-analysis demonstrated statistically significant benefits of TCC plus TXA combination treatment compared with TCC alone. Furthermore, the results suggest that the addition of TXA to TCC therapy may reduce melasma recurrence.
PubMed: 38848545
DOI: 10.1093/ced/llae226 -
Blood Jun 2024Acute hemorrhage can be a life-threatening emergency that is complex in its management and affects many patient populations. The last 15 years has seen the introduction...
Acute hemorrhage can be a life-threatening emergency that is complex in its management and affects many patient populations. The last 15 years has seen the introduction of comprehensive massive hemorrhage protocols, wider use of viscoelastic testing, new coagulation factor products, and the publication of robust randomized controlled trials in diverse bleeding patient populations. Although gaps continue to exist in the evidence-base for several aspects of patient care, there is now sufficient evidence to allow for an individualized hemostatic response based on the type of bleeding and specific hemostatic defects. We present three clinical cases that highlight some of the challenges in acute hemorrhage management, focusing on the importance of inter-professional communication, rapid provision of hemostatic resuscitation, repeated measures of coagulation, immediate administration of tranexamic acid, and prioritization of surgical or radiologic control of hemorrhage. This article provides a framework for the clear and collaborative conversation between the bedside clinical team and the consulting hematologist to achieve prompt and targeted hemostatic resuscitation. In addition to providing consultations on the hemostatic management of individual patients, the hematology service must be involved in setting hospital policies for the prevention and management of patients with major hemorrhage.
PubMed: 38848525
DOI: 10.1182/blood.2023022901 -
Archives of Orthopaedic and Trauma... Jun 2024Intravenous tranexamic acid (TA) has proven efficacy in reducing blood loss and incidence of transfusion of blood products in elective total joint arthroplasty. However,...
A randomised controlled trial assessing the effect of tranexamic acid on post-operative blood transfusions in patient with intra-capsular hip fractures treated with hemi- or total hip arthroplasty.
BACKGROUND
Intravenous tranexamic acid (TA) has proven efficacy in reducing blood loss and incidence of transfusion of blood products in elective total joint arthroplasty. However, evidence of efficacy in the setting of intracapsular hip fractures needing hip hemiarthroplasty (HA) or total hip arthroplasty (THA) are scarce. This study aimed to assess post-operative transfusion incidence in this clinical setting.
METHODS
Over a five-year period 250 patients with intracapsular neck of femur fractures requiring arthroplasty were randomised to two groups. The treatment group received three-dose intravenous TA protocol and the control group received usual treatment without administration of TA. Blood loss was estimated from the change in Hb levels on day 1, 3 and 5 after surgery compared to preoperative levels. Transfusions of blood products were recorded when they were triggered by an a priori protocol. Post-operative complications were recorded during patient hospital admission.
RESULTS
The intervention group showed significantly lower transfusion incidence of packed red blood cells (PRBC) (6 vs. 15, p = 0.04, OR = 0.37, 95%CI OR = 0.14 to 0.99) and in the group of patients who received a blood transfusion, a trend was observed for patients who received TA to have lesser number of units of PRBC (mean = 1.3 vs. 1.6, p = 0.51). A significant difference was noted in post-operative Hb levels of day 1,3 and 5. Backward stepwise multivariable regression analysis showed the use of TA was the most significant factor for reduction in postoperative blood transfusion (p = 0.047, OR = 0.37, 95% CI OR = 0.14 to 0.99). Assessment of the strength of the correlation showed modest correlation (Pearson correlation - 0.13 p = 0.04, 95% CI correlation= -0.25 to -0.01). There was no increase in adverse events in patients who received TA.
CONCLUSION
The use of TA in setting of intracapsular hip fractures requiring arthroplasty reduces blood loss, the need for transfusion of blood products and may reduce surgical site complications without increasing the risk of VTE.
PubMed: 38847833
DOI: 10.1007/s00402-024-05325-2 -
Orthopedic Reviews 2024Primary total knee arthroplasty (TKA) is the gold standard treatment for degenerative joint disease, but it carries a significant risk of blood loss that may require...
BACKGROUND
Primary total knee arthroplasty (TKA) is the gold standard treatment for degenerative joint disease, but it carries a significant risk of blood loss that may require transfusion. Various techniques are implemented to reduce the possibility of the need for allogeneic blood transfusion (ABT). To this end, this study aims to assess the effectiveness of tranexamic acid (TXA) in decreasing blood loss following primary TKA.
MATERIALS AND METHODS
This study is a randomized controlled study of 100 cases of primary total knee arthroplasty conducted in Damascus from July 2021 to September 2022, followed up with every patient for six months. The patients were randomized into two groups. We compared intraoperative, postoperative, total, and hidden blood loss and perioperative complications.
RESULTS
We observed a statistically significant difference between the two groups in total calculated, hidden, and postoperative blood loss. However, this difference does not seem clinically significant, as we didn't find a significant difference in allogeneic blood transfusion between the groups. Regarding complications, the TXA group had five cases of superficial wound infection and six cases of deep venous thrombosis. In contrast, the control group had eight cases of superficial wound infection and five cases of deep venous thrombosis.
CONCLUSION
Our study suggests that the role of TXA in primary unilateral total knee arthroplasty in the hands of an experienced surgeon might be overrated. The reduced blood loss did not seem to have clinical importance and didn't affect the transfusion rates.
PubMed: 38846341
DOI: 10.52965/001c.118441 -
Nature Medicine Jun 2024Timely detection and treatment of postpartum hemorrhage (PPH) are crucial to prevent complications or death. A calibrated blood-collection drape can help provide...
Timely detection and treatment of postpartum hemorrhage (PPH) are crucial to prevent complications or death. A calibrated blood-collection drape can help provide objective, accurate and early diagnosis of PPH, and a treatment bundle can address delays or inconsistencies in the use of effective interventions. Here we conducted an economic evaluation alongside the E-MOTIVE trial, an international, parallel cluster-randomized trial with a baseline control phase involving 210,132 women undergoing vaginal delivery across 78 secondary-level hospitals in Kenya, Nigeria, South Africa and Tanzania. We aimed to assess the cost-effectiveness of the E-MOTIVE intervention, which included a calibrated blood-collection drape for early detection of PPH and a bundle of first-response treatments (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination and escalation), compared with usual care. We used multilevel modeling to estimate incremental cost-effectiveness ratios from the perspective of the public healthcare system for outcomes of cost per severe PPH (blood loss ≥1,000 ml) avoided and cost per disability-adjusted life-year averted. Our findings suggest that the use of a calibrated blood-collection drape for early detection of PPH and bundled first-response treatment is cost-effective and should be perceived by decision-makers as a worthwhile use of healthcare budgets. ClinicalTrials.gov identifier: NCT04341662 .
PubMed: 38844798
DOI: 10.1038/s41591-024-03069-5 -
Journal of Shoulder and Elbow Surgery Jun 2024
Letter To Editor regarding "The effect of intravenous tranexamic acid on visual clarity in arthroscopic shoulder surgery compared to epinephrine and a placebo: a double-blinded, randomized controlled trial".
PubMed: 38844157
DOI: 10.1016/j.jse.2024.03.072 -
Journal of Shoulder and Elbow Surgery Jun 2024
Response to Letter to the Editor regarding "The effect of intravenous tranexamic acid on visual clarity in arthroscopic shoulder surgery compared to epinephrine and a placebo: a double-blinded, randomized controlled trial-letter to editor.".
PubMed: 38844156
DOI: 10.1016/j.jse.2024.03.071 -
The Journal of Dermatological Treatment Dec 2024This study aimed to evaluate the efficacy of tranexamic acid (TXA) in treating melasma through a meta-analysis and systematic review of randomized controlled trials... (Meta-Analysis)
Meta-Analysis Review
This study aimed to evaluate the efficacy of tranexamic acid (TXA) in treating melasma through a meta-analysis and systematic review of randomized controlled trials (RCTs). The study focused on identifying associated adverse effects and comparing TXA's effectiveness with other melasma treatments. Following PROSPERO and PRISMA guidelines, an extensive electronic search was conducted across four databases for RCTs on TXA use in melasma. Inclusion criteria encompassed full-text English articles with specific outcome measures, while studies with high bias risk or non-English publications were excluded. Data were extracted from 22 relevant studies and analyzed using the RevMan software, with heterogeneity identified using I² statistics and forest plots. A total of 22 studies with 1280 patients were included. TXA was administered orally, topically, or via injection, with treatment durations ranging from 8 weeks to nearly 2 years. TXA significantly reduced melasma severity, evidenced by reductions in MASI, mMASI, MI, and hemi-MASI scores. Oral TXA showed the most substantial decrease in MASI scores, followed by injections and topical applications. However, studies exhibited high heterogeneity, particularly in combined treatments. Adverse effects included gastrointestinal discomfort, skin irritation, and menstrual irregularities. TXA is effective in treating melasma, either alone or combined with other treatments. Despite significant reductions in melasma severity, further research is necessary to standardize TXA administration methods and address long-term effects. The high heterogeneity observed suggests a need for more consistent treatment protocols.
Topics: Melanosis; Humans; Tranexamic Acid; Randomized Controlled Trials as Topic; Treatment Outcome; Administration, Oral; Antifibrinolytic Agents; Severity of Illness Index; Administration, Cutaneous
PubMed: 38843906
DOI: 10.1080/09546634.2024.2361106