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Spine Surgery and Related Research May 2024Tranexamic acid (TXA) has gained popularity in spinal surgery because of its potential to reduce blood loss. However, concerns regarding its safety and efficacy remain.... (Review)
Review
BACKGROUND
Tranexamic acid (TXA) has gained popularity in spinal surgery because of its potential to reduce blood loss. However, concerns regarding its safety and efficacy remain. This systematic review and meta-analysis aimed to evaluate the efficacy of TXA in reducing blood loss and its safety profile in spinal surgeries.
METHODS
A comprehensive search was conducted in electronic databases for randomized controlled trials and prospective studies evaluating the use of TXA in spinal surgery. The primary outcomes were intraoperative and total estimated blood loss (EBL), and the secondary outcomes included the incidence and types of complications associated with TXA use. Meta-analyses were performed using random-effects models.
RESULTS
Thirteen studies involving 1,213 participants were included in the meta-analysis. The use of TXA was associated with significant reductions in both intraoperative (mean difference: -46.56 mL [-73.85, -19.26], p<0.01]) and total EBL (mean difference: -210.17 mL [-284.93, -135.40], p<0.01) while also decreasing the need for blood transfusions (risk ratio: 0.68 [0.51, 0.90], p<0.01). No significant difference was found in the incidence and types of thrombotic complications when TXA was used in spinal surgery. Subgroup analysis showed consistent results in instrumentation and fusion surgery and different doses of TXA.
CONCLUSIONS
TXA is effective in reducing intraoperative and overall blood loss in spinal surgery without increasing the risk of complications. These findings support the use of TXA to improve patient outcomes. However, caution should be exercised because of the heterogeneity among the included studies. Further research is needed to confirm these findings and explore potential long-term complications.
PubMed: 38868794
DOI: 10.22603/ssrr.2023-0244 -
Journal of Cosmetic Dermatology Jun 2024Substances that can efficiently enhance skin penetration while exerting no adverse effect are useful for drug and cosmetics formulation.
BACKGROUND
Substances that can efficiently enhance skin penetration while exerting no adverse effect are useful for drug and cosmetics formulation.
OBJECTIVE
To investigate the safety and enhance skin penetration efficacy of Putocrin®, a combination containing 2% isosorbide dimethyl ether, 1% pentanediol, and 0.5% inositol.
METHODS
An in vitro keratinocyte cell assay using 3-(4,5-dimethylthiazolyl-2)-2,5 diphenyltetrazolium bromide (MTT), and an in vitro EpiKutis® skin study adopted hematoxylin and eosin staining, immunostaining, and liquid chromatography-mass spectrometry (LC-MS) analysis were carried out to investigate the safety of Putocrin®. A pigskin-Franz cell system experiment applied high-performance liquid chromatography (HPLC) to compare the skin penetration efficiency of fluorescein isothiocyanate (Fitc)-labeled tranexamic acid with or without the assistance of Putocrin®. The safety and efficacy of Putocrin® was further evaluated on zebrafish embryos.
RESULTS
The MTT assay showed that Putocrin® at concentration ≤2.5% did not significantly affect cell viability. The in vitro EpiKutis® skin study revealed that 2.5% Putocrin® did not affect skin morphology, filaggrin content, ceramide/protein, or fatty acid/protein ratios, but significantly increased loricrin content by 86.00% (p < 0.001). The pigskin-Franz cell penetration experiment demonstrated that Fitc-labeled tranexamic acid could barely penetrate the skin (with penetration rate of 1.121%), while Putocrin® significantly enhanced the penetration rate up to 83.983%, which was close to unlabeled tranexamic acid (90.013%). The zebrafish embryo study showed that 2.5% Putocrin® did not exert observable toxicity and obviously assisted the skin penetration of Fitc-labeled tranexamic acid into fish embryos. These results indicate the strong enhancing skin penetration potency of Putocrin®.
CONCLUSION
This study demonstrated the safety as well as the strong enhancing skin penetration potency of Putocrin® for cosmetics formulation use.
PubMed: 38867384
DOI: 10.1111/jocd.16409 -
BMJ (Clinical Research Ed.) Jun 2024call for greater use of this inexpensive generic drug that can improve surgical outcomes, avoid unnecessary blood transfusion, and conserve blood stocks
call for greater use of this inexpensive generic drug that can improve surgical outcomes, avoid unnecessary blood transfusion, and conserve blood stocks
Topics: Tranexamic Acid; Humans; Antifibrinolytic Agents; Blood Loss, Surgical
PubMed: 38866414
DOI: 10.1136/bmj-2024-079444 -
Journal of Thrombosis and Haemostasis :... Jun 2024Bleeding disorder of unknown cause (BDUC) is characterised by a bleeding phenotype in the setting of normal haemostatic testing. No standardised diagnostic criteria or...
EXAMINING VARIABILITY IN THE DIAGNOSIS AND MANAGEMENT OF PEOPLE WITH BLEEDING DISORDERS OF UNKNOWN CAUSE: COMMUNICATION FROM THE ISTH SSC SUBCOMMITTEE ON VON WILLEBRAND FACTOR.
BACKGROUND
Bleeding disorder of unknown cause (BDUC) is characterised by a bleeding phenotype in the setting of normal haemostatic testing. No standardised diagnostic criteria or treatment algorithms exist for people with BDUC. To address the unmet need, the International Society on Thrombosis and Haemostasis von Willebrand Factor Scientific Subcommittee (ISTH VWF SCC) performed a real-world survey, aimed at addressing knowledge gaps, developing consensus pathways and ultimately improving care.
OBJECTIVES AND METHODS
We sought to determine current international clinical practices in the investigation, registration, and treatment of people with BDUC through an online structured survey of health care providers (HCPs) who managed patient with bleeding disorders.
RESULTS
Two hundred and sixteen respondents from 39 countries were included in the final analysis. The clinical assessment of those with a possible bleeding disorder varied, with only 55% excluding hypermobility but high levels (80%) of bleeding assessment tools (BAT) usage. In haemostatic testing only the prothrombin time (PT) and activated partial thromboplastin time (APTT) tests gained universal support. Tranexamic acid (TXA) was favoured for prophylaxis for minor (71%)/major (59%) surgeries and pregnancy (58%) but advice on the treatment advised if bleeding occurred was heterogeneous. The management of heavy menstrual bleeding (HMB) in women despite combined oral contraceptive pill (COCP) use also proved challenging with HCPs selecting multiple alternative strategies.
CONCLUSION
Significant variation exists in the recognition, registration and management of people with BDUC worldwide. This survey emphasises the need for consensus pathways to diagnose and treat BDUC to standardise and improve care for patients internationally.
PubMed: 38866246
DOI: 10.1016/j.jtha.2024.05.027 -
Updates in Surgery Jun 2024Bariatric surgery has become a leading treatment for obesity, with techniques such as Laparoscopic Sleeve Gastrectomy (LSG) and Laparoscopic Roux-en-Y Gastric Bypass...
Bariatric surgery has become a leading treatment for obesity, with techniques such as Laparoscopic Sleeve Gastrectomy (LSG) and Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) demonstrating notable success in sustained weight loss and improved quality of life. Technological advancements and improved techniques have enhanced the safety of these procedures. The surgical procedures of Jehovah's Witnesses, who refuse blood transfusions as part of their beliefs, pose unique challenges and have rarely been addressed in the context of bariatric surgery. This report aimed to investigate the safety of bariatric surgery in patients who refuse blood transfusion, with an established protocol to minimize the risk of bleeding. We examined the prospectively collected data of Jehovah's Witness patients who underwent bariatric surgery from 2019 to 2023. The surgeries were conducted following a protocol that included specific measures to prevent bleeding. Data were reviewed for demographics, anthropometrics, comorbidities, preoperative medications, operative time, blood loss, length of hospital stay, hemoglobin level, drainage volume, tranexamic acid use, and postoperative 30-day complications. Eleven Jehovah's Witness patients underwent bariatric surgery, including 10 LSG and 1 LRYGB. A patient with iron deficiency anemia underwent intravenous iron treatment before the surgery. There were no intraoperative complications or major postoperative complications. All patients maintained stable hemodynamics postoperatively. Only one patient encountered nausea-vomiting, classified as a minor complication. One patient experienced a small amount of hemorrhagic drainage, which transitioned to serous after tranexamic acid infusion. Bariatric surgery can be performed safely with established protocols in patients who refuse blood transfusions.
PubMed: 38865002
DOI: 10.1007/s13304-024-01912-5 -
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