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Thrombosis Research Nov 2023Life-long anticoagulation is the recommended management for chronic thromboembolic pulmonary hypertension (CTEPH). Evidence regarding the use of direct oral... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Life-long anticoagulation is the recommended management for chronic thromboembolic pulmonary hypertension (CTEPH). Evidence regarding the use of direct oral anticoagulants (DOAC) for CTEPH is yet to be established. We performed a systematic review and meta-analysis to clarify the outcomes of CTEPH in patients who used DOAC or vitamin K antagonists (VKA).
METHODS
We reviewed literature in PubMed and EMBASE through March 2023. We included studies involving patients with CTEPH where DOAC and VKA were compared. We collected data including intervention history for CTEPH, bleeding events, recurrence of VTE (venous thromboembolism), and mortality. We performed a meta-analysis using the Mantel-Haenszel method with a fixed-effects model.
RESULTS
We included one randomized clinical trial and six observational studies, with a total of 2969 patients. Six studies investigated major bleeding outcomes, and seven investigated all bleeding outcomes. There were no differences in major bleeding (RR 0.59, 95 % CI [0.34-1.02], I = 0 %) and all-bleeding (RR 0.87, 95 % CI [0.67-1.13], I = 0 %). Based on the five studies we included, DOAC was associated with a lower risk of mortality (RR 0.54, 95 % CI: 0.37-0.79, I = 5 %). However, a higher risk of recurrent pulmonary embolism (PE) was seen in three studies (RR 3.80, 95 % CI: [1.93-7.50], I = 11 %). No significant differences were noted in terms of VTE.
CONCLUSION
DOAC compared to VKA was associated with a significantly lower mortality and higher risk of recurrent PE. Since most of the included studies are observational, we must consider the existence of multiple biases and confounding factors.
Topics: Humans; Venous Thromboembolism; Hypertension, Pulmonary; Anticoagulants; Blood Coagulation; Hemorrhage; Pulmonary Embolism; Fibrinolytic Agents; Administration, Oral; Vitamin K; Randomized Controlled Trials as Topic
PubMed: 37839150
DOI: 10.1016/j.thromres.2023.10.003 -
International Journal of Molecular... Oct 2023Bisphenols such as bisphenol A (BPA), S (BPS), C (BPC), F (BPF), AF (BPAF), tetrabromobisphenol, nonylphenol, and octylphenol are plasticizers used worldwide to... (Meta-Analysis)
Meta-Analysis Review
Bisphenols such as bisphenol A (BPA), S (BPS), C (BPC), F (BPF), AF (BPAF), tetrabromobisphenol, nonylphenol, and octylphenol are plasticizers used worldwide to manufacture daily-use articles. Exposure to these compounds is related to many pathologies of public health importance, such as infertility. Using a protector compound against the reproductive toxicological effects of bisphenols is of scientific interest. Melatonin and vitamins have been tested, but the results are not conclusive. To this end, this systematic review and meta-analysis compared the response of reproductive variables to melatonin and vitamin administration as protectors against damage caused by bisphenols. We search for controlled studies of male rats exposed to bisphenols to induce alterations in reproduction, with at least one intervention group receiving melatonin or vitamins (B, C, or E). Also, molecular docking simulations were performed between the androgen (AR) and estrogen receptors (ER), melatonin, and vitamins. About 1234 records were initially found; finally, 13 studies were qualified for review and meta-analysis. Melatonin plus bisphenol improves sperm concentration and viability of sperm and increases testosterone serum levels compared with control groups; however, groups receiving vitamins plus bisphenols had lower sperm concentration, total testis weight, and testosterone serum levels than the control. In the docking analysis, vitamin E had the highest negative MolDock score, representing the best binding affinity with AR and ER, compared with other vitamins and melatonin in the docking. Our findings suggest that vitamins could act as an endocrine disruptor, and melatonin is most effective in protecting against the toxic effects of bisphenols.
Topics: Male; Rats; Animals; Melatonin; Vitamins; Molecular Docking Simulation; Semen; Benzhydryl Compounds; Reproduction; Receptors, Estrogen; Vitamin A; Vitamin K; Testosterone; Endocrine Disruptors
PubMed: 37834378
DOI: 10.3390/ijms241914930 -
The American Journal of Cardiology Nov 2023Direct oral anticoagulants (DOACs) are a newer class of anticoagulants that inhibit factor Xa or factor IIa and include drugs such as rivaroxaban, apixaban, edoxaban,... (Meta-Analysis)
Meta-Analysis
An Evidence-Based Approach to Anticoagulation Therapy Comparing Direct Oral Anticoagulants and Vitamin K Antagonists in Patients With Atrial Fibrillation and Bioprosthetic Valves: A Systematic Review, Meta-Analysis, and Network Meta-Analysis.
Direct oral anticoagulants (DOACs) are a newer class of anticoagulants that inhibit factor Xa or factor IIa and include drugs such as rivaroxaban, apixaban, edoxaban, betrixaban, and dabigatran. Although vitamin K antagonists (VKAs) have been traditionally used to prevent thromboembolic events, DOACs have gained popularity because of their faster onset and offset of action and reduced need for monitoring. This study aimed to provide more data for anticoagulants in patients with atrial fibrillation with bioprosthetic heart valves by incorporating all available trials to date. A search was performed across 5 electronic databases to identify relevant studies. We analyzed the data using a pooled risk ratio for categorical outcomes and used the I test to determine heterogeneity. The quality of randomized controlled trials was assessed using the Cochrane risk of bias assessment tool, and the National Institutes of Health tool was used for observational studies. Our study included a frequentist network meta-analysis (MA) of the aggregate data to obtain the network estimates for the outcomes of interest. We retrieved 28 studies with a total of 74,660 patients with bioprosthetic heart valves. Our MA significantly showed that DOACs decrease the risk of all-cause bleeding (risk ratio [RR] 0.80, 95% confidence interval [CI] 0.75 to 0.85, p >0.00001), stroke and systemic embolization (RR 0.89, 95% CI 0.80 to 0.99, p = 0.03), and intracranial bleeding outcomes (RR 0.62, 95% CI 0.45 to 0.86, p = 0.004) compared with VKA. In contrast, there was no significant difference between the compared groups in major bleeding (RR = 0.92, 95% CI 0.84 to 1.02, p = 0.10) and all-cause mortality outcomes (RR = 0.96, 95% CI 0.85 to 1.07, p = 0.43), respectively. In addition, the network MA results did not favor any of the studied interventions over each other (p <0.05) regarding all-cause bleeding, mortality, stroke and systemic embolization, and major bleeding outcomes. In conclusion, our study found that DOACs are more effective in reducing the risk of bleeding, stroke, systemic embolism, and intracranial bleeding than VKAs. However, no significant difference was observed in the incidence of gastrointestinal bleeding, major bleeding, thromboembolic events, and all-cause mortality. In addition, our network MA did not identify any specific DOAC treatment as more favorable than others.
Topics: Humans; Atrial Fibrillation; Network Meta-Analysis; Anticoagulants; Hemorrhage; Stroke; Thromboembolism; Fibrinolytic Agents; Intracranial Hemorrhages; Vitamin K; Administration, Oral
PubMed: 37703679
DOI: 10.1016/j.amjcard.2023.07.141 -
Blood Reviews Nov 2023Optimal peri-operative management for women with Von Willebrand disease (VWD) and heavy menstrual bleeding (HMB) remains undetermined. (Review)
Review
BACKGROUND
Optimal peri-operative management for women with Von Willebrand disease (VWD) and heavy menstrual bleeding (HMB) remains undetermined.
AIM AND METHODS
To evaluate (pre)operative management in relation to (post)operative bleeding after endometrial ablation (EA) and hysterectomy in VWD women with HMB by performing a database search between 1994 and 2023.
RESULTS
Eleven cohort studies and 1 case-report were included, of overall 'low' quality, describing 691 operative procedures. Prophylaxis (Desmopressin, clotting factor concentrates or tranexamic acid) to prevent bleeding was described in 100% (30/30) of EA procedures and in 4% (24/661) of hysterectomies. Bleeding complications despite prophylaxis were described in 13% (3/24) of hysterectomies vs 0% (0/30) in EA.
CONCLUSION
VWD women often seem to experience bleeding complications during hysterectomy and all women with VWD received preprocedural hemostatic agents during EA, indicating potential under- and overdosing of current prophylactic strategies. Prospective studies are needed to determine the optimal (pre)operative strategy for gynecological surgical procedures in women with VWD.
Topics: Female; Humans; Hemorrhage; Menorrhagia; Prospective Studies; Tranexamic Acid; von Willebrand Diseases; von Willebrand Factor
PubMed: 37716881
DOI: 10.1016/j.blre.2023.101131 -
Nutrients Dec 2023This systematic review aims to assess whether edible vegetable oils and fats fortified with vitamin A and/or D are effective and safe in improving vitamin intake and... (Meta-Analysis)
Meta-Analysis Review
Benefits and Harms of Edible Vegetable Oils and Fats Fortified with Vitamins A and D as a Public Health Intervention in the General Population: A Systematic Review of Interventions.
This systematic review aims to assess whether edible vegetable oils and fats fortified with vitamin A and/or D are effective and safe in improving vitamin intake and ameliorating deficiency states in the general population. In November 2022, we systematically searched MEDLINE, Cochrane CENTRAL, Scopus, Global Index Medicus, ClinicalTrials.gov, and WHO ICTRP (International Clinical Trials Registry Platform) for randomized controlled trials (RCT) and non-randomized studies of interventions (NRSI) investigating the fortification of edible vegetable oils and fats with either vitamin A or vitamin D or both as compared to the same vegetable oils and/or fats without vitamin A and D fortification or no interventions, in the general population, without age restriction. We assessed the methodological quality of included RCTs using Cochrane's risk of bias tool 2.0 and of NRSIs using ROBINS-I tool. We performed random-effects meta-analysis and assessed certainty of evidence using GRADE. We included eight studies. Available evidence showed no significant effect of fortification with vitamin A on serum retinol levels (RCTs: MD 0.35 µmol/L, 95% CI -0.43 to 1.12; two trials; 514 participants; low-certainty evidence; CCTs: MD 0.31 µmol/L, 95% CI -0.18 to 0.80; two trials; 205 participants; very low-certainty evidence) and on subclinical vitamin A deficiency. Low-certainty evidence showed no effect of vitamin D fortification on serum 25-hydroxy vitamin D concentration (MD 6.59 nmol/L, 95% CI -6.89 to 20.07; one trial; 62 participants). In conclusion, vitamin A-fortified vegetable oils and fats may result in little to no difference in serum retinol levels in general populations. The dose of vitamin A used in the trials may be safe but may not be sufficient to reduce subclinical vitamin A deficiency. Further, the evidence suggests that vitamin D fortification results in little to no difference in serum 25-hydroxy vitamin D concentration. Several aspects of providing fortified oils and fats to the general population as a public health intervention should be further investigated, including optimal fortification dose, effects on vitamin D deficiency and its clinical symptoms and potential adverse effects.
Topics: Humans; Vitamins; Vitamin A; Vitamin A Deficiency; Vegetables; Public Health; Plant Oils; Food, Fortified; Vitamin K; Vitamin D
PubMed: 38140394
DOI: 10.3390/nu15245135 -
Archives of Gynecology and Obstetrics Sep 2023Africa is a developing continent with a high maternal mortality rate. It is beneficial to implement interventions that alleviate the problem. As a result, this... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Africa is a developing continent with a high maternal mortality rate. It is beneficial to implement interventions that alleviate the problem. As a result, this systematic review and meta-analysis was carried out to summarize evidence that will assist concerned bodies in proposing strategies to reduce maternal mortality due to post-partum hemorrhage.
METHODS
This systematic review and meta-analysis includes randomized control trials (RCT) studies searched from various databases (PubMed, Web of Sciences, SCOPUS, African Journal Online, Clinical trials, and African indexes Medics). Data synthesis and statistical analysis were conducted using a combination of review manager 5.3 and STATA Version 14 software. The effect measure utilized was the standardized mean difference for estimated mean blood loss and mean hemoglobin level.
RESULTS
This systematic review and meta-analysis includes a total of 3308 women. The pooled standardized mean difference showed that tranexamic acid statistical significantly reduced the estimated amount of blood loss after vaginal delivery (standardized mean difference with 95% CI - 0.93 [- 1.45, - 0.41]) and during and after cesarean delivery (standardized mean difference with 95% CI - 1.93 [- 2.40, - 1.47]).
CONCLUSION
Tranexamic acid has been found to be a good choice for reducing blood loss during and after delivery in Africa regardless of the mode of delivery. Tranexamic acid had no effect on hemoglobin levels before and after delivery. To reduce maternal mortality due to post-partum hemorrhage, it is critical to implement and strengthen interventions aimed at increasing tranexamic acid uptake in Africa.
Topics: Female; Pregnancy; Humans; Tranexamic Acid; Antifibrinolytic Agents; Postpartum Hemorrhage; Africa; Hemoglobins
PubMed: 36436014
DOI: 10.1007/s00404-022-06845-1 -
European Journal of Internal Medicine Jan 2024The prevalence of atrial fibrillation (AF) in individuals with end-stage renal disease (ESRD) on chronic hemodialysis is increasing. The optimal anticoagulant choice in... (Meta-Analysis)
Meta-Analysis
Efficacy and safety of direct oral anticoagulants vs vitamin K antagonists in patients with atrial fibrillation and end-stage renal disease on hemodialysis: A systematic review and meta-analysis.
BACKGROUND
The prevalence of atrial fibrillation (AF) in individuals with end-stage renal disease (ESRD) on chronic hemodialysis is increasing. The optimal anticoagulant choice in this population is unclear since these patients were excluded from the pivotal randomized controlled trials (RCTs) of direct oral anticoagulants (DOACs) vs. vitamin K antagonists (VKAs) in the general AF population. We aimed to assess the efficacy and safety of DOACs vs. VKAs in patients with AF and ESRD on chronic hemodialysis through a systematic review and meta-analysis of all available evidence.
PATIENTS/METHODS
We performed a systematic search in MEDLINE and Scopus for RCTs or observational studies of patients with AF and ESRD on chronic hemodialysis who were treated with DOACs or VKAs. The outcomes of interest included ischemic stroke, the composite of ischemic stroke or systemic embolism, major bleeding, gastrointestinal bleeding, minor bleeding events and all-cause mortality.
RESULTS
Among 397 studies identified from the literature search, six studies (three RCTs and three observational studies) were included in the meta-analysis. Compared with VKA-treated patients, those treated with DOACs had similar risk of ischemic stroke (RR:0.76, 95% CI:0.41-1.41), ischemic stroke or systemic embolism (RR:0.65, 95% CI:0.38-1.10), major bleeding (RR:0.79, 95% CI:0.49-1.28) and all-cause death (RR:0.79, 95% CI:0.56-1.12). The risk of gastrointestinal bleeding was lower in DOAC- vs VKA-treated patients in three eligible observational studies (RR:0.73, 95% CI: 0.54-0.99, I2 = 79%) but this was not confirmed in two eligible RCTs (RR:0.69, 95% CI: 0.33-1.43, I2 = 0%).
CONCLUSIONS
Among AF patients with ESRD on chronic hemodialysis, the risk of ischemic stroke, ischemic stroke or systemic embolism, minor bleeding, major bleeding, and all-cause mortality is similar in patients treated with DOACs compared to VKAs. Given that the meta-analysis of RCTs on gastrointestinal bleeding did not confirm the results of the meta-analysis of the observational studies, it cannot be concluded that gastrointestinal bleeding is lower among DOAC-treated patients.
PROTOCOL REGISTRATION
PROSPERO CRD42023391966.
Topics: Humans; Administration, Oral; Anticoagulants; Atrial Fibrillation; Embolism; Gastrointestinal Hemorrhage; Ischemic Stroke; Kidney Failure, Chronic; Randomized Controlled Trials as Topic; Renal Dialysis; Stroke; Vitamin K
PubMed: 37648582
DOI: 10.1016/j.ejim.2023.08.020 -
The Cochrane Database of Systematic... Oct 2023Percutaneous nephrolithotomy (PCNL) is the gold standard for the treatment of large kidney stones but comes with an increased risk of bleeding compared to other... (Review)
Review
BACKGROUND
Percutaneous nephrolithotomy (PCNL) is the gold standard for the treatment of large kidney stones but comes with an increased risk of bleeding compared to other treatments, such as ureteroscopy and shock wave lithotripsy. Tranexamic acid (TXA) is an antifibrinolytic agent that has been used to reduce bleeding complications in other settings.
OBJECTIVES
To assess the effects of TXA in individuals with kidney stones undergoing PCNL.
SEARCH METHODS
We performed a comprehensive literature search of the Cochrane Library, PubMed (including MEDLINE), Embase, Scopus, Global Index Medicus, trials registries, other sources of the grey literature, and conference proceedings. We applied no restrictions on the language of publication nor publication status. The latest search date was 11 May 2023.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) that compared treatment with PCNL with administration of TXA to placebo (or no TXA) for patients ≥ 18 years old.
DATA COLLECTION AND ANALYSIS
Two review authors independently classified studies and abstracted data. Primary outcomes were: blood transfusion, stone-free rate (SFR), and thromboembolic events (TEEs). Secondary outcomes were: adverse events (AEs), secondary interventions, major surgical complications, minor surgical complications, unplanned hospitalizations or readmissions, and hospital length of stay (LOS). We performed statistical analyzes using a random-effects model. We rated the certainty of evidence (CoE) according to the GRADE approach using a minimally contextualized approach with predefined thresholds for minimally clinically important differences (MCIDs).
MAIN RESULTS
We analyzed 10 RCTs assessing the effect of systemic TXA in PCNL versus placebo (or no TXA) with 1883 randomized participants. Eight studies were published as full text. One was published in abstract proceedings, but it was separated into two separate studies for the purpose of our analyzes. Average stone surface area ranged 3.45 to 6.62 cm. We also found a single RCT published in full text assessing the effects of topical TXA in PCNL versus placebo (or no TXA) with 400 randomized participants, the results of which are further described in the review. Here we focus only on the results of TXA used systemically. Blood transfusion - Based on a representative baseline risk of 5.7% for blood transfusions taken from a large presentative observational studies, systemic TXA may reduce blood transfusions (risk ratio (RR) 0.45, 95% confidence interval (CI) 0.27 to 0.76; I = 28%; 9 studies, 1353 participants; low CoE). We assumed an MCID of ≥ 2%. Based on 57 participants per 1000 with placebo (or no TXA) being transfused, this corresponds to 31 fewer (from 42 fewer to 14 fewer) participants being transfused per 1000. Stone-free rate - Based on a representative baseline risk of 75.7% for SFR, systemic TXA may increase SFRs (RR 1.11, 95% CI 0.98 to 1.27; I = 62%; 4 studies, 603 participants; low CoE). We assumed an MCID of ≥ 5%. Based on 757 participants per 1000 being stone free with placebo (or no TXA), this corresponds to 83 more (from 15 fewer to 204 more) stone-free participants per 1000. Thromboembolic events - There is probably no difference in TEEs (risk difference (RD) 0.00, 95% CI -0.01 to 0.01; I = 0%; 6 studies, 841 participants; moderate CoE). We assumed an MCID of ≥ 2%. Since there were no thromboembolic events in intervention and/or control groups in 5 out of6 studies, we opted to assess a risk difference with systemic TXA for this outcome. Adverse events - Systemic TXA may increase AEs (RR 5.22, 95% CI 0.52 to 52.72; I = 75%; 4 studies, 602 participants; low CoE). We assumed an MCID of ≥ 5%. Based on 23 participants per 1000 with placebo (or no TXA) having an adverse event, this corresponds to 98 more (from 11 fewer to 1000 more) participants with adverse events per 1000. Secondary interventions - Systemic TXA may have little to no effect on secondary interventions (RR 1.15, 95% CI 0.84 to 1.57; I = 0%; 2 studies, 319 participants; low CoE). We assumed an MCID of ≥ 5%. Based on 278 participants per 1000 with placebo (or no TXA) having a secondary intervention, this corresponds to 42 more (from 44 fewer to 158 more) participants with secondary interventions per 1000. Major surgical complications - Based on a representative baseline risk for major surgical complications of 4.1%, systemic TXA may reduce major surgical complications (RR 0.36, 95% CI 0.21 to 0.62; I = 0%; 5 studies, 733 participants; moderate CoE). We assumed an MCID of ≥ 2%. Based on 41 participants per 1000 with placebo (or no TXA) having a major surgical complication, this corresponds to 26 fewer (from 32 fewer to 16 fewer) participants with major surgical complications per 1000. Minor surgical complications - Systemic TXA may reduce minor surgical complications (RR 0.71, 95% CI 0.45 to 1.10; I = 76%; 5 studies, 733 participants; low CoE). We assumed an MCID of ≥ 5%. Based on 396 participants per 1000 with placebo (or no TXA) having a minor surgical complication, this corresponds to 115 fewer (from 218 fewer to 40 more) participants with minor surgical complications per 1000. Unplanned hospitalizations or readmissions - We are very uncertain how unplanned hospitalizations or readmissions are affected (RR 1.55, 95% CI 0.45 to 5.31; I = not applicable; 1 study, 189 participants; very low CoE). We assumed an MCID of ≥ 2%. Hospital length of stay - Systemic TXA may reduce hospital LOS (mean difference 0.52 days lower, 95% CI 0.93 lower to 0.11 lower; I = 98%; 7 studies, 1151 participants; low CoE). We assumed an MCID of ≥ 0.5 days.
AUTHORS' CONCLUSIONS
Based on 10 RCTs with substantial methodological limitations that lowered all CoE of effect, we found that systemic TXA in PCNL may reduce blood transfusions, major and minor surgical complications, and hospital LOS, as well as improve SFRs; however, it may increase AEs. We are uncertain about the effects of systemic TXA on other outcomes. Findings of this review should assist urologists and their patients in making informed decisions about the use of TXA in the setting of PCNL.
Topics: Humans; Adolescent; Tranexamic Acid; Nephrolithotomy, Percutaneous; Kidney Calculi; Antifibrinolytic Agents; Hemostatics
PubMed: 37882229
DOI: 10.1002/14651858.CD015122.pub2 -
Journal of Shoulder and Elbow Surgery Nov 2023Although tranexamic acid (TXA) is being increasingly used in orthopedic arthroplasty and lower-extremity arthroscopic procedures, its use in arthroscopic rotator cuff... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Although tranexamic acid (TXA) is being increasingly used in orthopedic arthroplasty and lower-extremity arthroscopic procedures, its use in arthroscopic rotator cuff repair (ARCR) is less widely reported. The aim of this study was to evaluate the clinical effectiveness and safety of TXA administration in ARCR.
METHODS
A systematic review and meta-analysis of randomized controlled trials was performed to compare clinical outcomes in patients who underwent ARCR with or without TXA. Literature was retrieved using the Cochrane Library, MEDLINE, PubMed, and Embase electronic databases. The primary outcome of this study was visual clarity. Secondary outcomes contained total operative time, postoperative pain score, amount of blood loss, shoulder swelling (change in shoulder circumference), volume of irrigation fluid, number of adjustments of the pump pressure for irrigation, and adverse cardiovascular events.
RESULTS
Seven studies (3 and 4 with level I and II evidence, respectively), which included 272 and 265 patients who underwent arthroscopy with and without TXA, respectively, met the eligibility criteria. Pooled analysis showed significant improvements in visual clarity (mean difference, 9.10%; 95% CI, 4.05-14.15; P = .0004) and total operative time (mean difference, -11.24 minute; 95% CI, -19.90 to -2.57) associated with perioperative TXA application. None of the trials reported adverse events and complications associated with TXA.
CONCLUSION
The best available evidence indicates that TXA administration could significantly improve arthroscopic visual clarity and effectively save operative time in ARCR without increasing the incidence of adverse events. Furthermore, the optimal dose, route, and timing of TXA application in ARCR surgery remains to be validated by future high-level evidence studies.
Topics: Humans; Tranexamic Acid; Rotator Cuff; Arthroscopy; Shoulder; Rotator Cuff Injuries; Arthroplasty; Treatment Outcome
PubMed: 37468032
DOI: 10.1016/j.jse.2023.06.013 -
European Journal of Obstetrics,... Dec 2023To conduct the first-ever systematic review and meta-analysis of randomized controlled trials (RCTs) on the antihemorrhagic utility and safety of tranexamic acid (TXA)... (Meta-Analysis)
Meta-Analysis Review
AIM
To conduct the first-ever systematic review and meta-analysis of randomized controlled trials (RCTs) on the antihemorrhagic utility and safety of tranexamic acid (TXA) versus misoprostol for management (prevention and/or treatment) of postpartum hemorrhage (PPH).
METHODS
Six databases were screened from inception until May 2023 and updated in September 2023. The RCTs were assessed for quality according to the Cochrane's risk of bias tool. The endpoints were summarized as mean difference (MD) or risk ratio (RR) with 95% confidence interval (CI) in a random-effects model.
RESULTS
Ten RCTs with 2121 patients (TXA = 1061 and misoprostol = 1060) were analyzed. There was no significant difference between TXA and misoprostol groups regarding the mean intraoperative blood loss (n = 9 RCTs, MD = 17.32 ml, 95% CI [-40.43, 75.07], p = 0.56), mean change in hemoglobin (n = 6 RCTs, MD = 0.11 mg/dl, 95% CI [-0.1, 0.31], p = 0.30), mean hospital stay (n = 2 RCTs, MD = -0.3 day, 95% CI [-0.61, 0.01], p = 0.06), blood transfusion rate (n = 4 RCTs, RR = 0.49, 95% CI [0.16, 1.47], p = 0.2), and rate of additional uterotonic agents (n = 4 RCTs, RR = 1.05, 95% CI [0.72, 1.53], p = 0.81). Leave-one-out sensitivity analysis showed robustness of the results, and there was no evidence of publication bias. Regarding safety endpoints, there was no significant difference between both groups regarding the rates of minor side effects, such as diarrhea, fever, nausea, and vomiting. No patient developed thromboembolic events in the TXA group.
CONCLUSION
There was no significant antihemorrhagic efficacy between adjunct TXA and misoprostol for the management of PPH. The safety profile was comparable between both agents.
Topics: Pregnancy; Female; Humans; Misoprostol; Postpartum Hemorrhage; Tranexamic Acid; Randomized Controlled Trials as Topic; Hemostatics; Blood Loss, Surgical; Antifibrinolytic Agents
PubMed: 37832480
DOI: 10.1016/j.ejogrb.2023.10.006