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Journal of Orthopaedic Surgery and... Jul 2023Calcaneal fractures are a common orthopedic disease, account for approximately 2% of all bone fractures, and represent 60% of fractures of tarsal bones. Tranexamic acid... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Calcaneal fractures are a common orthopedic disease, account for approximately 2% of all bone fractures, and represent 60% of fractures of tarsal bones. Tranexamic acid (TXA) is a synthetic antifibrinolytic drug that competitively blocks the lysine-binding sites of plasminogen, plasmin, and tissue plasminogen activator, delaying fibrinolysis and blood clot degradation. However, the effect of TXA on patients with calcaneal surgery remains controversial. Our objective was to evaluate the effectiveness of TXA in calcaneal fractures surgeries.
METHODS
The electronic literature databases of Pubmed, Embase, and Cochrane library were searched in December 2022. The data on blood loss, the stay in the hospital, the duration of surgery, hemoglobin, hematocrit, platelet count, prothrombin time, activated partial thromboplastin time, and wound complication were extracted. The Stata 22.0 software was used for the meta-analysis.
RESULTS
Four randomized controlled studies met our inclusion criteria. This meta-analysis showed that TXA significantly reduced postoperative blood loss during the first 24 h (p < 0.001), improved the level of hemoglobin (p < 0.001) and hematocrit (p = 0.03), and reduced the risk of wound complications (p = 0.04). There was no significant difference between the two groups regarding total and intraoperative blood loss, hospital stay, duration of surgery, platelet count, activated partial thromboplastin time, and prothrombin time.
CONCLUSION
TXA significantly reduced blood loss during the first 24 h postoperatively, improved the level of hemoglobin and hematocrit, and reduced the risk of wound complications. Given the evidence, TXA can be used in patients with calcaneal fractures and had the potential benefit of blood reduction.
PROTOCOL REGISTRATION
The protocol was registered in PROSPERO (registration No. CRD42023391211).
Topics: Humans; Tranexamic Acid; Tissue Plasminogen Activator; Randomized Controlled Trials as Topic; Calcaneus; Tarsal Bones; Ankle Injuries
PubMed: 37438798
DOI: 10.1186/s13018-023-03924-0 -
Blood Advances Oct 2023Postpartum hemorrhage (PPH) is a leading cause of maternal morbi-mortality. Although obstetric risk factors are well described, the impact of predelivery hematologic and... (Meta-Analysis)
Meta-Analysis
Postpartum hemorrhage (PPH) is a leading cause of maternal morbi-mortality. Although obstetric risk factors are well described, the impact of predelivery hematologic and hemostatic biomarkers remains incompletely understood. In this systematic review, we aimed to summarize the available literature on the association between predelivery hemostatic biomarkers and PPH/severe PPH. Searching MEDLINE, EMBASE, and CENTRAL databases from inception to October 2022, we included observational studies on unselected pregnant women without bleeding disorder reporting on PPH and on predelivery hemostatic biomarkers. Two review authors independently performed title, abstract and full-text screening, upon which quantitative syntheses of studies reporting on the same hemostatic biomarker were conducted, calculating the mean difference (MD) between women with PPH/severe PPH and controls. A search on 18 October 2022 yielded 81 articles fitting our inclusion criteria. The heterogeneity between studies was considerable. With regard to PPH, the estimated average MD in the investigated biomarkers (platelets, fibrinogen, hemoglobin, Ddimer, activated partial thromboplastin time, and prothrombin time) were not statistically significant. Women who developed severe PPH had lower predelivery platelets than controls (MD = -26.0 109/L; 95% confidence interval, -35.8 to -16.1), whereas differences in predelivery fibrinogen concentration (MD = -0.31 g/L; 95% confidence interval, -0.75 to 0.13) and levels of factor XIII or hemoglobin were not statistically significant in women with and without severe PPH. Predelivery platelet counts were, on average, lower in women with severe PPH compared with controls, suggesting the potential usefulness of this biomarker for predicting severe PPH. This trial was registered at the International Prospective Register of Systematic Reviews as CRD42022368075.
Topics: Female; Pregnancy; Humans; Postpartum Hemorrhage; Hemostatics; Hemoglobins; Fibrinogen; Biomarkers
PubMed: 37307172
DOI: 10.1182/bloodadvances.2023010143 -
EClinicalMedicine May 2023Isolated pulmonary embolism (PE) appears to be associated with a specific clinical profile and sequelae compared to deep vein thrombosis (DVT)-associated PE. The...
BACKGROUND
Isolated pulmonary embolism (PE) appears to be associated with a specific clinical profile and sequelae compared to deep vein thrombosis (DVT)-associated PE. The objective of this study was to identify clinical characteristics that discriminate both phenotypes, and to characterize their differences in clinical outcome.
METHODS
We performed a systematic review and meta-analysis of studies comparing PE phenotypes. A systematic search of the electronic databases PubMed and CENTRAL was conducted, from inception until January 27, 2023. Exclusion criteria were irrelevant content, inability to retrieve the article, language other than English or German, the article comprising a review or case study/series, and inappropriate study design. Data on risk factors, clinical characteristics and clinical endpoints were pooled using random-effects meta-analyses.
FINDINGS
Fifty studies with 435,768 PE patients were included. In low risk of bias studies, 30% [95% CI 19-42%, = 97%] of PE were isolated. The Factor V Leiden [OR: 0.47, 95% CI 0.37-0.58, = 0%] and prothrombin G20210A mutations [OR: 0.55, 95% CI 0.41-0.75, = 0%] were significantly less prevalent among patients with isolated PE. Female sex [OR: 1.30, 95% CI 1.17-1.45, = 79%], recent invasive surgery [OR: 1.31, 95% CI 1.23-1.41, = 65%], a history of myocardial infarction [OR: 2.07, 95% CI 1.85-2.32, = 0%], left-sided heart failure [OR: 1.70, 95% CI 1.37-2.10, = 76%], peripheral artery disease [OR: 1.36, 95% CI 1.31-1.42, = 0%] and diabetes mellitus [OR: 1.23, 95% CI 1.21-1.25, = 0%] were significantly more frequently represented among isolated PE patients. In a synthesis of clinical outcome data, the risk of recurrent VTE in isolated PE was half that of DVT-associated PE [RR: 0.55, 95% CI 0.44-0.69, = 0%], while the risk of arterial thrombosis was nearly 3-fold higher [RR: 2.93, 95% CI 1.43-6.02, = 0%].
INTERPRETATION
Our findings suggest that isolated PE appears to be a specific entity that may signal a long-term risk of arterial thrombosis. Randomised controlled trials are necessary to establish whether alternative treatment regimens are beneficial for this patient subgroup.
FUNDING
None.
PubMed: 37152363
DOI: 10.1016/j.eclinm.2023.101973 -
BMC Gastroenterology Mar 2023The effectiveness of Helicobacter pylori (H. pylori) eradication depends on the treatment protocol. This study investigates the H. pylori eradication rate in Africa... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The effectiveness of Helicobacter pylori (H. pylori) eradication depends on the treatment protocol. This study investigates the H. pylori eradication rate in Africa using the best available evidence from databases.
METHODS
Databases were searched and results were pooled together. Heterogeneity between studies was assessed using I test statistics. Stata version 13 software was employed to compute the pooled eradication rate. In the subgroup analysis comparison, the finding is considered significant when the confidence intervals did not overlap.
RESULTS
Twenty-two studies from 9 African countries with a total population of 2,163 were included in this study. The pooled eradication rate of H. pylori was 79% (95% CI: 75%-82%), heterogeneity (I = 93.02%). In the subgroup analysis by study design, a higher eradication rate was reported from observational studies (85%, 95% CI: 79%-90%), compared to randomized control trials (77%, 95% CI: 73%-82%); by the duration of therapy, higher eradication rate was reported in 10-days regimen (88%, 95% CI: 84%-92%), compared to 7-days regimen (66%, 95% CI: 55%-77%); by country, the highest eradication rate was found in Ethiopia (90%; 95% CI: 87%-93%) and the lowest eradication rate was reported in Ivory Coast (22.3%; 95% CI:15%-29%); by type of H. pylori test, the highest eradication rate was reported when rapid urease test coupled with histology (88%, 95% CI: 77%-96%), and the lowest eradication rate was reported with histology alone (22.3%; 95% CI:15%-29%). Significant heterogeneity was observed with pooled prevalence (I = 93.02%, P < 0.000).
CONCLUSIONS
In Africa, the first-line therapy showed a variable eradication rate for H. pylori. This study demonstrates the necessity to optimize current H. pylori treatment regimens in each country, taking into account the antibiotic susceptibility. Future RCT studies with standardized regimens are warranted.
Topics: Humans; Helicobacter pylori; Helicobacter Infections; Ethiopia; Databases, Factual; Prothrombin Time; Randomized Controlled Trials as Topic
PubMed: 36882697
DOI: 10.1186/s12876-023-02707-5 -
Pharmaceutics Feb 2023Rivaroxaban has been widely used to prevent and treat various thromboembolic diseases for more than a decade. However, whether a lower dose of rivaroxaban is required... (Review)
Review
Rivaroxaban has been widely used to prevent and treat various thromboembolic diseases for more than a decade. However, whether a lower dose of rivaroxaban is required for Asians is still debatable. This review aimed to explore the potential ethnic difference in pharmacokinetic/pharmacodynamic (PK/PD) characteristics between Asians and Caucasians. A systematic search was conducted and twenty-four studies were identified, of which 10 were conducted on Asian adults, 11 on predominantly Caucasian adults, and 3 on Caucasian pediatrics. The apparent clearance (CL/F) of rivaroxaban in Caucasian adults with non-valvular atrial fibrillation (6.45-7.64 L/h) was about 31-43% higher than that in Asians (4.46-5.98 L/h) taking 10~20 mg rivaroxaban every 24 h. Moreover, there was no obvious difference in CL/F among Japanese, Chinese, Thai, and Irani people. Regarding PK/PD relationship, prothrombin time was linked to rivaroxaban concentration in a linear or near-linear manner, and Factor Xa activity was linked with the E model. The exposure-response relationship was comparable between Asians and Caucasians. Renal function has a significant influence on CL/F, and no covariate was recognized for exposure-response relationship. In conclusion, a lower dose of rivaroxaban might be required for Asians, and further studies are warranted to verify this ethnic difference to facilitate optimal dosing regimens.
PubMed: 36839909
DOI: 10.3390/pharmaceutics15020588 -
Frontiers in Public Health 2023The current 2019 novel coronavirus disease (COVID-19) pandemic is a major threat to global health. It is currently uncertain whether and how liver injury affects the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The current 2019 novel coronavirus disease (COVID-19) pandemic is a major threat to global health. It is currently uncertain whether and how liver injury affects the severity of COVID-19. Therefore, we conducted a meta-analysis to determine the association between liver injury and the severity of COVID-19.
METHODS
A systematic search of the PubMed, Embase, and Cochrane Library databases from inception to August 12, 2022, was performed to analyse the reported liver chemistry data for patients diagnosed with COVID-19. The pooled odds ratio (OR), weighted mean difference (WMD) and 95% confidence interval (95% CI) were assessed using a random-effects model. Furthermore, publication bias and sensitivity were analyzed.
RESULTS
Forty-six studies with 28,663 patients were included. The pooled WMDs of alanine aminotransferase (WMD = 12.87 U/L, 95% CI: 10.52-15.23, = 99.2%), aspartate aminotransferase (WMD = 13.98 U/L, 95% CI: 12.13-15.83, = 98.2%), gamma-glutamyl transpeptidase (WMD = 20.67 U/L, 95% CI: 14.24-27.10, = 98.8%), total bilirubin (WMD = 2.98 μmol/L, 95% CI: 1.98-3.99, = 99.4%), and prothrombin time (WMD = 0.84 s, 95% CI: 0.46-1.23, = 99.4%) were significantly higher and that of albumin was lower (WMD = -4.52 g/L, 95% CI: -6.28 to -2.75, = 99.9%) in severe cases. Moreover, the pooled OR of mortality was higher in patients with liver injury (OR = 2.72, 95% CI: 1.18-6.27, = 71.6%).
CONCLUSIONS
Hepatocellular injury, liver metabolic, and synthetic function abnormality were observed in severe COVID-19. From a clinical perspective, liver injury has potential as a prognostic biomarker for screening severely affected patients at early disease stages.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/, Identifier: CRD42022325206.
Topics: Humans; COVID-19; Liver; SARS-CoV-2
PubMed: 36817905
DOI: 10.3389/fpubh.2023.1003352 -
Revista de Salud Publica (Bogota,... May 2020To identify the procoagulant phenomenon in SARS-CoV-2 patients and propose sustainable therapeutic guidance for low-income countries.
OBJECTIVE
To identify the procoagulant phenomenon in SARS-CoV-2 patients and propose sustainable therapeutic guidance for low-income countries.
METHODS
A systematic review was conducted. It identified 5 observational studies from a scrutiny from 78 results. 712 patients were examined and the results were grouped according to mortality and severity. The comparison of the groups was interpreted using descriptive statistics.
RESULTS
D-dimer values were significantly associated with greater severity and mortality. Prothrombin was associated in some observations with higher mortality, but in terms of severity it was inconclusive.
CONCLUSION
COVID-19 disease has significant procoagulant activity and its timely treatment can alter the prognosis. The explored evidence supports sustainable methods. More evidence is needed to improve management. An early systematic approach to patients with sustainable therapeutic measures tailored to the health system is recommended.
Topics: Humans; COVID-19; SARS-CoV-2; Anticoagulants; Clinical Reasoning
PubMed: 36753166
DOI: 10.15446/rsap.V22n3.87321 -
Therapeutic Advances in Neurological... 2023Intravenous thrombolysis (IVT) is standard of care for disabling acute ischemic stroke (AIS) within a time window of ⩽ 4.5 h. Some AIS patients cannot be treated...
BACKGROUND AND AIMS
Intravenous thrombolysis (IVT) is standard of care for disabling acute ischemic stroke (AIS) within a time window of ⩽ 4.5 h. Some AIS patients cannot be treated with IVT due to limiting contraindications, including heparin usage in an anticoagulating dose within the past 24 h or an elevated activated prothrombin time (aPTT) > 15 s. Protamine is a potent antidote to unfractionated heparin.
OBJECTIVES
The objective of this study was to investigate the safety and efficacy of IVT in AIS patients after antagonization of unfractionated heparin with protamine.
METHODS
Patients from our stroke center (between January 2015 and September 2021) treated with IVT after heparin antagonization with protamine were analyzed. National Institutes of Health Stroke Scale (NIHSS) was used for stroke severity and modified Rankin Scale (mRS) for outcome assessment. Substantial neurological improvement was defined as the difference between admission and discharge NIHSS of ⩾8 or discharge NIHSS of ⩽1. Good outcome at follow-up after 3 months was defined as mRS 0-2. Safety data were obtained for mortality, symptomatic intracerebral hemorrhage (sICH), and for adverse events due to protamine. Second, a systematic review was performed searching PubMed and Scopus for studies and case reviews presenting AIS patients treated with IVT after heparin antagonization with protamine. The search was limited from January 1, 2011 to September 29, 2021. Furthermore, we conducted a propensity score matching comparing protamine-treated patients to a control IVT group without protamine (ratio 2:1, match tolerance 0.2).
RESULTS
A total of 16 patients, 5 treated in our hospital and 11 from literature, [65.2 ± 13.1 years, 37.5% female, median premorbid mRS (pmRS) 1 (IQR 1, 4)] treated with IVT after heparin antagonization using protamine were included and compared to 31 IVT patients [76.2 ± 10.9 years, 45% female, median pmRS 1 (IQR 0, 2)]. Substantial neurological improvement was evident in 68.8% of protamine-treated patients 38.7% of control patients ( = 0.028). Good clinical outcome at follow-up was observed in 56.3% 58.1% of patients ( = 0.576). No adverse events due to protamine were reported, one patient suffered sICH after secondary endovascular thrombectomy of large vessel occlusion. Mortality was 6.3% 22.6% ( = 0.236).
CONCLUSION
IVT after heparin antagonization with protamine seems to be safe and, prospectively, may extend the number of AIS patients who can benefit from reperfusion treatment using IVT. Further prospective registry trials would be helpful to further investigate the clinical applicability of heparin antagonization.
PubMed: 36710724
DOI: 10.1177/17562864221149249 -
Thrombosis and Haemostasis Jan 2023Long-term anticoagulation is used worldwide to prevent or treat thrombotic events. Anticoagulant therapy using vitamin K antagonists (VKAs) is well established; however,... (Meta-Analysis)
Meta-Analysis
Long-term anticoagulation is used worldwide to prevent or treat thrombotic events. Anticoagulant therapy using vitamin K antagonists (VKAs) is well established; however, anticoagulants carry an increased risk of potentially life-threatening bleeding. In cases of bleeding or need for surgery, patients require careful management, balancing the need for rapid anticoagulant reversal with risk of thromboembolic events. Prothrombin complex concentrates (PCCs) replenish clotting factors and reverse VKA-associated coagulopathy. Two forms of PCC, 3-factor (3F-PCC) and 4-factor (4F-PCC), are available. Using PRISMA methodology, we systematically reviewed whether 4F-PCC is superior to 3F-PCC for the reversal of VKA-associated coagulopathy. Of the 392 articles identified, 48 full texts were reviewed, with 11 articles identified using criteria based on the PICOS format. Data were captured from 1,155 patients: 3F-PCC, = 651; 4F-PCC, = 504. ROBINS-I was used to assess bias. Nine studies showed international normalized ratio (INR) normalization to a predefined goal, ranging from ≤1.5 to ≤1.3, following PCC treatment. Meta-analysis of the data showed that 4F-PCC was favorable compared with 3F-PCC overall (odds ratio [OR]: 3.50; 95% confidence interval [CI]: 1.88-6.52, < 0.0001) and for patients with a goal INR of ≤1.5 or ≤1.3 (OR: 3.45; 95% CI: 1.42-8.39, = 0.006; OR: 3.25; 95% CI: 1.30-8.13, = 0.01, respectively). However, heterogeneity was substantial ( = 62%, = 70%, = 64%). Neither a significant difference in mortality (OR: 0.72; 95% CI: 0.42-1.24, = 0.23) nor in thromboembolisms was reported. These data suggest that 4F-PCC is better suited than 3F-PCC for the treatment of patients with VKA-associated coagulopathy, but further work is required for a definitive recommendation.
Topics: Humans; Vitamin K; Blood Coagulation Factors; Anticoagulants; Blood Coagulation Disorders; Hemorrhage; Factor IX; Thromboembolism; Fibrinolytic Agents; International Normalized Ratio; Retrospective Studies
PubMed: 36626899
DOI: 10.1055/s-0042-1758653 -
JHEP Reports : Innovation in Hepatology Jan 2023The risk of serious clinical outcomes following cessation of nucleos(t)ide analogues (NUCs) in individuals with chronic hepatitis B remains poorly characterized. This...
BACKGROUND & AIMS
The risk of serious clinical outcomes following cessation of nucleos(t)ide analogues (NUCs) in individuals with chronic hepatitis B remains poorly characterized. This systematic review and meta-analysis aimed to evaluate current literature on this issue.
METHODS
We searched PubMed, Embase, and Web of Science for NUC stop studies that noted clinical outcomes published between January 1, 2006 and August 18, 2022. We performed meta-research analyses to examine the relationships of reported outcomes with study designs and characteristics and also pooled studies with non-overlapping populations to provide risk estimates for the proportions of (1) severe hepatitis flares or hepatic decompensation or (2) hepatitis flare-related death or liver transplantation.
RESULTS
The meta-research analysis included 50 studies of highly heterogeneous designs and characteristics. We found that reporting of safety outcomes varied widely according to outcome definition, follow-up duration, and sample size. Only ten studies prespecified safety events as the study outcome, and only four had an outcome definition to include hepatic insufficiency, a follow-up duration >12 months, and a sample size >100 patients. We further pooled 15 studies with 4,525 individuals and estimated that severe hepatitis flares or decompensation would occur in 1.21% (95% CI 0.70-2.08%), with significant heterogeneity ( = 54%, <0.01), while hepatitis flare-related death or liver transplantation would occur in 0.37% (95% CI 0.20-0.67%), without significant heterogeneity ( = 0.00%, = 1.00).
CONCLUSIONS
Current literature on the risk of serious clinical outcomes following NUC cessation is very limited and highly heterogeneous. Pooled analyses of available data found approximately 1% of patients who stopped NUCs developed severe flares or hepatic decompensation.
IMPACT AND IMPLICATIONS
Current literature regarding the safety concerns surrounding NUC cessation for individuals with chronic hepatitis B is limited and heterogeneous in designs and characteristics, and thus should be interpreted with great caution. Based on currently available data, the proportion of patients that develop severe hepatitis flares or hepatic decompensation was estimated at 1.21% and that of flare-related death or liver transplantation at 0.37%. Our findings are important for individuals receiving nucleos(t)ide analogues for hepatitis B virus infection because we not only pooled currently available data to estimate the risk of serious clinical adverse events following treatment cessation but also uncovered critical limitations of existing literature regarding the safety of finite therapy.
PubMed: 36466989
DOI: 10.1016/j.jhepr.2022.100617