Aim. The study focused on the analysis of short-term results of aortic arch reconstruction in patients undergoing open heart surgery for ascending aortic aneurysms and dissections, comparison of intra-operative brain protection methods and verification of predictors of complications.Methods. 84 patients (mean age 55.5 ± 11.5 years, 72.6 % (61) males) with ascending aortic aneurysms and Stanford type A ascending aortic and arch dissections underwent surgery over a period from January, 2013, to March, 2015. Patients were divided into 3 groups. The 1st group included patients with ascending aortic aneurysm combined with aortic dilatation at the level of innominate artery >4.0 cm (n = 41). The 2nd group consisted of patients with Stanford type A acute ascending aortic and arch dissection (n = 25). In the 3rd group there were patients with type A chronic ascending aortic and arch dissection (n = 18). No significant differences between the groups were observed. Mean values of the maximum ascending aortic diameter did not differ significantly and were 59.6, 58.4 and 62.4 mm in the 1st, 2nd and 3rd groups, respectively. 3 patients from the 2nd group presented with acute heart failure, 6 – acute myocardial infarction, and 3 – stroke. Higher values of pressure gradient on the aortic valve were registered in the 1st group, as compared to those in the 2nd and 3rd groups (mean value of the peak gradient was 4.5, 8.1 and 12.4 mm Hg, respectively). EuroSCORE II value in the 1st , 2nd and 3rd groups was 9.4 %, 17.7 % and 5.8 %, respectively. Results. Overall hospital mortality was 1.2 %: 1 patient with acute type A aortic dissection and later dissection of innominate artery developed stroke and died due to multiple organ failure. More prolonged cardiopulmonary bypass time and aortic cross-clamp time were required for patients with acute ascending aortic dissections, but the total surgery time and circulatory arrest time differed significantly only in the 2nd and 3rd groups. Lengthy inotropic support, ventilation time and total ICU stay, as well as a higher rate of neurologic disorders in patients with aortic dissections in comparison with patients with aneurysms were observed. We verified correlation of the urgent type of surgery, acute type A aortic dissection, including arch and descending thoracic aortic dissection, also with dissection of cervicocerebral arteries, with a more complicated hospital period, increased inotropic support and prolonged duration of stay in the intensive care unit.Conclusion. Hemiarch repair of aortic arch dilatation in case of ascending aortic replacement is an effective and safe method of treatment of extended ascending aortic aneurysms and dissections. Unilateral anterograde cerebral perfusion with simultaneous crossclamping of contralateral common carotid artery allows to maintain effective cerebral protection in conditions of moderate hypothermia and duration of circulatory arrest for at least 30-40 minutes. Adverse prognostic factors are urgent surgery, ascending aortic, arch and descending thoracic aortic dissection, prolonged extracorporeal circulation and myocardial ischemia, and disuse of the axillary artery for cannulation.Received 6 October 2016. Accepted 24 November 2016.Funding: The study was carried out within the government’s task for 2015-2017, “Cardiovascular pathologies”, theme No. 4 “Research on genome and cellular mechanisms of formation of aorta and aortic valve pathology and development of new methods for its treatment including hybrid technologies”.Conflict of interest: The authors declare no conflict of interest.Author contributionsMaterial acquisition and analysis: Gordeev M.L., Uspenskiy V.E., Bakanov A.Y., Volkov V.V., Ibragimov A.N., Scherbinin T.S., Irtyuga O.B., Naimushin A.V. Article writing: Gordeev M.L., Uspenskiy V.E., Bakanov A.Y. Review & editing: Gordeev M.L., Naimushin A.V.AcknowledgmentThe authors express their gratitude for support in diagnostics and management of patients with aortic abnormalities to I. V. Basek, PhD, Head of X-Ray CT Department, and to the employees of X-ray CT Department; to D.A. Zverev, PhD, Head of X-ray Endovascular Surgery Research Lab and the employees of X-ray Endovascular Surgery Departments; O.M. Moiseyeva, Doc. Sci. (Medicine), Head of Noncoronarogenic Heart Diseases Department and her employees, as well as to the employees of Anesthesiology & Resuscitation and Cardiovascular Surgery Departments.
BACKGROUND: Peripheral arterial disease (PAD), caused by narrowing of the arteries in the limbs, is increasing in incidence and prevalence as our population is ageing and as diabetes is becoming more prevalent. PAD can cause pain in the limbs while walking, known as intermittent claudication, or can be more severe and cause pain while at rest, ulceration, and ultimately gangrene and limb loss. This more severe stage of PAD is known as 'critical limb ischaemia'. Treatments for PAD include medications that help to reduce the increased risk of cardiovascular events and help improve blood flow, as well as endovascular or surgical repair or bypass of the blocked arteries. However, many people are unresponsive to medications and are not suited to surgical or endovascular treatment, leaving amputation as the last option. Gene therapy is a novel approach in which genetic material encoding for proteins that may help increase revascularisation is injected into the affected limbs of patients. This type of treatment has been shown to be safe, but its efficacy, especially regarding ulcer healing, effects on quality of life, and other symptomatic outcomes remain unknown. OBJECTIVES: To assess the effects of gene therapy for symptomatic peripheral arterial disease. SEARCH METHODS: The Cochrane Vascular Information Specialist searched Cochrane CENTRAL, the Cochrane Vascular Specialised Register, MEDLINE Ovid, Embase Ovid, CINAHL, and AMED, along with trials registries (all searched 27 November 2017). We also checked reference lists of included studies and systematic reviews for further studies. SELECTION CRITERIA: We included randomised and quasi-randomised studies that evaluated gene therapy versus no gene therapy in people with PAD. We excluded studies that evaluated direct growth hormone treatment or cell-based treatments. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, performed quality assessment, and extracted data from the included studies. We collected pertinent information on each study, as well as data for the outcomes of amputation-free survival, ulcer healing, quality of life, amputation, all-cause mortality, ankle brachial index, symptom scores, and claudication distance. MAIN RESULTS: We included in this review a total of 17 studies with 1988 participants (evidence current until November 2017). Three studies limited their inclusion to people with intermittent claudication, 12 limited inclusion to people with varying levels of critical limb ischaemia, and two included people with either condition. Study investigators evaluated many different types of gene therapies, using different protocols. Most studies evaluated growth factor-encoding gene therapy, with six studies using vascular endothelial growth factor (VEGF)-encoding genes, four using hepatocyte growth factor (HGF)-encoding genes, and three using fibroblast growth factor (FGF)-encoded genes. Two studies evaluated hypoxia-inducible factor 1-alpha (HIF-1α) gene therapy, one study used a developmental endothelial locus-1 gene therapy, and the final study evaluated a stromal cell-derived factor-1 (SDF-1) gene therapy. Most studies reported outcomes after 12 months of follow-up, but follow-up ranged from three months to two years.Overall risk of bias varied between studies, with many studies not providing sufficient detail for adequate determination of low risk of bias for many domains. Two studies did not utilise a placebo control, leading to risk of performance bias. Several studies reported in previous protocols or in their Methods sections that they would report on certain outcomes for which no data were then reported, increasing risk of reporting bias. All included studies reported sponsorships from corporate entities that led to unclear risk of other bias. The overall quality of evidence ranged from moderate to very low, generally as the result of heterogeneity and imprecision, with few or no studies reporting on outcomes.Evidence suggests no clear differences for the outcomes of amputation-free survival, major amputation, and all-cause mortality between those treated with gene therapy and those not receiving this treatment (all moderate-quality evidence). Low-quality evidence suggests improvement in complete ulcer healing with gene therapy (odds ratio (OR) 2.16, 95% confidence interval (CI) 1.02 to 4.59; P = 0.04). We could not combine data on quality of life and can draw no conclusions at this time regarding this outcome (very low-quality evidence). We included one study in the meta-analysis for ankle brachial index, which showed no clear differences between treatments, but we can draw no overall association (low-quality evidence). We combined in a meta-analysis pain symptom scores as assessed by visual analogue scales from two studies and found no clear differences between treatment groups (very low-quality evidence). We carried out extensive subgroup analyses by PAD classification, dosage schedule, vector type, and gene used but identified no substantial differences. AUTHORS' CONCLUSIONS: Moderate-quality evidence shows no clear differences in amputation-free survival, major amputation, and all-cause mortality between those treated with gene therapy and those not receiving gene therapy. Some evidence suggests that gene therapy may lead to improved complete ulcer healing, but this outcome needs to be explored with improved reporting of the measure, such as decreased ulcer area in cm², and better description of ulcer types and healing. Further standardised data that are amenable to meta-analysis are needed to evaluate other outcomes such as quality of life, ankle brachial index, symptom scores, and claudication distance.
Background Coronary artery bypass grafting (CABG) is known to improve heart function and quality of life, while rates of surgery-related mortality are low. However, delirium and cognitive decline are common complications. We sought to identify preoperative, intraoperative, and postoperative risk or protective factors associated with delirium and cognitive decline (across time) in patients undergoing CABG. Methods and Results We conducted a systematic search of Medline, PsycINFO, EMBASE, and Cochrane (March 26, 2019) for peer-reviewed, English publications reporting post-CABG delirium or cognitive decline data, for at least one risk factor. Random-effects meta-analyses estimated pooled odds ratio for categorical data and mean difference or standardized mean difference for continuous data. Ninety-seven studies, comprising data from 60 479 patients who underwent CABG, were included. Moderate to large and statistically significant risk factors for delirium were as follows: (1) preoperative cognitive impairment, depression, stroke history, and higher European System for Cardiac Operative Risk Evaluation (EuroSCORE) score, (2) intraoperative increase in intubation time, and (3) postoperative presence of arrythmia and increased days in the intensive care unit; higher preoperative cognitive performance was protective for delirium. Moderate to large and statistically significant risk factors for acute cognitive decline were as follows: (1) preoperative depression and older age, (2) intraoperative increase in intubation time, and (3) postoperative presence of delirium and increased days in the intensive care unit. Presence of depression preoperatively was a moderate risk factor for midterm (1-6 months) post-CABG cognitive decline. Conclusions This meta-analysis identified several key risk factors for delirium and cognitive decline following CABG, most of which are nonmodifiable. Future research should target preoperative risk factors, such as depression or cognitive impairment, which are potentially modifiable. Registration URL: https://www.crd.york.ac.uk/prospero/; Unique identifier: CRD42020149276.
Background: Vascular graft infection is a severe cardiovascular complication with high mortality rates. Antibacterial vascular graft coatings are widely used and continue to be improved.Objective: To develop a sealant with antimicrobial effect for Dacron vascular grafts and experimentally test the coating properties.Methods: We used 2 types of vascular grafts: graft No. 1 (plain weave) with initial water permeability of 78.8 ± 2.7 mL/cm2/min and graft No. 2 (2/1 twill + 6/4 satin weave) with water permeability of 549.8 ± 20.7 mL/cm2/min. We developed an original gelatin impregnation technique, tested it using a scanning electron microscopy, and measured water permeability and kink radius. We evaluated the antibacterial activity of vancomycin and gelatin impregnation by the disk diffusion test using media with Staphylococcus aureus ATCC 29213 and Enterococcus faecalis ATCC 29212 and measured inhibition zones after 24-hour incubation. We used samples cut out of grafts with vancomycin-containing (experimental group) and no vancomycin-containing (control group) impregnation.Results: The gelatin coating of the samples is visualized as a thin even film and provides zero water permeability. On the negative side, it increased stiffness and the kink radius. Thanks to vancomycin added to the coating, bacterial growth significantly inhibits: the mean diameter of the growth inhibition zone for Staphylococcus aureus and Enterococcus faecalis was 15.60 ± 0.65 and 14.40 ± 0.66 mm, respectively. The grafts untreated with vancomycin showed no growth inhibition zones.Conclusion: Vascular graft treatment with gelatin impregnation and vancomycin solution is a simple measure to prevent the growth of gram-positive bacteria on vascular grafts. Received 14 November 2022. Revised 15 December 2022. Accepted 19 December 2022. Funding: The work was supported by Russian Science Foundation (project No. 22-15-20005). Conflict of interest: The authors declare no conflict of interest. Contribution of the authorsConception and study design: I.Yu. Zhuravleva, A.A. Shadanov, D.A. SirotaData collection and analysis: A.A. Shadanov, L.M. Samoylova, S.V. Vladimirov, T.P. Timchenko, N.E. Luchnikov, E.V. KarpovaStatistical analysis: A.A. ShadanovDrafting the article: A.A. Shadanov, L.M. Samoylova, T.P. Timchenko, A.G. EdemskiyCritical revision of the article: D.A. Sirota, I.Yu. Zhuravleva, A.V. Bogachev-Prokofiev, A.M. ChernyavskiyFinal approval of the version to be published: A.A. Shadanov, I.Yu. Zhuravleva, L.M. Samoylova, T.P. Timchenko, S.V. Vladimirov, E.V. Karpova, N.E. Luchnikov, D.A. Sirota, A.G. Edemskiy, A.V. Bogachev-Prokofiev, A.M. Chernyavskiy
BACKGROUND: Peripheral artery disease (PAD) is associated with a high clinical and socioeconomic burden. Treatments to alleviate the symptoms of PAD and decrease the risks of amputation and death are a high societal priority. A number of growth factors have shown a potential to stimulate angiogenesis. Growth factors delivered directly (as recombinant proteins), or indirectly (e.g. by viral vectors or DNA plasmids encoding these factors), have emerged as a promising strategy to treat patients with PAD. OBJECTIVES: To assess the effects of growth factors that promote angiogenesis for treating people with PAD of the lower extremities. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Specialised Register (June 2016) and CENTRAL (2016, Issue 5). We searched trial registries for details of ongoing or unpublished studies. We also checked the reference lists of relevant publications and, if necessary, tried to contact the trialists for details of the studies. SELECTION CRITERIA: We included randomised controlled trials comparing growth factors (delivered directly or indirectly) with no intervention, placebo or any other intervention not based on the growth factor's action in patients with PAD of the lower extremities. The primary outcomes were limb amputation, death and adverse events. The secondary outcomes comprised walking ability, haemodynamic measures, ulceration and rest pain. DATA COLLECTION AND ANALYSIS: statistic and Cochrane's Q test. We conducted meta-analysis for the overall effect and for each growth factor as a subgroup analysis using OR in a fixed-effect model. We evaluated the robustness of the results in a sensitivity analysis using risk ratio (RR) and/or a random-effects model. We also assessed the quality of the evidence for each outcome. MAIN RESULTS: We included 20 trials in the review and used 14 studies (on approximately 1400 participants) with published results in the analyses. Six published studies compared fibroblast growth factors (FGF), four studies hepatocyte growth factors (HGF) and another four studies vascular endothelial growth factors (VEGF), versus placebo or no therapy. Six of these studies exclusively or mainly investigated participants with intermittent claudication and eight studies exclusively participants with critical limb ischaemia. Follow-up generally ranged from three months to one year. Two small studies provided some data at 2 years and one of them also at 10 years.The direction and size of effects for growth factors on major limb amputations (OR 0.99, 95% CI 0.71 to 1.38; 10 studies, N = 1075) and death (OR 0.99, 95% CI 0.69 to 1.41; 12 studies, N = 1371) at up to two years are uncertain. The quality of the evidence is low due to risk of bias and imprecision (at one year, moderate-quality evidence due to imprecision). However, growth factors may decrease the rate of any limb amputations (OR 0.56, 95% CI 0.31 to 0.99; 6 studies, N = 415). The quality of the evidence is low due to risk of bias and selective reporting.The direction and size of effects for growth factors on serious adverse events (OR 1.09, 95% CI 0.79 to 1.50; 13 studies, N = 1411) and on any adverse events (OR 1.10, 95% CI 0.73 to 1.64; 4 studies, N = 709) at up to two years are also uncertain. The quality of the evidence is low due to risk of bias and imprecision (for serious adverse events at one year, moderate-quality evidence due to imprecision).Growth factors may improve haemodynamic measures (low-quality evidence), ulceration (very low-quality evidence) and rest pain (very low-quality evidence) up to one year, but they have little or no effect on walking ability (low-quality evidence). We did not identify any relevant differences in effects between growth factors (FGF, HGF and VEGF). AUTHORS' CONCLUSIONS: The results of this review do not support the use of therapy with the growth factors FGF, HGF or VEGF in people with PAD of the lower extremities to prevent death or major limb amputation or to improve walking ability. However, the use of these growth factors may improve haemodynamic measures and decrease the rate of any limb amputations (probably due to preventing minor amputations) with an uncertain effect on adverse events; an improvement of ulceration and rest pain is very uncertain. New trials at low risk of bias are needed to generate evidence with more certainty.
Abstract Vascular transplantation is a widely employed surgical approach for treating cardiovascular diseases (CVDs). However, artificial vascular grafts exhibit high thrombogenicity. Consequently, developing grafts with enhanced antithrombotic properties represents a critical strategy for addressing CVD-related complications. In this study, double-layered vascular grafts were fabricated via electrospinning, featuring a polycaprolactone (PCL)/zwitterionic polyurethane (sulfobetaine polyurethane [SBPU]) inner layer and a pure PCL outer layer, followed by covalent heparin modification. Fiber surface morphology and chemical composition were characterized using scanning electron microscopy and Fourier-transform infrared spectroscopy, respectively. Evaluations included contact angle measurement, mechanical testing, protein/platelet adsorption assays, cytotoxicity assessment, and degradation analysis to determine antithrombotic performance and biocompatibility. Results demonstrated that heparin-modified PCL containing 20 wt% SBPU (PCLH/SBPU20) exhibited exceptional hydrophilicity, potent antithrombotic effects, superior anti-protein adsorption, favorable anticoagulant properties, and non-cytotoxicity. Among all samples, PCLH/SBPU20 demonstrated optimal comprehensive performance, positioning it as a promising candidate for clinical vascular graft applications.
Surgery of the aorta remains the most difficult and most dynamic part of cardiovascular surgery. Aortic aneurysm surgery had passed through several stages: from non-reconstructive, when the improvised tools were used to decrease the risk of aorta-related complications, to endovascular one. Aortic valve surgery being the essential part of aortic surgery developed dramatically as well. However, open procedures still remain the gold standard for aortic surgery. Visceral protection methods and devices develop.The review follows main achievements for reconstructive surgery of aortic diseases and aortic valve lesions. It elucidates only vital and successful procedures performed by outstanding specialists for the first time. Moreover, the contribution of Soviet and Russian surgeons is shown.Received 11 July 2017. Accepted 21 July 2017.Funding: The study did not have sponsorship.Conflict of interest: The authors declare no conflict of interests.
Abstract Importance Transparency and data sharing are valuable practices in research, contributing to improved precision and flexibility in cumulative evidence; and ultimately expanding the research ecosystem by addressing one of the philosophical research norms that implies that knowledge belongs to society. Objectives The objective of the Reproducibility Policies In Cardiology Journals (REPLICA) study was to estimate the proportions of policies and guidance for reproducibility and transparency practices among Cardiology journals, as well as to determine details of completeness of reporting and data sharing conditions whenever disclosed. Design Cross-sectional analysis. Setting Cross-sectional study through analyses of journals deposited in the National Library of Medicine (NLM) Catalog tagged with the “ Cardiology ” and “ Vascular Diseases ” entry terms. Eligibility Criteria Cardiology journals from the NLM Catalog database that published at least one randomized clinical trial in 2018. Journals that published articles in English, Spanish, French, or Portuguese and were available in MEDLINE/PubMed were eligible for inclusion. Exposures The exposures were mainly related to journal’s characteristics such as publisher operations characteristics (e.g., journal access only by subscription), indexation in the DOAJPlus, requirement for registration for RCTs, and others. Main outcomes and measures We prespecified a primary composite outcome composed of data-sharing policy or guidance. Secondary outcomes were proportions of reporting guidelines within the journal’s instructions for the author’s section (e.g., CONSORT), and also other components of sharing practices. Results We assessed 148 journals. Of them, 74 (50.0%, 95%CI 41.9% to 58.1%) presented policy or guidance for data sharing. We found guidance for data sharing in 68 journals (47.5% 95%CI 39.4% to 55.8%). Notably, among them, only two mentioned sharing individual participant data (IPD). Regarding guidelines for article reporting, we identified that 132 journals displayed guidance for authors, in which 27 (20.45%, 95%CI 14.34% to 28.29%) had CONSORT and EQUATOR Network guidance content. Conclusion and relevance In summary, we found a mild proportion of policies and guidance for data-sharing. Moreover, transparency practices inclined to RCTs are suboptimal, as mirrored by the very low prevalence of IPD data-sharing policy and guidance as well as specific reporting guidelines instructions for RCTs. Key Points Question What is the proportion of journals displaying policies and guidance about data sharing in cardiology journals? Findings We found a low prevalence of policy and guidance for data sharing in Cardiology journals, as well as transparency and reproducibility practices; details, individual participant data sharing, registration, and completeness of reporting, for example. Meaning Journals play a role in driving reproducibility and transparency among scientific areas. Stakeholders involved in the editorial processes should be open to understand the valuable impact of data-sharing practices and learn how to implement such mechanisms, that being the case.
Aim. The aim of this study is to show the outcomes of an open intervention on the ascending aorta and arch combined with stenting of aorta in type I aortic dissection.Methods. 6 patients with type I aortic dissection underwent implantation of Djumbodis® Dissection System bare stents at I.M. Sechenov First Moscow Medical University’s Aortic and Cardiovascular Surgery Clinic. In 4 patients, aortic stenting was combined with ascending aorta replacement, in 1 patient, hemiarch ascending aorta and arch replacement was performed and in 1 patient aorta and arch replacement was complemented with a Sun procedure.Results. Total operation time, cardiopulmonary bypass time, cross clamp time and hypothermic circulatory arrest time were just similar to those performed in conventional open surgery. There were no intraoperative deaths in this series. 30-day mortality was 16.7 % (1 patient). The patient died because of progressive respiratory and cardiovascular failure, encephalopathy, and gastrointestinal bleeding. 1 patient had acute renal failure and left leg ischemia because of the false lumen thrombosis, 1 patient suffered from cardiac tamponade and 1 patient underwent prolonged mechanical ventilation. Total false lumen thrombosis developed in 1 patient, 4 patients had partial false lumen thrombosis, and in 1 patient the false lumen remained patent.Conclusion. Stenting of aortic arch and descending aorta is a good alternative to aortic arch replacement in type I aortic dissection. It promotes stabilization of false and true lumen diameters and global aortic diameter.Received 18 October 2016. Accepted 7 November 2016.Funding: The study had no sponsorship.Conflict of interest: The authors declare no conflict of interest.Author contributionsConceptualization and study design: Komarov R.N., Soborov M.A.Material acquisition and analysis: Karavaykin P.A. Project curation: Komarov R.N., Belov Yu.V.Article writing: Karavaykin P.A. Review & editing: Komarov R.N., Belov Yu.V., Soborov M.A.
Percutaneous coronary intervention is the main strategy of revascularization and has been shown to improve outcomes in some patients with ST-segment elevation myocardial infarction (STEMI). However, multivessel disease (MVD), a common condition in these patients, is associated with worse clinical outcomes compared to single-vessel disease. Despite intervention being a standard treatment for coronary artery disease, optimal strategies and timings for patients with STEMI and MVD remain unclear. Numerous studies and meta-analyses have investigated this topic; however, many current conclusions are based on observational studies. Furthermore, clinical guidelines regarding the management of patients with STEMI and MVD contain conflicting recommendations. Therefore, we aimed to compile relevant studies and newly available evidence-based medicines to explore the most effective approach.
BACKGROUND: Chronic venous insufficiency (CVI) is a common condition caused by valvular dysfunction with or without associated obstruction, usually in the lower limbs. It might result in considerable discomfort with symptoms such as pain, itchiness and tiredness in the legs. Patients with CVI may also experience swelling and ulcers. Phlebotonics are a class of drugs often used to treat CVI. This is an update of a review first published in 2005. OBJECTIVES: To assess the efficacy and safety of phlebotonics administered both orally and topically for treatment of signs and symptoms of lower extremity CVI. SEARCH METHODS: For this update, the Cochrane Vascular Trials Search Co-ordinator (TSC) searched the Specialised Register (August 2015), as well as the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 7). The reference lists of the articles retrieved by electronic searches were searched for additional citations. We also contacted pharmaceutical companies and searched the World Health Organization (WHO) International Clinical Trials Registry Platform Search Portal for ongoing studies (last searched in August 2015). SELECTION CRITERIA: Randomised, double-blind, placebo-controlled trials (RCTs) assessing the efficacy of rutosides, hidrosmine, diosmine, calcium dobesilate, chromocarbe, Centella asiatica, disodium flavodate, french maritime pine bark extract, grape seed extract and aminaftone in patients with CVI at any stage of the disease. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the quality of included RCTs. We estimated the effects of treatment by using risk ratios (RRs), mean differences (MDs) and standardised mean differences (SMDs), according to the outcome assessed. We calculated 95% confidence interval (CIs) and percentage of heterogeneity (I(2)). Additionally, we performed sensitivity analyses. MAIN RESULTS: We included 66 RCTs of oral phlebotonics, but only 53 trials provided quantifiable data (involving 6013 participants; mean age 50 years) for the efficacy analysis: 28 for rutosides, 10 hidrosmine and diosmine, nine calcium dobesilate, two Centella asiatica, two aminaftone, two french maritime pine bark extract and one grape seed extract. No studies evaluating topical phlebotonics, chromocarbe, naftazone or disodium flavodate fulfilled the inclusion criteria.Moderate-quality evidence suggests that phlebotonics reduced oedema in the lower legs compared with placebo. Phlebotonics showed beneficial effects among participants including reduced oedema (RR 0.70, 95% CI 0.63 to 0.78; I(2) = 20%; 1245 participants) and ankle circumference (MD -4.27 mm, 95% CI -5.61 to -2.93 mm; I(2) = 47%; 2010 participants). Low-quality evidence reveals no difference in the proportion of ulcers cured with phlebotonics compared with placebo (RR 0.94, 95% CI 0.79 to 1.13; I(2) = 5%; 461 participants). In addition, phlebotonics showed greater efficacy for trophic disorders, cramps, restless legs, swelling and paraesthesia, when compared with placebo. We identified heterogeneity for the variables of pain, itching, heaviness, quality of life and global assessment by participants. For quality of life, it was not possible to pool the studies because heterogeneity was high. However, high-quality evidence suggests no differences in quality of life for calcium dobesilate compared with placebo (MD -0.60, 95% CI -2.15 to 0.95; I(2) = 40%; 617 participants), and low-quality evidence indicates that in the aminaftone group, quality of life was improved over that reported in the placebo group (MD -10.00, 95% CI -17.01 to - 2.99; 79 participants). Moderate-quality evidence shows that the phlebotonics group had greater risk of non-severe adverse events than the placebo group (RR 1.21, 95% CI 1.05 to 1.41; I(2) = 0; 3975 participants). Gastrointestinal disorders were the most frequently reported adverse events. AUTHORS' CONCLUSIONS: Moderate-quality evidence shows that phlebotonics may have beneficial effects on oedema and on some signs and symptoms related to CVI such as trophic disorders, cramps, restless legs, swelling and paraesthesia when compared with placebo but can produce more adverse effects. Phlebotonics showed no differences compared with placebo in ulcer healing. Additional high-quality RCTs focused on clinically important outcomes are needed to improve the evidence base.
Objective: This study aims to elucidate the mechanism of Xuefu Zhuyu decoction (XFZY) in treating lower limb venous thrombosis (LLVT) using network pharmacology and molecular docking technology.Methods: The active ingredients and corresponding targets of XFZY were determined through the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform, PubChem, and SwissTargetPrediction databases.LLVT-related targets were searched from the Human Gene and Online Mendelian Inheritance in Man databases.Intersection targets were subjected to protein-protein interaction (PPI) network construction using the STRING database, with core targets identified based on their betweenness.Cytoscape was used to construct a "drug-component-target" network, and major compounds were screened out according to the betweenness.Gene Ontology (GO) and Kyoto Encyclopedia of Genes Genomes (KEGG) pathways enrichment analyses were conducted using the Metascape database.Molecular docking validation was carried out using AutoDock 1.5.7.Results: A total of 154 active constituents were identified, including major compounds such as baicalin, luteolin and flavanones.PPI, GO, and KEGG highlighted key targets for LLVT, including TP53, SRC and HSP90AA1, with major signaling pathways like PI3K-Akt, MAPK, and Rap1 pathways, involving various biological processes such as cancer, cell migration and phosphorylation.Stable complexes could be formed between the active constituents of XFZY and target proteins.Conclusion: This study provides preliminary insights into the multicomponent, multi-target, and multi-pathway therapeutic mechanisms of XFZY for LLVT, laying a foundation for its clinical development.
Introduction: The development of a new generation of hybrid prostheses is a way to improve the results of surgical treatment of combined lesions of the aortic arch and descending aorta. Objective: The study was aimed to evaluate the biocompatibility of the new branched hybrid stent graft.Methods: The developed hybrid stent graft consisted of two parts including the vascular part and the stent graft part, which were supplemented with a stented branch for reconstruction of the left subclavian artery. To assess the biological compatibility, a stent graft was implanted in the descending thoracic aorta in 25 large pigs. The results were assessed by surgical mortality, postoperative complications, selective aortic angiography and histological examination after 6 month follow up period.Results: Implantation of a hybrid stent graft was successful in all cases, without complications. In the early period, 3 animals died. The causes of animal death were respiratory failure caused by lung barotrauma, intraoperative bleeding and sudden cardiac death. The remaining pigs survived until the end of the follow up period without complications and were subsequently withdrawn from the experiment. The duration of perfusion by carotid-femoral bypass surgery was 55 [50; 60] minutes. The volume of blood sweating through the vascular part of the prosthesis was 2.28 ± 0.23 ml/cm2/min; the blood loss for the first hour through drain tube was approximately 70.2 ± 8.9 ml. In 6 months after surgery the aortic angiography showed that the main body and branches of the hybrid stent graft were completely passable. No migration, deformation or endolics were observed. The analysis of histological sections showed the presence of a confluent layer of neointima continuously and evenly distributed throughout the luminal surface of the conduits, including lateral branchlets and anastomoses. The neointima was hyperplasized and represented by layers of unidirectional fibroblast cells, its luminal surface was covered with a layer of endotheliocytes. Conclusion: These results demonstrate the technical feasibility and safety of using a new hybrid stent graft with an additional stented branch. Received 16 July 2024. Revised 1 August 2024. Accepted 15 August 2024. FundingThe study was carried out within the framework of project No. 22-15-20005 (agreement No. 22-15-20005 with the Russian Science Foundation, dated 22.03.2022, agreement No. р-12 with the Ministry of Science and Innovation Policy of the Novosibirsk Region, dated 13.03.2023). Conflict of interestThe authors declare no conflict of interest. Contribution of the authorsConception and study design: A.M. Chernyavskiy, I.Yu. Zhuravleva, D.A. Sirota, A.A. ShadanovData collection and analysis: A.A. Shadanov, D.A. Sirota, M.M. Lyashenko, S.V. Vladimirov, T.P. Timchenko, A.A. Dokuchaeva, V.P. Borodin, A.K. Sabetov, D.V. Khomushku, M.N. Murtazaliev, Ya.L. Rusakova, E.V. KuznetsovaStatistical analysis: A.A. ShadanovDrafting the article: A.A. Shadanov, D.A. SirotaCritical revision of the article: I.Yu. Zhuravleva, D.A. Sirota, A.M. ChernyavskiyFinal approval of the version to be published: A.A. Shadanov, A.M. Chernyavskiy, D.A. Sirota, M.M. Lyashenko, S.V. Vladimirov, T.P. Timchenko, A.A. Dokuchaeva, V.P. Borodin, A.K. Sabetov, D.V. Khomushku, M.N. Murtazaliev, Ya.L. Rusakova, E.V. Kuznetsova, I.Yu. Zhuravleva
Introduction. Urethral pain syndrome (UPS) is a little-studied issue. Aim. To determine the role of intracellular infections in the UPS etiology and evaluate the efficacy of azithromycin in the treatment of UPS. Materials and methods. A total of 18 female patients with UPS were included in the study. In addition to standard diagnostic procedures, urethra palpation and PCR examination of urethral discharge were performed. Quality of life was assessed using the SF-36 questionnaire filled out by the patients. Along with pathogenetic drugs, all patients received antibacterial therapy in the form of azithromycin (Azithromycin Express) according to the following scheme: 1.0 g as a single dose on Day 1, followed by 500 mg once daily for three days (the cycle dose is 2.5 g). The efficacy of treatment was estimated as a decrease in pain intensity after 7 days. The quality of life, pathogen eradication and pain intensity were assessed 2 months after completion of therapy. In addition, 73 domestic and foreign publications devoted to the issue of diagnosis and treatment of UPS were reviewed. Results. On the day of presentation, Chlamydia trachomatis was detected in 5 patients, and Mycoplasma genitalium was detected in 12 patients. The leukocyte counts in urine averaged 12.7 ± 2.3. All patients had bacteriuria with a titer of 102–103 CFU/ml. The total pain intensity score averaged 7,2 ± 0,8. The quality of life scores measured by the SF-36 scale was 15.2 ± 1.7. After a week, the pain intensity decreased on average to 3.2 ± 1.7. During a follow-up examination after 2 months, C. trachomatis was not detected in the urethral scraping, and M. genitalium DNA was only detected in 1 patient. The pain intensity in the urethra averaged 1.4 ± 0.1. Therefore, the quality of life increased significantly (21.7 ± 0.9 scores). Conclusion. The antibiotic prescription in UTS is justified. UTS cannot be considered an uncomplicated chlamydia infection, so we prescribed more than a single dose. Further research is needed to develop an optimal treatment regimen, including antibacterial one, for patients with UTS.
The gut microbiome plays a critical role in the pathogenesis of type 2 diabetes mellitus (T2DM). However, the inconvenience of obtaining fecal samples hinders the clinical application of gut microbiome analysis. In this study, we hypothesized that tongue coating color is associated with the severity of T2DM. Therefore, we aimed to compare tongue coating, gut microbiomes, and various clinical parameters between patients with T2DM with yellow (YC) and non-yellow tongue coatings (NYC). Tongue coating and gut microbiomes of 27 patients with T2DM (13 with YC and 14 with NYC) were analyzed using 16S rDNA gene sequencing technology. Additionally, we measured glycated hemoglobin (HbA1c), random blood glucose (RBG), fasting blood glucose (FBG), postprandial blood glucose (PBG), insulin (INS), glucagon (GC), body mass index (BMI), and homeostasis model assessment of β-cell function (HOMA-β) levels for each patient. The correlation between tongue coating and the gut microbiomes was also analyzed. Our findings provide evidence that the levels of Lactobacillus spp. are significantly higher in both the tongue coating and the gut microbiomes of patients with YC. Additionally, we observed that elevated INS and GC levels, along with decreased BMI and HOMA-β levels, were indicative of a more severe condition in patients with T2DM with YC. Moreover, our results suggest that the composition of the tongue coating may reflect the presence of Lactobacillus spp. in the gut. These results provide insights regarding the potential relationship between tongue coating color, the gut microbiome, and T2DM.
Atherosclerosis-predominant vasculopathy is a common complication of diabetes with high morbidity and high mortality, which is ruining the patient's daily life. As is known to all, traditional Chinese medicine (TCM) SHENQI compound and western medicine rosiglitazone play an important role in the treatment of diabetes. In particular, SHENQI compound has a significant inhibitory effect on vascular lesions. Here, to explore and compare the therapeutic mechanism of SHENQI compound and rosiglitazone on diabetic vasculopathy, we first built 7 groups of mouse models. The behavioral, physiological and pathological morphological characteristics of these mice showed that SHENQI compound has a more comprehensive curative effect than rosiglitazone and has a stronger inhibitory effect on vascular lesions. While rosiglitazone has a more effective but no significant effect on hypoglycemic. Further, based on the gene expression of mice in each group, we performed differential expression analysis. The functional enrichment analysis of these differentially expressed genes (DEGs) revealed the potential pathogenesis and treatment mechanisms of diabetic angiopathy. In addition, we found that SHENQI compound mainly exerts comprehensive effects by regulating MCM8, IRF7, CDK7, NEDD4L by pivot regulator analysis, while rosiglitazone can rapidly lower blood glucose levels by targeting PSMD3, UBA52. Except that, we also identified some pivot TFs and ncRNAs for these potential disease-causing DEG modules, which may the mediators bridging drugs and modules. Finally, similar to pivot regulator analysis, we also identified the regulation of some drugs (e.g. bumetanide, disopyramide and glyburide etc.) which have been shown to have a certain effect on diabetes or diabetic angiopathy, proofing the scientific and objectivity of this study. Overall, this study not only provides an in-depth comparison of the efficacy of SHENQI compound and rosiglitazone in the treatment of diabetic vasculopathy, but also provides clinicians and drug designers with valuable theoretical guidance.
Chronic venous insufficiency (CVI) is a widespread condition affecting millions worldwide. Each year, approximately 150,000 new patients are diagnosed with CVI, and nearly $500 million is used in the care of these patients. The venous system has sturdy valves and muscle pumps that keep blood flowing back to the heart against gravity. The inadequacy of these systems leads to difficulties in blood circulation, blood pooling, and venous hypertension, all which have the potential to lead to the development of varicose veins, edema, discomfort, alterations in the skin, and potentially even the formation of ulcers. Conditions that induce CVI are genetic predisposition, obesity (body mass index greater than 30), continuous standing/sitting work, age, pregnancy, gender, and lifestyle. Conventional venous insufficiency treatments include compression therapy, surgical interventions like vein stripping, and sclerotherapy. Venoactive drugs used in conservative treatment have the potential to enhance both varicose veins and symptoms associated with chronic venous disorders throughout all stages of venous insufficiency. In addition to synthetic drugs, naturally derived coumarins, flavonoids, rutin derivatives, pycnogenol, micronized purified flavonoid fraction, and saponosides are essential in the treatment. Medicinal plants and natural compounds are highly preferred for treating CVI and varicose veins due to their biological activities, such as anti-inflammatory, antioxidant, and vascular tone improvement. The present review provides a concise overview of the utilization of natural compounds and plant extracts in treating varicose veins, both in medical practice and traditional folk medicine.
Background. It is caused by primary problems in the vascular wall and valve structure, as well as their insufficiency. Additionally, factors such as hormonal changes, pregnancy, obesity, insufficient movement, working in a sedentary position, and oral contraceptives contribute to impaired vascular tension and structure. Objective. This study compares the effect of soft tissue manipulation technique and therapeutic exercise on inadequate venous supply in postpartum women. Methodology. Thirty individuals were included in the study based on inclusion and exclusion criteria. They were randomly allocated into two groups receiving one of the two physiotherapy interventions. NPRS and SF-36 were used to assess the effect of the interventions by comparing venous blood flow improvement before and after the allotted treatment for 10 weeks. Results. A significant difference in NPRS and SF-36 scores was observed in both groups, indicating the effectiveness of both myofascial release manual therapy and therapeutic exercise. However, myofascial release manual therapy proved to be more effective in improving venous blood flow. Conclusion. This study concludes that both soft tissue manipulation and therapeutic exercise improve venous blood flow. However, soft tissue manipulation was significantly more effective than therapeutic exercise.
A large study found that women taking GLP-1 drugs, the medication class behind Ozempic, Wegovy, Mounjaro, and Zepbound, were about 30% less likely to develop breast cancer。 Researchers say the findings are promising but not yet proof, and clinical trials are now being planned to test whether these drugs could help prevent breast cancer
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