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Oral direct thrombin inhibitors or oral factor Xa inhibitors versus conventional anticoagulants for the treatment of deep vein thrombosis
Background:Deep vein thrombosis (DVT) is a condition in which a clot forms in the deep veins, most commonly of the leg. It occurs in approximately one in 1000 people. If left untreated, the clot can travel up to the lungs and cause a potentially life-threatening pulmonary embolism (PE). Previously, a DVT was treated with the anticoagulants heparin and vitamin K antagonists. However, two forms of direct oral anticoagulants (DOACs) have been developed: oral direct thrombin inhibitors (DTIs) and oral factor Xa inhibitors, which have characteristics that may be favourable compared to conventional treatment, including oral administration, a predictable effect, lack of frequent monitoring or dose adjustment and few known drug interactions. DOACs are now commonly being used for treating DVT: recent guidelines recommended DOACs over conventional anticoagulants for both DVT and PE treatment. This Cochrane Review was first published in 2015. It was the first systematic review to measure the effectiveness and safety of these drugs in the treatment of DVT. This is an update of the 2015 review. OBJECTIVES: To assess the effectiveness and safety of oral DTIs and oral factor Xa inhibitors versus conventional anticoagulants for the long-term treatment of DVT. Search methods:The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 1 March 2022. Selection criteria:We included randomised controlled trials (RCTs) in which people with a DVT, confirmed by standard imaging techniques, were allocated to receive an oral DTI or an oral factor Xa inhibitor compared with conventional anticoagulation or compared with each other for the treatment of DVT. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were recurrent venous thromboembolism (VTE), recurrent DVT and PE. Secondary outcomes included all-cause mortality, major bleeding, post-thrombotic syndrome (PTS) and quality of life (QoL). We used GRADE to assess the certainty of evidence for each outcome. Main results:We identified 10 new studies with 2950 participants for this update. In total, we included 21 RCTs involving 30,895 participants. Three studies investigated oral DTIs (two dabigatran and one ximelagatran), 17 investigated oral factor Xa inhibitors (eight rivaroxaban, five apixaban and four edoxaban) and one three-arm trial investigated both a DTI (dabigatran) and factor Xa inhibitor (rivaroxaban). Overall, the studies were of good methodological quality. Meta-analysis comparing DTIs to conventional anticoagulation showed no clear difference in the rate of recurrent VTE (odds ratio (OR) 1.17, 95% confidence interval (CI) 0.83 to 1.65; 3 studies, 5994 participants; moderate-certainty evidence), recurrent DVT (OR 1.11, 95% CI 0.74 to 1.66; 3 studies, 5994 participants; moderate-certainty evidence), fatal PE (OR 1.32, 95% CI 0.29 to 6.02; 3 studies, 5994 participants; moderate-certainty evidence), non-fatal PE (OR 1.29, 95% CI 0.64 to 2.59; 3 studies, 5994 participants; moderate-certainty evidence) or all-cause mortality (OR 0.66, 95% CI 0.41 to 1.08; 1 study, 2489 participants; moderate-certainty evidence). DTIs reduced the rate of major bleeding (OR 0.58, 95% CI 0.38 to 0.89; 3 studies, 5994 participants; high-certainty evidence). For oral factor Xa inhibitors compared with conventional anticoagulation, meta-analysis demonstrated no clear difference in recurrent VTE (OR 0.85, 95% CI 0.71 to 1.01; 13 studies, 17,505 participants; moderate-certainty evidence), recurrent DVT (OR 0.70, 95% CI 0.49 to 1.01; 9 studies, 16,439 participants; moderate-certainty evidence), fatal PE (OR 1.18, 95% CI 0.69 to 2.02; 6 studies, 15,082 participants; moderate-certainty evidence), non-fatal PE (OR 0.93, 95% CI 0.68 to 1.27; 7 studies, 15,166 participants; moderate-certainty evidence) or all-cause mortality (OR 0.87, 95% CI 0.67 to 1.14; 9 studies, 10,770 participants; moderate-certainty evidence). Meta-analysis showed a reduced rate of major bleeding with oral factor Xa inhibitors compared with conventional anticoagulation (OR 0.63, 95% CI 0.45 to 0.89; 17 studies, 18,066 participants; high-certainty evidence). AUTHORS' CONCLUSIONS: The current review suggests that DOACs may be superior to conventional therapy in terms of safety (major bleeding), and are probably equivalent in terms of efficacy. There is probably little or no difference between DOACs and conventional anticoagulation in the prevention of recurrent VTE, recurrent DVT, pulmonary embolism and all-cause mortality. DOACs reduced the rate of major bleeding compared to conventional anticoagulation. The certainty of evidence was moderate or high.
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Effects of telemedicine-based follow-up management on adults with obstructive sleep apnea: A systematic review and meta-analysis
OBJECTIVES: This meta-analysis aimed to investigate the effects of telemedicine-based follow-up management on adults with obstructive sleep apnea. METHODS: Publications were searched in the Cochrane Library, PubMed, Scopus, Web of Science and Embase. Studies were selected according to the predefined screening criteria, and their qualities were assessed by the Revised Cochrane risk-of-bias tool for randomized trials. The statistical analyses were performed using Stata12.0 software. It was registered in PROSPERO with the number: CRD42021276414. RESULTS: A total of 33 articles with 8,689 participants were included. Telemedicine-based follow-up management improved average daily continuous positive airway pressure usage by 36 min (weighted mean difference:0.61;95% confidence interval: 0.39 to 0.83), and the percentage of days with continuous positive airway pressure usage more than four hours by 10.67% in obstructive sleep apnea patients. The meta-analysis of good continuous positive airway pressure compliance showed telemedicine-based follow-up management did not lead to good continuous positive airway pressure compliance (odds ratio: 1.13;95% confidence interval: 0.72 to 1.76). The pooled mean difference of sleep quality was 0.15 (standardized mean difference:0.15; 95% confidence interval: -0.03 to 0.32), and daytime sleepiness was -0.26 (weighted mean difference: -0.26;95% confidence interval: -0.79 to 0.28). The pooled mean difference of apnea hypopnea index was -0.53 (95% confidence interval: -3.58 to 2.51). As for the overall quality of life, the pooled mean difference was -0.25 (standardized mean difference: -0.25;95% confidence interval: -0.25 to 0.76). CONCLUSION: Telemedicine-based follow-up management was beneficial for continuous positive airway pressure compliance of obstructive sleep apnea patients within six months. However, it could not improve sleep quality, daytime sleepiness, the severity of obstructive sleep apnea, and quality of life in obstructive sleep apnea patients compared with traditional follow-up. Moreover, it was more cost-effective, but there was no consensus on whether it would increase the workload of medical staff.
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Efficacy of virtual reality-based interventions for patients with breast cancer symptom and rehabilitation management: A systematic review and meta-analysis
Objectives: To determine the effectiveness of virtual reality (VR)-based intervention on the symptoms and rehabilitation management in patients with breast cancer. Design: Systematic review and meta-analysis. Study selection: We included all eligible randomised controlled trials and quasi-experimental studies (published in English and Chinese). Participants: Patients with breast cancer (≥18 years) undergoing cancer treatment. Interventions: Any intervention administered to improve the symptoms and rehabilitation of patients with breast cancer. The control group was given conventional care. Outcomes: All outcomes were as follows: pain, fatigue, anxiety, depressive symptoms, cognitive function, and range of motion of upper limb in patients with breast cancer. Data sources: We searched PubMed, Embase, CENTRAL and SinoMed, four electronic databases, covering the database establishment period to January 2022. Review methods: Two reviewers independently extracted content and data consistent with the prespecified framework and assessed risk bias. Random-effects meta-analysis was used to pool data across trials. Meta-analysis was performed using Review Manager V.5.4. Results: A total of eight studies met the eligibility criteria and were included in this study. The combined effect size showed that VR was positive for improving patients' anxiety(standard mean differenc (SMD)=-2.07, 95% CI= (-3.81 to -0.34), I2=95%) and abduction of upper limbs (MD=15.54, 95% CI= (12.79 to 18.29), I2=0%), but fatigue (SMD=-0.92, 95% CI= (-4.47 to 2.62), I2=99%) was not. Qualitative analysis showed VR improved patients' depressive symptoms, pain and cognitive function. Conclusions: VR technology has a good effect on symptoms and rehabilitation management of patients with breast cancer, but the quality of evidence is low, and the sample size is small. To date, there are few intervention studies, therefore, giving precise recommendation or conclusion is difficult. We have a favourable view of this, and more clinical studies are needed in the future to improve the credibility of the results.
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