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INTRODUCTION: Whether and when to monitor the amount of anti-factor Xa (aFXa) activity in critically ill patients with complex diseases to prevent venous thromboembolism (VTE) remain unclear. This study is a randomised controlled trial to investigate the effect of aFXa level monitoring on reducing VTE and to establish a new method for accurately preventing VTE in critically ill patients with low-molecular-weight heparin (LMWH). METHODS AND ANALYSIS: A randomised controlled trial is planned in two centres with a planned sample size of 858 participants. Participants will be randomly assigned to three groups receiving LMWH prophylaxis at a 1:1:1 ratio: in group A, peak aFXa levels will serve as the guide for the LMWH dose; in group B, the trough aFXa levels will serve as the guide for the LMWH dose; and in group C, participants serving as the control group will receive a fixed dose of LMWH. The peak and trough aFXa levels will be monitored after LMWH (enoxaparin, 40 mg, once daily) reaches a steady state for at least 3 days. The monitoring range for group A's aFXa peak value will be 0.3-0.5 IU/mL, between 0.1 and 0.2 IU/mL is the target range for group B's aFXa trough value. In order to reach the peak or trough aFXa levels, groups A and B will be modified in accordance with the monitoring peak and trough aFXa level. The incidence of VTE will serve as the study's primary outcome indicator. An analysis using the intention-to-treat and per-protocol criterion will serve as the main outcome measurement. ETHICS AND DISSEMINATION: The Xuanwu Hospital Ethics Committee of Capital Medical University and Peking University First Hospital Ethics Committee have approved this investigation. It will be released in all available worldwide, open-access, peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT05382481.
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Heparina de Baixo Peso Molecular , Tromboembolia Venosa , Humanos , Anticoagulantes/uso terapêutico , Estado Terminal/terapia , Enoxaparina/uso terapêutico , Heparina , Heparina de Baixo Peso Molecular/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Tromboembolia Venosa/tratamento farmacológico , Inibidores do Fator Xa/sangueRESUMO
OBJECTIVE: To evaluate the efficacy of deep vein thrombosis (DVT) prevention among real-world surgical inpatients who received panax notoginseng saponins (PNS) combined with low-molecular-weight heparin (LMWH). METHODS: A prospective cohort study was conducted among surgical patients between January 2016 and November 2018 in Xuanwu Hospital, Capital Medical University, Beijing, China. Participants received LMWH alone or PNS combined with LMWH for preventing DVT. The primary outcome was incidence of lower extremity DVT, which was screened once a week. Participants in the LMWH group were given LMWH (enoxaparin) via hypodermic injection, 4000-8000 AxalU once daily. Participants in the exposure group received PNS (Xuesaitong oral tablets, 100 mg, 3 times daily) combined with LMWH given the same as LMWH group. RESULTS: Of the 325 patients screened for the study, 281 participants were included in the final analysis. The cohort was divided into PNS + LMWH group and LMWH group with 134 and 147 participants, respectively. There was a significant difference of DVT incidence between two groups (P=0.01), with 21 (15.7%) incident DVT in the PNS + LMWH group, and 41 (27.9%) incident DVT in the LMWH group. Compared with participants without DVT, the participants diagnosed with DVT were older and had higher D-dimer level. The multivariate logistic regression model showed a significant lower risk of incident DVT among participants in the PNS + LMWH group compared with the LMWH group (odds ratio 0.46, 95% confidence interval, 0.25-0.86). There were no significant differences in thromboelaslography values (including R, K, Angle, and MA) and differences in severe bleeding between two groups. No symptomatic pulmonary embolism occurred during the study. CONCLUSION: Combined application of PNS and LMWH can effectively reduce the incidence of DVT among surgical inpatients compared with LMWH monotherapy, without increased risk of bleeding.
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Panax notoginseng , Saponinas , Trombose Venosa , Anticoagulantes/uso terapêutico , Hemorragia , Heparina de Baixo Peso Molecular/efeitos adversos , Heparina de Baixo Peso Molecular/uso terapêutico , Humanos , Estudos Prospectivos , Saponinas/uso terapêutico , Trombose Venosa/induzido quimicamente , Trombose Venosa/tratamento farmacológico , Trombose Venosa/prevenção & controleRESUMO
Carotid body tumors (CBT) are rare chemical receptor tumors. We report nine cases of CBT who were diagnosed at our center during 2004 to 2008 with a literature review. Of these nine patients, eight underwent complete resection, one received palliative resection due to the malignant nature of the tumor, and the other one refused surgery. No perioperative mortality and stroke occurred. During a mean follow up of 2.2 years, no deaths related to CBT occurred. Surgical treatment for CBT is relatively safe. The surgeon should be careful to maintain the integrity of carotid artery, and prevent cerebral ischemia and cranial nerve injuries in order to improve outcome.
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Aortic deceleration injury is a common and critical condition following automobile accident with high fatality. The survivors complicated with associated serious injuries are even rare and definitive treatment is required. A 37-year-old male patient had both aortic blunt injury and coronary artery injury after a frontal car collision. After failed coronary artery percutaneous transluminal angioplasty (PTA) and deteriorated aortic lesion, the ruptured aorta was subsequently successfully treated by us with a self-made individualized endograft. The endograft was well in position and the patient functioned well in 11-year followup. With the development of endograft and technique, the endovascular treatment may be an option for patients with complicated aortic blunt injury. Yet careful patient selection and the long-term followup are essential.
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BACKGROUND: Diagnosis and treatment for respiratory symptoms (RSs) of gastroesophageal reflux disease (GERD) is more difficult than that for common esophageal symptoms. The goal of this study was to evaluate the efficacy and safety of radiofrequency (RF) treatment on RSs of GERD in a preliminary 12-month follow-up observation. METHODS: From April 2006 to October 2008, 505 GERD patients with mainly respiratory presentations such as wheezing, chronic cough or hoarseness, were treated by endoscopic RF. A questionnaire was completed before and after treatment, using a six-point scale ranging from 0 to 5 to assess symptom severity and frequency. The symptom score was the sum of frequency and severity. RESULTS: Symptom scores were significantly improved at the end of the follow-up period. The mean heartburn score decreased from 5.31 to 1.79. The mean regurgitation score decreased from 5.02 to 1.64; mean cough score decreased from 6.77 to 2.85; mean wheezing score decreased from 7.83 to 3.07; and mean hoarseness score decreased from 5.13 to 1.81 (P < 0.01). No major complications or deaths occurred. Minor complications included temporary post-procedural retrosternal unease or pain (n = 106; 21.0%), mild fever (n = 86; 17.0%), transient nausea/vomiting (n = 97; 19.2%), and transient dysphagia (n = 42; 9.3%). Thirty-five (6.9%) patients had recurrence of symptoms. Endoscopic RF treatment was repeated in six patients, and laparoscopic fundoplication was performed in seven. CONCLUSION: Endoscopic RF is an effective and safe means to treat RSs in patients with GERD.