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ObjectivesTo assess the efficacy and safety of hydroxychloroquine (HCQ) plus standard-of-care (SOC) compared with SOC alone in adult patients with COVID-19. DesignMulticenter, open-label, randomized controlled trial. Setting16 government-designated COVID-19 treatment centers in China through 11 to 29 in February 2020. Participants150 patients hospitalized with laboratory confirmed COVID-19 were included in the intention to treat analysis. 75 patients were assigned to HCQ plus SOC and 75 to SOC alone. InterventionsHCQ was administrated with a loading dose of 1, 200 mg daily for three days followed by a maintained dose of 800 mg daily for the remaining days (total treatment duration: 2 or 3 weeks for mild/moderate or severe patients, respectively). Main outcome measuresThe primary outcome was whether participants had a negative conversion of SARS-CoV-2 by 28 days, and was analyzed according to the intention-to-treat principle. Adverse events were analyzed in the safety population in which HCQ recipients were participants who actually received at least one dose of HCQ and HCQ non-recipients were those actually managed with SOC alone. ResultsAmong 150 patients, 148 were with mild to moderate disease and 2 were with severe disease. The mean days ({+/-} standard deviation, min to max) from symptoms onset to randomization was 16.6 ({+/-}10.5 days, 3 to 41 days). The negative conversion probability by 28 days in SOC plus HCQ group was 85.4% (95% confidence interval (CI) 73.8% to 93.8%), similar to that in the SOC group 81.3% (95%CI 71.2% to 89.6%). Between-group difference was 4.1% (95%CI -10.3% to 18.5%). In the safety population, adverse events were recorded in 7 (8.8%) HCQ non-recipients (N=80) and in 21 (30%) HCQ recipients (N=70). The most common adverse event in the HCQ recipients was diarrhea, reported in 7 (10%) patients. Two HCQ recipients reported serious adverse events. ConclusionsThe administration of HCQ did not result in a significantly higher negative conversion probability than SOC alone in patients mainly hospitalized with persistent mild to moderate COVID-19. Adverse events were higher in HCQ recipients than in HCQ non-recipients. Trial registrationChiCTR2000029868 What is already known on this topic-- The pandemic of coronavirus disease 2019 (COVID-19) imposes substantial burdens on individuals, communities, health-care facilities, markets, governments, etc. globally. -- There is no specific treatment approved for COVID-19 or vaccine to prevent infection with the novel coronavirus. -- During the urgent pandemic, media headlines the utility of drugs without solid evidence but buries the side-effects of these drugs. What this study adds-- In this randomized clinical trial of patients mainly with persistent mild to moderate COVID-19, exposure to hydroxychloroquine led to a similar probability of virus elimination comparing to the current standard-of-care. -- Adverse events, mostly gastrointestinal related, were significantly increased in patients who received hydroxychloroquine. -- Overall, the results from our trial do not support the use of hydroxychloroquine in patients with persistent mild to moderate COVID-19. Print abstractO_ST_ABSStudy questionC_ST_ABSTo assess the efficacy and safety of hydroxychloroquine (HCQ) plus standard-of-care (SOC) compared with SOC alone in adult patients with COVID-19. MethodsThis is a multicenter, open-label, randomized controlled trial conducted in 16 government-designated COVID-19 treatment centers in China through 11 to 29 in February 2020. A total of 150 patients hospitalized with laboratory confirmed COVID-19 were included in the intention to treat analysis. Among them, 75 patients were assigned to HCQ plus SOC and 75 to SOC alone. HCQ was administrated with a loading dose of 1, 200 mg daily for three days followed by a maintained dose of 800 mg daily for the remaining days (total treatment duration: 2 or 3 weeks for mild/moderate or severe patients, respectively). The primary outcome was whether participants had a negative conversion of SARS-CoV-2 by 28 days, and was analyzed according to the intention to treat principle. Adverse events were analyzed in the safety population in which HCQ recipients were participants who actually received at least one dose of HCQ and HCQ non-recipients were those actually managed with SOC alone. Study answer and limitationsAmong 150 patients, 148 were with mild to moderate disease and 2 were with severe disease. The mean days ({+/-} standard deviation, min to max) from symptoms onset to randomization was 16.6 ({+/-}10.5 days, 3 to 41 days). The negative conversion probability by 28 days in SOC plus HCQ group was 85.4% (95% confidence interval (CI) 73.8% to 93.8%), similar to that in the SOC group 81.3% (95%CI 71.2% to 89.6%). Between-group difference was 4.1% (95%CI -10.3% to 18.5%). In the safety population, adverse events were recorded in 7 (8.8%) HCQ non-recipients (N=80) and in 21 (30%) HCQ recipients (N=70) with two serious adverse events. The most common adverse event in the HCQ recipients was diarrhea, reported in 7 (10%) patients. Two HCQ recipients reported serious adverse events. What this study addsOur trial does not support the use of hydroxychloroquine in patients with persistent mild to moderate COVID-19 due to limited effects on virus eliminating and significantly increased adverse events. Funding, competing interests, data sharingThis work was supported by the Emergent Projects of National Science and Technology (2020YFC0844500), National Natural Science Foundation of China (81970020, 81770025), National Key Research and Development Program of China (2016YFC0901104), Shanghai Municipal Key Clinical Specialty (shslczdzk02202, shslczdzk01103), National Innovative Research Team of High-level Local Universities in Shanghai, Shanghai Key Discipline for Respiratory Diseases (2017ZZ02014), National Major Scientific and Technological Special Project for Significant New Drugs Development (2017ZX09304007), Key Projects in the National Science and Technology Pillar Program during the Thirteenth Five-year Plan Period (2018ZX09206005-004, 2017ZX10202202-005-004, 2017ZX10203201-008). All authors declared no competing interests. Anonymized datasets can be made available on reasonable request after approval from the trial management committee. Study registrationChiCTR2000029868
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Objective@#To compare the clinical application of three-dimensional laparoscopic pancreatoduodenectomy (3D-LPD) with that of two-dimensional laparoscopic pancreatoduodenectomy (2D-LPD), and to explore the safety and feasibility of 3D-LPD.@*Methods@#A retrospective analysis was made from the data of 45 patients with 3D-LPD and 45 patients with 2D-LPD who underwent total laparoscopic pancreatoduodenectomy from March 2017 to August 2018 at Department of Hepato-Pancreato-Biliary Surgery, the First People′s Hospital of Changzhou.The differences of intraoperative conditions, postoperative complications and postoperative pathological findings between the two methods were compared.Measurement data were compared with independent sample t-test, enumeration data were statistically analyzed with Chi-square test or Fisher exact probability.@*Results@#The operation time of 3D-LPD group was shorter than that of 2D-LPD group ((335±95) min vs. (419±113) min, t=-3.817, P=0.000), which mainly showed that the time of digestive tract reconstruction was reduced ((92±26) min vs. (131±46) min, t=-4.951, P=0.000). The intraoperative blood loss in the 3D-LPD group was significantly less than that in the 2D-LPD group ((242±124) ml vs. (350±176) ml, t=-3.365, P=0.001), and the perioperative blood transfusion in the 3D-LPD group was significantly less than that in the 2D-LPD group (χ2=4.444, P=0.035). Postoperative hospitalization days and ICU stay time were not significantly different between the two groups(both P>0.05). Postoperative complications such as pancreatic fistula, biliary fistula, postoperative bleeding, gastric emptying disorders, abdominal infection, were not significantly different between the two groups(all P>0.05).@*Conclusions@#The operation time of 3D-LPD is shorter than that of 2D-LPD, and the amount of bleeding is less. Short-term clinical data showed that, 3D-LPD is effective, safe and worth popularizing.
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Background and purpose:Thyroid carcinoma is a common endocrine tumor with an incidence that has increased over recent decades. The aim of the present study was to investigate the effectiveness of carbon nano-par-ticles-labeled lymph nodes in neck dissection for papillary thyroid cancer (PTC), focusing on the protectiveness for the recurrent laryngeal nerve (RLN) and parathyroid glands.Methods:Forty-eight patients with PTC treated from Apr. to Aug. 2015 were randomly divided into two groups. Group A patients (24 patients) were treated with lobectomy/total thyroidectomy plus unilateral/bilateral central lymph node dissection by conventional meticulous capsular dissection technique; Group B patients (24 patients) were treated with the same surgical procedures as group A, 5 min after the injection of carbon nano-particles. The operative time, intra-operative blood loss, incidence of RLN injury, incidence of transient hypocalcemia, the number of total lymph nodes and the ratio of metastatic nodes were collected and analyzed. Results:For unilateral lobectomy, the number of lymph nodes in group B was signiifcantly greater than that in group A (P<0.05). For total thyroidectomy, the operative time, and the incidence of transient hypocalcemia in group B were both lower than those in group A (P<0.05), and the number of total lymph nodes was signiifcantly higher than that in group A (P<0.05). In group B, the ratio of metastatic nodes were 26.7% (unilateral) and 33.3% (bilateral) in stained lymphnodes, and 11.8% and 25.9% in non-stained lymph nodes.Conclusion:The carbon nano-particles-labeled lymph nodes in neck dissection could facilitate to protect parathyroids and increase the number of lymph nodes, especially in total thyroidectomy plus bilateral central lymph node dissection.
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Objective To suvey the clinical application of antibacterials and drug resistance of antibacterials in the hospital in 2013.Methods To make statistical analysis on the frequency of drug use and drug resistance rate in 2013.Results Piperacillin wasn′t used in 2013 in the hospital.No hemolytic streptococcus was detected with drug resistance.Drug resistance rate of Esche-richia coli to piperacillin was 33.22%.Conclusion Bacterial resistance might be related to the using frequency of drugs and the types of antibacterials used in a region.
