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Objective:The standardized medical device clinical trials in China began in a short time, and the quality of trials needs to be improved.This article intends to explore possible ways for the improvement of quality management of the medical device clinical trials.Methods:Through working practice and literature review, analyze the current status of medical device clinical trials and in vitro diagnostic reagent in China; put forward targeted improved measures for the quality management system; as well as verify its feasibility through practice.Results:This article summarizes three factors that limit the improvement of the quality of medical device clinical trials, including the insufficient research and development strength of sponsors, the limited professional level of research teams, and the differences in verification and drugs, based on the risk-based quality management concepts, puts forward improved measures from three aspects, which including building risk-based quality certification system, making full use of electronic information systems to ensure the trial quality, and strengthening training of clinical trial capacity of researchers, and verifies the feasibility of these measures via the practical experience of our hospital since 2016.Conclusions:The application of risk-based quality management system, electronic information system and clinical trial capacity training can improve the management quality for medical device clinical trial centers.
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The bacterium Streptomyces peucetius produces doxorubicin and daunorubicin,and the two widely used anticancer antibiotics.Two open reading frames,drrA and drrB,were proposed to encode for an ABC (ATP-binding cassette) type of permease that carries out export of the antibiotic ABC (ATP binding cassette)-type transporter for the exportation of these two antibiotics.In this paper,the structure,expression and interaction of DrrA and DrrB protein and the research progress of the assembly and multi drug efflux function of DrrAB are briefly reviewed.
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Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia worldwide with a trend of increasing morbidity and prevalence. It usually links to a high disability and mortality rate. Stroke is the most important and severe complication of AF, as a core strategy to prevent it, anticoagulation therapy is recommended to reduce the risk of stroke events. However, management risks including poor treatment adherence, individual difference and bleeding risk can′t be ignored. In the western countries, they have successively established a nurse-led integrated chronic care program for patients with atrial fibrillation. We can use it to guide our future work. Anticoagulation therapy is a long-term managing process. To integrate the existing medical resources, nurses must give their full play to access the deep needs and guide them to learn the core skills of management, thus improving the adherence to anticoagulation therapy.
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Objective To investigate the level about illness perception in patients with coronary heart disease. Methods From July to De-cember, 2015, 198 inpatients with coronary heart disease who were admitted into hospitals twice or more were enrolled. They were assessed with Illness Perception Questionnaire-Revised (IPQ-R). Results The score of common symptoms was (4.55±1.64). The symptoms, for exam-ple, chest pains, uncomfortable feeling in chest, cold sweat, flustered and breathlessness were most frequently experienced and most often identified. For the illness perception part, the scores on subscales of treatment control and consequences were higher than 3, which was the neutral point. For the cause dimension part, the highest scores was (3.38 ± 0.90) in diet or eating habits, followed by (3.38 ± 0.89) in aging. Among these factors, immune factors had the highest mean score, followed by stress factor. Conclusion The level of illness perception in pa-tients with coronary heart disease was in the middle level, and individual differences were obvious. The awareness of the disease and the in-tervention of the patient should be strengthened.
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@#Objective To evaluate the effectiveness of exercise rehabilitation intervention by using self-efficacy theory on patients with chronic stable heart failure, and to provide evidences for rehabilitation nursing of patients. Methods Using the method of randomized controlled studies, 132 patients with chronic stable heart failure from Nanshitou Street and Shayuan Street communities in Haizhu, Guangzhou, Guangdong were randomly divided into two groups according to the community's name. The patients in the intervention group received self-efficacy and education intervention while the control group received health education only. The patients' exercise self-efficacy scores and six minute walk distances were separately measured by exercise self-efficacy scale and six minute walk test before and after intervention. Results The scores of exercise self-efficacy and six minute walk distances increased more significantly in the intervention group than in the control group after intervention (P<0.01). Conclusion Self-efficacy and education intervention can effectively improve the exercise self-efficacy and six minute walk distance of patients with heart failure.
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Objective To explore the effects of home-based 6-minute walk test on self-management in patients after percutaneous coronary intervention (PCI). Methods Eighty-four patients who admitted for PCI in the past five years in Cardiovascular Medicine of Zhujiang Hospital of Southern Medical University were recruited from the three major communities and were divided into intervention group and control group by random digits table method with 42 cases each. The intervention group had the home-based 6-minute walk test and monthly telephone follow-up while the control group was followed up by telephone and keep daily activities. Six months after the intervention,the changes of chronic disease self-management in-ventory were compared. Results There were significant differences the overall health self-assessment, fa-tigue,chest pain, time of aerobic exercise, the increase of self-efficacy between intervention group and control group[ (0.62±1.28) points vs. (0.20±1.71) points, (-0.84±3.27) points vs. (0.36±2.71) points, (0.04 ±3.56) points vs. (0.34 ±3.56) points, (30.47 ±123.29) min/week vs. (6.62 ±84.82) min/week, (0.42±3.01) points vs. (-0.29±2.94) points ], and there were significant differences, F=9.15, 7.42, 5.24, 3.91, 12.18, P0.05). Conclusions Home-based 6-minute walk test can be a simple self-assessment tool used at home for patients after PCI.
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Objective To evaluate the effectiveness of exercise rehabilitation intervention by using self-efficacy theory on patients with chronic stable heart failure, and to provide evidences for rehabilitation nursing of patients. Methods Using the method of randomized con-trolled studies, 132 patients with chronic stable heart failure from Nanshitou Street and Shayuan Street communities in Haizhu, Guangzhou, Guangdong were randomly divided into two groups according to the community's name. The patients in the intervention group received self-efficacy and education intervention while the control group received health education only. The patients' exercise self-efficacy scores and six minute walk distances were separately measured by exercise self-efficacy scale and six minute walk test before and after interven-tion. Results The scores of exercise self-efficacy and six minute walk distances increased more significantly in the intervention group than in the control group after intervention (P<0.01). Conclusion Self-efficacy and education intervention can effectively improve the exercise self-efficacy and six minute walk distance of patients with heart failure.
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<p><b>OBJECTIVE</b>To investigate the effect of carvacrol pretreatment on myocardial ischemia-reperfusion (I/R) injury and its underlying mechanisms.</p><p><b>METHODS</b>Wild-type male C57 BL/6 mice were randomized into 5 groups (n=13), namely the sham-operated group, vehicle (DMSO in saline)+ I/R group, carvacrol (20 mg/kg) + I/R group, carvacrol (40 mg/kg) + I/R group, and carvacrol (60 mg/kg) + I/R group. The mouse models of myocardial I/R injury were established by a 45-min occlusion of the left anterior descending coronary artery (LAD) followed by reperfusion for 2 h. Carvacrol or vehicle was administered intravenously 15 min before LAD occlusion. After reperfusion, the mice were examined for myocardial oxidative stress level and apoptosis rate.</p><p><b>RESULTS</b>Compared with the vehicle group, the 3 carvacrol-pretreated groups showed significantly reduced myocardial infarct size, oxidative stress level and cardiac myocyte apoptosis rate (P<0.01).</p><p><b>CONCLUSION</b>Carvacrol can protect against myocardial I/R injury by inhibiting myocardial oxidative stress and apoptosis in mice.</p>
Subject(s)
Animals , Male , Mice , Antioxidants , Pharmacology , Apoptosis , Cardiotonic Agents , Pharmacology , Mice, Inbred C57BL , Monoterpenes , Pharmacology , Myocardial Infarction , Pathology , Myocardial Reperfusion Injury , Metabolism , Pathology , Myocytes, Cardiac , Cell Biology , Oxidative Stress , Random AllocationABSTRACT
Business process cost management is key to hospital business process management It mostly consists of process cost accumulation and cost analysis. The paper probed into theories of Activity Based Costing (ABC), and built a model for hospital process costing based on the hospital organizational structure Discussed herein include the items of hospital medical services and their activity costs, followed by a case study to prove ABC as practical in the analysis and calculation of hospital business process costs.
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Objective To know the effects of training for community residents about cardiopulmonary resuscitation.Methods 60 community residents were trained by CPR with varied training methods,evaluated the effects by the ABC for life questionnaire.Results The knowledge of cardiopulmonary resuscitation among the trained community residents were better than before expect 4 aspects.Conclusions The knowledge of cardiopulmonary resuscitation in community residents was not enough,systemic training can effective promote their skills of CPR.
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OBJECTIVE To find out the clinic air disinfectant effect and the damage to human body between air aerosol sprayer of hydrogen peroxide and peracetic acid. METHODS New ninety eight sickrooms were randomly disported into two groups. The group of using peracetic acid was a control one. Then the clinic air disinfectant effect and the damage between two groups were observed. RESULTS After thirty minutes, to sample through flat exposure method. The total number of bacteria of two groups reached the third grade of environment eligible standard without pathogenic bacteria being checked. Hydrogen peroxide had not obvious mucous membrane stimulation and hypersusceptible reaction to human body. But peracetic acid had mucous membrane stimulation and hypersusceptible reaction to human body. CONCLUSIONS The air disinfection using aerosol sprayer is still an available method when there are no person in new sickrooms or extended sickrooms. At present, some chemical disinfectant methods that have strong poisonous reactions and pollute environment, such as peracetic acid, have been restricted to be used because of thrill, toxicity to human body and causticity to goods. But the method of dynamic air disinfectant machine that can be used in the situation of ventilation, dust catching, decontaminating, and ultraviolet irradiation, at the same time having someone has became a new idea of air disinfection.
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Objective To explore the best position in bed for the patients who have under the operation of percutaneous coronary intervention (PCI) and then used heparin sodium within 24 hours. Methods The 159 patients were divided into two groups randomly:the experimental group and the control group. After the PCI, the subjects in these two groups will rest in bed by two ways. Using McGill′s present Pain Index to evaluate hematoma, using the PPI to evaluate the pain of back, using the STAI to evaluate the condition of anxiety, write the number of patient who have anuresises. Results There are no significant difference between two groups in wound blooding, while the difference of back pain, anxiety and the anuresises are significant between two groups. Conclusion The position of half-lie is safe and comfortable for the patients who have under the operation of PCI.
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OBJECTIVE To improve the accuracy of the radiant intensity detection of ultraviolet lamp and ensure its disinfection effect.METHODS At the different time after use of the ultraviolet lamp,its radiant intensity was measured by using the luminometer,and estimated.RESULTS If the ultraviolet lamp with good uality and worked one hour each day,with detected intensity ≥90 ?W/cm2,it could be used one year continuously,when ≥80 ?W/cm2,it could be used 6 months continuously,and when 80-75 ?W/cm2,it could be used 1 month continuously.The lump's detected intensity must be exceeded over 70 ?W/cm2.CONCLUSIONS The method that detecting the radiant intensity of ultraviolet lamp in scheduled time and consulting the used time of lump is viable.The method is real,simple,convenient and easy manipulated and ensures the effectiveness of disinfection by using ultraviolet lamp.
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Objective:In order to reduce the incidence of infection and disablement,and increase the efficiency of wound flushing and debriding,the irrigating pressure of firearm wound was designed.Methods Canine models wounded with gunshot at the limbs were established.Two irrigating methods,including meddling irrigating pressure and high irrigating were used to irrigating wound,respectively.General observation,optical microscopy and quantitative bacterial analysis were performed immediately after injured and irrigated.Results The bacteria counts after irrigating on the surface of wound are much less than those before irrigating in two groups(p