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Objective:To explore the main management points and ethical considerations of diabetic subjects involved in hypoglycemic drug clinical trials.Methods:Taking the subject management of a hypoglycemic drug clinical trial in Yuncheng Central Hospital as an example, the problems and measures in the subject management of diabetic patients were systematically discussed.Results:In hypoglycemic drug clinical trial that involving diabetic patients, ethical considerations regarding to the subjects' rights, safety and health should take into account in the whole process of subjects' recruitment, screening, enrollment and follow-up.Conclusions:Subject management taking into account of ethical consideration can better protect the safety and rights of subjects, enhance the compliance of subjects and improve the quality of drug clinical trials.
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Objective To evaluate the methodological quality of the systematic evaluation literature of Shenfu injection in the treatment of heart failure with AMSTAR 2 statement.Methods Searching includes Chongqing VIP Database,China Knowledge Network Database,China Biomedical Literature Database.Wanfang Database,PubMed Database,Cochrane library database,search time limit from database construction to Dec 31 st,2017.Two evaluators independently screened the literature based on inclusion and exclusion criteria,and applied the AMSTAR 2 statement list to evaluate all the systematic review literatures included.Results A total of 9 articles were included in the study,and the average reporting rate is 43.75％.The low-reporting domains focused on the review protocols prior to the research,the types of the included studies,the list of excluded documents,the evaluation and causes of bias of risks and heterogeneity,and reports on funds and conflicts of interest.Conclusions The average reporting rate is low overall,indicating that the current reports of the systematic review has defects,which affects the credibility of the systematic review and the use of evidence.For the determination of clinical decision-making,it is recommended that researchers should follow the AMSTAR 2 statement to improve the methodological or reporting quality.
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To explore the effect of Kaixin Capsule (KC, composed of Radix Panacis Quinquefolii, Radix Astragali, Radix Ophiopogonis, Rhizoma Chuanxiong,Rhizoma Cyperi, etc.) in reconstructing the collagen of non infarct region of left ventricle in rats after myocardial infarction (MI) and to study its mechanism.Seventy rats were allocated to mimic operation group (Group Ⅰ), model group (Group Ⅱ), high dosage KC group (Group Ⅲ), low dosage KC group (Group Ⅳ) and positive control group (Group Ⅴ). Rat models of left ventricle reconstruction were established by the ligation of the main stem of left coronary artery. Three days after modeling, the rats were treated with KC for eight weeks. And then the total collagen content in the myocardium of non infarct region and angiotensin Ⅱ (AngⅡ) and aldosterone (ALD) levels in blood and myocardium were measured by oxyproline hydroxyproline method and radioimmunoassay. The total collagen content was higher in Group Ⅱ than that in Group Ⅰ (P0 05) . [Conclusion]KC can inhibit the production of collagen and increase myocardial compliance and its mechanism may be involved in the regulation of rennin angiotensin aldosterone system.
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Objective To investigate the clinical, imaging and pathological findings of the primary (CNS) lymphoma in patients without AIDS. Methods The clinical, laboratory, neuroradiological and pathological data of such 15 cases were analysed. Results The clinical features of the primary malignant lymphoma of CNS are variable,however,more than half of patients were presented with an increased intracranial pressure and a neurologic dysfunction, such as weakness of limbs,speech changes and seizures. These symptoms were always misdiagnosed as some other tumors.Examination of CSF revealed a mild or intermediate increase of protein in all patients by way of lumbar punctures. Imaging examinations by CT and MRI both showed solitary or multiple masses of tumor located more likely in the frontal and temporal lobes. Only 20% patients mimiced the demyelineting disease and were misdiagnosed as multiply sclerosis. Conclusions Patients with such CNS lymphoma usually do not present the characteristically clinical manifestations or findings in the imaging scanning. Brain biopsy may be a method more reliable to confirm this disease and be important for improving the prognosis of patients.