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Objective To explore the relationship between the levels of serum BDNF,IL-6 and Hcy with cognitive impairment in the patients with first episode schizophrenia.Methods One hundred and thirty-five patients with schizophrenia(patients group)and 130 mental healthy volunteers (control group)in our hospital from January 2015 to January 2016 were selected as the research sub-jects.The levels of IL-6 and BDNF were detected by adopting the enzyme linked immunosorbent assay (ELISA)and Hcy level was detected by using the circulating enzymatic method.The mental symptoms were evaluated by the positive and negative symptom rat-ing scale (PANSS),cognitive function was evaluated by the Wisconsin Card Sorting Test (WCST)and their relationship was ana-lyzed.Results The BDNF level in the patients group was significantly lower than that in the control group,while the Hcy and IL-6 levels were significantly higher than those in the control group,the differences were statistically significant(P<0.05).The WCST errors response number,persistent errors number and total responses number in the patients group were significantly higher than those in the control group,while the complete classification number and correct response number were significantly lower than those in the control group,the differences were statistically significant (P<0.05).The levels of BDNF,IL-6 and Hcy had significant cor-relation with the WCST total responses number,persistent errors number,errors response number and complete classification num-ber.Conclusion The levels of serum Hcy,IL-6 and BDNF in the patients with first episode schizophrenia have a certain relation with the mental symptoms and cognitive function,which demonstrates the existence of nerve-humor-immune regulation network regulation mechanism in a certain degree and plays a synergic action in the occurrence and development of schizophrenia.
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The implementation process management plays a important role for the quality of centralized safety monitoring study of post-marketing Chinese medical injections.One of the critical link is hospital.Currently,there is no principle or specification for hospital choosing,number of monitoring points,data collection responsible part and forms of data collection as well.These issues caused uneven quality,huge differences in results and questioned conclusion.Based on the previous research experience,this paper focused on discussing the link of hospital where research data may be influenced,and proposed some suggestions.
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Safety is a critical link restricting the development of TCM injections.Hospital centralized monitoring is of importance in the safety evaluation of TCM injections.However,the results of centralized monitoring studies usually deviated from the actual situation because of problems in design and process quality.Our research team have completed several projects over centralized monitoring in recent years.Based on the previous research experience,this paper mainly discussed the current statuation,the significance and methods for standard process of hospital centralized monitoring in regard to TCM injections,in order to improve the quality of centralized monitoring studies and provide technique support for recognizing the safety of TCM injections.
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According to the related requirements of safety reevaluation of TCM injections,hospital centralized monitoring of the safety of TCM injection was consecutively pressed ahead.Centralized security monitoring was a large-scale real world research involving numerous data acquisition,transmission,verification and analysis.The quality of data acquisition and data verification directly affected the authenticity and reliability of research data and results.Therefore,data management played a significant role in the safety monitoring of TCM injections.Based on the analysis of previous researches,this paper discussed the implementation content,links and the frequent problems and corresponding solutions of data management during the safety monitoring of TCM injections,combining with the experience in the implementation of projects.
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Comparative effectiveness research (CER) is well developed in international medical research. This article analyzes the basic connotations of CER from five aspects, including selection of objective, positioning of target population, comparison of intervention scheme, identification of contrast condition and analysis of therapeutic effects. The inclusiveness and advanced nature of CER were revealed by comparing with modern medical research methods, such as evidence-based medicine, patient-important outcome and randomized controlled trials. Based on the superiority of CER, the feasibility of applying CER in clinical evaluation of traditional Chinese medicine is explored. CER should be combined with the holistic concept, syndrome differentiation and individuality-concerned treatment so as to facilitate its development in research of traditional Chinese medicine in China.
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Case recruitment of large-scale clinical trials should be strictly checked in quality and quantity for it is the key to clinical trial. This study discusses the main difficulties and countermeasures in the case recruitment of large sample, multi-center clinical trials according to the national research project "Myocardial Infarction Secondary Prevention Study in Traditional Chinese Medicine".
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Abstract: Large-scale clinical trial is an important measure of clinical evaluation on drugs. This paper introduces the concept and features of large-scale clinical trial, the possibility and necessity of large-scale clinical trial of traditional Chinese medicine, as well as its administration and quality control, with Myocardial Infarction Secondary Prevention Study in Traditional Chinese Medicine (MISPS-TCM), a National Program Subject, as an example.