Analysis Of Using Condition Of Efficacy And Safety Assessment Scales On Clinical Studies/Investigation Of The Treatment Of Schizophrenia

Objective :This article designed to analyze curative efficacy and the selection of the safety evaluation scale tool as well as their difference in treatment of schizophrenia clinical study at home and abroad, and to offer reference and guidance for the schizophrenia clinical effectiveness and selection of safety evaluation tools in our country for the future, and to offer the basis of the effectiveness and safety evaluation in the choice of evaluation tools to reach consensus.Method :This research adopts the methods of literature analysis, searching schizophrenia clinical research literature at home and abroad of the year 2004, 2009 and 2014, has determined the selected condition and the trends of clinical efficacy and safety of schizophrenia in the past decade, and comparative the use condition of effectiveness schizophrenia clinical research at home and abroad.Result: 937 articles in China and 306 articles abroad were counted. As the main efficacy and the safety evaluation index,the Mental symptoms evaluation and the evaluation of the adverse reactions has been use by schizophrenia clinical studies, and overall evaluation, social function,emotional/anxiety symptoms, quality of life, cognitive function assessment and others as know as secondary efficacy index. ①There is no significant difference between China and abroad for mental symptom assessment, and so far, positive and negative symptoms scale(PANSS) has the highest utilization rate(the rate in China in three years are 45%, 76%and 69%,the rate in three years abroad are 51%, 66%,and78%). Brief psychiatric scale(BRPS)has the second utilization rate, and it has a tendency to reduce in China and abroad. ② There is high significant difference between China and abroad for adverse reactions rating scale between China and abroad,Treatment Emergent Symptom(TESS) has the highest utilization rates in three years in China(respectively56%,70%and36%). Extrapyramidal symptoms assessment as the main assessment for adverse drug reactions abroad, usually using the scale Simpson Angus extrapyramidal side effect scale(SAS),and it often been used with abnormal involuntary movement scale(AIMS) and Barnes akathisia rating scale(BARS). ③ Overall evaluation has the third utilization rates in three years in China and abroad. As a secondary curative effect, clinical global impression(CGI) is the only such assessment scale in domestic and foreign literature ofthe scale, and it always been used with mental symptoms rating scale. The utilization rate of CGI in foreign literature is higher than domestic literature, and in domestic literature utilization ratio in 2014 is less than 2009 and 2004. ④ Social function, emotional/anxiety symptoms, quality of life, cognitive function assessment as the secondary efficacy index of therapeutic effect evaluation has the least utilization rate, but the utilization rate of social function, cognitive function assessment at home and abroad both have gradually increasing trend, and the utilization rate in demostic is higher than foreign research literature references. AS the secondary efficacy index, especially for global assessment scale(GAF/GAS), Social and Occupational Functiong Assessment Scale(PSP), Calgary depression scale for schizophrenia(CDSS), Quality of Life Scale(QLS) and Brief Assessment of Cognition in Schizophrenia(BACS) have the significant differences between theirselves, what is more, utilization ratio of foreign research literature is higher than domestic research literature.Conclusion : ① At present, domestic schizophrenia clinical research mainly adopts the PANSS and TESS as the primary efficacy indicators and safety indicators. ② Foreign schizophrenia clinical research mainly adopts PANSS and extrapyramidal symptoms rating scale(including SAS*, AIMS, BARS) as the primary efficacy outcomes and safety indicators. ③ Overall assessment(CGI), social function, emotional/anxiety symptoms, quality of life, cognitive function assessment in domestic and foreign research for assessment of curative effect of the secondary efficacy indicators, usually used with primary efficacy indicators and safety indicators.