| Background:Traditional Chinese Medicine is a significant part of Chinese medical science system,which plays a vital role in the medical care of the Chinese nation.With the development of modern medicine,Chinese medicine urgently needs to apply advanced modern science and technology to explain its scientific connotation.Research on evidence-based medicine is a scientific method to promote the development of TCM imperatively.In the development of evidence-based medicine research,besides the rationality of clinical trial design and the strictness of program implementation,the quality of biological samples also has a significant impact on the accuracy of clinical research results of traditional Chinese medicine.The collection of multi-center clinical biological specimens is faced with various differences in personnel,environment and conditions,as well as a series of links such as temporary processing,preservation and transportation after collection.Therefore,it is very easy for the biological samples to have irregular sample collection and uneven quality during the whole circulation process after ex vivo.Biological specimens not only support a certain clinical research,but also provide resources for more research such as mechanisms of Action,theory of medicinal potency and syndromes of TCM through long-term preservation at low temperatures.Therefore,ensuring the quality of biological specimens is of utmost importance.Objective:In order to reduce the multi-center biological specimen quality on bias of the problems of multi-center clinical research of TCM,get accord with the characteristics of high quality clinical research of TCM resources and improve the quality of the biological sample library construction,this study intends to develop multi-center clinical trials to collect,transport and preserve specifications for biological specimens,increase personnel training and control the circulation to achieve the purpose of ensuring the quality of biological specimens.Provide guarantee for the accuracy and sustainability of TCM research.Methods:According to the characteristics of the clinical research methods of TCM,establish standardized operation specifications for multi-center biological specimens,including collection,transportation,processing and preservation of biological samples.Taking the clinical research of TCM led by our hospital as the source of the specimens,the entire process is followed in the implementation of the specimen collection standard in clinical research.Through the research methods of DNA quality comparison,protein electrophoresis and biomacromolecules,the quality of multi-center biological samples obtained during the study was evaluated.Results:In this study,a multi-center biological sample operation standard was established and a multi-center clinical trial of TCM treatment of chronic kidney disease was conducted based on the hospital.We received a total of 795 enrolled patients from 34 research centres nationwide during the period of March in 2017 to December in 2017,including 2269 tables of EDTA anticoagulant,2269 tabkes of prothrombotic,2335 tables of morning urine and 2144 tubes of 24 hr urine.The results showed that the concentration of serum potassium increased and glucose concentration decreased at room temperature.Through to the polycentric serum samples of potassium,blood glucose,creatinine and urinary inhibition C to recheck and compared with the instant test results of the centre for the study of evaluation quality of serum samples,the result showed that there was no significant difference in serum potassium,blood glucose,creatinine and cystatin C in 170 serum samples from 34 research centers(P > 0.05).The DNA concentration purity and gel electrophoresis analysis showed that the samples collected were of high quality without obvious degradation,and the concentration was between 100 ng and 300 ng,which could meet the long-term preservation requirements.The serum and urine protein electrophoresis map showed that the species of biological samples were abundant,the protein abundance was high,and the electrophoresis bands were clear.Conclusion:Based on multi-center clinical trials of TCM,this project developed specifications for the collection,transportation,procession,and preservation of multi-centric biological specimens.By strengthening the training of multicenter specimen collection participants,strictly performing multi-center standardized collection and operations,the quality of biological samples was ensured,which provided important biological resources for traditional Chinese medicine and modern medical research. |
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