Based On Literature Databases And Traditional Pharmacovigilance Thinking Of Traditional Chinese Medicine Injection Safety Studies

In recent years, ADR cases of Chinese herbal injection increased dramatically and the safety of it is becoming a major concern of Chinese medicine. However, at present, study on the safety of Chinese herbal injection is at the bottleneck due to scarcity of excellent information platform and ignorance of Traditional Chinese Medicine(TCM)characteristics.In this study, we carried out the research on the safety of Chinese herbal injection by literature, statistics and informatic(sdatabase and data-mining)method. The study is composed of four main parts as follows:â… Literature reviewIn the part of literature review, we discussed the safety problem of Chinese herb firstly and briefly, and then gave a global and comprehensive review of Chinese herbal injection and its safety problems. Moreover, in the third chapter of this part, we reviewed the evaluation or assessment methods of ADR cases in detail and put forward some new ideas of evaluation skills and technology.â…¡Establishment of databaseIn this part, we established literature database of safety information on Chinese herbal injection which has both TCM and injection characteristics. This database we established not only includes 5424 ADR cases of Chinese herbal injection but also includes general information of 150 kinds of injection and 164 kinds of Chinese herbs which are the ingredients of those injections. Moreover, this database has the information on imcompatibility of some kinds of Chinese herbal injection. Therefore, users of our database have the opportunity to obtain comprehensive and detailed information on the safety of Chinese herbal injection.â…¢Study on epidemiological characteristics of ADR of Chinese herbal injection On the basis of database platform established in partâ…¡, we analyzed ADR cases of Chinese herbal injection by bibliometric,statistic and data mining method including decision tree and Apriori arithmetic to investigate their epidemiological characteristics. In the first chapter of partâ…¢,we discussed global characteristics of the ADR cases in the database. In the second chapter, four injections including shuanghuanglian,qingkailing,chuanhuning and yuxingcao which had serious safety problem were studied in detail. Furthermore, we analyzed the epidemiological characteristics of anaphylactic shock caused by Chinese herbal injection in the third chapter. From these studies, we detected some unusual significant difference of ADR data which was never reported.â…£Study on the safety of Chinese herbal injection based on Chinese traditional pharmacovigilance thinkingIn TCM theory, there are lots of discussions about drug safety which are called Chinese traditional pharmacovigilance thinking. In this part of our study, we firstly elucidated the essence of traditional pharmacovigilance thinking through our literature research. Then, we collected and arranged the pharmacovigilance discussions about ingredient herbs of Chinese herbal injection. In the third chapter, we put forward some new opinions of precautions for the use of Chinese herbal injection based on our preceding study in this part.Conclusively, our study on the safety of Chinese herbal injection is an original and creative work which embodies both modern scientific ideology and TCM thinking, and the result of our research provides excellent platform and theoretic materials for the evaluation and rational utilization of Chinese herbal injection.