| 1. BackgroundTraditional Chinese Medicine (TCM) has been used in China for more than thousands of years, It has been considered as safe drugs in the past. With gradual deepening research in TCM, new varieties and new formulations continue to emerge, plus the increasing use of combination of TCM and western Medicine, the incidence of adverse drug reactions and even drug-induced diseases are also increasing.Because of study limitations before Traditional Chinese Medicine Injection (TCMI) been put into market, such as clear emphasis on the effectiveness, ignore the specie difference between people and animals, limited number of cases, limited spectrum of disease, limited age range of participants, short-term observation, not strict case selection, narrow crowd range of drug application, limited case number of combination of drug use, and many other restrictions, plus its chemical composition is more complex, quality standards are not reasonable enough, preparation technology need to be perfect, lack, of strict observation during clinical use, all of these cause many adverse reactions, including many serious adverse reactions.Due to study limitations, it is necessary to re-evaluation TCMI in order to ensure its safety after it has been put in use. Re-evaluation method is the key point of the study. But because China’s drug re-evaluation research work started late, and the special nature of TCMI, together with many problems in reporting ADR/AE of TCMI. There is no standard of TCMI safety report which unable to prompt accurate safety signals, therefore lack the basis for assessment of drug risk management. So we need to systematic study TCMI then formulate the standard of quality evaluation and ADR/AE report. It became an urgent priority to thoroughly understand the characteristic and effective path to re-evaluate the safety by the application of drug risk management in TCMI.2. PurposeThe study on the safety of Lianbizhi injection, supported by the national natural science foundation funded project (81001596) and major projects of national science and technology funded project (2012ZX10005009), created the ADR database, adopted the modern Pharmacoepidemiology and META analysis to figure out the relationship between the ADR and various factors, defined the feature of the ADR and influencing factors, identify risk factors and risk control elements, provide a reference for safe use of Lianbzhi injection. Through the document analysis, objectively evaluated the quality of the Lianbizhi injection ADR reports and analyzed the related factors, consistent with China’s national condition and drew up the standard of quality evaluation and ADR/AE report, Through the TCMI risk management theory research, attempted to establish the clinical risk management path with the characteristics of the TCMI, provide the reference for safety evaluation and safe use of TCMI.3. Study methodsIn this article, use literature analysis and META analysis of Pharmacoepidemiology to retrieve the Chinese journal full-text database, CHKD journal full-text database, VIP medical information resources system periodical database (1978.1-2012.1), with "Lianbizhi injection","adverse reaction,""treatment","reported cases" as the search term, obtained the full text of130references, including36articles about ADR, then use metrological analysis to study the data.To nail down anaphylactic shock related factors caused by Lianbizhi injection, we used regression analysis method, extracted the data of safety factors from the database. The symptoms of anaphylactic shock "rash" and "breathing difficulties" as the dependent variable, adverse reaction will be divided into "target adverse reaction group" and "other adverse reaction group", established logistic regression model, exploratory studied the influence factors of the adverse reactions.Through the document analysis and experts several rounds of reasoning, summarized the technical key points of ADR report of TCMI, and objectively evaluated the quality of the ADR report and analyzed the related factors of Lianbizhi injection, laid down the standard of quality evaluation and ADR/AE report of TCMI according to China’s national condition. Through the theoretical study, Summarized the basic structure and process of the risk management of TCMI. After multiple rounds of argumentation on basic guiding ideology, structure frame and process of the risk management of TCMI, tried to establish clinical risk management route in accordance with the characteristics of TCMI, in order to provide the reference for safety evaluation and safe use of TCMI.4. Conclusion4.1The most common ADR of Lianbizhi injection are skin lesions, allergic reaction and gastrointestinal damage, or can cause allergic shock, acute renal failure; Adverse reaction happened within30minutes accounted for45.05%,51.37%in1hour, the combination use of drugs accounted for70.36%. The ADR is quick onset mainly, it happens mostly to the young adults and middle-aged,and those use the combination of Lianbizhi Injection and other drugs at the same time with higher rates. Regression analysis suggests:allergic history is the related factor causes rash.4.2From the literature evaluation of Lianbizhi injection ADR reports, we can find that the quality of most ADR literature reports of TCMI is not high, this will go against TCMI safety information collection and the find of the safety signals.The attempt to establish the standard of quality evaluation and ADR/AE report, will help improve the quality of TCMI reports.4.3Risk management is the important content of TCMI and the safety ensurance, through case analysis, the establishment of clinical risk management process of TCMI, will help to regulate the basic process of the risk management of TCMI and reduce the clinical safety risks, and safeguard the life and health of the patient. |
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