A total of 109 varieties of Chinese medicine injections have been approved by the State Food and Drug Administration of China, all of which have the potential to induce adverse drug reactions (ADRs). Major ADRs include systemic anaphylaxis, anaphylactic shock, acute intravascular hemolysis, hepatorenal damage, skin lesion, cardiac damage, respiratory system injury, and gastrointestinal disorders. Contributing factors of ADRs include healthcare workers’ inadequate attention to ADRs of Chinese medicine injections, complex ingredients, allergic uncertainties, and inappropriate drug use in children and the aged. To decrease ADRs resulting from Chinese medicine injections, it is essential to improve the selection of drug indications, delivery of proper dosage regimens, compliance with drug instructions, and selection of solvents for the drugs.
ObjectivesTo systematically review the safety of traditional Chinese medicine injection based on clinical centralized monitoring studies that have been carried out and listed so far, to understand basic situation of adverse reactions and explore the risk factors of traditional Chinese medicine injections and to provide evidence for clinical rational use of drugs and optimizing centralized monitoring methods. MethodsCFDA, CNKI, VIP, WanFang Data, Sinomed, PubMed and The Cochrane Library databases were electronically searched to collect studies on safety monitoring of listed traditional Chinese medicine injections from inception to February, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed by using Excel software. ResultsA total of 14 studies involving 14 varieties of injections, 296 200 cases were included. The highest incidence rate of adverse reactions was found in the XueBiJing injection (2.54%). The related factors of ADR extraction were age, sex, drug combined usage, time from administration, allergic history, administration days, indication, dose and distribution of the tube. ConclusionsThe safety of traditional Chinese medicine injection is generally high. Middle and old age is an important factor in the occurrence of ADR. The incidence of ADR is relatively high in the first 6 days of drug use, and the incidence of ADR is more likely to be caused by irrational use of drugs in clinic, and the history of allergy may be related to the occurrence of ADR. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusion.
The post-marketing clinical safety re-evaluation studies of traditional Chinese medicine injections have obtained safety evidence of various research types such as active monitoring, passive monitoring and literature review. However, there is a lack of comprehensive evaluation methods that can effectively integrate the data of the above research types. So far, it is impossible to further produce more comprehensive and objective high-level evidence-based evidence, which seriously affects the supervision and management of traditional Chinese medicine injections and clinical rational use. The key to establishment of a comprehensive evaluation method is to first establish a comprehensive evaluation of the core indicators of the preferred method, the formation of weighted quantitative scoring model applied to the comprehensive evaluation method. Mixed methods research (MMR) can effectively and deeply integrate different types of research data and scientifically and normatively complete the screening of indicators in the evaluation model through repeated quantitative and qualitative research on data. Secondly, for the most critical index weighting and weight adjustment research in the model construction research, the author innovatively combines the analytic hierarchy process with the invariant weight sub-constraint method, and introduces the quantitative research part of the MMR design. It ensures the accurate weighting of indicators in the process of model construction. Therefore, based on the research on the core outcome set proposed for the core outcome outcomes of the effectiveness test, this paper proposes the use of MMR to carry out index screening and weight adjustment research based on multi-source complex data, and to construct a comprehensive evaluation model of post-marketing clinical safety of traditional Chinese medicine injections that integrates different research types of data. It provides measurement tools and new methods for the comprehensive evaluation of post-marketing clinical safety of traditional Chinese medicine injections.