Analysis Of Adverse Reactions Of Traditional Chinese Medicine Preparations In Jiaozuo City From 2017 To 2021

Traditional Chinese medicine(TMC)has been a traditional medication of the Chinese nation for thousands of years,making outstanding contributions to the physical health and life safety of all humanity.However,with the vigorous development of TCM preparations,the number of adverse reactions caused by them has gradually increased,which has increasingly attracted people’s attention.This article analyzes the adverse reaction reports of TCM preparations in Jiaozuo City,discusses the basic situation and related characteristics of adverse reaction monitoring,identifies existing problems,and proposes reasonable suggestions to improve the level of adverse reaction monitoring of drugs,providing reference for the rational use of TCM preparations in clinical practice.This article extracts 2669 adverse reaction reports of TCM preparations collected by the Drug Adverse Reaction Monitoring Center of Jiaozuo City from 2017 to 2021,and conducts a retrospective analysis and discussion on relevant patient information,medication information,report types,affected organs/systems,and report sources.Select TCM injections with a large number of reports,focus on analyzing the characteristics and main manifestations of adverse reactions,and deeply explore targeted preventive measures and treatment methods for adverse reactions of TCM injections.From 2017 to 2021,the number of reports of ADRs of TCM preparations in Jiaozuo City basically showed an upward trend year by year,with a total of 2669 cases collected and reported in five years,accounting for 16.4% of all adverse drug reaction reports,of which the proportion of new reports reached 37.4%,which was significantly higher than that of other drugs.The ratio of male to female patients is about 1:1.2,and the age is mainly middle-aged and elderly over 40 years old,accounting for nearly 73%.The proportion of patients with previous ADRs,familial ADRs and related important information was "unknown",32.3%,60.2%,and 83.2%,respectively.Adverse reactions involve organs/systems,digestive system,skin and its appendages,systemic reactions are the top three,mainly manifested as nausea,vomiting,rash,itching.The types of drugs involved in ADRs were mainly antipyretics and blood conditioning agents,with a total of 53%.The top three drug dosage forms involved were injections(including injection and powder injection),capsules and tablets,accounting for 36.1%,18.6% and 15.65%,and the corresponding routes of administration were mainly oral administration and intravenous drip,accounting for a total of 94.5%.In terms of reporting sources,medical institutions account for about 90%,while manufacturers account for only 3%.Among the professions of reporters,doctors accounted for the highest proportion,reaching 67%,pharmacists about 20%,and full-time ADRs monitors only 1.3%.In terms of regional distribution,the ADRs of TCM preparations in counties are higher than those in urban.There were 984 cases of adverse reactions of TMC injections,accounting for 36.9% of all TCM preparations,of which 162 cases were seriously reported,accounting for 84.4% of all serious adverse reactions of TCM preparations.It is mainly manifested as anaphylactic shock,systemic reactions,respiratory depression,etc.,and some are even life-threatening.The top three reported adverse reactions of TMC injection were Qingkailing injection,with 117 cases;eleuthero injection,91 cases;Blood plugging(lyophilized)for injection,88 cases.The main causes of ADR/ADE are the composition of the drug,the quality of the injection,the combination of drugs and the dosage used.In 2018,National State Medical Products Administration(NMPA)required that the instructions of the above TCM injections be revised,warning content added,and the use requirements and related risk points clarified,so as to provide guidelines for more reasonable and safe clinical use.Through the analysis of the monitoring of adverse reactions of TCM preparations in Jiaozuo City,it is found that there are shortcomings such as imperfect monitoring system,insufficient standardization of adverse reaction reporting,and monitoring capacity to be strengthened,and it is recommended to further improve the relevant systems and mobilize the enthusiasm of pharmaceutical enterprises to participate in post-marketing re-evaluation research of TCM preparations.Improve the quality of adverse reaction reports,make the report content more true,accurate and complete,and report in a timely manner.Through adverse reaction monitoring,guide the rational use of clinical TCM preparations,especially for key varieties,key populations and serious adverse reactions should be paid attention to,strictly follow the requirements of the instructions,pay attention to monitoring and reporting adverse drug reactions,and take corresponding measures in a timely manner.It is also necessary to strengthen publicity and training to ensure the safety of people’s medication and promote the further improvement of the monitoring level of adverse reactions at the grassroots level.