Safety of traditional Chinese medicine injection based on spontaneous reporting system from 2014 to 2019 in Hubei Province, China

Rui Huang,Shangfeng Tang,Bishwajit Ghose,Linhui Yang,Xiaofang Shangguan,Yuanxuan Cai

doi:10.1038/s41598-021-88339-9

Rui Huang, Shangfeng Tang + Show 4 more

Open Access

https://doi.org/10.1038/s41598-021-88339-9

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Abstract

Traditional Chinese medicine (TCM) injection is widely used in clinical settings, but its adverse drug reactions (ADRs) can be a serious public health concern. The objective is to study the safety of TCM injection and provide suggestions for clinical use. ADR reports collected by the Hubei Adverse Drug Reaction Monitoring Center from 2014 to 2019 were analysed. The safety of TCM injections was described by descriptive analysis and three signal mining methods, including the reporting odd ratio (ROR), proportional reporting ratio (PRR) and comprehensive standard method (MHRA). The findings indicate that the age groups of 0–10 and 41–80 years had the highest rates of reporting ADRs. A total of 96.41% of the ADRs occurred within one week, mostly on the same day that the injection was administered. Among the 60 TCM injections, Shenmai, Xiangdan, Salvia, Shengmai, Astragalus and Xuebijing injection had an above average ratio of severe ADRs (12.63%). A total of 99.24% of the cases improved after treatment. There were 9 deaths whose ADRs were mainly anaphylactic shock, dyspnoea and anaphylactoid reaction. In signal mining, the three methods produced 19 signals that were the same, and 14 of them were off-label ADRs. The frequency of TCM injections in children and elderly patients should be reduced and monitored strictly. Close observation is necessary during the first seven days after receiving the injection. The clinical use of Shenmai, Xiangdan, Salvia, Shengmai, Astragalus and Xuebijing injections should be investigated. Signal mining and more research are needed on TCM injections.

Highlights

Modern Chinese medicines include almost all modern preparation forms, such as capsules, inhalants, dropping pills, injections and injectable powder[1]
Since there was no unified standard for the entry of drug names and adverse drug reactions (ADRs) in the report, the drug names registered in the National Medical Products Administration (NMPA) were used as the standard to unify the generic names and the ADRs and clinical manifestations were organized according to the World Health Organization Adverse Reaction Terms (WHO-ART)
Statistics showed that the reports of Traditional Chinese medicine (TCM) injections reported by the spontaneous reporting system in the past 6 years were mostly from children and middle-aged and elderly patients

Summary

Introduction

Modern Chinese medicines include almost all modern preparation forms, such as capsules, inhalants, dropping pills, injections and injectable powder[1]. With the development and widespread use of TCM injections, adverse drug reactions (ADRs) have gradually become a public concern. On April 20, 2009, National Adverse Drug Reaction Monitoring Center issued a warning that Qingkailing injection may have serious ADRs, as more than one-quarter of the hust.edu.cn. The latest ADR notification related to TCM injection was reported in 2013, showing that there were a total of 3306 cases of safflower injection in the ADR monitoring database in 2012, including 154 severe cases. Special populations, including new-borns, infants, children, the elderly, pregnant women and lactating women, are restricted in the use of TCM injections, and some of them are forbidden. The purpose of this study was to analyse a database of provincial spontaneous reporting systems (SRSs) and study the safety of TCM injections from all aspects of ADRs

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