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

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...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Rui Huang, Yuanxuan Cai, Linhui Yang, Xiaofang Shangguan, Bishwajit Ghose, Shangfeng Tang
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/7b0c19e691dd4da6bef417926382f940
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:7b0c19e691dd4da6bef417926382f940
record_format	dspace
spelling	oai:doaj.org-article:7b0c19e691dd4da6bef417926382f9402021-12-02T16:45:39ZSafety of traditional Chinese medicine injection based on spontaneous reporting system from 2014 to 2019 in Hubei Province, China10.1038/s41598-021-88339-92045-2322https://doaj.org/article/7b0c19e691dd4da6bef417926382f9402021-04-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-88339-9https://doaj.org/toc/2045-2322Abstract 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.Rui HuangYuanxuan CaiLinhui YangXiaofang ShangguanBishwajit GhoseShangfeng TangNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Rui Huang Yuanxuan Cai Linhui Yang Xiaofang Shangguan Bishwajit Ghose Shangfeng Tang Safety of traditional Chinese medicine injection based on spontaneous reporting system from 2014 to 2019 in Hubei Province, China
description	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.
format	article
author	Rui Huang Yuanxuan Cai Linhui Yang Xiaofang Shangguan Bishwajit Ghose Shangfeng Tang
author_facet	Rui Huang Yuanxuan Cai Linhui Yang Xiaofang Shangguan Bishwajit Ghose Shangfeng Tang
author_sort	Rui Huang
title	Safety of traditional Chinese medicine injection based on spontaneous reporting system from 2014 to 2019 in Hubei Province, China
title_short	Safety of traditional Chinese medicine injection based on spontaneous reporting system from 2014 to 2019 in Hubei Province, China
title_full	Safety of traditional Chinese medicine injection based on spontaneous reporting system from 2014 to 2019 in Hubei Province, China
title_fullStr	Safety of traditional Chinese medicine injection based on spontaneous reporting system from 2014 to 2019 in Hubei Province, China
title_full_unstemmed	Safety of traditional Chinese medicine injection based on spontaneous reporting system from 2014 to 2019 in Hubei Province, China
title_sort	safety of traditional chinese medicine injection based on spontaneous reporting system from 2014 to 2019 in hubei province, china
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/7b0c19e691dd4da6bef417926382f940
work_keys_str_mv	AT ruihuang safetyoftraditionalchinesemedicineinjectionbasedonspontaneousreportingsystemfrom2014to2019inhubeiprovincechina AT yuanxuancai safetyoftraditionalchinesemedicineinjectionbasedonspontaneousreportingsystemfrom2014to2019inhubeiprovincechina AT linhuiyang safetyoftraditionalchinesemedicineinjectionbasedonspontaneousreportingsystemfrom2014to2019inhubeiprovincechina AT xiaofangshangguan safetyoftraditionalchinesemedicineinjectionbasedonspontaneousreportingsystemfrom2014to2019inhubeiprovincechina AT bishwajitghose safetyoftraditionalchinesemedicineinjectionbasedonspontaneousreportingsystemfrom2014to2019inhubeiprovincechina AT shangfengtang safetyoftraditionalchinesemedicineinjectionbasedonspontaneousreportingsystemfrom2014to2019inhubeiprovincechina
_version_	1718383461510676480

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

Ejemplares similares