{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T11:55:25Z","timestamp":1790510125925,"version":"4.1.0"},"reference-count":31,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,4,23]],"date-time":"2021-04-23T00:00:00Z","timestamp":1619136000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,4,23]],"date-time":"2021-04-23T00:00:00Z","timestamp":1619136000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["7187040708"],"award-info":[{"award-number":["7187040708"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100010909","name":"Young Scientists Fund","doi-asserted-by":"publisher","award":["71503089"],"award-info":[{"award-number":["71503089"]}],"id":[{"id":"10.13039\/501100010909","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Sci Rep"],"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Traditional Chinese medicine (TCM) injection is widely\u00a0used\u00a0in 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\u201310 and 41\u201380\u00a0years 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.<\/jats:p>","DOI":"10.1038\/s41598-021-88339-9","type":"journal-article","created":{"date-parts":[[2021,4,23]],"date-time":"2021-04-23T10:12:30Z","timestamp":1619172750000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":28,"title":["Safety of traditional Chinese medicine injection based on spontaneous reporting system from 2014 to 2019 in Hubei Province, China"],"prefix":"10.1038","volume":"11","author":[{"given":"Rui","family":"Huang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuanxuan","family":"Cai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linhui","family":"Yang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaofang","family":"Shangguan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bishwajit","family":"Ghose","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shangfeng","family":"Tang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,4,23]]},"reference":[{"key":"88339_CR1","doi-asserted-by":"publisher","first-page":"69","DOI":"10.4103\/0973-1296.75905","volume":"7","author":"S Shetti","year":"2011","unstructured":"Shetti, S., Kumar, C. D., Sriwastava, N. K. & Sharma, I. P. Pharmacovigilance of herbal medicines: Current state and future directions. Pharmacogn. Mag. 7, 69\u201373. https:\/\/doi.org\/10.4103\/0973-1296.75905 (2011).","journal-title":"Pharmacogn. Mag."},{"key":"88339_CR2","doi-asserted-by":"publisher","first-page":"134","DOI":"10.1016\/j.yrtph.2009.06.008","volume":"55","author":"K Ji","year":"2009","unstructured":"Ji, K. et al. Comments on serious anaphylaxis caused by nine Chinese herbal injections used to treat common colds and upper respiratory tract infections. Regul. Toxicol. Pharmacol. 55, 134\u2013138. https:\/\/doi.org\/10.1016\/j.yrtph.2009.06.008 (2009).","journal-title":"Regul. Toxicol. Pharmacol."},{"key":"88339_CR3","doi-asserted-by":"publisher","first-page":"249","DOI":"10.1016\/j.fitote.2018.07.009","volume":"129","author":"H Li","year":"2018","unstructured":"Li, H., Wang, S., Yue, Z., Ren, X. & Xia, J. Traditional Chinese herbal injection: Current status and future perspectives. Fitoterapia 129, 249\u2013256. https:\/\/doi.org\/10.1016\/j.fitote.2018.07.009 (2018).","journal-title":"Fitoterapia"},{"key":"88339_CR4","unstructured":"The reporting and monitoring administration measure on ADR. http:\/\/www.gov.cn\/flfg\/2011-05\/24\/content_1870110.htm (2011)."},{"key":"88339_CR5","unstructured":"Drug safety Warning. https:\/\/www.nmpa.gov.cn\/yaopin\/ypanqjsh\/index.html (2020)."},{"key":"88339_CR6","unstructured":"Adverse Drug Reaction Information Bulletin (vol. 4). https:\/\/www.nmpa.gov.cn\/xxgk\/yjjsh\/ypblfytb\/20030901125601660.html (2003)."},{"key":"88339_CR7","unstructured":"Adverse Drug Reaction Information Bulletin (vol. 21). https:\/\/www.nmpa.gov.cn\/xxgk\/yjjsh\/ypblfytb\/20090420120001639.html (2009)."},{"key":"88339_CR8","doi-asserted-by":"publisher","first-page":"1002","DOI":"10.1002\/pds.4805","volume":"28","author":"H Li","year":"2019","unstructured":"Li, H., Deng, J., Deng, L., Ren, X. & Xia, J. Safety profile of traditional Chinese herbal injection: An analysis of a spontaneous reporting system in China. Pharmacoepidemiol. Drug Saf. 28, 1002\u20131013. https:\/\/doi.org\/10.1002\/pds.4805 (2019).","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"88339_CR9","doi-asserted-by":"publisher","first-page":"929","DOI":"10.1517\/14740338.4.5.929","volume":"4","author":"M Hauben","year":"2005","unstructured":"Hauben, M., Madigan, D., Gerrits, C. M., Walsh, L. & Van Puijenbroek, E. P. The role of data mining in pharmacovigilance. Expert Opin. Drug Saf. 4, 929\u2013948. https:\/\/doi.org\/10.1517\/14740338.4.5.929 (2005).","journal-title":"Expert Opin. Drug Saf."},{"key":"88339_CR10","doi-asserted-by":"publisher","first-page":"285","DOI":"10.1002\/pds.1058","volume":"14","author":"N Moore","year":"2005","unstructured":"Moore, N., Thiessard, F. & Begaud, B. The history of disproportionality measures (reporting odds ratio, proportional reporting rates) in spontaneous reporting of adverse drug reactions. Pharmacoepidemiol. Drug Saf. 14, 285\u2013286. https:\/\/doi.org\/10.1002\/pds.1058 (2005).","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"88339_CR11","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1002\/pds.668","volume":"11","author":"EP van Puijenbroek","year":"2002","unstructured":"van Puijenbroek, E. P. et al. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol. Drug Saf. 11, 3\u201310. https:\/\/doi.org\/10.1002\/pds.668 (2002).","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"88339_CR12","doi-asserted-by":"publisher","first-page":"4347","DOI":"10.19540\/j.cnki.cjcmm.20180815.004","volume":"43","author":"Y Wang","year":"2018","unstructured":"Wang, Y. et al. Retrospective analysis and discussion on 74 cases of adverse reactions of traditional Chinese medicine injection. China J. Chin. Mater. Med. 43, 4347\u20134351. https:\/\/doi.org\/10.19540\/j.cnki.cjcmm.20180815.004 (2018).","journal-title":"China J. Chin. Mater. Med."},{"key":"88339_CR13","doi-asserted-by":"publisher","DOI":"10.1155\/2019\/8310368","author":"L Tan","year":"2019","unstructured":"Tan, L., Li, M. & Lin, Y. Safety concerns of traditional chinese medicine injections used in Chinese children. Evid. Based Complement. Altern. Med. https:\/\/doi.org\/10.1155\/2019\/8310368 (2019).","journal-title":"Evid. Based Complement. Altern. Med."},{"key":"88339_CR14","doi-asserted-by":"publisher","DOI":"10.1155\/2015\/420607","author":"Y-J Guo","year":"2015","unstructured":"Guo, Y.-J., Wang, D.-W., Meng, L. & Wang, Y.-Q. Analysis of anaphylactic shock caused by 17 types of traditional Chinese medicine injections used to treat cardiovascular and cerebrovascular diseases. Biomed. Res. Int. https:\/\/doi.org\/10.1155\/2015\/420607 (2015).","journal-title":"Biomed. Res. Int."},{"key":"88339_CR15","doi-asserted-by":"publisher","first-page":"604","DOI":"10.1016\/s0254-6272(15)30070-4","volume":"34","author":"W Yang","year":"2014","unstructured":"Yang, W., Zhang, W., Xie, Y. & Han, B. Establishment of safety evidence for Xingxue (R) Shuxuening injection. J. Trad. Chin. Med. 34, 604\u2013608. https:\/\/doi.org\/10.1016\/s0254-6272(15)30070-4 (2014).","journal-title":"J. Trad. Chin. Med."},{"key":"88339_CR16","first-page":"3013","volume":"38","author":"W Yang","year":"2013","unstructured":"Yang, W., Xiang, Y., Xie, Y. & Shen, H. Analysis of adverse reactions and pharmacovigilance research to parenterally administered shuxuening. China J. Chin. Mater. Med. 38, 3013\u20133018 (2013).","journal-title":"China J. Chin. Mater. Med."},{"key":"88339_CR17","first-page":"4752","volume":"40","author":"L Wang","year":"2015","unstructured":"Wang, L., Xie, Y., Ai, Q. & Song, N. Post-marketing clinical safety assessment of Shenmai injection based on active monitoring and passive monitoring in large data background. China J. Chin. Mater. Med. 40, 4752\u20134756 (2015).","journal-title":"China J. Chin. Mater. Med."},{"key":"88339_CR18","doi-asserted-by":"publisher","first-page":"827","DOI":"10.1016\/s0254-6272(14)60019-4","volume":"33","author":"L Wang","year":"2013","unstructured":"Wang, L. et al. Postmarketing studies on safety of Dengfeng (R) shenmai injection. J. Trad. Chin. Med. 33, 827\u2013831. https:\/\/doi.org\/10.1016\/s0254-6272(14)60019-4 (2013).","journal-title":"J. Trad. Chin. Med."},{"key":"88339_CR19","first-page":"930","volume":"32","author":"H Liu","year":"2016","unstructured":"Liu, H., Chen, Z. & Sun, S. Research on the clinical rationality and safety of Ginkgolid injections in certain hospital: An integrated approach. Chin. J. Clin. Pharmacol. 32, 930\u2013932 (2016).","journal-title":"Chin. J. Clin. Pharmacol."},{"key":"88339_CR20","first-page":"135","volume":"30","author":"B Zhao","year":"2021","unstructured":"Zhao, B. Effect of ginkgolide injection combined with atorvastatin calcium tablet on neurological function, hemodynamics and adverse drug reactions in Senile Patients with acute cerebral infarction. Henan Med. Res. 30, 135\u2013137 (2021).","journal-title":"Henan Med. Res."},{"key":"88339_CR21","doi-asserted-by":"publisher","first-page":"4038","DOI":"10.21037\/apm-20-1990","volume":"9","author":"L Yan","year":"2020","unstructured":"Yan, L. et al. Adverse drug reactions and nursing interventions in the treatment of non-Hodgkin\u2019s lymphoma by Aidi injection. Ann. Palliat. Med. 9, 4038\u20134043. https:\/\/doi.org\/10.21037\/apm-20-1990 (2020).","journal-title":"Ann. Palliat. Med."},{"key":"88339_CR22","first-page":"383","volume":"31","author":"L Hu","year":"2012","unstructured":"Hu, L., Yang, X., Su, Y. & Bai, X. Retrospective study of 96 patients with tumor treated with Aidi injection. Herald Med. 31, 383\u2013385 (2012).","journal-title":"Herald Med."},{"key":"88339_CR23","doi-asserted-by":"publisher","first-page":"878","DOI":"10.1002\/cjoc.201400265","volume":"32","author":"J Li","year":"2016","unstructured":"Li, J., Li, C., Liang, S. & Zhuang, S. Clinical study of Aidi injection. J. Changchun Univ. Chin. Med. 32, 878\u2013879 (2016).","journal-title":"J. Changchun Univ. Chin. Med."},{"key":"88339_CR24","first-page":"167","volume":"9","author":"S Yang","year":"2016","unstructured":"Yang, S., Shu, J. & Xu, X. Causes and prevention of adverse drug reactions of reduning injection. Chin. J. Clin. Ration. Drug Use 9, 167\u2013168 (2016).","journal-title":"Chin. J. Clin. Ration. Drug Use"},{"key":"88339_CR25","first-page":"7871","volume":"4","author":"H Ye","year":"2017","unstructured":"Ye, H. Analysis and prevention of adverse drug reaction of reduning injection. J. Clin. Med. 4, 7871 (2017).","journal-title":"J. Clin. Med."},{"key":"88339_CR26","first-page":"1795","volume":"40","author":"C Ke","year":"2011","unstructured":"Ke, C. & Chen, W. Retrospective analysis of 105 cases of adverse reaction of salvia miltiorrhiza injection. Chongqing Med. 40, 1795\u20131796 (2011).","journal-title":"Chongqing Med."},{"key":"88339_CR27","first-page":"47","volume":"13","author":"S Zhu","year":"2015","unstructured":"Zhu, S., Mei, D., Wang, L., Feng, L. & Zhang, X. Adverse reaction induced by salvia miltiorrhiza injection: A 10-year review of reported cases in Beijing. Clin. Med. J. 13, 47\u201350 (2015).","journal-title":"Clin. Med. J."},{"key":"88339_CR28","first-page":"166","volume":"1","author":"W Hu","year":"2008","unstructured":"Hu, W. Literature analysis of 97 cases of adverse drug reactions induced by mailuoning injection. Chin. J. Hosp. Pharm. 1, 166\u2013167 (2008).","journal-title":"Chin. J. Hosp. Pharm."},{"key":"88339_CR29","first-page":"171","volume":"19","author":"Y Lu","year":"2011","unstructured":"Lu, Y., Yu, X. & Li, M. Analysis of 264 cases of adverse drug reactions induced by mailuoning injection. Pharm. Clin. Res. 19, 171\u2013173 (2011).","journal-title":"Pharm. Clin. Res."},{"key":"88339_CR30","first-page":"169","volume":"13","author":"L Sun","year":"2016","unstructured":"Sun, L. & Tang, H. Literature analysis of 178 cases of adverse drug reactions induced by mailuoning injection. Chin. J. Pharmacovigil. 13, 169\u2013172 (2016).","journal-title":"Chin. J. Pharmacovigil."},{"key":"88339_CR31","first-page":"1322","volume":"1","author":"G Xing","year":"2008","unstructured":"Xing, G., Li, C. & Yang, Y. Analysis of 162 cases of adverse drug reactions induced by mailuoning injection. China J. Chin. Mater. Med. 1, 1322\u20131326 (2008).","journal-title":"China J. Chin. Mater. Med."}],"container-title":["Scientific Reports"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.nature.com\/articles\/s41598-021-88339-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41598-021-88339-9","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41598-021-88339-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,12,3]],"date-time":"2022-12-03T07:10:09Z","timestamp":1670051409000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.nature.com\/articles\/s41598-021-88339-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,4,23]]},"references-count":31,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2021,12]]}},"alternative-id":["88339"],"URL":"https:\/\/doi.org\/10.1038\/s41598-021-88339-9","relation":{},"ISSN":["2045-2322"],"issn-type":[{"value":"2045-2322","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,4,23]]},"assertion":[{"value":"10 December 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"9 April 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 April 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The authors declare no competing interests.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"8875"}}