Safety Concerns of Traditional Chinese Medicine Injections Used in Chinese Children

Objective. To explore risks underlying traditional Chinese medicine (TCM) injection-related adverse drug reactions (ADRs) in Chinese children, and to discuss the implications of postmarketing reevaluation studies. Methods. We identified potential cases of exposure to TCM injections for children (<...

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Main Authors: Liping Tan, Mujin Li, Ying Lin
Format: Article
Language:English
Published: Hindawi Limited 2019-01-01
Series:Evidence-Based Complementary and Alternative Medicine
Online Access:http://dx.doi.org/10.1155/2019/8310368
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spelling doaj-bafeffd6c87e4f6cb0bf969cafff92392020-11-25T00:20:50ZengHindawi LimitedEvidence-Based Complementary and Alternative Medicine1741-427X1741-42882019-01-01201910.1155/2019/83103688310368Safety Concerns of Traditional Chinese Medicine Injections Used in Chinese ChildrenLiping Tan0Mujin Li1Ying Lin2Medical College of Shaoguan University, Shaoguan, Guangdong 512026, ChinaMedical College of Shaoguan University, Shaoguan, Guangdong 512026, ChinaMedical College of Shaoguan University, Shaoguan, Guangdong 512026, ChinaObjective. To explore risks underlying traditional Chinese medicine (TCM) injection-related adverse drug reactions (ADRs) in Chinese children, and to discuss the implications of postmarketing reevaluation studies. Methods. We identified potential cases of exposure to TCM injections for children (<18 years of age) and adults (18 years and upwards) from database of ADRs. First, the associations between TCM injection-related ADRs and three administration routes (i.e., intravenous or intramuscular administration, oral administration, and external use) and the imbalance of TCM injection-related ADRs between the paediatric and adult populations were tested using the Chi-square (χ2) test. Second, the proportional reporting ratio (PPR) was applied to identify statistically significant associations between drugs and anaphylactic shock in the paediatric population. Results. The χ2 test revealed that the highest frequency of paediatric ADRs was due to 5 types of herbal injections (i.e., Shuanghuanglian (SHL), Yuxingcao (YXC), Qingkailing (QKL), Xiyanping (XYP), and Reduning (RDN) herbal injections) (P<0.000), and the reports of ADRs attributed to the XYP and RDN herbal injections in children accounted for a greater proportion than the reports for adults (P<0.000). The PPR identified 5 types of herbal injections-anaphylactic shock pairs (i.e., the SHL, XYP, QKL, YXC, and Fufang Danshen herbal injections) that met the minimum criteria (i.e., a PPR of at least 2 and χ2 of at least 4 and three or more cases), which suggested that TCM injections were significantly associated with anaphylactic shock. Conclusions. TCM injections pose graver risks to the paediatric population than the adult population. To achieve optimal benefits and minimal risk to children treated with TCM injections, we suggest reevaluating the effectiveness and safety, monitoring the risks, and promoting rational use of TCM injections in Chinese children.http://dx.doi.org/10.1155/2019/8310368
collection DOAJ
language English
format Article
sources DOAJ
author Liping Tan
Mujin Li
Ying Lin
spellingShingle Liping Tan
Mujin Li
Ying Lin
Safety Concerns of Traditional Chinese Medicine Injections Used in Chinese Children
Evidence-Based Complementary and Alternative Medicine
author_facet Liping Tan
Mujin Li
Ying Lin
author_sort Liping Tan
title Safety Concerns of Traditional Chinese Medicine Injections Used in Chinese Children
title_short Safety Concerns of Traditional Chinese Medicine Injections Used in Chinese Children
title_full Safety Concerns of Traditional Chinese Medicine Injections Used in Chinese Children
title_fullStr Safety Concerns of Traditional Chinese Medicine Injections Used in Chinese Children
title_full_unstemmed Safety Concerns of Traditional Chinese Medicine Injections Used in Chinese Children
title_sort safety concerns of traditional chinese medicine injections used in chinese children
publisher Hindawi Limited
series Evidence-Based Complementary and Alternative Medicine
issn 1741-427X
1741-4288
publishDate 2019-01-01
description Objective. To explore risks underlying traditional Chinese medicine (TCM) injection-related adverse drug reactions (ADRs) in Chinese children, and to discuss the implications of postmarketing reevaluation studies. Methods. We identified potential cases of exposure to TCM injections for children (<18 years of age) and adults (18 years and upwards) from database of ADRs. First, the associations between TCM injection-related ADRs and three administration routes (i.e., intravenous or intramuscular administration, oral administration, and external use) and the imbalance of TCM injection-related ADRs between the paediatric and adult populations were tested using the Chi-square (χ2) test. Second, the proportional reporting ratio (PPR) was applied to identify statistically significant associations between drugs and anaphylactic shock in the paediatric population. Results. The χ2 test revealed that the highest frequency of paediatric ADRs was due to 5 types of herbal injections (i.e., Shuanghuanglian (SHL), Yuxingcao (YXC), Qingkailing (QKL), Xiyanping (XYP), and Reduning (RDN) herbal injections) (P<0.000), and the reports of ADRs attributed to the XYP and RDN herbal injections in children accounted for a greater proportion than the reports for adults (P<0.000). The PPR identified 5 types of herbal injections-anaphylactic shock pairs (i.e., the SHL, XYP, QKL, YXC, and Fufang Danshen herbal injections) that met the minimum criteria (i.e., a PPR of at least 2 and χ2 of at least 4 and three or more cases), which suggested that TCM injections were significantly associated with anaphylactic shock. Conclusions. TCM injections pose graver risks to the paediatric population than the adult population. To achieve optimal benefits and minimal risk to children treated with TCM injections, we suggest reevaluating the effectiveness and safety, monitoring the risks, and promoting rational use of TCM injections in Chinese children.
url http://dx.doi.org/10.1155/2019/8310368
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