A Retrospective Analysis on 1330 Adverse Event Reports of Qingkailing in China: Further Perception of Its Risks and Rational Use

Abstract

Qingkailing (QKL) is a modern preparation exploited according to the traditional Chinese medicine theory. It becomes the second leading cause of adverse drug events (ADEs) in all traditional Chinese medicine injections. The safety evaluation and rational use of QKL are of special importance. This retrospective study used data from Adverse Drug Reaction Monitoring Center of Hubei Province in China from January 2012 to December 2014. ADE cases induced by QKL were collected and analyzed according to patients’ demographics, characteristics of drugs involved, characteristics of ADEs, causality, and outcomes. A total of 1330 qualified ADEs were included. Most ADEs occurred within 30 min after administration and the 0–10 years old age group had the highest number of ADEs. The common ADEs included anaphylactic reaction, dyspnea and nausea. Serious reactions accounted for 5.19%. Combination with cephalosporin (74/146, 50.69%) caused more ADEs than other drugs did. Serious attention should be paid when QKL is used for children, and combination with cephalosporin should be avoided.

Keywords

adverse drug event / anaphylaxis / drug safety / Qingkailing

References

[1] World Health Organization. (2013}). WHO traditional medicine strategy: 2014-2023}. World Health Organization}. https://doi.org/www.who.int/iris/handle/10665/92

[2] ChanK, ZhangH, LinZX. An overview on adverse drug reactions to traditional Chinese medicines. Br J Clin Pharmacol, 2015, 80(4): 834-843

[3] ZhangJ, WangS, XuL, et al.. Multiple perspectives of qingkailing injection-fraction-single compound in revealing the hepatotoxicity of baicalin and hyodeoxycholic acid. J Ethnopharmacol, 2018, 215: 147-155

[4] JiK, ChenJ, LiM, 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, 2009, 55(2): 134-138

[5] Strengthening Pharmaceutical Systems (SPS) Program. Indicator-Based Pharmacovigilance Assessment Tool: Manual for Conducting Assessments in Developing Countries. Arlington, VA: Management Sciences for Health, 2009. https://doi.org/pdf.usaid.gov/pdf_docs/PNADS167.pdf

[6] NebekerJR, BarachP, SamoreMH. Clarifying adverse drug events: a clinician’s guide to terminology, documentation, and reporting. Ann Intern Med, 2004, 140(10): 795-801

[7] Provisions for Adverse Drug Reaction Reporting and Monitoring (Order No.81 of the Ministry of Health) https://doi.org/www.moh.gov.cn/mohzcfgs/pgz/201105/51770.shtml

[8] MiaoX, ZhouJ, LiJ, et al.. Chinese Medicine in Inhalation Therapy: A Review of Clinical Application and Formulation Development. Curr Pharm Des, 2015, 21(27): 3917-3931

[9] YangY, WangSC, BaiWJ, et al.. Evaluation by survival analysis on effect of traditional Chinese medicine in treating children with respiratory syncytial viral pneumonia of phlegm-heat blocking Fei syndrome. Chin J Integr Med, 2009, 15(2): 95-100

[10] WangZ, WangD, SuiY, et al.. Experimental study on anaphylaxis of qingkailing injection and its components on Beagle dogs. J Tradit Chin Med, 2012, 32(4): 641-645

[11] LiH, DengJ, YueZ, et al.. Detecting drug-herbal interaction using a spontaneous reporting system database: an example with benzylpenicillin and qingkailing injection. Eur J Clin Pharmacol, 2015, 71(9): 1139-1145

[12] GaoP, ZhangCL, ZengFD, et al.. Pharmacovigilance in China: issues of concern identified through an analysis of the Chinese Adverse Drug Reaction Information Bulletin 2001 to 2014. J Clin Pharm Ther, 2015, 40(5): 594-598

[13] The State Pharmacopoeia Commission of the P. R. China.. Pharmacopoeia of the P. R. China (Chinese), 2010, Beijing, Chemical Industry Press: 1110-1111

[14] LiQ, ZhangXY, ChenGK. Adverse effect and mechanism of chlorogenic acid in clearing heat and detoxication traditional Chinese medicine injections. Chin J Mod Appl Pharm (Chinese), 2009, 26(7): 555-558

[15] LiBQ, DongX, YangGQ, et al.. Role of chlorogenic acid in the toxicity induced by Chinese herbal injections. Drug Chem Toxicol, 2010, 33(4): 415-420

[16] ZhangZ, QinL, PengL, et al.. Pharmacokinetic-Pharmacodynamic Modeling to Study the Antipyretic Effect of Qingkailing Injection on Pyrexia Model Rats. Molecules, 2016, 21(3): 317

[17] GuoM, ZhangL, LiuH, et al.. A metabolomic strategy to screen the prototype components and metabolites of Qingkailing injection in rat urine by high-performance liquid chromatography with tandem mass spectrometry. J Sep Sci, 2014, 37(20): 2844-2850

[18] PengL, GaoX, SongY, et al.. A rapid and sensitive UPLCMS/MS method for quantification of two caffeoylquinic acids and four main active components in rat plasma after an intravenous administration of Qingkailing injection and its application to a pharmacokinetic study. Biomed Chromatogr, 2014, 28(5): 601-609

[19] ZhangL, WangX, SuJ, et al.. One single amino Acid for estimation the content of total free amino acids in qingkailing injection using high-performance liquid chromatography-diode array detection. J Anal Methods Chem, 2014, 2014: 951075