Risks of liver injury caused by Shiduqing preparations

doi:10.19803/j.1672-8629.20240137

Abstract

Abstract: Objective To analyze the risks of liver injury posed by Shiduqing preparations and provide reference for proper clinical use. Methods Literature about adverse reactions related to Shiduqing preparations in China’s adverse drug reaction monitoring database (collected between 2004 and 2023) and domestic database (from inception to December 31, 2023) was sorted out and analyzed. Results The National Adverse Drug Reaction Monitoring System Database documented 24 cases of adverse reactions related to liver and gallbladder damage and involving Shiduqing preparations. No adverse reactions related to hepatobiliary damage were found in clinical studies. The adverse reactions mentioned in individual reports were drug induced liver disease and liver injury. Conclusion Clinicians should be alert to the risk of liver injury when Shiduqing preparations are used in clinic. The awareness of safe and proper medications should be raised, and medications monitored. At the same time, drug marketing authorization holders should strengthen pharmacovigilance and provide guidance to ensure safe medication.

Key words: Shiduqing, Cortex Dictamni, liver injury, Chinese patent drug, adverse reaction, safety, risk

CLC Number:

R994.11
R986

SHAO Bo, XU Lili, ZHU Lan, LIU Shuo, WAN Hao, HUANG Guangrui. Risks of liver injury caused by Shiduqing preparations[J]. Chinese Journal of Pharmacovigilance, 2024, 21(6): 666-670.

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https://www.zgywjj.com/EN/Y2024/V21/I6/666

References

[1] NMPA. Announcement of the NMPA on Revising the Instructions of Shiduqing Preparations [EB/OL].(2021-01-19)[2024-04-01]. https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypshmshxdgg/20210119105826125.html.
[2] MA SW, LIU CH, LIU XY, et al.Chinese guideline for diagnosis and management of drug-induced liver injury (2023 version)[J]. Chinese Journal of Gastroenterol(胃肠病学), 2022, 27(6): 341-375.
[3] XIONG DZ, CHEN HQ, ZHAO M.Effect of fire needle acupoint therapy combined with Shiduqing capsule and paeonol ointment on the treatment of blood deficiency wind-dryness type eczema and its effect on the minimum erythema amount and the level of transforming growth Factor-β₁ in patients[J]. China’s Naturopathy(中国民间疗法), 2023, 31(4): 63-66.
[4] QIU JL, LI W, WU YG, et al.Effects of Shiduqing and Levocetirizine on inflammatory factor and therapeutic effects in elderly patients with diabetic pruritus[J]. Chinese Journal of Dermatovenereology of Integrated Traditional and Western Medicine(中国中西医结合皮肤性病学杂志), 2020, 19(4): 342-345.
[5] LIN WJ, LIN YQ, LIN HW.Observation on the clinical effect of Shiduqing combined with ebastine in the treatment of atopic dermatitis[J]. Guangming Journal of Chinese Medicine(光明中医), 2017, 32(15): 2232-2234.
[6] BI JR.Evaluation of the efficacy and safety of Shiduqing capsule in the treatment of diabetic skin pruritus[J]. Diabetes New World(糖尿病新世界) , 2015, 35(4): 43.
[7] XIE M, SHA W, CUI QM.Clinical observation on enoxacin combined with Shiduqing capsules for preventing infection after bladder wall flap ureteroplasty on 40 cases[J]. China Pharmaceuticals(中国药业), 2014, 23(16): 114-115.
[8] YAO ZY, WANG C, YOU LP, et al.Clinical observation on the treatment of diabetic skin pruritus with Shiduqing[J]. Journal of Clinical Dermatology(临床皮肤科杂志), 2008, 37(12): 808.
[9] PAN WH, ZHENG J, ZHANG W, et al.Observation of multi-center effect of Shiduqing capsule on skin pruritus[J]. Journal of Clinical Dermatology(临床皮肤科杂志), 2008, 37(12): 811-812.
[10] GAO G.35 cases of chronic urticaria treated by loratadine combined with Shiduqing capsule umbilical seal therapy[J]. Jilin Medical Journal(吉林医学), 2008, 29(7): 587-588.
[11] YANG DQ, JIANG XN, BAI YP.Clinical study of blood insufficiency and wind dryness type of senile pruritus treated Byshiduqing capsule together with benzhydramine[J]. Beijing Journal of Traditional Chinese Medicine(北京中医药), 2008, 27(11): 866-868.
[12] HAO LY, LI ZC, WANG LH.Liver injury caused by Shiduqing capsules[J]. Adverse Drug Reactions Journal(药物不良反应杂志), 2020, 22(7): 420-421.
[13] HUANG L, LUO SP.One case of severe liver injury induced by Shiduqing tablets[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2019, 16(8): 511-512.
[14] ZHAO YL, MA XL.1 case of drug-induced liver disease caused by Shiduqing tablets[J]. For all Health(大家健康学术版), 2015, 9(17): 271-272.
[15] ZHANG XJ, YU SWQ.Research progress on the chemical constituents and pharmacological effects of Radix Sophorae Flavescentis[J]. Information on Traditional Chinese Medicine(中医药信息), 2023, 40(12): 79-87.
[16] MA XN, YANG SQ, ZHANG JC, et al.Research progress on pharmacological action of Kushen(Sophorae Flavescentis Radix)[J]. Journal of Liaoning University of Traditional Chinese Medicine(辽宁中医药大学学报), 2023, 25(1): 152-156.
[17] HUANG YX, GUO YM, ZHOU YF, et al.Dictamni cortex powder-induced liver injury based on integrated evidence chain[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2017, 42(3): 600-606.
[18] XIONG P, CHEN SS, SONG D, et al.Clinical cases and experimental evaluation of liver injury related to anti-psoriasis Keyin pills[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2020, 45(20): 5017-5023.
[19] SHI W.Idiosyncratic hepatotoxicity evaluation and mechanism of Cortex Dictamni based on immune stress[D]. Nanchang: Jiangxi University of Chinese Medicine, 2020.
[20] WU KL.The hepatic protein adduction derived from reactive metabolites of multiple furanoids in Cortex Dictamni[D]. Zunyi: Zunyi Medicine University, 2022.
[21] NIU LN, WANG CG, JING L. Study on microbial-lipid metabolism mechanism of liver injury in wistar rats caused by Cortex Dictamni-Sophora Flavescens[J/OL]. (2024-01-08)[2024-04-11]. https://doi.org/10.13422/j.cnki.syfjx.20240424.
[22] FAN QY, ZHAO BS, ZHANG JX, et al.Analysis on drug factors for hepatotoxicity of Zhixue capsule[J]. Chinese Journal of Experimental Traditional Medical Formulae(中国实验方剂学杂志), 2018, 24(1): 150-157.
[23] XIAO XH, TANG JY, MAO YM, et al.Technical guidelines for clinical evaluation of liver injury induced by traditional Chinese medicine[J]. Acta Pharmaceutica Sinica(药学学报), 2018, 53(11): 1931-1942.
[24] LYU DX, ZHANG F, QIN JQ, et al.Current status and advance of diagnosis of herb-induced liver injury[J]. Chinese Traditional and Herbal Drugs(中草药), 2024, 55(5): 1761-1769.