Landscape of Hepatobiliary Adverse Drug Reactions Related to Preparations Containing <italic style="font-style: italic">Psoraleae Fructus</italic> and Its Application in Pharmacovigilance<sup>*</sup>

Fei-lin GE; Ming NIU; Zi-xin HAN; Jun-ling CAO; Jia-bo WANG; Zhao-fang BAI; Hai-bo SONG; Yu-ming GUO; Xiao-he XIAO

doi:10.1007/s11655-021-3442-2

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Landscape of Hepatobiliary Adverse Drug Reactions Related to Preparations Containing Psoraleae Fructus and Its Application in Pharmacovigilance^*

Original Article | Updated：2021-11-05

- Landscape of Hepatobiliary Adverse Drug Reactions Related to Preparations Containing Psoraleae Fructus and Its Application in Pharmacovigilance^*
- Landscape of Hepatobiliary Adverse Drug Reactions Related to Preparations Containing Psoraleae Fructus and Its Application in Pharmacovigilance^*
- Chinese Journal of Integrative Medicine 2021年27卷第11期页码：832-837
- Affiliations：
  
  1.School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing (100029), China
  2.Department of Hepatology, Fifth Medical Center of Chinese PLA General Hospital, Beijing (100039), China
  3.Department of Pharmacy, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing (100078), China
  4.Center for Drug Reevaluation, National Medical Products Administration, Beijing(100022), China
- Author bio：
  
  Dr. SONG Hai-bo, E-mail: Songhaibo@cdr.gov.cn
  Dr. GUO Yu-ming, E-mail: guoyuming_0520@126.com;
- Funds：
  
  the National Natural Science Foundation of China(81630100);Beijing Nova Program(Z181100006218001);Project of China PLA General Hospital(2019MBD-023)
- DOI：10.1007/s11655-021-3442-2
  中图分类号：
- 纸质出版日期：2021-11-01，
  
  网络出版日期：2021-05-08，
  
  录用日期：2021-01-13
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Fei-lin GE, Ming NIU, Zi-xin HAN, 等. Landscape of Hepatobiliary Adverse Drug Reactions Related to Preparations Containing Psoraleae Fructus and Its Application in Pharmacovigilance^*[J]. Chinese Journal of Integrative Medicine, 2021,27(11):832-837.

Fei-lin GE, Ming NIU, Zi-xin HAN, et al. Landscape of Hepatobiliary Adverse Drug Reactions Related to Preparations Containing Psoraleae Fructus and Its Application in Pharmacovigilance^*[J]. Chinese Journal of Integrative Medicine, 2021,27(11):832-837.
Fei-lin GE, Ming NIU, Zi-xin HAN, 等. Landscape of Hepatobiliary Adverse Drug Reactions Related to Preparations Containing Psoraleae Fructus and Its Application in Pharmacovigilance^*[J]. Chinese Journal of Integrative Medicine, 2021,27(11):832-837. DOI： 10.1007/s11655-021-3442-2.

Fei-lin GE, Ming NIU, Zi-xin HAN, et al. Landscape of Hepatobiliary Adverse Drug Reactions Related to Preparations Containing Psoraleae Fructus and Its Application in Pharmacovigilance^*[J]. Chinese Journal of Integrative Medicine, 2021,27(11):832-837. DOI： 10.1007/s11655-021-3442-2.

摘要

目的

分析含补骨脂制剂的肝损伤相关药物不良反应 (L-ADR) 临床特点及其用药特征

挖掘其相关风险信号

为含补骨脂制剂的安全性评价及临床合理用药提供参考.

方法

回顾性分析2012年1月—2016年12月国家药品不良反应监测系统中使用含补骨脂制剂引起的L-ADR报告的临床特征、用药信息及用药合理性.

结果

共筛选收集到使用含补骨脂制剂的L-ADR报告355例

全部报告和评估为严重ADR的报告均呈逐年升高趋势 (P<0.05)

其中10.43%的L-ADR报告存在超剂量用药、重复用药和多药联用等不合理用药情况. 在190例单独使用含补骨脂制剂的L-ADR报告中

超过40%的患者伴见白癜风、银屑病等免疫异常活化相关疾病

年龄分布多见于41-50岁女性患者 (P<0.05) . 服药后肝损伤发生的潜伏期分析表明

从服药到发生肝损伤的时间跨度为1-386d

中位时间27.5d

折算后服药到发生肝损伤的补骨脂日剂量范围为0.09-2.64g

累积剂量范围为0.45-520.02g.

结论

含补骨脂制剂的L-ADR临床特征存在显著个体差异

服药时间和剂量与肝损伤的发生没有明显相关性

与特异质型药物性肝损伤特征极为相似. 建议临床应用含补骨脂制剂时应当注意合理用药

加强患者肝功能监测

尤其是患有免疫性相关基础疾病的女性患者需重点关注其肝损伤风险.

Abstract

Objective:

To analyze clinical feature and information of medication to explore the risk signals of preparations containing

Psoraleae Fructus

(BGZP) related with hepatobiliary adverse drug reactions (ADR)

in order to reinforce pharmacovigilance.

Methods:

A retrospective study was conducted based on hepatobiliary ADR related with BGZP from the China Adverse Drug Reaction Monitoring System in years from January 2012 to December 2016. Serious and general ADRs were analyzed and assessed.

Results:

There were 355 cases of hepatobiliary ADR related to BGZP. Both the amount of cases and the proportion of serious ADR showed an increasing growth by years (

0.05). It was found that 10.43% of 355 cases may be involved with irrational drug use

including overdose

repeated medication

and combination of multiple drugs. There were 190 cases which used BGZP (non-combination)

and they were mainly for common in diseases caused by abnormal immune activation (accounting for 40.53% of the total cases). Especially at the age group with the most cases with age of 41–50 years

the cases associated with immunological diseases of female were obviously more than that of male (

0.05). The latency of hepatobiliary ADR related to BGZP ranged from 1 to 386 days

and the median latency was 27.5 days

along with the range of cumulative dose (0.45–520.02 g) as well as the daily dose (0.09–2.64 g/d) after the conversion.

Conclusions:

Cases of hepatobiliary ADR related to BGZP showed significant individual differences

and there was no correlation between drug usage duration and dosage and the occurrence of hepatobiliary ADR. It may be similar with idiosyncratic drug-induced liver injury

and recommended that BGZP should be used with more caution under monitoring liver function

especially in female patients with immunological diseases.

关键词

Keywords

drug safetyhepatobiliary adverse drug reactionPsoraleae Fructuspharmacovigilance

references

Yang JJ, Yang J, Du J, Feng YX, Chai X, Xiao MM, et al. General survey of Fructus Psoraleae from the different origins and chemical identification of the roasted from raw Fructus Psoraleae. J Food Drug Anal 2017;26:1-8.

Wang JY, Jiang ZZ, Ji JZ, Li YY, Chen M, Wang YR, et al. Evaluation of hepatotoxicity and cholestasis in rats treated with EtOH extract of Fructus Psoraleae. J Ethnopharmacology 2012;144:73-81.

National Commission of Chinese Pharmacopoeia. Pharmacopoeia of the People's Republic of China. Beijing: Chinese Medical Science and Technology Press; 2015;1:188.

Garg BJ, Garg NK, Beg S, Singh B, Katare OP. Nanosized ethosomes-based hydrogel formulations of methoxsalen for enhanced topical delivery against vitiligo: formulation optimization, in vitro evaluation and preclinical assessment. J Drug Target 2016;24:233-246.

Huang FF, Liang SM, Wang LY, Yang DP. Study of the pharmacodynamics of psoralen gel on experimental vitiligo. Chin J Hosp Pharm (Chin) 2007;27:36-38.

Zhou PL, Ouyang H, Wang ZX. The advancement of drug therapy for vitiligo. Guid J Tradit Chin Med Pharm (Chin) 2005;11:77-79.

Cao JY, Liu JJ, Huang WH, Guo BL. Progress in the pharmacological action and clinical application of psoralen. Chin Med Pharm Clin (Chin) 2008;24:89-92.

Wang W, Liao SP, Wei L. Clinical efficacy of appendix treatment with Gukang capsules in elder patients with a distal radius fracture. J Chin Med Mater (Chin) 2015;38:193-196.

Qiao CF, Han QB, Song JZ, Mo SF, Kong LD, Kung SF, et al. Chemical fingerprint and quantitative analysis of Fructus Psoraleae by high-performance liquid chromatography. J Sep Sci 2007;30:813-818.

Li WD, Yan CP, Wu Y, Weng ZB, Yin FZ, Yang GM, et al. Osteoblasts proliferation and differentiation stimulating activities of the main components of Fructus Psoraleae corylifoliae. Phytomedicine 2014;21:400-405.

Song HB. Risk signals and main risk characteristics of clinical psoralen drugs based on adverse reaction monitoring data. Chinese Society of Toxicology and Hubei Association for Science & Technology. Proceedings of the 7th National Toxicology Conference of the Chinese Society of Toxicology and the 8th Hubei Science and Technology Forum, Chinese Society of Toxicology and Hubei Association for Science & Technology. Wuhan; 2015.

Nam SW, Baek JT, Lee DS, Kang SB, Ahn BM, Chung KW. A case of acute cholestatic hepatitis associated with the seeds of Psoralea corylifolia (Boh-Gol-Zhee). Clin Tox 2005;43:589-591.

Tian WY, Lan S, Zhang L, Sun L, Huang JK, Yang XH, et al.Safety evaluation and risk control measures of Psoralea corylifolia.Chin a J Chin Mater Med (Chin) 2017;42:4059-4066.

China Food and Drug Administration. Be alert to the risk of liver damage caused by the oral preparation of Xianling Gubao.Shanghai Med (Chin) 2017;38:80.

Jin R, Gu HY, Li LL, Sun LL. Current status of Chinese herbal preparations included in the Liver Tox database. Chin J Hepatol(Chin) 2016;24:817-823.

Li A, Gao MH, Zhao N, Li P, Zhu JG, Li WF. Acute liver failure associated with Fructus Psoraleae: a case report and literature review. BMC Complem Altern M 2019;19:1-4.

World Health Organization (WHO), Uppsala Monitoring Centre. The use of the WHO-UMC system for standardised case causality assessment. Available at: http://www.who-umc.org/Graphics/26649.pdfhttp://www.who-umc.org/Graphics/26649.pdf 2018.

Drug-induced Liver Disease Study Group, Chinese Society of Hepatology, Chinese Medical Association. Diagnosis and treatment guideline on drug-induced liver injury. Chin J Hepatol (Chin)2015;23:810-820.

Wang JB, Zhu Y, Bai ZF, Wang FS, Li XH, Xiao XH. Guidelines for the diagnosis and management of herb-induced liver injury. Chin J Integr Med 2018;24:696-706.

China Food and Drug Administration. Measures for the reporting and monitoring of adverse drug reactions. Available at: http://samr.cfda.gov.cn/WS01/CL1031/62621_7.htmlhttp://samr.cfda.gov.cn/WS01/CL1031/62621_7.html. Accessed 04 May 2011.

Gao Y, Wang ZL, Tang JF, Liu XF, Shi W, Qin N, et al. New incompatible pair of TCM: Epimedii Folium combined with Psoraleae Fructus induces idiosyncratic hepatotoxicity under immunological stress conditions. Front Med (Chin) 2020;14:68-80.

Tang JF, Li WX, Wang XY, Li YH, Zhang HZ, Cao YJ, et al. Related biomarker screening of Zhuanggu Guanjie Pill induced idiosyncrasy liver injury based on metabolomics. China J Trait Chin Med Pharm(Chin) 2018;33:4336-4340.

Tang JF, Wang XY, Yang W, Li WX, Li YH, Bai ZF, et al.Cytokine analysis of Zhuangguguanjie wan-induced idiosyncratic liver injury based on mathematical modeling. Acta Pharm Sin 2018;53:574-584.

Ge FL, Niu M, Han ZX, Zhang YF, Wang JB, Xiao XH, et al.Analysis of epidemiological characteristics of drug induced liver injury associated with Baixianpi preparations. China J Chin Mater Med (Chin) 2019;44:1048-1052.

Xia LT, Rang C, Wang DY. Analysis on the standardization and rationality of the prescription of Chinese herbal decoction pieces.Chin J Clin Ration Drug Use (Chin) 2019;12:77-78.

Shen T, Liu YX, Shang J, Xie Q, Li J, Yan M, et al. Incidence and etiology of drug-induced liver injury in mainland China.Gastroenterology 2019;156:2230-2241.

Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. Gastroenterology 1999;118:984-985.

O'Dell JR, Zetterman RK, Burnett DA. Centrilobular hepatic fibrosis following acetaminophen-induced hepatic necrosis in an alcoholic.JAMA 1986;255:2636.

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Landscape of Hepatobiliary Adverse Drug Reactions Related to Preparations Containing Psoraleae Fructus and Its Application in Pharmacovigilance*

Landscape of Hepatobiliary Adverse Drug Reactions Related to Preparations Containing Psoraleae Fructus and Its Application in Pharmacovigilance*

DOI：10.1007/s11655-021-3442-2

摘要

Abstract

关键词

Keywords

references

Landscape of Hepatobiliary Adverse Drug Reactions Related to Preparations Containing Psoraleae Fructus and Its Application in Pharmacovigilance^*

Landscape of Hepatobiliary Adverse Drug Reactions Related to Preparations Containing Psoraleae Fructus and Its Application in Pharmacovigilance^*