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^*
- Chinese Journal of Integrative Medicine Vol. 27, Issue 11, Pages: 832-837(2021)
- 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：
- DOI：10.1007/s11655-021-3442-2
  CLC：
- Published：01 November 2021，
  
  Published Online：08 May 2021，
  
  Accepted：13 January 2021
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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 27(11):832-837(2021)
DOI：

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 27(11):832-837(2021) 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

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Renal Division, Department of Medicine, Peking University First Hospital

Department of Pharmacy, Chongqing Hospital of Traditional Chinese Medicine

China Military Institute of Chinese Materia, Fifth Medical Center of Chinese PLA General Hospital

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Department of Pharmacy, Affiliated Hospital of Shandong University of Traditional Chinese Medicine

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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^*