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| 基于生熟异用的何首乌及其制剂相关肝损伤不良反应报告分析 |
| Processing related Differences of Polygoni Multiflori Radix and Its Preparations induced Liver Injury Based on Reports |
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| DOI： |
| 中文关键词: 何首乌 药物性肝损伤 药品不良反应 炮制减毒 安全用药 |
| 英文关键词:Polygoni Multiflori Radix Drug induced liver injury Adverse drug reaction Detoxication by processing Safe medication |
| 基金项目:国家自然科学基金项目（编号：81630100）；国家"重大新药创制"科技重大专项（编号：2015ZX09501004-001-004）；国家药品不良反应监测中心课题（编号：2017X001 01）；国家中医药管理局中医药行业科研专项（编号：201507004-4-2） |
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| 中文摘要: |
| 摘 要 目的：分析对比生、制何首乌及其制剂相关药物性肝损伤（DILI）病例报告的临床特征及用药特点。方法：基于2012～2016年中草药肝损伤病例数据库收集的疑似DILI病例报告，经过临床医生再评价排除非DILI的病例报告，参考《中草药相关肝损伤临床诊疗指南》及《中药药源性肝损伤临床评价技术指导原则》中的整合证据链法进行因果关系评价进而筛查出生、制何首乌及其制剂相关DILI病例报告，并对其进行回顾性研究。结果：共筛选出何首乌及其制剂相关DILI的病例报告258例，经再评价排除111例，筛查到单用生何首乌及其制剂相关DILI 37例（生何首乌组）及单用制何首乌及其制剂相关DILI 96例（制何首乌组）。研究发现两组间性别、年龄的构成总体差异无统计学意义，但体现出何首乌生熟异用相关的疾病人群特点，可能存在病证和免疫状态相关的易感因素。两组的用药剂量及时间分布均较广，其中10例(63%)使用单味中药饮片是在临床规定剂量范围内出现肝损伤，可能与特异质型肝损伤有关。与生何首乌组相比，制何首乌组服药至发生DILI的时间相对较长，严重药品不良反应报告的构成比较低，提示炮制可降低其肝损伤风险。结论：生、制何首乌及其制剂均可导致DILI。本文首次基于临床不良反应报告验证了何首乌炮制后可降低肝损伤风险。建议临床应用何首乌及其制剂须注意生熟异用，并加强炮制质量标准研究。 |
| 英文摘要: |
| ABSTRACT Objective: To compare the medication and clinical characteristics of drug induced liver injury (DILI) reports associated with the raw Polygoni Multiflori Radix (rPMR), processed Polygoni Multiflori Radix (pPMR) and their preparations. Methods:A retrospective study was conducted based on DILI case reports associated with rPMR, pPMR and their preparations extracted from the database of herb induced liver injury cases from 2012 to 2016, which were a part of the revaluation on excluding the non-DILI case reports by clinicians, according to Guidance for the clinical evaluation of traditional Chinese medicine induced liver injury and Guideline for Diagnosis and Treatment of Herb Induced Liver Injury. Results:A total of 258 case reports of DILI associated with rPMR, pPMR and their preparations were screened out. After the further evaluation, 111 case reports were excluded; 37 case reports of DILI associated with rPMR and its preparations (the rPMR group), and 96 cases of DILI associated with pPMR and its preparations (the pPMR group) were included. The results showed no significant difference in the proportion of gender and age in both groups generally. However, with the characteristic of disease crowd related to the processing related difference of rRPMR and pPMR, there would be some susceptibility factors associated with disease syndrome and immune status. Within the limits of stipulated dosage in pharmacopoeia and the drug label, DILI still occurred in 10 patients (63% of 16) using rPMR or pPMR singly in both groups. Compared with rPMR and its preparations, taking pPMR and its preparations might take more time to occur DILI along with much more mild DILI cases rather than the serious ones(with lower proportion of serious ADRs). The median of latency of RPMR group was shorter than that of PPMR group, which suggested that processing could reduce the liver injury risk of Polygoni Multiflori Radix. Conclusion: All of rPMR, pPMR, and their preparations could cause DILI. It’s the first time to prove that processing can reduce liver injury risk of Polygoni Multiflori Radix in our study. It should be considering the processing related difference of Polygoni Multiflori Radix and their preparations in clinical application and strengthening the quality standard research of processing. |
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