• 国家药监局综合司 国家卫生健康委办公厅
  • 国家药监局综合司 国家卫生健康委办公厅

我院281例药物性肝损伤不良反应分析

通讯作者: 朱晓静, fll861031@126.com
DOI:10.12201/bmr.202412.00015
声明:预印本系统所发表的论文仅用于最新科研成果的交流与共享,未经同行评议,因此不建议直接应用于指导临床实践。

Corresponding author: Zhu Xiaojing, fll861031@126.com
  • 摘要:目的 探讨DILI的患者特征、怀疑药物及转归,为临床规范使用药物,减少DILI不良反应提供参考依据。方法 回顾性分析某院2016-2023年期间的281例DILI病例。结果 在 281例DILI患者中,男性164例,女性117例;一般ADR 83份(29.54%),严重ADR 198份(70.46%);两种不良反应报告类型与患者的性别、年龄无显著差异。从临床表现来看,有190例(67.62%)患者无临床表现,91例(32.38%)患者有临床表现,主要表现为皮肤巩膜发黄、纳差、乏力等。按照临床分型,肝细胞损伤型150例(53.38%),胆汁淤积型79例(28.11%),混合型52例(18.51%),3个组间RUCAM量表评分(很可能/可能)有显著性差异。从损伤程度来看,轻度肝损伤156例(55.52%),中度肝损伤121例(43.06%),有4例重度肝损伤患者(1.42%)。从联用与否来看,联合用药164例(58.36%),单一用药117例(41.64%)。患者疾病种类排名靠前的是肿瘤、呼吸科疾病、结核感染等。合并基础疾病167例(59.43%),其中排名前三的基础疾病是合并高血压(54例次),糖尿病(41例次),高血脂(38例次)。怀疑药物中,排名前三的药物,依次是中药、抗肿瘤类药、抗结核类药,不同怀疑药物类别与是否联用存在显著差异。最后患者经过治疗后有效 246例(87.54%),治疗无效35例(12.46%),临床分型与转归存在显著差异。结论 中药、抗肿瘤药、抗结核药等相对容易引发DILI。患者肝细胞损伤类型、联合用药、疾病种类、基础疾病等都会影响DILI的发生。这些为临床医务工作者安全、合理用药提供借鉴。

    关键词: 药物性肝损中药抗肿瘤药抗结核药

     

    Abstract: Objective To explore the characteristics of patients with DILI, suspected drugs and outcomes, and to provide reference for the clinical standard use of drugs and reduce the adverse reactions of DILI. Methods 281 cases of DILI in a hospital from 2016 to 2023 were retrospectively analyzed. Results Among 281 patients with DILI, 164 were males and 117 were females. There were 83 general ADRs (29.54%) and 198 serious ADRs (70.46%). There was no significant difference between the two types of adverse reaction reports and the gender and age of patients. In terms of clinical manifestations, 190 patients (67.62%) had no clinical manifestations, 91 patients (32.38%) had clinical manifestations, mainly manifested as skin scleral yellow stain,fatigue, poor appetite and so on. From the clinical classification, there were 150 cases (53.38%) with hepatocyte injury, 79 cases (28.11%) with cholestasis, and 52 cases (18.51%) with mixed type. There were significant differences in RUCAM scale scores (very likely/probable) among the three groups. In terms of injury degree, 156 cases (55.52%) suffered mild liver injury, 121 cases (43.06%) suffered moderate liver injury, and 4 cases (1.42%) suffered severe liver injury. There were 164 cases(58.36%) of combined medication and 117cases(41.64%) of single medication. The disease types of patients include tumor, respiratory disease, tuberculosis infection, etc. There were 167 cases (59.43%) of underlying diseases, among which the top three underlying diseases were hypertension (54 cases), diabetes (41 cases) and hyperlipidemia (38 cases). Among the suspected drugs, the top three drugs are Chinese medicine, anti-tumor drugs and anti-tuberculosis drugs in order. There were significant differences between different types of suspected drugs and whether they were used in combination.Finally, 246 patients (87.54%) were effective after treatment, 35 patients (12.46%) were ineffective, and there were significant differences in clinical classification and outcome. Conclusion Chinese medicine, antitumor drugs and antituberculosis drugs are relatively easy to cause DILI. The type of liver cell damage, combination of drugs, types of diseases, and underlying diseases all affect the occurrence of DILI. These provide reference for clinical workers to use drugs safely and rationally.

    Key words: drug-induced liver damage; Chinese medicine; Antitumor drug; Antituberculosis drug

    提交时间:2024-12-04

    版权声明:作者本人独立拥有该论文的版权,预印本系统仅拥有论文的永久保存权利。任何人未经允许不得重复使用。
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  • 序号 提交日期 编号 操作
    1 2024-07-04

    bmr.202412.00015V1

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范玲, 朱晓静. 我院281例药物性肝损伤不良反应分析. 2024. biomedRxiv.202412.00015

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