叶茜 王凤玲 孟祥云

[摘要]目的了解中药注射剂不良反应（ADR）的发生情况、特点及规律，为临床合理用药提供参考。方法采用回顾性研究方法，对2017—2020年合肥市第二人民医院不良反应报告信息系统收集到的中药注射剂不良反应病例报告进行统计和分析。结果引起 ADR 发生例数最多的5个品种主要是理血剂中的活血化瘀药，其中以60岁以上人群发生较多，中药注射剂 ADR45%以上的前5个品种发生总例数多达104例，本组中药注射剂的 ADR 发生时间范围较宽，在注射后立即至7 d 后均有分布，ADR 累及的系统/器官主要为皮肤及附件和心血管系统，其中有95例痊愈，128例好转，以及4例未好转。结论应重视中药注射剂的 ADR，加强中药注射剂的质量控制，规范临床使用，提高合理用药水平。

[关键词]中药;中药注射剂;不良反应;医院药学

[中图分类号] R288  [文献标识码] A   [文章编号]2095-0616（2021）24-0142-04

Analysis report of adverse reactions following administration of traditional Chinese medicine injections in a hospital from 2017 to 2020

YE  Xi    WANG  Fengling    MENG  Xiangyun

Department of Pharmacy， the Second People's Hospital of Hefei， Anhui， Hefei 230011， China

[Abstract] Objective To understand the occurrence， characteristics and regularity of adverse reactions following administration of traditional Chinese medicine injections（TCMIs）， and to provide references for clinical rational use of drugs. Methods By retrospective research methods， a statistical analysis was conducted for the adverse reaction case reports related to TCMIs collected in the ADR report information system of the Second People's Hospital of Hefei from 2017 to 2020. Results The five varieties of TCMIs that caused the largest number of adverse reactions were mainly the blood-activating and stasis-removing Chinese drugs in blood regulating agents. Among them， the adverse reactions occurred more frequently in the population over 60 years old and there were up to 104 cases related to the top five varieties of TCMIs， accounting for more than 45% of the adverse reactions related to TCMIs. The adverse reactions related to TCMIs in the above-mentioned group had a wide range of onset time， and they developed immediately after injection or continued to develop 7 days after injection. The involved systems/organs for adverse reactions were mainly the skin， appendages and the cardiovascular system. Among them， 95 cases were cured， 128 cases were improved， and 4 cases were not improved. Conclusion We shall pay attention to the adverse reactions related to TCMIs， strengthen the quality control of TCMIs， standardize their clinical use， and improve the level of rational drug use.

[Key words] Traditional Chinese medicine; Traditional Chinese medicine injection; Adverse reactions; Hospital pharmacy

中藥注射剂是指从中药材中提取的有效成分，经采用现代科学技术和方法制成的可供注入体内包括肌肉、穴位、静脉注射和静脉滴注使用的无菌溶液、混悬液，或临用前配成液体的无菌粉末等注入人体的制剂[1]。中药注射剂不仅保留了中医药的传统治疗优势，而且具备西药起效快的特点，近些年已在临床上得到广泛应用。然而，随着中药注射剂在临床上的广泛应用，关于中药注射剂安全性问题的报道也日益增多。2017年国家不良反应（adverse reaction， ADR）监测年度报告显示，中药注射剂所引起的 ADR 占中药 ADR 的54.0%，所引起的严重 ADR 占中药严重 ADR 的84.1%，提示临床需持续关注中药注射剂的用药风险[2]。……