中文摘要：

目的：系统梳理中药注射剂用于治疗慢性乙型病毒性肝炎的报道,分析其药理作用、临床应用、不良反应等用药过程所涉及到的情况,提出药物警戒与合理用药建议。方法：系统检索国内外文献报道,收集和整理治疗慢性乙型病毒性肝炎的中药注射剂,以及肝炎灵注射液、苦黄注射液的药品不良反应/事件,采用回顾性研究和统计学方法对上述药品不良反应进行分析。结果：共检索到治疗慢性乙型病毒性肝炎的中药注射剂26种,其中抗病毒类中药注射剂的代表药物有肝炎灵注射液、苦黄注射液、清开灵注射液等;抗肝细胞损害、促肝细胞生长、改善肝功能类中药注射剂的代表药物有丹参注射液、复方丹参注射液、参麦注射液、生脉注射液、灯盏细辛注射液、茵栀黄注射液等;调节机体免疫功能类中药注射剂的代表药物有黄芪注射液、艾迪注射液、猪苓多糖注射液等。共收集药品不良反应/事件文献报道139篇,分析结果显示,导致药品不良反应/事件的主要原因有剂量过大、个体差异等。结论：中药注射剂广泛用于慢性乙型病毒性肝炎的治疗,其导致安全事件的原因多样。本调查提出了慢性乙型病毒性肝炎患者使用中药注射剂的警戒措施,可为临床合理用药提供参考和指导。

英文摘要：

OBJECTIVE： To systematically summarize the reports of traditional Chinese medicine（ TCM） injections in treatment of chronic hepatitis B,and analyze the pharmacological effects,clinical applications and adverse drug reactions during the treatment effects,so as to provide suggestions for the pharmacovigilance and rational drug use. METHODS：Domestic and foreign literatures were systematically retrieved,TCM injections in treatment of chronic hepatitis B were statistically collected,and analysis was conducted on the adverse drug reactions by retrospectivestudy method and statistic method. RESULTS： 26 kinds of TCM injections were retrieved,among which the representative drugs of antiviral TCM injections were respectively Ganyanling injections,Kuhuang injections and Qingkailing injections,etc; and the representative drugs of anti-damage,growth-promoting and improving of liver cells were respectively Danshen injections,compound Dansen injections,Shenmai injections,Shengmai injections,Dengzhanxixin injections and Yinzhihuang injections,etc; the representative drugs of regulating immune function were respectively astragalus injections,Aidi injections and polyporus polysaccharide injections,etc. 139 reports of adverse drug reactions / events were collected.According to the analysis,adverse drug reactions / events were mainly induced by over dosage and individual difference.CONCLUSIONS： TCM injections are widely used in the treatment of chronic hepatitis B,the causes of security incidents are various. This study put forward corresponding pharmacovigilance for the patients with TCM injections,so as to provide reference and guidance for the rational clinical application of drug use.