葛根素注射剂不良反应及其影响因素分析  

An Analysis of Adverse Drug Reactions of Puerarin Injection and Related Risk Factors

作　　者：邓培媛[1] 李群娜[1] 朱玉珍[2] 裴振峨[1] 张俊[1] 翟伟[1] 张京航[1] 闫伟[1] 詹思延[3] 

机构地区：[1]北京市药品不良反应监测中心,北京市朝阳区管庄乡1号100024 [2]北京大学第一医院输血科 [3]北京大学流行病与卫生统计学系

出　　处：《药物流行病学杂志》2005年第1期14-17,24,共5页Chinese Journal of Pharmacoepidemiology

摘　　要：目的:研究葛根素注射剂(GGS)引起的药物不良反应(ADR)发生率、ADR类型,探索GGS引起的溶血性贫血(HemolyticAnemia,HA)的发生机制。方法:利用北京市ADR监测网络,选择32家医疗单位参加本课题研究。课题以使用GGS的1319例病例为暴露组,同期使用丹参/复方丹参注射液(DS)的541例病例为对照组,进行队列研究。并将暴露组中临床拟诊为HA的6例患者作为病例组,设立正常对照组进行血液免疫学临床试验研究,以探索GGS引起的HA的发生机制。结果:GGS的ADR发生率3.34%,与DS(3.14%)相比两组差并无统计学意义(P>0.05)。暴露组ADR以转氨酶升高、药疹和HA最为多见;对照组ADR以药疹为主,两组ADR表现形式的构成差异呈高度显著(P<0.001)。暴露组中、重度病例15.9%,死亡2例。GGS引起的HA属于Ⅱ型变态反应。结论:GGS与DS的ADR发生率差异无显著性,但对GGS引起的严重ADR应给予特别关注。对于使用GGS的患者应定期监测相关指标,特别是对于体内已存在抗葛根素药物性抗体(GGS-Ab)的患者应避免再次使用该药。Objective： To investigate the incidence and profile of adverse drug reactions （ADRs） of puerarin injection, and explore the mechanism of Hemolytic Anemia （HA） ADR due to puerarin. Method： A prospective cohort study was conducted at 32 hospitals through Beijing ADR monitoring system. A total of 1860 patients were eligible for the study, and 1319 cases of them were exposed to puerarin and 541 cases were exposed to the control drug Danshen. Meanwhile, a case-control study was conducted to explore the mechanism of HA. The Coombs＇tests were performed to detect antibodies to puerarin in the patients with the signs of HA. 10 non HA patients as a control group were also recruited. Result： The incidences of ADRs of puerarin and Danshen are 3.34% and 3.14% , respectively. The difference between the two groups was not significant （ P = 0.831 ）. The most common ADRs in the puerarin group were increased ALT, drug eruptions and HA, while drug eruptions were most frequently seen in the control group. Moderate to severe ADRs occurred in 15.9% of the patients in the puerarin group and two cases died. All the ADR cases were mild in the control group. HA caused by puerarin was associated with type 1] hypersensitivity. It suggested that monitoring indices such as hemoglobin concentrations, reticulocyte counts and urine helped identifying HA timely. In addition, stopping administering puerarin and offering active treatments could avoid severe ADRs. Conclusion： The incidences of ADRs were similar between the compared groups, but careful attention should be paid. Monitoring signs of HA is essential to the patients to be treated with puerarin and those who had antibodies to puerarin should not be treated with puerarin in the future.

关 键 词：葛根素注射剂 药物不良反应 贫血 溶血性 队列研究 

分 类 号：R282.71[医药卫生—中药学]