166例中药制剂不良反应报告的回顾性分析

Retrospective Analysis of 166 Cases of Adverse Drug Reactions Caused by Traditional Chinese Medicine Preparation

目的 :分析了解本地区中药制剂不良反应发生的总体情况和规律,提高基层食品药品监管部门对中药药品不良反应(ADR)的监测水平,促进涉药单位指导公众合理运用中药,守护基层用药安全。方法:采用回顾性分析研究方法,从国家药品不良反应监测系统安徽平台筛选本地2012-2016年上报的中药ADR报表数据进行分类统计、分析。结果 :共有166例中药ADR纳入研究,≥45且<65岁年龄段ADR发生率最高,为44.58%;注射给药方式单品种的ADR发生率最高,达到5.3例/品种;合并用药会增加ADR发生的风险、一般ADR占比高,为96.39%;严重不良反应占比3.61%,需重视;药师占上报人职业的比例为66.87%,是ADR报告的主体。结论 :应重视中药ADR,强化ADR监测,促进中药制剂工艺、标准和作用机理研究,完善药品说明书,发挥药师职能,深入拓展药学服务,降低公众用药风险。

Objective:To analyze the overall situation and regularity of adverse drug reaction(ADR) caused by traditional chinese medicine(TCM) preparations in Jixi County, Anhui Province, China, improve the monitoring level of the ADR by food and drug administration, promote the relevant department to guide the rational use of TCM in public and protect the safety of drug use. Methods:The data on ADRs caused by TCM preparations reported in Jixi County, Anhui Province from 2012 to 2016 were downloaded from the Anhui Platform of National Adverse Reaction Monitoring System, and analyzed retrospectively. Results:A total of 116 cases of ADR were included in this study. The incidence of ARD in age group of ≥45 and <65 years was the highest, which was 44.58%. The incidence of ADR caused by a single drug by injection route was the highest, which was 5.3 cases/kind. Combined adminstration of drugs increased the risk of ADR. General ADR accounted for 96.39% of total cases, while severe ADR accounted for 3.61%, which should be paid more attention. A portion of 66.87% of ADR were reported by the pharmacists. Conclusion:ADRs caused by TCM should be paid more attention, on which the monitoring should be strengthened. The research on preparation technology, standard and mechanism of TCM should be promoted, while the drug instructions should be improved, and the pharmacists should take part in and expand pharmaceutical services to reduce the risk of drug use in public.