我院218例中药注射剂不良反应报告分析

目的：了解该院中药注射剂不良反应（ADR）发生的特点及一般规律，为临床合理用药提供参考依据。方法：对该院2006年3月-2011年12月ADR监测小组收集并上报的218例中药注射剂ADR报告，按年龄、性别、ADR发生时间、引起ADR的药品类别和品种、ADR涉及器官／系统及临床表现进行回顾性统计与分析。结果：218例ADR主要集中在60岁以上的人群中（占37．16％）；男女之间比较差异无统计学意义（男女分别占48．62％、51．38％）；ADR通常发生于给药后5～30min内（占56．88％）；引起ADR的主要药物品种为清热解毒类（占47．25％）；ADR涉及的器官／系统主要为皮肤及附件损害（占41．74％），其次为全身性损害（占20．64％）。结论：临床应加强ADR监测和报告工作，减少或避免ADR的重复发生，促进中药注射剂的安全、合理使用。

Analysis of 21S Cases of Adverse Drug Reaction Induced by TCM Injection in Our Hospital

OBJECTIVE： To learn the characteristics and regularity of adverse drug reactions （ADR） induced by TCM injec- tion in The Affiliated Zhengzhou Central Hospital of Zhengzhou University, and to provide reference for rational drug use in the clinic. METHODS： In retrospective study, 218 cases of ADR collected from the hospital during Mar. 2006 to Dec. 2011 were ana- lyzed statistically in respects of patients＇ age and gender, occurrence time, drug category, organs or systems involved in ADR and clinical manifestations. RESULTS： Among 218 cases of ADR reports, the incidence rate of ADR was higher in patients aged over 60 than others, accounting for 37.16% ; there was no statistical significance between male （48.62%） and female （51.38%）. The time of ADR occurrence was centralized from 5 to 30 min （56.89%）. The main types of drugs were heat-clearing and detoxifying drugs（47.25% ）. Organs or systems involved in ADR mainly were lesion of skin and its appendants （41.74%）, followed by system- ic damage （20.64%）. CONCLUSIONS： ADR monitoring and reporting should be strengthened in the clinic to reduce or avoid the occurrence of ADR and promote rational and safe use of TCM injection.