33例中成药不良反应报告分析

Analysis of 33 ADR reports associated with traditional Chinese patent medicines and simple preparations

目的了解本院中成药不良反应的发生情况,为临床合理使用中成药提供参考。方法总结2010年上报的33例中成药不良反应报告,从患者的性别、年龄分布、药物品种、剂型分布、涉及部位、临床表现、同一批次药物发生不良反应情况以及不良反应程度等方面进行统计分析。结果 33例中成药不良反应中,注射剂引起的有25例(75.75%),涉及8个品种,其余8例为口服制剂引起(24.25%);男18例(54.54%),女15例(45.46%),男性略高多于女性;高发年龄段为21～30岁(21.21%)、51～60岁(27.27%)、61～70岁(15.15%);不良反应主要为皮肤及其附件损害、全身性损害、神经系统损害、消化系统损害、泌尿生殖系统损害;同一批次药物不良反应发生率较高的有5个品种,均为注射剂;不良反应程度主要为一般的和新的一般的。结论临床应重视中成药临床不良反应的监测、报告和分析工作,以尽量减少或避免中成药不良反应的发生。

Objective To review the ADRs of traditional Chinese patent medicines and simple preparations occurred in our hospital for clinical rational use of them. Methods 33 ADR cases reported in our hospital in 2010 were ana- lyzed statistically in respect of age and gender of patients, varieties and distribution of dosage forms, organs and sys- tems, clinical manifestation and degree involved in ADR. Results In the total of 33 ADR cases, 25 cases were caused by injections involving 8 varieties and another 8 cases were caused by oral preparations. The gender of 33 patients was 18 males and 15 females. The high risk age ranged from 21 to 30 years old, 51 to 60 years old, 61 to 70 years old was 121.21%, 27.27% and 15.15%. Main clinical manifestations were damage of lesion of skin and its appendents, sys- temic, nervous system, digestive system and genitourinary system. The same batch number of drugs in a higher rate of ADRs of 5 varieties was injection. The extent of ADR was mainly about general and new general. Conclusion Great importance should be attached to traditional Chinese patent medicines and simple preparations and its monitoring, re- porting and analysis to reduce the incidence of ADR.