摘要
目的：分析中药制剂发生不良反应的原因,并针对原因制定相应的预防对策。方法：选取2014年1月至2015年12月期间上报的230例中药制剂不良反应报告进行回顾性分析。对患者的性别、年龄段、报告人员身份、发生中药制剂不良反应的药品剂型、给药途径、发生时间、累及器官及临床表现等进行统计分析,并根据导致不良反应发生的原因,制定相应措施,预防和减少中药制剂不良反应再次发生。结果：男性患者不良反应发生率高于女性患者,但差异并不明显,不具有统计学意义（P〉0.05）;不良反应发生率较高的年龄段是大于60的患者;报告人员比例较大的是医生,药师的报告比例最低;引起不良反应比例最高的剂型为注射剂;静脉给药途径的不良反应发生率明显高于外敷、肌注等给药途径,差异具有统计学意义（P〈0.05）;注射剂患者发生不良反应的时间集中在30 min以内,非注射剂患者不良反应多在1~24 h内发生;皮肤及附件损害是主要累及器官。结论：中药制剂引发的不良反应具有明显的特点性,针对不良反应集中发生的年龄段、中药剂型、给药途径等制定相应措施,能够有效预防和减少中药制剂不良反应的发生,提高临床用药安全性。
Objective： To analyze the causes of adverse reactions of traditional Chinese medicine（ TCM） preparation and to formulate the corresponding preventive measures. Methods： A retrospective analysis was made on 230 cases of adverse drug reactions reported in TCM preparations during January 2014 to December 2015. The patient＇ s gender,age,reporter＇ s identity,forms of TCM preparation,pathway of administration,occurrence time,relevant organ and clinical manifestations were recorded and analyzed. Then establish corresponding preventive measures. Results： 1） The incidence of adverse reactions in male patients is higher than that of female patients,but the difference is not statistically significant（ P〉 0. 05）; 2） The most risky age of adverse reactions is around sixty; 3） Doctors take the largest percent in reporters and pharmacists take the least; 4） Intravenous injection correlates to the highest percentage of adverse reactions,higher than that of oral,intramuscular and other pathways of administration,with P 〈0. 05; 5） Adverse reactions of injection often happen within 30 minutes and other forms of preparations occurred within 1-24 h; 6） Skin and adnexa are the mainly affected organs. Conclusion： Adverse reactions caused by TCM preparation has obvious characteristics. In light of the adverse reactions in different age,dosage form,pathway of administration,corresponding measures can be formulated,which will effectively prevent and reduce the incidence of adverse reactions.
出处
《世界中医药》
CAS
2016年第7期1348-1350,共3页
World Chinese Medicine
关键词
中药制剂
不良反应
预防对策
报告
Traditional Chinese medicine preparation
Adverse reaction
Preventive measures
Report
