中药注射剂引发药品不良反应报告分析

Analysis on adverse drug reactions caused by traditional Chinese medicine injections

目的探讨中药注射剂引起药品不良反应的特点及其规律,为临床合理用药提供重要的参考。方法选取2016年1月~2017年12月在我院接受中药注射剂治疗的100例患者为研究对象,将其随机分为研究组(n=50例)与对照组(n=50例),对照组患者未实施药学干预,研究组患者接受临床药学干预,在统计100例患者药品不良反应报告基础上,对比两组药学干预不良反应发生情况。结果引发药品不良反应的中药注射剂排在前三位的分别为丹参注射液(42%)、血塞通(冻干)粉针(19%)、疏血通注射液(14%);药品不良反应发生最高的时间段为31min^1h,其发生率为38%,其次分别为1h^1d、11~30min这两个时间段,发病率分别为29%、22%;药品不良反应累及器官及系统发病率占在前三位依次为中枢神经系统(35%)、皮肤及附件(30%)、消化系统(21%),临床表现主要为失眠、局部肿痛、丘疹、消化不良等。对比可知,研究组接受药学干预不良反应发生率为12%,对照组为50%,组间数据对比差异有统计学意义(P<0.05)。结论中药注射剂引起药品不良反应的情况不容忽视,药品说明书有待进一步规范和补充。因此,要设法加强药物规范管理,做好用药监测及其药学干预,促进患者的快速康复。

Objective To explore the characteristics and regularity of adverse drug reactionscaused by traditional Chinese medicine injections so as to provide important reference for clinical rational drug use.Methods 100 patientswho were treated with traditional Chinese medicine injections in our hospital from January 2016 to December 2017were selected as research objects and they were randomly divided into the study group(n=50)and the control group(n=50).Patients in the control group were not given clinical pharmaceutical intervention while patients in the study group were given clinical pharmaceutical intervention.On the basis of the statistics of adverse drug reaction reports of 100 patients,the occurrence of adverse drug reactions in pharmaceutical intervention was compared between the two groups.Results Danshen injection(42%),Xuesaitong(freeze-dried)powder injection(19%)and Shuxuetong injection(14%)were the top three TCM injections that caused adverse drug reactions.The time period for the highest incidence of adverse drug reactions was 31 min-1 h with the incidence rate was 38%,followed by the two time periods of 1 h-1 d and 11-30 min,respectively,with an incidence of 29%and 22%.Adverse drug reactions involving organs and systems accounted for the top three in the central nervous system(35%),skin and accessories(30%)and digestive system(21%).The main clinical manifestations were mainly insomnia,local swelling and pain,papules and indigestion.The comparison showed that the incidence of adverse reactions in pharmacy interventions in the study group was 12%and 50%in the control group.There was significant difference in the data between the two groups(P<0.05).Conclusion The situation of adverse drug reactions caused by traditional Chinese medicine injections cannot be ignored,and the drug specifications need to be further standardized and supplemented.Therefore,it is necessary to try to strengthen the management of drug standards,do a good job in drug monitoring and pharmaceutical interventions and promote rapid recovery of patients.