血塞通注射液临床安全性评价及风险评估

The clinical safety evaluation and risk assessment on xue-sai-tong Injection

目的通过探讨血塞通注射液不良反应的一般规律和特点,对其进行安全性评价及风险评估,指导临床用药。方法采用回顾性研究方法,对2011~2014年报告的1366例血塞通注射液药品不良反应/事件进行统计分析,总结规律,提出应对措施。结果 1366例发生严重不良反应的有41例,其中危及生命的不良反应有31例,占75.61%;50岁以上的患者923例,占67.57%;超剂量用药187例,占13.69%;原患疾病以循环系统中的脑梗塞、高血压病、脑供血不足、冠心病等疾病最多;不良反应主要以皮肤及其附件损害为主;注射用血塞通较血塞通注射液不良反应率高,粉针剂较注射剂不良反应率高;吸烟、饮酒可能是不良反应产生的潜在危险因素。结论临床需加强对血塞通注射液的监测,提高临床合理用药水平,减少不良反应的发生。

Object general rules and ve To probe the characteristics of adverse reactions about xue-sai-tong injection, evaluate its safety and risk, guide the cli Methods 1366hDR/ADE nical treatment. reports of xuesai-tong injection collected by Gaungxi center for from 2011 to 2014 using retrospective summed up the law countermeasures. Resu ADR monitoring were analyzed study , put ts 31 serious adverse reactions threatening accounted for method, forward cases of to life- 75.61%; 923 cases of patients over the age 50 accounted for 67.57%; 187 cases of them were drug overdose, accounting for 13.69%; The most original illness were cerebral infarction, hypertension , cerebral insufficiency , coronary heart disease and other circulatory diseases; The main adverse reactions were skin and its accessories; The adverse reaction rate of injection xue-sai-tong was higher than xue-saitong injection, The adverse reaction rate of the power was higher than the injection; Smoking, alcohol consumption may be a potential risk factor for adverse reactions. Conclusion It should strengthen the monitoring of xue-sai-tong injection in the clinic use , to improve the level of rational drug use , reduce the incidence of adverse reactions.