我院125例住院患者使用丹参酮IIA磺酸钠注射液的安全性分析

摘要

目的：对丹参酮IIA磺酸钠注射液上市后的安全性进行评价，保障患者用药安全。方法：收集并详细记录我院神经内科和内分泌科2015年9月—2016年3月使用丹参酮IIA磺酸钠注射液患者的用药情况以及安全性相关信息，采用描述性分析法总结分析发生不良事件的可能原因。结果：共收集了125例病例，未观察到严重不良事件发生，其中有7例患者发生了轻度不良事件，占5.6%。观察到的不良事件包括4例肝脏转氨酶水平异常升高，1例转氨酶水平异常升高伴粪隐血可疑阳性，1例转氨酶水平异常升高伴右前臂上臂瘀斑，1例出现左眼结膜出血，7例患者在使用丹参酮IIA磺酸钠注射液期间均联用其他可能导致该不良事件发生的药物如他汀类药物、抗栓药物等。结论：丹参酮IIA磺酸钠注射液总体安全性良好，但与他汀类药物和抗栓药物合用时仍需加强药学监护。%Objective: To evaluate the safety of the marketed sodium tanshinone IIA sulfonate injection and to ensure the safety of medication. Methods:The information about the clinical applications and safety of sodium tanshinone IIA sulfonate injection used in department of neurology and endocrinology from September, 2015 to March, 2016 was collected and recorded in detail and the possible reasons of adverse events were analyzed by descriptive analysis.Results:One hundred and twenty-ifve cases of inpatients were collected, however, severe adverse events were not observed, among which mild adverse events occurred in 7 patients, accounting for 5.6%. There were 4 cases with the abnormal elevation of serum aminotransferase level, 1 case with the abnormal elevation of serum aminotransferase level and also with suspected positive fecal occult blood, 1 case with the abnormal elevation of serum aminotransferase level and also with right forearm ecchymosis, and 1 case with left eye conjunctival hemorrhage. These patients were administered with statins and antithrombotic drugs which may lead to such adverse events occurred when they underwent the treatment of sodium tanshinone IIA sulfonate injection.Conclusion:Overall, sodium tanshinone IIA sulfonate injection has a good safety, however, pharmaceutical care should be strengthened when it is used in combination with statins and antithrombotic drugs.