39例丹红注射液导致的药物不良反应/事件分析

罗佳　王钦　郭青松

[摘要] 目的 了解丹红注射液导致的药物不良反应/事件的特点，为其临床应用提供分析数据。 方法 收集39例丹红注射液导致的药物不良反应/事件，采用回顾性分析法，分析患者的原患疾病、药物联用情况、不良反应/事件的发生时间、临床症状。 结果 在39例药物不良反应/事件中，原患疾病类型构成比最大的是心血管疾病和神经系统疾病，而原发性高血压是构成比最大的原发疾病，占28.21%（11/39）。丹红注射液单独使用者5例，占12.82%；其余34例为药物联用，占87.18%。药物不良反应/事件的发生时间<30min11例，占28.21%；30min～1h 10例，占25.64%；1～3h 7例，占17.95%；3～24h 5例，占12.82%；>24h 6例，占15.38%。最常见的临床症状是皮肤症状（35.90%）与消化系统症状（25.64%），主要有皮疹、注射部位红肿、恶心呕吐等。药物不良反应/事件发生率为7.28%（39/536）；≥60岁者的发生率为15.52%（27/174），均高于<40岁者和40～59岁者，差异均有统计学意义（x2=25.166、9.060，P<0.05）。 结论 丹红注射液导致的药物不良反应/事件发生时间快，症状较轻，在临床用药中应加强监护，及时发现处理。

[关键词] 丹红注射液；中药注射剂；药物不良反应；药物不良事件；安全用药

[中图分类号] R288 [文献标识码] B [文章编号] 2095-0616（2015）24-42-04

[Abstract] Objective To know about the characteristics of adverse drug reactions /events caused by Dan Hong injection and to provide analysis data for its clinical application. Methods 39 cases of adverse drug reactions/events caused by Dan Hong injection were collected.The primary disease，drug combination， occurrence time of adverse reactions/events and clinical symptoms of patients were analyzed by retrospective analysis. Results In 39 cases of adverse drug reactions/events，cardiovascular disease and nervous system disease take the largest part in primary diseases.And primary hypertension was the largest proportion of the primary diseases，accounting for 28.21%（11/39）.Dan Hong injections were used alone in 5 cases， accounting for 12.82% and the remaining 34 cases were of drug combination， accounting for 87.18%.Duration of adverse drug reactions/events was less than 30 min in 11 cases，accounting for 28.21%.Duration of 30 min to 1 hour was in 10 cases，accounting for 25.64%.Duration of 1 to 3 hours was in 7 cases，accounting for 17.95%；Duration of 3 to 24 hours was in 5 cases，accounting for 12.82%；Duration of more than 24 hours was in 6 cases，accounting for 15.38%.The most common clinical symptoms were skin symptom（35.90%）and digestive system symptom（25.64%）including rash，injection site swelling，nausea and vomiting，etc.The incidence rate of adverse drug reactions/events was 7.28%（39/536）；The incidence rate of that in patients of more than 60 years old was 15.52%（27/174），higher than that of patients of less than 40 years old and patients of 40 to 59 years old.The differences were statistically significant（x2=25.166， 9.060，P<0.05）. Conclusion The adverse drug reactions/ events caused by Dan Hong injection have short occurrence time and the symptoms were mild.Thus，in clinical medication we should strengthen the monitoring，timely discover and resolve.

[Key words] Dan Hong injection；Traditional Chinese medicine injection；Adverse drug reaction；Adverse drug event；Safe medication

丹红注射液是采用中药丹参和红花为原材料，将其有效化学成分加以提取而制备的中药注射剂，具有通经活络、活血化瘀之功效[1-2]。临床中可用于瘀血闭塞引起的胸痹与中风，可治疗心绞痛、冠心病、心肌梗塞、缺血性脑病、瘀血性肺心病、脑血栓等疾病[3-6]。然而作为一种中药注射剂，在其临床应用过程中必须严格把握适应证，并观察可能出现的药物不良反应，这对药物的安全使用尤为重要[7-9]。为了了解丹红注射液导致的药物不良反应/事件的特点，为其临床应用提供分析数据，本文回顾性分析39例丹红注射液导致的药物不良反应/事件的资料，现报道如下。……