活血化瘀类中药注射剂治疗缺血性脑卒中的不良反应分析及应对策略

Analysis and countermeasures of adverse drug reactions of traditional Chinese medicine injections for promoting blood circulation and removing blood stasis

目的分析活血化瘀类中药注射剂在缺血性脑卒中患者临床使用中的不良反应(ADR)发生情况,指导临床合理用药。方法选择天津市环湖医院2015年1月—2020年4月诊断为缺血性脑卒中应用活血化瘀类中药注射剂治疗后出现ADR的71例患者病历资料,记录患者年龄、性别等情况,分析ADR的分级、临床表现、涉及的具体中药注射剂的品种,并进行危险因素和策略分析。结果在发生ADR的患者中,男性44例(61.97%),多于女性27例(38.03%);其中≥55岁的患者ADR发生率较高;注射用红花黄色素ADR发生率最高,ADR主要表现在皮肤系统及全身性损害包括寒战、高热等。结论缺血性脑卒中患者使用活血化瘀类中药注射剂,不仅要根据病情辨证施治,根据患者个体化选择用药,减少相同成分活血化瘀类中药注射剂的联用,更要结合缺血性脑卒中患者联合用抗血小板药物的情况,加强药物监测,严格掌握药物的适应证及用药原则。

Objective To analyze the adverse drug reactions of traditional Chinese medicine injections in the clinical use of ischemic stroke patients, so as to guide the rational clinical use of drugs. Methods The medical records of 81 patients diagnosed with ischemic stroke who had ADR after treatment with traditional Chinese medicine injections for promoting blood circulation and removing blood stasis in Tianjin Huanhu Hospital from January 2015 to April 2020 were selected, the age and gender of the patients were recorded, classification, clinical manifestations and the varieties of traditional Chinese medicine injections involved in ADR were analyzed, and risk factors and strategies were analyzed. Results Among the patients with ADR, the numble of males(44, 61.97%) were more than that of females(27, 38.03%). The incidence of ADR was higher in patients aged ≥ 55 years old. The incidence of ADR induced by safflower yellow for injection were the highest, mainly manifested in skin system, systemic damage including chills, high fever and so on. Conclusion The use of traditional Chinese medicine injections for activating blood circulation and removing blood stasis in patients with ischemic stroke should not only be based on syndrome differentiation and treatment, but also be individualized according to the patient’s condition, so as to reduce the combined use of traditional Chinese medicine injections for activating blood circulation and removing blood stasis with the same composition. What’s more, it should be combined with the situation of antiplatelet drugs in patients with ischemic stroke, strengthen drug monitoring, and strictly grasp the indications and medication principles of drugs.