CAJ | 학술논문

目的：探讨醒脑静注射液不良反应/事件的发生原因与规律，为临床安全用药提供参考。方法对30例国内文献报道的醒脑静注射液不良反应/事件进行统计和分析。结果中老年患者占56.67%；43.33%的病例用于治疗非说明书适应证的病症；13.33%的病例超剂量用药；70.00%的患者在用药开始后的30 min内发生不良反应/事件；不良反应/事件可发生首次用药和连续用药过程中；33.33%的病例有合并用药情况；不良反应/事件累及6个系统-器官，以过敏反应和过敏性休克为主的全身性损害占60.00%。结论临床医务人员应注意询问患者的过敏史，应严格遵照说明书规定的适应证和用法用量使用醒脑静注射液，谨慎联合用药，用药过程中加强不良反应监测；药品生产企业应加强醒脑静注射液的质量控制研究与安全性研究，以及修改完善说明书的安全性内容。
목적：탐토성뇌정주사액불량반응/사건적발생원인여규률，위림상안전용약제공삼고。방법대30례국내문헌보도적성뇌정주사액불량반응/사건진행통계화분석。결과중노년환자점56.67%；43.33%적병례용우치료비설명서괄응증적병증；13.33%적병례초제량용약；70.00%적환자재용약개시후적30 min내발생불량반응/사건；불량반응/사건가발생수차용약화련속용약과정중；33.33%적병례유합병용약정황；불량반응/사건루급6개계통-기관，이과민반응화과민성휴극위주적전신성손해점60.00%。결론림상의무인원응주의순문환자적과민사，응엄격준조설명서규정적괄응증화용법용량사용성뇌정주사액，근신연합용약，용약과정중가강불량반응감측；약품생산기업응가강성뇌정주사액적질량공제연구여안전성연구，이급수개완선설명서적안전성내용。
Objective To analyze the causes and characteristics of the adverse drug reaction/event (ADR/ADE) cases induced by Xingnaojing injection provide references for clinical rational drug use. Methods 30 ADR/ADE cases induced by Xingnaojing injection were analyzed retrospectively. Results The middle-aged and the old patients ac counted for 56.67%. The use of Xingnaojing injection in 43.33% cases is beyond the indications of the drug instruc tions. The dosage of Xingnaojing injection in 13.33% cases is more than the dosage of the drug instructions. 70.00% of ADR/ADE occurred within 30 minutes after administration. The ADR/ADE can occur in the first time medication or continuous administration process. 33.33% of the patients had combined medication. The ADR/ADE involved six systems-organs. Systemic damage in which allergic reactions and anaphylactic shock is majority accounted for 60.00%. Conclusion Clinicians should pay attention to allergies of patients. The instruction should be adhered to. The combined medication should be cautious. The monitoring of adverse drug reactions should been strengthened. The drug manufacturing enterprise should strengthen the quality control and drug safety research, and improve the drug instructions of Xingnaojing injection.