基于文献计量分析的参麦注射液临床安全性评估

目的:对参麦注射液临床安全性研究文献进行分析,以了解参麦注射液不良反应特征。方法:对患者的性别、年龄、所患疾病等基础信息,使用剂量、溶媒等用药信息,以及不良反应发生时间、症状等信息进行分析。结果:不良反应多集中在41～50岁的中年人,原患肿瘤的患者不良反应发生较多,各种溶媒、各用药剂量段均有不良反应发生,并以30 min以内出现的速发型过敏反应为主,以过敏性休克最为严重。结论:参麦注射液不良反应发生与药品生产质量控制、临床合理用药及患者个体因素等关系密切,要求临床医师高度警惕,以保障用药安全。

Analysis of clinical safety for Shenmai injection based on literature

Objective: To analyze the literature about clinical safety of Shenmai injection and know the adverse reaction characteristics of Shenmai injection. Method: Many kinds of information are analyzed. The basic information includes sex, age and disease of patients. The drug information includes dosage and solvent. The time of adverse reaction and symptom is also analyzed. Result: The patients' age between 41 and 50 is the most. The adverse reaction happens more on patients with the disease of tumor and out of specification. All the solvent and dosage can cause adverse reaction. Immediate anaphylactic reaction within 30 minutes is the main type and anaphylactic shock is the most. Conclusion: The occurrence of adverse reaction of Shenmai injection is closely related to production quality of drug, rational drug use in clinical and individual factors of patients. Conclusion is demanded for clinician to ensure the safe medication.