论文部分内容阅读
目的探讨参麦注射液在非小细胞肺癌患者中的不良反应及相关的因素。方法对324名使用参麦注射液治疗的非小细胞肺癌患者病历进行回顾性研究,对患者的基本情况、参麦注射液的使用以及不良反应的临床表现、发生时间等方面进行统计并对相关因素进行Logistic回归分析。结果 324例患者中有14例出现不良反应,参麦注射液不良反应的发生率为4.32%,年龄主要分布在50~60岁。不良反应根据临床表现分为31种,其中以皮肤及附件损害的发生率(29.03%)最高,其次为心血管系统(25.80%)、消化系统(19.35%)、呼吸系统(12.90%)及神经系统(4.45%)、免疫系统(4.45%)。不良反应的严重程度为1~3度,其中1~2度占87.10%(27/31),3度的临床表现为过敏性休克、呼吸困难、喉头水肿及寒战高热。不良反应在首次使用时出现的占71.43%(10例),在30 min内出现的占71.43%(10例)。Logistic回归分析提示年龄、性别、PS评分、病理类型、分期、过敏史、吸烟史、同治疾病、化疗史、靶向治疗史、参麦注射液的剂量、用法及溶媒介质、合并用药等因素均与不良反应的发生无明显的相关性。结论参麦注射液在非小细胞肺癌治疗中不良反应以首用即发型和速发型为主。因缺乏对参麦注射液不良反应的大规模随机对照研究,其不良反应的相关因素仍需进一步探讨。
Objective To investigate the adverse reactions and related factors of Shenmai injection in patients with non-small cell lung cancer. Methods A retrospective study was conducted on the medical records of 324 patients with non-small cell lung cancer treated with Shenmai injection. The patients’ basic conditions, the use of Shenmai injection and the clinical manifestations and the timing of adverse reactions were statistically analyzed and correlated Logistic regression analysis of factors. Results There were 14 adverse reactions in 324 patients, the incidence of adverse reactions in Shenmai injection was 4.32%, and the age was mainly distributed in 50-60 years old. Adverse reactions were classified according to the clinical manifestations into 31 species, of which the incidence of skin and accessory lesions was the highest (29.03%) followed by the cardiovascular system (25.80%), digestive system (19.35%), respiratory system (12.90%) and nerves System (4.45%), Immune System (4.45%). The severity of adverse reactions was 1 ~ 3 degrees, of which 1 ~ 2 degrees accounted for 87.10% (27/31), 3 degrees of clinical manifestations of anaphylactic shock, dyspnea, laryngeal edema and chills fever. Adverse reactions accounted for 71.43% (10 cases) in first use and 71.43% (10 cases) in 30 minutes. Logistic regression analysis showed that age, gender, PS score, pathological type, staging, allergy history, smoking history, Tongzhi disease, history of chemotherapy, history of targeted therapy, dose of Shenmai injection, usage and vehicle, No significant correlation with the occurrence of adverse reactions. Conclusion Shenmai injection in the treatment of non-small cell lung cancer adverse reactions to the first use of hair and quick-hairstyle-based. Due to the lack of large-scale randomized controlled trials of adverse reactions of Shenmai injection, the related factors of adverse reactions still need to be further explored.