参麦注射液在非小细胞肺癌治疗中不良反应的回顾性研究

A retrospective study on adverse drug reactions( ADRs) of shenmai injection in patients with non-small cell lung cancer

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.

Objectlve To investigate the side effects and correlated factors of Shenmai（SM） injection in the treatment of patients with non-small cell lung cancer（NSCLC）. Methods Medical records of patients with NSCLC receiving SM were investigated Data including patient demographics, tumor stages, pathology, performance status, allergic history, smoking history,co-morbidities, concomitant medications, and timing and occurrences of ADRs were collected The severities of ADRs were graded based upon NCI-CTCAE version 4.0. Data were analyzed with SPSS 19.0. Results A total of 324 NSCLC patients with a mean age of 61.6 ±9.7 were identified ADRs occurred in 14 patients（4.32% ） with 31 incidents. Of those 31 incidents,the cutaneous toxicities were the most common（29.30% ）, followed by toxicities in cardiovascular system（25.80% ）, digestive system （ 19.35% ）, respiratory system （ 12.90% ）, nervous system （ 4.45% ）, and immune system（4.45% ）. The most severe toxicities were grade 3 that occurred in 2 cases（0.6% ） with symptoms of anaphylaxis, dyspnea, laryngeal edema, and fever Most incidents occurred in first-time users and in the first 30 minutes after SM administration. Binary logistic regression analysis showed gender, age, pathology, allergic history, co-morbidities, concomitant medications had no significant association with ADRs of SM. Conclusion Current evidence showed that Shen- mai injection had lower ADR occurrence, but potential risk factors of ADRs of Shenmai injection were unclear Further investigation was needed to identify other potential risk factors and related biological mechanisms.