摘要
目的分析参麦注射液的临床使用情况和安全性。方法收集2009年9月至2013年6月全国26家医院30012例使用参麦注射液的患者数据,使用SPSS 15.0软件对人口学特征、诊断信息和具体使用情况进行统计分析。结果使用参麦注射液的患者中男性15742例(52.45%),女性14270例(47.55%);45~60岁8218例(27.38%),61~75岁10452例(34.83%)。临床中主要用于肿瘤患者化疗的辅助治疗,使用最多的3种肿瘤分别是肺癌(1533,5.11%)、乳腺癌(1509,5.03%)和胃癌(847,2.82%);其次是用于冠心病的治疗(5703,19.00%)。单次给药剂量50 mL占比最大(14406,48.00%),其次是100 mL(10804,36.00%)和200 mL(600,2.00%)。18902例(62.98%)在注射时使用了溶媒,最多(84.64%)采用的是5%葡萄糖注射液。总不良反应发生率为0.15%,57.78%的不良反应发生在输液后24小时内。不良反应最常表现为心血管系统的损害,其次分别是血液系统和呼吸系统。结论真实世界中参麦注射液应用范围广、可治疗疾病多,不良反应的出现多与超说明书使用有关。
Objective To analyze the clinical application and safety of Shenmai injection.Methods We collected clinical data of 30012 patients using Shenmai injection from 26 hospitals nationwide from September,2009 to June,2013.The SPSS 15.0 software was used to analyze demographic characteristics,diagnostic information,and clinical application of the injection.Results Among all patients,14270 were females(47.55%),8218 were aged 45-60(27.38%),and 10452 were aged 61-75(34.83%).The primary use of Shenmai injection was as an adjuvant treatment of chemotherapy for cancer patients,and the top 3 cancers were lung cancer(1533,5.11%),breast cancer(1509,5.03%)and gastric cancer(847,2.82%).The second important use of Shenmai injection was the treatment of coronary heart disease(5703,19.00%),of which the most common single dose was 50 mL(14406,48.00%),followed by 100 mL(10804,36.00%)and 200 mL(600,2.00%).The solvents were used in 18902 patients(62.98%),and the 5%glucose injection was used most frequently(84.64%).The adverse effects(AEs)rate was 0.15%,and 57.78%AEs occurred within 24 hours of infusion.The most common AEs were damage of the cardiovascular system,followed by damaging of blood system and respiratory system.Conclusions Shenmai injection has a wide range of applications and can be used in treatment of numerous diseases in the real-world,and the AEs have been linked to off-label uses.
作者
王明霞
王淑梅
刘明
高亚
田金徽
WANG Mingxia;WANG Shumei;LIU Ming;GAO Ya;TIAN Jinhui(The Fourth Hospital of Hebei Medicine University,Shijiazhuang 050019,P.R.China;The Second Hospital of Hebei Medicine University,Shijiazhuang 050019,P.R.China;Evidence-Based Medicine Center,School of Basic Medical Sciences,Lanzhou University,Lanzhou 730000,P.R.China)
出处
《中国循证医学杂志》
CSCD
北大核心
2021年第2期133-138,共6页
Chinese Journal of Evidence-based Medicine
基金
甘肃省技术创新引导计划项目(编号:20CX4ZA027)。
关键词
参麦注射液
真实世界
大数据
临床特征
安全性
Shenmai injection
Real word
Big data
Clinical characteristics
Safety
作者简介
通信作者:田金徽,Email:tianjh@lzu.edu.cn。
