Usage and safety of Shenmai injection: a real-word study based on 30 012 patients_Chinese Journal of Evidence-Based Medicine

Authors：

WANG Mingxia ¹ , WANG Shumei ² , LIU Ming ³ , GAO Ya ³ ,  TIAN Jinhui ³

1. The Fourth Hospital of Hebei Medicine University, Shijiazhuang 050019, P.R.China;
2. The Second Hospital of Hebei Medicine University, Shijiazhuang 050019, P.R.China;
3. Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, P.R.China;

Corresponding author：

TIAN Jinhui, Email: tianjh@lzu.edu.cn

Keywords：

Shenmai injection; Real word; Big data; Clinical characteristics; Safety

DOI：

10.7507/1672-2531.202010001

Video：

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Objective To analyze the clinical application and safety of Shenmai injection.Methods We collected clinical data of 30 012 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, 14 270 were females (47.55%), 8 218 were aged 45-60 (27.38%), and 10 452 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 (1 533, 5.11%), breast cancer (1 509, 5.03%) and gastric cancer (847, 2.82%). The second important use of Shenmai injection was the treatment of coronary heart disease (5 703, 19.00%), of which the most common single dose was 50 mL (14 406, 48.00%), followed by 100 mL (10 804, 36.00%) and 200 mL (600, 2.00%). The solvents were used in 18 902 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.

Citation： WANG Mingxia, WANG Shumei, LIU Ming, GAO Ya, TIAN Jinhui. Usage and safety of Shenmai injection: a real-word study based on 30 012 patients. Chinese Journal of Evidence-Based Medicine, 2021, 21(2): 133-138. doi: 10.7507/1672-2531.202010001 Copy

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1. 余健, 辛艳飞, 宣尧仙. 参麦注射液药理作用的物质基础研究进展. 医药导报, 2013, 32(4): 497-500.
2. 胡晶, 张雯, 谢雁鸣, 等. 参麦注射液治疗急性心肌梗死的Meta分析. 中国中药杂志, 2012, 37(18): 2760-2767.
3. Su X, Ma Y, Huang R, et al. Effects of shenmai injection on blood SOD activity and MDA level in senile patients with coronary heart disease. J Tradit Chin Med, 2005, 25(1): 50-53.
4. 陈弘东, 谢雁鸣, 王连心, 等. 参麦注射液辅助治疗慢性心力衰竭的有效性及安全性系统评价. 中国中药杂志, 2014, 39(18): 3650-3661.
5. 胡元春, 谢雁鸣, 杨薇, 等. 基于HIS的参麦注射液治疗肿瘤临床用药特征真实世界研究. 中国中药杂志, 2014, 39(18): 3509-3513.
6. 王连心, 程豪, 谢雁鸣, 等. 基于倾向性评分的不同疗程使用参麦注射液肝肾功能变化分析. 中国中药杂志, 2013, 38(18): 3053-3059.
7. 原卫生部. 药品不良反应报告和监测管理办法(中华人民共和国卫生部第81号令), 2011. Available at: http://www.nhc.gov.cn/wjw/bmgz/201105/b442a66fc52b4793a57160002ac2a1a9.shtml.
8. 韩利文, 张友刚, 李昊楠, 等. 参麦注射液治疗新型冠状病毒肺炎(COVID-19)合并冠心病的网络药理分子机制探析. 中草药, 2020, 51(9): 2334-2344.
9. 王春燕, 王希营, 金红. 新型冠状病毒诊疗方案(试行第七版). 兰州大学学报(医学版), 2020, 46(2): 1-7.
10. 中国心血管病报告编写组. 《中国心血管病报告2016》概要. 中国循环杂志, 2017, 32(6): 521-530.
11. 王维琼. 2016年中国恶性肿瘤发病和死亡分析. 临床医药文献电子杂志, 2017, 4(19): 3604.
12. 赵云平. 参麦注射液对老年高血压患者脉压指数、脉搏波传导速度及血脂的影响研究. 中国医药导报, 2013, 10(15): 94-95, 101.
13. 黄秋阳. 参麦注射液联合硫酸镁治疗妊娠期高血压病的临床观察. 中国中医药科技, 2015, 22(1): 83-84.
14. 张志华, 刘达燕, 武成荣. 参麦注射液联合硝酸甘油治疗慢性心力衰竭的有效性和安全性研究. 中国药物与临床, 2019, 19(4): 652-654.
15. 浦清, 华玮, 居培红, 等. 参麦注射液治疗老年心力衰竭患者的临床研究. 中国临床保健杂志, 2017, 20(1): 92-93.
16. 杜婧, 杨薇, 易丹辉, 等. 基于HIS数据库“真实世界”的参麦注射液临床用药规律. 中国中药杂志, 2011, 36(20): 2813-2816.
17. 王连心, 谢雁鸣, 杨薇, 等. 基于HIS真实世界的参麦注射液临床实效研究. 中国中药杂志, 2012, 37(18): 2710-2713.

Chinese Journal of Evidence-Based Medicine

Usage and safety of Shenmai injection: a real-word study based on 30 012 patients

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