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：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

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

1.	余健, 辛艷飛, 宣堯仙. 參麥注射液藥理作用的物質基礎研究進展. 醫藥導報, 2013, 32(4): 497-500.
2.	胡晶, 張雯, 謝雁鳴, 等. 參麥注射液治療急性心肌梗死的Meta分析. 中國中藥雜志, 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.	陳弘東, 謝雁鳴, 王連心, 等. 參麥注射液輔助治療慢性心力衰竭的有效性及安全性系統評價. 中國中藥雜志, 2014, 39(18): 3650-3661.
5.	胡元春, 謝雁鳴, 楊薇, 等. 基于HIS的參麥注射液治療腫瘤臨床用藥特征真實世界研究. 中國中藥雜志, 2014, 39(18): 3509-3513.
6.	王連心, 程豪, 謝雁鳴, 等. 基于傾向性評分的不同療程使用參麥注射液肝腎功能變化分析. 中國中藥雜志, 2013, 38(18): 3053-3059.
7.	原衛生部. 藥品不良反應報告和監測管理辦法(中華人民共和國衛生部第81號令), 2011. Available at: http://www.nhc.gov.cn/wjw/bmgz/201105/b442a66fc52b4793a57160002ac2a1a9.shtml.
8.	韓利文, 張友剛, 李昊楠, 等. 參麥注射液治療新型冠狀病毒肺炎(COVID-19)合并冠心病的網絡藥理分子機制探析. 中草藥, 2020, 51(9): 2334-2344.
9.	王春燕, 王希營, 金紅. 新型冠狀病毒診療方案(試行第七版). 蘭州大學學報(醫學版), 2020, 46(2): 1-7.
10.	中國心血管病報告編寫組. 《中國心血管病報告2016》概要. 中國循環雜志, 2017, 32(6): 521-530.
11.	王維瓊. 2016年中國惡性腫瘤發病和死亡分析. 臨床醫藥文獻電子雜志, 2017, 4(19): 3604.
12.	趙云平. 參麥注射液對老年高血壓患者脈壓指數、脈搏波傳導速度及血脂的影響研究. 中國醫藥導報, 2013, 10(15): 94-95, 101.
13.	黃秋陽. 參麥注射液聯合硫酸鎂治療妊娠期高血壓病的臨床觀察. 中國中醫藥科技, 2015, 22(1): 83-84.
14.	張志華, 劉達燕, 武成榮. 參麥注射液聯合硝酸甘油治療慢性心力衰竭的有效性和安全性研究. 中國藥物與臨床, 2019, 19(4): 652-654.
15.	浦清, 華瑋, 居培紅, 等. 參麥注射液治療老年心力衰竭患者的臨床研究. 中國臨床保健雜志, 2017, 20(1): 92-93.
16.	杜婧, 楊薇, 易丹輝, 等. 基于HIS數據庫“真實世界”的參麥注射液臨床用藥規律. 中國中藥雜志, 2011, 36(20): 2813-2816.
17.	王連心, 謝雁鳴, 楊薇, 等. 基于HIS真實世界的參麥注射液臨床實效研究. 中國中藥雜志, 2012, 37(18): 2710-2713.

1. 余健, 辛艷飛, 宣堯仙. 參麥注射液藥理作用的物質基礎研究進展. 醫藥導報, 2013, 32(4): 497-500.
2. 胡晶, 張雯, 謝雁鳴, 等. 參麥注射液治療急性心肌梗死的Meta分析. 中國中藥雜志, 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. 陳弘東, 謝雁鳴, 王連心, 等. 參麥注射液輔助治療慢性心力衰竭的有效性及安全性系統評價. 中國中藥雜志, 2014, 39(18): 3650-3661.
5. 胡元春, 謝雁鳴, 楊薇, 等. 基于HIS的參麥注射液治療腫瘤臨床用藥特征真實世界研究. 中國中藥雜志, 2014, 39(18): 3509-3513.
6. 王連心, 程豪, 謝雁鳴, 等. 基于傾向性評分的不同療程使用參麥注射液肝腎功能變化分析. 中國中藥雜志, 2013, 38(18): 3053-3059.
7. 原衛生部. 藥品不良反應報告和監測管理辦法(中華人民共和國衛生部第81號令), 2011. Available at: http://www.nhc.gov.cn/wjw/bmgz/201105/b442a66fc52b4793a57160002ac2a1a9.shtml.
8. 韓利文, 張友剛, 李昊楠, 等. 參麥注射液治療新型冠狀病毒肺炎(COVID-19)合并冠心病的網絡藥理分子機制探析. 中草藥, 2020, 51(9): 2334-2344.
9. 王春燕, 王希營, 金紅. 新型冠狀病毒診療方案(試行第七版). 蘭州大學學報(醫學版), 2020, 46(2): 1-7.
10. 中國心血管病報告編寫組. 《中國心血管病報告2016》概要. 中國循環雜志, 2017, 32(6): 521-530.
11. 王維瓊. 2016年中國惡性腫瘤發病和死亡分析. 臨床醫藥文獻電子雜志, 2017, 4(19): 3604.
12. 趙云平. 參麥注射液對老年高血壓患者脈壓指數、脈搏波傳導速度及血脂的影響研究. 中國醫藥導報, 2013, 10(15): 94-95, 101.
13. 黃秋陽. 參麥注射液聯合硫酸鎂治療妊娠期高血壓病的臨床觀察. 中國中醫藥科技, 2015, 22(1): 83-84.
14. 張志華, 劉達燕, 武成榮. 參麥注射液聯合硝酸甘油治療慢性心力衰竭的有效性和安全性研究. 中國藥物與臨床, 2019, 19(4): 652-654.
15. 浦清, 華瑋, 居培紅, 等. 參麥注射液治療老年心力衰竭患者的臨床研究. 中國臨床保健雜志, 2017, 20(1): 92-93.
16. 杜婧, 楊薇, 易丹輝, 等. 基于HIS數據庫“真實世界”的參麥注射液臨床用藥規律. 中國中藥雜志, 2011, 36(20): 2813-2816.
17. 王連心, 謝雁鳴, 楊薇, 等. 基于HIS真實世界的參麥注射液臨床實效研究. 中國中藥雜志, 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

Abstract Full text Figures/Tables Video References Cited by

Previous Article

Next Article

Format

Content