Clinical Application Analysis of Andrographolide Total Ester Sulfonate Injection,a Traditional Chinese Medicine Licensed in China

• Published in: Journal of Huazhong University of Science and Technology. Medical sciences Vol. 37; no. 2; pp. 293 - 299
• Main Author: 赵瑛 黄璞 陈喆 郑思维 喻锦扬 史琛
• Format: Journal Article
• Language: English
• Published: Wuhan Huazhong University of Science and Technology 01.04.2017; Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China%Center for ADR Monitoring of Guangdong, Guangzhou 510000, China
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Child; Child, Preschool; China; Diterpenes - administration & dosage; Diterpenes - adverse effects; Drug Utilization; Female; Hospitals; Humans; Infant; Infant, Newborn; Injections; Male; Medicine; Medicine & Public Health; Medicine, Chinese Traditional; Middle Aged; Respiratory Tract Infections - drug therapy; Treatment Outcome; Young Adult; 中医; 临床应用; 总酯; 慢性阻塞性肺疾病; 注射液; 磺酸钠; 穿心莲内酯; 药物不良反应; clinical use; andrographolide total ester sulfonate; post-marketing reassessment; adverse reaction; hospital centralized monitoring
• ISSN: 1672-0733; 1993-1352; 1993-1352
• DOI: 10.1007/s11596-017-1730-z

Andrographolide total ester sulfonate（ATES） injection is one of the products of traditional Chinese medicine（TCM） currently used against viral infection in China.ATES injection was approved for manufacturing and marketing in January 2002.It is indicated for acute respiratory infections,tonsillitis,chronic obstructive pulmonary disease,influenza,foot and mouth disease,bronchiolitis,herpangina,mumps,infectious mononucleosis and psychosis.However,its usage also carries risk.We investigated the use of ATES at the Wuhan Union Hospital from January 2014 to December 2014 and evaluated its real-world clinical application using the hospital centralized monitoring method.A total of 848 cases were enrolled in this study.In these cases,it was mainly used for postoperative anti-inflammation and treating upper respiratory infection,pneumonia and bronchitis.Among them,39.86% were contraindicated.Irregular medication of adults and children accounted for 1.91% and 23.38%,respectively.Improper choice of solvent accounted for 3.18%.The choice of intravenous drip versus aerosol inhalation was reasonable.A case of adverse events（AEs） was observed in the monitoring period,and the incidence of adverse drug reaction（ADR） of ATES injection was 0.12%.ATES injection in our hospital is relatively safe with a low incidence of adverse reactions.The study assesses the clinical usage and adverse reactions of ATES injection,and provides suggestions for rational use in clinical practice.