title: Clinical application analysis of andrographolide total ester sulfonate injection, a traditional Chinese medicine licensed in China.
abstract: 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.
authors.affiliation: Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Zhao
authors.affiliation: Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.
authors.forename: Pu
authors.initials: P
authors.lastname: Huang
authors.affiliation: Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.
authors.forename: Zhe
authors.initials: Z
authors.lastname: Chen
authors.affiliation: Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.
authors.forename: Si-Wei
authors.initials: SW
authors.lastname: Zheng
authors.affiliation: Center for ADR Monitoring of Guangdong, Guangzhou, 510000, China.
authors.forename: Jin-Yang
authors.initials: JY
authors.lastname: Yu
authors.affiliation: Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China. 29136909@qq.com.
authors.forename: Chen
authors.initials: C
authors.lastname: Shi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D002681:China; D004224:Diterpenes / Q000008:administration & dosage* / Q000009:adverse effects; D004363:Drug Utilization; D005260:Female; D006761:Hospitals; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007267:Injections; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004224:Diterpenes; C030419:andrographolide
keywords: adverse reaction; andrographolide total ester sulfonate; clinical use; hospital centralized monitoring; post-marketing reassessment