Clinical centralized safety monitoring and evaluation of traditional Chinese medicine formula granules.
10.19540/j.cnki.cjcmm.20230423.501
- Author:
Cheng-Feng WU
1
;
Jia-Bao LIAO
1
;
Dan LI
1
;
Mao-Lin YANG
2
;
Qiu-Zhen CHEN
2
;
Zhong-Qi YANG
3
Author Information
1. China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. Shenzhen 518110, China China Resources Sanjiu Modern Chinese Medicine Pharmaceutical Co., Ltd. Huizhou 516000, China.
2. Guangzhou Evidence-based Medicine Tech Co., Ltd. Guangzhou 510060, China.
3. the First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou 510407, China.
- Publication Type:Journal Article
- Keywords:
centralized safety monitoring;
medication analysis;
traditional Chinese medicine formula granules
- MeSH:
Humans;
Medicine, Chinese Traditional/adverse effects*;
Drugs, Chinese Herbal/adverse effects*;
Prospective Studies;
Drug-Related Side Effects and Adverse Reactions/epidemiology*;
China
- From:
China Journal of Chinese Materia Medica
2023;48(15):4231-4236
- CountryChina
- Language:Chinese
-
Abstract:
Traditional Chinese medicine(TCM) formula granules are highly praised for the advanced, convenient, and modern use of Chinese medicinal materials. The safety of TCM formula granules has long been a concern of regulatory authorities and the medical industry. A multi-center, prospective, open, non-interventional, and centralized monitoring was carried out for the patients treated with TCM formula granules in 252 medical institutions from February 5, 2020 to April 19, 2022. All the case data and the incidence of adverse drug reactions/events were recorded. This study evaluated the safety of TCM formula granules, aiming to provide a reference for the clinically use. A total of 20 547 patients were included in this study. Four adverse events were recorded, including 3 adverse drug reactions with an adverse drug reaction rate of 0.015%, all of which occurred in the digestive system. There was no serious adverse event, and no factors related to adverse drug reactions/events were identified. The incidence of adverse drug reactions/events associated with China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. TCM formula granules was rare, which proved their safety in clinical use. A comprehensive data mining and objective analysis was carried out for the medicines with high frequency in TCM formula granules, the commonly used medicine pairs and combinations, and departmental medication. The drug use characteristics, prescription rules, and departmental use of TCM formula granules were summarized, which can shed light on the prescription compatibility and clinical application.
