Safety analysis of Tenghuang Jiangu tablets (藤黄健骨片) in the treatment of knee osteoarthritis
10.3760/cma.j.cn114015-20221019-00964
- VernacularTitle:藤黄健骨片治疗膝骨关节炎的安全性分析
- Author:
Rui QUAN
1
;
Shuwen LI
;
Xisheng WENG
;
Na LI
;
Weiheng CHEN
Author Information
1. 北京中医药大学第三附属医院骨科，北京 100029
- Publication Type:Journal Article
- Keywords:
Safety;
Tenghuang Jiangu tablets;
Adverse drug events
- From:
Adverse Drug Reactions Journal
2023;25(5):276-280
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the safety of Tenghuang Jiangu tablets in the treatment of knee osteoarthritis. Methods:Medical records of knee arthritis patients who used Tenghuang Jiangu tablets in 43 hospitals from September 2019 to January 2021 were collected and the incidence, clinical manifestations, severity and outcome of adverse events were descriptively analyzed. Results:A total of 2 505 patients were entered in the analysis, including 788 males (31.46%) and 1 717 females (68.54%), with ages of 50-76 years and a median age of 61 years. The duration of medication was (57±3) days. Among the 2 505 patients, 1 949 cases (77.80%) received the drug twice daily, 553 (22.08%) thrice daily, and 3 (0.12%) once daily; 79(3.15%) patients developed 82 adverse events during Tenghuang Jiangu tablets treatment, including 39 cases of adverse events of digestive system (42 times), 8 cases of systemic adverse events, 6 cases of infectious adverse events, 6 cases of skin and mucous membrane adverse events, 5 cases of neurological adverse events, 4 cases of respiratory system adverse events, 3 cases of eye organ adverse events, 3 cases of cardiac organoid adverse events, 3 cases of injury adverse events, and 2 cases of reproductive system and breast adverse events. A causal evaluation was conducted on the above-mentioned adverse events, with only one case evaluated as possible and the rest as suspicious. Only one patient stopped using Tenghuang Jiangu tablets after an adverse event occurred, while the other patients did not stop the medication, and all patients returned to normal after untreated or symptomatic treatments. Conclusions:The incidence of adverse events in the treatment of knee osteoarthritis with Tenghuang Jiangu tablets is 3.15%. Common adverse events include digestive system adverse events, systemic adverse events, infectious adverse events, skin and mucous membrane adverse events, and neurological adverse events.
