Safety evaluation on the clinical application of Tenghuangjiangu tablet for osteoarthritis: a hospital registration study

摘要

Highlights Tenghuangjiangu tablet is a Chinese medicinal formula preparation which no cutaneous anaphylaxis was found previously. In this paper, the author found two adverse reactions in combination therapy. The adverse reaction rate of the clinical application of Tenghuangjiangu tablet was 0.059%, belonged to the rare category. Abstract To evaluate the treatment safety of Tenghuangjiangu tablet on osteoarthritis, 3365 osteoarthritis patients whose prescription included Tenghuangjiangu tablet from 15 hospitals were involved in the prospective and multi-center clinical trial. Tenghuangjiangu tablet dosage was decided by instruction or doctors’ experience. The course of treatment and observation was 4 weeks. The adverse drug reactions were observed in the treatment process. Results showed male and female patients were 1018(30.25%) and 2347(69.75%), respectively, and 528 patients had allergic history. The patients’ average age was 58.30 ± 8.99 years, and the average disease course was 33.29 ± 37.40 months. The average score of WOMAC scale was 95.07 ± 42.42, which indicated the light conditions. 2275 patients were treated with combined drug regimen. There were two adverse drug reactions in this research. One reaction was skin rashes with itching and the interventions were stopped original drugs and give antianaphylactic treatment. The other reaction was stomach discomfort with disgusting and the intervention was stopped the original drugs temporarily, then continued to take two drugs after 3 days and the reaction didn’t appear. The accident rate of adverse drug reaction was 0.059%. The safety of Tenghuangjiangu tablet clinical application was good, and the mechanism of adverse drug reaction should be researched in-depth.