WITHDRAWN: Post-marketing Centralized Monitoring of clinical safety of Naoxintong Capsules in 7345 patients

Abstract Background: Naoxintong Capsules (NXT), a type of preparation for long-term oral administration in the clinic, is mainly used for preventing and treating cardiovascular and cerebrovascular diseases such as coronary heart disease, angina pectoris, and stroke. However, currently, there are no reliable clinical data on NXT safety assessment.Aim: To evaluate the frequency and categories of the adverse drug reaction (ADR) of NXT in clinical application in China and analyze the factors related to ADR incidence.Methods: A total of 7345 inpatients and outpatients from 14 hospitals in China who were orally administrated with NXT between January 2018 and December 2018 were followed up at least once. The monitored items mainly included gender, age, nationality, BMI, personal drug and food allergy history and family allergy history, patients' disease types, NXT medication, and the occurrence, characteristics, and recovery of ADR. Univariate and multivariate logistic regression were used to analyze the influencing factors of ADR.Results: The incidence of ADR was 3.44‰, and gastrointestinal system damage was the most common adverse reaction. All ADRs were mild or moderate. Most ADRs (86.36%) occurred within 4 weeks after administration, while in 81.82% of patients who continuously took NXT, ADRs improved or were fully resolved. There were no indicators related to the significant increase of ADR risk.Conclusion: NXT was well tolerated in the general population. The hospital centralized monitoring research method, which was established based on data from the Hospital Information System and Web-tracking follow-up system, is necessary to carry out the safety research study for post-marketing of traditional Chinese medicines.Trial registration: This protocol has international registration in the China Clinical Trials Registration Center through international registration (No. ChiCTR-OPC-17013912) on December 14, 2017.