Study on Clinical Safety Monitoring of Yunnan Baiyao Capsule in Yunnan Area

OBJECTIVE Through the centralized monitoring of 1 875 patients using Yunnan Baiyao capsules in several hospitals in Yunnan, observe the incidence of adverse reactions of Yunnan Baiyao capsules under the real drug environment, and find unknown or rare adverse reactions. Improve the safety information of Yunnan Baiyao capsule in special populations(such as the elderly, chronic patients, etc.). To provide a scientific basis for the rational clinical use of Yunnan Baiyao capsules. METHODS During the monitoring period from June 2015 to December 2016, eleven hospitals in Yunnan Province were used as centralized monitoring points, the patients treated with Yunnan Baiyao capsule were taken as the research object, and the dosage regimen, according to the patients' condition, which was determined by the clinician responsible for the current monitoring. Information such as characteristics of adverse events, time of occurrence and disappearance, treatment measures, and outcomes were monitored and recorded. RESULTS Fifty two cases of adverse events were collected from 1 875 patients, four cases of which were finally identified as related to Yunnan Baiyao capsules. The incidence of adverse reactions in Yunnan Baiyao capsules combined with other drugs was 0.256%, which was occasional. New and serious adverse reactions were not found. CONCLUSION Yunnan Baiyao capsule has a wide range of ages for use and has little interaction with other drugs. It is safe to use according to the usage and dosage of the manual.