摘要
目的通过对云南地区多家医院内使用云南白药胶囊的1875例患者集中监测,观察在真实用药环境下云南白药胶囊的不良反应发生率,发现未知或罕见不良反应,完善云南白药胶囊在特殊人群(如老人、慢性患者等)中的安全性信息,为云南白药胶囊临床合理使用提供科学依据。方法在监测期2015年6月—2016年12月,云南省内11家医院作为集中监测点,以接受云南白药胶囊治疗的患者为研究对象,给药方案由各医院负责本次监测的临床医师根据患者的病情制定。监测记录不良事件特征、发生时间、消失时间、处理措施及转归等信息。结果从1 875例用药患者中收集到52例不良事件,最终判定出4例不良反应与云南白药胶囊有关。云南白药与其他药物联合使用不良反应发生率为0.256%,属偶见。未发现新的和严重的不良反应。结论云南白药胶囊用药年龄覆盖范围广,与其他药物相互作用小,依据说明书用法用量进行使用安全性高。
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.
引文
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