| 引用本文: | 张琛,陈家星,马彬斌,代学忠,曹有良,孔庆利,张丽,刘春贵,艾呈斌,鲁保全,谢建忠,查天文,卫灿红,周葵,陈玉文,和文宇,张金凤,杨宁,王友芳,钱永生.云南地区云南白药胶囊临床安全性集中监测研究[J].中国现代应用药学,2019,36(3):353-359. |
| ZHANG Chen,CHEN Jiaxing,MA Binbin,DAI Xuezhong,CAO Youliang,KONG Qingli,ZHANG Li,LIU Chungui,AI Chengbin,LU Baoquan,XIE Jianzhong,ZHA Tianwen,WEI Canhong,ZHOU Kui,CHEN Yuwen,HE Wenyu,ZHANG Jinfeng,YANG Ning,WANG Youfang,QIAN Yongsheng.Study on Clinical Safety Monitoring of Yunnan Baiyao Capsule in Yunnan Area[J].Chin J Mod Appl Pharm(中国现代应用药学),2019,36(3):353-359. |
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| 云南地区云南白药胶囊临床安全性集中监测研究 |
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张琛1, 陈家星1, 马彬斌1, 代学忠2, 曹有良2, 孔庆利3, 张丽3, 刘春贵4, 艾呈斌4, 鲁保全5, 谢建忠5, 查天文6, 卫灿红6, 周葵6, 陈玉文7, 和文宇7, 张金凤8, 杨宁9, 王友芳10, 钱永生11
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1.玉溪市人民医院, 云南 玉溪 653100;2.云南省第三人民医院, 昆明 650011;3.楚雄彝族自治州人民医院, 云南 楚雄 675000;4.楚雄彝族自治州中医医院, 云南 楚雄 675000;5.西双版纳傣族自治州人民医院, 云南 西双版纳 666100;6.普洱市中医医院, 云南 普洱 665000;7.怒江州人民医院, 云南 怒江 673100;8.云南疼痛病医院, 昆明 650000;9.昆明市盘龙区人民医院, 昆明 650000;10.永善县中医医院, 云南 昭通 657300;11.禄劝忠爱医院, 昆明 651500
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| 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1 875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。 |
| 关键词: 云南白药胶囊 不良事件 不良反应 安全性 |
| DOI：10.13748/j.cnki.issn1007-7693.2019.03.020 |
| 分类号:R965.3 |
| 基金项目: |
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| Study on Clinical Safety Monitoring of Yunnan Baiyao Capsule in Yunnan Area |
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ZHANG Chen1, CHEN Jiaxing1, MA Binbin1, DAI Xuezhong2, CAO Youliang2, KONG Qingli3, ZHANG Li3, LIU Chungui4, AI Chengbin4, LU Baoquan5, XIE Jianzhong5, ZHA Tianwen6, WEI Canhong6, ZHOU Kui6, CHEN Yuwen7, HE Wenyu7, ZHANG Jinfeng8, YANG Ning9, WANG Youfang10, QIAN Yongsheng11
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1.People's Hospital of Yuxi City, Yuxi 653100, China;2.Yunnan Third People's Hospital, Kunming 650011, China;3.The People's Hospital of Chuxiong Yi Autonomous Prefecture, Chuxiong 675000, China;4.The Traditional Chinese Medicine of Chuxiong Yi Autonomous Prefecture Hospital, Chuxiong 675000, China;5.The People's Hospital of Xishuangbanna Dai Nationality Autonomous Prefecture, Xishuangbanna 666100, China;6.Pu'er City Traditional Chinese Medicine Hospital, Pu'er 665000, China;7.Nu River State People's Hospital, Nujiang 673100, China;8.Yunnan Pain Disease Hospital, Kunming 650000, China;9.Kunming Panlong District People's Hospital, Kunming 650000, China;10.Yongshan County Traditional Chinese Medicine Hospital, Zhaotong 657300, China;11.Luquan Love Hospital, Kunming 651500, China
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| Abstract: |
| 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. |
| Key words: Yunnan Baiyao capsule adverse event adverse reaction safety |
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