云南地区云南白药胶囊临床安全性集中监测研究
|
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.
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
[1]王婷安,禹正杨.云南白药临床应用新进展[J].现代医药卫生,2012,28(9):1358.
[2]FAN C,SONG J,WHITE C M.A comparision of the hemost-atic effects of notoginseng and yun nan bai yao to placebocontrol[J].J Herb Pharmacother,2005,5(2):1.
[3]LI R,ALEX P,YE M,et al.An old herbal medicine with apotentially new therapeutic application in inflammatorybowel disease[J].Int J Clin Exp Med,2011,4(4):309.
[4]LIU X S,GUAN X B,CHEN R Y,et al.Repurposing of yunnanbaiyao as an alternative therapy for minor recurrent aphthous stomatitis[J].Evid Based Complement Alternat Med,2012:284620.
[5]郭兵,黄河涛,刘俊,等.云南白药胶囊和活血止痛胶囊治疗软组织损伤200例疗效成本分析[J].中国医药指南,2014,12(6):177-178.
[6]张梦,樊光辉,张宜,等.云南白药在创伤中的新应用[J].中国药房,2014,25(23):2194-2196.
[7]段晓丽.云南白药药理学探讨[J].中华临床医学卫生杂志,2005,3(11):76-77.
[8]卢祺炯,夏丽娟,闫俊岭,等.云南白药的一般药理学研究[J].中华中医药学刊,2014,32(8):1879-1881.
[9]国家基本药物临床应用指南编委会.国家基本药物临床应用指南(中成药)2009年版基层部分[M].北京:人民卫生出版社,2010:151-155.
[10]卫生部.国家基本药物目录:2012年版[S].2013.
[11]国家食品药品监督管理局药品安全监管司,国家药品不良反应监测中心.药品不良反应报告和监测工作手册[S].2005:46-47.
[12]NARANJO C A,BUSTO U,SELLERS E M,et al.A method for estimating the probability of adverse drug reactions[J].Clin Pharmacol Ther,1981,30(2):239-245.
[13]CIOMS.1990 CIOMS criteria of drug-induced liver disorders.Report of International consensus[J].J Hepaol,1990,11(2):272-276.
[14]袁青,秦小容.云南白药胶囊治疗膝关节骨性关节炎行膝关节镜术后疼痛和肿胀的疗效观察[J].湖北中医药大学学报,2016,18(1):94-96.
[15]赵常军,贾东岗,雷招宝.“超说明书用药”的现状、危害性及对策[J].医学理论与实践,2012,25(8):984.
[2]FAN C,SONG J,WHITE C M.A comparision of the hemost-atic effects of notoginseng and yun nan bai yao to placebocontrol[J].J Herb Pharmacother,2005,5(2):1.
[3]LI R,ALEX P,YE M,et al.An old herbal medicine with apotentially new therapeutic application in inflammatorybowel disease[J].Int J Clin Exp Med,2011,4(4):309.
[4]LIU X S,GUAN X B,CHEN R Y,et al.Repurposing of yunnanbaiyao as an alternative therapy for minor recurrent aphthous stomatitis[J].Evid Based Complement Alternat Med,2012:284620.
[5]郭兵,黄河涛,刘俊,等.云南白药胶囊和活血止痛胶囊治疗软组织损伤200例疗效成本分析[J].中国医药指南,2014,12(6):177-178.
[6]张梦,樊光辉,张宜,等.云南白药在创伤中的新应用[J].中国药房,2014,25(23):2194-2196.
[7]段晓丽.云南白药药理学探讨[J].中华临床医学卫生杂志,2005,3(11):76-77.
[8]卢祺炯,夏丽娟,闫俊岭,等.云南白药的一般药理学研究[J].中华中医药学刊,2014,32(8):1879-1881.
[9]国家基本药物临床应用指南编委会.国家基本药物临床应用指南(中成药)2009年版基层部分[M].北京:人民卫生出版社,2010:151-155.
[10]卫生部.国家基本药物目录:2012年版[S].2013.
[11]国家食品药品监督管理局药品安全监管司,国家药品不良反应监测中心.药品不良反应报告和监测工作手册[S].2005:46-47.
[12]NARANJO C A,BUSTO U,SELLERS E M,et al.A method for estimating the probability of adverse drug reactions[J].Clin Pharmacol Ther,1981,30(2):239-245.
[13]CIOMS.1990 CIOMS criteria of drug-induced liver disorders.Report of International consensus[J].J Hepaol,1990,11(2):272-276.
[14]袁青,秦小容.云南白药胶囊治疗膝关节骨性关节炎行膝关节镜术后疼痛和肿胀的疗效观察[J].湖北中医药大学学报,2016,18(1):94-96.
[15]赵常军,贾东岗,雷招宝.“超说明书用药”的现状、危害性及对策[J].医学理论与实践,2012,25(8):984.