广东地区云南白药胶囊临床安全性集中监测研究
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摘要
目的:评价云南白药胶囊在上市后大规模真实临床使用过程中的群体安全性,考察单用云南白药胶囊及云南白药胶囊联合用药时可能会发生的不良反应及不良反应发生率。方法:采用多中心、大样本、巢式病例对照研究的方法,收集了2015年6月至2016年12月广东地区7家医院内服用云南白药胶囊的患者病例进行研究分析。结果:观察用药患者共1 338例,有合并用药患者393例,无合并用药患者914例。所有入组患者中,27例患者在研究期间发生不良事件,0例患者在研究期间发生不良反应。结论:在此次广东地区7家医院内云南白药胶囊的大规模临床安全性集中监测研究中,未发现患者服用云南白药胶囊后出现不良反应,说明在严格按照药品说明书的用法用量正常使用云南白药胶囊时,该药是安全可靠的。
Objective: To comprehensively evaluate the safety of Yunnan Baiyao capsules in the process of large-scale and real clinical use after it was marketed,and to investigate the adverse reactions and their incidence in clinical use of the capsules alone or in combination. Methods: All the patients treated with Yunnan Baiyao capsules in 7 hospitals of Guangdong province from June 2015 to December 2016 were analyzed in a multicenter,large sample,nested case-control study. Results: A total of 1 338 patients treated with Yunnan Baiyao capsules were collected. Among them,393 patients were treated in combination with other drugs,914 patients were treated with Yunnan Baiyao capsules alone. Among all the patients treated with Yunnan Baiyao capsules,adverse events occurred in 27 patients and no adverse reaction occurred during the study of period. Conclusion: No adverse reaction of Yunnan Baiyao capsules has been found in 7 contributed hospitals of Guangdong province during the whole period of the investigation. Thus,Yunnan Baiyao capsules are safe and reliable in clinical application when using the capsules in strict accordance with the usage and dosage of the drug instructions.
Objective: To comprehensively evaluate the safety of Yunnan Baiyao capsules in the process of large-scale and real clinical use after it was marketed,and to investigate the adverse reactions and their incidence in clinical use of the capsules alone or in combination. Methods: All the patients treated with Yunnan Baiyao capsules in 7 hospitals of Guangdong province from June 2015 to December 2016 were analyzed in a multicenter,large sample,nested case-control study. Results: A total of 1 338 patients treated with Yunnan Baiyao capsules were collected. Among them,393 patients were treated in combination with other drugs,914 patients were treated with Yunnan Baiyao capsules alone. Among all the patients treated with Yunnan Baiyao capsules,adverse events occurred in 27 patients and no adverse reaction occurred during the study of period. Conclusion: No adverse reaction of Yunnan Baiyao capsules has been found in 7 contributed hospitals of Guangdong province during the whole period of the investigation. Thus,Yunnan Baiyao capsules are safe and reliable in clinical application when using the capsules in strict accordance with the usage and dosage of the drug instructions.
引文
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[10]NARANJO CA,BUSTO U,SELLERS EM,et al.A method for estimating the probability of adverse drug reactions[J].Clin Pharmacol Ther,1981,30(2):239-245.
[2]张晓燕,梁素东,王淑英.艾灸法合用云南白药胶囊外敷治疗轻中度褥疮26例[J].中国民间疗法,2014,22(6):29.
[3]徐日升.云南白药治疗妇科疾病临床进展[J].中国中医急症,2008,17(5):683-684.
[4]王光强,严晟.云南白药胶囊用于整形术后面部肿胀的效果观察[J].新中医,2014,(4):104-106.
[5]李涛,张东敏,柳瑜.云南白药局部外敷辅助治疗下生殖道感染的疗效观察[J].科技风,2015(3):198.
[6]林利军,董敬艳,祁丽霞.云南白药胶囊在肛肠病术后的应用[J].中国肛肠病杂志,2009,29(3):45.
[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.
[10]NARANJO CA,BUSTO U,SELLERS EM,et al.A method for estimating the probability of adverse drug reactions[J].Clin Pharmacol Ther,1981,30(2):239-245.