河北地区云南白药胶囊多中心临床安全性集中监测研究
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摘要
目的全面评估云南白药胶囊在真实临床使用过程中的不良反应。方法采用巢式病例对照研究法,以集中监测中出现不良反应的患者为"病例",以未发生不良反应的患者为"对照"。选择2015年6月至2016年12月河北地区5家医院接受云南白药胶囊治疗的患者1 072例作为集中监测对象。结果研究期间有34例患者发生不良事件,无与云南白药胶囊有关的不良反应。结论云南白药胶囊临床应用疗效良好,安全性较高,且不良反应极少,值得临床推广。
Objective To evaluate the adverse reactions of Yunnan Baiyao Capsules in real clinical use. Methods Nested case-control study method was adopted,patients with adverse reactions in centralized monitoring were taken as ″case of illness″,and those without adverse reactions were taken as ″controls″. From June 2015 to December 2016,1 072 patients treated with Yunnan Baiyao Capsule in5 hospitals in Hebei Province were selected as the subjects of centralized monitoring. Results During the study period,34 patients had adverse events,and there were no adverse reactions associated with Yunnan Baiyao Capsules. Conclusion Yunnan Baiyao Capsules have good clinical efficacy,high safety and few adverse reactions,which are worthy of clinical promotion.
Objective To evaluate the adverse reactions of Yunnan Baiyao Capsules in real clinical use. Methods Nested case-control study method was adopted,patients with adverse reactions in centralized monitoring were taken as ″case of illness″,and those without adverse reactions were taken as ″controls″. From June 2015 to December 2016,1 072 patients treated with Yunnan Baiyao Capsule in5 hospitals in Hebei Province were selected as the subjects of centralized monitoring. Results During the study period,34 patients had adverse events,and there were no adverse reactions associated with Yunnan Baiyao Capsules. Conclusion Yunnan Baiyao Capsules have good clinical efficacy,high safety and few adverse reactions,which are worthy of clinical promotion.
引文
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[15]沈庆梅.合理应用中成药确保临床用药安全[J].今日健康,2016,15(11):328.
[2]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):1358-1359.
[3]向明,叶韶勤,陈牡蓉.云南白药胶囊用于小儿过敏性紫癜伴消化道出血的临床研究[J].江西医药,2016,51(4):352-353.
[4]李艳.云南白药胶囊治疗牙周炎牙龈出血的临床分析[J].深圳中西医结合杂志,2015,25(6):79-78.
[5]马广昊.针刺放血结合云南白药外敷治疗急性期带状疱疹30例[J].针灸临床杂志,2015,31(6):4-6.
[6]赵文珍,刁娜,谷艺修,等.云南白药辅助治疗溃疡性结肠炎的开放随机对照研究[J].南方医科大学学报,2016,36(9):1186-1191.
[7]胡倩倩.云南白药联合宫颈环形电切术治疗慢性宫颈炎82例[J].河南中医,2015,35(4):859-861.
[8]吴征,曹干生,李曙波.云南白药胶囊在骨伤科中的应用[J].湖北中医杂志,2005(10):47.
[9]刘晓宁,王晓梅,宋海霞.云南白药的临床应用现状[J].中国中医急症,2009,18(9):1504-1505.
[10]连素萍,庞立杰.云南白药的临床应用进展[J].临床医药实践杂志,2007(S4):1203-1205.
[11]安蓉.合理运用中成药确保临床用药安全[J].中国实用医药,2015,10(29):265-266.
[12]李长英,雷招宝.云南白药致不良反应/不良事件38例文献分析[J].中国药房,2013,24(40):3817-3819.
[13]韩晓东.云南白药胶囊口服引起过敏休克1例[J].中医药应用与监测,2008,5(1):31
[14]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):984-986.
[15]沈庆梅.合理应用中成药确保临床用药安全[J].今日健康,2016,15(11):328.