黑龙江地区云南白药胶囊临床安全性集中监测统计与分析
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摘要
目的探讨云南白药胶囊不良反应发生的影响因素,促进临床合理用药。方法采用巢式病例对照研究法,以集中监测中出现严重不良反应的患者作为病例,以未发生不良反应的患者为对照,收集其临床资料及其他特征,进行对照研究。结果收集的906例服用云南白药胶囊的病例中,出现不良反应1例,发生率为0. 11%。结论云南白药胶囊在合并用药的情况下,临床大样本集中监测发现未知或罕见不良反应极少且临床症状轻微。
Objective To investigate the influencing factors of adverse drug reactions caused by Yunnan Baiyao Capsules and to promote rational drug use in clinic. Methods Nested case-control study was adopted to collect clinical data and other characteristics of patients for case-control study by taking the patients with severe adverse reactions during centralized monitoring as ″cases″ and the patients without adverse reactions during centralized monitoring as ″controls″. Results Among 906 patients treated with Yunnan Baiyao Capsules,1 case had adverse reactions,the incidence rate was 0. 11%. Conclusion In the cases of Yunnan Baiyao Capsules combined with the other drugs,the centralized monitoring of large clinical samples shows that unknown or rare adverse drug reactions were very few and the clinical symptoms were mild.
Objective To investigate the influencing factors of adverse drug reactions caused by Yunnan Baiyao Capsules and to promote rational drug use in clinic. Methods Nested case-control study was adopted to collect clinical data and other characteristics of patients for case-control study by taking the patients with severe adverse reactions during centralized monitoring as ″cases″ and the patients without adverse reactions during centralized monitoring as ″controls″. Results Among 906 patients treated with Yunnan Baiyao Capsules,1 case had adverse reactions,the incidence rate was 0. 11%. Conclusion In the cases of Yunnan Baiyao Capsules combined with the other drugs,the centralized monitoring of large clinical samples shows that unknown or rare adverse drug reactions were very few and the clinical symptoms were mild.
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):1358-1359.
[2]杨琦,赵靖松,杨凯.云南白药联合锡类散保留灌肠治疗溃疡性结肠炎的疗效观察[J].中国实用医药,2011,6(25):156-157.
[3]谢莉,苏振福,刘新,等.云南白药胶囊致剥脱性皮炎1例[J].中国中医眼科杂志,2002,12(3):174.
[4]张强,渠立振,刘鹏,等.云南白药胶囊促进骨折愈合的临床研究[J].中国医药指南,2013,11(36):214-215.
[5]宫斌,刘春元,魏洪昌,等.云南白药止血及活血作用的药理研究[J].四川生理科学杂志,1988(4):50.
[6]陶娜,杨幼林.云南白药治疗溃疡性结肠炎的临床应用及作用机制研究概述[J].中国中医药科技,2011,18(6):544-545.
[7]纪英.云南白药胶囊治疗外科整形术后面部肿胀56例[J].中国药业,2013,22(16):105-106.
[8]孙丽娜.云南白药胶囊治疗慢性宫颈炎的疗效及护理观察[J].中国临床研究,2015,7(33):79-80.
[9]张娅娣.云南白药治疗腹部手术切口脂肪液化的疗效观察[J].吉林医学,2013,34(31):6531-6532.
[10]宋向奎.急诊消化内科上消化道出血治疗研究[J].中外医疗,2015,34(26):17-18.
[11]鲁子龙.云南白药治疗上消化道出血的临床效果观察[J].临床合理用药杂志,2016,9(8):46-47.
[12]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.
[13]寇秋爱,赵素萍,冯国双,等.中药上市后安全性再评价方法探讨[J].中国中药杂志,2011,36(20):2771-2775.
[14]张冰,吴嘉瑞.关于中药注射剂安全性问题的思考[J].临床药物治疗杂志,2006,4(6):14-18.
[15]谭乐俊,王萌,朱彦.中药注射剂的不良反应研究进展[J].中国中药杂志,2014,39(20):3889-3898.
[2]杨琦,赵靖松,杨凯.云南白药联合锡类散保留灌肠治疗溃疡性结肠炎的疗效观察[J].中国实用医药,2011,6(25):156-157.
[3]谢莉,苏振福,刘新,等.云南白药胶囊致剥脱性皮炎1例[J].中国中医眼科杂志,2002,12(3):174.
[4]张强,渠立振,刘鹏,等.云南白药胶囊促进骨折愈合的临床研究[J].中国医药指南,2013,11(36):214-215.
[5]宫斌,刘春元,魏洪昌,等.云南白药止血及活血作用的药理研究[J].四川生理科学杂志,1988(4):50.
[6]陶娜,杨幼林.云南白药治疗溃疡性结肠炎的临床应用及作用机制研究概述[J].中国中医药科技,2011,18(6):544-545.
[7]纪英.云南白药胶囊治疗外科整形术后面部肿胀56例[J].中国药业,2013,22(16):105-106.
[8]孙丽娜.云南白药胶囊治疗慢性宫颈炎的疗效及护理观察[J].中国临床研究,2015,7(33):79-80.
[9]张娅娣.云南白药治疗腹部手术切口脂肪液化的疗效观察[J].吉林医学,2013,34(31):6531-6532.
[10]宋向奎.急诊消化内科上消化道出血治疗研究[J].中外医疗,2015,34(26):17-18.
[11]鲁子龙.云南白药治疗上消化道出血的临床效果观察[J].临床合理用药杂志,2016,9(8):46-47.
[12]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.
[13]寇秋爱,赵素萍,冯国双,等.中药上市后安全性再评价方法探讨[J].中国中药杂志,2011,36(20):2771-2775.
[14]张冰,吴嘉瑞.关于中药注射剂安全性问题的思考[J].临床药物治疗杂志,2006,4(6):14-18.
[15]谭乐俊,王萌,朱彦.中药注射剂的不良反应研究进展[J].中国中药杂志,2014,39(20):3889-3898.