基于自发呈报系统1500例桂枝茯苓胶囊不良反应特征及预警分析
|
摘要
为了解使用桂枝茯苓胶囊后患者不良反应发生特征并发现预警信号,对国家药品不良反应自发呈报系统2008—2017年桂枝茯苓胶囊ADR报告采用PRR法、BCPNN法及倾向性评分法进行分析。ADR报告数量逐年上升,到2014年第4季度达到最高峰。共监测到ADR 1 500例,其中严重ADR病例10例。发生ADR的患者年龄18～44岁最多,共934例,占62.27%。全部患者口服给药,1 398例患者单次剂量符合药品说明书,57.4%的患者ADR发生于开始用药24 h内。ADR临床表现前5位依次为胃功能紊乱、腹痛、恶心、呕吐、皮疹,损害涉及的系统主要为消化系统损害。对ADR信号进行分析,用PRR法提示"胃功能紊乱"和"腹痛"为桂枝茯苓胶囊的预警信号,用BCPNN法提示"恶心""腹痛"为桂枝茯苓胶囊的预警信号,采用倾向评分加权法对混杂因素进行控制后,预警信号不变。结果表明,桂枝茯苓胶囊不良反应发生较少,比较安全。该研究为桂枝茯苓胶囊ADR研究提供依据,可以为其药物警戒和风险管理提供指导。
To understand the characteristics of adverse reactions and find early warning signs after intake of Guizhi Fuling Capsules. The 1 500 adverse reaction(ADR) cases of Guizhi Fuling Capsules obtained by spontaneous reporting system(SRS) from 2008 to 2017 were analyzed by proportional reporting ratios method(PRR), Bayesian confidence propagation neural network method(BCPNN) and propensity score method. The number of ADR reports increased year by year, and reached the peak in the fourth quarter of 2014. A total of 1 500 ADR cases were monitored, including 10 severe ADR cases. There were a total of 934 cases aged between 18-44 years old, accounting for 62.27%. All patients were orally administered. Among them, 1 398 patients received a single dose according to the package insert, and 57.4% had ADR within 24 h. The top five clinical manifestations of ADR were gastric dysfunction, abdominal pain, nausea, vomiting and rash, which mainly damaged the digestive system. The ADR signals were analyzed. PRR suggested that "gastric dysfunction" and "abdominal pain" were the early warning signals of Guizhi Fuling Capsules. BCPNN suggested that "nausea" and "abdominal pain" were the early warning signals of Guizhi Fuling Capsules. After the propensity score weighting method was used to control the confounding factors, the warning signals remained unchanged. The results show that Guizhi Fuling Capsules has fewer adverse reactions and is relatively safe. This study provides a basis for studying ADR of Guizhi Fuling Capsules, and guidance for drug vigilance and risk management of Guizhi Fuling Capsules.
To understand the characteristics of adverse reactions and find early warning signs after intake of Guizhi Fuling Capsules. The 1 500 adverse reaction(ADR) cases of Guizhi Fuling Capsules obtained by spontaneous reporting system(SRS) from 2008 to 2017 were analyzed by proportional reporting ratios method(PRR), Bayesian confidence propagation neural network method(BCPNN) and propensity score method. The number of ADR reports increased year by year, and reached the peak in the fourth quarter of 2014. A total of 1 500 ADR cases were monitored, including 10 severe ADR cases. There were a total of 934 cases aged between 18-44 years old, accounting for 62.27%. All patients were orally administered. Among them, 1 398 patients received a single dose according to the package insert, and 57.4% had ADR within 24 h. The top five clinical manifestations of ADR were gastric dysfunction, abdominal pain, nausea, vomiting and rash, which mainly damaged the digestive system. The ADR signals were analyzed. PRR suggested that "gastric dysfunction" and "abdominal pain" were the early warning signals of Guizhi Fuling Capsules. BCPNN suggested that "nausea" and "abdominal pain" were the early warning signals of Guizhi Fuling Capsules. After the propensity score weighting method was used to control the confounding factors, the warning signals remained unchanged. The results show that Guizhi Fuling Capsules has fewer adverse reactions and is relatively safe. This study provides a basis for studying ADR of Guizhi Fuling Capsules, and guidance for drug vigilance and risk management of Guizhi Fuling Capsules.
引文
[1] 任经天,王胜锋,侯永芳,等.常用药品不良反应信号检测方法介绍[J].中国药物警戒,2011,8(5):294.
[2] 张玉珍.中医妇科学[M].北京:中国中医药出版社,2002.
[3] 古伟文,陈华.中药不良反应现状及原因概述[J].实用中医药杂志,2015,31(11):1084.
[4] 魏戌,谢雁鸣,王永炎.皮试试验与中药注射剂上市后临床安全性再评价[J].中国中药杂志,2011,36(20):2877.
[5] 管玫,陈泽莲,潘晓鸥,等.中成药药物不良反应的临床特征及发生的相关因素分析[J].中国药房,2004,15(7):44.
[6] 缪睿.我院2008—2015年妇科中成药不良反应报告分析[J].中国药房,2016,27(17):2355.
[7] 王桂倩,高阳,刘福梅,等.基于文献综述的桂枝茯苓胶囊上市后安全性研究[J].中国中药杂志,2018,43(4):820.
[8] 陶晓倩,李娜,曹亮,等. 桂枝茯苓胶囊中主要成分对人子宫肌瘤细胞增殖及小鼠离体子宫收缩活动的影响[J]. 中国实验方剂学杂志,2016,22(2):91.
[9] 蒋志滨,于蓓蓓,华浩明,等.桂枝茯苓胶囊联合米非司酮治疗子宫肌瘤疗效的Meta分析[J].中成药,2013,35(1):36.
[10] 宋俊生,高岑,熊俊,等.桂枝茯苓胶囊与西药治疗子宫肌瘤疗效比较的系统评价[J].中国循证医学杂志,2010,10(12):1439.
[11] 廖正根,平其能,萧伟,等.桂枝茯苓胶囊中有效成分的大鼠在体肠吸收研究[J].中国天然药物,2005,3(5):303.
[12] 韩丽,张玲非,贾春英,等.白芍总苷大鼠在体胃肠吸收动力学研究[J].中药药理与临床,2014,30(6):58.
[13] 朱克近,孙晓萍,常秀娟,等.桂枝茯苓胶囊主要效应成分在比格犬体内的药代动力学[J].中国中药杂志,2011,36(8):1015.
[14] 谢勇,范志平,施伽,等.苦杏仁苷的分析及生物功能研究进展[J].北方园艺,2017(6):190.
[15] 李骅,王四旺,张邦乐.丹皮酚的药理活性和药物动力学研究进展[J].亚太传统医药,2010,6(2):110.
[16] 钱维,叶小飞,王超,等.药品不良反应信号检测中混杂因素的控制方法[J].中国药物警戒,2010,7(3):142.
[17] 江静,侯永芳,刘秀娟,等.不同信号检测方法在我国药品不良反应自发呈报系统中的应用[J].中国药物警戒,2010,7(3):154.
[18] 王连心,谢雁鸣,艾青华,等.参麦注射液上市后临床安全性主动监测与被动监测大数据综合评估[J].中国中药杂志,2015,40(24):4752.
[19] 卢鹏飞,向永洋,谢雁鸣,等.基于自发呈报系统丹参多酚酸盐安全信号预警分析[J].中国中药杂志,2013,38(18):3003.
[20] 姜俊杰,廖星,谢雁鸣.疏血通注射液安全性证据体的构建[J].中国中药杂志,2014,39(18):3630.
[2] 张玉珍.中医妇科学[M].北京:中国中医药出版社,2002.
[3] 古伟文,陈华.中药不良反应现状及原因概述[J].实用中医药杂志,2015,31(11):1084.
[4] 魏戌,谢雁鸣,王永炎.皮试试验与中药注射剂上市后临床安全性再评价[J].中国中药杂志,2011,36(20):2877.
[5] 管玫,陈泽莲,潘晓鸥,等.中成药药物不良反应的临床特征及发生的相关因素分析[J].中国药房,2004,15(7):44.
[6] 缪睿.我院2008—2015年妇科中成药不良反应报告分析[J].中国药房,2016,27(17):2355.
[7] 王桂倩,高阳,刘福梅,等.基于文献综述的桂枝茯苓胶囊上市后安全性研究[J].中国中药杂志,2018,43(4):820.
[8] 陶晓倩,李娜,曹亮,等. 桂枝茯苓胶囊中主要成分对人子宫肌瘤细胞增殖及小鼠离体子宫收缩活动的影响[J]. 中国实验方剂学杂志,2016,22(2):91.
[9] 蒋志滨,于蓓蓓,华浩明,等.桂枝茯苓胶囊联合米非司酮治疗子宫肌瘤疗效的Meta分析[J].中成药,2013,35(1):36.
[10] 宋俊生,高岑,熊俊,等.桂枝茯苓胶囊与西药治疗子宫肌瘤疗效比较的系统评价[J].中国循证医学杂志,2010,10(12):1439.
[11] 廖正根,平其能,萧伟,等.桂枝茯苓胶囊中有效成分的大鼠在体肠吸收研究[J].中国天然药物,2005,3(5):303.
[12] 韩丽,张玲非,贾春英,等.白芍总苷大鼠在体胃肠吸收动力学研究[J].中药药理与临床,2014,30(6):58.
[13] 朱克近,孙晓萍,常秀娟,等.桂枝茯苓胶囊主要效应成分在比格犬体内的药代动力学[J].中国中药杂志,2011,36(8):1015.
[14] 谢勇,范志平,施伽,等.苦杏仁苷的分析及生物功能研究进展[J].北方园艺,2017(6):190.
[15] 李骅,王四旺,张邦乐.丹皮酚的药理活性和药物动力学研究进展[J].亚太传统医药,2010,6(2):110.
[16] 钱维,叶小飞,王超,等.药品不良反应信号检测中混杂因素的控制方法[J].中国药物警戒,2010,7(3):142.
[17] 江静,侯永芳,刘秀娟,等.不同信号检测方法在我国药品不良反应自发呈报系统中的应用[J].中国药物警戒,2010,7(3):154.
[18] 王连心,谢雁鸣,艾青华,等.参麦注射液上市后临床安全性主动监测与被动监测大数据综合评估[J].中国中药杂志,2015,40(24):4752.
[19] 卢鹏飞,向永洋,谢雁鸣,等.基于自发呈报系统丹参多酚酸盐安全信号预警分析[J].中国中药杂志,2013,38(18):3003.
[20] 姜俊杰,廖星,谢雁鸣.疏血通注射液安全性证据体的构建[J].中国中药杂志,2014,39(18):3630.