12930例莫西沙星用药人群中肝损害及血细胞减少的多中心自动监测研究
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摘要
目的:获取莫西沙星致肝损害和血细胞减少相关数据;探讨实施多中心自动监测与评价的规律和相关因素;提供莫西沙星的安全性再评价参考依据。方法:由经过集训的哨点医院人员,按照"医疗机构ADE主动监测与智能评估警示系统"(ADE-ASAS)统一方案,开展住院患者莫西沙星相关"肝功能""血小板""血红蛋白""白细胞"回顾性自动监测。ADE-ASAS报警病例经临床药师人工再评价确定阳性病例后,进行汇总分析。结果:6所医院12 930例用药人群中,莫西沙星相关肝损害、血小板减少、白细胞减少、贫血的发生率分别为3. 88%,0. 49%,0. 95%,2. 21%。结论:专项软件ADE-ASAS可以高效、快捷、精准地获得多个哨点医院的莫西沙星相关ADR发生率。基于信息化技术的ADE-ASAS是开展重点药物风险监测研究,特别是多中心自动监测研究的有效工具。
Objective: To investigate and analyze the incidence of hepatic impairment and hypocytosis caused by moxifloxacin and finish automatic surveillance in 6 hospitals with inpatient's ADE active surveillance and assessment system( ADE-ASAS). Methods: The data of hospitalized patients using moxifloxacin in 6 hospitals were extracted and analyzed retrospectively. Event configuration parameters for"liver function","blood platelet","hemoglobin","white blood cell"were set according to the method in our hospital,and incidence of adverse drug reactions were analyzed. Results: A total of 12 930 cases using moxifloxacin were automatically observed. The incidence of hepatic impairment,thrombopenia,anemia and leukopenia in multi-center hospitals was respectively 3. 88%,0. 49%,2. 21% and 0. 95%. Conclusion: This study could use ADE-ASAS to quickly,accurately,and accurately obtain the incidence of ADR related moxifloxacin in 6 hospitals. The ADE-ASAS based on information technology was an effective tool for monitoring risk of key drug in multi-center hospitals.
Objective: To investigate and analyze the incidence of hepatic impairment and hypocytosis caused by moxifloxacin and finish automatic surveillance in 6 hospitals with inpatient's ADE active surveillance and assessment system( ADE-ASAS). Methods: The data of hospitalized patients using moxifloxacin in 6 hospitals were extracted and analyzed retrospectively. Event configuration parameters for"liver function","blood platelet","hemoglobin","white blood cell"were set according to the method in our hospital,and incidence of adverse drug reactions were analyzed. Results: A total of 12 930 cases using moxifloxacin were automatically observed. The incidence of hepatic impairment,thrombopenia,anemia and leukopenia in multi-center hospitals was respectively 3. 88%,0. 49%,2. 21% and 0. 95%. Conclusion: This study could use ADE-ASAS to quickly,accurately,and accurately obtain the incidence of ADR related moxifloxacin in 6 hospitals. The ADE-ASAS based on information technology was an effective tool for monitoring risk of key drug in multi-center hospitals.
引文
1陈超,郭代红,薛万国,等.住院患者药品不良事件主动监测与评估警示系统的研发[J].中国药物警戒,2013,10(7):411-414,418
2 王啸宇,郭代红,徐元杰.基于文本分类技术的住院患者药源性变态反应自动监测模块研究[J].中国药物应用与监测,2016,13(2):117-120
3 贾王平,郭代红,朱曼,等.莫西沙星相关性肝损害及血细胞减少的自动监测研究[J].中国药物应用与监测,2016,13(5):306-309
4 贾王平,郭代红,朱曼,等.左氧氟沙星相关性肝损害及血细胞减少的自动监测研究[J].药物流行病学杂志,2017,26(1):37-39
5 国家药品不良反应监测中心.药品不良反应术语使用指南[S].监测与评价综[2016]77号
6 郭代红,胡鹏洲,马亮,等.马来酸桂哌齐特关联性肝肾损害的自动监测研究[J].药物流行病学杂志,2017,26(1):33-36
7 胡鹏洲,马亮,郭代红,等. 3181例马来酸桂哌齐特注射液相关血细胞减少的自动监测研究[J].中国药物警戒,2016,13(12):745-747
8 寇炜,郭代红,赵博宇,等.国产与进口多西他赛致乳腺癌患者血系不良反应的自动监测研究[J].中国药物警戒,2017,14(12):755-759
9 王啸宇,郭代红,陈超,等.基于电子医疗档案的ADR自动监测规范化操作流程[J].中国药物应用与监测,2016,13(5):302-305
10 Tulkens PM,Arvis P,Kruesmann F. Moxifloxacin Safety:An Analysis of 14 Years of Clinical Data[J]. Drugs RD,2012,12(2):71-100
11 Moxifloxacin hydrochloride injection, solution[EB/OL].(2016-07-12)[2018-10-01]https:∥dailymed. nlm. nih.gov/dailymed/drugI nfo. cfm? setid=a4e28b09-714b-46e7-b4e6-0163cad78fc5
2 王啸宇,郭代红,徐元杰.基于文本分类技术的住院患者药源性变态反应自动监测模块研究[J].中国药物应用与监测,2016,13(2):117-120
3 贾王平,郭代红,朱曼,等.莫西沙星相关性肝损害及血细胞减少的自动监测研究[J].中国药物应用与监测,2016,13(5):306-309
4 贾王平,郭代红,朱曼,等.左氧氟沙星相关性肝损害及血细胞减少的自动监测研究[J].药物流行病学杂志,2017,26(1):37-39
5 国家药品不良反应监测中心.药品不良反应术语使用指南[S].监测与评价综[2016]77号
6 郭代红,胡鹏洲,马亮,等.马来酸桂哌齐特关联性肝肾损害的自动监测研究[J].药物流行病学杂志,2017,26(1):33-36
7 胡鹏洲,马亮,郭代红,等. 3181例马来酸桂哌齐特注射液相关血细胞减少的自动监测研究[J].中国药物警戒,2016,13(12):745-747
8 寇炜,郭代红,赵博宇,等.国产与进口多西他赛致乳腺癌患者血系不良反应的自动监测研究[J].中国药物警戒,2017,14(12):755-759
9 王啸宇,郭代红,陈超,等.基于电子医疗档案的ADR自动监测规范化操作流程[J].中国药物应用与监测,2016,13(5):302-305
10 Tulkens PM,Arvis P,Kruesmann F. Moxifloxacin Safety:An Analysis of 14 Years of Clinical Data[J]. Drugs RD,2012,12(2):71-100
11 Moxifloxacin hydrochloride injection, solution[EB/OL].(2016-07-12)[2018-10-01]https:∥dailymed. nlm. nih.gov/dailymed/drugI nfo. cfm? setid=a4e28b09-714b-46e7-b4e6-0163cad78fc5