A computerized system for detecting signals due to drug-drug interactions in spontaneous reporting systems
被引:34
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作者:
Qian, Yifeng
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Second Mil Med Univ, Dept Hlth Stat, Shanghai 200433, Peoples R ChinaSecond Mil Med Univ, Dept Hlth Stat, Shanghai 200433, Peoples R China
Qian, Yifeng
[1
]
Ye, Xiaofei
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Second Mil Med Univ, Dept Hlth Stat, Shanghai 200433, Peoples R ChinaSecond Mil Med Univ, Dept Hlth Stat, Shanghai 200433, Peoples R China
Ye, Xiaofei
[1
]
Du, Wenmin
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机构:
Adverse Drug React Monitoring Ctr Shanghai, Shanghai, Peoples R ChinaSecond Mil Med Univ, Dept Hlth Stat, Shanghai 200433, Peoples R China
Du, Wenmin
[2
]
Ren, Jingtian
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机构:
SFDA Natl Ctr ADR Monitoring, Ctr Drug Reevaluat, Beijing, Peoples R ChinaSecond Mil Med Univ, Dept Hlth Stat, Shanghai 200433, Peoples R China
Ren, Jingtian
[3
]
Sun, Yalin
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Second Mil Med Univ, Dept Hlth Stat, Shanghai 200433, Peoples R ChinaSecond Mil Med Univ, Dept Hlth Stat, Shanghai 200433, Peoples R China
Sun, Yalin
[1
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Wang, Hainan
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Second Mil Med Univ, Dept Hlth Stat, Shanghai 200433, Peoples R China
State Food & Drug Adm, Ctr Drug Evaluat, Beijing, Peoples R ChinaSecond Mil Med Univ, Dept Hlth Stat, Shanghai 200433, Peoples R China
Wang, Hainan
[1
,4
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Luo, Baozhang
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Second Mil Med Univ, Dept Hlth Stat, Shanghai 200433, Peoples R ChinaSecond Mil Med Univ, Dept Hlth Stat, Shanghai 200433, Peoples R China
Luo, Baozhang
[1
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Gao, Qingbin
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Second Mil Med Univ, Dept Hlth Stat, Shanghai 200433, Peoples R ChinaSecond Mil Med Univ, Dept Hlth Stat, Shanghai 200433, Peoples R China
Gao, Qingbin
[1
]
Wu, Meijing
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Second Mil Med Univ, Dept Hlth Stat, Shanghai 200433, Peoples R ChinaSecond Mil Med Univ, Dept Hlth Stat, Shanghai 200433, Peoples R China
Wu, Meijing
[1
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He, Jia
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Second Mil Med Univ, Dept Hlth Stat, Shanghai 200433, Peoples R ChinaSecond Mil Med Univ, Dept Hlth Stat, Shanghai 200433, Peoples R China
He, Jia
[1
]
机构:
[1] Second Mil Med Univ, Dept Hlth Stat, Shanghai 200433, Peoples R China
[2] Adverse Drug React Monitoring Ctr Shanghai, Shanghai, Peoples R China
[3] SFDA Natl Ctr ADR Monitoring, Ctr Drug Reevaluat, Beijing, Peoples R China
[4] State Food & Drug Adm, Ctr Drug Evaluat, Beijing, Peoples R China
adverse drug reaction;
drug-drug interactions;
signal detection;
CONCOMITANT USE;
DATABASE;
DISPROPORTIONALITY;
PHARMACOVIGILANCE;
EVENTS;
CHINA;
D O I:
10.1111/j.1365-2125.2009.03557.x
中图分类号:
R9 [药学];
学科分类号:
1007 ;
摘要:
AIMS In spontaneous reporting systems (SRS), there is a growing need for the automated detection of adverse drug reactions (ADRs) resulting form drug-drug interactions. In addition, special attention is also needed for systems facilitating automated data preprocessing. In our study, we set up a computerized system to signal possible drug-drug interactions by which data acquisition and signal detection could be carried out automatically and the process of data preprocessing could also be facilitated. METHODS This system was developed with Microsoft Visual Basic 6.0 and Microsoft Access was used as the database. Crude ADR reports submitted to Shanghai SRS from January 2007 to December 2008 were included in this study. The logistic regression method, the Q shrinkage measure method, an additive model and a multiplicative model were used for automatic detection of drug-drug interactions where two drugs were used concomitantly. RESULTS A total of 33 897 crude ADR reports were acquired from the SRS automatically. The 10 drug combinations most frequently reported were found and the 10 most suspicious drug-drug ADR combinations for each method were detected automatically after the performance of the system. CONCLUSIONS Since the detection of drug-drug interaction depends upon the skills and memory of the professionals involved, is time consuming and the number of reports is increasing, this system might be a promising tool for the automated detection of possible drug-drug interactions in SRS.
机构:
Univ Utah, Sch Med, Div Infect Dis, Salt Lake City, UT USA
CSC, Salt Lake City, UT USAUniv Utah, Sch Med, Div Infect Dis, Salt Lake City, UT USA
Classen, David C.
Phansalkar, Shobha
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机构:
Brigham & Womens Hosp, Div Gen Med & Primary Care, Boston, MA 02115 USA
Harvard Univ, Sch Med, Boston, MA USA
Partners HealthCare Syst, Wellesley, MA USAUniv Utah, Sch Med, Div Infect Dis, Salt Lake City, UT USA
Phansalkar, Shobha
Bates, David W.
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机构:
Brigham & Womens Hosp, Div Gen Med & Primary Care, Boston, MA 02115 USA
Harvard Univ, Sch Med, Boston, MA USA
Partners HealthCare Syst, Wellesley, MA USAUniv Utah, Sch Med, Div Infect Dis, Salt Lake City, UT USA
机构:
Univ Florida Lake Nona, Ctr Pharmacometr & Syst Pharmacol, Coll Pharm, Orlando, FL 32827 USAUniv Florida Lake Nona, Ctr Pharmacometr & Syst Pharmacol, Coll Pharm, Orlando, FL 32827 USA
Lagishetty, Chakradhar V.
Deng, Jiexin
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机构:
Univ Florida Lake Nona, Ctr Pharmacometr & Syst Pharmacol, Coll Pharm, Orlando, FL 32827 USAUniv Florida Lake Nona, Ctr Pharmacometr & Syst Pharmacol, Coll Pharm, Orlando, FL 32827 USA
Deng, Jiexin
Lesko, Lawrence J.
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机构:
Univ Florida Lake Nona, Ctr Pharmacometr & Syst Pharmacol, Coll Pharm, Orlando, FL 32827 USA
Amer Coll Clin Pharmacol FCP, Ashburn, VA USAUniv Florida Lake Nona, Ctr Pharmacometr & Syst Pharmacol, Coll Pharm, Orlando, FL 32827 USA
Lesko, Lawrence J.
Rogers, Hobart
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机构:
US FDA, FDA Genom & Targeted Therapy Grp, Off Clin Pharmacol, Off Translat Sci,CDER, Silver Spring, MD USAUniv Florida Lake Nona, Ctr Pharmacometr & Syst Pharmacol, Coll Pharm, Orlando, FL 32827 USA
Rogers, Hobart
Pacanowski, Michael
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US FDA, FDA Genom & Targeted Therapy Grp, Off Clin Pharmacol, Off Translat Sci,CDER, Silver Spring, MD USAUniv Florida Lake Nona, Ctr Pharmacometr & Syst Pharmacol, Coll Pharm, Orlando, FL 32827 USA
Pacanowski, Michael
Schmidt, Stephan
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机构:
Univ Florida Lake Nona, Ctr Pharmacometr & Syst Pharmacol, Coll Pharm, Orlando, FL 32827 USAUniv Florida Lake Nona, Ctr Pharmacometr & Syst Pharmacol, Coll Pharm, Orlando, FL 32827 USA