Method for detecting drug sex difference adverse reaction signal

A detection method and adverse reaction technology, applied in drug reference, informatics, medical informatics, etc., can solve problems such as difficulty in mining ADR gender differences, lack of female subjects, etc.

Active Publication Date: 2021-01-05
CHONGQING MEDICAL UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the lack of data on female subjects in most drug clinical trials, it is difficult to mine the gender differences in ADR.
There is currently no data mining research involving gender differences in ADR signals of ACEI drugs

Method used

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  • Method for detecting drug sex difference adverse reaction signal
  • Method for detecting drug sex difference adverse reaction signal
  • Method for detecting drug sex difference adverse reaction signal

Examples

Experimental program
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Effect test

Embodiment 1

[0035] Data source: The data comes from the Adverse Drug Event (ADE) Reporting System (FDA Adverse Event Reporting System, FAERS) database established by the US Food and Drug Administration (Food and Drug Administration, FDA). The database uses the preferred terms (PreferredTerms, PT) of the "ICH International Medical Dictionary for Regulatory Activities (MedDRA)" (MedDRA) to encode and count ADR, and the raw data are structured. This application included the FAERS database from January 1, 2004 to December 31, 2018 for mining ADR signals involving five ACEI antihypertensive drugs.

[0036] The specific process is as follows:

[0037] 1. Data preprocessing

[0038] Using the OpenVigilFDA analysis tool, the site analysis tool directly obtains the original information in the OpenVigilFDA database through the application program interface API, and performs structured processing, with high extraction efficiency and accuracy. Obtain captopril, benazepril, enalapril, perindopril an...

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PUM

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Abstract

The invention discloses a method for detecting a drug sex difference adverse reaction signal. The method comprises the following steps: S1, data preprocessing: obtaining a drug adverse event report ofa target drug from a known drug adverse event report database; S2, extracting ADR signals of the male and female patients by adopting an ROR algorithm, calculating a ratio a / b of a target adverse event to other adverse reaction events in the female patients of the target drug, dividing the ratio a / b by a ratio c / d of a target adverse event to other adverse reaction events in the male patients ofthe target drug, and evaluating the relative risk degree of occurrence of the adverse event of the target drug in different genders; if the ROR value is greater than 1, judging that the risk that thefemale has the target adverse event is greater; and if the ROR is greater than 0 and less than 1, judging that the risk that the male has the target adverse event is greater, signal judgment standardsare as follows: the number a of female target drug adverse events is greater than 5, the number c of male target drug adverse events is greater than 5, and a+c is greater than 50, and the log2ROR isgreater than 1 or the log2ROR is less than -1.

Description

technical field [0001] The invention relates to the technical field of drug safety data mining, in particular to a detection method for a drug gender-differentiated adverse reaction signal. Background technique [0002] Angiotensin-Converting Enzyme Inhibitor (ACEI), a compound that inhibits the activity of angiotensin-converting enzyme, is a class of antihypertensive drugs widely used clinically, also known as prix-type antihypertensive drugs . Its mechanism of action is to reduce the synthesis of angiotensin II by inhibiting angiotensin-converting enzyme, thereby inhibiting vascular tension and lowering blood pressure. Although this type of drug has a good antihypertensive effect and can improve heart function and blood flow to a certain extent, the incidence of side effects is still high during drug treatment, especially adverse drug reactions caused by the treatment of cardiology diseases (Adverse Drug Reaction, ADR) is particularly serious, and some even lead to the d...

Claims

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Application Information

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IPC IPC(8): G16H50/20G16H50/70G16H70/40
CPCG16H50/20G16H50/70G16H70/40
Inventor 赵文龙谈军涛
Owner CHONGQING MEDICAL UNIVERSITY
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