Detection method of 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: 2022-04-01
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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  • Detection method of drug sex difference adverse reaction signal
  • Detection method of drug sex difference adverse reaction signal
  • Detection method of drug sex difference adverse reaction signal

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Data source: The data comes from the Adverse Drug Event (ADE) Reporting System (FDAAdverse 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.

[0037] The specific process is as follows:

[0038] 1. Data preprocessing

[0039] 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 and...

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Abstract

The invention discloses a detection method of a drug gender-differential adverse reaction signal: S1, data preprocessing: obtaining the drug adverse event report of the target drug from a known drug adverse event report database; S2, using the ROR algorithm to extract male and female patients The ADR signal of the target drug is calculated by dividing the ratio of the target adverse event to other adverse events in female patients with the target drug (a / b) by the ratio of the target adverse event to other adverse events in male patients with the target drug (c / d), and evaluating the occurrence of different genders The relative risk of the adverse event of the target drug; ROR value>1, women have a greater risk of the target adverse event; when 0 <ror<1则说明男性发生目标不良事件的风险更大；信号判断标准：女性目标药物‑不良事件数a>5. Number of male target drug-adverse events c>5, a+c>50; log 2 ROR>1 or log 2 ROR<‑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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Patent Type & Authority Patents(China)
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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