Method for detecting drug sex difference adverse reaction signal

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...

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

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