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Method for evaluating disease treatment effect according to clinical symptom changes

A technology for disease treatment and clinical symptoms, applied in data processing applications, instruments, calculations, etc., can solve the problems that symptom research cannot be simply used for reference, and achieve the effects of high sensitivity, strong scientificity, and high statistical efficiency

Inactive Publication Date: 2015-07-01
JIANGXI HUIREN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Obviously, symptom research cannot simply learn from research methods similar to blood sugar and blood drug concentration

Method used

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  • Method for evaluating disease treatment effect according to clinical symptom changes
  • Method for evaluating disease treatment effect according to clinical symptom changes
  • Method for evaluating disease treatment effect according to clinical symptom changes

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] Efficacy evaluation of Ganshen'an Granules in the treatment of dry eyes in type 2 diabetes mellitus

[0060] 1. Experimental design: The study adopts a randomized, double-blind, parallel placebo-controlled (2:1), superiority test design.

[0061] 2. Study population: type 2 diabetic patients who meet the diagnostic criteria of liver and kidney yin deficiency.

[0062] 3. Grading and quantification of symptoms and signs and visual simulation standards

[0063] Refer to "Guidance for Industry Patient-Reported Outcome Measures: Use in Medical The Anchored or categorized Visual analog scale (Anchored or categorized Visual analog scale) method published in Product Development to Support Labeling Claims, the subject performs a visual analog scale on the target TCM syndrome, and the symptom disappearance standard is that the visual analog scale reaches 1 points or 0 points.

[0064] 4. Endpoint event of symptom measurement: disappearance of symptoms.

[0065] 5. Symptom Me...

Embodiment 2

[0082] Preliminary experiment on the curative effect evaluation of Liqi Nuanwei Granules in the treatment of epigastric distension and pain in patients with non-atrophic gastritis

[0083] 1. Experimental design: The study adopts a randomized, open, single-arm, multi-center clinical trial design.

[0084] 2. Study population: patients meeting the diagnostic criteria for non-atrophic gastritis.

[0085] 3. Grading and quantification of symptoms and signs and visual simulation standards

[0086] The subjects performed a visual analogue scale on the symptoms of epigastric distension and pain, and the criterion for the disappearance of symptoms was that the visual analogue scale reached 1 or 0.

[0087] 4. Symptom measurement endpoint event: epigastric distension and pain symptoms disappear.

[0088] 5. Symptom Measurement Data

[0089] The start time of the follow-up visit was after the treatment was enrolled in the group, and the end time of the follow-up visit was divided in...

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Abstract

The invention provides a method for evaluating disease treatment effect according to clinical symptom changes, applies to the field of human symptom measurement and evaluation, and specifically relates to the design principle of human symptom study, definition of symptom observing end events and composition and evaluation of human symptom data. The method is that time dimension data which can be accurately measured and evaluated are introduced and acquired according to the fuzz property of the human symptom strength data, and the survival analysis method is carried out to count and analyze the time data. The technology revolves the definition of the symptom observing end, the sandwich method design in symptom study and calculation of symptom removal (relieve) time of 50% of patients. With the adoption of the method, the problem of adaptability of most of principle of statistics in human symptom study at present can be solved; the method can be applied to the accurate evaluation for clinical treatment effect of expectant treatment medicines or treatment methods.

Description

technical field [0001] The invention relates to a method for evaluating the curative effect of disease treatment according to the change of clinical symptoms, which belongs to the field of human symptom research and symptomatic drug curative effect evaluation. It specifically involves the acquisition and measurement method of human medical symptom data; the statistical method of human medical symptom data. Background technique [0002] In 1965, Professor L.A. Zadeh, a famous American computer and control expert, proposed the fuzzy concept. He extended the general set theory to fuzzy set theory, which is to make the original clear idea that a set either "belongs" or "does not belong". The relationship is extended to the ambiguous relationship that the index belongs to a certain set according to a "certain degree" (such as any real number from 0 to 1), thus establishing the concept of fuzzy sets (Fuzzy Sets). The so-called "certain degree" refers to the membership function va...

Claims

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Application Information

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IPC IPC(8): G06Q50/22
Inventor 孙军蒋健周青罡梅玲华元唯安
Owner JIANGXI HUIREN PHARMA CO LTD
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