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Application method of traditional Chinese medicine composition and clinical model establishing method

A technology for model building and application methods, used in drug reference, alternative medicine, electronic clinical trials, etc.

Pending Publication Date: 2021-12-10
SHANTOU CITY SIJI PHARMA
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Problems solved by technology

[0005] Although the above scheme solves the problem of depression treatment, the therapeutic mechanism of Chinese medicine composition is the unique theoretical system of "integral concept syndrome differentiation and treatment" of traditional Chinese medicine, which cannot be explained according to contemporary scientific biopharmaceuticals and chemical pharmaceuticals, so it is urgent A clinical trial model needs to be constructed to prove the safety and medicinal properties of the composition

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  • Application method of traditional Chinese medicine composition and clinical model establishing method
  • Application method of traditional Chinese medicine composition and clinical model establishing method
  • Application method of traditional Chinese medicine composition and clinical model establishing method

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Experimental program
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Embodiment Construction

[0032] The following is further described in detail through specific implementation methods:

[0033] The specific implementation process is as follows: the application method of the traditional Chinese medicine composition and the establishment method of the clinical model, according to "taking placebo as a parallel control, further evaluating the efficacy and safety of Shenwei Ningyu Tablets in the treatment of depression (qi and yin deficiency syndrome)" Randomized, double-blind single-simulation, multi-center clinical trial" protocol was written after statistical analysis of the research data after the database was locked.

[0034] 1. Statistical Analysis Datasets

[0035] All indicators are analyzed by PPS and FAS at the same time

[0036] Full analysis data set: a collection of all cases that were randomized and used the study drug at least once.

[0037] Per-protocol data set: A data set generated by subjects who fully complied with the trial protocol, including the t...

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Abstract

The invention discloses an application method of a traditional Chinese medicine composition and a clinical model establishment method in the field of medical pharmacy, and aims to overcome the difficulty in reduction of a theoretical system of a treatment mechanism of the traditional Chinese medicine composition for supporting the traditional Chinese medicine composition in the prior art, namely treatment based on syndrome differentiation of holistic concept. According to the defects which cannot be explained by current scientific biological pharmacy and chemical pharmacy, the composition is applied to a receptor TLR4 signal channel and a brain signal transduction channel radiation range of channel radiation to generate a model group, a baseline serves as a boundary of the model group, and difference data between treatment endpoint remission rate and endpoint response rate groups are filled into parameters in the model group. According to the technical scheme, the composition is applied to divided receptors, compared with analysis of effective components of a mixture by existing drug avoidance; meanwhile, the drug effect principle is explained through bioengineering, and the therapeutic dose of the optimal area is determined.

Description

technical field [0001] The invention belongs to the field of medical pharmacy, in particular to an application method of a traditional Chinese medicine composition and a method for establishing a clinical model. Background technique [0002] Depression, as a common mental disorder, has caused a heavy burden on human society. The efficacy and acceptability of current first-line antidepressants are not ideal. [0003] A depressive disorder characterized by a combination of symptoms such as low mood, loss of interest or pleasure, guilt, low self-worth, disturbed sleep or appetite, tiredness, and difficulty concentrating, which seriously interfere with an individual's ability to study, work, or cope with daily life ability, which in the most severe cases can lead to suicide. According to the 2013 global burden of disease statistics published by The Lancet, mental illness accounts for 22.8% of the global burden of disease. Among them, depression, driven by population growth an...

Claims

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Application Information

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IPC IPC(8): G16H20/90G16H70/40G16H10/20G16H50/70
CPCG16H20/90G16H70/40G16H10/20G16H50/70
Inventor 曾美桦
Owner SHANTOU CITY SIJI PHARMA
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