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Polymorphism site genotype estimation depression, use and process of medicine effect and kit

A polymorphic site and genotype technology, applied in the field of medicine, can solve the problems of slow clinical onset of antidepressant drugs, backward diagnosis and treatment of depression, and lack of biological markers

Active Publication Date: 2009-01-07
深圳泰乐德医疗有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For a long time, the diagnosis and treatment of depression have almost entirely relied on the clinical experience of doctors, which is highly subjective and lacks objective biological markers, making the diagnosis and treatment of depression lag behind other physical diseases
At the same time, only about 1 / 2-2 / 3 of patients with conventional antidepressant treatment have clinical curative effect, and as low as 1 / 3-1 / 2 of patients who can achieve clinical remission, and the clinical onset of antidepressant drugs is slow, usually taking 4 -The antidepressant effect can be fully exerted after 6 weeks (Berman RM, Narasimhan M, Charney DS: Treatment-refractory depression: definitions and characteristics. Depress Anxiety.1997; 5: 154-164), and different patients use the same drug and its efficacy and Significant difference in side effects
These questions have long plagued clinicians

Method used

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  • Polymorphism site genotype estimation depression, use and process of medicine effect and kit
  • Polymorphism site genotype estimation depression, use and process of medicine effect and kit
  • Polymorphism site genotype estimation depression, use and process of medicine effect and kit

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Example 1 Determination of the effect of 5-HTT gene 13C / T polymorphism genotype in predicting the severity of depression

[0044] 1. Research objects

[0045] 1 Patient source:

[0046] Psychiatric or psychological outpatients in 12 psychiatric hospitals and general hospitals across the country.

[0047] 2 Inclusion criteria:

[0048] Male and female patients aged ≥18 years; diagnosed with major depressive disorder (major depressive disorder) according to the Diagnostic and Statistical Manual for Mental Disorders-IV (DSM-IV), without prior mania or a history of hypomanic episodes. Pure dysthymia was excluded; HAMD 17-item total score ≥16; patients must be able to cooperate with all study procedures, according to the investigator.

[0049] 3 Exclusion Criteria:

[0050] ●Past psychiatric history: 1) Other organic or drug-induced secondary depression or bipolar disorder cannot be excluded; 2) A history of severe suicidal tendencies, stupor, obsessive-compulsive disor...

Embodiment 2

[0118] Example 2 The relationship between fluoxetine drug efficacy and serotonin transporter gene polymorphism

[0119] a research object

[0120] 1 Patient source: see Example 1.

[0121] 2. Study drug: Fluoxetine, produced by Eli Lilly, USA, trade name Baiyoujie. Batch number: A022974, A042635, A057046, A060206, A077246), (1 tablet once a day, 20 mg each, 43 days in total), fixed dose.

[0122] 3Clinical research process:

[0123] (1) Research process: On the first day after screening, eligible patients completed the Hamilton Depression Scale and the Clinical Global Impression (CGI) assessment, completed the baseline assessment of the Treatment Emergent Side Effects (TESS) scale, and used diagnostic tests for genetic research ( DIGS) and epidemiological questionnaires; doctors instruct patients to take one tablet of fluoxetine (20 mg), and introduce the characteristics of drug treatment and common side effects to patients. Make an appointment for follow-up, instruct to f...

Embodiment 3

[0157] Example 3: Kit and method for implementing the same

[0158] The present embodiment exemplarily provides a kit for predicting the occurrence risk of depression, which is composed of the following components:

[0159] (1) Red blood cell lysate: containing NH4Cl, KHCO3, EDTA;

[0160] (2) Leukocyte Lysate: Contains Proteinase K (Sigma), RNase A (Promega), NaCl, 5×Tris, EDTA, SDS;

[0161] (3) Protein precipitation solution: 7.5M amine acetate (pH 7.4)

[0162] (4) Nucleic acid storage solution: 1M tris-hydrochloric acid (Tris-HCl, pH8.0);

[0163] (5) PCR reaction mixture: 1.0 ml [100 mM Tris-HCl, 100 mM KCl, pH 8.3 (20°C)]; 5.0 μM MgCl2 (Applied Biosystem); each 0.4 mM dATP, dCTP, dGTP, dTTP, sterile double Prepared by steaming 10 water, pH 7.0 (BioBasic Inc.); PCRP gene polymorphic site genotype detection primers (Shanghai Sangon Bioengineering Co., Ltd.);

[0164] (6) Taq DNA polymerase (Applied Biosystems) (5 U / μl): Storage buffer: 20 mM Tris-HCl (pH 8.0), 100 mM ...

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Abstract

The invention relates to a 5-HTT gene 13C / T polymorphism site genotype used for forecasting an individual depression sickness degree as well as the sickness degree of the core symptom of the depression, forecasting the effect of an antidepressant as well as the usage, the method and the reagent box of the effect of the antidepressant on the core symptom of the depression; wherein, when the 5-HTT gene 13C / T polymorphism site genotype is of 13TT homozygous type, the individual depression sickness degree and the sickness degree of the core symptom of the depression are forecasted to be more serious; the effect after taking the antidepressant is better; the effect of the antidepressant to the core symptom of the depression is better; when the 5-HTT gene 13C / T polymorphism site genotype is of 13CC homozygous type or 13CT heterozygote type, the individual depression sickness degree and the sickness degree of the core symptom of the depression are forecasted to be lighter; the effect after taking the antidepressant is poorer; the effect of the antidepressant to the core symptom of the depression is poorer.

Description

technical field [0001] The present invention relates to the use of the polymorphic site genotype of serotonin transporter (5-HTT) gene for predicting the prevalence of depression and the efficacy of antidepressants. The invention also relates to a method and kit for predicting the prevalence of depression and the efficacy of antidepressants by determining the genotype of the polymorphic site of the 5-HTT gene. The present invention belongs to the field of medicine. Background technique [0002] Depression (Major depression) is an affective disorder characterized by depression, anhedonia and loss of interest as the main manifestations and accompanied by other psychological and somatic symptoms. The clinical manifestations of depression vary greatly, and its main clinical manifestations can be divided into two categories: core symptoms and accompanying symptoms (psychological symptom group and somatic symptom group). The core symptoms of depression, including low mood or moo...

Claims

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Application Information

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IPC IPC(8): C12Q1/68G01N21/64G01N33/50
Inventor 刘平王玉于多王燕徐希平
Owner 深圳泰乐德医疗有限公司
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