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Plasma miRNA (micro Ribonucleic Acid) profile and assay kit for predicting curative effect of interferon on treatment of chronic hepatitis B

A technology for chronic hepatitis B and interferon, which is applied in the fields of molecular biology and medicine, can solve problems such as limited prediction ability, and achieve the effects of low cost, convenient detection method, and reduced treatment cost.

Inactive Publication Date: 2012-08-22
SHANGHAI PUBLIC HEALTH CLINICAL CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the predictive ability of current indicators is limited, and there is an urgent need for a molecular marker that can be detected in blood and has high predictive accuracy

Method used

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  • Plasma miRNA (micro Ribonucleic Acid) profile and assay kit for predicting curative effect of interferon on treatment of chronic hepatitis B
  • Plasma miRNA (micro Ribonucleic Acid) profile and assay kit for predicting curative effect of interferon on treatment of chronic hepatitis B
  • Plasma miRNA (micro Ribonucleic Acid) profile and assay kit for predicting curative effect of interferon on treatment of chronic hepatitis B

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1: Detection of miRNA expression profiles

[0026] 1. Experimental materials:

[0027] The invention obtains plasma and serum samples from 94 cases of chronic hepatitis B patients receiving long-acting interferon and common interferon. This study was approved by the Ethics Committee, and all patients signed informed consent. The training set included 66 HBV patients who received EG-IFN α2a (180μg / week) or PEG-IFN α2b (100μg / week), and the test set included 28 patients who received common interferon (IFN-α2b or IFN-α1b, 3-5MU / qod) HBV patients. The basic clinical data of the enrolled patients are shown in Table 1, 81.9% of them were positive for e antigen, and the average viral load was 7.05 log 10 copies / ml. Inclusion and exclusion criteria: The enrolled HBV patients had not received nucleoside analogs or interferon therapy 6 months before starting treatment, and the viral load was 5×10 4 copies / ml and above, abnormal liver alanine aminotransferase (>1...

Embodiment 2

[0043] Embodiment 2: Statistical analysis and establishment of forecasting model

[0044] 1. Test method:

[0045] Sorting of eigenvalues: the present invention uses the OneR method in the weka software package to sort miRNAs. The OneR method scores each feature by comparing the frequency table of feature values ​​and the correlation of treatment effects.

[0046] Support Vector Machine (SVM)

[0047] Support Vector Machine (SVM) is evolved from statistical learning algorithm and is one of the most effective methods among many complex binary classification algorithms. In this study, R software was used to train and test the SVM classification model.

[0048] The present invention uses a leave-one-out cross-validation method to evaluate the performance of the prediction model. In this method, each data is sequentially removed as test data for other data, and the prediction engine is trained through multiple detections. The final total forecast accuracy is calculated as f...

Embodiment 3

[0062] Example 3 Prediction of 28 samples receiving common interferon therapy

[0063] The present invention further tested whether the prediction model of these 11 miRNAs could effectively distinguish the initial virological response in a test set consisting of 28 patients. As shown in Table 1, the basic clinical data of the test set and the training set are similar, except that the patients in the test set received common interferon treatment. Since different interferon preparations will cause differences in the effective drug concentration in vivo, this may affect the performance of the prediction. Nevertheless, we still get an overall prediction accuracy of 71.4% on the training set.

[0064] Comparison of miRNA prediction models with known factors associated with efficacy

[0065] The present invention further carried out univariate and multivariate Logistic regression analysis to evaluate whether the miRNA model is an independent predictor related to curative effect...

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Abstract

The invention belongs to the fields of molecular biology and medicine, and provides a plasma miRNA (micro Ribonucleic Acid) profile and an assay kit for predicting the curative effect of interferon on treatment of chronic hepatitis B. The miRNA profile comprises one or more miRNAs in SEQ ID NO1-11. Meanwhile, the invention provides corresponding high-efficiency and low-cost kit, assay chip and assay method. According to the plasma miRNA profile and the assay kit, the miRNA level in plasma and serum is assayed; and the plasma miRNA profile and the assay kit are suitable for being applied to clinically judging the effectiveness of interferon treatment. Compared with other known curative effect related factors, the expression profile is an independent prediction factor. Higher prediction accuracy can be achieved by combining the prediction profile with the ALT (Alanine Aminotransferase) level of a patient before treatment. The development of a personalized treatment plan is facilitated by combining the expression profile with HBV (Hepatitis B Virus) medicine resistance mutation analysis; and finally, the treatment cost is reduced and the proportion of complete response is increased.

Description

technical field [0001] The present invention relates to the fields of molecular biology and medicine. More specifically, it involves plasma miRNA expression levels to predict the efficacy of interferon therapy for chronic hepatitis B. The present invention also relates to methods and kits for detecting miRNA levels. Background technique [0002] Hepatitis B virus (HBV) infection causes chronic liver disease and significantly increases the risk of hepatocellular carcinoma. Although HBsAg recombinant antigen vaccines have been widely used to prevent infection, HBV infection remains an important health problem in countries around the world. Interferon α and nucleoside analogs, such as lamivudine, adefovir, entecavir, telbivudine, etc., are the main drugs for the treatment of HBV infection. Interferon therapy can usually only achieve complete response in limited patients, and it is easy to relapse after discontinuation of treatment. In recent years, the application of pegyla...

Claims

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Application Information

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IPC IPC(8): C12N15/11C12Q1/68
Inventor 袁正宏张小楠邬敏陈良张继明张欣欣张占卿吴景迪王介非陈晓蓉黄涛
Owner SHANGHAI PUBLIC HEALTH CLINICAL CENT
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