Method and system for reevaluating safety of drug after appearance on market
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A safety and drug technology, applied in the direction of instruments, data processing applications, prediction, etc.
Inactive Publication Date: 2015-12-09
石庆平
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[0005] The purpose of the present invention is to provide a method and system for re-evaluating drug safety after marketing based on signal capture technology. The system uses computer software to capture sensitive signals in the process of medication in time, and can not only effectively overcome the problems caused by manual monitoring. The shortcomings of data omission, deviation and low work efficiency can also effectively reflect the real world of clinical application of drugs, and can also analyze and count various factors that affect the safety of clinical applications of drugs after they are marketed
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Embodiment 1
[0046] Example 1: Re-evaluation of the safety of salvianolate for injection after marketing
[0047] The specific methods and steps include:
[0048] (1) Determine the research drug: determine that the research drug of this project is salvianolate for injection, and conduct research on the relevant information of the instructions, its indications, usage and dosage, contraindications, adverse reactions, etc. The indications are: Promoting blood circulation, removing blood stasis, dredging the veins. It is used for stable angina pectoris of coronary heart disease, graded as grade Ⅰ or Ⅱ. The symptoms of angina pectoris are mild to moderate, and the TCM syndrome is heart-blood stagnation syndrome. Symptoms include chest pain, chest tightness, and palpitations.
[0049] (2) Set sensitive signal: According to the purpose of the study is to understand the influencing factors of clinical suspected anaphylaxis of salvianolate for injection, this study only needs to set a sensitive si...
Embodiment 2
[0057] Example 2: Using the drug safety re-evaluation system to conduct post-marketing safety re-evaluation of Shenmai Injection
[0058] The specific content and operation steps are as follows:
[0059] (1) Determine the research drug, set the sensitive signal, and determine the number of cases collected: the setting of the research drug and its sensitive signal is realized through the input module, and the execution steps are as follows:
[0060] ①Create a new Shenmai injection research project and create a directory of research documents;
[0061] ②Shenmai Injection is displayed as a new research project in the system, and the research drug information is saved. Enter the indications, contraindications, usage and dosage of the study, its sensitive signals, and the number of cases collected according to the instructions.
[0062] The relevant information set by Shenmai injection according to the instruction manual includes: indications, usage and dosage, contraindications, a...
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Abstract
The invention discloses a method and a system for reevaluating the safety of a drug after appearance on the market. The method comprises the following steps of: determining a studied drug; setting a sensitive signal; determining a case collection quantity; acquiring data and establishing a database; processing the data and carrying out data statistics; establishing a logistic model and determining associated risk factors; and predicting the safety for applying the drug to a patient. The system comprises: an input module; an output module; a storage module; a commonly-used drug database; an international disease classification standard database; a drug classification database; an adverse drug reaction term set database; a signal capture module; a data processing and statistic module; and a safety reevaluating module and a safety predicting module for the drug after appearance on the market. The method and the system can provide a basis for clinical rational drug administration and risk management after the drug appears on the market, can provide a scientific and reasonable analysis platform for establishing the safety evaluation after the drug appears on the market, and are reliable in principle, timely and accurate in data capture, flexible and convenient in application operation, and good in visibility.
Description
technical field [0001] The invention relates to a method and system for post-market drug safety re-evaluation research based on signal capture technology, so that the post-market drug safety re-evaluation research can effectively screen out various factors affecting drug safety. Background technique [0002] In the past hundred years, especially in recent years, a large number of drugs have been continuously launched on the market, which have played an important role in the process of human disease prevention, treatment, and protection of people's health. At the same time, people have gradually realized the harm caused by their adverse reactions to human beings. According to a study of 153 hospitals in the United States in 1998, it was pointed out that from 1966 to 1996, among hospitalized patients in the United States, the incidence of serious adverse drug reactions was 6.9%, and the resulting death rate was about 0.32%. Even if timely and appropriate medication was taken a...
Claims
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