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Method for detecting anaphylactic reaction of traditional Chinese medicine injection

A detection method and anaphylaxis technology, applied in the field of drug evaluation, to achieve the effects of ensuring drug safety, promoting clinical rational use, and early warning of allergic reactions

Inactive Publication Date: 2019-05-21
天津中医药大学第二附属医院
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  • Abstract
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  • Application Information

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Problems solved by technology

However, there is currently no method to predict whether allergic reactions will occur after traditional Chinese medicine injections

Method used

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  • Method for detecting anaphylactic reaction of traditional Chinese medicine injection
  • Method for detecting anaphylactic reaction of traditional Chinese medicine injection

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] 1 Experimental design

[0014] A single center, open, stratified, controlled trial design was adopted.

[0015] The diagnostic test design is adopted, and the research process mainly includes two steps: skin test (including skin prick test and intradermal injection test) and challenge test (including subcutaneous injection and intravenous infusion test). For the basic ideas of experimental design, see figure 1 .

[0016] 2 subject selection

[0017] Male or female patients aged 18 to 70 were recruited and divided into four groups:

[0018] Unexposed group: never used any preparation containing the taste of the tested traditional Chinese medicine;

[0019] Exposure and non-allergic group: those who have used the medicinal preparation containing the tested traditional Chinese medicine and have no allergic reaction;

[0020] Exposure allergy group: those who have used the preparation of the tested traditional Chinese medicine and had allergic reactions;

[0021] Othe...

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Abstract

The invention provides a method for detecting anaphylactic reaction of a traditional Chinese medicine injection. According to the invention, the method comprises the following steps: determining whether the anaphylactic reaction is positive by a skin prick test, if the skin prick test is positive, performing a subcutaneous injection test, if the skin prick test continues to be positive, determining that the allergic reaction occurs, and if negative, determining that no allergic reaction is generated; if the skin prick test is negative, performing an intradermal injection test; if the intradermal injection test is positive, performing a subcutaneous injection test, if the skin prick test continues to be positive, determining that the allergic reaction occurs, and if negative, determining that no allergic reaction is generated; if the intradermal injection test is negative, performing a subcutaneous injection test, if it is positive, determining that the allergic reaction occurs, and ifit is negative, performing an intravenous infusion test, if the test result is positive, determining that the allergic reaction occurs, and if negative, determining that no allergic reaction is generated. The detection method can effectively predict the occurrence of the anaphylactic reaction of traditional Chinese medicine injections.

Description

technical field [0001] The invention relates to the technical field of drug evaluation, in particular to a method for detecting allergic reactions of traditional Chinese medicine injections. Background technique [0002] Traditional Chinese medicine injections are guided by the theory of traditional Chinese medicine, applying modern science and technology, extracting the effective substances of traditional Chinese medicine prescriptions or compound Chinese medicines, and making them into preparations that can be injected into the human body. Traditional Chinese medicine injections not only retain the traditional therapeutic advantages of traditional Chinese medicine, but also have the characteristics of rapid onset of Western medicine, and have been widely used in clinical practice. According to statistics, among the top 20 types of Chinese patent medicine purchases, there are 16 kinds of Chinese medicine injections, and the top 5 are all Chinese medicine injections. Today,...

Claims

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Application Information

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IPC IPC(8): A61K49/00
Inventor 黄宇虹李艳芬孙金霞吕春晓王保和米博李宏高铎王瑞华
Owner 天津中医药大学第二附属医院
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