CN101231284A

CN101231284A - Urea kit for diagnosing pylorus helicobacterium infestation

Info

Publication number: CN101231284A
Application number: CNA200710073017XA
Authority: CN
Inventors: 张厚德; 黄晋杰; 金桂花
Original assignee: Individual
Current assignee: Zhang Houde
Priority date: 2007-01-23
Filing date: 2007-01-23
Publication date: 2008-07-30
Anticipated expiration: 2027-01-23
Also published as: CN101231284B

Abstract

The invention relates to a medical chemical reagent, in particular to a urea reagent box which uses <13>C-UBT (Urea Breath Test) to diagnose helicobacter pylori (Hp) infection, and the reagent box comprises a urea<13>C reagent with a certain dosage, a conduit used for huffing, a CO2 collecting bag and also comprises a sensitizer, wherein, the urea<13>C reagent in each dosage contains 15 to 25 mg of urea<13>C, or the richness of the <13>C in each dosage urea<13>C is 40 to 90 percent, the contained quantity of the urea<13>C is equal to 15 to 25mg of urea<13>C with 99 percent of <13>C richness. The urea reagent box of the invention comprises the sensitizer, reduces the false rate, and ensures that the detection result also can be ensured through using the urea<13>C reagent with small dosage or using the urea<13>C reagent with lower <13>C richness, thereby effectively reducing the cost of the reagent.

Description

The urea kit of diagnosing helicobacter pylori infection

Technical field

The present invention relates to Iatrochemistry reagent, more particularly, relate to use ¹³C-UBT (Urea BreathTest, urea breath test) comes diagnosing helicobacter pylori (Helicobacter pylori, Hp) kit of Gan Raning.

Background technology

Be used to detect UBT that helicobacter pylori (Hp) infects with its no pain, no wound, accurate, quick, safe characteristics, be widely used in clinical.The UBT of present clinical use is divided into ¹⁴C-UBT and ¹³Two kinds of C-UBT.Wherein, ¹⁴C-UBT has radioactivity, is not suitable for persons under inspection such as pregnant woman and children. ¹³What adopt among the C-UBT is stable isotope ¹³C does not have radioactivity, adds that urea also is the normal composition of human body, so be applicable to the person under inspection of institute's has age and type.But, implement ¹³The cost of C-UBT is higher, has limited ¹³The widespread use of C-UBT.

Urea [ ¹³C] the reagent cost height is ¹³The high main cause of the cost of C-UBT it.The urea of present clinical use [ ¹³C] in the reagent, ¹³C abundance height (generally being 99%), the dosage of use big (being generally 75mg) causes reagent cost higher, thereby has influenced ¹³C-UBT is extensive use of.

In addition, upper gastrointestinal bleeding, use antiacid, anti-Hp medicine patient in the recent period, this part patient's false determination ratio is than higher.The accuracy rate that how to improve this part patient is further to improve the key of overall accuracy.

Summary of the invention

The objective of the invention is to, guaranteeing to detect under the prerequisite of effect, reduce ¹³The cost of C-UBT; It is right to reduce simultaneously ¹³C-UBT is to the patient's of particular subject such as recent use antiacid, anti-Hp medicine false determination ratio.

The present invention realizes goal of the invention like this: a kind of urea kit of diagnosing helicobacter pylori infection is provided, comprise certain formulation urea [ ¹³C] reagent, the conduit of air blowing usefulness is characterized in that, CO ₂Collecting bag also comprises sensitizer.

At the urea kit of diagnosing helicobacter pylori infection of the present invention, described sensitizer comprises any one or the combination in any in citric acid, malic acid, ascorbic acid, the tartrate.

At the urea kit of diagnosing helicobacter pylori infection of the present invention, every dose of described sensitizer contains citric acid 1～5 gram.

At the urea kit of diagnosing helicobacter pylori infection of the present invention, every dose of urea [ ¹³C] contain in the reagent 15～25 milligrams of urea [ ¹³C].

At the urea kit of diagnosing helicobacter pylori infection of the present invention, every dose of urea [ ¹³C] in the reagent ¹³The C abundance is 40%～90%, wherein contained urea [ ¹³C] amount be equivalent to 15～25 milligrams ¹³The C abundance be 99% urea [ ¹³C].

Comprise sensitizer in the urea kit of diagnosing helicobacter pylori infection of the present invention, can improve and pass through ¹³The accuracy of C-UBT diagnosing helicobacter pylori infection and susceptibility reduce false determination ratio, guaranteed to use low dose of urea [ ¹³C] reagent or use lower ¹³The urea of C abundance [ ¹³C] reagent also can guarantee testing result.Thereby reduced the cost of reagent effectively.

Embodiment

Embodiment 1

1, experimental subjects: volunteer 30 people, these 30 volunteers are all greater than 18 years old.Wherein the male sex is 15, and the age is 19～65 years old, average 37 years old; 15 of women, 20～53 years old age, average 33 years old.

2, experimental technique:

(1), at first the volunteer is carried out gastroscope, extract biopsy specimen then, biopsy specimen is carried out conventional pathology test and urease test.

(2), the sensitizer of potion is made into the solution of 100ml, use the solution that is made into take the urea of potion [ ¹³C] capsule, observe pathology, urease and ¹³The result of C-UBT.

Described sensitizer principal ingredient is a citric acid, and every dose of sensitizer contains citric acid 5 grams.Every dose of urea [ ¹³C] in the capsule ¹³The C abundance is 99%, wherein contain urea [ ¹³C] 17 milligrams, be lower than conventional content.

(3), use CO ₂Collecting bag is collected the gas that the volunteer breathes out.Method is earlier air-breathing deeply, continuous call gas afterwards, exhalation process roughly is divided into two parts, does not collect the gas that forward part is breathed out in the present embodiment, only collects the gas of breathing out in the rear section, this be for the gas that guarantees to collect be gas in the alveolar.

3, experimental result

Experimental result such as following table, wherein, "+" ecbatic is positive, and "-" ecbatic is negative.

Table 1: the test findings of biopsy specimen pathology, urease and UBT-13

4, conclusion

From table 1, can see, sensitizer auxiliary down, adopt be lower than conventional urea [ ¹³C] content ¹³The C-UBT test findings is quite accurately, satisfies clinical requirement.

Need to prove that sensitizer can comprise any one or the combination in any in citric acid, malic acid, ascorbic acid, the tartrate.Can also in sensitizer, add sweeteners such as Aspartame, acesulfame potassium, improve the mouthfeel of sensitizer.

Embodiment two

The experimental procedure of the experimental procedure of present embodiment and a last embodiment is roughly the same, and different places are: in the present embodiment, urea [ ¹³C] in the capsule ¹³The C abundance is not 99% of a routine, but 45%.In addition, every dose of urea [ ¹³C] the contained urea of capsule [ ¹³C] amount, be equivalent to 15～25 milligrams ¹³The C abundance be 99% urea [ ¹³C].

Experimental result shows, under the effect of sensitizer, adopts ¹³The C abundance is 45% ¹³The C-UBT test findings is quite accurately, satisfies clinical requirement. ¹³The C abundance be 45% urea [ ¹³C] preparation cost far below ¹³The C abundance be 99% urea [ ¹³C], thus the cost of reagent reduced.What illustrate is exactly, every dose of urea [ ¹³C] the contained urea of capsule [ ¹³C] amount, preferably be equivalent to 15～75 milligrams ¹³The C abundance be 99% urea [ ¹³C].

Embodiment three

Present embodiment is selected upper gastrointestinal bleeding, is used the volunteer of antiacid, anti-Hp medicine in the recent period.At first the volunteer is carried out gastroscope, extract biopsy specimen then, biopsy specimen is carried out conventional pathology test and urease test.

Then, the volunteer is carried out conventional ¹³C-UBT test (below be called for the first time ¹³The C-UBT test).Sensitizer is not taken in current test.

Conventional ¹³After the C-UBT test, volunteer's fasting 6 hours.Then the volunteer is carried out the second time ¹³The C-UBT test.In the current test, experimental procedure, urea [ ¹³C] reagent, urea [ ¹³C] use amount and above-mentioned first time of reagent ¹³The C-UBT test is identical; Different places are, allow the experimenter take sensitizer in the current test.

The result shows, for the first time ¹³Certain False Rate has appearred among the C-UBT.And for the second time ¹³False Rate does not appear in C-UBT.

Experiment shows, adopts kit of the present invention, every dose of urea [ ¹³C] contain in the reagent 15～25 milligrams of urea [ ¹³C] just can satisfy the requirement of clinical testing; Perhaps, adopt ¹³The C abundance be 40%～90% urea [ ¹³C] reagent, suitably increase the urea amount in every dose of reagent, make every dose of urea [ ¹³C] urea in the reagent [ ¹³C] content between 15 to 75 milligrams, also can satisfy the requirement of clinical testing.In addition, kit of the present invention also has lower False Rate.

Claims

1. the urea kit of a diagnosing helicobacter pylori infection, comprise certain formulation urea [ ¹³C] reagent, the conduit of air blowing usefulness, CO ₂Collecting bag is characterized in that, also comprises sensitizer.

2. urea kit according to claim 1 is characterized in that, described sensitizer comprises any one or the combination in any in citric acid, malic acid, ascorbic acid, the tartrate.

3. urea kit according to claim 1 is characterized in that, every dose of described sensitizer contains citric acid 1～5 gram.

4. according to any described urea kit in the claim 1 to 3, it is characterized in that, every dose of urea [ ¹³C] contain in the reagent 15～25 milligrams of urea [ ¹³C].

5. according to any described urea kit in the claim 1 to 4, it is characterized in that, every dose of urea [ ¹³C] in the reagent ¹³The C abundance is 40%～90%, wherein contained urea [ ¹³C] amount be equivalent to 15～25 milligrams ¹³The C abundance be 99% urea [ ¹³C].