CN107260128B - Olfactory disorder detection kit and application thereof - Google Patents
Olfactory disorder detection kit and application thereof Download PDFInfo
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- CN107260128B CN107260128B CN201710442680.6A CN201710442680A CN107260128B CN 107260128 B CN107260128 B CN 107260128B CN 201710442680 A CN201710442680 A CN 201710442680A CN 107260128 B CN107260128 B CN 107260128B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/40—Detecting, measuring or recording for evaluating the nervous system
- A61B5/4005—Detecting, measuring or recording for evaluating the nervous system for evaluating the sensory system
- A61B5/4011—Evaluating olfaction, i.e. sense of smell
Abstract
The invention relates to the field of detection kits, and discloses an olfactory disorder detection kit and application thereof. The kit of the invention comprises one or more solid odor blocks consisting of a solid phase solvent, a vehicle and an odor fragrance; the solid phase solvent is a solvent which is solid at normal temperature and liquid after being heated and can dissolve the essence. The kit adopts the solid material as the odor carrier and is matched with the specific essence components, thereby avoiding the liquid reagent similar to the Sniffin's Sticks and five-flavor odor testing liquid method, reducing the risks of scattering, container damage, environmental pollution and volatilization of the liquid, simultaneously ensuring that the solid odor block has better olfaction test effect, having more excellent performance indexes compared with the similar B-SIT method, being particularly suitable for Chinese people, and being applied to auxiliary diagnosis of the Parkinson's disease and preparation of related detection products.
Description
Technical Field
The invention relates to the field of detection kits, and particularly relates to a smell disorder detection kit and application thereof.
Background
Parkinson's Disease (PD) and Alzheimer's Disease (AD) are common chronic progressive neurological diseases in the elderly. The clinical characteristics of the Parkinson's disease are that the Parkinson's disease is mainly characterized by motor symptoms (resting tremor, bradykinesia and muscular rigidity), and a large number of non-motor symptoms (hyposmia, constipation, depression and sleep disorder) and later complicated symptoms (such as balance disorder, falling, freezing phenomenon, dysphagia, language disorder and the like) are accompanied before and after the motor symptoms appear. Alzheimer's disease (commonly known as senile dementia) is mainly manifested by cognitive dysfunction and memory impairment, and clinical manifestations of olfactory disorders related to cognitive decline can also appear in the early stage of the disease, namely Mild Cognitive Impairment (MCI).
With the acceleration of population aging, PD and AD have become major health, economic and social problems faced by our country currently and even decades from now on. Investigation shows that the prevalence rate of PD in the population over 60 years old is about 1.7-2%, and the prevalence rate of AD is about 3-7%, and nearly 50% of PD and AD patients all over the world are in China due to the large population base of China. For example only in parkinson's disease: studies speculate that more than 500 million PD patients will be present in china in 2030, accounting for approximately 57% of the total number of patients worldwide. Because the disease course of PD is long, the pathological changes are progressive, no effective method for inhibiting the disease progress exists, the disability rate is high, a large number of patients in middle and late stages exist, the treatment effect is poor, the treatment cost is high, and heavy mental and economic burdens are brought to families and society.
Many studies find that the marked hyposmia appears 4 years before the onset of the Parkinson disease, and the risk of the Parkinson disease of normal old people with hyposmia increases by about 5 times within 4 years, wherein 10 percent of the old people with hyposmia can develop into the Parkinson disease patients within 2 years. Therefore, hyposmia is considered to be an important symptom in preclinical stages of parkinson's disease. The Society of International dyskinesia (MDS) has listed hyposmia in diagnostic criteria for Parkinson's disease from 2015, and has also pointed out early warning value of hyposmia in the research criteria for the pre-stage of Parkinson's disease, so that olfactory examination is not only important for accurate diagnosis of Parkinson's disease patients, but also can help to screen high-risk population of early-stage Parkinson's disease in healthy elderly.
Mild cognitive impairment in the elderly (MCI) is a clinical manifestation, an intermediate transitional state between normal aging and Alzheimer's Disease (AD), an early stage of AD. MCI patients develop AD at a rate of 10% to l 5% per year, which is 10 times the probability of normal elderly to develop AD. Until now, because there is no effective treatment for AD, studies of MCI at this particular stage have helped to identify the high risk population for dementia, finding the best intervention time for senile dementia. In recent years, there has been increasing evidence that olfactory disorders are closely related to AD and may be one of the earliest symptoms. The olfactory center is located in the temporal lobe, amygdala and piriformis cortex (including the anterior part of the hippocampus, hamate and cortex in its vicinity), which is the area where pathological changes occur early in AD. The researchers suggested that olfaction disorder is one of the indicators for early diagnosis of MCI and AD. The general research at home and abroad considers that the olfactory disorder exists in the early stage of AD, the degree of the olfactory disorder is proportional to the severity of dementia along with the progressive disease course, and part of the research considers that the olfactory pathway can become a drug delivery pathway for effectively controlling and treating AD/MCI. Therefore, olfactory examination has important diagnosis and screening value for early stage of Alzheimer's disease, namely MCI stage.
The olfactory detection methods of Parkinson's disease and Alzheimer's disease are relatively limited, and the foreign methods mainly comprise an UPSIT method and a Sniffin ' Sticks olfactory stick method. The former mainly adopts an odor nano coating, releases odor by scratching the coating with a pencil, and can be used for testing the olfactory recognition capability. The method is basically simple and easy to operate, and patients can perform self-evaluation, so that the method is widely applied to clinical and community population olfactory examination of Parkinson's disease and Alzheimer's disease by countries in the world. UPSIT has 40 kinds of odors, and its simplified version B-SIT has 12 kinds of odors. However, the UPSIT method is still lack of research reports in Chinese population, and the Caoming team in the Xuanwu Hospital has used the method to perform olfaction tests on Parkinson's disease patients in Chinese population, wherein part of odors are not familiar to the elderly people in China, such as: pizza flavor, chocolate flavor, etc., and the sensitivity index of the method is not ideal. The sniffing stick method of Sniffin' Sticks comprises three tests of an olfactory recognition threshold, an olfactory detection threshold and an olfactory discrimination threshold, so that the olfactory function can be completely evaluated. However, the test tool of the method is large in size, and the test is in a liquid reagent form, so that the method is not convenient to carry and store. Moreover, the test process requires professional personnel to guide the use of the test subject, and the test subject cannot evaluate the test subject by himself, so that the test process is not favorable for wide-scale screening work.
The 'five-flavor olfactory examination liquid' method developed by the semiconductor research institute of Chinese academy of sciences in China is proved to be applicable to olfactory examination of patients with Parkinson's disease and Alzheimer's disease through clinical research, but the method has some defects, such as: the smell test solution is bottled by glass, is easy to damage and is not easy to carry; the smell has certain volatility and is inconvenient to store; only 5 selected odors were tested and none of the selections passed the population familiarity survey at the beginning; the determination of the normal value range only aims at the research data determination of the young people of 18-25 years old, and the olfactory function of the normal old people is not set. Therefore, a smell detection tool which can be familiar to Chinese people, is simple and convenient to operate, convenient to store and easy to carry and aims at patients with Parkinson's disease and Alzheimer's disease is lacking in China.
Disclosure of Invention
In view of the above, the present invention provides an olfactory disorder detection kit for assisting in diagnosing parkinson's disease and alzheimer's disease, which is simple and convenient to operate, easy to carry, and less prone to volatilization and deterioration, and has good olfactory testing effects, such as odor release effect, detection sensitivity, detection specificity, shelf life, and the like.
In order to achieve the above purpose, the invention provides the following technical scheme:
a kit for detecting olfactory disorder comprises one or more solid odor blocks composed of a solid phase solvent, a vehicle and an odorant; the solid phase solvent is a solvent which is solid at normal temperature and liquid after being heated and can dissolve the essence. Wherein the solid phase solvent is preferably solid at normal temperature and becomes liquid by heating at 80 ℃; the non-solid phase solvent refers to a solvent which is liquid at normal temperature or is solid after being heated (such as 80 ℃) and does not meet the requirement of the invention, so the expected purpose of the invention can not be achieved.
Aiming at the problem that the existing olfactory disorder detection products for assisting in diagnosing the Parkinson's disease and the Alzheimer's disease are all liquid products, the invention adopts a solid form, and a solid odor block consisting of a solid-phase solvent, an excipient and an odor essence is taken as a key component, namely an odor releaser, in the detection kit, so that the kit is simple and convenient to operate, easy to carry, difficult to volatilize and deteriorate, and the olfactory testing effect is improved to a certain extent.
Preferably, the solid-phase solvent is a fat-soluble solvent, is solid at normal temperature, is heated to 80 ℃ to become liquid, and the solid odor block in the kit can achieve better odor release effect and better preservation effect under the solvent. In a specific embodiment of the present invention, the fat-soluble solvent is one or more selected from palmitic acid, stearic acid, beeswax, microcrystalline wax, paraffin wax, and ink.
Besides the mechanical support for the solid phase solvent, the excipient has an influence on the release effect of the odor, and in the specific embodiment of the invention, the excipient is selected from one or more of cotton sheets (such as polypropylene cotton sheets, polystyrene cotton sheets or polyurethane cotton sheets), filter paper and oil absorbent cotton.
Preferably, the mass ratio of the solid phase solvent to the odor essence is 10:1-1000: 1.
In order to optimize the support effect of the vehicle and the odor releasing effect of the vehicle and the solid-phase solvent, in the implementation process of the invention, the vehicle is wrapped by the mixture of the solid-phase solvent and the odor essence to form a solid odor block.
The selection of the prior related detection products to the smell is lack of rationality, so that the olfactory function of a subject cannot be comprehensively and accurately reflected, particularly the olfactory function of the old, and 12 kinds of smell which is high in familiarity and convenient to distinguish among people, banana smell, apple smell, aniseed (star anise), rose smell, pineapple smell, lemon smell, milk smell, mint smell, resin (rosin) smell, camphor smell, wood smell and garlic smell are selected through the investigation of smell crowds; in order to exert the odor release effect to the best in the actual detection process, the invention selects essence substances which are more matched with the solid odor block aiming at the odors, and the essence substances are selected from one or more than two of the folic alcohol acetate, the malyl, the anisic aldehyde, the rhodinol, the ethyl butyrate, the citral, the 2, 3-butanedione, the menthol, the ethyl laurate, the isoborneol acetate, the musk T and the garlic oil. Usually, for more accurate detection, all of the 12 odors are generally used.
In the 12 kinds of odor essences, the mass ratio of the solid phase solvent to the essence can be any suitable ratio, but in the specific implementation of the invention, the mass ratio of the solid phase solvent to the isoborneol acetate can be 10:1, the mass ratio of the solid phase solvent to the leaf alcohol acetate, the apple ester, the rose alcohol, the citral, the 2, 3-butanedione, the menthol and the ethyl laurate can be 100:1, and the mass ratio of the solid phase solvent to the anisic aldehyde, the ethyl butyrate, the musk T and the garlic oil can be 1000: 1.
In addition to the key solid odor block, the kit of the invention also comprises a Parkinson disease/Alzheimer disease olfactory disorder auxiliary diagnosis card and/or an odor selection card; the Parkinson disease/Alzheimer disease olfactory disorder auxiliary diagnosis card is also called as a personal information card, and can contain the name, sex, age, medical history (whether nose diseases or allergic diseases exist mainly, whether influenza medical history in nearly 2 weeks exists, whether drugs influencing olfactory sensation are taken or not, whether nose trauma surgical history exists or not, and the like), smoking history, diagnosis results of existing products and products of the invention, and the like, wherein the specific forms can refer to Table 1, the Table 1 is only taken as an example for illustration, and the kit of the invention is not limited to the forms;
TABLE 1 Parkinson disease/Alzheimer disease dysosmia auxiliary diagnosis card
The odor selection card is a tab which is made for the selected odor and contains correct options and incorrect options, the specific form can refer to table 2, and table 2 is only used as an example and does not limit the kit of the invention to this form;
TABLE 2 odor selection card
According to the kit provided by the invention, the flow of the olfactory disorder detection is generally as follows: (1) firstly, filling a personal information card in a testee; (2) sequentially or randomly selecting one solid odor block, placing 3-5cm in front of nose of the subject, and testing without limiting the sniffing time of the subject; (3) after the testee finishes smelling, searching a question stem corresponding to the label of the solid smell block in the smell tab, and selecting from 4 alternative answers (each question stem testee must give an answer); (4) after the selection is finished, the solid odor block is discarded, and after 15 seconds, the next smell test block is tested (the last smell is understood to disappear under the action of the nose); (5) and checking the result. All odors must be completely completed, all questions must be selected, and the total score is calculated as the test result, with a 12-point full score.
The scoring standard is that each question is answered with 1 point, wrong answers with 0 point and total points with 12 points. The diagnosis standard is that the olfaction is normal if the score is higher than 8, the olfaction disorder is diagnosed if the score is lower than 8, the diagnosis standard can be used as one of the support standards for the confirmed diagnosis of the Parkinson's disease and can also be used as an auxiliary basis for the prediction of the risk of the Alzheimer's disease, and the risk of the Parkinson's disease or the Alzheimer's disease progressing within several years is higher than that of a tester with normal olfaction.
Through comparison tests, different solid-phase solvents and excipients can influence the release effect and the preservation effect of the odor, and the release effect of the odor is optimal in the range of the lipid solvent limited by the invention, wherein the polypropylene cotton sheet, the palmitic acid/the paraffin wax/the stearic acid/the microcrystalline wax/the beeswax, the oil absorbent cotton sheet, the palmitic acid/the paraffin wax/the stearic acid/the microcrystalline wax/the beeswax, the polystyrene cotton sheet, the palmitic acid/the paraffin wax/the stearic acid/the microcrystalline wax/the beeswax have better effect, the polyurethane cotton sheet, the palmitic acid/the paraffin wax/the stearic acid/the microcrystalline wax/the beeswax have better effect, and the combination of the paraffin wax and the cotton sheet is optimal in consideration of the supporting effect of the excipients.
In addition, in order to verify whether the kit has higher sensitivity and specificity and performance indexes such as PPV (positive predictive value) and NPV (negative predictive value), the kit and the American B-SIT method are respectively adopted to carry out olfaction tests on a Parkinson disease patient group and a healthy control group, and the result shows that the sensitivity and the specificity of the kit can respectively reach 75.0 percent and 86.7 percent, and the PPV with a positive predictive value and the NPV with a negative predictive value can respectively reach 86.7 percent and 75.0 percent. Compared with the American B-SIT product, the kit provided by the invention can achieve the same effect on diagnosis of the Parkinson disease, but has better specificity, positive predictive value and negative predictive value. Meanwhile, the kit disclosed by the invention has a better effect on the detection of the olfactory disorder, and is also applicable to the Alzheimer disease which belongs to the neurodegenerative disease and also has the pathological change of hyposmia and has a better expected effect.
Based on the excellent technical effects of the product, the invention provides the application of the kit in the preparation of detection products for assisting in diagnosing the Parkinson's disease and the Alzheimer's disease.
Meanwhile, the invention also correspondingly provides a preparation method of the kit, which comprises the following steps:
heating and melting the solid phase solvent, adding the odor essence, uniformly mixing, soaking the forming object into the mixture of the solid phase solvent and the odor essence, taking out the forming object, airing and solidifying to obtain the kit. Wherein the specification and size of the excipient can be specifically adjusted according to requirements, and the mass ratio of the solid phase solvent to the odor essence is 10:1-1000: 1.
More specifically, 10g of solid-phase solvent is weighed and put into a 50mL centrifuge tube, incubated in a water bath kettle at 80 ℃ until the solid-phase solvent is completely melted, 0.01-1g of odor essence is added, and the centrifuge tube is slightly shaken to uniformly dissolve the odor essence;
cutting the forming materials into 20 × 10mm sheets, adding into centrifuge tube, soaking for 5min, taking out with tweezers, and air drying on tray.
After the preparation is accomplished, the solid smell piece can be packed and numbered, be convenient for preserve and correspond to the smell option card, for example the extranal packing can contain PVC plastics bottom plate and easily tear sealed film, and the outward appearance design is the rectangle, is equipped with a sunken smell groove, can place a solid smell piece in every inslot, and every smell groove surface accessible easily tears sealed film and seals, and certain region is reserved at upper and lower both ends, tears sealed film among the facilitate the use and exposes the smell groove.
According to the technical scheme, the kit disclosed by the invention adopts a solid material as an odor carrier and is matched with a specific essence component, so that a liquid reagent similar to Sniffin's Sticks and a five-flavor odor testing liquid method is avoided, the risks of scattering, container damage, environmental pollution and volatilization of liquid can be reduced, and meanwhile, the solid odor block has a better olfaction test effect.
Detailed Description
The invention discloses a kit for detecting olfactory disorder and application thereof, and a person skilled in the art can use the contents of the kit for reference and appropriately improve process parameters for realization. It is expressly intended that all such similar substitutes and modifications which would be obvious to one skilled in the art are deemed to be included in the invention. The kit product of the present invention, the preparation method and the application thereof have been described by way of preferred embodiments, and it is obvious to those skilled in the art that the technology of the present invention can be implemented and applied by modifying or appropriately modifying and combining the separation and purification methods described herein without departing from the content, spirit and scope of the present invention.
The present invention provides a kit for detecting olfactory disorder and the application thereof.
Example 1: preparation of solid odor Block of kit of the present invention
Weighing 10g of solid-phase solvent, putting the weighed solid-phase solvent into a 50mL centrifuge tube, incubating the solid-phase solvent in a water bath kettle at 80 ℃ until the solid-phase solvent is completely melted, adding 0.1g of odor essence, and slightly shaking the centrifuge tube to uniformly dissolve the odor essence;
cutting polypropylene cotton sheet into 20 × 10mm sheets, adding into centrifuge tube, soaking for 5min, taking out with tweezers, and air drying on tray.
Wherein the solid phase solvent is palmitic acid, stearic acid, paraffin, beeswax, microcrystalline wax or printing ink; the odor essence is selected from the group consisting of folic alcohol acetate, malyl ester, anisic aldehyde, rhodinol, ethyl butyrate, citral, 2, 3-butanedione, menthol, ethyl laurate, isobornyl acetate, musk T or garlic oil.
Example 2: preparation of solid odor Block of kit of the present invention
Weighing 10g of solid-phase solvent, putting the weighed solid-phase solvent into a 50mL centrifuge tube, incubating the solid-phase solvent in a water bath kettle at 80 ℃ until the solid-phase solvent is completely melted, adding 1g of odor essence, and slightly shaking the centrifuge tube to uniformly dissolve the odor essence;
cutting filter paper into 20 × 10mm sheets, soaking in centrifuge tube for 5min, taking out with tweezers, and air drying on tray.
Wherein the solid phase solvent is palmitic acid, stearic acid, paraffin, beeswax, microcrystalline wax or printing ink; the odor essence is selected from the group consisting of folic alcohol acetate, malyl ester, anisic aldehyde, rhodinol, ethyl butyrate, citral, 2, 3-butanedione, menthol, ethyl laurate, isobornyl acetate, musk T or garlic oil.
Example 3: preparation of solid odor Block of kit of the present invention
Weighing 10g of solid-phase solvent, putting the weighed solid-phase solvent into a 50mL centrifuge tube, incubating the solid-phase solvent in a water bath kettle at 80 ℃ until the solid-phase solvent is completely melted, adding 0.01g of odor essence, and slightly shaking the centrifuge tube to uniformly dissolve the odor essence;
cutting oil-absorbing cotton into pieces of 20 × 10mm, adding into centrifuge tube, soaking for 5min, taking out with tweezers, and air drying on tray.
Wherein the solid phase solvent is palmitic acid, stearic acid, paraffin, beeswax, microcrystalline wax or printing ink; the odor essence is selected from the group consisting of folic alcohol acetate, malyl ester, anisic aldehyde, rhodinol, ethyl butyrate, citral, 2, 3-butanedione, menthol, ethyl laurate, isobornyl acetate, musk T or garlic oil.
Example 4: the kit of the invention
(1) 12 kinds of solid odor blocks, personal information cards and odor option cards prepared using paraffin as a solid phase solvent in example 1;
(2) 12 solid odor blocks, personal information cards and odor tabs prepared in example 2 with palmitic acid as the solid phase solvent;
(3) 12 solid odor blocks, personal information cards and odor tabs prepared in example 3 with stearic acid as the solid phase solvent;
(4) 12 kinds of solid odor blocks, personal information cards and odor option cards prepared by using beeswax as a solid phase solvent in example 1;
(5) 12 solid odor blocks, personal information cards and odor tabs prepared in example 1 using microcrystalline wax as the solid phase solvent;
example 5: odor Release Effect study
1. Solid-phase fat-soluble solvent: myristic acid, stearic acid, paraffin, beeswax, microcrystalline wax, palmitic acid, glyceryl monostearate;
2. the preparation method of the solid odor block comprises the following steps: referring to the preparation method of example 1, the odor essence is selected from acetic acid leaf alcohol ester;
3. detecting by a gas chromatography mass spectrometer:
and taking the solid odor block as a sample, adding the sample into the headspace bottle, and detecting by using a gas chromatography mass spectrometer.
Headspace injector conditions: heating to balance temperature 50 deg.C, balancing time 4min, injection needle temperature 50 deg.C, and injection volume 0.5 mL.
Gas chromatography conditions: the injection port temperature was 250 ℃. Temperature rising procedure: keeping the temperature at 50 deg.C for 1min, increasing the speed at 10 deg.C/min to 200 deg.C, and keeping the temperature for 5 min.
Mass spectrum conditions: electron bombardment (EI) ion source with ion source temperature of 230 ℃ and ionization energy of 70 eV. The Scan range was 35-200 amu for a full Scan (Scan) mode Scan.
4. The research method comprises the following steps:
each solid odor block was analyzed by GC-MS, and the ability of different combinations to release odor was characterized by the peak area of the peak of the folate acetate, and since the olfactory test product needs to smell the subject by releasing odor and determine the odor type, the higher the peak area, the stronger the ability to release odor, the more excellent the olfactory test product can be considered, and the results are shown in table 3.
TABLE 3 Peak area of the different solid odor block leaf alcohol acetate peaks
The results in the above table show that the combination of polypropylene cotton sheet + palmitic acid/paraffin/stearic acid/microcrystalline wax/beeswax, oil absorbent cotton sheet + palmitic acid/paraffin/stearic acid/microcrystalline wax/beeswax, polystyrene cotton sheet + palmitic acid/paraffin/stearic acid/microcrystalline wax/beeswax, polyurethane cotton sheet + palmitic acid/paraffin/stearic acid/microcrystalline wax/beeswax has a better peak area, and can be used as a candidate for solid phase solvent + excipient, and the above combinations all have better odor release effect.
The melting point of the paraffin is lower, while the melting point of the stearic acid is close to 80 ℃ (the boiling point of 2, 3-butanedione in 12 essences is only 88 ℃), and the essence is easy to solidify on the tube wall when being shaken and dissolved in the production process, thereby having certain influence on the production; in addition, the oil absorption cotton and the cotton sheet are both made of multi-layer fiber materials, but the oil absorption cotton is looser than the cotton sheet in structure, and the risk of scattering exists in the production and use processes. In addition, according to the test result data of other essences, the peak area of each other essence is above 1.80E +09 under the above combination situation, while most essences can achieve the best release effect under the combination of paraffin and cotton sheets (including three cotton sheets in table 3), and the combination of cotton sheets and paraffin is a more excellent product combination from the viewpoint of production and use.
Example 6: comparison of sensitivity and specificity of the detection method of the kit of the invention and the B-SIT method
1. The purpose is as follows: and verifying whether the olfactory detection method has higher sensitivity and specificity, and PPV and NPV.
2. Study subjects: 50 Parkinson patients and 50 healthy control groups were selected.
(1) Group PD: patients with Parkinson's disease are from outpatients and wards of Xuanwu hospital and Reian hospital, and are diagnosed with Parkinson's disease according to the diagnosis standard of MDS in 2015, the age is more than 50 years old (according to the clinical prodromal period standard of PD established by MDS of the International Association for dyskinesia in 2015, the calculation of risk prediction value is from 50 years old.), and the sex ratio is 1: 1.
exclusion criteria: MMSE is less than 24 points, and there are olfactory diseases (rhinitis and the like) or surgical history of nasal trauma and the history of cold in nearly two weeks.
(2) Control group: healthy control groups were from the parkinsonian spouse and the Beijing elderly community cohort population, according to age 1: 1 match into the group.
Exclusion criteria: MMSE is less than 24 points, there is a history of olfactory diseases (rhinitis, etc.) or nasal trauma surgery, a history of nearly two weeks of cold, and a history of clearly diagnosed neurological diseases (PD, AD, etc.).
3. The research method comprises the following steps: all subjects received olfactory tests of a two-week olfactory test method with 15 minutes intervening between each olfactory test method.
4. The olfactory test method comprises the following steps: methods based on the kit of the invention (example 4) and the U.S. B-SIT method. The U.S. B-SIT method was performed with reference to the test card front specification. The test method of the invention comprises the following steps:
(1) firstly, filling a personal information card in a testee; (2) sequentially or randomly selecting one solid odor block, placing 3-5cm in front of nose of the subject, and testing without limiting the sniffing time of the subject; (3) after the testee finishes smelling, searching a question stem corresponding to the label of the solid smell block in the smell tab, and selecting from 4 alternative answers (each question stem testee must give an answer); (4) after the selection is finished, the solid odor block is discarded, and after 15 seconds, the next smell test block is tested (the last smell is understood to disappear under the action of the nose); (5) and checking the result. All odors must be completely completed, all questions must be selected, and the total score is calculated as the test result, with a 12-point full score.
5. Statistical analysis: this was done using SPSS 19.0.
6. The results are shown in Table 4.
TABLE 4
The results in the table show that the sensitivity and specificity of the kit can respectively reach 75.0% and 86.7%, and the positive predictive value PPV and the negative predictive value NPV can respectively reach 86.7% and 75.0%. Compared with the American B-SIT product, the kit provided by the invention can achieve the same effect on diagnosis of the Parkinson disease, but has better specificity, positive predictive value and negative predictive value.
Since both parkinson's disease and alzheimer's disease are neurodegenerative diseases and the olfactory system is pathologically altered during the onset, parkinson's disease and alzheimer's disease have similar manifestations of olfactory disorders, and this example extends to alzheimer's disease.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.
Claims (6)
1. A kit for detecting olfactory disorder, comprising one or more solid odor blocks composed of a solid phase solvent, a vehicle and an odorant; the solid phase solvent is one or more than two of paraffin, microcrystalline wax and printing ink, and the excipient is a cotton sheet; the vehicle is coated with a mixture of a solid phase solvent and an aroma fragrance.
2. The kit according to claim 1, wherein the mass ratio of the solid phase solvent to the odor essence is 10:1-1000: 1.
3. The kit of claim 1, wherein the odorant is selected from the group consisting of folic acid ester, malic acid ester, anisic acid, rhodinol, ethyl butyrate, citral, 2, 3-butanedione, menthol, ethyl laurate, isobornyl acetate, T-musk, and garlic oil.
4. The kit of any one of claims 1 to 3, further comprising a Parkinson's disease/Alzheimer's disease olfactory disorder auxiliary diagnostic card and/or an odor selection card.
5. Use of the kit according to any one of claims 1 to 4 for the preparation of a test product for the auxiliary diagnosis of parkinson's disease/alzheimer's disease.
6. The method for preparing the kit according to claim 1, comprising:
heating and melting the solid phase solvent, adding the odor essence, uniformly mixing, soaking the forming object into the mixture of the solid phase solvent and the odor essence, taking out the forming object, airing and solidifying to obtain the kit.
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| CN1070091A (en) * | 1992-07-09 | 1993-03-24 | 刘中申 | The preparation method of odoriferous artificial flower |
| JP2000053589A (en) * | 1998-08-11 | 2000-02-22 | Takasago Internatl Corp | Medicine for diagnosing dementia |
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