Method for detecting mouth dryness

Abstract

The invention discloses a method for detecting mouth dryness, which is characterized in that test paper is used for detection, the test paper comprises a plurality of detection layers, and the detection layer on the outer side wraps the other detection layers in sequence, so that the whole body is in a water drop shape; the color developing layer adopts a starch coating, can be subjected to specific biochemical reaction with a specific marker in saliva, is only sensitive to'saliva marker abnormity 'caused by pathology or drugs, and is not interfered by drinking water physiological factors; compared with the traditional humidity measurement principle, the problem of misjudgment of physiological thirst is solved.

Description

TECHNICAL FIELD

[0001] The application is a method for detecting the degree of dry mouth, belonging to the field of dry mouth detection. BACKGROUND

[0002] Dry mouth symptoms are not simply "oral discomfort", which is associated with disease diagnosis and treatment and drug safety two core scenarios: on the one hand, head and neck cancer patients will cause hypofunction of salivary glands during radiotherapy, resulting in dry mouth as a complication, which seriously affects the quality of life of patients. Therefore, accurate and convenient dry mouth detection method is the key requirement of clinical diagnosis and treatment and daily health monitoring.

[0003] However, the existing dry mouth detection technology has significant defects and cannot meet the actual application requirements. The most commonly used method in the clinic is inquiry + scale score, that is, the doctor judges through the frequency of dry mouth, whether drinking water is needed to assist eating, etc., or the patient fills out the "dry mouth symptom score scale" (such as VAS visual analog score).

[0004] Measuring the saliva secretion amount per unit time (usually 5-10 minutes) (normal adult resting saliva flow rate ≥0.3mL / min) through professional instruments (such as portable saliva flow meter) is a relatively objective detection means. However, the unit price of the instrument is generally 100,000-1,000,000 yuan, and it needs to be operated by professional medical personnel (such as calibrating the instrument and guiding the patient to collect saliva), which is difficult to popularize in primary hospitals and families. SUMMARY

[0005] In view of the deficiencies of the prior art, the application aims to provide a method for detecting the degree of dry mouth to solve the problem.

[0006] In order to achieve the above-mentioned purpose, the application is implemented by the following technical scheme: a method for detecting the degree of dry mouth, which is detected by test paper, the test paper comprises a plurality of detection layers, the detection layers on the outside are wrapped in turn, and the whole is in the shape of a water droplet; The detection layers comprise, from the outside to the inside, a water guiding layer, a color developing layer and a supporting layer; the water guiding layer is used for water absorption; the color developing layer contains a substance having specific recognition and binding capacity for specific markers in saliva, and reacts with the markers in saliva based on the principle of biochemical reaction to generate a detectable signal; the supporting layer is pasted on the surface of the water guiding layer of another detection layer, and the supporting layer and the water guiding layer of another detection layer can be separated by tearing; The color developing layer is treated with iodine reagent; The detection method comprises the following steps: Step 1: Place the test paper in the mouth so that the water guiding layer is in full contact with saliva; Step 2: Hold in your mouth and wait 3-5 minutes to allow the water-conducting layer to transfer moisture to the color-developing layer; Step 3: Remove the test strip and let it stand for 20-25 minutes; Step 4: Gradually tear open the outer support layer to allow the outer detection layers to fall off one by one. Then add the detection reagent and observe the color change of the torn color development layer. Step 5: Repeat step 4 until all the torn display layers have been treated with reagent; The application of the test strip and the detection method described herein in medical diagnosis and health monitoring.

[0007] Preferably, the water-conducting layer is made of, but is not limited to, medical absorbent cotton or highly absorbent resin material.

[0008] Preferably, the color development layer is a starch coating, and the reagent is an iodine reagent, i.e., an iodine-potassium iodide solution, wherein the molar ratio of iodine to potassium iodide is 1:2-1:3. The color development layer uses a porous cellulose membrane as a carrier, with a pore size of 0.22-0.45 μm and a porosity of 60%-70%, so that the iodine reagent is uniformly loaded in the carrier, ensuring the consistency and stability of the signal when reacting with saliva.

[0009] Preferably, the support layer is made of modified medical nonwoven fabric, and the support layer is wrapped in a fence-like manner on the surface of another detection layer.

[0010] Preferably, in step two, the mouth should be kept closed to reduce swallowing, and the test strip should be gently rotated once every 1 minute.

[0011] Preferably, the number of detection layers is at least three.

[0012] Preferably, in step four, a dry mouth standard is defined, which includes four gradients: no dry mouth, mild dry mouth, moderate dry mouth, and severe dry mouth, with each gradient corresponding to a specific range of saliva marker concentrations.

[0013] Preferably, the test strip is used in medical diagnosis as follows: for regular monitoring of dry mouth symptoms in patients with salivary gland damage caused by radiotherapy, and by observing the changes in the number of layers of the chromogenic layer from blue to other colors, it helps doctors judge the patient's condition progression and treatment effect.

[0014] Preferably, the test strip is mounted on the end of a handle, and the test strip is formed into a teardrop shape at one end of the handle.

[0015] Preferably, the handle is hollow; the other end of the handle has a easily breakable sealing head, and the handle contains the reagent.

[0016] Beneficial effects The color development layer of this invention uses a starch coating, which can undergo a specific biochemical reaction with specific markers in saliva (such as salivary amylase) (amylase decomposes starch, causing the blue color of the iodine-starch complex to dissociate). It is only sensitive to pathological or drug-induced "abnormalities in salivary markers" and is not affected by physiological factors such as drinking water. Compared with the principle of traditional humidity measurement, it solves the problem of misjudging physiological dry mouth. Attached Figure Description

[0017] Other features, objects, and advantages of the present invention will become more apparent from the following detailed description of non-limiting embodiments with reference to the accompanying drawings: Figure 1 This is a schematic diagram of a method for detecting the degree of dry mouth according to the present invention. Detailed Implementation

[0018] To make the technical means, creative features, objectives and effects of this invention easier to understand, the invention will be further described below in conjunction with specific embodiments.

[0019] Please see Figure 1 This invention provides a method for detecting the degree of dry mouth: A test strip is fixed to one end of a medical-grade handle 4, and is teardrop-shaped. The teardrop shape conforms to the curvature of the oral mucosa, avoiding sharp edges that could irritate the mouth and improving user comfort. The handle 4 is designed for easy hand operation, avoiding finger contact with the test strip's detection area, reducing the risk of contamination, and ensuring accurate test results. Furthermore, the handle 4 is hollow, with a easily breakable sealing head at the other end. The handle 4 contains the reagent. By blocking one end of the handle 4 with several detection layers and the easily breakable sealing head at the other end, a vacuum is created within the handle 4 during manufacturing, stabilizing the filled reagent within the handle 4. When the sealing head is broken, the vacuum within the handle 4 is disrupted, and when placed vertically, under atmospheric pressure, the reagent flows into the several detection layers.

[0020] Each detection layer consists of a water-conducting layer 1, a color-developing layer 2, and a support layer 3, and the outer detection layer can be torn apart independently; furthermore, the support layer 3 has an extension for quick tearing by medical personnel.

[0021] The water-absorbing layer 1 preferentially contacts saliva to quickly absorb saliva and evenly transfer moisture to the color-developing layer 2. Preferably, it can be medical absorbent cotton or super absorbent resin. The chromogenic layer 2 reacts specifically with a specific marker in saliva, and the concentration of the marker is fed back through color change. In one embodiment, the specific marker is salivary amylase. A starch coating is applied to a porous cellulose membrane, and a reagent consisting of an iodine-potassium iodide solution (iodine to potassium iodide molar ratio 1:2-1:3, pH 5.5-6.5) is added after the membrane is torn open.

[0022] The support layer 3 is made of medical-grade modified non-woven fabric and is set up in a fence-like form to fix the inner detection layer structure and can be torn open without damage. The use of modified non-woven fabric prevents saliva from seeping into the support layer 3 and causing the structure to loosen, ensuring the stability of the test strip shape during the test. At the same time, the force is even when torn, which can achieve layer-by-layer peeling and avoid misjudgment caused by multiple layers peeling off at the same time. It also reduces the peeling force (does not peel off during the test) and makes it easy for users to tear open by hand.

[0023] The reason why salivary amylase in saliva can be used as a specific marker to react with starch and iodine-potassium iodide reagent in chromogenic layer 2 is: In normal saliva, amylase breaks down the starch components in the chromogenic layer, causing the iodine-starch complex (blue) to dissociate, and the chromogenic layer 2 becomes colorless, pale yellow, or other colors. Dry mouth (low marker concentration): insufficient amylase makes it difficult to completely break down starch. When iodine-starch complex is added, the chromogenic layer 2 turns blue.

[0024] By observing the color changes of the chromogenic layer 2 layer by layer, the concentration of salivary markers can be deduced in reverse, thereby quantifying the degree of dry mouth.

[0025] The criteria for dry mouth are defined, which include four gradients: no dry mouth, mild dry mouth, moderate dry mouth, and severe dry mouth. Each gradient corresponds to a specific range of salivary marker concentrations.

[0026] In one embodiment, preferably, the number of detection layers is at least three. In one embodiment, the detection method includes the following steps: Step 1: Place the test strip into your mouth, ensuring the absorbent layer is in full contact with saliva; Step 2: Hold in your mouth and wait 3-5 minutes to allow the water-conducting layer to transfer moisture to the color-developing layer; Step 3: Remove the test strip and let it stand for 20-25 minutes; Step 4: Gradually tear open the outer support layer to allow the outer detection layers to fall off one by one. Then add the detection reagent and observe the color change of the torn color development layer. Step 5: Repeat step 4 until all the torn display layers have been treated with reagent.

[0027] In one embodiment, the detection method differs in that: in step four, after the sealing head is broken, the vacuum state inside the handle 4 is disrupted, and after being placed vertically, the reagent will flow into the detection layer under atmospheric pressure.

[0028] Define gradient 1, which means that the outer and inner layers are not blue, and the corresponding concentration range of saliva markers (U / mL) is 150-200, which means no dry mouth; Define gradient 2, i.e., the outer layer is not blue, the middle layer is not blue, and the inner layer is blue. The corresponding saliva marker concentration range (U / mL) is 100-150, which is mild dry mouth. Gradient 3 is defined as an outer layer that is not blue, a middle layer that is blue, and an inner layer that is blue. The corresponding concentration range of saliva markers (U / mL) is 50-100, which is moderate dry mouth. Gradient 4 is defined as blue from the outer layer to the inner layer, corresponding to a salivary marker concentration range (U / mL) of less than 50, which indicates severe dry mouth.

[0029] Example 1 The patient is a 52-year-old male who was diagnosed with nasopharyngeal carcinoma more than two months ago. He has already undergone 10 radiotherapy sessions. His oral mucosa is intact, but he has developed persistent dry mouth and reports that he needs to drink water about every 2 hours to relieve it.

[0030] No food, water, or smoking was consumed within 10 hours prior to the test, and no artificial saliva was used (to avoid affecting the concentration of saliva markers).

[0031] Open the sealed packaging, hold the end of handle 4, and confirm that the detection layer is free from moisture and damage. Start operation within 5 minutes of opening.

[0032] Place the teardrop-shaped test end of the test strip between the tongue and the palate, close your mouth, and avoid swallowing (swallowing intervals should be controlled at more than 40 seconds). Rotate the test strip clockwise once every 1 minute.

[0033] Remove the test strip, break off the other end of the handle 4, and atmospheric pressure will cause the reagent on the handle 4 to flow downwards onto the detection layer, where the reagent contacts the test strip; place it upright on a disposable sterile tray and in a room at 23°C and 50% humidity for 20 minutes.

[0034] Gently peel off the outer support layer 3 from the extension, and observe that the outer color developing layer 2 is colorless; continue peeling off the middle support layer 3, and observe that the middle color developing layer 2 is blue; finally peel off the inner support layer 3, and observe that the inner color developing layer 2 is blue.

[0035] The state of the chromogenic layer 2: the outer layer is not blue, the middle layer is blue, and the inner layer is blue, which corresponds to the color judgment standard of gradient 3 in the technical solution. The concentration of saliva marker is 50-100U / mL, and the degree of dry mouth is moderate dry mouth.

[0036] Through long-term monitoring, at 10 radiotherapy sessions (early stage of radiotherapy), the test strips showed colorless, blue, blue (outer, middle, inner), corresponding to gradient 3. The doctor's intervention measures included prescribing medical mouthwash, emphasizing oral care, recommending the use of the Bass brushing method (at least 3 times / day), and drinking small amounts of water frequently (approximately 2000-3000ml per day). At 15 radiotherapy sessions (early to mid-stage of radiotherapy), the test strips showed colorless, blue, blue (outer, middle, inner), corresponding to gradient 3. Despite the increase in cumulative radiation dose, the degree of dry mouth remained at gradient 3 and did not worsen further. This was considered a sign that the intervention measures were effective and successfully delayed the rapid progression of the disease. The doctor's intervention measures included the use of artificial saliva. At 20 radiotherapy sessions (mid-stage), the test strips showed colorless, blue, blue (outer, middle, inner), corresponding to gradient 3. The patient reported that dry mouth symptoms had not worsened, but sputum felt thicker. The doctor continued to use mucolytic agents (such as acetylcysteine) and switched to gargling with 3%–5% sodium bicarbonate solution to alleviate the thick saliva sensation. At 25 radiotherapy sessions (mid-to-late stage), the test strips showed blue, blue, blue (outer, middle, inner), corresponding to gradient 4. With the increase in total radiotherapy dose, the cumulative damage to the salivary glands further increased. The doctor instructed the patient to use artificial saliva more frequently and increase the use of M-cholinergic receptor agonists (pilocarpine), closely monitoring symptom changes and intervention responses. At 30 radiotherapy sessions (late stage), the test strips showed colorless, blue, blue (outer, middle, inner), corresponding to gradient 3. The doctor recommended continuing to use M-cholinergic receptor agonists and maintaining the frequency of artificial saliva use. After 33 radiotherapy sessions (at the end of radiotherapy), the test strips showed colorless, blue, and blue (outer, middle, and inner layers), corresponding to gradient 3. The acute reaction phase of radiotherapy had ended, and salivary gland function was in a plateau phase. The doctor recommended discontinuing the use of M-cholinergic receptor agonists and continuing to use artificial saliva, medical mouthwash, oral care, and drinking small amounts of water frequently. A follow-up examination was scheduled for one month later. One month after the end of radiotherapy, the test strips showed colorless, colorless, and blue (outer, middle, and inner layers), corresponding to gradient 2. The doctor recommended discontinuing the use of artificial saliva and using saline mouthwash, oral care, and drinking small amounts of water frequently. A follow-up examination was scheduled for three months later.

[0037] By objectively reflecting the treatment effect, it proves that the intervention plan adopted by the doctor has a certain positive effect, and avoids the doctor adjusting the treatment based solely on the patient's subjective description.

[0038] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. It will be apparent to those skilled in the art that the invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered illustrative and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the scope of the invention. No reference numerals in the claims should be construed as limiting the scope of the claims. Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A method for detecting the degree of dry mouth, characterized in that: The test is performed using a test strip, which includes several detection layers. The outer detection layer sequentially wraps around the other detection layers, making the whole strip resemble a teardrop. The detection layer comprises, from the outside to the inside, a water-absorbing layer, a color-developing layer, and a support layer. The water-absorbing layer is used to absorb water. The color-developing layer contains a substance that has the ability to specifically recognize and bind to specific markers in saliva, and reacts with the markers in saliva based on the principle of biochemical reaction to generate a detectable signal. The support layer is adhered to the surface of the water-absorbing layer of another detection layer, and the support layer can be torn apart from the water-absorbing layer of the other detection layer. The colorimetric layer is treated with iodine reagent; The detection method includes the following steps: Step 1: Place the test strip into your mouth, ensuring the absorbent layer is in full contact with saliva; Step 2: Hold in your mouth and wait 3-5 minutes to allow the water-conducting layer to transfer moisture to the color-developing layer; Step 3: Remove the test strip and let it stand for 20-25 minutes; Step 4: Gradually tear open the outer support layer to allow the outer detection layers to fall off one by one. Then add the detection reagent and observe the color change of the torn color development layer. Step 5: Repeat step 4 until all the torn display layers have been treated with reagent; The application of the test strip and the detection method described herein in medical diagnosis and health monitoring.

2. The method for detecting the degree of dry mouth according to claim 1, characterized in that: The water-absorbing layer includes, but is not limited to, being made of medical absorbent cotton or highly absorbent resin materials.

3. The method for detecting the degree of dry mouth according to claim 1, characterized in that: The color development layer is a starch coating, and the reagent is an iodine reagent, namely an iodine-potassium iodide solution, wherein the molar ratio of iodine to potassium iodide is 1:2-1:

3. The color development layer uses a porous cellulose membrane as a carrier, with a pore size of 0.22-0.45 μm and a porosity of 60%-70%, so that the iodine reagent is uniformly loaded in the carrier.

4. The method for detecting the degree of dry mouth according to claim 1, characterized in that: The support layer is made of modified medical nonwoven fabric, and the support layer is wrapped in a fence-like manner on the surface of another detection layer.

5. A method for detecting the degree of dry mouth according to claim 1, characterized in that: In step two, keep your mouth closed, reduce swallowing, and gently rotate the test strip once every 1 minute.

6. The method for detecting the degree of dry mouth according to claim 1, characterized in that: The number of detection layers is at least 3.

7. A method for detecting the degree of dry mouth according to claim 6, characterized in that: In step four, a dry mouth standard is defined, which includes four gradients: no dry mouth, mild dry mouth, moderate dry mouth, and severe dry mouth. Each gradient corresponds to a specific range of saliva marker concentrations.

8. A method for detecting the degree of dry mouth according to claim 7, characterized in that: The test strip is specifically used in medical diagnosis for the regular monitoring of dry mouth symptoms in patients with salivary gland damage caused by radiotherapy. By observing the changes in the number of layers of the chromogenic layer from blue to other colors, it helps doctors determine the patient's condition progression and treatment effectiveness.

9. A method for detecting the degree of dry mouth according to claim 1, characterized in that: The test strip is mounted on the end of a handle, and the test strip is formed into a teardrop shape at one end of the handle.

10. A method for detecting the degree of dry mouth according to claim 9, characterized in that: The handle is hollow, and the other end of the handle has a sealed head that is easy to break off. The handle contains the reagent.

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