JP5696326B2 - CT colonography test medicine - Google Patents

Description

  The present invention relates to a test drug and a method of using the same in CT colonography.

  Large intestine examination (CT colonography) by computed tomography (CT) is an examination method that is becoming common with the development of helical CT and multi-row detector CT. In order to successfully draw a 3D image of the large intestine using a multi-row detector CT such as MDCT (Multi detector-row CT), it is necessary to eliminate the intestinal contents in the intestinal preparation, and the presence of feces and liquid residues Is greatly involved in examination time and interpretation of lesions. However, when an oral intestinal cleanser is used to reduce residual stool, there is a problem that liquid residue increases.

  For this reason, it is preferable to perform a colonoscopy prior to MDCT to aspirate the liquid residue. Colonoscopy is a method of inspecting the colon lumen visually through a scope by inserting a flexible tube called a coroscope and a flexible tube integrated with an endoscope. In colonoscopy, a doctor operates a tube to detect a lesion such as a tumor in the colon lumen.Some patients have an uncomfortable tube inserted in their body and have a long examination time. There is a case that complains about pain, and good evaluation is not always obtained from the viewpoint of patient acceptability (compliance).

For example, when a barium sulfate aqueous suspension is used as a contrast medium, its use has been proposed based on the knowledge that a gastrointestinal function promoter improves the contrast performance of an X-ray contrast medium for gastrointestinal examination (Patent Document) 1).
Further, although a simple method has been proposed as a pretreatment method for CT, there remains a problem as a pretreatment method for precise examination in that the imaging ability is sacrificed.

  In recent years, the time required for intestinal irrigation and the problem of liquid residues in the intestinal tract have been discussed. As a concrete problem, in order to perform a good CT colonography examination, it is necessary to eliminate intestinal contents by intestinal preparation, and the presence of residual stool or liquid residue leads to false negative or false positive of the lesion. Largely related to inspection accuracy.

  In order to solve this problem, in CT colonography, by taking a composition for gastrointestinal contrast in which an iodine contrast medium is blended with an oral intestinal irrigant, an image of a liquid residue portion that can be depicted with an iodine contrast medium, A proposal has been made that an aerial image (gas image) is synthesized to run the entire large intestine and confirm the position of the lesion site together with detection of colorectal cancer (Patent Document 2). In Patent Document 2, a gastrointestinal contrast medium is used, and a CT value is increased by labeling a residue in the intestinal tract with a contrast medium, so that it can be distinguished from a polyp lesion that is not labeled with a contrast medium. This greatly reduces false positives and contributes to improved testing accuracy.

  However, even when this method is used, it is desirable that the liquid residue is small. The reason is that in a 3D image that is easy to interpret, the remaining water in the intestinal tract is blind, so the blind part must be confirmed with a 2D MPR image (multiplanar reformation). . For this reason, in the examination correspondence of Patent Document 2, there is a problem that a long interpretation time, diagnostic technique, and interpretation experience of the interpreter are required.

The purpose is to reduce lesion sites that cannot be extracted because they are buried in the residual fluid of the digestive tract based on the knowledge that the total amount of residual fluid in the intestinal tract that cannot be depicted in CT colonography is reduced by taking mosapride citrate. It is proposed to use a gastrointestinal function promoter (Patent Document 3).
As described above, various proposals have been made for CT colonography, but not only pretreatment for intestinal irrigation but also the entire examination system, including image interpretation, should be reviewed and improved for use as a mass screening or clinical examination. It is hoped that.

JP 2002-53496 A Japanese Patent Laid-Open No. 2005-2006 WO2004-087218

  Thus, it is an object of the present invention to reduce the residual water of the intestinal rinsing fluid and the liquid residue storage of the intestinal fluid that often appear in the colon cavity after intestinal irrigation in examinations such as colorectal cancer by CT colonography. An object of the present invention is to provide a medicine for CT colonography examination capable of reducing the burden of the above and maintaining high imaging ability.

  The present inventors have successfully solved the problem of liquid residue in CT colonography, have excellent imaging ability, and can be incorporated into a hospital inspection system so that many patients can be examined in a short time as an examination system for mass screening or clinical examination. The present invention was completed as a result of various investigations on drugs for colonography testing.

That is, the present invention includes the following aspects.
1. A medicine for CT colonography examination comprising a combination of an osmotic pressure adjusting agent, an iodine compound, and a gastrointestinal function promoter.
2. Furthermore, said 1 CT colonography test | inspection pharmaceutical which combines dimethylpolysiloxane.
3. 3. The test pharmaceutical according to 1 or 2 above, wherein the composition for gastrointestinal imaging comprising an osmotic pressure adjusting agent and an iodine compound is combined with a composition for promoting gastrointestinal motility including a gastrointestinal function promoter.

4). 4. The test medicine according to any one of 1 to 3, wherein the composition for gastrointestinal imaging is a combination of an intestinal irrigation composition containing an osmotic pressure adjusting agent and an iodine compound.
5. At least one colloid osmotic pressure adjusting agent selected from the group consisting of polyethylene glycol, polydextrose, dextran, dextrin, hydroxyethyl starch, gum arabic, pullulan, pectin, albumin and carboxymethylcellulose, and an electrolyte or electrolyte; 5. The test pharmaceutical according to any one of 1 to 4 above, which comprises a crystalline osmotic pressure regulator which is a saccharide.
6). 5. The saccharide according to 5 above, wherein the saccharide contained in the osmotic pressure adjusting agent is at least one saccharide selected from the group consisting of sorbitol, xylitol, erythritol, mannitol, trehalose, lactitol, lactulose, maltitol, palatinose, raffinose, sucrose, and glycerin. Drug for testing.

7). 7. The test pharmaceutical according to any one of 1 to 6 above, wherein the iodine compound content is 15 to 90 mg / mL.
8). The examination according to any one of 1 to 7 above, wherein the osmotic pressure adjusting agent contains an electrolyte such that Na ⁺ is 30 to 150 mEq / L, K ⁺ is 3 to 20 mEq / L, and Cl ⁻ is 20 to 70 mEq / L. Pharmaceuticals.
9. 9. The test pharmaceutical according to any one of 1 to 8 above, wherein the gastrointestinal function promoter is mosapride citrate.

10. 10. An image processing method comprising: constructing a gastric image of a large intestine and an iodinated contrast image treated with the medicine for CT colonography examination according to any one of 1 to 9 above by MDCT imaging, and synthesizing both image data.

11. 10. A method for constructing an iodine contrast image in CT colonography, comprising constructing an iodine contrast image using the CT colonography examination medicine according to any one of 1 to 9 above.
12 12. The method for constructing an iodine contrast image in CT colonography as described in 11 above, wherein a liquid residue existing in the large intestine is constructed as an iodine contrast image.

13. A CT colonography examination medicine described in any one of the above 1 to 9 is used in an image processing method characterized in that a gas image and an iodine contrast image of the large intestine are constructed by MDCT imaging and both image data are synthesized. Method.

  In the present invention, the use form of the “medicine for examination” includes an osmotic pressure regulator, an iodine compound, and an osmotic pressure regulator, iodine, and a pharmaceutical composition for CT colonography examination containing a gastrointestinal function promoter. When a composition for gastrointestinal tract contrast comprising a compound and a composition for promoting gastrointestinal motility including a gastrointestinal function promoter are used in combination, the composition for cleaning the intestinal tract containing an osmotic pressure regulator and the iodine compound are combined. There are cases where a composition for gastrointestinal imaging and a gastrointestinal function promoter are used in combination, and cases where dimethylpolysiloxane is further used in combination with these compositions, and these compositions and compounds are administered simultaneously. Or may be administered over time.

According to the present invention, in the examination of colon polyps and colon cancer by CT colonography, a large amount of the intestinal lavage fluid and the liquid portion of the intestinal fluid occupying the colon cavity after intestinal lavage are significantly reduced. It provides a reduction in burden by shortening the pretreatment time and reducing the amount of the composition for gastrointestinal imaging. Furthermore, it is possible to provide a reduction in the technology and time burden of the diagnostician.
Further, even when foamy mucus is present in the intestinal tract, it is possible to improve the reading accuracy and reading efficiency of a lesion from a captured image.

Axial image for measuring liquid residue area in CT colonography in Test Example 1 Sagittal image for liquid residue area measurement in CT colonography in Test Example 1 Example of intraluminal imaging of colon in the absence of dimethylpolysiloxane Example of intraluminal imaging of large intestine treated with dimethylpolysiloxane Example of liquid residue area measured in volume in Test Example 2 Example of liquid residue area measured in volume in Test Example 2

Hereinafter, the present invention will be described in detail.
Examples of the iodo (iodine) compound used in the test composition of the present invention include organic iodo compounds such as triiodobenzenes having iodine bonded to the 2, 4 and 6 positions of the benzene ring. Specific compounds include amidotrizoic acid (chemical name 3,5-diacetamino-2,4,6-triiodobenzoic acid), sodium amidotrizoate meglumine, amidotrizoic acid meglumine, sodium iotaramate, meglumine iotaramate, iotroxic acid Examples include meglumine, iotrolane, ioxagric acid, ioxirane, iopamidol, iopromide, iohexol, ioversol, and iomeprol.
As specific products using these, commercially available products such as “Omni Park ^(R) ” and “Iomeron ^(R) ” are known.

  Each iodo compound may exhibit side effects such as anaphylaxis-like reaction, and can be appropriately selected depending on the patient background such as allergic constitution.

  The use of sodium amidotrizoate meglumine is particularly preferred for patients with a low risk of side effects such as allergic constitution from the standpoint of pharmaceutical stability and cost.

  Sodium amidotrizoate meglumine can be prepared as an aqueous solution containing 1 to 70 g of amidotrizoic acid, 5 to 700 mg of sodium hydroxide and 1 to 20 g of meglumine in 100 mL, and should be blended with other ingredients such as a colloid osmotic pressure regulator. Is preferred. More preferably, a solution prepared as an aqueous solution containing 55 to 65 g of amidotrizoic acid, 600 to 650 mg of sodium hydroxide and 14 to 18 g of meglumine in 100 mL is preferable.

Examples of the osmotic pressure adjusting agent used in the test composition of the present invention include a mixture of a colloid osmotic pressure adjusting agent and an electrolyte, or a mixture of an electrolyte and a saccharide as a colloid osmotic pressure adjusting agent and a crystalline osmotic pressure adjusting agent. Can do.
Examples of the colloid osmotic pressure adjusting agent include polyethylene glycol, polydextrose, dextran, dextrin, hydroxyethyl starch, gum arabic, pullulan, pectin, carboxymethylcellulose and the like. Among these, a polymer selected from polydextrose, dextran, hydroxyethyl starch, gum arabic, pullulan and pectin is particularly preferable from the viewpoint of pharmaceutical stability and the like.

  As the crystalline osmotic pressure adjusting agent, an electrolyte or a mixture of an electrolyte and a saccharide is used. As a preferable test composition in CT colonography, particularly screening test, a mixture of electrolyte and saccharide can be mentioned because it has excellent patient acceptability including formulation stability and ease of administration.

The electrolyte refers to a substance that is dissociated into an ion in a solution. Na ⁺ , K ⁺ , Ca ⁺⁺ , Mg ⁺⁺ , Cl ⁻ , HCO ₃ ⁻ , SO ₄ ⁻ , HPO ₄ ⁻ , organic acid Groups, organic bases and the like. More specifically, examples include the same compounds as those used in intravenously administered electrolyte infusions and the like. Sodium ion sources include sodium chloride, sodium acetate, sodium citrate, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium sulfate, sodium lactate, sodium ascorbate, and potassium ion sources include potassium chloride, acetic acid. Potassium, potassium citrate, potassium dihydrogen phosphate, dipotassium hydrogen phosphate, potassium sulfate, potassium lactate, potassium ascorbate, etc. include calcium chloride, calcium gluconate, calcium pantothenate, calcium lactate, Calcium acetate, calcium ascorbate, calcium glycerophosphate, etc., and magnesium ion sources include magnesium sulfate, magnesium chloride, magnesium acetate, magnesium citrate, etc. Examples of hydrogen sources include sodium dihydrogen phosphate, disodium hydrogen phosphate, and sodium glycerophosphate. Examples of chloride ion sources include sodium chloride, potassium chloride, calcium chloride, and magnesium chloride. And sodium hydrogen carbonate are exemplified. Examples of the organic acid group source include citric acid, lactic acid, ascorbic acid and the like. These compounds may be in the form of hydrates.
As a product of the crystalloid osmotic agent which is commercially available, such as "MOVIPREP" can be cited as a product containing "Magukororu ^(R) P 'or ascorbic acid and sodium ascorbate containing magnesium citrate as an electrolyte.

  The saccharide mixed with the electrolyte includes sugar alcohol in addition to sugar. Specific examples include sorbitol, xylitol, erythritol, mannitol, trehalose, lactitol, lactose, maltitol, palatinose, raffinose, sucrose, glycerin and the like. Among these, xylitol, sorbitol, lactulose, lactitol, sucrose, and raffinose are particularly preferable for reasons such as formulation stability and patient acceptability including ease of administration.

The above-mentioned colloid osmotic pressure adjusting agent and / or crystalline osmotic pressure adjusting agent, which is an active ingredient of the test pharmaceutical of the present invention, is important for minimizing fluctuations in serum electrolyte balance and osmotic pressure in vivo. It is an ingredient. As the osmotic pressure adjusting agent, the colloid osmotic pressure adjusting agent and the crystalline osmotic pressure adjusting agent are used alone or in combination. The amount is adjusted according to the time until the CT colonography test is performed after the intestinal irrigation, the content of the meal on the day before the patient's test, and the like.
The test pharmaceutical of the present invention can be used for isotonic solution administration or hypertonic solution administration. The osmotic pressure when dissolved in water can be used as an aqueous solution of 200 to 2000 Osm / L, but 200 to 500 mOsm / L. It is preferable to use it as an aqueous solution of L. More preferably, the type and amount of each component should be selected so that the isotonic pressure range of 320 to 360 mOsm / L or an osmotic pressure range close to isotonicity can be adjusted.

  In the test composition of the present invention, it is preferable to adjust the content of the iodine compound that affects the imaging performance of the gastrointestinal tract to 15 mg / mL or more in order to depict the residual water of the intestinal lavage fluid and the liquid residue storage portion of the intestinal fluid. Preferably, it is adjusted to 18-80 mg / mL. In particular, a liquid preparation of 350 to 450 mL with an iodine content adjusted to 18 to 19 mg / mL is preferable because it can clearly depict the liquid residue storage part of the intestinal irrigation solution and reduce the burden of the patient on the contrast medium.

The usage-amount of a colloid osmotic pressure regulator is 2-40 grams, for example in a 400 mL liquid formulation, Preferably it is 10-30 grams. In order to maintain the serum electrolyte balance by offsetting the electrolytic mass absorbed from the intestinal tract and the electrolytic mass secreted into the intestinal tract, when the test composition is dissolved in water, Na ⁺ : 30 to 150 mEq / L, K ⁺ It is preferable to add an electrolyte so as to be: _{3 to} 20 mEq / L, Cl ⁻ : 20 to 70 mEq / L, and HCO ₃ ⁻ : 10 to 50 mEq / L. In order to suppress the absorption of moisture and electrolytes in the intestinal tract of the gastrointestinal contrast solution dissolved in water, it is preferable to add hardly absorbable ions such as magnesium ions and sulfate ions. In the case of magnesium ions, when the test composition is dissolved in water, it is preferably adjusted to be 40 to 120 mEq / L. In the case of sulfate ions, it is preferable to adjust the composition to be 40 to 120 mEq / L when the test composition is dissolved in water. When the saccharide is used as the crystalline osmotic pressure adjusting agent, the amount used is 2 to 40 grams, preferably 5 to 10 grams, in a 400 mL solution.

  Also, iodine compounds are very bitter. Therefore, it is preferable to apply taste-masking and flavoring means to the test composition of the present invention. For example, by adding a sweetener such as saccharin sodium and a citrus fragrance, the liquid formulation can be easily taken.

  The colloid osmotic pressure adjusting agent and / or the crystalline crystalline osmotic pressure adjusting agent contained as an active ingredient in the test composition of the present invention is airtight after adjusting the particle diameter so that each component can be mixed. It is preferable that the container is filled and sealed and placed in circulation. And it is suitable for the purpose of use to adjust the internal volume so that one package can be taken as, for example, a 400 mL liquid preparation. In particular, for easy use and convenience of use, it is preferable to adjust the internal volume so that all of the iodine compound and other components are dissolved in 350 to 450 mL in one package.

Examples of the gastrointestinal function promoter used in the test composition of the present invention include serotonin 5-HT ₄ receptor stimulants. Examples of serotonin 5-HT ₄ receptor stimulants include benzamide derivatives represented by the general formula described in Japanese Patent Publication No. 3-54937 “Claims” including mosapride citrate, cisapride, and metroclopra A mid and the like can be mentioned. Among these compounds, mosapride citrate is considered to be most preferable in terms of few side effects such as induction of arrhythmia (“Mosaprid and gastrointestinal motility” issued in 1998 by Medical Review Co., Ltd.). It is preferable that 5-40 mg of mosapride citrate is contained.

  The composition for examination of the present invention may be in any form as long as the large intestine to be examined by CT colonography is finally treated with an osmotic pressure adjusting agent, an iodine compound, and a gastrointestinal function promoter. . For example, the form which contains an osmotic pressure regulator, an iodine compound, and a digestive tract function promoter in one preparation may be sufficient, and the form which combined each individual preparation may be sufficient. You may combine the composition for gastrointestinal tract contrast containing an osmotic pressure regulator and an iodine compound, and the composition for gastrointestinal motility promotion containing a gastrointestinal tract function promoter. In the composition for gastrointestinal tract contrast, an osmotic pressure adjusting agent and an iodine compound may be combined.

  It is preferable that the test composition of the present invention is administered in conjunction with the administration of an intestinal irrigation agent that is performed as a pretreatment for CT colonography. The intestinal cleanser used at that time is composed of a combination of polyethylene glycol and an electrolyte (for example, “NIFREC” (trade name) relating to the invention disclosed in JP-A-1-125319, Ajinomoto Pharma Co., Ltd.). This intestinal rinsing agent may be used as an osmotic pressure adjusting agent.

  In general, in CT colonography examinations, it is often experienced that the presence of foamy mucus in the intestinal tract makes it difficult to read lesions from captured images. Even when the amount of liquid residue is reduced according to the present invention, foamy mucus may be present, which may make it difficult to read lesions from images. In such a case, dimethylpolysiloxane is further combined. Can be used in the pretreatment of CT colonography examination. Thereby, dimethylpolysiloxane shows a defoaming action with respect to the bubble by foamy mucus, and the reading accuracy and reading efficiency of the lesion from the image | photographed image | video can be improved.

  Conventionally, dimethylpolysiloxane has been used to improve abdominal symptoms caused by gas in the gastrointestinal fistula, remove gastric foamy mucus during gastroscopy, and eliminate gastrointestinal gas during abdominal X-ray examination However, it has never been used as a pretreatment for CT colonography. Moreover, the antifoaming action of dimethylpolysiloxane is different from the role of conventional dimethylpolysiloxane, and as a result, it is unexpected that it was possible to improve the reading accuracy and reading efficiency of lesions from captured images. .

The dimethylpolysiloxane used for the CT colonography pretreatment is usually in the range of 30 to 120 mg, preferably 40 to 80 mg at a time for an adult. In combination with a function promoter, it is orally administered simultaneously or sequentially. The products containing dimethyl polysiloxane may be used in the present invention are commercially available as the gastrointestinal tract gas Pesticides "Gascon ^(R)", and the like.

Hereinafter, the present invention will be described in more detail with reference to test examples.
Example 1: Composition for test | inspection The liquid composition for CT colonography test | inspection containing an osmotic pressure regulator, an iodine compound, and a digestive tract function promoter is prepared as follows.
2.93 g of sodium chloride, 1.49 g of potassium chloride, 3.37 g of sodium bicarbonate, 11.37 g of anhydrous sodium sulfate, 118 g of polyethylene glycol, 59.74 g of amidotrizoic acid, 629 mg of sodium hydroxide, 15.92 g of meglumine, calcium diedetate 10 mg of sodium, 200 mg of saccharin sodium, 20 mg of mosapride citrate and orange flavor are dissolved in water to make 2 L, and a liquid CT colonography test composition is prepared.

Example 2: Gastrointestinal contrast medium preparation kit 2.93 g of sodium chloride, 1.49 g of potassium chloride, 3.37 g of sodium hydrogen carbonate, 11.37 g of anhydrous sodium sulfate and 118 g of polyethylene glycol are mixed to obtain a mixed powder. .

  On the other hand, 100 mg of mosapride citrate, 59.74 g of amidotrizoic acid, 629 mg of sodium hydroxide, 15.92 g of meglumine, 10 mg of calcium disodium edetate, 200 mg of sodium saccharin, and orange flavor were dissolved in water to prepare 100 mL of sodium amidotrizoate meglumine and citric acid. An acid mosapride combination liquid is prepared.

  27.43 g of the mixed powder is filled in an oxygen and carbon dioxide gas hardly permeable plastic container body having an internal volume capable of accommodating 400 mL of an aqueous solution, and 20 mL of the sodium amidotrizoate meglumine solution is placed in a small chamber provided in the cap part of the container body. And sealed with a breakable film. This multi-chamber plastic container separately contains the powder component and the liquid component for gastrointestinal tract imaging of the present invention, and is provided with a filling port capable of filling water. After filling a predetermined amount of water from the filling port at the time of use and dissolving the powder component, the cap film is pressed to break the sealing film filled with the sodium amidotrizoate meglumine solution, and the solution containing sodium amidotrizoate meglumine and mosapride citrate And a solution of powder components can be mixed in a container.

Example 3: Composition for testing 75.6 g magnesium citrate, 40 mg mosapride citrate, 2.93 g sodium chloride, 1.49 g potassium chloride, 3.37 g sodium bicarbonate, 11.37 g anhydrous sodium sulfate, 59. amidotrizoic acid 74 g, sodium hydroxide 629 mg, meglumine 15.92 g, calcium disodium edetate 10 mg, saccharin sodium 200 mg, and orange flavor were dissolved in water to 2 L. This solution is filled and sealed in a plastic container that is hardly permeable to oxygen and carbon dioxide gas having an internal volume of 4500 mL, and sterilized by heating.

Example 4: As the antifoaming composition antifoam composition, a commercial gastrointestinal tract gas removal agent containing dimethylpolysiloxane 80mg "Gascon ^(R) Tablets" (manufactured by Kissei Pharmaceutical) was prepared.

Test example 1: Reduction of liquid residue (%) in each large intestine section by gastrointestinal function promoter (1) CT colonography test in a control example not taking a gastrointestinal motor function improving agent In the CT colonography test, a gastrointestinal motor function improving agent Was examined whether it had the effect of reducing liquid residues throughout the large intestine. About 7 elderly people who need a colorectal cancer test from 67 to 81 years old without ileus symptom, dissolve 137.16g of oral intestinal cleanser (trade name “Niflec” manufactured by Ajinomoto Pharma Co., Ltd.) in water to make 2L, Of these, 1600 mL is orally administered over about 3 hours, and then a water-soluble iodine contrast medium (trade name “Gastrografin” manufactured by Schering) is taken. Subsequently, when 400 mL of oral intestinal irrigation agent was taken, finally a water-soluble iodine contrast medium was further taken.
In addition, although 400 ml of a preparation liquid containing both a water-soluble iodine contrast medium and an intestinal tract cleaning agent may be taken, it is preferable that the iodine content in the preparation liquid is adjusted to 15 mg / ml or more.
MDCT imaging was performed at the time when the excretory fluid became transparent after taking all of the intestinal irrigant and water-soluble iodine contrast medium. For MDCT, a multi-slice CT apparatus (manufactured by Toshiba Medicals) was used. Three-dimensional image processing was performed using three-dimensional image processing software, and both a gas image and an iodinated contrast image were constructed from the data obtained by injecting carbon dioxide gas transanally and synthesizing both image data. Moreover, an axial image (FIG. 1) and a sagittal image (FIG. 2) were constructed as two-dimensional images, and liquid residue regions were measured.
The liquid residue area was measured by classifying the large intestine into five categories: cecum / ascending colon (AC), transverse colon (T), descending colon (D), sigmoid colon (S), and rectum (R). . Among them, in T and S, one slice in which the area of each section is displayed largest was selected in the axial image (FIG. 1), and the area (mm ² ) of the gas region and the liquid residue portion was measured. For measurement, polygon measurement of a 2D measurement tool was used. For AC, D, and R, the area of the liquid residue portion was similarly measured with a sagittal image (FIG. 2).
An axial image and a sagittal image can be observed in any cross section, and are important information in observing a raised lesion in the intestinal tract. It is essential in diagnosis that both images can be drawn with high accuracy.

(2) CT colonography test when taking a gastrointestinal motility improving agent For 6 elderly people who need a colorectal cancer test from 62 to 74 years old without ileus symptoms, start taking 1600 ml of intestinal cleanser in (1) Occasionally, 20 mg of mosapride citrate (trade name “Gasmotin” manufactured by Dainippon Sumitomo Pharma Co., Ltd.) is taken together with 180 ml of intestinal irrigation liquid, and when the same detergent is continuously taken over about 3 hours (the intestinal irrigation dosage is 1600 ml) ), Taking a water-soluble iodine contrast medium, followed by the remaining 400 ml of intestinal lavage fluid and water-soluble iodine contrast medium in this order. Finally, 20 mg of mosapride citrate was taken with a small amount of water. Similarly to (1), MDCT imaging was performed when the excretory liquid became transparent, and the liquid residue area was measured.

Comparison of imaging results Using the area of the two-dimensional image area where the liquid residue in the colon cavity is used as an index, comparison was made with and without taking the gastrointestinal motility function improving agent, and the results are shown in Table 1.

In a CT colonography examination, a liquid residue site can be imaged by taking a preparation liquid containing a water-soluble iodine contrast medium and an oral intestinal irrigant before the end of intestinal irrigation. From the above test results, when a gastrointestinal motility function improving agent was further blended, it was possible to obtain a prominent reduction effect in 7 of the 10 colons compared to the case where no gastrointestinal motility function improving agent was used. .
Since the laparoscopic surgery for colorectal cancer, including advanced cancer, is rapidly spreading, the composite image of both the gas image and the iodine contrast agent cannot be confirmed by touching the lesion in the current operation. It is necessary to determine the insertion position of the hole (port), the site and length of the small abdominal wound, the length of the intestinal resection, the position of the artificial anus, etc. with high accuracy in order to insert the base scope and operation canister. An image with high descriptive accuracy is useful. Furthermore, an axial image and a sagittal image can be drawn with high accuracy, and cross-sectional observation becomes easy.

Test example 2: Reduction of the total volume of liquid residue (mm ³ ) in the entire large intestine area by a gastrointestinal function promoter (1) CT colonography test in a control example that does not take a gastrointestinal motor function improving agent In the CT colonography test, gastrointestinal motility Whether the function improving agent has the effect of reducing the liquid residue throughout the large intestine was examined by actually measuring the volume of the liquid residue on the image. For 10 people who need a colon cancer test aged between 60 and 81 years without ileus symptoms, dissolve 137.16 g of oral intestinal cleanser (trade name “Nifurec” manufactured by Ajinomoto Pharma Co., Ltd.) in water to make 2 L, of which 1600 mL Is orally administered over about 3 hours, and then a water-soluble iodine contrast medium (trade name “Gastrografin” manufactured by Schering) is taken. Subsequently, when 400 mL of oral intestinal irrigation agent was taken, finally a water-soluble iodine contrast medium was further taken.
In addition, although 400 ml of a preparation liquid containing both a water-soluble iodine contrast medium and an intestinal tract cleaning agent may be taken, it is preferable that the iodine content in the preparation liquid is adjusted to 15 mg / ml or more.
MDCT imaging was performed at the time when the excretory fluid became transparent after taking all of the intestinal irrigant and water-soluble iodine contrast medium. MDCT used a multi-slice CT apparatus (manufactured by Toshiba Medical Systems). In the data obtained by transanal injection of carbon dioxide, the liquid residue in the large intestine is labeled white with a high CT value by a water-soluble iodine contrast medium. The labeled liquid residue region in the large intestine is a region that is blinded during three-dimensional interpretation in diagnosis. The volume of the blind area in the large intestine was measured with volume measurement software. The volume measurement software measures the volume of a large intestine residual liquid portion labeled in white as shown in FIGS. 5 and 6 in a region having a high CT value (200 HU to 4096 HU) in the large intestine over all slices of CT data. Was set as follows. Conventional residue area measurement was low in accuracy because it was subjectively evaluated by the interpreting physician, but objective and accurate measurement can be achieved by measuring the area labeled with contrast medium with volumetric measurement software. It has become possible.

(2) CT colonography test when taking a gastrointestinal motility improving agent About 10 people who need a colorectal cancer test from 55 to 88 years old without ileus symptoms, at the start of taking 1600 ml of intestinal cleansing agent in (1) When 20 mg of mosapride citrate (trade name “Gasmotin” manufactured by Dainippon Sumitomo Pharma Co., Ltd.) was taken with 180 ml of intestinal irrigation solution, and the same cleaning agent was subsequently taken over about 3 hours (dosage of intestinal irrigation agent was 1600 ml) Then, a water-soluble iodine contrast medium is taken, and then the remaining 400 ml of intestinal lavage fluid and a water-soluble iodine contrast medium are taken in this order. Finally, 20 mg of mosapride citrate was taken with a small amount of water. Similarly to (1), MDCT imaging was performed when the excretory liquid became transparent, and the liquid residue area was measured with volume measurement software.

Comparison of imaging results Using the volume of the image area covered by the liquid residue in the colon cavity as an index, a comparison was made between the case of not taking the gastrointestinal motility improving agent (Table 2) and the case of taking it (Table 3). When the Wilcoxon rank sum test was performed on these, the two-sided P value was 0.0185 (<0.05), and the residual liquid decreased statistically significantly.

From the results of Test Example 2, when blended with gastrointestinal motor function improving agent (average of about 140,000 mm ³⁾ is compared with the case of not using the gastrointestinal motor function improving agent (average of about 278,000 mm ³⁾ As a result, the total amount of liquid residue throughout the large intestine was reduced to about half, and a remarkable reduction effect was obtained.
From the results of Test Example 1 and Test Example 2 above, a pretreatment agent comprising an oral intestinal lavage fluid containing an osmotic pressure adjusting agent and a water-soluble gastrointestinal contrast agent such as an iodine contrast agent and a gastrointestinal motility function improving agent. It was shown that the amount of liquid residue was significantly small throughout the large intestine section (Test Example 1), and the effect of significantly reducing the total amount of liquid residue in the large intestine was observed (Test Example 2).
.
In this way, the present invention solves the problems that have required long interpretation time, acquisition of diagnostic techniques, and interpretation experience of the interpreter by increasing the number of 3D image regions that are easy to interpret in CT colonography. Is.

Test Example 3: Defoaming of liquid residue using dimethylpolysiloxane (1) Similar to Test Example 2 (2), 20 mg of mosapride citrate (trade name “Gasmotin” Sumitomo Dainippon at the start of taking 1600 ml of intestinal cleanser Pharmaceutical Co., Ltd.) was taken with 180 ml of intestinal irrigation solution, and when the same detergent was subsequently taken over about 3 hours (intestinal irrigation dose was 1600 ml), followed by taking a water-soluble iodine contrast agent, followed by dimethyl commercially available gut gas disinfection agent containing a polysiloxane 80mg "Gascon ^(R) tablets" (manufactured by Kissei Pharmaceutical) and the remainder of the intestinal tract cleaning solution 400 ml, taking the order of the water-soluble iodinated contrast agents. Finally, 20 mg of mosapride citrate was taken with a small amount of water.
MDCT imaging was performed at the point of time when the excretory fluid became transparent as in Test Example 2 (2).
In the test of Test Example 2 (2), the image of the site where the foamy mucus was present (in the colon cavity) (FIG. 3) and the image of the same site when dimethylpolysiloxane was administered (FIG. 4) were compared. In the former, the waving state due to foaming of the liquid residue in the colon lumen is observed, whereas in the latter, the bubbles disappear completely and the liquid residue in the colon lumen is flat because there is no foam. It turns out that it is. This clearly improves the reading accuracy and reading efficiency of the lesion.

Claims (13)

For improving the reading accuracy and reading efficiency of lesions in CT colonography, which is a combination of one or more osmotic pressure regulators selected from polyethylene glycol, magnesium citrate, ascorbic acid and sodium ascorbate, iodine compounds, and dimethylpolysiloxane Medicine . The lesion according to claim 1, comprising a combination of dimethylpolysiloxane and a composition for gastrointestinal imaging comprising at least one osmotic pressure regulator selected from polyethylene glycol, magnesium citrate, ascorbic acid and sodium ascorbate and an iodine compound. For improving reading accuracy and reading efficiency . The composition for gastrointestinal imaging is a combination of an iodine compound and an intestinal irrigation composition containing at least one osmotic pressure regulator selected from polyethylene glycol, magnesium citrate, ascorbic acid and sodium ascorbate, The medicament for improving the reading accuracy and reading efficiency of a lesion according to claim 1 or 2 . The pharmaceutical composition for improving lesion reading accuracy and reading efficiency according to claim 2 or 3, wherein the composition for gastrointestinal tract imaging is a liquid preparation of 350 to 450 mL in which the iodine compound content is adjusted to 15 mg / mL or more . The medicament for improving the reading accuracy and reading efficiency of a lesion according to claim 5, wherein the iodine compound content is adjusted to 18 to 19 mg / mL . Seo the osmotic agent Rubitoru, xylitol, erythritol, mannitol, trehalose, lactitol, lactulose, maltitol, claims 1-5 contained the palatinose, raffinose, and at least one saccharide selected from the group consisting of sucrose and glycerin The medicament for improving the reading accuracy and reading efficiency of a lesion according to any one of the above . The medicine for improving the reading accuracy and reading efficiency of a lesion according to any one of claims 1 to 6, wherein the iodine compound content is 15 to 90 mg / mL. The osmotic pressure adjusting agent has Na ⁺ of 30 to 150 mEq / L, K ^{+ of 3} to 20 mEq / L, Cl ^−.
The medicament for improving the reading accuracy and reading efficiency of a lesion according to any one of claims 1 to 7, which comprises an electrolyte such that is 20 to 70 mEq / L. The medicament for improving the reading accuracy and reading efficiency of a lesion according to any one of claims 1 to 8, which is contained in a plastic container that is hardly permeable to oxygen and carbon dioxide . A gas image and an iodine contrast image of the large intestine processed with a medicine for improving the reading accuracy and reading efficiency of a lesion in CT colonography examination according to any one of claims 1 to 9 are constructed by MDCT imaging, and both image data An image processing method characterized by combining the above. A method for constructing an iodine contrast image in CT colonography, comprising using the medicine for improving lesion reading accuracy and reading efficiency in CT colonography examination according to any one of claims 1 to 9 to construct an iodine contrast image. .   The method for constructing an iodine contrast image in CT colonography according to claim 11, wherein the liquid residue existing in the large intestine is constructed as an iodine contrast image. A lesion in CT colonography examination according to any one of claims 1 to 9, wherein a gas image and an iodine contrast image of the large intestine are constructed by MDCT imaging, and both image data are synthesized. Of using a medicament for improving the reading accuracy and reading efficiency of a tablet.