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JPH07300430A - Reagent for clinical analysis of gastric discharge function - Google Patents

Reagent for clinical analysis of gastric discharge function

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Publication number
JPH07300430A
JPH07300430A JP6114479A JP11447994A JPH07300430A JP H07300430 A JPH07300430 A JP H07300430A JP 6114479 A JP6114479 A JP 6114479A JP 11447994 A JP11447994 A JP 11447994A JP H07300430 A JPH07300430 A JP H07300430A
Authority
JP
Japan
Prior art keywords
gastric
stomach
gastric emptying
test
pills
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
JP6114479A
Other languages
Japanese (ja)
Other versions
JP2858295B2 (en
Inventor
Akira Torii
明 鳥居
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Individual
Original Assignee
Individual
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Filing date
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Priority to JP6114479A priority Critical patent/JP2858295B2/en
Publication of JPH07300430A publication Critical patent/JPH07300430A/en
Application granted granted Critical
Publication of JP2858295B2 publication Critical patent/JP2858295B2/en
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Expired - Lifetime legal-status Critical Current

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Abstract

PURPOSE:To enable analysis of gastric discharge function even by a general clinical doctor, safe and ready measurement of hypofunction of gastric discharge even by a general clinical doctor, understanding of the morbid state by a patient and useful diagnosis and therapy under a condition in which the patient feels easy. CONSTITUTION:This reagent for clinic analysis of gastric discharge function is prepared by using sugar as a core material of a barium particle, hardening the surface of the barium particle with methyl cellulose, controlling the size so that the maximum diameter may be <=3.2mm and encapsulating many particles in a capsule soluble in the stomach.

Description

【発明の詳細な説明】Detailed Description of the Invention

【0001】[0001]

【産業上の利用分野】本発明は胃排出機能検査剤に関す
るもので、一般臨床医でも安全で簡便に施行可能な胃排
出機能検査ができるようにし、且つ胃排出機能の低下を
客観的に判定し、さらにその病態を患者に理解してもら
い、その患者の安心のもとに、診断および治療に役立て
ることを目的とする。
BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a gastric emptying function test agent, which enables a general clinician to perform a gastric emptying function test which is safe and easy to perform, and objectively determines a decrease in gastric emptying function. In addition, the purpose is to make the patient understand the condition and to use it for diagnosis and treatment with the patient's peace of mind.

【0002】[0002]

【従来の技術】近年、胃のもたれや胸焼け、食欲不振な
どの原因として胃排出機能の低下が注目されており、そ
れを客観的に評価する検査として種々の方法が試みられ
ている。従来の代表的な胃排出機能検査法としては直接
法のアイソト−プ法、間接法のアセトアミノフェン法が
あげられる。また、直接法としてX線不透過性マ−カ−
を用いて胃排出機能の検査をする方法も試みられてい
る。
2. Description of the Related Art In recent years, a decrease in gastric emptying function has been attracting attention as a cause of stomach upset, heartburn, loss of appetite, etc., and various methods have been attempted as tests for objectively evaluating it. As typical conventional gastric emptying function test methods, there are a direct method, an isotope method, and an indirect method, an acetaminophen method. As a direct method, a radiopaque marker is used.
A method for examining gastric emptying function using the method has also been attempted.

【0003】[0003]

【発明が解決しようとする課題】しかしながら、前記の
アイソト−プ法は放射性同位元素を使用するため管理が
煩雑であり、測定に用いるガンマカメラも高価であっ
て、その使用は専門施設に限られてしまう。一方、アセ
トアミノフェン法は解熱剤であるアセトアミノフェンを
常用量以上に内服する必要があり、肝障害、薬剤アレル
ギ−の発症も予想される。さらに間接法であるため、小
腸での吸収、肝臓での代謝、腎臓からの排泄などの影響
を受け易い。検査の対象も流動試験食に限られてしま
う。また、超音波法は、検査する者が熟練であることを
必要とする。これらの問題点を有するため、従来の胃排
出機能検査は、一般臨床の場では十分な普及をみていな
い。さらに、従来存在しているX線不透過性マ−カ−法
にあっては、本来は腸内排出機能検査を目的に作製され
たものであり、マ−カ−自体が最小でも長さ4.0mm
以上、通常で1.0cm程度の固形体であるため、食物
と同時に幽門より排出されず、食物が全て排出された後
の空腹時強収縮により排出される。そのため、本来の食
物の排出機能を正確に検査することはできなかった。
However, since the above-mentioned isotope method uses a radioactive isotope, the management is complicated and the gamma camera used for measurement is expensive, and its use is limited to specialized facilities. Will end up. On the other hand, in the acetaminophen method, it is necessary to take acetaminophen, which is an antipyretic drug, at a dose higher than the usual dose, and it is expected that liver damage and drug allergy will occur. Furthermore, since it is an indirect method, it is easily affected by absorption in the small intestine, metabolism in the liver, excretion from the kidney, and the like. The subject of inspection is limited to the fluid test meal. In addition, the ultrasonic method requires the examiner to be skilled. Due to these problems, the conventional gastric emptying function test has not been widely used in general clinical situations. In addition, the conventional radiopaque marker method was originally prepared for the purpose of examining the intestinal excretion function, and the marker itself has a minimum length of 4 mm. 0.0 mm
As described above, since the solid is usually about 1.0 cm, it is not discharged from the pylorus at the same time as food, but is discharged by the fasting fast contraction after all food is discharged. Therefore, it was not possible to accurately test the original food discharge function.

【0004】[0004]

【課題を解決するための手段】そこで、食物の胃排出と
同調するX線不透過マ−カ−を作製することによって、
本発明の目的を達成し、且つ従来技術の課題を解決する
ために提供するものである。すなわち、本発明は、胃排
出機能検査剤において、砂糖をバリウム粒子の芯材と
し、そのバリウム粒子の表面をメチルセルロ−スで固め
て最大直径3.2mm以下を可とする丸剤の多数個を胃
溶性カプセルの中に封入したものである。
Therefore, by producing a radiopaque marker that is synchronized with gastric emptying of food,
The present invention is provided to achieve the object of the present invention and solve the problems of the prior art. That is, the present invention relates to a gastric emptying function test agent, wherein sugar is used as a core material of barium particles, and the surface of the barium particles is solidified with methyl cellulose to obtain a large number of pills having a maximum diameter of 3.2 mm or less. It is encapsulated in a gastric-soluble capsule.

【0005】[0005]

【作用】上記の手段に基づく胃排出機能検査剤を用いた
作用を説明する。まず、患者等の被検査者は所定時間を
絶飲絶食とし、多数個のバリウム丸剤を詰めた所定数の
胃溶性カプセルを所定量の水で内服し、試験食として設
定量の半固形食を摂取する。内服したカプセルは胃内で
溶解し、1カプセル内より胃排出機能検査剤の多数個が
放出され、放出された多数個の検査剤は試験食と混和さ
れ、順次に幽門より排出される。カプセル内服後の所定
時間時間後に所定量の発泡剤を所定量の水で内服し、そ
の直後に腹部単純X線写真を、左側臥位側面と仰臥正面
で撮影する。発泡剤内服により、胃の位置を描出し、撮
影時の体位変換で胃内丸剤の重なりを防ぐ。胃内残存検
査剤数と内服検査剤全個数との比を胃内残存率として%
で表し、胃排出機能の指標とする。
The operation of the gastric emptying function test agent based on the above means will be described. First, a subject such as a patient fasted for a predetermined period of time and took a prescribed number of gastric-soluble capsules filled with a large number of barium pills with a prescribed amount of water, and a semisolid diet of a set amount as a test diet. Ingest. The orally-administered capsule dissolves in the stomach, and a large number of gastric emptying function test agents are released from one capsule. The released multiple test agents are mixed with the test meal and sequentially discharged from the pylorus. A predetermined amount of foaming agent is orally administered with a predetermined amount of water after a predetermined time after the oral administration of capsules, and immediately after that, plain abdominal X-ray photographs are taken on the left lateral side and the supine front. By taking an effervescent drug, the position of the stomach is visualized, and the position of the stomach is changed to prevent overlapping of the pills in the stomach. The ratio of the number of residual test agents in the stomach to the total number of test agents taken orally is defined as the residual rate in the stomach.
, And is used as an index of gastric emptying function.

【0007】[0007]

【実施例】次に、本発明の実施例を図面を以て説明す
る。図5において1は胃排出機能検査用の丸剤であり、
砂糖(ノンパレル)をバリウム粒子3の芯材2とし、且
つそのバリウム粒子の表面をメチルセルロ−ス4で固め
て最大直径3.2mm、最小直径1.0mm、好ましく
は2.0mmに設定する。前記の丸剤は、バリウム粒子
3によりX線を通さない不透過の性質を有している。図
6において5は胃溶性カプセルであり、前記の丸剤1を
多数個、好ましくは20個単位で封入できる大きさに設
定する。
Embodiments of the present invention will now be described with reference to the drawings. In FIG. 5, 1 is a pill for gastric emptying function test,
Sugar (non-pareil) is used as the core material 2 of barium particles 3, and the surface of the barium particles is hardened with methyl cellulose 4 to have a maximum diameter of 3.2 mm and a minimum diameter of 1.0 mm, preferably 2.0 mm. The above-mentioned pills have the property of being impermeable to X-rays due to the barium particles 3. In FIG. 6, reference numeral 5 denotes a gastric-soluble capsule, which is set to a size capable of enclosing a large number of the pills 1, preferably 20 units.

【0008】[0008]

【具体的な検査例】まず、検査法を基準化すると、マ−
カ−としては直径2.0mmのX線不透過性の検査用丸
剤を合計40個を使用し、体位は座位で、試験食は白粥
250gである。白粥はもたれなどの消化器症状を有す
る場合の一般的な食事である。時間は3時間で判定し、
解読には胃内残存率を用いる。上記の試験食として用い
る白粥は、レトルトパウチ食品で、1パック250g、
105kcalの全粥を用いる。また、本検査で使用するカ
プセル5はゼラチンによる胃溶性カプセルであり、砂糖
(ノンパレル)を芯材2とするバリウム粒子3はメチル
セルロ−ス4で固められている。その丸剤1は20個単
位でカプセル5に封入しておく。そして、被検査者は検
査前12時間を絶飲絶食とし、20個の検査用の丸剤1
を詰めた胃溶性カプセル5を2個宛30ccの水で内服
し、試験食として白粥250gを摂取する。内服したカ
プセル5は胃内で溶解し、各カプセル内より直径1.0
mm〜3.2mm、好ましくは2.0mmのバリウム粒
子20個が放出され、合計40個の丸剤は白粥と混和さ
れ、順次に幽門より排出される。カプセル内服1時間
(図5)、2時間(図6)、3時間(図7)後に発泡剤
4.0gを30ccの水で内服し、その直後に腹部単純
X線写真を、左側臥位側面と仰臥正面で撮影する。発泡
剤内服により、胃の位置を描出し、撮影時の体位変換で
胃内丸剤の重なりを防ぐ。胃内残存丸剤数と内服丸剤全
個数との比を胃内残存率として%で表し、胃排出機能の
指標とする。
[Specific inspection example] First, if the inspection method is standardized,
As the car, a total of 40 X-ray opaque test pills having a diameter of 2.0 mm were used, the posture was sitting, and the test meal was 250 g of white porridge. White porridge is a common diet when you have digestive symptoms such as lean. Judgment time is 3 hours,
The residual rate in the stomach is used for decoding. The white porridge used as the test food is a retort pouch food, 250 g per pack,
Use 105kcal whole porridge. Further, the capsule 5 used in this test is a stomach-soluble capsule made of gelatin, and the barium particles 3 having the core material 2 of sugar (nonpareil) are solidified with methylcellulose 4. The pills 1 are sealed in capsules 5 in units of 20. Then, the person to be inspected fasted for 12 hours before the inspection, and 20 pills for inspection 1
Gastric-soluble capsules 5 filled with is orally taken with 30 cc of water each and 250 g of white porridge is taken as a test meal. The capsules 5 taken internally dissolve in the stomach and have a diameter of 1.0 from each capsule.
Twenty barium particles of mm-3.2 mm, preferably 2.0 mm are released, a total of 40 pills are admixed with the white porridge and sequentially discharged from the pylorus. After 1 hour (Fig. 5), 2 hours (Fig. 6) and 3 hours (Fig. 7) of the capsule, 4.0g of effervescent was taken with 30cc of water. Immediately after that, a plain abdominal X-ray photograph was taken on the left lateral lateral position. And shoot in the supine front. By taking an effervescent drug, the position of the stomach is visualized, and the position of the stomach is changed to prevent overlapping of the pills in the stomach. The ratio of the number of remaining pills in the stomach to the total number of oral pills is expressed as a percentage of remaining in the stomach and is used as an index of gastric emptying function.

【0009】[0009]

【具体的な検査結果】健常者15名の胃内残存率の変化
を示す。検査用の丸剤1は胃内において食物と混和し、
且つその食物と同調して幽門より排出され、胃液中でも
安定性があり、非吸収性であると共に、X線不透過性に
優れ、X線フィルム上で容易に確認できる。そして、1
時間値平均84.2±18.6%、2時間値49.2±
32.3%、3時間値11.0±9.4%であり、1時
間のlag phase の後に直線的減少が認められた(図
1)。検査前にシサプリドを投与すると、胃内残存率
は、1時間値60.4±24.4%、2時間値5.4±
5.5%、3時間値2.1±3.0%と、1時間・2時
間において有意に減少しており、排出機能の促進が認め
られた(図2)。これに対し、検査前にスコポラミンブ
チルブロマイドを投与すると、胃内残存率は、1時間値
95.6±4.8%、2時間値86.3±14.8%、
3時間値56.9±42.0%と、2時間値で有意に増
加しており、排出機能の低下が示された(図3)。さら
に、食欲不振、もたれなどの症状を有する患者では、胃
内残存率は1時間、2時間、3時間値とも99.2±
1.2%といずれも有意に増加しており、症状の原因が
排出機能の低下によることが証明された(図4)。な
お、診断基準は平均±3SDで正常範囲を設定し、3時
間値40%以上を胃排出機能低下と診断する。
[Specific test results] Changes in the gastric residual rate of 15 healthy subjects are shown. The test pill 1 mixes with food in the stomach,
Moreover, it is excreted from the pylorus in synchronism with the food, is stable in gastric juice, is non-absorbable, and has excellent radiopacity, and can be easily confirmed on an X-ray film. And 1
Time value average 84.2 ± 18.6%, 2-hour value 49.2 ±
32.3%, 3 hours value was 11.0 ± 9.4%, and a linear decrease was observed after 1 hour of lag phase (FIG. 1). When cisapride was administered before the test, the gastric residual rate was 60.4 ± 24.4% for 1 hour and 5.4 ± 2 hours for 2 hours.
The value was 5.5% and the value at 3 hours was 2.1 ± 3.0%, which was significantly decreased in 1 hour and 2 hours, and promotion of the excretion function was observed (FIG. 2). In contrast, when scopolamine butyl bromide was administered before the test, the gastric residual rate was 95.6 ± 4.8% for 1 hour and 86.3 ± 14.8% for 2 hours.
The 3-hour value was 56.9 ± 42.0%, which was significantly increased at the 2-hour value, indicating a decrease in the excretory function (FIG. 3). Furthermore, in patients with symptoms such as anorexia and leaning, the gastric residual rate was 99.2 ± for all 1 hour, 2 hours and 3 hours values.
It was significantly increased to 1.2%, and it was proved that the cause of the symptom was a decrease in excretory function (FIG. 4). The diagnostic standard is set to a normal range with an average of ± 3 SD, and a 3 hour value of 40% or more is diagnosed as gastric emptying function decline.

【0009】[0009]

【発明の効果】本発明は上記の構成および作用であるか
ら、検査する者は熟練を要せず、X線撮影装置を有する
施設であれば一般診療所でも実施可能である。安全性に
関しては検査による合併症はなく、肝障害、腎障害患者
でも安全である。浸襲は、X線を被爆するが、腹部単純
X線撮影の範囲である。有効性は胃排出機能を経時的に
定量的に客観評価できるということで、胃排出機能低下
の診断および治療に有用といえる。また、非浸襲的であ
るから患者等の被検査者に苦痛を与えることがない。従
って、X線撮影装置を有する施設であれば、誰でもどこ
でも安全、簡便に測定可能であり、また胃排出機能を視
覚的に単純とらえることがてきるため、患者に病態を説
明する際にも説得性がある。さらに、直接法のため胃の
排出機能を正確に反映し、感度、特異性、再現性に優れ
ており、しかも検査にかかる費用も低廉に抑えることが
できる。なお、症状群としての non-ulcerdyspepsia に
対し、機能障害を中心に考えた症候群としての「胃排出
機能低下症」という症患概念を確立し、その診断および
治療に役立つ胃排出機能検査方法の一般化が、保険適応
も含め、早急に必要である期待に応えられる。さらに、
バリウム丸剤は胃排出機能の低下を安全に且つ簡便に測
定し、さらにその病態つき患者の理解を得て、積極的に
検査を受けて貰うことが可能であり、日常診療における
「胃排出機能低下症」の診断および治療に新規有益であ
る。
Since the present invention has the above-described structure and operation, the examiner does not need to be skilled and can be implemented in general clinics as long as the facility has an X-ray imaging apparatus. Regarding safety, there are no complications due to examination, and it is safe for patients with liver and kidney disorders. The invasion is exposed to X-rays but is within the range of plain abdominal radiography. Efficacy can be said to be useful for the diagnosis and treatment of gastric emptying function decline, as it allows a quantitative objective evaluation of gastric emptying function over time. In addition, since it is non-invasive, it does not cause pain to a subject such as a patient. Therefore, any facility that has an X-ray radiographer can safely and easily measure the gastrointestinal function, and since the gastric emptying function can be visually grasped, it is possible to explain the condition to the patient. Persuasive. Further, since the direct method accurately reflects the gastric emptying function, it has excellent sensitivity, specificity and reproducibility, and the cost for the examination can be kept low. In addition, for non-ulcerdyspepsia as a symptom group, we established a concept of "gastric emptying function" as a syndrome mainly focusing on dysfunction, and established a general gastric emptying function test method useful for its diagnosis and treatment. It is possible to meet the urgent need for employment, including insurance adaptation. further,
Barium pills can safely and conveniently measure the decline in gastric emptying function, and with the understanding of patients with pathological conditions, they can be positively tested, and the "gastric emptying function" in daily medical care can be used. It is a new benefit for the diagnosis and treatment of "hypophemia".

【図面の簡単な説明】[Brief description of drawings]

【図1】 本発明に係る丸剤を使用した胃排出機能検査
において、健常者の時間経過ごとの胃内残存率を示すグ
ラフである。
FIG. 1 is a graph showing the residual rate in the stomach of healthy subjects over time in a gastric emptying function test using the pill according to the present invention.

【図2】 本発明に係る丸剤を使用した胃排出機能検査
において、シサプリド前投与群の時間経過ごとの胃内残
存率を示すグラフである。
FIG. 2 is a graph showing the gastric residual rate in the pre-administered cisapride group over time in the gastric emptying function test using the pill according to the present invention.

【図3】 本発明に係る丸剤を使用した胃排出機能検査
において、スコポラブチクルブロマイド前投与群の時間
経過ごとの胃内残存率を示すグラフである。
FIG. 3 is a graph showing a gastric residual ratio in a pre-administration group of scopolbutycur bromide with time in a gastric emptying function test using the pill according to the present invention.

【図4】 本発明に係る丸剤を使用した胃排出機能検査
において、有症状群の時間経過ごとの胃内残存率を示す
グラフである。
FIG. 4 is a graph showing the gastric residual rate in the symptom group over time in a gastric emptying function test using the pill according to the present invention.

【図5】 1時間経過における丸剤の胃内残存状態を示
す概略図である。
FIG. 5 is a schematic diagram showing the state of pills remaining in the stomach after 1 hour.

【図6】 2時間経過における丸剤の胃内残存状態を示
す概略図である。
FIG. 6 is a schematic diagram showing the state of pills remaining in the stomach after 2 hours.

【図7】 3時間経過における丸剤の胃内残存状態を示
す概略図である。
FIG. 7 is a schematic view showing the state of pills remaining in the stomach after 3 hours.

【図8】 本発明に係る丸剤の拡大縦断面図である。FIG. 8 is an enlarged vertical sectional view of a pill according to the present invention.

【図9】 本発明に係る丸剤を多数個封入した胃溶性カ
プセルの拡大正面図である。
FIG. 9 is an enlarged front view of a gastric-soluble capsule containing a large number of pills according to the present invention.

【符号の説明】[Explanation of symbols]

1 丸剤 2 砂糖から成る芯材 3 バリウム粒子 4 メチルセルロ−ス 5 胃溶性カプセル 1 Pills 2 Core material consisting of sugar 3 Barium particles 4 Methylcellulose 5 Gastric soluble capsule

Claims (1)

【特許請求の範囲】[Claims] 【請求項1】 砂糖をバリウム粒子の芯材とし、そのバ
リウム粒子の表面をメチルセルロ−スで固め、最大直径
3.2mm以下を可とする複数の丸剤を胃溶性カプセル
の中に封入したことを特徴とする胃排出機能検査剤。
1. Sugar as a core material of barium particles, the surface of the barium particles is hardened with methyl cellulose, and a plurality of pills having a maximum diameter of 3.2 mm or less are enclosed in a gastric-soluble capsule. A gastric emptying function test agent characterized by:
JP6114479A 1994-04-29 1994-04-29 Gastric emptying function test agent Expired - Lifetime JP2858295B2 (en)

Priority Applications (1)

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Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP6114479A JP2858295B2 (en) 1994-04-29 1994-04-29 Gastric emptying function test agent

Publications (2)

Publication Number Publication Date
JPH07300430A true JPH07300430A (en) 1995-11-14
JP2858295B2 JP2858295B2 (en) 1999-02-17

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Family Applications (1)

Application Number Title Priority Date Filing Date
JP6114479A Expired - Lifetime JP2858295B2 (en) 1994-04-29 1994-04-29 Gastric emptying function test agent

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001097863A1 (en) * 2000-06-21 2001-12-27 Otsuka Pharmaceutical Co., Ltd. PREPARATIONS FOR MEASURING GASTRIC pH VALUE AND METHOD OF MEASURING GASTRIC pH VALUE BY USING THE SAME
JP2002200065A (en) * 2000-12-31 2002-07-16 Yasuto Takeuchi Method and apparatus for x-ray diffraction image contrast by microballoons
US10228365B2 (en) 2012-08-20 2019-03-12 Otsuka Pharmaceutical Co., Ltd. Method for measuring carbohydrate metabolism ability, and composition for use in said method
US10444229B2 (en) 2013-03-15 2019-10-15 Otsuka Pharmaceutical Co., Ltd. Method of measuring insulin resistance with fatty acid combustion, and composition used herein

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001097863A1 (en) * 2000-06-21 2001-12-27 Otsuka Pharmaceutical Co., Ltd. PREPARATIONS FOR MEASURING GASTRIC pH VALUE AND METHOD OF MEASURING GASTRIC pH VALUE BY USING THE SAME
JP2002200065A (en) * 2000-12-31 2002-07-16 Yasuto Takeuchi Method and apparatus for x-ray diffraction image contrast by microballoons
US10228365B2 (en) 2012-08-20 2019-03-12 Otsuka Pharmaceutical Co., Ltd. Method for measuring carbohydrate metabolism ability, and composition for use in said method
US10444229B2 (en) 2013-03-15 2019-10-15 Otsuka Pharmaceutical Co., Ltd. Method of measuring insulin resistance with fatty acid combustion, and composition used herein

Also Published As

Publication number Publication date
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