JP6830620B2 - Non-steroidal analgesics Prevent and / or improve small bowel injury - Google Patents
Non-steroidal analgesics Prevent and / or improve small bowel injury Download PDFInfo
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- JP6830620B2 JP6830620B2 JP2016162698A JP2016162698A JP6830620B2 JP 6830620 B2 JP6830620 B2 JP 6830620B2 JP 2016162698 A JP2016162698 A JP 2016162698A JP 2016162698 A JP2016162698 A JP 2016162698A JP 6830620 B2 JP6830620 B2 JP 6830620B2
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Description
本発明は、非ステロイド系鎮痛薬起因性小腸傷害予防及び／又は改善剤に関する。 The present invention relates to a non-steroidal analgesic-induced small intestinal injury prevention and / or ameliorating agent.
非ステロイド系鎮痛薬（ＮＳＡＩＤｓ：Non-Steroidal Anti-Inflammatory Drug）は、脳血管障害や心疾患の予防薬、関節痛の鎮痛薬として広く用いられている医薬品であり、その使用量は年々増加傾向にある。それに伴い、ＮＳＡＩＤｓ起因性上部消化管粘膜傷害が急増している。
ＮＳＡＩＤｓ起因性胃傷害について、特許文献１には、非ステロイド性解熱鎮痛消炎剤による胃粘膜障害を軽減するトラネキサム酸及び有胞子性乳酸菌を含有する医薬組成物が開示されている。
一方、ＮＳＡＩＤｓ起因性小腸傷害に関しては、特許文献２に、ＮＳＡＩＤｓ等により誘発される小腸障害を予防及び／又は治療するためのアルギン酸塩を含有する組成物が開示されているものの、さらに新規な予防・改善剤が求められている。
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are drugs widely used as preventive drugs for cerebrovascular disorders and heart diseases, and analgesics for arthralgia, and their usage is increasing year by year. It is in. Along with this, NSAIDs-induced upper gastrointestinal mucosal injuries are increasing rapidly.
Regarding gastric injury caused by NSAIDs, Patent Document 1 discloses a pharmaceutical composition containing tranexamic acid and spore-forming lactic acid bacteria that reduce gastric mucosal damage caused by a non-steroidal antipyretic analgesic and anti-inflammatory drug.
On the other hand, regarding NSAIDs-induced small intestinal injury, although Patent Document 2 discloses a composition containing alginate for preventing and / or treating small intestinal disorder induced by NSAIDs and the like, further novel prevention・ Improvement agents are required.
本発明の目的は、ＮＳＡＩＤｓ起因性小腸傷害に対する新規な予防・改善剤を提供することにある。 An object of the present invention is to provide a novel preventive / ameliorating agent for NSAIDs-induced small intestinal injury.
本発明によれば、以下の非ステロイド系鎮痛薬起因性小腸傷害予防及び／又は改善剤等を提供できる。
１．乳酸菌を有効成分として含有することを特徴とする非ステロイド系鎮痛薬起因性小腸傷害予防及び／又は改善剤。
２．前記乳酸菌がラクトバチルス属乳酸菌であることを特徴とする、１に記載の非ステロイド系鎮痛薬起因性小腸傷害予防及び／又は改善剤。
３．前記乳酸菌がラクトバチルス・ガセリ（Lactobacillus gasseri）ＯＬＬ ２７１６（ＦＥＲＭ ＢＰ−６９９９）であることを特徴とする、１に記載の非ステロイド系鎮痛薬起因性小腸傷害予防及び／又は改善剤。
４．前記乳酸菌の菌数のヒトに対する１日当たりの投与量が１×１０８〜５×１０１０個であることを特徴とする、１〜３のいずれかに記載の非ステロイド系鎮痛薬起因性小腸傷害予防及び／又は改善剤。
５．摂取後１週間で非ステロイド系鎮痛薬起因性小腸傷害改善効果を奏することを特徴とする、１〜４のいずれかに記載の非ステロイド系鎮痛薬起因性小腸傷害予防及び／又は改善剤。
According to the present invention, the following non-steroidal analgesic-induced small intestinal injury prevention and / or ameliorating agents can be provided.
1. 1. A non-steroidal analgesic-induced small intestinal injury preventive and / or ameliorating agent containing lactic acid bacteria as an active ingredient.
2. 2. The non-steroidal analgesic-induced small intestinal injury prevention and / or ameliorating agent according to 1, wherein the lactic acid bacterium is a lactic acid bacterium belonging to the genus Lactobacillus.
3. 3. The non-steroidal analgesic-induced small intestinal injury preventive and / or ameliorating agent according to 1, wherein the lactic acid bacterium is Lactobacillus gasseri OLL 2716 (FERM BP-6999).
4. The non-steroidal analgesic-induced small intestinal injury according to any one of 1 to 3, wherein the daily dose of the lactic acid bacterium to a human is 1 × 10 8 to 5 × 10 10. Preventive and / or improver.
5. The non-steroidal analgesic-induced small intestinal injury prevention and / or ameliorating agent according to any one of 1 to 4, which exhibits a non-steroidal analgesic-induced small intestinal injury improving effect one week after ingestion.
本発明によれば、ＮＳＡＩＤｓ起因性小腸傷害に対する新規な予防・改善剤を提供することができる。 According to the present invention, it is possible to provide a novel preventive / ameliorating agent for NSAIDs-induced small intestinal injury.
本発明の非ステロイド系鎮痛薬起因性小腸傷害予防及び／又は改善剤は、乳酸菌を有効成分として含有することを特徴とする。
乳酸菌は、ヨーグルト、チーズ、バター、漬物等の発酵食品に使用され、一般的に食習慣があることから、本発明の非ステロイド系鎮痛薬起因性小腸傷害予防及び／又は改善剤は、摂取する際に抵抗感がなく、摂取しやすいものとすることができる。
また、乳酸菌は摂取した際に副作用が殆どないことから、本発明の非ステロイド系鎮痛薬起因性小腸傷害予防及び／又は改善剤は、副作用が殆どないものとすることができる。
The non-steroidal analgesic-induced small intestinal injury preventive and / or ameliorating agent of the present invention is characterized by containing lactic acid bacteria as an active ingredient.
Lactic acid bacteria are used in fermented foods such as yogurt, cheese, butter, and pickles, and since they generally have eating habits, the non-steroidal analgesic-induced small bowel injury prevention and / or ameliorating agent of the present invention is ingested. It can be made easy to ingest without a feeling of resistance.
In addition, since lactic acid bacteria have almost no side effects when ingested, the non-steroidal analgesic-induced small intestinal injury preventive and / or ameliorating agent of the present invention can be considered to have almost no side effects.
本明細書中において、「非ステロイド系鎮痛薬起因性小腸傷害」とは、非ステロイド系鎮痛薬を服用することに起因して発生する小腸の傷害をいうものとする。具体的には、発赤、びらん、潰瘍等の疾患のほか、痛みや嘔吐等の患者のＱＯＬを低下させるような症状も含むものとする。
本発明の非ステロイド系鎮痛薬起因性小腸傷害予防及び／又は改善剤を摂取することにより、非ステロイド系鎮痛薬起因性小腸傷害を予防したり、改善したりする効果を奏する。
In the present specification, "non-steroidal analgesic-induced small intestinal injury" refers to injury of the small intestine caused by taking a non-steroidal analgesic. Specifically, in addition to diseases such as redness, erosion, and ulcer, symptoms such as pain and vomiting that lower the patient's QOL are also included.
By ingesting the non-steroidal analgesic-induced small intestinal injury prevention and / or ameliorating agent of the present invention, the effect of preventing or ameliorating the non-steroidal analgesic-induced small intestinal injury is exhibited.
本発明において使用する乳酸菌は、糖類を資化して乳酸を生成するものであれば、その属や種や由来等は任意である。なかでも、ラクトバチルス属の乳酸菌が好ましく、特に、ラクトバチルス・ガセリ（Lactobacillus gasseri）が好ましい。より具体的には、ラクトバチルス・ガセリ（Lactobacillus gasseri）ＯＬＬ ２７１６（ＦＥＲＭ ＢＰ−６９９９）を好適に用いることができる。 The lactic acid bacterium used in the present invention has any genus, species, origin, etc. as long as it assimilate saccharides to produce lactic acid. Among them, lactic acid bacteria of the genus Lactobacillus are preferable, and Lactobacillus gasseri is particularly preferable. More specifically, Lactobacillus gasseri OLL 2716 (FERM BP-6999) can be preferably used.
本発明の実施形態では、乳酸菌の菌数のヒトに対する１日当たりの投与量が１×１０８〜５×１０１０個であることが好ましい。より好ましくは、５×１０８〜１×１０１０個であり、さらに好ましくは、１×１０９〜３×１０９個である。
１日当たりの投与量が１×１０８個より少ないと、非ステロイド系鎮痛薬起因性小腸傷害の予防及び／又は改善の効果が得られにくく、１日当たりの投与量が５×１０１０個より多いと、これらの効果に大きな変化がみられない。
１日当たりの投与量は、１回で摂取してもよく、又は、２回以上の複数回に分けて摂取してもよい。
また、１日当たりの投与量は、投与する期間における平均の量を意味し、その効果が認められる限り、必ず毎日投与すべきものではない。
In the embodiment of the present invention, the daily dose of lactic acid bacteria to a human is preferably 1 × 10 8 to 5 × 10 10 . More preferably, 5 × a 10 8 ~1 × 10 10 atoms, more preferably from 1 × 10 9 ~3 × 10 9 cells.
If the daily dose is less than 1 × 10 8 , it is difficult to obtain the effect of preventing and / or ameliorating non-steroidal analgesic-induced small intestinal injury, and the daily dose is more than 5 × 10 10. And, there is no big change in these effects.
The daily dose may be taken once, or may be taken in two or more divided doses.
In addition, the daily dose means the average amount during the administration period, and as long as the effect is observed, it should not always be administered every day.
本発明の実施形態における乳酸菌の培養物は、公知の培地成分で乳酸菌を培養（増殖）させて得ることができる。また、得られた乳酸菌の培養液を遠心分離すること等により、培養液の単位質量当たりの乳酸菌の数を高めることができる。本発明の実施形態における乳酸菌は、培養（増殖）させたばかりの状態でもよく、凍結保護剤等と混合して凍結させた状態でもよく、又は、凍結乾燥させた状態でもよい。また、本発明の実施形態における乳酸菌は、生菌でも死菌であってもよく、好ましくは生菌である。 The culture of lactic acid bacteria in the embodiment of the present invention can be obtained by culturing (proliferating) lactic acid bacteria with known medium components. In addition, the number of lactic acid bacteria per unit mass of the culture solution can be increased by centrifuging the obtained culture solution of lactic acid bacteria. The lactic acid bacterium in the embodiment of the present invention may be in a state of being just cultured (proliferated), in a state of being mixed with a cryoprotectant or the like and frozen, or in a state of being freeze-dried. In addition, the lactic acid bacterium in the embodiment of the present invention may be a live bacterium or a dead bacterium, and is preferably a live bacterium.
また、本発明の実施形態における乳酸菌が含有されている市販商品を便宜的に使用してもよい。例えば、ラクトバチルス・ガセリ（Lactobacillus gasseri）ＯＬＬ ２７１６（ＦＥＲＭ ＢＰ−６９９９）の場合、株式会社明治が販売している「明治プロピオヨーグルトＬＧ２１」から乳酸菌を分離することができる。 Further, a commercially available product containing lactic acid bacteria according to the embodiment of the present invention may be used for convenience. For example, in the case of Lactobacillus gasseri OLL 2716 (FERM BP-6999), lactic acid bacteria can be isolated from "Meiji Propio Yogurt LG21" sold by Meiji Co., Ltd.
本発明の実施形態における乳酸菌と、その他の摂取可能な成分を一緒に摂取する場合、その他の摂取可能な成分に制限はないが、例えば、乳性成分が好適に用いられる。乳性成分とは、乳そのもの、又は、乳を加工した乳成分を含む組成物を意味し、例えば、生乳（牛乳等）、還元乳（粉乳、クリーム、バター）、発酵乳（ヨーグルト、チーズ）、乳調製品（ホエイ、カゼイン、乳糖、乳清ミネラル、パーミエイト）等の乳成分を含んでいる全ての成分を含み、その由来や形態は特に限定されない。 When the lactic acid bacterium according to the embodiment of the present invention and other ingestible components are ingested together, the other ingestible components are not limited, but for example, a milky component is preferably used. The milky component means the milk itself or a composition containing a processed milk component, for example, raw milk (milk, etc.), reduced milk (powdered milk, cream, butter), fermented milk (yogurt, cheese). , Milk preparations (whey, casein, lactose, lactose minerals, permeate) and all other components including milk components, the origin and form thereof are not particularly limited.
本発明の実施形態に係る非ステロイド系鎮痛薬起因性小腸傷害予防及び／又は改善剤は、摂取する方法は特に限定されず、経口、経管、経腸、血管注射、塗薬、座薬等の公知の摂取方法を適用することができ、特に経口摂取を好適に適用できる。
本発明の実施形態に係る非ステロイド系鎮痛薬起因性小腸傷害予防及び／又は改善剤は、経口摂取を適用する場合に、その形態に制限はなく、経口摂取可能な錠剤や散剤の形態であってもよく、又は、ヨーグルト、ヨーグルトタイプドリンク、チーズ等の食品の形態であってもよい。
The method of ingesting the non-steroidal analgesic-induced small intestinal injury prevention and / or ameliorating agent according to the embodiment of the present invention is not particularly limited, and may be taken orally, by tube, intestine, vascular injection, ointment, suppository, etc. A known ingestion method can be applied, and in particular, oral ingestion can be preferably applied.
The non-steroidal analgesic-induced small intestinal injury preventive and / or ameliorating agent according to the embodiment of the present invention is in the form of tablets or powders that can be orally ingested without limitation in its form when oral ingestion is applied. It may be in the form of food such as yogurt, yogurt type drink, cheese and the like.
さらに、本発明の実施形態に係る非ステロイド系鎮痛薬起因性小腸傷害予防及び／又は改善剤は、摂取後１週間で非ステロイド系鎮痛薬起因性小腸傷害改善効果を奏するものであることが好ましい。
これは、本発明の実施形態に係る非ステロイド系鎮痛薬起因性小腸傷害予防及び／又は改善剤を、１週間より長く継続して摂取することを制限する趣旨ではなく、２週間以上継続して摂取することが好ましく、４週間以上継続して摂取することがより好ましい。
Further, the non-steroidal analgesic-induced small intestinal injury prevention and / or ameliorating agent according to the embodiment of the present invention preferably exerts a non-steroidal analgesic-induced small intestinal injury improving effect one week after ingestion. ..
This is not intended to limit the continuous ingestion of the non-steroidal analgesic-induced small intestinal injury preventive and / or ameliorating agent according to the embodiment of the present invention for longer than 1 week, and continuously for 2 weeks or more. It is preferable to take it, and it is more preferable to take it continuously for 4 weeks or more.
本発明の実施形態に係る非ステロイド系鎮痛薬起因性小腸傷害予防及び／又は改善剤は、その摂取方法及び摂取頻度に特段の制限はない。 The non-steroidal analgesic-induced small intestinal injury preventive and / or ameliorating agent according to the embodiment of the present invention is not particularly limited in its ingestion method and ingestion frequency.
以下、実施例を示して本発明をさらに具体的に説明するが、本発明の範囲はこれら実施例の記載に何ら限定されるものではない。
実験例１
ＮＳＡＩＤｓ起因性小腸粘膜傷害に対するLactobacillus gasseri ＯＬＬ ２７１６含有ヨーグルトの効果を調べるため、プラセボ対照二重盲検比較試験を行った。アスピリン服用中の被験者３０人に、Lactobacillus gasseri ＯＬＬ ２７１６を１×１０９ｃｆｕ／本含むドリンクヨーグルト（１１２ｍＬ／本）を、別のアスピリン服用中の被験者３１人に、Lactobacillus gasseri ＯＬＬ ２７１６を含まないドリンクヨーグルト（１１２ｍＬ／本）を、それぞれ毎日２本ずつ６週間摂取してもらい、カプセル内視鏡（オリンパス社製、ＥＮＤＯＣＡＰＳＵＬＥ）により摂取前後の小腸の病変を診断した。具体的には、病変（発赤、びらん、潰瘍）の数をカウントした。また、消化器症状についてＧＳＲＳ（Ｇａｓｔｒｏｉｎｔｅｓｔｉｎａｌ Ｓｙｍｐｔｏｍ Ｒａｔｉｎｇ Ｓｃａｌｅ）により評価した。ＧＳＲＳは消化器症状のＱＯＬに関するアンケート調査であり、数値は低い方が良い結果を示している。各結果の統計処理はＳｔａｔＦｌｅｘ ｖｅｒ．６（株式会社アーテック）を用いて実施した。
Hereinafter, the present invention will be described in more detail with reference to Examples, but the scope of the present invention is not limited to the description of these Examples.
Experimental Example 1
A placebo-controlled, double-blind, controlled trial was conducted to investigate the effect of Lactobacillus gasseri OLL 2716-containing yogurt on NSAIDs-induced small intestinal mucosal injury. Drink yogurt (112 mL / bottle) containing 1 × 10 9 cfu / bottle of Lactobacillus gasseri OLL 2716 was given to 30 subjects taking aspirin, and a drink not containing Lactobacillus gasseri OLL 2716 was given to 31 subjects taking another aspirin. Two yogurts (112 mL / bottle) were ingested daily for 6 weeks, and capsule endoscopy (ENDOCAPPULE, manufactured by Olympus Corporation) was used to diagnose small intestinal lesions before and after ingestion. Specifically, the number of lesions (redness, erosion, ulcer) was counted. In addition, gastrointestinal symptoms were evaluated by GSRS (Gastrointestinal Symptom Rating Scale). GSRS is a questionnaire survey on QOL of gastrointestinal symptoms, and the lower the number, the better the result. Statistical processing of each result is described in StatFlex ver. 6 (Artec Co., Ltd.) was used.
Ｍｕｃｏｓａｌ Ｂｒｅａｋ（びらん、潰瘍）の数の変化を図１に、病変（発赤、びらん、潰瘍）の数の変化を図２に、ＧＳＲＳの変化を図３に示す。「内服前」と「内服後」を結ぶグラフ中の１つの直線が、被験者１人分の結果を示している。 The change in the number of mucosal breaks (erosion, erosion) is shown in FIG. 1, the change in the number of lesions (redness, erosion, ulcer) is shown in FIG. 2, and the change in GSRS is shown in FIG. One straight line in the graph connecting "before oral administration" and "after oral administration" shows the result for one subject.
Lactobacillus gasseri ＯＬＬ ２７１６を含むドリンクヨーグルトの６週間の摂取前後で、Ｍｕｃｏｓａｌ Ｂｒｅａｋ（びらん、潰瘍）の数と、病変（発赤、びらん、潰瘍）の数は、有意に低下した。一方、プラセボの摂取による効果は有意差がみられなかった。
ＧＳＲＳは、Lactobacillus gasseri ＯＬＬ ２７１６を含むドリンクヨーグルトの６週間の摂取前後で、有意に改善したことから、摂取者の消化管ＱＯＬが改善したことが示唆される。
Before and after 6 weeks of ingestion of drink yogurt containing Lactobacillus gasseri OLL 2716, the number of Mucosal Breaks (erosions, erosions) and the number of lesions (redness, erosions, ulcers) were significantly reduced. On the other hand, there was no significant difference in the effect of taking placebo.
GSRS significantly improved before and after 6 weeks of ingestion of drink yogurt containing Lactobacillus gasseri OLL 2716, suggesting that the gastrointestinal QOL of the ingestor improved.
本発明によれば、脳血管障害や心疾患の予防薬、関節痛の鎮痛薬としてＮＳＡＩＤｓを服用している人のＱＯＬを改善することができる。社会の高齢化に伴いＮＳＡＩＤｓ服用者は増加していることから、本発明の社会的意義は大きいと考えられる。 According to the present invention, it is possible to improve the QOL of a person taking NSAIDs as a preventive agent for cerebrovascular accidents and heart diseases, and an analgesic for joint pain. Since the number of NSAIDs users is increasing with the aging of society, it is considered that the present invention has great social significance.
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