JP4146816B2 - Prophylactic and / or therapeutic agent for equine flexor tendonitis - Google Patents
Prophylactic and / or therapeutic agent for equine flexor tendonitis Download PDFInfo
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本発明は、トラネキサム酸またはその塩を有効成分とするウマの屈腱炎の予防および／または治療剤および予防および／または治療方法に関する。 The present invention relates to a preventive and / or therapeutic agent and a preventive and / or therapeutic method for equine flexor tendinitis comprising tranexamic acid or a salt thereof as an active ingredient.
トラネキサム酸は、公知の化合物であり、動物用薬（非特許文献１）および医薬品（非特許文献２）として既に上市されている。その主要作用は、抗プラスミン作用であり、止血作用、抗アレルギー・抗炎症作用により出血性疾患および下痢に効果を発揮することが知られている。これまで、動物薬としては、手術時の出血防止、血尿症や血乳症等の出血性疾患の治療、下痢治療などで、主に、牛、子牛、犬、豚等に静脈内注射、皮下注射、筋肉注射、腹腔内注射等の投与方法で使用されてきた。 Tranexamic acid is a known compound and is already on the market as a veterinary drug (Non-Patent Document 1) and a pharmaceutical (Non-Patent Document 2). Its main action is an antiplasmin action, and it is known to exert an effect on hemorrhagic diseases and diarrhea by hemostatic action, antiallergic / antiinflammatory action. Until now, animal drugs have been mainly used for intravenous injection in cattle, calves, dogs, pigs etc. It has been used in administration methods such as subcutaneous injection, intramuscular injection, and intraperitoneal injection.
ウマの屈腱炎は四肢に発生するが後肢よりも前肢の浅指屈筋腱に多く発生する炎症性疾患である（非特許文献３）。この腱は上腕骨と中節骨を繋ぐ腱で、下肢部を支えるとともに、手根関節と指節関節を曲げる重要な役目を担っている。屈腱炎は競走ウマに頻発する疾患であるが、比較的運動負荷が少ない乗馬用のウマも罹患する疾患である。競走ウマの屈腱炎の発病の原因としては長期間にわたる運動荷重による腱の組織疲労および腱の過度の伸展による機械的な腱繊維の破綻が考えられている。また、屈腱炎の前駆病変として腱の組織内における微細血管の変性が認められており、循環障害が原因とする説もある。このように種々の原因説があるが詳細については未解明の状況である。
屈腱炎を発症した場合、症状が重い競走ウマでは引退を余儀なくされるか、または、回復の見込みがある競走ウマでも長期間の休養を要し、レースへの復帰が大幅に遅れる。休養により一旦治癒してレースに復帰した場合であっても再発する可能性が高く、競走ウマにとっては不治の病として恐れられている。
Equine flexor tendinitis is an inflammatory disease that occurs in the extremities but more frequently in the superficial digital flexor tendons in the forelimbs than in the hindlimbs (Non-patent Document 3). The tendon is a tendon that connects the humerus and the middle phalanx and supports the lower limbs, and plays an important role in bending the carpal and phalangeal joints. Tendonitis is a disease that frequently occurs in race horses, but it also affects horses for riding with relatively little exercise load. Causes of flexion tendonitis in race horses are considered to be tendon tissue fatigue due to long-term exercise load and mechanical tendon fiber rupture due to excessive extension of the tendon. In addition, microvascular degeneration in tendon tissue has been recognized as a precursor lesion of flexor tendinitis, and there is a theory that it is caused by circulatory disturbance. There are various causes for this, but the details are still unclear.
When a flexor tendonitis develops, a racehorse with severe symptoms is forced to retire, or even a racehorse that is expected to recover requires a long rest, and the return to the race is greatly delayed. Even if the patient recovers from rest and then returns to the race, there is a high possibility of recurrence, which is feared as an incurable disease for racing horses.
本病の初期治療には炎症を抑える目的で流水、氷、冷却剤または冷却シートにより患部を冷やすことが通常行なわれているが、一度発症した屈腱炎を完全に治す治療法は未だ見出されていない。そのため再発あるいは重症化する場合も多く、屈腱炎を完治できる薬物療法の発明が強く望まれている。最近、ウマ遺伝子組換成長ホルモンによる浅屈腱炎治療が試みられており、損傷の治癒促進が期待されているが、実用においては十分な効果は確認されていない（非特許文献４）。
本発明の解決しようとする課題は、ウマの屈腱炎の新規な予防および／または治療方法および新規な予防および／または治療剤を提供することにある。 An object of the present invention is to provide a novel method for preventing and / or treating equine flexor tendinitis and a novel preventive and / or therapeutic agent.
本発明者らは、前記課題を解決するため鋭意臨床研究を進めた結果、動物用薬として上市されているトラネキサム酸にはウマの屈腱炎に対する治療薬としての新たな効能があること、特に他の抗炎症剤では無効であるにもかかわらず、ウマの屈腱炎に対して優れた予防・治療効果を見出し、本発明を完成した。
つまり、本発明は以下よりなる；
１．トラネキサム酸またはその塩を有効成分とするウマの屈腱炎の予防および／または治療剤。
２．投与対象が以下から選ばれる前項１に記載のウマの屈腱炎の予防および／または治療剤；
１）屈腱炎の初発ウマ
２）屈腱炎の軽度または中等度の再発ウマ
３）長期間の運動荷重よる腱の組織疲労および／または腱の過度の伸展による機械的腱繊維の破綻の予備軍ウマ。
３．投与が以下から選ばれる前項１または２に記載のウマの屈腱炎の予防および／または治療剤；
１）有効成分であるトラネキサム酸またはその塩を、投与量２〜１０ｇ／頭で２〜３０日間連続投与
２）有効成分であるトラネキサム酸またはその塩を、投与量２〜１０ｇ／頭で２〜３０日間に渡り断続的投与。
４．静脈投与される前項１〜３の何れか一に記載のウマの屈腱炎の予防および／または治療剤。
５．投与後、休養期間を設定する治療に用いられる前項１〜４の何れか一に記載のウマの屈腱炎の予防および／または治療剤。
６．冷却療法との併用を行う治療に用いられる、前項１〜５の何れか一に記載のウマの屈腱炎の予防および／または治療剤。
７．治療の程度が以下から選ばれる前項１〜６の何れか一に記載のウマの屈腱炎の予防および／または治療剤；
１）屈腱炎の治癒
２）屈腱炎の進行の停止
３）屈腱炎の発症の防止。
８．ウマが競走ウマおよび／または乗馬用ウマである前項１〜７に記載のウマの屈腱炎の予防および／または治療剤。
９．競走ウマおよび／または乗馬用ウマがサラブレッドである前項８に記載のウマの屈腱炎の予防および／または治療剤。
１０．年齢が３〜６歳である前項９に記載のウマの屈腱炎の予防および／または治療剤。
１１．前項１〜１０の何れか一に記載の予防および／または治療剤によるウマの屈腱炎の予防および／または治療方法。
１２．以下のいずれかと診断されたウマに対して、前項１〜１０の何れか一に記載の予防および／または治療剤が投与されるウマの屈腱炎の予防および／または治療方法；
１）軽度の屈腱炎
２）中等度の屈腱炎
３）腱の組織疲労
４）腱の過度の伸展
５）初発ウマの屈腱炎。
１３．病状が浅指屈筋腱部の腫脹の大きさによって軽度、中等度、および重度のいずれかに判定される前項１２に記載のウマの屈腱炎の予防および／または治療方法。
１４．以下；
１）浅指屈筋腱部の腫脹
２）浅指屈筋腱部の熱感
３）浅指屈筋腱部の圧痛
４）跛行
から選択されるいずれか一の検査項目によって、以下；
１）軽度の屈腱炎
２）中等度の屈腱炎
３）腱の組織疲労
４）腱の過度の伸展
５）初発ウマの屈腱炎
のうちのいずれかと診断されたウマに対して、
前項１〜１０のいずれか一に記載の予防および／または治療剤が投与されるウマの屈腱炎の予防および／または治療方法。
１５．トラネキサム酸および／またはその塩を有効成分とするウマの浅指屈腱炎の予防および／または治療剤であって、以下から選ばれる投与対象に、トラネキサム酸の約５ｇ／頭を１日１回で３〜２１日間の間に２〜９回断続投与する、ウマの浅指屈腱炎の予防および／または治療剤。
１）浅指屈腱炎の初発ウマ
２）浅指屈腱炎の軽度または中等度の再発ウマ
１６．前項１５に記載の予防および／または治療剤が投与されるウマの浅指屈腱炎の予防および／または治療方法。
１７．ウマの屈腱炎の予防および／または治療のために使用されるトラネキサム酸製剤。
１８．投与対象が以下から選ばれるウマの屈腱炎を予防および／または治療するために使用されるトラネキサム酸製剤；
１）屈腱炎の初発ウマ
２）屈腱炎の軽度または中等度の再発ウマ
３）長期間の運動荷重による腱の組織疲労および／または腱の過度の伸展による機械的腱繊維の破綻の予備軍ウマ。
１９．前項１７または１８に記載のトラネキサム酸製剤が投与されるウマの屈腱炎の予防および／または治療方法。
２０．ウマの浅指屈腱炎を予防および／または治療するために使用されるトラネキサム酸製剤であって、以下；
１）浅指屈腱炎の初発ウマ
２）浅指屈腱炎の軽度または中等度の再発ウマ
から選ばれる投与対象に、トラネキサム酸の約５ｇ／頭を１日１回で３〜２１日間の間に２〜９回断続投与する、トラネキサム酸製剤。
２１．前項２０に記載のトラネキサム酸製剤が投与されるウマの浅指屈腱炎の予防および／または治療方法。
As a result of intensive clinical research to solve the above problems, the present inventors have found that tranexamic acid marketed as a veterinary drug has a new effect as a therapeutic agent for equine flexor tendinitis. The present invention was completed by finding an excellent preventive / therapeutic effect on equine flexor tendinitis despite being ineffective with any anti-inflammatory agent.
That is, the present invention comprises:
1. A prophylactic and / or therapeutic agent for equine flexor tendinitis comprising tranexamic acid or a salt thereof as an active ingredient.
2. The preventive and / or therapeutic agent for equine flexor tendinitis according to item 1, wherein the administration target is selected from the following:
1) Initial horse with flexor tendonitis 2) Mild or moderate recurrent horse with flexor tendonitis 3) Reserve horse with mechanical tendon fiber failure due to tendon tissue fatigue and / or excessive tendon extension due to prolonged exercise load .
3. The preventive and / or therapeutic agent for equine flexor tendinitis according to item 1 or 2, wherein administration is selected from the following:
1) Continuous administration of tranexamic acid or a salt thereof as an active ingredient at a dose of 2 to 10 g / head for 2 to 30 days 2) Tranexamic acid or a salt thereof as an active ingredient at a dose of 2 to 10 g / head at a dose of 2 to 2 Intermittent administration over 30 days.
4). 4. The prophylactic and / or therapeutic agent for equine flexor tendinitis according to any one of 1 to 3 above, which is administered intravenously.
5. 5. The prophylactic and / or therapeutic agent for equine flexor tendonitis according to any one of the preceding items 1 to 4, which is used for treatment for setting a rest period after administration.
6). The prophylactic and / or therapeutic agent for equine flexor tendonitis according to any one of the preceding items 1 to 5, which is used for treatment in combination with cooling therapy.
7). The prophylactic and / or therapeutic agent for equine flexor tendinitis according to any one of the preceding items 1 to 6, wherein the degree of treatment is selected from the following:
1) Healing flexor tendonitis 2) Stopping the progression of flexor tendonitis 3) Preventing the development of flexor tendonitis.
8). 8. The preventive and / or therapeutic agent for equine flexor tendonitis according to 1 to 7 above, wherein the horse is a racehorse and / or a horse for riding.
9. 9. The prophylactic and / or therapeutic agent for equine flexor tendinitis according to 8 above, wherein the racing horse and / or horse for riding is Thoroughbred.
10. 10. The preventive and / or therapeutic agent for equine flexor tendinitis according to 9 above, wherein the age is 3-6 years.
11. A method for preventing and / or treating equine flexor tendinitis by the preventive and / or therapeutic agent according to any one of 1 to 10 above.
12 A method for preventing and / or treating equine flexor tendinitis, wherein the preventive and / or therapeutic agent according to any one of 1 to 10 above is administered to a horse diagnosed as any of the following:
1) Mild flexor tendinitis 2) Moderate flexor tendinitis 3) Tissue tissue fatigue 4) Excessive tendon extension 5) Primary horse flexor tendonitis
13. 13. The method for preventing and / or treating equine flexor tendinitis according to item 12 above, wherein the pathological condition is determined to be mild, moderate, or severe depending on the magnitude of swelling of the superficial digital flexor tendon.
14 Less than;
1) swelling of the superficial digital flexor tendon 2) thermal sensation of the superficial digital flexor tendon 3) tenderness of the superficial digital flexor tendon 4) depending on any one test item selected from lameness, the following:
1) Mild flexor tendonitis 2) Moderate flexor tendinitis 3) Tendon tissue fatigue 4) Excessive tendon extension 5) For horses diagnosed with any of the first equine flexor tendonitis,
A method for preventing and / or treating equine flexor tendinitis to which the preventive and / or therapeutic agent according to any one of 1 to 10 above is administered.
15. A prophylactic and / or therapeutic agent for equine superficial digital flexor tendinitis comprising tranexamic acid and / or a salt thereof as an active ingredient, wherein about 5 g / head of tranexamic acid is administered to a subject selected from A prophylactic and / or therapeutic agent for equine superficial flexor tendonitis administered intermittently 2-9 times during 3-21 days.
1) First equine flexor tendonitis 2) Mild or moderate recurrent equine flexor tendonitis A method for preventing and / or treating equine superficial flexor tendonitis to which the preventive and / or therapeutic agent according to item 15 is administered.
17. A tranexamic acid preparation used for the prevention and / or treatment of equine flexor tendinitis.
18. Tranexamic acid preparation used to prevent and / or treat equine flexor tendinitis, the subject of which is selected from:
1) Initial horse with flexor tendonitis 2) Mild or moderate horse with flexor tendonitis 3) Tissue fatigue due to long-term exercise load and / or reserve horse with mechanical tendon fiber failure due to excessive extension of tendon .
19. 19. A method for preventing and / or treating equine flexor tendinitis to which the tranexamic acid preparation according to item 17 or 18 is administered.
20. A tranexamic acid formulation used to prevent and / or treat equine superficial digital flexor tendinitis, comprising:
1) The first equine of superficial digital flexor tendinitis 2) About 5g / head of tranexamic acid once a day for 3 to 21 days to subjects to be selected from mild or moderate recurrent equine flexor tendonitis Tranexamic acid preparation administered intermittently 2-9 times.
21. 21. A method for preventing and / or treating equine superficial flexor tendonitis to which the tranexamic acid preparation according to item 20 is administered.
本発明は、ウマの屈腱炎に対してトラネキサム酸またはその塩を投与することにより、本疾患をほぼ完治できる薬物療法剤の提供に成功した。 The present invention has succeeded in providing a pharmacotherapeutic agent that can almost completely cure this disease by administering tranexamic acid or its salt to equine flexor tendinitis.
本発明のウマの屈腱炎の予防および／または治療剤の有効成分は、公知のトラネキサム酸またはその塩である。トラネキサム酸は、化学名trans-4-aminomethylcyclohexanecarboxylic acidである。さらに、トラネキサム酸の水和物、エタノール等の溶媒和物や結晶多形の物質もすべて本発明の有効成分として包含される。なお、本発明において、トラネキサム酸自体水に対する溶解性が高いのでそのまま液状製剤として調製することができる。既にトラネキサム酸の注射剤は上市され、第一製薬株式会社によって商品名バソラミン（登録商標）注として使用に供されており、本発明のウマの屈腱炎の予防および／または治療剤としてはこの製剤をそのまま使用できる。なお、バソラミン（登録商標）注は、１ｍｌ中に日本薬局方トラネキサム酸50mgを含有する（１００ｍｌ中に５ｇ含有）。 The active ingredient of the preventive and / or therapeutic agent for equine flexor tendinitis of the present invention is a known tranexamic acid or a salt thereof. Tranexamic acid has the chemical name trans-4-aminomethylcyclohexanecarboxylic acid. Furthermore, hydrates of tranexamic acid, solvates such as ethanol, and polymorphic substances are all encompassed as active ingredients of the present invention. In the present invention, tranexamic acid itself has a high solubility in water, and thus can be prepared as a liquid preparation as it is. An injection of tranexamic acid has already been put on the market and is used by Daiichi Pharmaceutical Co., Ltd. under the trade name Basoramine (registered trademark) Note. This preparation is used as a preventive and / or therapeutic agent for equine flexor tendinitis according to the present invention. Can be used as is. In addition, Vasolamin (registered trademark) Note contains 50 mg of Japanese Pharmacopoeia tranexamic acid in 1 ml (containing 5 g in 100 ml).
本発明の予防および／または治療剤の投与対象は、１）屈腱炎の初発ウマ、２）屈腱炎の軽度または中等度の再発ウマ、３）長期間の運動荷重よる腱の組織疲労および／または腱の過度の伸展による機械的腱繊維の破綻の予備軍ウマから選ばれる。
屈腱炎の診断方法は、ウマにおける、１）浅指屈筋腱部の腫脹、２）浅指屈筋腱部の熱感、３）浅指屈筋腱部の圧痛、４）跛行等の検査によって判定されるが、特に浅指屈筋腱部の病態的変化によって判定される。腫脹とは、いわゆる脹れを意味し、浅指屈筋腱部が異常にふくらむことを意味する。この脹れの大きさによって、腫脹レベルが判定され、例えば軽度、中等度、重度の３段階に分類される。そして、軽度とは、腫脹の大きさとして例えば長径が１ｃｍ〜３ｃｍ未満であり、中等度とは、腫脹の大きさとして例えば長径が３ｃｍ以上〜１５ｃｍ未満であり、そして重度とは、腫脹の大きさとして例えば長径が１５以上であるとして定義づけることができる。このような浅指屈筋腱部の腫脹における変化がもっとも好適な検査項目であるが、加えて、浅指屈筋腱部の熱感や浅指屈筋腱部の圧痛によってより確実な屈腱炎の判定がされる。熱感とは、常温に対する上昇温感を意味し、数度の浅指屈筋腱部での体温上昇で屈腱炎の判定補助が可能となる。圧痛とは、圧迫または接触すると痛みがあることを意味する。浅指屈筋腱部を圧する、例えば浅指屈筋腱部の腫脹を指圧することによって、ウマは即座の痛みによる反応をおこすので屈腱炎の判定補助が可能となる。さらに、屈腱炎を起こしたウマは、走行が困難となり、中等度以上の浅指屈筋腱部腫脹のウマでは、跛行が観察される。跛行とは、びっこをひくことを意味する。このような検査項目のうち最も初期の段階から確認されるのが腫脹である。
The subject of administration of the preventive and / or therapeutic agent of the present invention is 1) primary horse with flexor tendinitis, 2) mild or moderate recurrent horse with flexor tendonitis, 3) tissue fatigue of tendon due to long-term exercise load and / or Selected from reserve horses with mechanical tendon fiber failure due to excessive tendon extension.
The method of diagnosis of flexor tendonitis is determined by examining 1) swelling of the superficial digital flexor tendon, 2) thermal sensation of the superficial digital flexor tendon, 3) tenderness of the superficial digital flexor tendon, 4) lameness, etc. In particular, it is determined by the pathological change of the superficial digital flexor tendon. Swelling means so-called swelling, and it means that the superficial digital flexor tendon bulges abnormally. The swelling level is determined based on the magnitude of the swelling, and is classified into three levels, for example, mild, moderate, and severe. Mild means that the major axis is, for example, the major axis is less than 1 cm to less than 3 cm, moderate means that the major magnitude is the major axis, for example, the major axis is not less than 3 cm to less than 15 cm, and severe is the magnitude of the swelling. For example, it can be defined that the major axis is 15 or more. Changes in the swelling of the superficial digital flexor tendon are the most suitable test items, but in addition, a more reliable determination of flexor tendonitis is possible due to the thermal sensation of the superficial digital flexor tendon and the tenderness of the superficial digital flexor tendon. Is done. The thermal sensation means an upward temperature sensation with respect to normal temperature, and it is possible to assist determination of flexor tendinitis by raising the body temperature at the superficial digital flexor tendon at several degrees. Tenderness means that there is pain when pressed or contacted. By applying pressure to the superficial digital flexor tendon, for example, by applying pressure to the swelling of the superficial digital flexor tendon, the horse reacts with immediate pain, so that it is possible to assist in the determination of flexotenitis. Furthermore, horses with flexor tendinitis have difficulty running, and lameness is observed in horses with moderate or higher superficial digital flexor tendon swelling. Lameness means catching a basket. Of these examination items, swelling is confirmed from the earliest stage.
本発明の予防および／または治療剤の投与対象は、屈腱炎の初発ウマであることが好ましい。初発ウマであれば、早期治療により完治可能であるが、再発ウマにおいては病状の進行停止に終わることが多い。初発ウマとは、屈腱炎と診断されるのが初めてのウマを意味する。再発ウマとは、間欠期また緩解の後に再び屈腱炎の症状が現れたウマを意味する。本発明の予防および／または治療剤の投与対象は、早期の屈腱炎であることが好ましく、その程度が低いほど治癒効果も完全である。つまり屈腱炎の軽度または中等度の初または再発ウマであることが、より有利な治療効果を達成できる。本発明の予防および／または治療剤の投与対象は、屈腱炎になる可能性が高い、例えば前記浅指屈筋腱部の腫脹の軽度判定以下のレベルであっても、長期間の運動荷重よる腱の組織疲労および／または腱の過度の伸展による機械的腱繊維の破綻が懸念される場合、予防のために投与することができる。このような予防投与の対象を予備軍ウマと定義した。 The subject to which the preventive and / or therapeutic agent of the present invention is administered is preferably the first horse with flexor tendinitis. If it is the first horse, it can be cured by early treatment, but in recurrent horses, it often ends in stopping the progression of the disease. First horse means the first horse diagnosed with flexor tendinitis. Recurrent horses mean horses that have flexor tendinitis again after an intermittent period or remission. The subject to which the prophylactic and / or therapeutic agent of the present invention is administered is preferably early flexor tendonitis, and the lower the degree, the more complete the healing effect. In other words, a mild or moderate initial or recurrent horse with flexor tendinitis can achieve a more advantageous therapeutic effect. The subject of administration of the preventive and / or therapeutic agent of the present invention has a high possibility of becoming flexor tendonitis, for example, a tendon caused by a long-term exercise load even if the level is less than the mild judgment of swelling of the superficial digital flexor tendon Can be administered for prevention if there is concern about mechanical tendon fiber failure due to tissue fatigue and / or excessive tendon extension. Such prophylaxis subjects were defined as reserve horses.
本発明の予防および／または治療剤の投与量は、その屈腱炎の程度によって異なるが、一般的には、トラネキサム酸またはその塩の約２〜約１０ｇ／頭／一回で投与することが好適である。これ以上多くても特に障害はないが、対費用効果を考えれば、この範囲で必要十分である。より、一般的な投与量は、約５ｇ／頭／一回である。投与期間は、その屈腱炎の治癒程度によって異なるが、一般的には約２〜約３０日間程度投与される。早期に腫脹が治癒されれば、３日というような短期間投与でも十分である。また、投与は毎日連続投与でも、隔日でも、不連続でもよい。具体的には、例えば１５日間の治療で、６回の投与を行い、完全治癒で再発なしという結果を得た。なお、予防剤として投与する場合は、投与量および投与頻度は、適宜減少させることが当然に可能である。例えば、上記一般的な投与量の半分量を数日毎に数ヶ月投与することが可能である。トラネキサム酸製剤とは、トラネキサム酸を有効成分とするあらゆる種類の製剤を意味し、ウマの屈腱炎を治療するために製造されたトラネキサム酸製剤に限定されない。 The dosage of the prophylactic and / or therapeutic agent of the present invention varies depending on the degree of tendonitis, but in general, it is preferably administered at about 2 to about 10 g / head / one dose of tranexamic acid or a salt thereof. It is. More than this will not cause any obstacle, but it is necessary and sufficient in this range considering cost effectiveness. A more common dose is about 5 g / head / once. The administration period varies depending on the degree of flexion tendonitis healing, but is generally administered for about 2 to about 30 days. If the swelling is healed early, administration for a short period of 3 days is sufficient. Administration may be continuous daily, every other day, or discontinuous. Specifically, for example, 6 times of administration was performed for 15 days, and a result of complete healing and no recurrence was obtained. In addition, when administering as a prophylactic agent, naturally, dosage and administration frequency can be reduced suitably. For example, half of the above general dosage can be administered every few days for several months. The tranexamic acid preparation means any kind of preparation containing tranexamic acid as an active ingredient, and is not limited to the tranexamic acid preparation manufactured for treating equine flexor tendinitis.
本発明の予防および／または治療剤の投与方法は、皮下、筋肉内、腹腔内、静脈内のいずれでも良いが、早期の効果を期待する場合、静脈投与が好適である。静脈投与は、速度が速すぎるとまれに振戦または嘔吐などがおこることもあり、投与速度は遅いほうが好ましい。 The method for administering the prophylactic and / or therapeutic agent of the present invention may be any of subcutaneous, intramuscular, intraperitoneal, and intravenous, but intravenous administration is preferred when an early effect is expected. Intravenous administration may cause tremors or vomiting in rare cases when the rate is too high, and it is preferable that the administration rate is low.
本発明の予防および／または治療剤の投与後、治療効果が腫脹の消失等で完治が確認されれば、直ちにレース等に復帰しても良いが、より好ましい態様としては一定期間例えば数日から数ヶ月の休養期間をとることが好ましい。休養とは、競走ウマの場合、レースへの復帰を控えることなどが該当する。一般的には、治癒後４〜１０日程度をへた後にレースへの復帰が好適である。 After the administration of the preventive and / or therapeutic agent of the present invention, if complete cure is confirmed by disappearance of swelling or the like, it may be immediately returned to the race or the like. It is preferable to take a rest period of several months. In the case of race horses, rest corresponds to refraining from returning to the race. Generally, it is preferable to return to the race after about 4 to 10 days after healing.
併用療法としては、患部の冷却を同時に行うことは好適である。冷却は、これまでも屈腱炎の治療のためにおこなわれており、自体公知の汎用方法によっておこなえばよい。たとえば、流水とクラッシュアイスによる患部の冷却が行える。あるいはアイスノン冷却でもよい。 As a combination therapy, it is preferable to simultaneously cool the affected area. Cooling has been performed for the treatment of flexor tendinitis so far, and may be performed by a general-purpose method known per se. For example, the affected area can be cooled by running water and crushed ice. Or ice non-cooling may be sufficient.
かくして、本発明の予防および／または治療剤による効果は、１）屈腱炎の治癒、２）屈腱炎の進行の停止、３）屈腱炎の発症の防止が達成される。屈腱炎の治癒とは、前記屈腱炎の検査項目の完全マイナスを意味し、屈腱炎の進行の停止とは、本発明の予防および／または治療剤投与後も各検査項目の全て或は少なくとも一つはマイナスにはならないが、その程度は投薬前と同じレベルにあることを意味する。屈腱炎の発症の防止とは、発症予備軍と認められるウマにおいて、投薬によって、発症が完全に防止されることを意味する。 Thus, the effects of the preventive and / or therapeutic agent of the present invention can be achieved by 1) healing of flexor tendonitis, 2) stopping the progression of flexor tendonitis, and 3) preventing the development of flexor tendonitis. Curing tendonitis means that the test item for flexor tendonitis is completely negative, and stopping the progression of flexor tendinitis means that all or at least one of the test items is administered even after administration of the preventive and / or therapeutic agent of the present invention. Means that the degree is at the same level as before dosing. Prevention of the development of flexor tendinitis means that the onset is completely prevented by medication in horses that are recognized as a reserve arm.
本発明の予防および／または治療剤の投与対象はウマであり、好ましくは競走ウマおよび／または乗馬用ウマであり、より好ましくは特に屈腱炎の問題が多い競走ウマにおいて格別の効果が期待される。そして、競走ウマのうち、特殊化された繁殖継代がなされるサラブレッドの屈腱炎の予防および／または治療剤として好適である。さらに、本発明の予防および／または治療剤の投与対象のウマの年齢が３〜６歳である場合に好適な効果が確認でき、これ以上年を経た場合には治癒は困難となり、病状進行停止が最大効果である。 The subject of administration of the prophylactic and / or therapeutic agent of the present invention is a horse, preferably a racehorse and / or a horse for riding, and more preferably a special effect is expected in a racehorse that is particularly prone to tendonitis. . And it is suitable as a prophylactic and / or therapeutic agent for thoroughbred flexor tendinitis, which is a specialized breeding passage among race horses. Furthermore, a suitable effect can be confirmed when the age of the horse to which the prophylactic and / or therapeutic agent of the present invention is administered is 3 to 6 years old. Is the maximum effect.
以上説明したように本発明の予防および／または治療剤は、従来にない優れたウマの屈腱炎の予防および／または治療剤になることから、本発明の予防および／または治療剤を使ったウマの屈腱炎の予防治療方法は極めて優れた新規な治療方法を提供する。そして、この治療方法においては、１）初発ウマの屈腱炎、２）軽度の屈腱炎、３）中等度の屈腱炎、４）腱の組織疲労、および５）腱の過度の伸展等が診断されたウマに対して、上記した投与量、投与方法によって従来ない優れた効果を達成する。この治療方法に際して、屈腱炎の判定は、病状が浅指屈筋腱部の腫脹の大きさによっておこなわれ、その大きさの程度で前記定義のように軽度、中等度、および重度等と判定され、治療方法が適用される。さらに、屈腱炎の検査項目は、上記のように１）浅指屈筋腱部の腫脹、２）浅指屈筋腱部の熱感、３）浅指屈筋腱部の圧痛、および４）跛行等が行われ、この結果をマーカーにして本発明の予防および／または治療剤によるウマの屈腱炎の予防治療方法が達成される。 As described above, since the prophylactic and / or therapeutic agent of the present invention is an excellent anti-preventive and / or therapeutic agent for equine flexor tendonitis, the horse using the prophylactic and / or therapeutic agent of the present invention is not suitable. The method for preventing and treating flexor tendonitis provides an extremely excellent novel treatment method. In this treatment method, 1) primary horse flexor tendonitis, 2) mild tendonitis, 3) moderate flexor tendonitis, 4) tendon tissue fatigue, and 5) excessive extension of the tendon are diagnosed. The above-mentioned dosage and administration method for horses achieves an unprecedented superior effect. In this treatment method, flexion tendonitis is determined according to the magnitude of swelling of the superficial digital flexor tendon, and the degree of the magnitude is determined as mild, moderate, severe, etc. as defined above, Treatment methods are applied. Furthermore, the examination items for flexor tendonitis are as follows: 1) swelling of the superficial digital flexor tendon, 2) thermal sensation of the superficial digital flexor tendon, 3) tenderness of the superficial digital flexor tendon, and 4) lameness. And the method for preventing and treating equine flexor tendinitis with the preventive and / or therapeutic agent of the present invention is achieved.
以下、本発明を実施例によりさらに具体的に説明するが、これらは本発明の予防および／または治療剤としての好適な一例を示すものであり、本発明の技術的範囲を限定するものではない。 EXAMPLES Hereinafter, the present invention will be described more specifically with reference to examples. However, these examples show preferred examples of the preventive and / or therapeutic agent of the present invention, and do not limit the technical scope of the present invention. .
実施例１
トラネキサム酸の投与によるウマ屈腱炎への治療効果を検討した。対照群には、解熱鎮痛消炎剤であるフルニキシンおよび／またはケトプロフェンを使用した。
ウマ屈腱炎の試験群の症例は、川崎競馬場（神奈川県川崎市）にて初期の浅指屈腱炎と診断されたサラブレッド種（体重438〜487kg）（年齢３〜６歳）を使用し７例をえた。試験群にはトラネキサム酸注射剤を、100mL/頭、１日１回投与で、３〜２１日間にわたり２〜９回、頚静脈内に注射投与でおこなった。トラネキサム酸注射剤は、製品名：バソラミン注（発売元：第一製薬株式会社）（成分分量：100ｍＬ中トラネキサム酸５gを含有）を用いた。
ウマ屈腱炎の対照群の症例は、川崎競馬場（神奈川県川崎市）にて初期の浅指屈腱炎と診断されたサラブレッド種（体重451〜474kg）（年齢４または５歳）を使用し３例をえた。対照群には、フルニキシン注射剤を、10または50mL/頭、１日１回投与で、１４〜４５日間にわたり２〜３回、頚静脈内に注射した。フルニキシン注射剤は、製品名：バナミン注（発売元：大日本製薬）（成分分量：1ｍL中にフルニキシン50mgを含有）を用いた。対照群の症例２では、解熱鎮痛消炎剤であるケトプロフェン注射剤（製品名：ケトフェン注、発売元：日本全薬工業、100ｍL中に1ｇのケトプロフェンを含有）を、5mL/頭、１日１回、２回で併用した。
屈腱炎の検査は、腫脹、熱感、圧痛、跛行について、投薬前と投薬治療終了後に検査した。なお、併用療法として、流水およびクラッシュアイスによる屈腱炎患部の冷却、アイスノン冷却、鉛糖湿布等を適宜選択して行った。
Example 1
We investigated the therapeutic effects of tranexamic acid on equi flexor tendonitis. For the control group, antipyretic analgesic / anti-inflammatory agent flunixin and / or ketoprofen was used.
Cases in the equine flexor tendonitis test group were the Thoroughbreds (weight 438-487 kg) (age 3-6 years) diagnosed as early superficial digital tendonitis at Kawasaki Racecourse (Kawasaki City, Kanagawa Prefecture) 7 I gave an example. In the test group, tranexamic acid injection was administered at 100 mL / head once a day, 2-9 times over 3 to 21 days, and injected into the jugular vein. As the tranexamic acid injection, a product name: Vasolamin injection (release source: Daiichi Pharmaceutical Co., Ltd.) (component amount: containing 5 g of tranexamic acid in 100 mL) was used.
The control group of equine flexor tendinitis uses a thoroughbred species (weight 451-474 kg) (age 4 or 5 years old) diagnosed as early superficial flexor tendonitis at Kawasaki Racecourse (Kawasaki City, Kanagawa Prefecture) 3 I gave an example. In the control group, flunixin injection was injected into the jugular vein at 10 or 50 mL / head once daily, 2-3 times over 14-45 days. As the flunixin injection, the product name: vanamin injection (distributor: Dainippon Pharmaceutical) (component amount: containing 1 mg of flunixin 50 mg) was used. In case 2 of the control group, ketoprofen injection that is an antipyretic analgesic / anti-inflammatory agent (Product name: Ketophen injection, distributor: Nippon Zenyaku Kogyo Co., Ltd., containing 1 g of ketoprofen in 100 mL) 5 mL / head once a day Used in combination twice.
In flexion tendonitis, swelling, heat, tenderness, and lameness were examined before and after treatment. As the combination therapy, cooling of the affected tendonitis by running water and crushed ice, ice non-cooling, lead sugar poultice, etc. were appropriately selected.
結果は、試験群については表１に、対照群については表２に示した。
試験群の症例中６症例は治癒してレースに復帰するとともに、その後においても再発は認められず、本剤の有効性が認められた。残りの１症例（症例４）は、再発症例であって、トラネキサム酸の注射によって臨床症状の完全消失は認められなかったが、病状の進行停止が認められレースに出走できるまで復帰した。本症例はその後、乗馬用に用途変更したが、浅指屈腱炎の進行は停止し、再発は認められていない。表１。表中の「+」は、各検査項目においてその所見・臨床症状が陽性である場合を意味し、「-」は、各検査項目においてその所見・臨床症状が陰性である場合を意味する。以下表２も同意である。
Six of the cases in the study group were cured and returned to the race, and no recurrence was observed thereafter, and the efficacy of this drug was confirmed. The remaining 1 case (case 4) was a relapsed case, and the disappearance of clinical symptoms was not observed by the injection of tranexamic acid, but it returned until the pathological progression was stopped and the race was able to start. The patient was subsequently repurposed for riding, but the progression of superficial digital flexor tendonitis stopped and no recurrence was observed. Table 1. In the table, “+” means a case where the findings / clinical symptoms are positive in each test item, and “-” means a case where the findings / clinical symptoms are negative in each test item. Table 2 below also agrees.
対照群では、３症例ともに症状の改善は認められず、治療を打ち切るとともに、その日のレースに出走させた後、２頭は廃用し、残りの１症例は休養させた。休養させた症例１では浅指屈腱炎が治癒せず結果的にはレースに復帰することなく廃用となった。表２。
以上の結果、トラネキサム酸のウマ屈腱炎への投与は、解熱鎮痛消炎剤では見られない明確な治癒効果を発揮するものであり、当該用途におけるトラネキサム酸の有用性および優位性が確認された。
As a result of the above, administration of tranexamic acid to equine flexor tendonitis exhibits a clear healing effect not seen with antipyretic analgesics and anti-inflammatory agents, confirming the usefulness and superiority of tranexamic acid in this application.
Claims (13)
１）屈腱炎の初発ウマ
２）屈腱炎の軽度または中等度の再発ウマ
３）長期間の運動荷重よる腱の組織疲労および／または腱の過度の伸展による機械的腱繊維の破綻の予備軍ウマ。 The prophylactic and / or therapeutic agent for equine flexor tendonitis according to claim 1, wherein the administration target is selected from the following:
1) Initial horse with flexor tendonitis 2) Mild or moderate recurrent horse with flexor tendonitis 3) Reserve horse with mechanical tendon fiber failure due to tendon tissue fatigue and / or excessive tendon extension due to prolonged exercise load .
１）屈腱炎の治癒
２）屈腱炎の進行の停止
３）屈腱炎の発症の防止。 The preventive and / or therapeutic agent for equine flexor tendinitis according to any one of claims 1 to 5, wherein the degree of treatment is selected from the following:
1) Healing flexor tendonitis 2) Stopping the progression of flexor tendonitis 3) Preventing the development of flexor tendonitis.
１）軽度の屈腱炎
２）中等度の屈腱炎
３）腱の組織疲労
４）腱の過度の伸展
５）初発ウマの屈腱炎。 A method for preventing and / or treating equine flexoritis, wherein the preventive and / or therapeutic agent according to any one of claims 1 to 9 is administered to a horse diagnosed as any of the following:
1) Mild flexor tendonitis 2) Moderate flexor tendonitis 3) Tissue tissue fatigue 4) Extensive extension of tendon 5) Tendon's flexor tendonitis
１）浅指屈筋腱部の腫脹
２）浅指屈筋腱部の熱感
３）浅指屈筋腱部の圧痛
４）跛行
から選択されるいずれか一の検査項目によって、以下；
１）軽度の屈腱炎
２）中等度の屈腱炎
３）腱の組織疲労
４）腱の過度の伸展
５）初発ウマの屈腱炎
のうちのいずれかと診断されたウマに対して、
請求項１〜９のいずれか一に記載の予防および／または治療剤が投与されるウマの屈腱炎の予防および／または治療方法。 Less than;
1) swelling of superficial digital flexor tendon 2) thermal sensation of superficial digital flexor tendon 3) tenderness of superficial digital flexor tendon 4) Depending on any one of the examination items selected from lameness, the following:
1) Mild flexor tendinitis 2) Moderate flexor tendonitis 3) Tissue tissue fatigue 4) Excessive tendon extension 5) For horses diagnosed as one of the first equine flexor tendinitis,
A method for the prevention and / or treatment of equine flexor tendinitis to which the preventive and / or therapeutic agent according to any one of claims 1 to 9 is administered.
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| Application Number | Priority Date | Filing Date | Title |
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| JP2004098419A JP4146816B2 (en) | 2004-03-30 | 2004-03-30 | Prophylactic and / or therapeutic agent for equine flexor tendonitis |
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| JP2004098419A JP4146816B2 (en) | 2004-03-30 | 2004-03-30 | Prophylactic and / or therapeutic agent for equine flexor tendonitis |
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| Publication Number | Publication Date |
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| JP2005281211A JP2005281211A (en) | 2005-10-13 |
| JP4146816B2 true JP4146816B2 (en) | 2008-09-10 |
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| JP2013237666A (en) * | 2012-04-16 | 2013-11-28 | Daiichi Sankyo Healthcare Co Ltd | Therapeutic and/or prophylactic agent for disease associated with overwork or chronic fatigue |
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