JP3545789B2 - Intraperitoneal adhesion inhibitor - Google Patents
Intraperitoneal adhesion inhibitor Download PDFInfo
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- JP3545789B2 JP3545789B2 JP26957893A JP26957893A JP3545789B2 JP 3545789 B2 JP3545789 B2 JP 3545789B2 JP 26957893 A JP26957893 A JP 26957893A JP 26957893 A JP26957893 A JP 26957893A JP 3545789 B2 JP3545789 B2 JP 3545789B2
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- adhesion
- intraperitoneal
- carrageenan
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- adhesion inhibitor
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Description
【０００１】
【産業上の利用分野】
本発明は、カラゲナンを有効成分とする腹腔内癒着防止剤に関する。
【０００２】
【従来の技術】
開腹手術後、特に消化管手術に際して生じる腸管の癒着は、手術手技及び機器の向上に伴い、少なくなる傾向にあるが、完全に防止できないのが現状であり、外科医を悩ませる大きな問題である。また婦人科領域においても術後癒着は卵管閉塞による不妊、時には腸閉塞を併発することもある。腹腔内癒着は必ず障害を引き起こすとは限らないが、癒着性イレウスを生じ再手術となったり、術後患者の予後を悪化させる可能性がある（馬越正通ら、外科治療， ６８， １００５（１９９３））。
【０００３】
癒着は生体防御反応の一つとして炎症性反応による組織修復機転の結果で、腸管漿膜又は腹膜の損傷がその引金となっている。種々の刺激を受けた後、損傷漿膜の脱落、フィブリノーゲンの滲出、さらに血液凝固と同じ機序によりフィブリンの析出を引き起こし、最終的に線維芽細胞などの関与により近辺の組織と線維素性癒合を形成すると考えられている（杉本修、産科と婦人科， ５３， １８５（１９８６））。現在、このような癒着に関する防止法は確立されておらず、種々の薬剤や特殊な膜を用いる試みがなされている。癒着を防止する薬剤として、高分子物質を中心とした創面被覆作用を持つもの、例えば、アルギン酸ナトリウム（特開昭５７−１６７９１９号公報）、コンドロイチン硫酸ナトリウム（Ｏｅｌｓｎｅｒ Ｇ． ｅｔ ａｌ．，Ｊ． Ｒｅｐｒｏｄ． Ｍｅｄ．， ３２， ８１２（１９８７））及びヒアルロン酸ナトリウム（Ｕｒｍａｎ Ｂ． ｅｔａｌ．， Ｆｅｒｔｉｌ． Ｓｔｅｒｉｌ， ５６， ５６３（１９９１））等の高分子多糖体に有効性が見い出されている。その他、繊維素溶解物質及びステロイド剤などが試され、一部臨床的に使用されているものもある。しかし、いずれも効果の点で十分とは言い難い。
【０００４】
【発明が解決しようとする課題】
本発明の課題は、優れた腹腔内癒着防止剤を提供することである。
【０００５】
【課題を解決するための手段】
本発明者らは上記実状に鑑み、高分子多糖体について鋭意研究した結果、既報物質より優れた癒着防止効果をカラゲナンに見出し、本発明を完成することができた。
【０００６】
すなわち、本発明はカラゲナンを有効成分とする腹腔内癒着防止剤に関する。
【０００７】
本発明において、カラゲナンは紅藻類に属するスギリノ属の海藻から熱水抽出で得ることができる。Ｄ−ガラクトース及びアンヒドロ−Ｄ−ガラクトースを構成糖とする硫酸を含む高分子多糖体で、食品の増粘剤、安定剤及びゲル化剤などとして広範な用途を持つ。本発明者らはカラゲナンを開腹手術後に腹腔内に投与することにより、腹腔内癒着を防止するという全く新しい知見から本発明を完成したものである。
【０００８】
本発明の腹腔内癒着防止剤におけるカラゲナンは通常０．１〜１．０Ｗ／Ｖ％のゲル状の溶液に調製される。その溶剤としては、生理食塩液又は適当な電解質液、例えば特開平２−３０４０２６号公報に記載されている腹腔洗浄液（表１）を用いることが望ましい。
【０００９】
【表１】
本発明の腹腔内癒着防止剤は開腹手術後、腹腔内に注入され、手術処置部を被覆するように適用するのが好ましい。注入量は年齢、体重、性差、症状及び腹腔内損傷面積に応じて、適宜選択すればよく、好ましくは１０〜２００ｍｌの範囲とすることができる。またカラゲナン溶液は濃度によっては室温でゲル化し、ゲルをそのまま腹腔内に適用することもでき、適用量はゲル５ｇ〜１００ｇが好ましい。
【００１１】
本発明における腹腔内癒着防止剤は必要に応じ、カラゲナンに加えて、他の薬効成分を加えることができる。
【００１２】
【実施例】
以下、本発明腹腔内癒着防止剤につき行われた実施例及び試験例を挙げ、本発明を詳細に説明する。
【００１３】
〔実施例１〕
カラゲナン１０ｇを表１に示した腹腔洗浄液を加え、３〜４時間室温で攪拌溶解した。溶解時加熱してもよい。均一な溶液になった後、同腹腔洗浄液で全量１０００ｍｌに調製し、目的とする１．０％腹腔内癒着防止剤を得た。なお、前記腹腔洗浄液の代わりに生理食塩液を用いてもよい。
【００１４】
得られた腹腔内癒着防止剤は室温でゲル状となる。
【００１５】
〔実施例２〜４〕
実施例１と同様にして、カラゲナン濃度０．０２％（実施例２）、０．１％（実施例３）及び０．５％（実施例４）の各濃度の腹腔内癒着防止剤を得た。
【００１６】
得られた腹腔内癒着防止剤は０．０２％では室温で溶液状態であるが、０．１％及び０．５％ではゲル状となる。
【００１７】
〔比較液１〕
前記表１に記載の腹腔洗浄液を比較液１とした。
【００１８】
〔比較液２〕
比較のため癒着防止効果が報告されている高分子多糖体として、ヒアルロン酸ナトリウムを用いた。即ち、実施例１と同様にして、カラゲナンの代わりにヒアルロン酸ナトリウム５ｇを用いて、目的とする比較液２を得た。
【００１９】
〔試験例〕
１０〜１３週齢ＳＤ系雄性ラットを用い、以下の癒着モデルを作製した。即ち、ペントバルビタール麻酔下に剣状突起より約３ｃｍの部分から正中線に沿って下部へ約４ｃｍ開腹し、左右の精巣上体脂肪を除去した後、乾燥ガーゼで回盲部から口側へ１０ｃｍまでの回腸を９回摩擦した（溢血が認められる程度）。その後、所定濃度のカラゲナンを含む実施例１及び２の各腹腔内癒着防止剤（１０ｍｌあるいはゲル状の場合は５ｇ）を腹腔内に適用し、二層縫合によって閉腹した。１週間後開腹し腸管癒着の状態を評価した。癒着の評価は処置部回腸同士及び処置部回腸への他の腸管（空腸、盲腸、大腸など）の癒着した長さ（癒着長）を測定することにより行った。同様にして、対照群は比較液１、１０ｍｌを、また陽性対照群は比較液２、１０ｍｌを腹腔内に注入した。その結果を表２に示した。
【００２０】
【表２】
表２より、カラゲナンは対照群より０．１〜１．０％で良好な癒着防止効果がみられ、特に０．５〜１．０％で優れた効果を認めた。この効果は、公知のヒアルロン酸ナトリウムより優れたものであった。
【００２２】
また今回使用した癒着モデルにおいて、公知のアルギン酸ナトリウム、コンドロイチン硫酸ナトリウム及びデキストラン７０について同様な評価を行った結果、癒着防止効果はほとんと認められなかった。
【００２３】
以上のことより、カラゲナンは腹腔内癒着防止剤の有効成分として優れた効果を持つことが明らかとなった。
【００２４】
【発明の効果】
本発明腹腔内癒着防止剤は、開腹手術時、組織の乾燥、出血および手術に伴う組織損傷などによる腹腔内癒着を防止することができる。従って、術後生じる腸管癒着症及び腸管閉塞症を防止し、術後患者の予後を良好に保つこができる。[0001]
[Industrial applications]
The present invention relates to an intraperitoneal adhesion inhibitor containing carrageenan as an active ingredient.
[0002]
[Prior art]
Intestinal adhesions that occur after laparotomy, especially during gastrointestinal surgery, tend to decrease with the improvement of surgical techniques and equipment, but cannot be completely prevented at present, and this is a major problem for surgeons. In the gynecological field, postoperative adhesions may be accompanied by infertility due to oviduct obstruction and sometimes intestinal obstruction. Intraperitoneal adhesions do not necessarily cause disability, but may cause adhesion ileus, leading to reoperation or worsening the prognosis of postoperative patients (Masatoshi Umagoshi et al., Surgical Therapy, 68, 1005 (1993) )).
[0003]
Adhesion is a result of tissue repair due to an inflammatory response as one of the host defense reactions, and is triggered by intestinal serosa or peritoneal damage. After various stimuli, it causes the detachment of damaged serosa, the exudation of fibrinogen, and the deposition of fibrin by the same mechanism as blood coagulation, and finally forms fibrinous fusion with nearby tissues due to the involvement of fibroblasts. (Osamu Sugimoto, Obstetrics and Gynecology, 53, 185 (1986)). At present, a method for preventing such adhesion has not been established, and attempts have been made to use various drugs and special membranes. Agents that prevent adhesions, such as those having a wound covering function centering on polymeric substances, such as sodium alginate (JP-A-57-167919) and sodium chondroitin sulfate (Oelsner G. et al., J. Reprod) Med., 32, 812 (1987)) and high molecular polysaccharides such as sodium hyaluronate (Urman B. et al., Fertil. Steril, 56, 563 (1991)). In addition, fibrinolytic substances and steroids have been tried, and some of them have been clinically used. However, it is hard to say that all are effective.
[0004]
[Problems to be solved by the invention]
An object of the present invention is to provide an excellent intraperitoneal adhesion preventing agent.
[0005]
[Means for Solving the Problems]
In view of the above situation, the present inventors have conducted intensive studies on high molecular polysaccharides, and as a result, have found an anti-adhesion effect superior to the previously reported substances in carrageenan, thereby completing the present invention.
[0006]
That is, the present invention relates to an intraperitoneal adhesion inhibitor containing carrageenan as an active ingredient.
[0007]
In the present invention, carrageenan can be obtained by hot water extraction from a seaweed belonging to the genus Sugirino belonging to the red algae. It is a high molecular weight polysaccharide containing sulfuric acid containing D-galactose and anhydro-D-galactose as constituent sugars, and has a wide range of uses as a thickener, a stabilizer, a gelling agent and the like for foods. The present inventors have completed the present invention from a completely new finding that carrageenan is administered intraperitoneally after laparotomy to prevent intra-abdominal adhesions.
[0008]
The carrageenan in the intraperitoneal adhesion preventing agent of the present invention is usually prepared in a 0.1 to 1.0 W / V% gel solution. As the solvent, it is desirable to use a physiological saline solution or a suitable electrolyte solution, for example, a peritoneal lavage solution (Table 1) described in JP-A-2-302626.
[0009]
[Table 1]
It is preferable that the anti-intraperitoneal adhesion preventive agent of the present invention be injected into the abdominal cavity after laparotomy and applied so as to cover the surgical treatment site. The injection amount may be appropriately selected according to the age, body weight, sex difference, symptom, and injured area in the abdominal cavity, and may be preferably in the range of 10 to 200 ml. The carrageenan solution gels at room temperature depending on the concentration, and the gel can be applied as it is to the peritoneal cavity, and the amount of the gel is preferably 5 g to 100 g.
[0011]
The intraperitoneal adhesion inhibitor of the present invention may contain other medicinal ingredients in addition to carrageenan, if necessary.
[0012]
【Example】
Hereinafter, the present invention will be described in detail with reference to Examples and Test Examples performed on the intraperitoneal adhesion preventing agent of the present invention.
[0013]
[Example 1]
10 g of carrageenan was added to the peritoneal washings shown in Table 1 and dissolved by stirring at room temperature for 3 to 4 hours. It may be heated during dissolution. After the solution became homogeneous, the total volume was adjusted to 1,000 ml with the same peritoneal washing solution to obtain the desired 1.0% anti-peritoneal adhesion inhibitor. Note that a physiological saline solution may be used instead of the peritoneal washing solution.
[0014]
The resulting intraperitoneal adhesion inhibitor becomes a gel at room temperature.
[0015]
[Examples 2 to 4]
In the same manner as in Example 1, carrageenan concentrations of 0.02% (Example 2), 0.1% (Example 3), and 0.5% (Example 4) were obtained at different concentrations in the intraperitoneal adhesion preventing agent. Was.
[0016]
The resulting intraperitoneal adhesion inhibitor is in a solution state at room temperature at 0.02%, but becomes a gel at 0.1% and 0.5%.
[0017]
[Comparative liquid 1]
The peritoneal lavage solution described in Table 1 was used as Comparative Solution 1.
[0018]
[Comparative liquid 2]
For comparison, sodium hyaluronate was used as a high molecular polysaccharide reported to have an adhesion preventing effect. That is, in the same manner as in Example 1, the intended comparative liquid 2 was obtained using 5 g of sodium hyaluronate instead of carrageenan.
[0019]
(Test example)
The following adhesion model was prepared using 10- to 13-week-old male SD rats. That is, under pentobarbital anesthesia, open about 4 cm from the part about 3 cm below the xiphoid process to the lower part along the midline, remove the epididymal fat on the left and right, and then use dry gauze to move 10 cm from the ileocecal part to the mouth side. Was rubbed 9 times (to the extent that extravasation was observed). Thereafter, the intraperitoneal adhesion preventive agent of each of Examples 1 and 2 (10 ml or 5 g in the case of a gel) containing a predetermined concentration of carrageenan was applied intraperitoneally, and the abdomen was closed by two-layer suture. One week later, the abdomen was opened and the state of intestinal adhesion was evaluated. The adhesion was evaluated by measuring the length of adhesion (adhesion length) between the treated ileums and other intestinal tracts (jejunum, cecum, large intestine, etc.) to the treated ileum. Similarly, the control group was intraperitoneally injected with 1, 10 ml of the comparative solution, and the positive control group was injected with 2, 10 ml of the comparative solution. The results are shown in Table 2.
[0020]
[Table 2]
From Table 2, it was found that carrageenan exhibited a better adhesion-preventing effect at 0.1 to 1.0% than that of the control group, and particularly exhibited an excellent effect at 0.5 to 1.0%. This effect was superior to the known sodium hyaluronate.
[0022]
In addition, in the adhesion model used this time, the same evaluation was performed for the known sodium alginate, sodium chondroitin sulfate, and dextran 70. As a result, the adhesion preventing effect was hardly recognized.
[0023]
From the above, it was revealed that carrageenan has an excellent effect as an active ingredient of the intraperitoneal adhesion inhibitor.
[0024]
【The invention's effect】
The intraperitoneal adhesion preventive agent of the present invention can prevent intraperitoneal adhesion due to drying of tissue, bleeding, and tissue damage accompanying the operation during laparotomy. Therefore, intestinal adhesion and intestinal obstruction occurring after the operation can be prevented, and the prognosis of the postoperative patient can be kept good.
Claims (1)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP26957893A JP3545789B2 (en) | 1993-09-30 | 1993-09-30 | Intraperitoneal adhesion inhibitor |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP26957893A JP3545789B2 (en) | 1993-09-30 | 1993-09-30 | Intraperitoneal adhesion inhibitor |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH07101865A JPH07101865A (en) | 1995-04-18 |
| JP3545789B2 true JP3545789B2 (en) | 2004-07-21 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP26957893A Expired - Fee Related JP3545789B2 (en) | 1993-09-30 | 1993-09-30 | Intraperitoneal adhesion inhibitor |
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| Country | Link |
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| JP (1) | JP3545789B2 (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6812220B2 (en) * | 2001-08-29 | 2004-11-02 | University Of British Columbia | Pharmaceutical compositions and methods relating to fucans |
| CN100333804C (en) * | 2003-04-18 | 2007-08-29 | 上海建华精细生物制品有限公司 | Sodium hyaluronate anti-adhesion film, and its prepn. method |
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| JPH07101865A (en) | 1995-04-18 |
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