JP4494594B2 - Painkiller - Google Patents
Painkiller Download PDFInfo
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- JP4494594B2 JP4494594B2 JP2000181294A JP2000181294A JP4494594B2 JP 4494594 B2 JP4494594 B2 JP 4494594B2 JP 2000181294 A JP2000181294 A JP 2000181294A JP 2000181294 A JP2000181294 A JP 2000181294A JP 4494594 B2 JP4494594 B2 JP 4494594B2
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- injection
- lidocaine
- pain
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- mepivacaine
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Description
【0001】
【発明の属する技術分野】
本発明は、筋筋膜性疼痛症候群における鎮痛に関する。
【0002】
【従来の技術】
筋筋膜性疼痛症候群とは、いわゆる肩こりや急性腰痛症などに代表される疾患群である。本症の治療方法としては、薬物動態および薬理作用が同一である2−ジエチラミノ−N−(2,6−ジメチルフェニル)アセタミドまたはその酸付加塩(一般名:リドカイン)あるいは、N−(2,6−ジメチルフェニル)−1−メチル−2−ピペリジンカルボキサミドモノヒドロクロライドまたはその酸付加塩(一般名:メピバカイン)などの1〜2%局所麻酔薬をトリガーポイント部位へ局所注入するのが一般的である。しかし、この場合、効果は一過性であり、過量投与時には局所麻酔薬中毒が問題となる。
【0003】
このリドカインあるいはメピバカインのトリガーポイント部位への局所注入に替わる有効な方法として、注射用蒸留水のトリガーポイント部位への注入が挙げられる。このトリガーポイント部位への注射用蒸留水注入は、局所麻酔薬注入に比べ効果の高いことが認められている。
【0004】
しかし、注射用蒸留水をトリガーポイント部位へ注入する時には一過性の激痛が伴うため、施行されることは希である。
【0005】
【発明が解決しようとする課題】
そこで、注射用蒸留水の注入時の激痛を除去し、これに匹敵する効果を見出すことが望まれている。
【0006】
【課題を解決するための手段】
本発明者等は、注射用蒸留水のトリガーポイント部位への注入による激痛を除去すべく鋭意検討を行った結果、0.2〜0.25%の低濃度リドカインあるいはメピバカイン存在下で注入時痛が除去されることを見出し、さらに従来の局所麻酔薬注入に比べ効果が高く、長期間作用することを証明し、本発明を完成した。低濃度のリドカインあるいはメピバカインを含有する注射用水に、この様な注入時痛除去作用があることは医学的に予見困難である。
【0007】
すなわち、本発明は、リドカインを0.2〜0.25W/V%含有し、等張液の1/2以下の無機塩濃度を有する注射用水からなる鎮痛剤に関する。
【0008】
また、本発明は、メピバカインを0.2〜0.25/V%含有し、等張液の1/2以下の無機塩濃度を有する注射用水からなる鎮痛剤に関する。
【0009】
さらに、本発明は、筋筋膜性疼痛症候群の疼痛緩和用鎮痛剤であって、リドカインおよび/またはメピバカインを0.2〜0.25W/V%含有し、等張液の1/2以下の無機塩濃度を有する注射用水からなる、鎮痛剤に関する。
【0010】
【発明の実施の形態】
本発明の鎮痛剤は、リドカインまたはメピバカインを0.2〜0.25W/V%含有し、等張液の1/2以下の無機塩濃度を有する注射用水からなる。
【0011】
本発明において、「等張液の1/2以下の無機塩濃度」とは、通常、注射液に用いられる等張(緩衝)液を構成する無機塩濃度の1/2以下の濃度をいう。無機塩濃度は、等張液の1/4以下が好ましく、1/4〜1/5がより好ましい。さらに、等張液の1/4以下には、無機塩を含まない場合、すなわち、リドカインまたはメピバカインまたはこれらの酸付加塩を注射用水に溶解する場合も含む。
【0012】
本発明で、注射用水には、日本薬局方でいう常水または精製水を蒸留して得られる注射用蒸留水、または精製水を超濾過して注射剤の調製に使用する水、これを滅菌したものが含まれる。注射用蒸留水が好ましく用いられる。
【0013】
本発明の鎮痛剤は、適切な濃度となるように無機塩およびリドカインまたはメピバカインを添加して溶解することにより得られる。最も簡単には、医薬品として認可、販売されている1%リドカインおよび1%メピバカインに注射用蒸留水を混合し、リドカインおよび/またはメピバカインの濃度として0.2〜0.25W/V%とすることにより調製することができる。
【0014】
本発明の鎮痛剤は、好ましくは、筋筋膜性疼痛症候群の疼痛緩和用に用いられる。リドカインおよびメピバカインは薬物動態および薬理作用が同一であるので、どちらを用いても効果は同じである。
【0015】
本発明の鎮痛剤を筋筋膜性疼痛症候群におけるトリガーポイント部位へ注入する場合、一箇所2ml、総量として10mlまでが臨床的に適当であるが、患者の年齢、状態等により適宜増減される。
【0016】
【実施例】
次に本発明を以下の処方例および試験例によって具体的に説明するが、本発明はこれらの例によって限定されるものではない。
【0017】
(実施例1:リドカイン濃度の違いによる注入時痛の比較試験)
以下の(1)〜(5)の注射剤を処方した。
(1)1W/V% リドカイン
(2)0.3W/V% リドカイン
1%リドカイン 3ml
注射用蒸留水 7ml
混合し、リドカインとして0.3W/V%濃度の注射剤とする。
(3)0.25W/V% リドカイン
1%リドカイン 2.5ml
注射用蒸留水 7.5ml
混合し、リドカインとして0.25W/V%濃度の注射剤とする。
(4)0.2W/V% リドカイン
1%リドカイン 2ml
注射用蒸留水 8ml
混合し、リドカインとして0.2W/V%濃度の注射剤とする。
(5)0.15W/V% リドカイン
1%リドカイン 1.5ml
注射用蒸留水 8.5ml
混合し、リドカインとして0.15W/V%濃度の注射剤とする。
【0018】
無作為割付した二重盲検法により、次の比較試験を行った。ボランティア25人の左右肩甲上部(合計50ヵ所)の僧帽筋に、処方例(1)〜(5)の注射剤を、各処方例につき10人となるように、2mlずつ25ゲ−ジ注射針を使用し注入した。
【0019】
ボランテイアへの問診により、薬液注入時痛の程度を1(痛くない)、2(軽い痛み)、3(中等度の痛み)、4(強い痛み)の4段階のスコアで判定した。結果を表1に示す。
【0020】
【表1】
【0021】
表1の結果は、1W/V%リドカイン濃度では中等度から強い痛みがあり、0.15W/V%リドカイン濃度および0.3W/V%リドカイン濃度では、軽い痛みに軽減されたが、依然として注射時の痛みは残る。これに対して、0.2〜0.25W/V%のリドカイン濃度の注射剤は、「痛くない」が90%を占め、疼痛緩和効果が認められた。
【0022】
(実施例2:メピバカインおよび生理食塩水希釈による注入時痛の比較試験)以下の(6)および(7)の注射剤を処方した。
(6)0.25W/V% メピバカイン
1%メピバカイン 2.5ml
注射用蒸留水 7.5ml
混合し、メピバカインとして0.25W/V%濃度の注射剤とする。
(7)0.25W/V% リドカイン
1%リドカイン 2.5ml
生理食塩水 7.5ml
混合し、リドカインとして0.25W/V%濃度の注射剤とする。
【0023】
無作為割付した二重盲検法により、次の比較試験を行った。ボランティア15人の左右肩甲上部(合計30ヵ所)の僧帽筋に、上記実施例の処方例(3)、(6)および(7)の注射液を、各処方例につき10人となるように、2mlずつ25ゲ−ジ注射針を使用して、注入した。ボランティアへの問診により、注入時痛の程度を1(痛くない)、2(軽い痛み)、3(中等度の痛み)、4(強い痛み)の4段階のスコアで判定した。結果を表2に示す。
【0024】
【表2】
【0025】
表2に示すように、0.25W/V%のリドカインおよびメピバカインは、痛みがなく、実施例1と同じ結果を示した。生理食塩水で希釈した場合、疼痛軽減効果は認められなかった。
【0026】
(実施例3:疼痛軽減効果と効果期間)
無作為割付した二重盲検法により、次の比較試験を行った。筋筋膜性疼痛症候群で左右同程度に肩こりを訴える患者20人を対象とした。左右肩甲上部のトリガーポイント部位に処方例(1)(1W/V%リドカイン)および(3)(0.25%W/Vリドカイン:注射用蒸留水で希釈)を、それぞれ2mlずつ25ゲージ注射針を使用し、左右無作為に注入した。治療前後および治療14日後までの改善効果を患者の自己評価により比較した。治療前の鎮痛スコアを4とし、治療後の改善効果を1(非常に改善)、2(中等度改善)、3(軽度改善)、4(変化なし)、5(増悪)の5段階で判定した。結果を図1に示す。
【0027】
以上の結果から、筋筋膜性疼痛症候群におけるトリガーポイント部位への本発明の鎮痛剤の注入は、注入時痛がほとんどなく、従来の治療より効果が高く、長期間効果のあることが明らかとなった。
【0028】
【発明の効果】
本発明の鎮痛剤は、従来の鎮痛治療剤に比べ、筋筋膜性疼痛症候群の疼痛および各種症状をより軽減することができるので、鎮痛剤として有用である。
【図面の簡単な説明】
【図1】本発明の鎮痛剤と従来の鎮痛剤の効果の比較を示す図である。[0001]
BACKGROUND OF THE INVENTION
The present invention relates to analgesia in myofascial pain syndrome.
[0002]
[Prior art]
Myofascial pain syndrome is a disease group represented by so-called stiff shoulders and acute low back pain. As a method for treating this disease, 2-dietyramino-N- (2,6-dimethylphenyl) acetamide or an acid addition salt thereof (generic name: lidocaine) having the same pharmacokinetics and pharmacological action or N- (2, It is common to inject 1-2% local anesthetics such as 6-dimethylphenyl) -1-methyl-2-piperidinecarboxamide monohydrochloride or its acid addition salt (generic name: mepivacaine) locally at the trigger point site. is there. However, in this case, the effect is transient, and local anesthetic poisoning becomes a problem at the time of overdose.
[0003]
An effective method for replacing the local injection of lidocaine or mepivacaine to the trigger point site is injection of distilled water for injection to the trigger point site. It has been confirmed that the injection of distilled water for injection at the trigger point site is more effective than the injection of local anesthetics.
[0004]
However, when distilled water for injection is injected into the trigger point site, it is rarely performed because it is accompanied by a temporary severe pain.
[0005]
[Problems to be solved by the invention]
Therefore, it is desired to remove the severe pain when injecting distilled water for injection and to find an effect comparable to this.
[0006]
[Means for Solving the Problems]
As a result of intensive studies to eliminate severe pain caused by injection of distilled water for injection into the trigger point site, the present inventors have found that pain during injection in the presence of 0.2 to 0.25% low-concentration lidocaine or mepivacaine. Was found to be removed, and further proved that the effect is higher than that of conventional local anesthetic injection and that it works for a long period of time, thereby completing the present invention. It is difficult to foresee medically that injection water containing a low concentration of lidocaine or mepivacaine has such a pain relieving action upon injection.
[0007]
That is, the present invention relates to an analgesic comprising water for injection containing 0.2 to 0.25 W / V% lidocaine and having an inorganic salt concentration of 1/2 or less that of an isotonic solution.
[0008]
The present invention also relates to an analgesic comprising water for injection containing mepivacaine in an amount of 0.2 to 0.25 / V% and having an inorganic salt concentration of 1/2 or less that of an isotonic solution.
[0009]
Furthermore, the present invention is a pain relieving analgesic for myofascial pain syndrome, comprising 0.2 to 0.25 W / V% lidocaine and / or mepivacaine, and ½ or less of isotonic solution The present invention relates to an analgesic consisting of water for injection having an inorganic salt concentration.
[0010]
DETAILED DESCRIPTION OF THE INVENTION
The analgesic of the present invention comprises water for injection containing 0.2 to 0.25 W / V% of lidocaine or mepivacaine and having an inorganic salt concentration of 1/2 or less of the isotonic solution.
[0011]
In the present invention, “an inorganic salt concentration of ½ or less of an isotonic solution” usually refers to a concentration of ½ or less of an inorganic salt concentration constituting an isotonic (buffer) solution used for an injection solution. The inorganic salt concentration is preferably ¼ or less, more preferably ¼ to よ り of the isotonic solution. Further, ¼ or less of the isotonic solution includes a case where an inorganic salt is not contained, that is, a case where lidocaine, mepivacaine or an acid addition salt thereof is dissolved in water for injection.
[0012]
In the present invention, for injection water, distilled water for injection obtained by distilling normal water or purified water as referred to in the Japanese Pharmacopoeia, or water used for preparing injections by ultrafiltration of purified water, which is sterilized Is included. Distilled water for injection is preferably used.
[0013]
The analgesic of the present invention is obtained by adding and dissolving an inorganic salt and lidocaine or mepivacaine so as to have an appropriate concentration. Most simply, 1% lidocaine and 1% mepivacaine approved and sold as pharmaceuticals are mixed with distilled water for injection to give a concentration of lidocaine and / or mepivacaine of 0.2 to 0.25 W / V%. Can be prepared.
[0014]
The analgesic of the present invention is preferably used for pain relief of myofascial pain syndrome. Since lidocaine and mepivacaine have the same pharmacokinetics and pharmacological action, the effect is the same regardless of which is used.
[0015]
When injecting the analgesic agent of the present invention to the trigger point site in myofascial pain syndrome, 2 ml per place and a total amount of up to 10 ml are clinically appropriate, but may be appropriately increased or decreased depending on the age, condition, etc. of the patient.
[0016]
【Example】
Next, the present invention will be specifically described by the following formulation examples and test examples, but the present invention is not limited to these examples.
[0017]
(Example 1: Comparative test of pain during injection due to difference in lidocaine concentration)
The following injections (1) to (5) were prescribed.
(1) 1W / V% lidocaine (2) 0.3W / V% lidocaine 1% lidocaine 3ml
7ml distilled water for injection
Mix and make 0.3 W / V% concentration injection as lidocaine.
(3) 0.25W / V% lidocaine 1% lidocaine 2.5ml
7.5ml distilled water for injection
It mixes and it is set as the injection of a 0.25 W / V% density | concentration as lidocaine.
(4) 0.2W / V% lidocaine 1% lidocaine 2ml
8ml distilled water for injection
It mixes and it is set as the 0.2 W / V% density | concentration injection as lidocaine.
(5) 0.15W / V% lidocaine 1% lidocaine 1.5ml
8.5ml distilled water for injection
It mixes and it is set as the injection of 0.15 W / V% density | concentration as lidocaine.
[0018]
The following comparative study was performed by a double-blind method with random assignment. 25 volunteers of 25 ml each of the injections of prescription examples (1) to (5) are applied to the trapezius muscles of the left and right upper scapula (total of 50 places) of 25 volunteers. Injection was performed using a syringe needle.
[0019]
Through the interview with volunteers, the degree of pain at the time of medicinal solution injection was determined by 4 grade scores of 1 (not painful), 2 (mild pain), 3 (moderate pain), 4 (strong pain). The results are shown in Table 1.
[0020]
[Table 1]
[0021]
The results in Table 1 show moderate to strong pain at 1 W / V% lidocaine concentration, and reduced to mild pain at 0.15 W / V% lidocaine and 0.3 W / V% lidocaine concentrations, but still injected The pain of time remains. On the other hand, in the case of an injection having a lidocaine concentration of 0.2 to 0.25 W / V%, “not painful” accounted for 90%, and a pain relieving effect was observed.
[0022]
(Example 2: Comparative test of pain upon injection by dilution of mepivacaine and physiological saline) The following injections (6) and (7) were prescribed.
(6) 0.25W / V% Mepivacaine 1% Mepivacaine 2.5ml
7.5ml distilled water for injection
Mix and make an injection of 0.25 W / V% concentration as mepivacaine.
(7) 0.25W / V% lidocaine 1% lidocaine 2.5ml
Physiological saline 7.5ml
It mixes and it is set as the injection of a 0.25 W / V% density | concentration as lidocaine.
[0023]
The following comparative study was performed by a double-blind method with random assignment. The injections of the prescription examples (3), (6), and (7) of the above example are applied to the trapezius muscles of the left and right upper scapula (total of 30 places) of 15 volunteers so that each prescription example becomes 10 persons. Inject 2 ml each using a 25 gauge needle. The degree of pain at the time of injection was determined by a four-point score of 1 (no pain), 2 (mild pain), 3 (moderate pain), and 4 (strong pain) by interviewing volunteers. The results are shown in Table 2.
[0024]
[Table 2]
[0025]
As shown in Table 2, 0.25 W / V% lidocaine and mepivacaine were painless and showed the same results as in Example 1. When diluted with physiological saline, no pain-reducing effect was observed.
[0026]
(Example 3: Pain relief effect and duration of effect)
The following comparative study was performed by a double-blind method with random assignment. Twenty patients with myofascial pain syndrome complaining of stiff shoulders to the left and right were included. Prescription example (1) (1 W / V% lidocaine) and (3) (0.25% W / V lidocaine: diluted with distilled water for injection) are injected into each of the trigger points on the upper left and right shoulders in 25 gauge injections Using needles, left and right were injected randomly. The effects of improvement before and after treatment and up to 14 days after treatment were compared by patient self-assessment. The analgesic score before treatment is 4, and the improvement effect after treatment is judged in 5 stages: 1 (very improved), 2 (moderate improvement), 3 (mild improvement), 4 (no change), 5 (exacerbation) did. The results are shown in FIG.
[0027]
From the above results, it is clear that the injection of the analgesic agent of the present invention to the trigger point site in myofascial pain syndrome has little pain at the time of injection, is more effective than conventional treatment, and is effective for a long time. became.
[0028]
【The invention's effect】
The analgesic of the present invention is useful as an analgesic because it can alleviate pain and various symptoms of myofascial pain syndrome as compared with conventional analgesics.
[Brief description of the drawings]
FIG. 1 is a diagram showing a comparison of the effects of an analgesic of the present invention and a conventional analgesic.
Claims (3)
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JP2000181294A JP4494594B2 (en) | 2000-06-16 | 2000-06-16 | Painkiller |
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JP2000181294A JP4494594B2 (en) | 2000-06-16 | 2000-06-16 | Painkiller |
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JP4494594B2 true JP4494594B2 (en) | 2010-06-30 |
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Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH08143449A (en) * | 1994-11-17 | 1996-06-04 | Lederle Japan Ltd | Injection for sustained release local anesthesia |
JPH09511519A (en) * | 1994-04-07 | 1997-11-18 | アストラ・アクチエボラーグ | Novel combination of beta-receptor blocker and local anesthetic |
JPH09315964A (en) * | 1996-05-27 | 1997-12-09 | Chinhin Boku | Cataplasm for stiff shoulder and frozen shoulder syndrome |
JPH11511465A (en) * | 1995-08-29 | 1999-10-05 | ニューヨーク メディカル カレッジ | Haloalkylamines and local anesthetic preparations and methods of treating reflex sympathetic dystrophy (RSD) |
-
2000
- 2000-06-16 JP JP2000181294A patent/JP4494594B2/en not_active Expired - Fee Related
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH09511519A (en) * | 1994-04-07 | 1997-11-18 | アストラ・アクチエボラーグ | Novel combination of beta-receptor blocker and local anesthetic |
JPH08143449A (en) * | 1994-11-17 | 1996-06-04 | Lederle Japan Ltd | Injection for sustained release local anesthesia |
JPH11511465A (en) * | 1995-08-29 | 1999-10-05 | ニューヨーク メディカル カレッジ | Haloalkylamines and local anesthetic preparations and methods of treating reflex sympathetic dystrophy (RSD) |
JPH09315964A (en) * | 1996-05-27 | 1997-12-09 | Chinhin Boku | Cataplasm for stiff shoulder and frozen shoulder syndrome |
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