藤沢のプロトピック軟膏が米国で承認取得
2000/12/11 Yahoo
- U.S. FDA approves Fujisawa eczema treatment Friday
December 8 FDA
Approves First New Eczema Therapy in Decades Dec. 8, 2000 (Washington)
---FDAが数十年ぶりにアトピーの新薬を認可The FDA cautioned that Protopic shouldn't be the first therapy for all patients, but reserved for those with moderate to severe eczema who aren't adequately helped by other treatments or can't tolerate them.
プロトピックがすべての患者の第一選択となるべきではなく、他の治療で上手くいかない中〜重症のアトピー患者に限られるべき。
The new drug is not a cure: Once people quit using the cream, eczema gradually returned. So far, the FDA can say only that using it for a year is safe; Fugisawa agreed to conduct longer-term safety studies.
Protopic has its own set of risks:
・ Users should stay out of the sun. Because Protopic affects the immune system, some scientists worry that it might mix with sun exposure to increase the risk of skin cancer. The possibility remains under study.
・ Don't use Protopic until skin infections are healed. The drug may increase risk of certain skin infections, including a serious herpes virus-caused infection called eczema herpeticum.
・ Most common side effects were skin burning or tingling in up to 60% of patients. But after a month of use, less than 10% report that it's still a problem.
プロトピックは完治させるものではないので、薬を塗るのを止めれば徐々に湿疹は戻ってくる。今のところ、1年間の使用は安全、と言えるのみで、より長期での安全性の研究に取り組むことを藤沢製薬は合意。
プロトピックにもリスクはある；
・ 使用者は日光を避けること。プロトピックは免疫システムに作用するので、日光を浴びることで皮膚ガンの危険性のが高まるのを懸念する研究者もいる。
・ 皮膚の感染が治るまで使用しない。プロトピックはある種の皮膚感染の危険性を高める可能性がある。
・ 最も一般的な副作用は、皮膚の火照り感や刺激感で60%の患者に起こる。しかし、1ヶ月の使用後でもそれを訴えるのは10%以下。
FDA
APPROVES NEW TREATMENT FOR ECZEMA (FDA Talk Papers December 8, 2000)
---FDAがアトピーの新しい治療を承認The Food and Drug Administration (FDA) today approved a new treatment for atopic dermatitis (eczema) - a non-contagious skin condition that can cause redness, itching and oozing lesions.
The drug is Protopic (tacrolimus) Ointment (0.1% and 0.03% for adults and 0.03% for children 2 years and older). The drug is for patients with moderate to severe eczema, for whom standard eczema therapies are deemed inadvisable because of potential risks, or who are not adequately treated by or who are intolerant of standard eczema therapies.
プロトピック（タクロリムス）軟膏（大人用に0.1%と0.03%、2歳以上の小児用に0.03%）がアトピー性皮膚炎の新治療薬としてFDAに承認された。中〜重症の患者で、スタンダードな治療がすすめられない場合、十分な治療効果が得られない場合などを対象。
Why
Do Patients with Atopic Dermatitis Refuse to Apply Topical Corticosteroids?
(Dermatology 2000;201(3):242-245) --- アトピー性皮膚炎患者はなぜステロイド外用剤の塗布を拒むか？Patients with atopic dermatitis who refuse to use topical corticosteroids attribute their feelings of resistance to personal experiences rather than to information from external sources. Information or warnings about associated side effects from physicians may help to reduce these fears and ultimately benefit the physician-patient relationship.
ステロイド外用を拒む患者の多くは、個人体験によってステロイドへの抵抗感を抱くのであって、外部からの情報（マスメディアなど）によってではない。医師から副作用に関する情報を得たり注意を受けることによって、不安を減らし、結果的には良好な医師-患者関係を築けるであろう。
PROTOPIC(R)
-- First Steroid-Free Treatment for Eczema in Over 40 Years Recommended
for FDA Approval --- 40年ぶりの非ステロイドアトピー治療薬、FDAの承認勧告 Safety
and efficacy of 1 year of tacrolimus ointment monotherapy in adults with
atopic dermatitis. The European Tacrolimus Ointment Study Group. (Arch
Dermatol 2000 Aug;136(8):999-1006)--- 成人アトピー性皮膚炎患者におけるタクロリムス軟膏治療1年めの安全性と効果Up to 1 year of tacrolimus ointment use was safe and effective in patients with atopic dermatitis.
タクロリムス軟膏、1年までの使用は、安全且つ有効である。
Long-term
Efficacy of Tacrolimus Ointment for Recalcitrant Facial Erythema Resistant
to Topical Corticosteroids in Adult Patients With Atopic Dermatitis
(Arch Dermatol 2000 Aug;136(8)）--- ステロイド外用剤に抵抗性のある成人アトピー性皮膚炎患者における難治の顔面紅斑へのタクロリムス軟膏の長期効能The proportion of patients whose symptoms were greatly or fairly improved by the tacrolimus ointment was 94% (48/51), 82% (42/51), and 62% (32/51) after 2 weeks, 3 months, and 1 year of treatment, respectively. The proportion of the excellent responders was 81% (22/27) for those patients whose skin lesions were restricted mainly to the face, whereas the proportion was 21% (3/14) for those who had widespread skin lesions on the trunk and limbs.
タクロリムス軟膏で症状が改善した人の割合は、2週間後、3ヶ月後、1年後で、それぞれ、94%、82%、62%。
よく効いたのは、患部が主に顔に限定されていた人達で、81%に有効だった。それに対し、体幹部や手足に患部が広がっている場合の有効率は21%。
Our results confirmed previous reports that short-term use of tacrolimus ointment shows excellent results with the recalcitrant facial erythema of atopic dermatitis. However, therapeutic efficacy was greatly reduced after continuous use of the ointment for 1 year. It is possible that prolonged application of tacrolimus ointment to the face often induces tachyphylaxis or contact hypersensitivity to the drug.
Long-term use of tacrolimus ointment for facial erythema was effective in patients who had sporadic skin lesions on the trunk, but ineffective in those with widespread lesions on the trunk.
結果として、タクロリムス軟膏の短期間の使用は難治の顔面紅斑に非常に有効であるが、1年の連用後には治療効果はかなり低くなることが確認された。顔への連用は薬剤へのタキフィラキシーや接触過敏を引き起こす可能性がある。
タクロリムス軟膏の顔面紅斑への長期使用は、体幹部に皮疹があまりない患者には有効だったが、体幹部に皮疹が広がっている場合は、有効ではなかった。
Skin
barrier function in patients with completely healed atopic dermatitis.These findings indicate that skin barrier function is not disturbed in patients with completely healed atopic dermatitis.
完治した患者では、皮膚のバリア機能は損なわれていない。
Allergies
'helped by homeopathy' (BBC NEWS 00/08/17) --- アレルギーにホメオパシーが効く？ New
Eczema Treatments (ABC NEWS 00/08/14) --- 新しいアトピーの治療 Climatotherapy
of atopic dermatitis.... ---アトピー性皮膚炎の気候療法 The
Further Adventures of Eczema Boy (The Washington Post 00/07/11) ---
アトピーボーイのさらなる冒険 Steroid
Creams Often Met With Unfounded FearA recent study in the British Journal of Dermatology showed as many as 73% of patients with eczema are afraid of corticosteroid creams and ointments. About 25% refuse to use them.
Mild corticosteroid creams are quite safe when used in an appropriate way, says Amy Paller, MD, professor of pediatrics and dermatology at Northwestern University Medical School. "That means limiting use to twice daily, and only applying a thin layer of the cream. Patients also need to be particularly careful when using these creams on the face or in fold areas, since there could be increased absorption in those areas and possible local side effects such as thinning of the skin.
Corticosteroid creams and ointments are very effective, and doctors should take time to educate patients about the low risk of side effects.
A painful search
for healthy skin (USA TODAY 00/05/31) ---
健康な皮膚への模索....Steroids initially were regarded as a godsend for those children, relieving inflammation and soothing irritation. But doctors soon discovered that the potent compounds could have severe side effects.
1960年代に登場したステロイドは、アレルギーの子供達には大変な福音であったが、この強い薬には深刻な副作用が起こり得ることに、医師達はまもなく気づいた。
Steroid ointments thin out the skin by blocking synthesis of connective tissues in its middle layer. Damage to the skin's middle layer inevitably damages the water-resistant barrier that keeps the skin properly hydrated.
ステロイドは皮膚を薄くし、皮膚の水分を保つバリアを破壊する。
Even the partial loss of the skin's barrier function, which is already weakened by eczema, leaves the skin prone to further irritation. It also increases the likelihood that the rash will rebound when the steroid's effect wears off, which in turn may lead to steroid dependency.
ただでさえ湿疹で弱っている皮膚のバリア機能が損なわれれば、より刺激を受けやすくなり、ステロイドの効果が弱まると発疹が再燃（リバウンド)しやすくなる。それでステロイド依存に陥る可能性がある。（特に顔に長期使用の場合）
Tacrolimus works by preventing T cells from releasing calcineurin, the first step in the skin-damaging cascade. And it appears to relieve eczema without any major side effects, apart from a mild burning sensation on the skin when it is first applied. After several applications, Shrager says, the discomfort fades.
タクロリムスはT-cell（アレルギーに多いに関与する）に働きかけて、皮膚のダメージを起こさせない。特に副作用もなく湿疹を治癒させるようだ。最初に軽い火照り感があるが、何度か塗るうちになくなる。
