皮内テストについてCDCガイドラインの一部


 抗生剤の皮内テストについて。すでにご承知のことと思いますがという丁重なスタンスをとりつつ、失礼なく(それぞれに理由があるのだ)、提案なんてできるのだろうか? 毎度迷う。

1.状況

 日本化学療法学会「臨床試験委員会皮内反応検討特別部会報告書」1)を受け、2004年10月に厚労省医薬食品局の通知「注射用抗生物質製剤等によるショック等に対する安全対策について」2)以降、抗生剤の皮内反応テストは、添付文書から記載がなくなりました。

 一方、医薬ビジランス研究所の浜六郎氏から「抗生物質皮内テスト廃止は死亡事故を多発させる」3)との見解も報告されております。

 また、米国では抗菌薬の皮内反応試験は,その種類にかかわらず一般的に実施されていない。添付文書中においても皮内反応試験に関する記載はありません。しかしながら,アレルギーの既往を有する患者に対しては皮内反応試験の実施が推奨されており、一部のガイドライン4)には、アレルギーの既往がある患者へのみ、皮内テストの実施が推奨されております。

2.提案

 皮内テストは、アレルゲン特定方法の一つとしては意義があると認識されております。しかし、現在での皮内テストの全般的な感度・特異度については方法がないという点で、推測・評価ができない状況です。

 新規に購入予定の注射抗生剤においては、皮内反応テストそのものが製造されない状況です。対応についてご検討いただきたく、よろしくお願いいたします。

*参考資料

1)「従来の抗菌薬投与に関連するアナフィラキシー対策のガイドラインとその概要版」日本化学療法学会, 2004年10月

2)「注射用抗生物質製剤等によるショック等に対する安全対策について」厚労省医薬食品局, 2004年10月

3)「抗生物質皮内テスト廃止は死亡事故を多発させる」医薬ビジランス研究所 浜六郎, 2004年10月

4)Centers for Disease Control and Prevention, Workowski KA, Berman SM.:Sexually transmitted diseases treatment guidelines, 2006. MMWR Recomm Rep. 2006 Aug 4;55(RR-11):1-94.

 ま、それはよいとしても、CDCのSTDガイドラインが当時化学療法学会が、2002年に引用したガイドラインから、2006年版に変更されて、”Management of Patients Who Have a History of Penicillin Allergy”の項目が変更されていないか?確認をしたかった。

参考文献4)より

■Management of Patients Who Have a History of Penicillin Allergy

No proven alternatives to penicillin are available for treating neurosyphilis, congenital syphilis, or syphilis in pregnant women. Penicillin also is recommended for use, whenever possible, in HIV-infected patients. Of the adult U.S. population, 3%–10% have experienced an immunoglobulin E (IgE) mediated allergic response to penicillin such as urticaria, angioedema, or anaphylaxis (i.e., upper airway obstruction, bronchospasm, or hypotension). Re-administration of penicillin to these patients can cause severe, immediate reactions. Because anaphylactic reactions to penicillin can be fatal, every effort should be made to avoid administering penicillin to penicillin-allergic patients, unless they undergo acute desensitization to eliminate anaphylactic sensitivity.

An estimated 10% of persons who report a history of severe allergic reactions to penicillin remain allergic. With the passage of time, the majority of persons who have had a severe reaction to penicillin stop expressing penicillin-specific IgE. These persons can be treated safely with penicillin. The results of many investigations indicate that skin testing with the major and minor determinants of penicillin can reliably identify persons at high risk for penicillin reactions. Although these reagents are easily generated and have been available for >30 years, only benzylpenicilloyl poly-L-lysine (Pre-Pen® [i.e., the major determinant]) and penicillin G have been available commercially. Testing with only the major determinant and penicillin G identifies an estimated 90%–97% of the currently allergic patients. However, because skin testing without the minor determinants would still miss 3%–10% of allergic patients and because serious or fatal reactions can occur among these minordeterminant–positive patients, specialists suggest exercising caution when the full battery of skin-test reagents is not available (Box 1). An additional challenge has occurred with the recent unavailability of Pre-Pen®; however, plans for future availability of this product have been made, as well as a companion minor determinant mixture.

■Recommendations

If the full battery of skin-test reagents is available, including the major and minor determinants (see Penicillin Allergy Skin Testing), patients who report a history of penicillin reaction and who are skin-test negative can receive conventional penicillin therapy. Skin-test–positive patients should be desensitized.

If the full battery of skin-test reagents, including the minor determinants, is not available, the patient should be skin tested using benzylpenicilloyl poly-L-lysine (i.e., the major determinant) and penicillin G. Patients who have positive test results should be desensitized. Some specialists suggest that persons who have negative test results should be regarded as probably allergic and should be desensitized. Others suggest that those with negative skin-test results can be test-dosed gradually with oral penicillin in a monitored setting in which treatment for anaphylactic reaction can be provided.

If the major determinant (Pre-Pen®) is not available for skin testing, all patients with a history suggesting IgE mediated reactions (anaphylaxis, angioedema, bronchospasm, or urticaria) to penicillin should be desensitized in a hospital setting. In patients with reactions not likely to be IgE mediated, outpatient oral desensitization or monitored test doses may be considered.

■Penicillin Allergy Skin Testing

Patients at high risk for anaphylaxis, including those who 1) have a history of penicillin-related anaphylaxis, asthma, or other diseases that would make anaphylaxis more dangerous or 2) are being treated with beta-adrenergic blocking agents should be tested with 100-fold dilutions of the full-strength skin-test reagents before being tested with full-strength reagents. In these situations, patients should be tested in a monitored setting in which treatment for an anaphylactic reaction is available. If possible, the patient should not have taken antihistamines recently (e.g., chlorpheniramine maleate or terfenadine during the preceding 24 hours, diphenhydramine HCl or hydroxyzine during the preceding 4 days, or astemizole during the preceding 3 weeks).

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