作者：Yael Waknine 齣處：WebMD醫學新聞 　　September 2 2009 — 美國食品藥物管理局（FDA）已經核準azelastine HCl 0.15%鼻噴劑（Astepr 一天一次的Azelastin鼻噴劑核準用於季節性過敏 - 趣味新聞網

發表日期 2009-09-19T08:01:39+08:00

     本帖最後由 lsc0019 於 2009-9-20 22:59 編輯

作者：Yael Waknine
齣處：WebMD醫學新聞

September 2, 2009 — 美國食品藥物管理局（FDA）已經核準azelastine HCl 0.15%鼻噴劑（Astepro Once-Daily，Meda AB公司），用於治療12歲以上季節性與常年性過敏性鼻炎患者。

該産品包括比原來Astepro劑型更濃50%的藥物，是第一個提供季節性過敏病患每天一次投予劑量的鼻噴劑抗組織胺。每個鼻孔噴兩次，每天兩次劑量，則適用於那些常年過敏患者。

根據該公司的新聞稿，這個劑型被證實作用起始快速，可以在投藥後30~45分鍾內緩解癥狀。

Irvine加州大學過敏與免疫學部門臨床教授William Berger醫師錶示，Azelastine提供快速緩解，且可以直接作用於病竈部位，鼻管，來治療許多鼻癥狀，包括因為室內或室外過敏原造成的鼻塞。根據鼻過敏癥狀的改善，azelastine 0.15%是受季節性與常年性過敏性鼻炎鼻癥狀所苦病患的第一綫治療。

Azelastine 0.15%鼻噴劑的療效在七項雙盲、隨機分派、安慰劑控製，為期二與四週的第三期臨床研究中展現，在這些研究中，這個藥物被用於改善整體鼻癥狀分數，包括流鼻水、鼻塞與鼻搔癢的分數。

在這些短期研究中，每天一次與兩次的Azelastine治療，一般而言是耐受性良好的；比較常報告的不良反應包括苦味（分彆為4%與6%）、鼻腔不適（分彆為4%與3%）、流鼻血（分彆為2%與1%）。低於1%的病患在接受藥物治療後發生嗜睡。

在一項為期一年的安全性研究中，針對常年性過敏病患，與使用每天兩次0.15% Azelastine鼻噴劑有關的不良反應，包括苦味、頭痛、鼻竇炎與流鼻血。並沒有觀察到嚴重的流鼻血、鼻腔潰瘍或是鼻中膈穿孔。

0.1% Azelastine鼻噴劑過去被核準用於12歲以上季節性過敏鼻炎，每天使用兩次。

Once-Daily Azelastine Nasal Spray Approved for Seasonal Allergies

By Yael Waknine
Medscape Medical News

September 2, 2009 — The US Food and Drug Administration has approved azelastine HCl 0.15% nasal spray (Astepro Once-Daily; Meda AB) for the treatment of seasonal and perennial allergic rhinitis in patients 12 years and older.

The product is 50% more concentrated than the original Astepro formulation and represents the first nasal antihistamine to offer once-daily dosing for patients with seasonal allergies. A twice-daily dose of 2 sprays per nostril is recommended for those with year-round allergies.

According to a company news release, the formulation has demonstrated a rapid onset of action, relieving symptoms within 30 to 45 minutes of dosing.

Azelastine provides fast-acting relief and is applied right at the site — in the nasal passage — to treat a broad spectrum of nasal symptoms, including congestion caused by indoor and outdoor allergies," said William Berger, MD, clinical professor in the Division of Allergy and Immunology at the University of California, in Irvine. "Based on demonstrated improvement in nasal allergy symptoms, [azelastine] 0.15% is a good first-line therapy option for seasonal and perennial allergic rhinitis patients suffering with nasal symptoms."

The efficacy of azelastine 0.15% nasal spray was demonstrated in 7 double-blind placebo-controlled 2- and 4-week phase?3 trials, in which its use significantly improved total nasal symptom score, a composite of rhinorrhea, nasal congestion, sneezing, and nasal itching scores.

Once- and twice-daily treatment with azelastine 0.15% nasal spray was generally well tolerated in these short-term studies; adverse events most commonly reported included bitter taste (4% and 6%, respectively), nasal discomfort (4% and 3%, respectively), epistaxis (2% and 1%, respectively), and sneezing (1% and 2%, respectively). Somnolence occurred in less than 1% of patients receiving active treatment.

In a 1-year long-term safety study of patients with perennial allergic rhinitis, adverse events associated with twice-daily use of azelastine 0.15% nasal spray included bitter taste, headache, sinusitis, and epistaxis. No severe epistaxis, nasal ulcerations, or septal perforations were observed.

Azelastine 0.1% nasal spray was previously approved for the twice-daily treatment of seasonal allergic rhinitis in patients 12 years and older.

分享鏈接