 |
 |
 |
 |
 |
 |
||
 |
 |
 |
 |
 |
| 2 | 1/1 | 返回列表 |
| 查看: 564 | 回復(fù): 1 | |||
lrj107hn鐵桿木蟲 (著名寫手)
路人甲-肥龍
|
[交流]
【轉(zhuǎn)帖】標題： FDA批準痛風(fēng)新藥 已有1人參與
|
|
標題： FDA批準痛風(fēng)新藥 1 美國食品和藥物管理局批準克瑞斯特可（帕格諾替凱斯）治療對傳統(tǒng)痛風(fēng)治療藥物沒有反應(yīng)或不耐受的疼痛性成年患者痛風(fēng)。 2 痛風(fēng)由于機體內(nèi)排泄廢物尿酸過量而引起的疾病，它最終沉積在關(guān)節(jié)和軟組織似針狀樣晶體。這些晶體能夠引起關(guān)節(jié)間歇性腫脹，發(fā)紅，發(fā)熱，疼痛和關(guān)節(jié)僵硬。 3 痛風(fēng)與肥胖、高血壓、高膽固醇和糖尿病顯著相關(guān)聯(lián)，發(fā)病以男性多見，女性在更年期后和患有腎臟疾病患者發(fā)病增加。 4 美國食品和藥物管理局藥物評價和審評中心肺臟疾病、過敏、風(fēng)濕病學(xué)藥物部主任巴德爾•喬杜里醫(yī)學(xué)博士說：“300萬成年痛風(fēng)患者中的大約3%患者，傳統(tǒng)痛風(fēng)藥物治療無效。這種新型藥物為他們提供了一種新型藥物的重要選擇�！� 5 痛風(fēng)患者，傳統(tǒng)痛風(fēng)治療藥物降低患者血液中尿酸水平，即，例如，黃嘌呤氧化酶抑制劑賽來力（別嘌呤醇），和優(yōu)絡(luò)瑞克（非布索坦）。克瑞斯特可是將尿酸代謝為無害的化學(xué)物質(zhì)而降低尿酸水平的一種酶（即尿酸酶）�；颊呤褂迷撍幬锩扛�2周靜脈輸注一次。 6 兩項6個月臨床試驗研究共計212名患者顯示該藥物能夠降低尿酸水平和降低尿酸晶體在關(guān)節(jié)和軟組織沉積。 7 由于， 當患者在接受克瑞斯特可靜脈輸注時，在臨床試驗研究中有四分之一患者發(fā)生嚴重過敏性反應(yīng)，因此，醫(yī)護人員必須事先準備好腎上腺皮質(zhì)激素和抗組織胺藥物以將該風(fēng)險降低到最小。在臨床試驗研究中，其他不良反應(yīng)包括痛風(fēng)發(fā)作、惡心 、注射部位瘀腫、鼻腔刺激癥狀、便秘、胸口疼痛和嘔吐。 8 警告內(nèi)科醫(yī)師給予患有充血性心力衰竭痛風(fēng)患者使用克瑞斯特可要格外小心，因為臨床試驗未研究克瑞斯特可對此類患者使用情況。 9 正在審查克瑞斯特可的風(fēng)險評估和補救策略包括患者藥物使用指導(dǎo)和與醫(yī)護人員交流使用藥物有關(guān)的嚴重輸液和過敏性反應(yīng)材料。 10 新澤西州東不倫瑞克沙維恩特制藥有限公司生產(chǎn)克瑞斯特可。 FDA approves new drug for gout The U.S. Food and Drug Administration today approved Krystexxa (pegloticase) to treat the painful condition known as gout in adults who do not respond to or who cannot tolerate conventional therapy. Gout occurs due to an excess of the bodily waste uric acid, which is eventually deposited as needle-like crystals in the joints or in soft tissue. These crystals can cause intermittent swelling, redness, heat, pain and stiffness in the joints. Gout is strongly associated with obesity, high blood pressure, high cholesterol and diabetes, and occurs more often in men, in women after menopause, and in people with kidney disease. “About 3 percent of the three million adults who suffer from gout are not helped by conventional therapy. This new drug offers an important new option for them,” said Badrul Chowdhury, M.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. For patients with gout, the conventional therapy is to receive drugs that lower the amount of uric acid in the blood, as, for example, the xanthine oxidase inhibitors Zyloprim (allopurinol) and Uloric (febuxostat). Krystexxa is an enzyme that lowers uric acid levels by metabolizing it into a harmless chemical that is excreted in the urine. The drug is administered to patients every two weeks as an intravenous infusion. Two six-month clinical trials of 212 total patients demonstrated that the drug lowered uric acid levels and reduced deposits of uric acid crystals in joints and soft tissue. Since one out of every four patients in the clinical trials experienced a severe allergic reaction when receiving an infusion of Krystexxa, health care providers should dispense a corticosteroid and an antihistamine to their patients beforehand to minimize the risk of such a reaction. Other reactions during the clinical trials included gout flare, nausea, injection site bruising, irritation of the nasal passages, constipation, chest pain and vomiting. Physicians are also being warned to be cautious about administering Krystexxa to patients with congestive heart failure because the drug was not studied in this patient population. Krystexxa is being approved with a Risk Evaluation and Mitigation Strategy that includes a medication guide for patients and materials for healthcare providers to communicate the risk of severe infusion and allergic reactions. Krystexxa is manufactured by Savient Pharmaceuticals Inc. of East Brunswick, N.J. http://www.fda.gov/NewsEvents/Ne ... ments/ucm225810.htm |
回復(fù)此樓» 本帖已獲得的紅花（最新10朵）
» 猜你喜歡
網(wǎng)報學(xué)科會評的方式
已經(jīng)有2人回復(fù)
-
香港理工大學(xué)眼視光學(xué)院Allen Cheong 課題組誠招博士后1名 （一年合同，可續(xù)簽）
已經(jīng)有11人回復(fù)
-
耳鼻咽喉頭頸科學(xué)論文潤色/翻譯怎么收費?
已經(jīng)有96人回復(fù)
-
300求調(diào)劑，本人抗壓又好學(xué)
已經(jīng)有0人回復(fù)
-
德國醫(yī)學(xué)博士申請
已經(jīng)有7人回復(fù)
-
公派讀博，個人渠道還是合作項目？
已經(jīng)有6人回復(fù)
-
R做相關(guān)圖時報錯，參數(shù)值意味著不同的行數(shù): 91, 78
已經(jīng)有0人回復(fù)
» 本主題相關(guān)商家推薦: (我也要在這里推廣)
» 本主題相關(guān)價值貼推薦，對您同樣有幫助:
- 2012年3月FDA批準新藥
已經(jīng)有8人回復(fù)
- FDA/歐盟/日本 08-12年全球批準新藥匯總報告
已經(jīng)有94人回復(fù)
- FDA批準新藥數(shù)量(1993-2011)
已經(jīng)有5人回復(fù)
- 2011 FDA批準的新分子實體藥物
已經(jīng)有12人回復(fù)
- teva新藥已通過fda批準，后立普妥時代一馬當先
已經(jīng)有12人回復(fù)
- 2011年FDA批準新產(chǎn)品
已經(jīng)有6人回復(fù)
- 【轉(zhuǎn)帖】2010年FDA批準哪些新藥?
已經(jīng)有5人回復(fù)
- 求救高人指點，F(xiàn)DA批準上市新藥及世界世界首次上市新藥信息
已經(jīng)有4人回復(fù)
送鮮花一朵 | thx |
2樓2011-09-15 11:13:58
相關(guān)版塊跳轉(zhuǎn)
我要訂閱樓主 lrj107hn 的主題更新
| 2 | 1/1 | 返回列表 |
| 最具人氣熱帖推薦 [查看全部] | 作者 | 回/看 | 最后發(fā)表 | |
|---|---|---|---|---|
|
[考研] 0710生物學(xué)求調(diào)劑！ +4 | 敘述文 2026-03-31 | 4/200 |
|
|---|---|---|---|---|
|
[考研] 284求調(diào)劑 +7 | 小熊～～ 2026-03-31 | 7/350 |
|
|
|
[考研] 085600 295分求調(diào)劑 +13 | W55j 2026-03-30 | 15/750 |
|
|
|
[考研] 272求調(diào)劑，接受跨專業(yè)調(diào)劑！ +3 | 閑魚盧 2026-03-31 | 3/150 |
|
|
|
[考研] 張芳銘-中國農(nóng)業(yè)大學(xué)-環(huán)境工程專碩-298 +8 | 手機用戶 2026-03-26 | 8/400 |
|
|
|
[有機交流]
 甲基亞磺磺酸鈉和甲基磺酸酯反應(yīng)機理
 10+3
|
kaobao456 2026-03-29 | 4/200 |
|
|
|
[考研] 調(diào)劑 +4 | GK72 2026-03-30 | 4/200 |
|
|
|
[考研] 289求調(diào)劑 +16 | 新時代材料 2026-03-27 | 16/800 |
|
|
|
[考研] 材料專碩 085600求調(diào)劑 +7 | BBQ233 2026-03-30 | 7/350 |
|
|
|
[考研] 317分 一志愿南理工材料工程 本科湖工大 求調(diào)劑 +12 | 芋泥小鈴鐺 2026-03-28 | 12/600 |
|
|
|
[考研] 0703 化學(xué) 求調(diào)劑，一志愿山東大學(xué) 342 分 +7 | Shern—- 2026-03-28 | 7/350 |
|
|
|
[考研] 291求調(diào)劑 +5 | Y-cap 2026-03-29 | 6/300 |
|
|
|
[考研] 本科雙非材料，跨考一志愿華電085801電氣，283求調(diào)劑，任何專業(yè)都可以 +6 | 芝士雪baoo 2026-03-28 | 8/400 |
|
|
|
[考研] 11408軟件工程求調(diào)劑 +3 | Qiu學(xué)ing 2026-03-28 | 3/150 |
|
|
|
[考研] 312，生物學(xué)求調(diào)劑 +3 | 小譯同學(xué)abc 2026-03-28 | 3/150 |
|
|
|
[考研] 394求調(diào)劑 +3 | 好事多磨靜候佳?/a> 2026-03-26 | 5/250 |
|
|
|
[考研] 299求調(diào)劑 +7 | 嗯嗯嗯嗯2 2026-03-27 | 7/350 |
|
|
|
[考研] 一志愿211院校 344分 東北農(nóng)業(yè)大學(xué)生物學(xué)學(xué)碩，求調(diào)劑 +5 | 丶風(fēng)雪夜歸人丶 2026-03-26 | 8/400 |
|
|
|
[考研] 調(diào)劑 +3 | 李嘉圖·S·路 2026-03-27 | 3/150 |
|
|
|
[考研] 一志愿天津大學(xué)339材料與化工求調(diào)劑 +3 | 江往賣魚 2026-03-26 | 3/150 |
|