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铁杆木虫 (著名写手)

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专业: 慢性阻塞性肺疾病

[交流] 【转帖】标题： FDA批准痛风新药已有1人参与

标题： FDA批准痛风新药

1 美国食品和药物管理局批准克瑞斯特可（帕格诺替凯斯）治疗对传统痛风治疗药物没有反应或不耐受的疼痛性成年患者痛风。

2 痛风由于机体内排泄废物尿酸过量而引起的疾病，它最终沉积在关节和软组织似针状样晶体。这些晶体能够引起关节间歇性肿胀，发红，发热，疼痛和关节僵硬。

3 痛风与肥胖、高血压、高胆固醇和糖尿病显著相关联，发病以男性多见，女性在更年期后和患有肾脏疾病患者发病增加。

4 美国食品和药物管理局药物评价和审评中心肺脏疾病、过敏、风湿病学药物部主任巴德尔•乔杜里医学博士说：“300万成年痛风患者中的大约3%患者，传统痛风药物治疗无效。这种新型药物为他们提供了一种新型药物的重要选择。”

5 痛风患者，传统痛风治疗药物降低患者血液中尿酸水平，即，例如，黄嘌呤氧化酶抑制剂赛来力（别嘌呤醇），和优络瑞克（非布索坦）。克瑞斯特可是将尿酸代谢为无害的化学物质而降低尿酸水平的一种酶（即尿酸酶）。患者使用该药物每隔2周静脉输注一次。

6 两项6个月临床试验研究共计212名患者显示该药物能够降低尿酸水平和降低尿酸晶体在关节和软组织沉积。

7 由于，当患者在接受克瑞斯特可静脉输注时，在临床试验研究中有四分之一患者发生严重过敏性反应，因此，医护人员必须事先准备好肾上腺皮质激素和抗组织胺药物以将该风险降低到最小。在临床试验研究中，其他不良反应包括痛风发作、恶心、注射部位瘀肿、鼻腔刺激症状、便秘、胸口疼痛和呕吐。

8 警告内科医师给予患有充血性心力衰竭痛风患者使用克瑞斯特可要格外小心，因为临床试验未研究克瑞斯特可对此类患者使用情况。

9 正在审查克瑞斯特可的风险评估和补救策略包括患者药物使用指导和与医护人员交流使用药物有关的严重输液和过敏性反应材料。

10 新泽西州东不伦瑞克沙维恩特制药有限公司生产克瑞斯特可。
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

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