爱华网发达国家已经将Hylenex，骶管注射作为脊柱疾病（颈，胸，腰椎间盘突出症及AS）治疗的主要手段。占脊柱疾病85%之上！手术治疗很少，因复发率高。
简介： 2010-12-21FDA批准重组人类透明质酸酶注射剂（Recombinant Human HyaluronidaseInjection，商品名Hylenex）用干临床。
骶管高压注射后七至十天，药物，扩散至受在神经根，松解神经，缓解压迫症状！目前国产还没有。
Pharmaceutical Liability News: Baxter notifies FDA of HYLENEXrecombinant recall
Deerfield, IL—Baxter International Inc., in cooperation with theU.S. Food and Drug Administration (FDA), announced the voluntaryrecall of all lots of HYLENEX recombinant (hyaluronidase humaninjection). The FDA announced the recall, which was issued inconjunction with the product’s NDA-holder, Halozyme Therapeutics,on Monday, May 17, 2010.
Baxter International and Halozyme Therapeutics recalled the drugafter routine stability tests revealed the presence of particulatematter in a limited number of HYLENEX vials. The particles found inthese lots were identified as glass.
Baxter reported there are approximately 3,500 vials in the marketplace. The company will be contacting consumers to inform them ofthe recall and advise them to return the defective product.
The HYLENEX recombinant “is a tissue permeability modifierindicated as an adjuvant in subcutaneous fluid administration forachieving hydration; to increase the dispersion and absorption ofother injected drugs; and in subcutaneous urography for improvingresorption of radiopaque agents.”
Though Baxter has received no reports of adverse medical episodesin association with the product, the recall was issued as a safetyprecaution.
Baxter and Halozyme are working together to probe what might havecaused the problem. According to the FDA press release, “Baxter andHalozyme are committed to quickly and appropriately addressing thesituation.”
