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首页> 外文期刊>Prescrire international >darvadstrocel (alorse°) for complex perianal fistulae in Crohn's disease: A rash marketing authorisation decision
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darvadstrocel (alorse°) for complex perianal fistulae in Crohn's disease: A rash marketing authorisation decision

机译：Darvadstrocel（Alorse°）在Crohn病中复杂的肛周瘘：皮疹营销授权决定

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Complex perianal fistula is a frequent complication of Crohn's disease, and it has a significant impact on the patient's quality of life.The mainstays of treatment are drainage of the fistula and immunosuppressant therapy. If these measures fail, surgery is an option, but it can have debilitating consequences. Healed fistulae frequently relapse. Darvadstrocel is a cell therapy product, prepared from donor cells, for injection into the tissues around the openings and tracts of a perianal fistula. Darvadstrocel has been evaluated in a single double-blind placebo-controlled trial in 212 patients. Six months after treatment, remission of the fistulae was observed in 49% of patients in the darvadstrocel group, versus 34% in the placebo group.This effect appeared to be maintained after one year of follow-up. Darvadstrocel was not proven to prevent relapse at 6 months, which occurred in about half of patients. Few patients received a second injection of darvadstrocel, despite the high relapse rate. The main adverse effects were serious abscesses around the anus, serious anal fistulae, and rectal pain. One-third of patients developed donor-specific antibodies, which were still present at 52 weeks in half of cases, although any consequences this may have are unknown.
机译：复杂的肛门瘘是克罗恩病的常见并发症，对患者的寿命产生重大影响。治疗的主要含量是瘘管和免疫抑制治疗的引流。如果这些措施失败，手术是一种选择，但它可以具有衰弱的后果。愈合的瘘管经常复发。 Darvadstrocel是一种由供体细胞制备的细胞疗法，用于注射到肛周瘘的开口和椎间的组织中。 DARVADSTROCEL已在212名患者的单一双盲安慰剂对照试验中进行评估。治疗后六个月后，在Darvadstrocel组的49％的患者中观察到瘘管的缓解，与安慰剂组中的34％。在一年后效果似乎保持维持。 Darvadstrocel未被证明预防6个月的复发，其中大约一半的患者发生。尽管复发率高，但少数患者每秒注射二次注射Darvadstrocel。主要不良反应是肛门，严重的肛门瘘和直肠疼痛的严重脓肿。三分之一的患者开发了患者特异性抗体，仍然在52周内仍存在于一半的案例中，尽管这可能存在任何后果是未知的。

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    《Prescrire international》 |2020年第213期|共4页
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  • 正文语种 eng
  • 中图分类 药学;
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