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帕利夫明:新药。口腔黏膜炎的预防:评估不当。

Palifermin: new drug. Prevention of oral mucositis: inappropriate evaluation.

出版信息

Prescrire Int. 2007 Aug;16(90):135-8.


DOI:
PMID:17724832
Abstract

(1) Patients treated with high-dose chemotherapy combined with total body irradiation (myeloablative therapy) often develop oral mucositis. Prevention is based mainly on sucking ice during chemotherapy. (2) Palifermin is a growth factor marketed for the prevention of severe oral mucositis in adults with malignant haemopathies who are receiving myeloablative therapy followed by peripheral stem cell autografting. (3) Palifermin has not been compared with sucking ice, despite the efficacy of this simple treatment. (4) In a randomised placebo-controlled double-blind trial involving 212 adult patients treated with high-dose chemotherapy and total body irradiation, palifermin reduced the incidence of severe oral mucositis (63% versus 98%) and its duration (about 3 days versus 9 days). The myeloablative regimen used in this trial is not that commonly used in Europe. The efficacy of palifermin during less aggressive regimens, which cause less severe oral mucositis, is not known. (5) The main adverse events noted in clinical trials were erythema and cutaneous oedema. It is not known whether palifermin increases the long-term risk of cancer. (6) Treatment with palifermin is expensive, 4800.00 euros in France); the optimal dosing schedule is not known and the unit dose chosen by the manufacturer is wastefully large. (7) In practice, it remains to be demonstrated that palifermin is more effective than simply sucking ice.

摘要

(1) 接受大剂量化疗联合全身照射(清髓疗法)的患者常发生口腔黏膜炎。预防主要基于化疗期间含服冰块。(2) 帕利夫明是一种生长因子,用于预防接受清髓疗法后进行外周干细胞自体移植的恶性血液病成年患者的严重口腔黏膜炎。(3) 尽管这种简单治疗方法有效,但帕利夫明尚未与含服冰块进行比较。(4) 在一项涉及212名接受大剂量化疗和全身照射的成年患者的随机安慰剂对照双盲试验中,帕利夫明降低了严重口腔黏膜炎的发生率(63% 对98%)及其持续时间(约3天对9天)。该试验中使用的清髓方案在欧洲并不常用。帕利夫明在侵袭性较小、导致口腔黏膜炎较轻的方案中的疗效尚不清楚。(5) 临床试验中记录的主要不良事件为红斑和皮肤水肿。尚不清楚帕利夫明是否会增加癌症的长期风险。(6) 帕利夫明治疗费用昂贵(在法国为4800.00欧元);最佳给药方案尚不清楚,且制造商选择的单位剂量过大造成浪费。(7) 在实际应用中,仍有待证明帕利夫明比单纯含服冰块更有效。

相似文献

[1]
Palifermin: new drug. Prevention of oral mucositis: inappropriate evaluation.

Prescrire Int. 2007-8

[2]
Palifermin: role in the prevention of chemotherapy- and radiation-induced mucositis.

Ann Pharmacother. 2007-1

[3]
Palifermin for patients with haematological malignancies: shifting nursing practice from symptom relief to prevention of oral mucositis.

Eur J Oncol Nurs. 2007

[4]
Palifermin for oral mucositis after intensive therapy for hematologic cancers.

N Engl J Med. 2004-12-16

[5]
Palifermin reduces the incidence of oral mucositis in patients with metastatic colorectal cancer treated with fluorouracil-based chemotherapy.

J Clin Oncol. 2006-11-20

[6]
Palifermin reduces patient-reported mouth and throat soreness and improves patient functioning in the hematopoietic stem-cell transplantation setting.

J Clin Oncol. 2006-11-20

[7]
Oral mucositis due to cancer treatments. Orodental hygiene and ice cubes.

Prescrire Int. 2008-2

[8]
Single-dose palifermin prevents severe oral mucositis during multicycle chemotherapy in patients with cancer: a randomized trial.

Ann Intern Med. 2010-9-21

[9]
Palifermin (Kepivance) for the treatment of oral mucositis in patients with hematologic malignancies requiring hematopoietic stem cell support.

J Oncol Pharm Pract. 2005-9

[10]
Phase II study of palifermin and concurrent chemoradiation in head and neck squamous cell carcinoma.

J Clin Oncol. 2008-5-20

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