Uncertain efficacy but real dangers

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Uncertain efficacy but real dangers

机译：不确定的功效，但真正的危险

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The only available trial, a non-comparative study with 63 patients, failed to determine the efficacy of ibru-tinib. In contrast, adverse effects are numerous and sometimes severe, including haematological disorders. Further evaluation of ibrutinib in this setting is necessary. Waldenstrom's macro-globulinaemia is a rare type of non-Hodgkin lymphoma that mainly affects men over the age of 60. The cause is unknown. Waldenstrom's macroglobulinaemia is characterized by excessive proliferation of lymphoplasmacytic cells in the bone marrow and spleen, leading to anaemia, neutropenia, thrombocytopenia, lymph-adenopathy, hepatomegaly and splenomegaly. It is also characterised by production of excess immunoglobulin M, sometimes resulting in hyperviscosity that can cause neurological disorders such as neuropathy, vision loss, headache, deafness, ataxia and, occasionally, confusion, stroke and coma. Prognosis varies widely and depends on the disease stage: between 21% and 87% of patients are still alive 5 years after diagnosis (1 -4). There is no curative treatment and no consensus treatment when patients start to experience symptoms. Relapses are inevitable. Antitumoural drugs such as rituximab, an anti-CD20 monoclonal antibody, are sometimes used, but their evaluation is generally limited to non-comparative trials (1-4). Ibrutinib (Imbruvica0, Janssen Cilag), an inhibitor of several tyrosine kinases, is authorised in the European Union in mantle cell lymphoma and chronic lym-phocytic leukaemia (5). It has been approved for use in selected patients with Waldenstrom's macroglobulinaemia.

机译：唯一可用的试验是一项对63名患者进行的非对比研究，未能确定伊布替尼的疗效。相反，不良反应很多，有时甚至很严重，包括血液系统疾病。有必要在这种情况下对伊布替尼进行进一步评估。Waldenstrom巨球蛋白血症是一种罕见的非霍奇金淋巴瘤，主要影响60岁以上的男性。原因不明。Waldenstrom巨球蛋白血症的特征是骨髓和脾脏中的淋巴浆细胞过度增殖，导致贫血、中性粒细胞减少、血小板减少、淋巴结病、肝肿大和脾肿大。其特点还包括产生过量的免疫球蛋白M，有时会导致高粘血症，可导致神经系统疾病，如神经病、视力丧失、头痛、耳聋、共济失调，偶尔还会出现困惑、中风和昏迷。预后差异很大，取决于疾病的阶段：21%到87%的患者在诊断后5年仍然活着（1-4）。当患者开始出现症状时，没有治疗方法，也没有共识治疗。复发是不可避免的。有时会使用抗肿瘤药物，如抗CD20单克隆抗体利妥昔单抗，但其评估通常仅限于非对比试验（1-4）。伊布替尼（Imbruvica0，Janssen-Cilag）是几种酪氨酸激酶的抑制剂，欧盟授权用于治疗套细胞淋巴瘤和慢性淋巴细胞白血病（5）。该药已被批准用于部分瓦尔登斯特罗姆巨球蛋白血症患者。

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《Prescrire international》 |2016年第175期|共1页
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Uncertain efficacy but real dangers

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