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英文药名：Fludara（Fludarabine Phosphate tablets）
中文药名：磷酸氟达拉滨片
生产厂家：赛诺菲有限公司
フルダラ錠10mg
药物分类名称
抗肿瘤药
批准日期：2007年7月
商標名
Fludara
構造式
一般名
フルダラビンリン酸エステル（Fludarabine Phosphate）〔JAN〕
化学名
(＋)-2-Fluoro-9-(5-O-phosphono-β-D-arabinofuranosyl)-9H-purin-6-amine
分子式
C10H13FN5O7P
分子量
365.21
性状
本品为白色结晶性粉末。
该产物易溶于N，N-二甲基甲酰胺，难溶于水或0.1mol / L盐酸试剂溶液，几乎不溶于乙醇（95）或乙醚。
本品具有吸湿性。
处理注意事项
指示孩子将他们放在他们没有到达的地方。
药效药理
1. 作用机序
它抑制DNA聚合酶，RNA聚合酶等，并抑制DNA合成和DNA修复，从而对增殖细胞和静止细胞产生抗肿瘤作用。
2. 抗肿瘤効果
在使用各种培养的人白血病细胞系的肿瘤选择性试验中，与骨髓性白血病细胞相比，其在慢性淋巴细胞性白血病，急性淋巴细胞白血病和成人T细胞白血病淋巴瘤细胞中显示出强烈的生长抑制作用。 对于非霍奇金淋巴瘤，其对患者来源的细胞和建立的细胞系显示增殖抑制作用，并且在从套细胞淋巴瘤患者收集的细胞中显示凋亡增强作用。 （体外）
静脉内给药（L1210，JOK-1）和口服给药（JOK-1）均显示小鼠L1210白血病细胞或人JOK-1白血病细胞腹膜内注射小鼠的延长效应。（体内）
适应病症
●复发性或难治性疾病
低级别B细胞非霍奇金淋巴瘤
套细胞淋巴瘤
●伴有贫血或血小板减少症的慢性淋巴细胞白血病
用法及与用量
成年人，每天口服给予40mg/m 2（体表面积）连续5天，并且撤回23天。重复给药。
根据体表面积，将下一剂量作为日剂量。但是，应根据患者的情况适当减少。
体表面积*（m 2）：0.89-1.13
每日剂量（每日片剂数）：40mg（4片）
体表面积*（m 2）：1.14-1.38
日剂量（每日片剂数）：50mg（5片）
体表面积*（m 2）：1.39-1.63
每日剂量（每日片剂数）：60mg（6片）
体表面积*（m 2）：1.64-1.88
日剂量（每日片剂数）：70mg（7片）
体表面积*（m 2）：1.89-2.13
每日剂量（每日片剂数量）：80mg（8片）
体表面积*（m 2）：2.14-2.38
日剂量（每日片剂数）：90mg（9片）
※：四舍五入到小数点后两位
包装规格
片剂
10毫克：PTP包装10片（5片x 2）
制造及销售（进口）
赛诺菲有限公司
注：以上中文资料不够完整，使用以原处方为准：http://www.info.pmda.go.jp/go/pack/4229002F1022_4_02/
Malignant lymphoma oral anticancer drug "Fuldara tablets 10 mg" is released
For the purpose of treating malignant lymphoma, Bayer has released oral purine derivative formulation "Fuldara tablet 10 mg". Recurrent or refractory, adapted to low-grade B-cell non-Hodgkin's lymphoma and mantle cell lymphoma. Because it is an oral type, treatment with outpatient is also possible.
In Fludara (generic name: fludarabine phosphate) preparation, injection was approved by the Ministry of Health, Labor and Welfare for indication of chronic lymphocytic leukemia accompanied by anemia or thrombocytopenia in 1999, and it is already sold domestically Has been done. "Fuldara tablet 10 mg" newly released this time will be used for indications that the injection does not have, and treatment options will increase for cancer patients suffering from malignant lymphoma.
Both formulations were developed and applied by former Nihon Schering Co., Ltd., and are to be sold under the "Manufacturer: Bayer Pharmaceutical" along with integration with Bayer chemical on July 1.
Malignant lymphoma is classified roughly into Hodgkin lymphoma and non-Hodgkin's lymphoma according to histopathological findings, and in Japan about 90% is classified as non-Hodgkin's lymphoma.
In addition, depending on the type of cancerated lymphocytes, there are B cell type and T cell type, and in Japan, about 70% of non-Hodgkin's lymphoma is B cell type.
Little progressive, low grade lymphoma is somewhat higher in men than in females, and the median age of onset is between 55 and 60 years old.
About malignant lymphoma
It is a cancer that can be made to the lymph nodes and lymphatic tissues of the whole body. If it originates from the lymph nodes in the neck, armpits, or the base of the foot (inguinal neck), a grinding lump is felt.
If it can be made between the left and right lungs (mediastinum), there are few symptoms at the beginning, but symptoms such as dyspnea appear after progression. Abdominal pain, abdominal pain, stomach tension can be seen. We may lose weight.
Once diagnosed as malignant lymphoma, therapy will be started with anti-malignant drugs etc. immediately.
Depending on the type of tumor, it is decided whether to focus mainly on antineoplastic agents or radiotherapy. The treatment is progressing and the cure rate is considerably higher.
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