培非格司亭中英文介绍

1、王婕 913103860408NEULASTA（PEGFILGRASTIM）|培非格司亭注射液1. Introduction(简介)【产地英文商品名】:NEULASTA6mg/0.6ml/Syringe【原产地英文药品名】:PEGFILGRASTIM【中文参考商品译名】:纽拉思塔-6毫克/0.6毫升/支【中文参考药品译名】:培非格司亭【生产厂家中文参考译名】:安进【生产厂家英文名】:Amgen, Inc Amgen Announces Novel Drugs for Antitumor Chemotherapy Side Effects of FGT (TM) (pegfilgrastim),

2、 a drug developed by the US Food and Drug Administration (FDA), has been approved by the US Food and Drug Administration (FDA) Approval. Amphetamycin, the chief executive of Amgen, says that pemetrexedin will make it easier for healthcare workers to prevent chemotherapy-induced neutropenia and its s

3、erious complications. The third drug approved by Amgen in the past six months will significantly improve the prognosis of chemotherapy patients and is expected to enter the market in early April. BUSINESS WIRE 2002年2月1日美国加州THOUSAND OAKS消息， 安进公司宣布抗肿瘤化疗副作用新药培非格司亭(TM) (pegfilgrastim)通过美国食品与药品管理局（FDA）的审

4、批。安进公司首席执行官Kevin Sharer说，培非格司亭会使医务人员预防化疗患者出现中性粒细胞减少症及其严重的并发症相对容易。培非格司亭是安进公司在过去的6个月中获得批准的第三个药物，它将大大改观化疗患者的预后，有望在4月初进入销售市场。2.Function(功能） Pegfilgrastim to patients with chronic myelodysplastic syndrome such as myelodysplastic syndrome, periodic neutropenia and aplastic anemia and other effects is very

5、 obvious, as well as chemotherapy-induced decrease in the number of white blood cells, pegfilgrastim can enhance the number of white blood cells. 培非格司亭对慢性粒细胞缺乏症病人如骨髓异常增生综合征、周期性中性粒细胞缺乏症和再生障碍性贫血等疗效非常明显，以及因化疗致白细胞数减少者，培非格司亭可提升白细胞数。 As an antitumor chemotherapeutic side effect, pegfilgrastim is effective

6、 in reducing the incidence of infection during chemotherapy, which is often associated with fever associated with neutropenia (ie, fever and anti-infective A serious decline in the number of white blood cells). 作为一种抗肿瘤化疗副作用的药物，培非格司亭适用于减低化疗过程中感染的发生率,这种感染常常表现为中性粒细胞减少症引起的相关的发热(即发热与抗感染的白细胞数量的严重下降有关)。 Ne

7、utropenia is a common complication of chemotherapy in cancer. Chemotherapeutic drugs kill cancer cells, but also on the bodys normal cells produce anti-inflammatory effect, including the human body used to resist infection of neutrophils. This often leads to the development of neutropenia, a severe

8、drop in neutrophils in the blood. Because of the decline in infection-resistant leukocytes, especially neutrophils, even small infections such as influenza can cause fatal consequences.中性粒细胞减少症是肿瘤化疗中常见的一种严重的并发症。化疗药物在杀死肿瘤细胞时，同时也会对人体内的正常细胞产生杀伤作用，其中包括人体内用于抵抗感染的中性粒细胞。这常常导致产生中性粒细胞减少症,也就是血液中中性粒细胞的严重下降。由于抵

9、抗感染的白细胞下降，特别是中性粒细胞的下降，即使像流感这样的小感染，也可以引起致命的后果。 Pefilgrastim makes it easier for healthcare professionals to prevent chemotherapy-induced neutropenia and its serious complications. 培非格司亭会使医务人员预防化疗患者出现中性粒细胞减少症及其严重的并发症相对容易。 When pegfilgrastim is not in use, Amgens another leukocyte stimulating drug-Flig

10、rastim, is the only drug used to reduce the incidence of chemotherapy-related neutropenia and its rate of rehospitalization A prescription drug. However, it is necessary to adhere to daily use (sometimes for two weeks in a row), which is why many occupational health practitioners are often treated w

11、ith pemetrexed paclitaxel in patients with neutropenia complicated by infection. And pemetrexedine chemotherapy in each course only need to use once, in non-bone marrow-derived patients with chemotherapy in the course of chemotherapy, chemotherapy drugs can also cause inhibition of myeloid granulocy

12、tes, which will appear neutrophils Reduced disease often increases the incidence of clinical neutropenia-related fever.培非格司亭未投入使用时，安进公司的另一种白细胞刺激药物培非司亭(Fligrastim)是用于减少化疗相关的中性粒细胞减少症发生率及其再住院率的唯一一种处方药物。但是，它需要坚持每天使用(有时要连续使用两周之久),这使得许多职业保健医生常常在患者出现中性粒细胞减少症并发感染后才用培非司亭进行治疗。而培非格司亭在每个化疗疗程中只需要使用一次，在非骨髓来源的恶性肿瘤

13、患者的化疗过程中，化疗药物也会引起髓系粒细胞的抑制作用，因而会出现中性粒细胞减少症，常常会增加临床中性粒细胞减少症相关的发热的发病率。 Dr. Frankie Ann Holmes, assistant director of the Houston Oncology Institute, who is responsible for clinical trials of the drug, says that each regimen of pegfilgrastim is used only once to reduce the pain caused by frequent inject

14、ions and to bring patients and doctors together To the risk of infection, do not have during chemotherapy due to severe infectious diseases and frequent interruption of treatment. The approval now shows that thousands of patients with chemotherapy can be protected with pegfilgrastim before each roun

15、d of chemotherapy complications, thus reducing the risk of chemotherapy. 负责该药临床试验研究的美国休斯顿肿瘤学研究院助理主管Frankie Ann Holmes博士说，培非格司亭每个化疗疗程只用一次，减少了频繁注射给患者带来的痛苦以及医生与患者相聚带来感染的几率，也不用在化疗期间由于严重的感染疾病而频繁中断治疗。现在通过审批表明成千上万的化疗患者可以在每一轮化疗出现感染并发症之前使用培非格司亭进行保护，从而减少了化疗风险。 3. Structure（结构） pegfilgrastim is a protein that

16、is a covalent conjugate of human granulocyte colony stimulating factor (G-CSF) and monomethoxypolyethylene glycol produced by DNA recombinant technology, so Pegfilgrastim is a pegylated form of its parent molecule. 培非格司亭(TM)是一种蛋白质，是由DNA重组技术产生的人粒细胞集落刺激因子(G-CSF)和单甲氧基聚乙二醇的共价结合物，即培非格司亭（pegfilgrastim）是其母

17、体分子培非司亭（Filgrastim）的聚乙二醇化形式。4. Mechanism of action（作用机制） Because of the relatively short half-life of pemetrexed in the blood, up to two weeks of continuous daily injections are required after each cycle of chemotherapy, and almost half of the patients receive 10 or more pemetrexed therapy. The addi

18、tion of polyethylene glycol (PEG) to pegfilgrastim increases the rate of clearance of the molecule, leading to a prolonged half-life. So in each round of chemotherapy as long as the injection can be. pegfilgrastim has a self-regulatory mechanism (neutrophil-mediated clearance) that is present in the

19、 blood when neutropenia is present in the patient. When the neutrophils return to normal, it will soon be cleared. 由于培非司亭在血液中的半衰期相对较短，需要在每一轮化疗后，进行最多连续两周的每天注射，几乎半数的患者都要接受10天或者10以上的培非司亭治疗。由于在培非格司亭中加入了聚乙二醇（PEG）增大其分子，使得它在体内的清除率减慢，半衰期大大延长。 因此在每轮化疗中只要注射一次便可。培非格司亭具有自我调节机制（中性粒细胞介导的清除作用），当患者中性粒细胞减少时，药物将一直存在于

20、血液中。当中性粒细胞恢复正常时，它将会很快被清除掉。5. Side effects（副作用） Clinical trials have shown that the use of pegfilgrastim is safe and well tolerated. The most common side effect in clinical trials occurred in 465 patients with lymphoma and solid tumors in patients with chemotherapy combined with felgistate after the

21、injection, of which 26% of patients had bone pain symptoms. Bone pain symptoms in most patients are controlled by injecting non-narcotic analgesics. The most serious complication of pegfilgrastim was the appearance of hypoxemia in one patient. Side effects such as adult respiratory distress syndrome

22、, splenic rupture, and sickle cell crisis, which occur in patients treated with pemetrexed, have not been reported in patients receiving pegfilgrastim. 临床试验表明培非格司亭使用安全，并且有良好的耐受性。在临床试验中最常见的副作用出现在对465名淋巴瘤和实体瘤联合化疗患者注射培非格司亭后，其中有26%的患者出现了骨痛症状。对大多数患者的骨痛症状都通过注射非麻醉性镇痛剂得到控制。培非格司亭最严重的并发症是在一名患者中出现了低氧血症。但是在接受培非

23、司亭治疗的患者中偶然出现的成人呼吸窘迫综合症、脾破裂和镰状细胞危象等副作用在接受培非格司亭的患者中没有报道。5. Precautions（注意事项）1. For the goods or other G-CSF allergy prohibition of use.2. Bone marrow immature cells are not fully reduced or the presence of immature cells in peripheral blood myeloid leukemia patients are prohibited.3. The use of this product is limited to patients with neutropenia. During the use of this product, to regularly check the blood, when neutrophils increased to more than necessary value