培非格司亭中英文介绍

1、王婕 913103860408NEULASTAPEGFILGRASTDM|培非格司亭注射液1. Introduction( 简介)药讯何wwwwp53kcri【产地英文商品名】：NEULASTA 6mg/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, IncAmgen Announces Novel Drugs for Antitumor Chemotherapy Side Effectsof FGT (TM) (peg

2、filgrastim), a drug developed by the US Food and DrugAdministration (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 neutropeni

3、a and its serious complications.The third drug approved by Amgenin 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 OAK、, 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治理局FDA的

4、审批.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 v

5、ery 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 effect

6、ive 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,培非格司亭适用丁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.Neu

7、tropenia 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 humanbody used to resist infection of neutrophils. This often leads to the development of neutropenia, a severe dr

8、op 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,其中包括人体内用丁反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.由丁反抗

9、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 makesit 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-Fligras

10、tim, 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 manyoccupational health practitioners are often treated with

11、pemetrexed paclitaxel in patientswith 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 granulocytes,

12、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)是用丁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 的恶性肿瘤患者

13、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 OncologyInstitute, who is responsible for clinical trialsof the drug, says thateach regimen of pegfilgrastimis used only once to reduce the pain causedby frequent injections and

14、 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 round of che

15、motherapy 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 AnnHolmes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 来的痈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丁严重的感染疾病而频繁中断治疗.现在通过审批说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 is a cova

16、lent conjugate of humangranulocyte colony stimulating factor (G-CSF) andmonomethoxypolyethylene 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 ) 是其母体分子培非司亭(Fi

17、lgrastim )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 addition of p

18、olyethylene glycol (PEG) to pegfilgrastim increases the rate of clearance of the molecule, leadingto 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 blood whe

19、n neutropenia is present in the patient. When the neutrophils return to normal, it will soon be cleared.由丁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.由丁在培非格司亭中参加了聚乙二醇(PEG增大其分子,使得它在体内的 活除率减慢,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(中性粒细胞介导的活除作用),当患者中性粒细胞减少 时,药物将一直存在丁血液中.当中性粒细

20、胞恢复正常时,它将会很快被活除掉.5. Side effects(副作用)Clinical trials have shown that the use of pegfilgrastim is safe andwell tolerated. The most common side effect in clinical trials occurredin 465 patients with lymphoma and solid tumors in patients with chemotherapy combined with felgistate after the injection, o

21、f 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 onepatient.Side effects such as adultrespiratorydistress syndrome,splenic rupture

22、, and sickle cell crisis,which occur in patients treatedwith pemetrexed, have not been reported in patients receiving pegfilgrastim.临床试验说明培非格司亭使用平安,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%勺患者出现了骨痈病症.对大多数患者的骨痈病症都通过注射非麻醉 性镇痈剂得到限制.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.但是在接受培非司亭治疗的患者中偶然出现的成人呼吸

23、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考前须知1. For the goods or other G-CSF allergy prohibition of use.are2. Bone marrow immature cells are not fully reduced or the presence of immature cells in peripheral blood myeloid leukemia patients 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,