培非格司亭中英文介紹

1、王婕 913103860408NEULASTA（PEGFILGRASTIM）|培非格司亭注射液1. Introduction(簡介)【產(chǎn)地英文商品名】:NEULASTA6mg/0.6ml/Syringe【原產(chǎn)地英文藥品名】:PEGFILGRASTIM【中文參考商品譯名】:紐拉思塔-6毫克/0.6毫升/支【中文參考藥品譯名】:培非格司亭【生產(chǎn)廠家中文參考譯名】:安進【生產(chǎn)廠家英文名】: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日美國加州THOUSAND OAKS消息， 安進公司宣布抗腫瘤化療副作用新藥培非格司亭(TM) (pegfilgrastim)通過美國食品與藥品管理局（FDA）的審

4、批。安進公司首席執(zhí)行官Kevin Sharer說，培非格司亭會使醫(yī)務(wù)人員預(yù)防化療患者出現(xiàn)中性粒細(xì)胞減少癥及其嚴(yán)重的并發(fā)癥相對容易。培非格司亭是安進公司在過去的6個月中獲得批準(zhǔn)的第三個藥物，它將大大改觀化療患者的預(yù)后，有望在4月初進入銷售市場。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. 培非格司亭對慢性粒細(xì)胞缺乏癥病人如骨髓異常增生綜合征、周期性中性粒細(xì)胞缺乏癥和再生障礙性貧血等療效非常明顯，以及因化療致白細(xì)胞數(shù)減少者，培非格司亭可提升白細(xì)胞數(shù)。 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). 作為一種抗腫瘤化療副作用的藥物，培非格司亭適用于減低化療過程中感染的發(fā)生率,這種感染常常表現(xiàn)為中性粒細(xì)胞減少癥引起的相關(guān)的發(fā)熱(即發(fā)熱與抗感染的白細(xì)胞數(shù)量的嚴(yán)重下降有關(guān))。 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.中性粒細(xì)胞減少癥是腫瘤化療中常見的一種嚴(yán)重的并發(fā)癥?；熕幬镌跉⑺滥[瘤細(xì)胞時，同時也會對人體內(nèi)的正常細(xì)胞產(chǎn)生殺傷作用，其中包括人體內(nèi)用于抵抗感染的中性粒細(xì)胞。這常常導(dǎo)致產(chǎn)生中性粒細(xì)胞減少癥,也就是血液中中性粒細(xì)胞的嚴(yán)重下降。由于抵

9、抗感染的白細(xì)胞下降，特別是中性粒細(xì)胞的下降，即使像流感這樣的小感染，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. 培非格司亭會使醫(yī)務(wù)人員預(yù)防化療患者出現(xiàn)中性粒細(xì)胞減少癥及其嚴(yán)重的并發(fā)癥相對容易。 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時，安進公司的另一種白細(xì)胞刺激藥物培非司亭(Fligrastim)是用于減少化療相關(guān)的中性粒細(xì)胞減少癥發(fā)生率及其再住院率的唯一一種處方藥物。但是，它需要堅持每天使用(有時要連續(xù)使用兩周之久),這使得許多職業(yè)保健醫(yī)生常常在患者出現(xiàn)中性粒細(xì)胞減少癥并發(fā)感染后才用培非司亭進行治療。而培非格司亭在每個化療療程中只需要使用一次，在非骨髓來源的惡性腫瘤

13、患者的化療過程中，化療藥物也會引起髓系粒細(xì)胞的抑制作用，因而會出現(xiàn)中性粒細(xì)胞減少癥，常常會增加臨床中性粒細(xì)胞減少癥相關(guān)的發(fā)熱的發(fā)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. 負(fù)責(zé)該藥臨床試驗研究的美國休斯頓腫瘤學(xué)研究院助理主管Frankie Ann Holmes博士說，培非格司亭每個化療療程只用一次，減少了頻繁注射給患者帶來的痛苦以及醫(yī)生與患者相聚帶來感染的幾率，也不用在化療期間由于嚴(yán)重的感染疾病而頻繁中斷治療?，F(xiàn)在通過審批表明成千上萬的化療患者可以在每一輪化療出現(xiàn)感染并發(fā)癥之前使用培非格司亭進行保護，從而減少了化療風(fēng)險。 3. Structure（結(jié)構(gòu)） 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)是一種蛋白質(zhì)，是由DNA重組技術(shù)產(chǎn)生的人粒細(xì)胞集落刺激因子(G-CSF)和單甲氧基聚乙二醇的共價結(jié)合物，即培非格司亭（pegfilgrastim）是其母

17、體分子培非司亭（Filgrastim）的聚乙二醇化形式。4. Mechanism of action（作用機制） 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對較短，需要在每一輪化療后，進行最多連續(xù)兩周的每天注射，幾乎半數(shù)的患者都要接受10天或者10以上的培非司亭治療。由于在培非格司亭中加入了聚乙二醇（PEG）增大其分子，使得它在體內(nèi)的清除率減慢，半衰期大大延長。 因此在每輪化療中只要注射一次便可。培非格司亭具有自我調(diào)節(jié)機制（中性粒細(xì)胞介導(dǎo)的清除作用），當(dāng)患者中性粒細(xì)胞減少時，藥物將一直存在于

20、血液中。當(dāng)中性粒細(xì)胞恢復(fù)正常時，它將會很快被清除掉。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. 臨床試驗表明培非格司亭使用安全，并且有良好的耐受性。在臨床試驗中最常見的副作用出現(xiàn)在對465名淋巴瘤和實體瘤聯(lián)合化療患者注射培非格司亭后，其中有26%的患者出現(xiàn)了骨痛癥狀。對大多數(shù)患者的骨痛癥狀都通過注射非麻醉性鎮(zhèn)痛劑得到控制。培非格司亭最嚴(yán)重的并發(fā)癥是在一名患者中出現(xiàn)了低氧血癥。但是在接受培非

23、司亭治療的患者中偶然出現(xiàn)的成人呼吸窘迫綜合癥、脾破裂和鐮狀細(xì)胞危象等副作用在接受培非格司亭的患者中沒有報道。5. Precautions（注意事項）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