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Neulasta(PEGFILGRASTIM)—长效制剂

2010-08-22 23:01:21 作者：新特药房来源：中国新特药网天津分站浏览次数：1159 文字大小：【大】【中】【小】

简介： 非格司亭的长效制剂Neulasta（Pegfilgrastim）于2002年1月获得FDA的批准。其适应证为减少与化疗引起的中性粒细胞减少症有关的感染发生率。这种药的独特之处为每个化疗周期只须注射一次。改变了安进公司 ...

关键字：非格司亭长效制剂 Neulasta(PEGFILGRASTIM)

非格司亭的长效制剂Neulasta（Pegfilgrastim）于2002年1月获得FDA的批准。其适应证为减少与化疗引起的中性粒细胞减少症有关的感染发生率。这种药的独特之处为每个化疗周期只须注射一次。改变了安进公司最初的此类药品Neupogen（Filgrastim）的复杂用药方式，Neupogen需要在每个化疗周期结束后的至多两周内每天注射，约一半的患者须要注射10天以上。
2001年，美国接受化疗的患者约有140万，预防中性粒细胞减少症是癌症治疗中十分重要的一个方面。

Neulasta,pegfilgrastim,聚乙二醇化非格司亭 - 集落刺激因子.

Neulasta(TM) 抗肿瘤化疗副作用新药Neulasta(TM) (pegfilgrastim)通过美国食品与药品管理局（FDA）的审批。

Neulasta在每个化疗疗程中只需要使用一次，主要适应征是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)。

中性粒细胞是白细胞的一种，在人体抵抗病原微生物感染中发挥着重要的作用。

在非骨髓来源的恶心肿瘤肿瘤患者的化疗过程中，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。

中性粒细胞减少症是大多数肿瘤化疗中最常见也是最严重的一种并发症。有超过一半的肿瘤患者会在化疗中出现严重的中性粒细胞减少症，这使得他们极易发生严重的危及生命的感染。平均只有不到10%的患者在化疗前接受过预防中性粒细胞减少症的治疗，研究表明30%-40%未接受此方面预防治疗的化疗患者将会出现带有发热症状的中性粒细胞减少症。

每年都有数千患者因为中性粒细胞减少症及其并发症而就医,并且会因此而需要重新住院治疗。

Neulasta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Neulasta进行保护，从而减少了化疗风险。''Neulasta Neulasta(TM)是一种蛋白质，它可以刺激抗感染的白细胞(中性粒细胞)的产生。而中性粒细胞正是化疗的细胞毒性作用的对象。

由于在Neulasta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。

Neulasta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，药物将一直存在于血液中。当中性粒细胞恢复正常时，它将会很快被清除掉。临床试验方面的证据 Neulasta的两个中心的3期临床试验显示，单剂量的Neulasta注射与平均为11天的NEUPOGEN (5 mcg/kg/day)注射以后的保护感染的作用相比，不但明显地缩短了中性粒细胞减少症的持续时间，而且也减少了伴发的发热症状。

他们对310名乳腺癌患者给予Neulasta 100 mcg/kg的注射量，对157名患者给予了Neulasta 6mg的注射量。这项随机双盲试验是在接受4个疗程阿霉素(doxorubicin)和紫衫萜(docetaxel)化疗的乳腺癌患者中进行的。

在每个疗程中，他们都对两组中的严重的中性粒细胞减少症的持续时间进行了比较。

第一疗程接受Neulasta和NEUPOGEN治疗的两组，并没有表现出很大的差异，严重的中性粒细胞减少症出现时间分别为平均1.8天和1.6天（固定剂量），1.7天和1.6天（体重剂量）。患者的平均体重为72.4公斤(160磅)，有76%的患者体重超过了70公斤(154磅)。和NEUPOGEN相比，Neulasta在每个化疗中出现中性粒细胞减少症相关发热的比率要略高一些。

Neulasta的2期临床试验是针对接受各种化疗方案的各种类型的肿瘤患者,以进一步支持该药物的安全性和有效性。这些肿瘤疾病包括乳腺癌、胸部肿瘤（包括肺癌）、非何杰金氏淋巴瘤和何杰金氏淋巴瘤。试验中使用Neulasta (100 mcg/kg) 单剂量注射，与每天注射NEUPOGEN (5 mcg/kg)有相似的疗效。试验证明Neulasta是安全而有效的。

安全试验

临床试验表明Neulasta(TM)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Neulasta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。Neulasta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NEUPOGEN?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Neulasta的患者中没有报道。

中性粒细胞减少症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。

由于抵抗感染的白细胞下降，特别是中性粒细胞的下降，即使象流感这样的小感染，也可以引起致命的后果。老年患者、既往存在中性粒细胞减少症患者、既往接收过化疗或放疗的患者以及存在其它免疫抑制疾病的肿瘤患者，更容易出现中性粒细胞减少症。70岁以上的老年患者，接受普通强度的化疗便容易产生中性粒细胞减少症而并发感染，往往会由于严重的感染而使住院时间延长。有90%的老年肿瘤患者没有接受中性粒细胞减少症的预防治疗。在今后的20年里，大部分接受肿瘤化疗患者将是超过70岁的老年患者。

Help for Infection Protection and Reduce Risk of Infection during Chemotherapy

As a cancer patient taking chemotherapy (this is sometimes called chemo), you may be aware how some chemo increases your chance of infection. While this may be true, there are steps you can take to help protect against infection.

At every step of your chemo, it's important to help protect yourself against infections. Taking a white cell booster such as Neulasta^® (pegfilgrastim) is one way to help protect yourself, but there are other everyday precautions that are also helpful, such as the following:

Always wash your hands with soap and plenty of water to avoid transmission of infection through things that you touch.
Avoid people with colds or the flu.
Avoid large crowds to avoid coming into contact with sick people.
Bathe daily and gently dry your skin.
Use lotion to help prevent cracks in your skin.
Prevent cuts or scrapes, which can provide places for infection to enter your body.
- Use an electric razor instead of a blade to prevent cuts.
- Handle sharp objects with caution.
- Wear protective gloves when appropriate.
If you get a cut or scrape, cover it with a clean bandage until it heals.
Cook food thoroughly to kill infection-causing bacteria that may be in raw food.

Watch for signs of infection

Be sure to report any of the following signs of infection immediately to your doctor:

Fever higher than 100.4°F (38.2°C)
Chills
Cough or sore throat
Loose stools/diarrhea over 24 hours
Changes in urination
Mouth ulcers or sores in the throat or around the rectum
Unusual vaginal discharge or itching
Redness, swelling, or sores on the skin

Are there any tests that can help monitor for infection?

Your doctor determines what kinds of tests are needed. If you are receiving chemotherapy, you may have blood work done anywhere from the day of or up to 7 days before your scheduled treatment. This blood work will include a complete blood count (CBC). A blood sample for a complete blood count (CBC) will also be collected seven to fourteen days following your chemotherapy. The CBC measures counts of different cells in your body, including the white blood cell (WBC) counts. Patients with a low WBC count are at increased risk of infection and may benefit from treatment with a low white blood cell booster such as Neulasta^®.

If you are concerned or unsure about your condition, it may help to make a list of questions to ask your doctor.

Neulasta^® (pegfilgrastim) is prescribed to reduce the risk of infection (initially marked by fever) in patients with some tumors receiving strong chemotherapy that decreases the number of infection-fighting white blood cells.

Important safety information
Ruptured spleen (including fatal cases) and a serious lung problem called acute respiratory distress syndrome have been reported. Call your doctor or seek emergency care right away if you have abdominal or shoulder tip pain, shortness of breath, trouble breathing, or a fast rate of breathing. In rare cases, serious allergic reactions can occur, causing shortness of breath, wheezing, dizziness, swelling around the mouth or eyes, fast pulse, sweating, and hives. Sometimes these symptoms could come back within days after stopping treatment for the allergic reaction. If you start to have any of these symptoms, call your doctor or seek emergency care right away. Sickle cell crises have also been reported.

In a clinical study, mild to moderate bone pain occurred in 31% of the patients taking Neulasta^® and in 26% of the patients taking a placebo injection. In most cases, bone pain was controlled with a non-narcotic pain reliever, such as acetaminophen. Other common side effects reported by patients in the study taking either Neulasta^® or placebo were consistent with the underlying cancer diagnosis and its treatment with chemotherapy, with the exception of bone pain.

If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.