盐酸吉西他滨,盐酸吉西他滨冻干粉注射剂(Gemzar Injection 200mg)

药店国别:

产地国家:日本

处方药:

所属类别: 200毫克/瓶

包装规格: 200毫克/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Eli Lilly Japan Ltd.

原产地英文商品名:Gemzar Injection(ジェムザール注射用)200mg/Vial

原产地英文药品名:Gemcitabine Hydrochloride

中文参考商品译名:Gemzar(ジェムザール注射用)200毫克/瓶

中文参考药品译名:盐酸吉西他滨

曾用名:

简介

部份中文盐酸吉西他滨处方资料(仅供参考)

英文药名:Gemzar(Gemcitabine Hydrochloride)

中文药名:盐酸吉西他滨

剂 型:注射剂

生产厂家:礼来公司

药品介绍

药物分类名称:抗代谢抗肿瘤剂

批准日期:2001年9月

商标名:Gemzar Injection

一般名:ゲムシタビン塩酸塩(JAN)Gemcitabine Hydrochloride

略 号:GEM

化学名:(+)-2’-Deoxy-2’,2’-difluorocytidine monohydrochloride分子式:C9H11F2N3O4・HCl

分子量:299.66構造式

性 状:它是白色至微黄色的白色结晶粉末。微溶于水,几乎不溶于甲醇,几乎不溶于乙醇和乙醚。

熔点:约237°C(分解)

药用药理学

1.抗肿瘤作用吉西他滨(DFDC),第一通道人实体瘤细胞,包括非小细胞肺癌和乳腺癌,和对抗多种其它鼠和人肿瘤细胞的表现出的细胞杀伤,其作用是浓度和这是时间依赖的。 DFDC,即使在使用异种移植物的人实体肿瘤模型中,非小细胞肺癌细胞(CALU-6),时间表依赖性相对于乳腺癌细胞(H-31,H-71),和各种其它肿瘤细胞的研究它显示出抗肿瘤作用。也就是说,虽然在每3至4天的非致死剂量给药毒性观察到优异的抗肿瘤效果在每天给药一次观察到的抗肿瘤效果强。在该异种移植的人肿瘤模型中,在效力人肺癌细胞,其已知是较不敏感的(H-74和CPH SCLC54B)在以往的抗癌剂进行了观察。此外,人胰腺癌细胞(MIA PACA-2和PANC-1),人胆管癌细胞(TGBC2TKB和HuCCT1)和人膀胱上皮癌的细胞(639-V,BFTC-909,RT-4,RT-112)在还表现出肿瘤生长抑制作用。

2.作用机制吉西他滨(DFDC)由二磷酸氧化物核苷酸在代谢活性细胞内(dFdCDP)和三磷酸氧化物(dFdCTP)下,这些直接或间接的DNA合成抑制杀死指示细胞活动。是直接,dFdCTP然后通过与27)DNA聚合酶和三磷酸脱氧胞苷(的dCTP)竞争掺入DNA链,诱导细胞死亡(细胞凋亡)。此外,dFdCDP抑制核糖核苷酸还原酶,从而降低细胞内dCTP浓度,间接增强DNA合成抑制。

适应症

非小细胞肺癌,胰腺癌,胆道癌,尿路上皮癌,不能手术或复发的乳腺癌,癌症化疗后恶化的卵巢癌,复发性或难治性恶性淋巴瘤。

用法与用量

1.在非小细胞肺癌,胰腺癌,胆道癌,尿路上皮癌,癌症化疗后恶化的卵巢癌,复发或难治性恶性淋巴瘤的情况下通常,成人每天一次接受1000mg/m 2作为吉西他滨,通过30分钟静脉滴注,每周一次,连续3周,以及4周撤回。以此作为一门课程重复管理。 另外,根据患者的状况进行减重。

2.在不能手术或复发的乳腺癌的情况下通常,成人接受1250mg/m 2静脉滴注,一次为吉西他滨30分钟,每周一次,连续2周,3周后停药。 以此作为一门课程重复管理。另外,根据患者的状况进行减重。

包装注射:200mg:1小瓶注射1克:1小瓶

制造供应商礼来日本有限公司注:以上中文处方资料不够完整,使用者以原处方资料为准。

英文版说明

General InformationGemzar has been approved for the treatment of locally advanced or metastatic pancreatic cancer.Clinical ResultsGemzar improved median survival in people with advanced and metastatic pancreatic cancer, as demonstrated by data from a study comparing Gemzar with 5-Fluorouracil (5-FU), which has been the most common treatment of pancreatic cancer.A second study followed subjects treated with Gemzar who had previously been treated with 5-FU.The Phase III study of Gemzar involved 126 pancreatic cancer subjects–63 of these subjects received Gemzar therapy and the other 63 subjects received treatment with 5-FU. Of these subjects, more than 70% entered the study with metastatic disease, the most advanced stage of pancreatic cancer.Gemzar demonstrated a statistically significant advantage in survival over 5-FU. Gemzar subjects had a 5.7month median survival as compared with 4.2months for 5-FU subjects. From this trial, the six-month probability estimate for survival of subjects treated with Gemzar is 46%(30 patients), compared with 29% (19 subjects) for 5-FU subjects.After one year, the survival probability estimate was 18% (9 subjects) for Gemzar subject, compared with 2%(two subjects) for 5-FU subjects. (Survival probability estimates take results from the clinical trial and, using a mathematical equation, generalize them to the larger population of pancreatic cancer subjects.)This study also demonstrated that 24% of previously untreated subjects who received Gemzar experienced a clinical benefit response, compared with 5% of subjects treated with 5-FU.This difference also is statistically significant.A phase II trial of Gemzar, conducted among 63 subjects who had previously been treated with 5-FU, showed median survival time of 3.9 months.In this trial, 87% of subjects entered the study with metastatic disease. Of these subjects, 31% survived for six months, and 4% survived for one year. In addition, clinical benefit response was observed in 27% of subjects.Side EffectsGemzar's side effects were generally manageable with less than 1% of subjects discontinuing their therapy for any of the following side effects.A decrease in some infection-fighting white blood cells, called neutropenia, was observed in 63% of subjects, with moderate to severe decreases in 25% of subjects. This effect on the blood was the most frequent reason for reducing or limiting the dose of Gemzar.Common adverse effects in clinical trials included nausea and vomiting (69%), fever (41%), edema or fluid retention (up to 34%), rash (30%), and flu-like symptoms (19%). Only about 10% of all subjects participating in Gemzar clinical trials discontinued therapy due to side effects.Hair loss was reported in 15% of subjects.This side effect was reversible, and none of the subjects experienced complete hair loss from their treatment.Mechanism of ActionGemzar is a nucleoside analogue that mimics a natural building block of DNA.Additional InformationPancreatic cancer, one of the most difficult cancers to treat, is hard to detect because subjects remain asymptomatic until late in the course of the disease. Currently, less than 10% of all pancreatic cancer patients live more than one year after diagnosis. An estimated 26,000 people in the United States will be diagnosed with pancreatic cancer in 1996.Given the difficulty in diagnosing pancreatic cancer, traditional means for establishing the activity of a chemotherapy agent, such as the rate of tumor growth or shrinkage, often cannot provide a useful measurement of a drug's effectiveness. Recognizing the unique needs associated with caring for pancreatic cancer patients, Lilly designed a clinical endpoint that would provide an objective, quantitative measurement of Gemzar's effect on several important disease-related symptoms experienced by subjects.Clinical benefit response is a measure of symptomatic improvement based on the following: level of pain; consumption of pain medication; ability to perform daily activities; weight change. Subjects were considered to be clinical benefit responders only if they experienced improvement in at least one measurement without deterioration in any of the others. This improvement must have reached an established level for at least four consecutive weeks.

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