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  药店国别: 日本药房
产地国家: 日本
所属类别: 抗癌药物->治疗卵巢癌药物
处方药:处方药
包装规格: 50毫克/瓶
计价单位:
   
生产厂家中文参考译名:
塩野義製薬
生产厂家英文名:
shionogi
该药品相关信息网址1:
http://www.hindawi.com/journals/chrp/2011/963159/
该药品相关信息网址2:
http://www.e-pharma.jp/dirbook/contents/data/prt/4291405F3028.html
该药品相关信息网址3:
http://www.info.pmda.go.jp/go/pack/4291405F1025_1_09/4291405F1025_1_09?view=body
原产地英文商品名:
AQUPLA(アクプラ) 50MG/VIAL
原产地英文药品名:
NEDAPLATIN
原产地英文化合物名称:
cis-Diammineglycolatoplatinum
中文参考商品译名:
AQUPLA(アクプラ) 50毫克/瓶
中文参考药品译名:
奈达铂
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Head and neck cancer
英文适应病症2:
Small cell lung cancer, non-small cell lung cancer
英文适应病症3:
Esophageal cancer
英文适应病症4:
Bladder cancer
英文适应病症5:
Testicular cancer, ovarian cancer, cervical cancer
临床试验期:
完成
中文适应病症参考翻译1:
头颈部癌
中文适应病症参考翻译2:
小细胞肺癌、非小细胞肺癌
中文适应病症参考翻译3:
食道癌
中文适应病症参考翻译4:
膀胱癌
中文适应病症参考翻译5:
睾丸癌、卵巢癌、子宫颈癌
药品信息:

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 详细处方信息以本药内容附件PDF文件(20125901400333.pdf,20125901395533.pdf)的“原文Priscribing Information”为准
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部分中文奈达铂处方资料(仅供参考)

【药物名称】奈达铂 Nedaplatin   

【药物别名】 Nedaplait、Aqupla   

【制剂规格】10mg/支,冻干   

【药理毒理】
作用机制同顺铂,与肿瘤细胞的DNA碱基结合,阻碍DNA复制,而发挥其抗肿瘤效果。   
奈达铂由日本盐野义公司开发,八十年代中期合成,结构比较新颖,使用时不需要水化过程。   

【适 应 症】头颈部癌、小细胞肺癌、非小细胞肺癌、食道癌、膀胱癌、睾丸癌、卵巢癌、子宫颈癌。   

【用法用量】将本品100mg/ml溶于300ml以上生理盐水或5%葡萄糖溶解成注射液,60分钟以上静脉滴注完,给药后接着进行1000ml以上静脉输液,每四周给药1次,共用四个疗程。   

【不良反应】
本品主要不良反应为骨髓抑制,表现为白细胞、血小板、血色素减少;其它较常见的不良反应包括恶心、呕吐、食欲不振等消化道症状以及肝肾功能异常、耳神经毒性、脱发等。
其它不良反应虽发生率较低,但应引起关注:   
(1)严重不良反应:
1)过敏性休克症状(0.1-5%):出现过敏性休克症状(潮红、呼吸困难、畏寒、血压下降等),应细心观察,发现异常应立即停药并做适当的处理。
2)骨髓抑制(频度不明):表现为红细胞减少、贫血、白细胞减少、中性粒细胞减少、血小板减少、出血倾向(0.1-5%),应细心观察末梢血象,发现异常,应延长给药间隔、减量或停药并进行适当的处理。
3)肾功能异常(0.1-5%):出现血尿素氮、血肌酐升高,肌酐清除率下降,β2球蛋白升高,以及血尿、蛋白尿、少尿、代偿性酸中毒及尿酸升高等,发现异常,对于是否继续给药,应慎重检查。
4)阿-斯综合症(Adams-StokesSyndrome)发作:有报道因使用本品引起阿-斯综合症而死亡的病例。
5)听觉障碍、听力低下、耳鸣(频度不明):本品可引起耳神经系统毒性反应,表现为听觉障碍、听力低下、耳鸣。用药期间应进行适当的听力检查并观察患者的状态,发现异常应停药并做适当的处理;治疗前用过其它铂类制剂的、给药前就有听力低下、肾功能低下的患者应特别注意。
6)间质性肺炎(频度不明):对于伴有发热、咳嗽、呼吸困难、胸部X线异常的间质性肺炎患者,应细心观察,发现异常应终止给药,并给予肾上腺皮质激素等药物进行适当的处理。
7)抗利尿激素分泌异常综合症(SIADH)(频度不明):表现为低钠血症,低渗透压血症,尿中钠离子排泄增加,伴有高张尿、意识障碍等,发现这些症状应终止给药,并采取限制水分摄取等适当的方法处理。   
(2)其他不良反应:频度5%以上0.1-5%;种类;神经系统痉挛、头痛、手足发冷等末梢神经功;能障碍;肾脏BUN升高(11.4%)、血清肌酐清除率低血尿、蛋白尿、少尿、代偿性酸中毒、下(25.3%)、β2小球蛋白升高尿酸升高、NAC升。消化系统恶心、呕吐(74.9%)、食欲不振(59.5%)、腹泻肠梗阻、腹痛、便秘、口腔炎等,循环系统心电图异常(心动过速、ST波低下),心肌受损;呼吸系统呼吸困难;泌尿系统尿痛、排尿困难;过敏症状变态反应(湿疹、发红)、发疹等;肝脏AST(GOT)升高(11.9%)胆红素升高、AL-P上升、LDH升高、ALT(GPT)升高(12.3%)血清总蛋白减少、血清白蛋白降低电解质钠、钾、氯等电解质异常其他如脱发、全身性疲倦、发热、静脉炎、浮肿、潮红、疱疹、白细胞增多(一过性)。   

【禁忌】
以下患者禁用:
1.有明显骨髓抑制及严重肝、肾功能不全者。
2.对其它铂制剂及右旋糖酐过敏者。
3.孕妇、可能妊娠及有严重并发症的患者。   

【注意事项】
1.本品应尽可能在具有肿瘤化疗经验的医师指导下使用,慎重选择患者,应具有应对紧急情况的处理条件。
2.听力损害、骨髓、肝、肾功能不良、合并感染和水痘患者及老年人慎用。
3.本品有较强的骨髓抑制作用,并可能引起肝、肾功能异常。应用本品过程中应定期经常检查血液、肝、肾功能并密切注意患者的全身情况,若发现异常应停药并适当处置。对骨髓功能低下及肾功能不全及应用过顺铂者,应适当降低初次给药剂量;本品长期给药时,毒副反应有增加的趋势,并有可能引起延迟性不良反应,应密切观察。
4.注意出血倾向及感染性疾病的发生或加重。
5.本品主要由肾脏排泄,应用本品过程中须确保充分的尿量以减少尿中药物对肾小管的毒性损伤。必要时适当输液及使用甘露醇、速尿等利尿剂。由于有报道应用速尿等利尿剂时,会加重肾功能障碍,听觉障碍,所以应进行输液等以补充水分。另外,饮水困难或伴有恶心、呕心、食欲不振、腹泻等的患者应特别注意。
6.对恶心、呕吐、食欲不振等消化道不良反应应注意观察,并进行适当的处理。
7.合用其它抗恶性肿瘤药物(氮芥类、代谢拮抗类、生物碱、抗生素等)及放疗可能使骨髓抑制加重。
8.育龄患者应考虑本品对性腺的影响。
9.本品只作静脉滴注,应避免漏于血管外。
10.本品配制时,不可与其它抗肿瘤药混合滴注,也不宜使用氨基酸输液、pH5以下的酸性输液(如电解质补液、5%葡萄糖输液或葡萄糖氯化钠输液等)。
11、本品忌与含铝器皿接触。本品在存放及滴注时应避免直接日光照射。
12.本品在国外的临床试验中(共632例),突然死亡2例及因阿-斯综合症(Adams-StokesSyndrome,心脏传导阻滞引起的脑缺氧综合症)死亡1例。突然死亡的1例患者死于因高血压而引起心功能不全;另1例患者死于既往心肌梗塞所引起的冠脉梗塞,或者由于脑部转移引起的出血。阿-斯综合症发作的1例,给药前可见心电图ST段降低,怀疑由于应用本品而引起的食欲不振、贫血是此次发作的诱因,但进行尸检没有异常发现,不能表明本品与此相关。

【孕妇及哺乳期妇女用药】
1.动物试验中观察到本品有致畸和引起胎儿死亡的作用,因此孕妇及可能妊娠的患者禁用本品。
2.有报道类似药物顺铂可通过乳汁分泌,因此哺乳期妇女用药时应终止授乳。   

【儿童用药】儿童使用本品的安全性尚未确立。

【老年患者用药】
1.本品主要经肾脏排泄,由于一般老年人肾功能减退,排泄延迟,因此应注意观察出现骨髓抑制的可能性。
2.建议老年患者初次用药剂量为80mg/m2。

【药物相互作用】
1.品与其它抗肿瘤药(如烷化剂、抗代谢药、抗肿瘤抗生素等)及放疗并用时,骨髓抑制作用可能增强。
2.与氨基糖苷类抗生素及盐酸万古霉素合用时,对肾功能和听觉器官的损害可能增加。

【贮藏】遮光、密闭,在阴凉处保存。   

【有效期】暂定18个月

Nedaplatin: A Radiosensitizing Agent for Patients with Cervical Cancer

Abstract
Despite the recent advances in the management of cervical cancer using cisplatin-based concurrent chemoradiotherapy, substantial treatment failure still occurs, especially in advanced-stage patients and early-stage cervical cancer patients with high-risk prognostic factors. Therefore, efforts to further improve the survival and quality of life of these patients are necessary. Nedaplatin (cis-diammine-glycoplatinum), a derivative of cisplatin, was developed with the aim of producing a treatment with a similar effectiveness to cisplatin but decreased renal and gastrointestinal toxicities. Based on the promising results of preclinical studies, the clinical efficacy of nedaplatin as a radiosensitizing agent was evaluated in patients with cervical cancer. Retrospective analysis of nedaplatin-based concurrent chemoradiotherapy (CCRT) against cervical cancer suggested that nedaplatin-based CCRT can be considered as an alternative to cisplatin-based CCRT in both early-stage and advanced-stage cervical cancer patients. However, due to the lack of a randomized controlled study, nedaplatin-based CCRT has not been convincingly proven to be clinically effective in patients with cervical cancer. Further investigations in randomized controlled trials are therefore needed.

Introduction
Nedaplatin (cis-diammine-glycoplatinum), a derivative of cisplatin, was developed in 1983 by Shionogi Pharmaceutical Company in Japan with the aim of producing a treatment with a similar effectiveness to cisplatin but decreased renal and gastrointestinal toxicities, nedaplatin has a novel chemical structure involving a five-membered ring structure in which glycolate is bound to the platinum ion as a bidentate ligand.

In a preclinical evaluation of cervical cancer, nedaplatin demonstrated similar antitumor activity to cisplatin. Its lower incidence of nephrotoxicity in comparison to cisplatin has been demonstrated to be associated with differences in the kidney distribution of these drugs. When the two agents were administered at the same dose, the accumulation of nedaplatin in the rat kidney was approximately 40% of that of cisplatin, which explains why nedaplatin is associated with less nephrotoxicity than cisplatin.

Clinically, previous phase II studies conducted in Japan suggested that nedaplatin has a particularly favorable clinical efficacy towards squamous cell carcinoma (SCC) of the lung, head and neck, esophagus, and uterine cervix. According to a clinical study of nedaplatin in nonsmall cell lung cancer patients, the response rate in patients with SCC histology was 57.1%, which is significantly higher than 5.5% observed in patients with nonSCC histology [9]. In the area of uterine cervical cancer, in a phase II clinical trial, nedaplatin demonstrated a response rate of 46% in patients with recurrent cervical cancer, which was slightly superior to that obtained with cisplatin (39%). Moreover, since nedaplatin does not require hydration, nedaplatin treatment can be managed in an outpatient setting. On the basis of these advantages, nedaplatin has been used clinically in Japan as an alternative to cisplatin for patients with recurrent cervical cancer.

The radiosensitizing properties of nedaplatin have been demonstrated in several preclinical studies. An in vitro investigation demonstrated that nedaplatin in combination with irradiation is highly effective for cervical cancer. Although the preliminary data from clinical studies of the use of nedaplatin-based CCRT in patients with head and neck or esophageal cancer has been reported [13], however, the clinical experience with this agent in the setting of CCRT for cervical cancer patients is limited. As shown in Table 1, the use of concurrent weekly nedaplatin in patients with invasive cervical cancer in the setting of definitive radiotherapy was investigated in two Phase I, two Phase II studies, and one retrospective study; however, in the setting of adjuvant radiotherapy, nedaplatin-based CCRT has only been evaluated in one Phase I  and two retrospective studies. Thus, it remains unclear whether nedaplatin-based CCRT is superior to RT alone in patients with cervical cancer.

Concurrent chemoradiotherapy, usually involving 40 mg/m2 of weekly cisplatin, is accepted as the standard first-line treatment for cervical cancer. However, its nephrotoxicity and gastrointestinal toxicity may limit its use. In a previous Japanese Phase I study, which determined the recommended dose of weekly cisplatin in the setting of CCRT after radical hysterectomy, dose-limiting toxicity (DLT) was observed at 40 mg/m2, indicating that a weekly dose of 40 mg/m2 of cisplatin may be too high for Japanese patients with cervical cancer. As nedaplatin exhibits minimal nephrotoxicity, it can be used in patients with marginal renal function. Moreover, since nedaplatin does not require hydration and shows minimal gastrointestinal toxicity, nedaplatin treatment can be managed in an outpatient setting. Thus, the substitution of nedaplatin for cisplatin as a concurrent chemotherapy for patients with cervical cancer may be beneficial.

Recently, we investigated the efficacy of nedaplatin-based CCRT in the settings of adjuvant treatment after radical hysterectomy and definitive radiotherapy. Although they were retrospective in nature, to the best of our knowledge, these are the only reports that have demonstrated a significant improvement in the survival of cervical cancer patients treated with nedaplatin-based CCRT. In this review, we show the results of these retrospective analyses and provide information on the results of other clinical studies that investigated the efficacy of nedaplatin-based CCRT in patients with cervical cancer.

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 详细处方信息以本药内容附件PDF文件(20125901400333.pdf,20125901395533.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2012-5-9
附件:




20125901400333.pdf    

20125901395533.pdf    

 
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