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盘雷汀（阿利维A酸胶囊/凝胶0.1％）

2011-07-15 18:54:44 作者：新特药房来源：中国新特药网天津分站浏览次数：530 文字大小：【大】【中】【小】

简介： 【中文品名】9-顺式维甲酸【药效类别】抗肿瘤药【通用药名】ALITRETINOIN【别　　名】Panretin，9-cis-retinoic acid，BAL-4079【化学名称】 2,4,6,8-Nonatetraenoic acid, 3,7-dimethyl-9-(2,6,6-trim ...

关键字：盘雷汀（阿利维A酸胶囊/凝胶0.1％）

【中文品名】9-顺式维甲酸
【药效类别】抗肿瘤药
【通用药名】ALITRETINOIN
【别　　名】Panretin，9-cis-retinoic acid，BAL-4079
【化学名称】 2,4,6,8-Nonatetraenoic acid, 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-, (2E,3F,6Z,8E)-
【CA登记号】[5300-03-8]
【结构式】

【分子式】C₂₀H₂₈O₂
【分子量】

Panretin（alitretinoin,ALRT-1057）是Ligand公司开发的9-顺-维A酸，作用于所有已知的retinoid受体。retinoid受体的激活能调节控制细胞分化和繁殖的基因表达。Panretin的局部用凝胶配方已于1999年2月上市，用于治疗卡波济肉瘤相关性损伤。这项新临床试验旨在评价它的口服胶囊配方用于下述适应证的疗效：乳腺癌和儿科癌症的治疗（Ⅱ期临床试验）、脊髓发育不良综合征、支气管转化和牛皮癣及牛皮癣性并发症（Ⅱ/Ⅲ期临床试验）

【原产地英文商品名】PANRETIN
【原产地英文药品名】ALITRETINOIN
【中文参考商品译名】盘雷汀
【中文参考药品译名】阿利维A酸
【生产厂家英文名】Ligand Pharmaceuticals

Panretin® (alitretinoin)

Panretin^® (alitretinoin) gel is a prescription medicine that is applied to the skin for the treatment of skin lesions in patients with AIDS-related Kaposi's sarcoma (KS). Panretin gel should not be used when systemic (oral or injectable) anti-KS therapy is required (e.g. more than 10 new KS lesions in the prior month, symptomatic lymphedema [swelling in tissues], symptomatic pulmonary KS [affecting the lungs], or symptomatic visceral involvement [affecting internal organs]). There is no experience to date using Panretin gel with systemic anti-KS treatment.

Kaposi's sarcoma is a cancer that causes patches of abnormal tissue to grow under the skin, in the lining of the mouth, nose and throat or in other organs. In the United States, approximately 1.21 men per 100,000, in 2007, were diagnosed with Karposi's sarcoma.

Important Safety Information

Panretin gel is not indicated in patients with a known hypersensitivity to retinoids or to any of the ingredients of the product.

Pregnancy Category D - Panretin gel could cause fetal harm if significant absorption were to occur in a pregnant woman. If Panretin gel is used during pregnancy, or if the patient becomes pregnant while taking it, the patient should be made aware of the potential harm to the fetus. Women of child-bearing potential should be advised to avoid becoming pregnant. Because of the potential for adverse reactions from Panretin gel in nursing infants, mothers should discontinue nursing prior to using the drug.

Patients with cutaneous T-cell lymphoma were less tolerant of Panretin gel; 5 of 7 patients had 6 episodes of treatment limiting toxicities - grade 3 dermal irritation - with Panretin gel (0.01 or 0.05%).

Patients should minimize exposure of treated areas to sunlight and sunlamps during the use of Panretin gel. Patients should not use products that contain DEET (N,N-diethyl-m-toluamide), a common ingredient of insect repellant products, while using Panretin gel.

The safety of Panretin gel was assessed in clinical studies of 385 patients with AIDS-related KS. Adverse events associated with the use of Panretin occurred almost exclusively at the gel application site. Dermal toxicity begins with erythema, with continued application of Panretin gel, erythema may increase and edema may develop. Dermal toxicity may become treatment limiting with intense erythema, edema, and vesiculation. Usually adverse events were mild to moderate to in severity and led to withdrawal from the study in 7% of the patients. Severe local (application site) skin adverse events occurred in about 10% of patients.

The most common adverse events with an incidence of at least 10% at the application site in Panretin gel-treated patients were; rash, pain, pruritus, and paraesthesia.

Please also see the Panretin Gel Full Prescribing Information.

Patients should consult their healthcare provider if they have any questions about, or are experiencing any side effects from, this product.

For more information about Panretin gel call Eisai Medical Services Oncology (877) 873-4724. To report suspected adverse reactions, call (877) 873-4724.

For more information on assistance with prescription drug costs that may be available to patients, call the Eisai Assistance Program at (866) 613-4724.

Panretin is a registered trademark of Eisai Inc.

治疗慢性手部湿疹的阿维A酸胶囊在英国上市

每日一次口服的阿维A酸胶囊（alitretinoin，Toctino）已在英国上市，用于治疗对局部外用强效糖皮质激素无效的慢性手部湿疹成年患者。许多重度慢性手部湿疹患者尝试了一切治疗方案但是病情还是没有改善，他们长年忍受着水泡瘙痒、抓痕疼痛及伤口发炎的困挠。这些症状严重影响他们的日常生活和工作。阿维A酸是天然维生素A的衍生物。

在1项大型的慢性手部湿疹患者的临床研究中，大约有一半服用阿维A酸的重度慢性湿疹患者的症状，在服药24周后，全部清除或者大部分清除。这些受试者为使用糖皮质激素无效的患者，他们的平均病历为9年以上。

据估算，在英国每10个人中有1人患有慢性手部湿疹，这些患者中大约有7%为重度慢性手部湿疹患者，且采用局部外用糖皮质治疗无效。