英文药名：FIBLAST Spray（Trafermin[genetical recombination]） 中文药名：曲弗明重组喷雾剂 生产厂家：科研制药 フィブラストスプレー250／フィブラストスプレー500 治疗类别名称 褥疮，皮肤溃疡处理剂 商標名 FIBLAST Spray 一般名 Trafermin（genetical recombination） （トラフェルミン（遺伝子組換え）） 本質 ヒト由来の塩基性線維芽細胞成長因子ゲノム遺伝子の発現により組換え体で産生される154個（C764H1201N217O219S6；分子量：17,122.67）及び153個（C761H1196N216O218S6；分子量：17,051.59）のアミノ酸残基からなるたん白質（N末端；Ala-Ala：65％以上、Ala：35％以下） 药效药理 1.伤口愈合促进活性在疾病模型 (1) 促进皮肤的愈合遗传的糖尿病小鼠的所有层赤字伤口和遗传性肥胖小鼠（减低区降低的效果或治愈天）。 (2) 它在恢复肝功能衰竭大鼠皮肤全层切开伤口的皮肤开裂张力减小。 (3) 为促进转基因糖尿病小鼠和大鼠的营养不良烧伤创面愈合的第一III（缩短治愈天）。 (4) 为促进转基因糖尿病小鼠（面积减少的影响）的细菌感染皮肤全层缺损创面愈合。 (5) 遗传糖尿病推动鼠标（增加固化示例的数量）的压力溃疡的愈合。 2.血管新生作用 成纤维细胞生长因子的血管内皮细胞（ACE细胞）的FGF与受体结合和特异性的，公认的细胞生长促进活性，细胞迁移促进活性，纤溶酶原激活产生促进作用，对管腔形成动作它是（体外）。此外，使用兔角膜微口袋方法，健康大鼠的纸片法，血管生成作用已经通过在健康小鼠中的血红蛋白量的测定方法和遗传性糖尿病小鼠的皮肤全层缺损创伤观察（体内）。 3.肉芽肿形成促进作用 成纤维细胞特异性结合FGF受体（BHK-21细胞），细胞增殖促进作用是允许的（体外）。此外，健康大鼠和受损伤口愈合的大鼠（类固醇治疗，多柔比星给药，X射线照射）的纸片法，由健康小鼠和遗传性糖尿病小鼠的棉球方法，已经发现肉芽肿形成促进作用，健康大鼠的纸片法已经观察到即使对肉芽形成由（体内）显著促进效果。 4.其他的作用 它增加了在全层缺损的伤口和渗出物的遗传性糖尿病小鼠的皮肤渗出量炎性细胞的数量。 5.作用机序 此剂是血管内皮细胞，和特异性结合存在于成纤维细胞等的FGF受体，通过指示血管生成作用或造粒促进效果或类似物，压疮，显示了皮肤溃疡的治疗效果。 适应症 压疮，皮肤溃疡（烧伤性溃疡，下肢溃疡） 剂量和给药方法 附溶液为100μg溶解在使用时按曲弗明（基因重组）1mL中，溃疡表面清拭后，使用该药物的专用喷雾器，每天一次，如果溃疡的最大直径是内6厘米是（如曲弗明（基因重组）和30μg的）从溃疡面的距离约5cm5喷洒。如果溃疡的最大直径为6cm以上，使得药物被5喷在同一溃疡面，通过从溃疡表面的距离约5cm重复相同的操作 包装规格 喷雾 250μg（含：30万国际标准单位） 250:(冻干产品和附带的溶液）×1，5 500μg（含：60万国际标准单位） 500:(冻干产品和附带的溶液）×1,5 生产商：科研制药 FIBLAST Spray（Trafermin(genetical recombination)） FIBLAST Spray 250（フィブラストスプレー250） Brand name : FIBLAST Spray 250 　Active ingredient: Trafermin(genetical recombination) 　Dosage form: liquid 　Print on wrapping: フィブラストスプレー250μg ----------------------------------- FIBLAST Spray 500（フィブラストスプレー500） Brand name : FIBLAST Spray 500 　Active ingredient: Trafermin(genetical recombination) 　Dosage form: liquid 　Print on wrapping: フィブラストスプレー500μg ----------------------------------- Effects of this medicine This medicine binds specifically to FGF (fibroblast growth factor) receptor in vascular endothelial cell or fibroblast cell that plays an important role in process to heal wounds. It shows vascularization or granulation to prompt pressure ulcer or skin ulcer healing. It is usually used to treat pressure ulcer (bedsore) and skin ulcer. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you have malignant tumor at the applied site. •If you are pregnant or breastfeeding. •If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) •Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>> •In general, apply the following dose at a time, once a day, about 5cm apart from the affected area using a special device. If the maximum diameter of the ulcer (wound) is less than 6cm, apply 5 sprays (30 mcg of the active ingredient). If the maximum diameter of the ulcer is more than 6cm, apply 5 sprays to the same site of ulcer and repeat the application. Strictly follow the instructions. •Apply this medicine after sterilizing or cleaning up the affected area. •If you miss a dose, apply a dose as soon as possible when you noticed. You should not apply two doses at one time. •If you accidentally use more than your prescribed dose, consult with your doctor or pharmacist. •Do not stop using this medicine unless your doctor instructs you to do so. Precautions while taking this medicine • Possible adverse reactions to this medicine The most commonly reported adverse reactions include stimulating feeling/pain on sprayed site, redness, itch and increase of effusion. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. No pertinent entries. The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions and other information •Store at 10℃ or below in a cold dark place such as refrigerator in a storage bag with put the lucent cap on. Store away from freezing. Do not use any medicine that has stored for more than 2 weeks after opening for the stability. •Discard the remainder. Do not store them. Kaken Pharmacetical Co.,LtdExternal Revised: 7/2007 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. http://fiblast.jp/howto.html http://www.info.pmda.go.jp/go/pack/2699710R1028_1_09/