英文商品名:PROTOPIC
英文药品名:TACROLIMUS
商品译名:普特皮
考药品译名:他克莫司
PROTOPIC 0.1% OINTMENT 60G/TUBE（普特皮0.1%软膏 60克/管 ） 、PROTOPIC 0.1% OINTMENT 30G/TUBE（普特皮0.1%软膏 30克/管） 、PROTOPIC 0.1% OINTMENT 100G/TUBE (普特皮0.1%软膏 100克/管)、PROTOPIC 0.03% OINTMENT 60G/TUBE(普特皮0.03%软膏 60克/管 ) 、PROTOPIC 0.03% OINTMENT 30G/TUBE(普特皮0.03%软膏 30克/管)、PROTOPIC 0.03% OINTMENT 100G/TUBE (普特皮0.03%软膏 100克/管 )
适应病症:
皮肤红肿、皮炎(湿疹)、白癜风

Protopic (Tacrolimus) Ointment
The Protopic (tacrolimus) ointment is an immunosuppressant used to treat the dermatitis. The dermatitis can easily be defined as an inflammation of the skin. However, this affection is described through a multitude of symptoms, such as dry skin, red skin, rash, crusts and other exfoliation wounds. There are multiple forms of dermatitis, according to the triggering factor. However, the treatment is pretty much the same for most of them. The active substance in this medication – tacrolimus – is used to lower the activity of your immune system. This way, the cell production is also lowered, therefore the dermatitis evolution is entirely stopped.

The Protopic (tacrolimus) ointment is indicated in the severe cases, when other medicines were proven to be ineffective. It is a powerful medication that might come up with severe adverse reactions if used inappropriately. This is why seeing a specialist doctor and getting a medical prescription is a must. You cannot use the ointment otherwise. It is FDA approved since 2000 and since then it is one of the main and most successful fighters against such conditions.

Administration
The Protopic (tacrolimus) ointment comes in two forms, differentiated by the medicine concentration – 0.03% and 0.1%. The 0.33% concentration is indicated for the children younger than 16. It is less powerful, therefore its side effects are also less aggressive. Besides, when the dermatitis affects children, their young organisms are easier to treat. Before the administration, you must wash your hands and the affected area, then let them dry. Wash your hands once you are done too, unless they are actually the affected area.

Apply a thin layer on the affected area only. Don’t use the Protopic (tacrolimus) ointment for healthy skin as a prevention method as it won’t work. Let it dry and give it a couple of hours before washing or having a shower. You can get dressed 30 to 60 minutes after the administration.

Contraindications
It is very important to discuss with your doctor about the side effects and all the complementary treatments you will stick to. Do not make any combinations without a professional advice.

Also, don’t cover your skin with a gauze or bandage after applying the Protopic (tacrolimus) ointment. This way you will administer a higher dose, which is contraindicated if the doctor didn’t mention anything about this aspect.

Adverse reactions
Some of the adverse reactions to the Protopic (tacrolimus) ointment include:

■Headaches
■Stinging or burning sensations
■Cold symptoms
■Acne
■Redness

加拿大卫生部医药处批准Protpic用于预防湿疹
2011年2月17日,加拿大Astellas Pharma公司宣布Protopic(他克莫司软膏)获加拿大卫生部医药处批准,增添新的适应证,用于局部湿疹的治疗。Protopic新批准的适应症包括预防皮肤红肿和延长特应性皮炎(湿疹)的发作间隔时间。他克莫司软膏是一类局部的神经钙蛋白抑制剂。
免疫调节剂（Protopic immunomodulator）是一种比较新的白癜风治疗方法。Protopic是由日本的Fujisawa 医药公司生产的用来抑制白斑处局部皮肤免疫反应的药膏。很多（但不是全部）使用它的人都取得了成功。Protopic曾成功地被用于湿疹的治疗，当前，批准的说明书中没有特别提到白癜风的治疗，美国食品与药品管理委员会规定现在不支持对Protopic用于白癜风的临床使用和研究。
Protopic一般的使用方法是每天涂两次，很多医生还建议他们的患者每周照射15-30分钟的自然光，也有医生选择用窄波UVB的。Protopic有0.03%（一般适用于儿童）和0.1%（加强型）两种型号。
Protopic免疫调节剂药膏是由日本本州的Tsukuba 山中发现的一种土壤中稀有的细菌制成的，此地因为有稀有的植物群而闻名，所以日本公司发现这种产品的特性也自然而然。
大多数专家认为白癜风是由于免疫系统错误地攻击了人体自身的黑色素细胞而导致的。在局部的白斑区使用后，Protopic能够阻止免疫系统攻击黑色素细胞，从而使之成长和再生长。Protopic不会很容易地被人体的血液吸收，使治疗真正限于局部，这一点可以使患者放心使用。
最近Protopic被美国食品与药品管理委员会批准用于湿疹的治疗（白癜风还没有被批准），尽管还没有发表和公开官方的研究、结论或者科学的数据，已经对很多白癜风患者显示了明显的效果。白癜风方面的权威Pearl Grimes大夫正在进行一个由调查人发起的研究，此研究由fujisawa公司所资助，用来评估protopic在白癜风治疗中的安全性和有效性。虽然还不会马上就在美国、日本和其他的地方正式应用，但是如果调查研究工作能够证明Protopic的价值的话，它将会被广泛地使用。
在美国，虽然这种药还没有得到食品与药品管理委员会的许可用于白癜风的治疗，医生还是可以开处方使用protopic治疗白癜风。

Protopic（他克莫司）治疗白癜风的介绍
Protopic（商品名），化学名他克莫司（Tacrolimus,又名FK506），是由日本藤泽公司生产的局部用免疫抑制剂。
他克莫司的治疗白癜风作用和毒副作用都是通过抑制细胞增殖的信号传导信道而产生的。T淋巴细胞是他克莫司作用的主要靶细胞，通过抑制早期淋巴细胞相关基因的表达，从而抑制T淋巴细胞的免疫活性。他克莫司也能抑制皮肤肥大细胞IgE介导的释放组织胺的作用，这可能也是治疗皮肤病的重要理论基础之一。实验研究发现，局部应用他克莫司可抑制唑酮（oxazolone）诱导的局部淋巴结细胞（LNC）的增殖。
最近，有人外用他克莫司治疗白癜风取得了成功。Tanghetti等用0.1%他克莫司软膏每日2次对15例患者（包括5例成年人）进行了为期9个月的治疗。疗程结束时有13例患者色素完全再生，1例出现50%-70%的色素再生，9例出现0-25%的色素再生。疗效一般在治疗6-8周时出现，且与季节、发病部位有关，在光暴露部位如头、颈部效果最好，肤色较黑者效果也较好。所有患者都能耐受治疗。局部不良反应和安全性在动物实验中，外用0.03%-0.3%他克莫司软膏52周未发现皮肤组织的超微结构改变；人体局部应用他克莫司在2期及3期临床试验证明是相当安全的，在表皮中无药物累积；在人体的临床试验中，仅有暂时性的轻度刺激作用，如红斑、轻度烧灼感等，未出现持久的刺激反应、过敏、光毒反应、光过敏性反应。离体研究中未发现对角质形成细胞产生影响，也未发现影响皮肤胶原的合成。与皮质类固醇相比，它无皮肤萎缩、毛细血管扩张、膨胀纹等，也无色素减退、皮肤功能紊乱等不良反应。在欧洲的一项多中心研究中，外用他克莫司时平均血清浓度为0.1mg/ml，即使大面积使用高浓度（0.3%）他克莫司时，血清中的浓度也是低的，保持在0.18-0.32mg/ml之间，与移植患者中>5-20mg/ml的浓度相比是安全的，局部应用不会出现全身用药后引起的全身感染、高血压、高血糖、肾毒性、神经毒性和肿瘤形成等。不同的文献报道他克莫司外用于小儿也相当安全，而且已有人用0.1%的浓度在2-15岁的儿童身上使用1年以上，未出现新的或严重的不良反应，长期使用可能是安全的。
使用他克莫司治疗白癜风的常见不良反应包括：皮肤灼烧、瘙痒，或者有痒觉，皮肤发红。这些不良反应一般持续时间较短，在治疗几天后反应会逐渐减轻。

Generic Name: tacrolimus topical (ta KROE li mus)
Brand Names: Protopic
DRUG DESCRIPTION
PROTOPIC (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only.
INDICATIONS
PROTOPIC Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable.
INDICATIONS
PROTOPIC Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable.
SIDE EFFECTS:
Stinging, burning, soreness, or itching in the area of treated skin may occur during the first few days of treatment. Headache, acne, "hair bumps" (folliculitis), stomach upset, flu-like symptoms (e.g., fever, chills, runny nose, sore throat, muscle aches), or increased sensitivity of the skin to hot/cold/pain/touch may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual tiredness, back/joint/muscle pain, appearance of any skin infections or sores (e.g., chicken pox, shingles, lip sores, tumors, warts).
Tell your doctor immediately if this rare but very serious side effect occurs: chest pain.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.