牛皮癣也叫做银屑病,是一种慢性的皮肤病,皮肤细胞过量产生并积累在皮肤表面形成红色的结痂的斑块,这种斑块会发痒并流血。大约有2%的人患这种病,其中30%的病例被认为是中等到严重程度的。不幸的是,目前治疗这种疾病的方法很有限。
由曼彻斯特大学的一名皮肤科专家领导的一个国际性研究组发现用一种叫做Infliximab(商品名Romicade,瑞米可)的新药物能迅速并显著地改善牛皮癣症状。
EXPRESS(European Infliximab for Psoriasis Efficacy and Safety Study欧洲Infiliximab治疗牛皮癣效果和安全性研究)是一项对378名患有中等和严重牛皮癣(银屑病)的病人进行的一项安慰剂-空白试验,以检测这种药物的疗效和安全性。这项研究的结果公布在10月15日的国际医学顶级杂志Lancet上。
研究表明,80%的病人在接受这种药物治疗10周后症状好转了75%,而接受安慰剂的病人症状仅好转了3%。Infliximab能够抑制肿瘤坏死因子-a(TNF-alpha,是一种与炎症有关的蛋白质,生物通网站注)的活性。临床试验结果显示这种新药物能清除大部分参与试验的患者的皮肤累积物。用药10周后,大约60%的病人皮肤症状好转了90%。在研究进行的50周内,这种疗效持续始终。
这些结果意味着Infliximab是牛皮癣较新的生物治疗方法中效果很好的一种药物,从而为治疗牛皮癣提供了一种新的较好的选择。
有关的使用方法标准介绍:
GENERIC NAME: infliximab
BRAND NAME: Remicade
DRUG CLASS AND MECHANISM: Infliximab is an injectable antibody that blocks the effects of tumor necrosis factor alpha (TNF alpha). There are two other injectable drugs that block TNF alpha--infliximab (Remicade) and etanercept (Enbrel). is a substance made by cells of the body which has an important role in promoting inflammation. Specifically, infliximab is used for treating the inflammation of Crohn's disease, rheumatoid arthritis, and psoriatic arthritis. By blocking the action of TNF-alpha, infliximab reduces the signs and symptoms of inflammation. Infliximab does not cure Crohn's disease, psoriatic arthritis?or rheumatoid arthritis; however, preliminary studies have demonstrated that infliximab can retard the destruction of joints by rheumatoid arthritis.
GENERIC AVAILABLE: No
PRESCRIPTION: Yes
PREPARATIONS: Powder for intravenous injection, 100 mg
STORAGE: Refrigerate at 2-8℃C (36-46F)
PRESCRIBED FOR: Infliximab?is approved for use?alone or combined with methotrexate for treating moderate to severe rheumatoid arthritis.? Infliximab is also used for reducing the signs and symptoms of inflammation in moderate to severe Crohn's disease and Crohn's disease in which there are fistulas (passageways created when the inflammation penetrates beyond the wall of the intestine). It also is approved for the treatment of active psoriatic arthritis.? Infliximab has also been reported to be helpful in reducing the joint inflammation of juvenile rheumatoid arthritis, ankylosing spondylitis, uveitis, psoriasis, and for sarcoidosis that is not responding to traditional therapies.
DOSING: Infliximab is administered intravenously. For moderate to severe Crohn's disease the dose is 5 mg/kg administered as a single dose. For fistulizing Crohn's disease, the dose is 5 mg/kg followed by additional doses of 5 mg/kg two and six week after the first dose.
The recommended dose for the treatment of rheumatoid arthritis is 3 mg/kg as a single dose. The initial dose should be followed by additional 3 mg/kg doses two and six weeks after the first dose. Thereafter, the maintenance dose is 3 mg/kg every eight weeks.
DRUG INTERACTIONS: The interaction of infliximab with other drugs has not been studied.
PREGNANCY: Use of infliximab in pregnant women has not been adequately evaluated.
NURSING MOTHERS: It is not known if infliximab is secreted in breast milk, and, therefore, if there is the potential for effects on the nursing infant.
SIDE EFFECTS: The most common side effects of infliximab are upper respiratory tract infections, urinary tract infections, cough, rash, back pain, nausea, vomiting, abdominal pain, headache, weakness and fever.
Side effects such as low or high blood pressure, chest pain, difficulty breathing, rash, itching, fever and chills may occur during or shortly after administration. These reactions could indicate an allergy to the drug. They are more common among patients who develop antibodies to infliximab and are less likely to occur in patients who are taking drugs that suppress the immune system, such as methotrexate. Infliximab should be discontinued if serious reactions occur.
Serious infections have been reported with other drugs that block TNF- alpha, and infections have been reported during treatment with infliximab. Therefore, infliximab should not be used in patients with serious infections. Moreover, infliximab should be discontinued if a serious infection develops during treatment.
Before starting infliximab, persons are recommended to have tuberculosis skin testing (PPD tests for TB), because of reports of reactivation of tuberculosis in patients taking infliximab.
Decreased white and red?blood cell and decreased platelet counts have been reported with infliximab. Vasculitis (inflammation of arteries) also has been reported.
Patients with Crohn's disease or rheumatoid arthritis, particularly patients with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to several fold) than the general population for the development of lymphoma. More malignancies have been observed in open-label, uncontrolled clinical studies at a rate several-fold higher than expected in the general population. In controlled studies of?TNF᭢locking agents, including infliximab, more cases of lymphoma and other malignancies have been observed among patients receiving the agents than among control group patients.?