牛皮癬也叫做銀屑病,是一種慢性的皮膚病,,皮膚細胞過量產(chǎn)生并積累在皮膚表面形成紅色的結痂的斑塊,,這種斑塊會發(fā)癢并流血。大約有2%的人患這種病,,其中30%的病例被認為是中等到嚴重程度的,。不幸的是,目前治療這種疾病的方法很有限,。
由曼徹斯特大學的一名皮膚科專家領導的一個國際性研究組發(fā)現(xiàn)用一種叫做Infliximab(商品名Romicade,,瑞米可)的新藥物能迅速并顯著地改善牛皮癬癥狀。
EXPRESS(European Infliximab for Psoriasis Efficacy and Safety Study歐洲Infiliximab治療牛皮癬效果和安全性研究)是一項對378名患有中等和嚴重牛皮癬(銀屑?。┑牟∪诉M行的一項安慰劑-空白試驗,,以檢測這種藥物的療效和安全性。這項研究的結果公布在10月15日的國際醫(yī)學頂級雜志Lancet上,。
研究表明,,80%的病人在接受這種藥物治療10周后癥狀好轉了75%,而接受安慰劑的病人癥狀僅好轉了3%,。Infliximab能夠抑制腫瘤壞死因子-a(TNF-alpha,,是一種與炎癥有關的蛋白質(zhì),生物通網(wǎng)站注)的活性,。臨床試驗結果顯示這種新藥物能清除大部分參與試驗的患者的皮膚累積物,。用藥10周后,大約60%的病人皮膚癥狀好轉了90%,。在研究進行的50周內(nèi),,這種療效持續(xù)始終。
這些結果意味著Infliximab是牛皮癬較新的生物治療方法中效果很好的一種藥物,從而為治療牛皮癬提供了一種新的較好的選擇,。
有關的使用方法標準介紹:
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.?