硝唑尼特治疗丙型肝炎的临床研究:硝唑尼特首先是作为肠寄生虫及厌氧菌的广谱药被开发的,硝唑尼特治疗丙型肝炎的临床研究,其抗病毒活性是在HIV患者隐孢子虫感染的开发项目中被发现的,硝唑尼特及其在循环中的代谢产物tizoxanide能以低浓度(纳摩尔及微摩尔 级)在细胞培养中选择性地抑制病毒结构蛋白的合成,从而抑制乙型及丙型肝炎病毒的复制。
硝唑尼特已被批准用于由隐孢子虫(Cryptosporidium parvum)或梨形鞭毛虫 (Giardia lamblia)引起的腹泻。新的使用是依据去年在埃及进行的1期试验令人鼓舞的资料。首先人选的20例患者的初步资料显示进食时用硝唑尼特500mg,每日二次,24 周后有50的病毒水平降低到不能测的水平,而安慰剂组是0 (P一0.03)。 这项研究中有10%左右的患者过去 用干扰素联合治疗无效,且全部患者都感染了基因型4病毒(90的埃及丙型肝炎患者感染这一菌株)。Romark说硝唑尼特耐受性良好,无显著的副作用,继续随访患者,以确定停止用药后这一效果的持久性。该公司说,在美国以外正在进行的其他试验是硝唑尼特与聚乙二醇化干扰素联合治疗研 究,临床及临床前试验结果将在今年的杂志及医学会议上报告。
Romark公司对噻唑类化合物Alinia(nitazoxanide,硝唑尼特)治疗丙型肝炎的临床研究。它希望这种广谱的抗感染药能在治疗用聚乙二醇化干扰素及利巴韦林(ribavirin)标准联合治疗无效的患者中找到一席之地。 Romark公司已经申请IND以进行一项研究,在过去用过联合治疗无效的丙肝患者中使用硝唑尼特500mg,每日二次,作为单药治疗,共24周。它也打算申请用于此症的快通道地位。
Romark的董事长兼首席科学家也是硝唑尼特的发明者Jean—Francois Rossiqnol说,“需作进一步的研究以全面了解这一独特作用机理的含义,但潜在的益处包括与其它抗病毒药的协同作用和减少发生耐药性病毒的危险”但硝唑尼特在进人治疗丙型肝炎的临床过 程中需与一些其他新药竞争,包括蛋白酶 抑制剂Vertex制药公司.的VX一950及Schering—Plough公司SCH503034,以及 Idenix 公司的RNA 聚合酶抑制剂valopicitabine
alinia
Uses Alinia is used to treat diarrhea in children due to certain intestinal parasitic infections. Storage Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59 to 86 degrees F (15 to 30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Discard any unused medication after 7 days.
Overdose If overdose is suspected, contact your local poison control center or emergency room immediately.
Photos ALINIA Alinia (nitazoxanide) 500 mg Alinia (nitazoxanide) 100 mg/5 ml Alinia Product Information (.PDF)
How To Use Shake the bottle well before each dose. Take Alinia by mouth every 12 hours for 3 days with food, or as directed by the doctor. Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take Alinia at evenly spaced intervals. Continue to take Alinia until the full-prescribed amount is finished even if symptoms disappear after a few doses. Stopping the medication too early may allow the parasites to continue to grow, which may result in a relapse of the infection.
Side Effects An allergic reaction to Alinia is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice any unusual effects, contact the doctor or pharmacist.
Precautions Before using Alinia, tell the doctor or pharmacist your medical history, especially of: liver disease, kidney disease, any allergies. This oral suspension contains sugar. Caution is advised if you have diabetes. Consult the doctor or pharmacist about the safe use of Alinia. Tell the doctor if you are pregnant before using Alinia. It is not known whether Alinia passes into breast milk. Consult the doctor before breast-feeding.
Missed Dose If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Drug Interactions Before using Alinia, tell the doctor or pharmacist of all prescription and nonprescription products you may use. Do not start or stop any medicine without doctor or pharmacist approval.
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