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英文药名: Alinia(Nitazoxanide Tablets)
中文药名: 硝唑尼特片
药品介绍
Romark大药厂1月10日宣布已经在美国开始开发Alinia(硝唑尼特，nitazoxanide) 片的新适应症—慢性丙型肝炎。该公司已经向FDA提交了新药临床申请，并申请了快速审批资格。在美国开始的临床试验将首先评价硝唑尼特500mg，每日两次，给药24周对之前干扰素和利巴韦林联合治疗失败的病人的疗效。硝唑尼特是一类称为thiazolides化合物的第一个成员，该类化合物为小分子，通过抑制病毒结构蛋白的合成来阻断特定病毒的复制。研究表明硝唑尼特及其循环中的代谢产物tizoxanide，可以在低浓度时抑制细胞培养中的HBV和HCV。
硝唑尼特可改善慢性丙肝的病毒学应答
美国胃肠病学会期刊日前发表一项研究，评估了硝唑尼特(nitrazoxa nide)联合聚乙二醇化干扰素α-2a与利巴韦林在慢性丙型肝炎(HCV)4型患者中的使用效果。研究显示，与只用聚乙二醇化干扰素α-2a加利巴韦林的标准治疗相比，在标准治疗外加用硝唑尼特可使患者持续病毒学应答率提高。
这是一项随机对照研究，在埃及两个中心共招募了97名未经治疗的4型慢性丙型肝炎患者，评估硝唑尼特、聚乙二醇化干扰素α-2a和利巴韦林联合使用与只用聚乙二醇化干扰素α-2a加利巴韦林的安全性和疗效。
研究主要终点为持续病毒学应答(SVR)，或治疗后24周血清HCV RNA<12IU/毫升。次要终点包括第4周(快速病毒学应答，或RVR)、第12周(完全早期病毒学应答，cEVR)以及治疗后(ETR)HCV RNA<12IU/毫升。
结果发现，使用三联疗法与标准治疗相比，RVR(定义为联合治疗第4周时血清HCV RNA测不出)和SVR的患者百分比显著提高(分别为64%比38%，79%比50%)。接受硝唑尼特加聚乙二醇化干扰素α-2a的患者达到RVR和SVR的比例中等(分别为54%和61%)。
各治疗组不良事件相似。在硝唑尼特治疗组，病毒学应答维持至治疗终末，无病毒学突破。值得注意的是，硝唑尼特的使用与复发率的降低相关。
硝唑尼特是一类新的广谱抗病毒药，它是HCV在衍生复制子细胞系中的强力抑制剂，研究显示它不会诱导病毒突变产生耐药。
近期一项Ⅱ期试验使用高低两种剂量的硝唑尼特控释片剂，显示其良好的药代动力学，使病毒载量显著降低，并有良好的耐受性和安全性。
Alinia
Pronunciation: nye-ta-ZOX-a-nide
Generic Name: Nitazoxanide
Brand Name: Alinia
Alinia is used for:
Treating certain parasitic infections of the intestine.
Alinia is an antiparasitic agent. It works by interfering with the production of certain substances that are needed by the parasite to live.
Do NOT use Alinia if:
you are allergic to any ingredient in Alinia
Contact your doctor or health care provider right away if any of these apply to you.
Before using Alinia:
Some medical conditions may interact with Alinia. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have liver or gallbladder problems, kidney problems, immune system problems, or HIV infection
Some MEDICINES MAY INTERACT with Alinia. Tell your health care provider if you are taking any other medicines, especially any of the following:
Warfarin because its actions and side effects may be increased by Alinia
This may not be a complete list of all interactions that may occur. Ask your health care provider if Alinia may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Alinia:
Use Alinia as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Alinia with food.
If you miss a dose of Alinia, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Alinia.
Important safety information:
Alinia may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Alinia. Using Alinia alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
Alinia is not recommended for use in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Alinia, discuss with your doctor the benefits and risks of using Alinia during pregnancy. It is not known if Alinia is excreted in breast milk. If you are or will be breast-feeding, check with your doctor or pharmacist to discuss the risk to your baby.
Possible side effects of Alinia:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; headache; nausea; stomach pain.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone pain; fainting; fast heartbeat; severe or persistent dizziness; shortness of breath; unusual tiredness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Alinia:
Store Alinia at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Alinia out of the reach of children and away from pets.
General information:
If you have any questions about Alinia, please talk with your doctor, pharmacist, or other health care provider.
Alinia is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.
Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about Alinia. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
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原产地英文商品名:
ALINIA 500MG/TAB 30TABS/BOTTLE
原产地英文药品名:
NITAZOXANIDE
中文参考商品译名:
ALINIA 500毫克/片 30片/瓶
中文参考药品译名:
硝唑尼特
生产厂家中文参考译名:
ROMARK
生产厂家英文名:
ROMARK
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原产地英文商品名:
ALINIA 200MG/TAB 30TABS/BOTTLE
原产地英文药品名:
NITAZOXANIDE
中文参考商品译名:
ALINIA 200毫克/片 30片/瓶
中文参考药品译名:
硝唑尼特
生产厂家中文参考译名:
ROMARK
生产厂家英文名:
ROMARK
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