| 德国默克公司近日宣布，多发性硬化症治疗药Cladribine的口服制剂在III期临床实验中表现良好，为期两年的实验中，该药在减少病情复发率上达到主要临床终点。
此次实验为期2年，属随机双盲安慰剂对照国际性临床实验。参加实验的受试者共1326人，均为复发型多发性硬化症患者。
在实验过程中，Cladribine受试者被分成两组，分别用不同剂量的药物进行治疗并观察其效果，最后发现与安慰剂相对比，它们均可以有效降低病情复发率，其中低剂量Cladribine受试组病情复发率降低58%，高剂量Cladribine受试组复发率降低55%。
此外，该药在实验中还达到了次要终点，包括病变部位损伤程度降低（通过磁共振成像技术检测），病情无复发率增加和身体伤残率减少等。
在治疗过程中，Cladribine片剂受试组中出现的不良反应病例极少，与安慰剂对照组相当，但使用该片剂治疗的受试者出现淋巴球减少症的比例高一些。
 
Chemical formula:
Cladribine Solution for injection
What is this medicine?
CLADRIBINE (KLA dri been) is a chemotherapy drug. This medicine reduces the growth of cancer cells and can suppress the immune system. It is used for treating leukemias.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
•bleeding problems
•infection (especially a virus infection such as chickenpox, cold sores, or herpes)
•kidney disease
•liver disease
•an unusual or allergic reaction to cladribine, benzyl alcohol, other medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding
How should I use this medicine?
This drug is given as an infusion into a vein. It is administered in a hospital or clinic by a specially trained health care professional.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you use two or more doses per day, use the missed dose as soon as you remember. If it is nearly time for the next dose, skip the missed dose and resume your regular schedule with the next dose. Do not use double doses.
If you use one dose per day, use the missed dose as soon as you remember on the day the dose was due. If you do not remember until the next day, skip the missed dose and resume your regular schedule with the next dose. Do not use double doses.
What may interact with this medicine?
•vaccines
Talk to your doctor or health care professional before taking any of these medicines:
•acetaminophen
•aspirin
•ibuprofen
•naproxen
•ketoprofen
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.
In some cases, you may be given additional medicines to help with side effects. Follow all directions for their use.
Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.
This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.
Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.
Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.
Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.
If you are a man, you should not father a child while receiving treatment.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
•low blood counts - This drug may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.
•signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
•signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, nosebleeds
•signs of decreased red blood cells - unusually weak or tired, fainting spells, lightheadedness
•abdominal pain
•breathing problems
•dizziness
•mouth sores
•trouble passing urine or change in the amount of urine
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
•diarrhea
•headache
•loss of appetite
•nausea, vomiting
•pain or redness at the injection site
•weak or tired
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
This drug is given in a hospital or clinic and will not be stored at home.
Last updated: 7/1/2002 | 
