의사와 환자가 환자의 상태에 대해 논의합니다

ITB 요법이란?

중증 경직

ITB TherapySM (수막강내 바클로펜 요법), 또는 Medbronic 바클로펜 펌프는 중증 경직의 증상 중 일부를 완화할 수 있는 치료법입니다.

 

수막강내 바클로펜 요법이란?

펌프가 다른 이유

경직 치료에 일반적인 약물은 바클로펜(baclofen)이라는 근육 완화제입니다. 경구로 복용하는 바클로펜은 많은 사람들에게 효과적이지만 일부에서 쇠약감, 졸음 또는 구역질과 같이 허약성 부작용을 일으킬 수 있습니다.

알약은 혈액에 들어간 필요한 곳(이 경우는 척추)에 도달하기 위해 신체 전체를 통해 이동합니다. 바클로펜 펌프는 약물을 다른 방식으로 전달합니다.

'전동식 이식형 의약품주입펌프'는 필요한 작용 위치에 직접 약물을 전달합니다. 작용 장소로 직접 전달되기 때문에 훨씬 적은 약물이면 충분합니다.1 이 전달 방법은 경구용 바클로펜에서 발생할 수 있는 부작용을 최소화하는 데 도움이 될 수 있습니다.1

펌프의 작동 방식

바클로펜(Baclofen) 펌프는 가는 관을 통해 척추 주위를 흐르는 유체(수막강내)에 정확한 양의 약물을 전달합니다. 외과의사는 복부 피부 바로 밑에 펌프를 삽입합니다. 펌프는 무선으로 프로그래밍되어 적정량의 약물을 적시에 방출합니다. 대부분의 환자들은 펌프가 편안하다고 느끼며 일상적인 움직임을 방해하지 않는다고 말합니다.

바클로펜 펌프 작동 방식

중증 경직 치료를 위해 펌프에서 방출되는 약물을 바클로펜 주사라고 합니다. 바클로펜 성분 주사 브랜드 중 하나는 Lioresal® Intrathecal입니다.

이 치료법은 FDA의 승인을 받았습니다.


참고

1

Penn RD, Savoy SM, Corcos D, et al. Intrathecal baclofen for severe spinal spasticity. N Engl J Med 1989; 320: 1517-1521.


The Medtronic baclofen pump is part of the Synchromed® Infusion System, which delivers the drug called Lioresal® Intrathecal (baclofen injection) for ITB TherapySM, a treatment for severe spasticity. Please read the following important safety information about ITB Therapy.

IMPORTANT SAFETY INFORMATION FOR ITB THERAPY (Intrathecal Baclofen Therapy)

Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious baclofen withdrawal symptoms such as high fever, changed mental status, muscle stiffness, and in rare cases may result in loss of function of many vital organs and death. It is very important that your doctor be called right away if you experience any of the above symptoms.

It is important for you to keep your scheduled refill visits so you don't run out of medication (baclofen) and to know the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; speak with your doctor about this.

People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, brain injury, or spinal cord injury may be candidates for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis, you may be considered for ITB Therapy if oral baclofen has not controlled your spasticity or has resulted in serious side effects that you cannot accept. If you suffered a brain injury due to trauma you must wait until one year after the injury to be considered for ITB Therapy. A trial of ITB Therapy will help to show if ITB Therapy can help you. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small for the implantable pump.

The implanted pump and catheter (tube that delivers the drug from the pump to the fluid around the spinal cord) are placed under the skin during a surgery. Some complications that you may experience with the surgery include infection, meningitis (infection of the lining of the brain and central nervous system), spinal fluid leak, paralysis, headache, swelling, bleeding, and bruising.

The most common and/or serious drug-related side effects of ITB Therapy include loose muscles, sleepiness, upset stomach, vomiting, headaches, and dizziness. Failure of the pump placed under your skin may cause symptoms due to overdose (receiving too much) or underdose (receiving too little) of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, dizziness, respiratory depression (difficulty breathing), hypothermia (lower than normal body temperature), seizures, loss of consciousness, and coma. Once the infusion system (the pump and the catheter) is implanted, possible complications include unintended movement of the catheter or pump within the body or breakdown of the skin over the pump. The catheter could leak, tear, kink, or become disconnected from the pump, resulting in underdose or no baclofen infusion. Symptoms of underdose include an increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early signs of baclofen withdrawal. The pump could stop because the battery has run out or because of a problem with one or more of its inner parts. The pump will sound an alarm when the pump needs to be filled with baclofen, replaced, or if there is a problem with the pump. You or your caregiver should always inform any healthcare personnel that you have an implanted infusion system before any medical or diagnostic procedure such as MRI or diathermy.

For more information, please read the Lioresal® Intrathecal (baclofen injection) Full Prescribing Information and the SynchroMed Infusion System Information.

This therapy is not for everyone. Please contact your doctor. A prescription is required.

Lioresal® is a registered trademark of Medtronic, Inc.

USA Rx Only Rev 0913

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.


Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.