싱크로메드(SynchroMed) 약물 주입 시스템에는 한 개의 프로그래밍 가능 펌프와 수술을 통해 복부의 피부 밑에 삽입되는 카테터가 포함됩니다. 이 시스템은 액체 상태의 약물 바클로펜(Lioresal® Intrathecal, 리오레살® 경막내)을 척수 주위의 체액에 직접 전달합니다.
대부분의 사람들이 프로그래밍 펌프가 불편하지 않거나 활동을 제한하지 않으며, 움직이는 데 방해가 되지 않는다고 보고했습니다. 귀하의 체형과 착용하는 복장에 따라 전혀 보이지 않을 수도 있습니다.
바클로펜을 경구로 복용할 때에는 대부분의 약물이 혈류에 남아 있습니다. 용량이 매우 높더라도 소량의 약물만 척수의 작용 부위에 도달합니다. 반면에, 펌프는 액체 상태의 바클로펜을 척수 주위의 체액에 직접 전달합니다. 약물이 필요한 곳에 정확하게 전달되면 필요한 용량이 적어지므로, 경구용 바클로펜에 수반될 수 있는 일부 부작용을 최소화하는 데 도움이 될 수 있습니다.
메드트로닉 ITB 요법(바클로펜 펌프)은 귀하의 질환의 일차 원인을 제거하거나 질병을 치유하는 것은 아니지만, 중증 경직 증상을 관리하는 데 도움이 될 수 있으며, 어렵거나 불가능하게 된 일상 활동을 다시 시작하는 데 도움이 될 수 있습니다.
메드트로닉 ITB 요법(바클로펜 펌프)의 적합한 후보자는 다음 조건을 충족해야 합니다:
또한, 의료 전문가는 귀하가 ITB 요법에 적합한지 여부를 결정하기 위해 다음 기준을 사용할 수 있습니다:
ITB 요법 경험 공유 프로그램은 ITB 요법을 받은 환자 가운데 자신의 경험을 나눌 수 있는 자원자를 귀하와 연결해 드릴 수 있습니다.
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.
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.