Martes 13 de Mayo 2014

Hola.

El 23 de Abril pasado la FDA emite un comunicado acerca de la seguridad de los  medicamentos usados en la inyección peridural de esteroides, procedimiento realizado en forma muy frecuente en el mundo entero  y en nuestra intitución, que no es la excepción, con cerca de 800 procedimientos por año .

El comunicado lo puede ver aquí 

En mi opinión,  en una forma coincidencial, un grupo de médicos holandeses, publica en mayo de este año un artículo acerca de los esteroides, con énfasis en su administración intratecal.   No olviden que cada vez que administramos un esteroide peridural, potencialmente lo podemos estar colocando en forma inadvertida intratecal con las consecuencias ahí descritas. 

Lo que si me gustó del artículo es la explicación detallada de su mecanismo de acción y su papel en el dolor neuropático y de los riesgos que conlleva su administración. 

Con esta información, los invito a que  identifiquen los problemas acá expuestos. 

Revisemos la farmacología y mecanismos de acción

La eficacia de la terapia

Los riesgos y efectos secundarios

Encuentren un estimado del numero de pacientes que son sometidos en el mundo a este tipo de tratamiento para entender así el alcance del comunicado emitido por la FDA

Que debemos hacer de ahora en adelante con este tipo de procedimiento ?

Una opinión importante:

Interventional Pain Medicine

ISSUE: APRIL 2014 | VOLUME: 12(4)

Timothy R. Deer, MD

Charleston, W. Va.

---

R

ecently in my hometown of Charleston, W.Va., we had a chemical leak that contaminated our drinking water. It was a terrible time for more than 300,000 people and led to a period of distrust and confusion about what is safe how we should best care for our families. Should we consider drinking water from the tap, drilling a well, buying a water purifier or other alternative sources?

I see some corollaries as we consider the safe use of steroids in the spine. The water issue for us in the beautiful mountain state is temporary, but unfortunately our time of confusion in pain treatment is constant and always tumultuous. I applaud the American Society of Anesthesiologists and other level-minded individuals for keeping calm and not contributing to fear and misinformation about the proper choice of steroids to treat chronic spinal disorders. As we move forward, we need to consider the picture as a whole and avoid tunnel vision that leads to long-term worsening of patient care.

Clinicians should always keep in mind the risk for a complication with a particulate steroid. But to conclude that similar events cannot occur with local anesthetics or nonparticulate steroids is like hiding under a blanket and hoping the monster under the bed will lumber away into the night. We can agree that safety issues are always the most important things for us to consider as we take our greatest efforts to do no harm and help people who are suffering.

Given an embolism rate of one in 5,000 transforaminal injections with particulate steroids, we cannot conclude that the drug was responsible for the events noted in the reports. In some settings, the events occurred secondary to local anesthetics injected into the cerebrospinal fluid causing cardiovascular collapse or from needles causing vasospasm and limiting blood flow to the spinal cord or brain. In fact, the true number may be much less, with some studies suggesting a rate of closer to one in 20,000 injections. If we further analyze these numbers, we also should consider physician training, use of fluoroscopic guidance and proper needle placement.

In my career, I have been asked to review cases of death and severe complications from steroid injections, oral medications, intrathecal medications, implantable stimulation systems and minimally invasive surgeries. Although these often are in the settings of litigation defense or quality improvement peer review, it is clear to me that any procedure can lead to poor outcomes despite great vigilance on the part of the clinician. To assume a change to use only nonparticulate steroids will make a huge impact on this issue is naive.

Having said that, in the cervical and thoracic spine it is in my opinion advisable to use nonparticulate steroids. The reason behind this recommendation is scientific and is based on the diameter of the feeder vessels in the cervical and thoracic spine. The size of the particles in particulate steroids such as triamcinolone, betamethasone and methylprednisolone can be as large as or larger than the diameter of the radicular or feeder arteries. Because nonparticulate steroids do not have the same diameter and do not aggregate in the lumen, the chance of an embolic event may be reduced. In the lumbar spine this anatomic argument does not appear to hold true, so comments on that issue are presumptive and biased and not based on scientific or clinical knowledge.

We can debate the absolutes of which steroids to use and uphold safety as our measure, but that may only be a portion of the argument to consider. Studies on the efficacy of particulate versus nonparticulate steroids have shown a slightly increased improvement with particulate steroids, but no investigation has looked at the ability to reduce the need for surgery, the reduction in opioid use or the effect on health care resources. If particulate steroids improve the other factors on a long-term basis, it may be that the morbidity and mortality improvement of nonparticulate steroids in the immediate postprocedure analysis is greatly overestimated because of the short-term effects of these drugs compared with agents such as triamcinolone. Reducing the need for opioids, eliminating surgeries and improving function would be major improvements for individual patients, for society and for the socioeconomic quandary that we often encounter in the delivery of health care.

It also should be stated that we should not put all of our eggs in one basket. The notion that physicians can control or completely eliminate complications is simply an illusion. In the past decade, I have attended and participated in meetings at which experts gave the solution for eliminating steroid-induced catastrophes. Live continuous fluoroscopy, safe triangle injection and the use of nonparticulate steroids are a few of those “standards” that have been published in the peer-reviewed literature and discussed at many national and international meetings.

Unfortunately, the placement of a needle under continuous fluoroscopy with nonparticulate steroids in the safe triangle does not completely mitigate the risk. Vasospasm, direct arterial injury and local-induced seizure can still result in patient morbidity and death.

In addition to the debate on particulate versus nonparticulate steroids, we should focus on other important issues. The recent disaster of contaminated compounded steroids causing fungal meningitis, and in some cases death, must lead us to avoid this type of practice in the future. The need to compound steroids should be critically considered because well-established, FDA-regulated companies make these drugs in the usual fashion. In my practice, we have found no need or use for these compounded steroid agents.

We also should focus on the recent escalation of the number of epidural steroid injections performed on patients in the past decade, based on published data by the American Society of Interventional Pain Physicians. The number has increased tremendously and we as a specialty should evaluate the proper selection of patients who undergo these techniques. Procedures that are not indicated should be eliminated, and we should work within our societies to reduce fraud and abuse as well as set standards for training.

Considering these important points, what can we conclude to improve patient care?

In the cervical and thoracic spine, it appears it is advisable to use nonparticulate steroids when doing procedures near the spinal arteries.

Compounding of steroids to inject in the spine is unnecessary, as many manufacturers commonly make sterile products that are subject to all FDA protocols.

Additional studies are needed to compare the long-term efficacy of particulate and nonparticulate steroids when used in the spine. This information will be helpful in allowing us to evaluate the risk–benefit ratio and may lead to changes in practice going forward.

We should mandate proper training for physicians injecting the spine, including the use of fluoroscopic guidance. Nonphysicians lack the training for these types of interventions and should not engage in these techniques. This is a patient safety issue.

To summarize, the use of nonparticulate steroids appears to be warranted in the cervical and thoracic spine when doing interventions near the spinal vessels. In the lumbar spine the risks appear low regardless of the choice of steroid. Future outcomes research to determine the best care is greatly needed, and this may include alternatives to the current therapies.

Mas información :   Que opinan ?

http://youtu.be/QCbzXqrG0ic
http://youtu.be/cPieVQdXP58