Identifying the first treatment for acute spinal cord injury, federal health officials said Friday that patients who receive the drug methylprednisolone within eight hours of injury recover motor and sensory functions to a dramatically greater extent than other patients do.
The drug, a steroid often used to treat symptoms of shock and to prevent swelling after strokes or surgery, appears to halt deterioration of spinal cord cells and tissue, according to study results announced by the National Institute of Neurological Disorders and Stroke.
Before the study, “the whole field (had) been absolutely dismal, with no hope of improving the fate of the patient,” said Dr. Phanor L. Perot Jr., chairman of the department of surgery of the Yale University School of Medicine and one of the study researchers. “This study gives concrete proof . . . that we can stop the lethal process.”
The study results are to be published in the New England Journal of Medicine next month, but the researchers said they took the unusual step of announcing the findings in advance because of their “immediate effect on a major national public health problem that has been extraordinarily resistant to treatment.”
Depending on the degree of the initial injury, methylprednisolone could determine whether some patients will be wheelchair-bound, said Dr. Michael B. Bracken, professor of epidemiology and public health at the Yale medical school and the study coordinator.
For most patients, however, administration of the drug will allow greater use of muscles or increased sensation that otherwise would be lost, Bracken said, speaking at a press conference sponsored by the national institute, which funded the study.
In a quadriplegic, for example, the drug could mean “the return of function of a hand” or, in a paraplegic, “being able to stand, or move from a wheelchair to a chair or to a vehicle without help,” where assistance would otherwise be needed, he said.
The improvement varies with the severity of the injury, “but all patients benefit,” Bracken said.
Because methylprednisolone was found to be effective only during the first eight hours after an injury, early treatment with the drug is critical, the researchers said.
“Since 95% of patients with acute spinal cord injury are admitted to a hospital within eight hours, almost all of them could benefit from this therapy,” Bracken said, adding that researchers hope the drug eventually will be administered by paramedics in ambulances or “at roadside, if possible.”
About 10,000 spinal cord injuries occur every year. Two-thirds involve people under the age of 30, and most result from automobile accidents, according to the institute. Survivors often are permanently disabled and face a lifetime of specialized care and rehabilitation.
The cost to the federal government of such care and services now exceeds $4 billion a year, the institute said.
In most cases, the spinal cord is not severed in an accident but is crushed or bruised, the institute said. In the hours following the injury, the body responds with a series of physiological changes that worsen the damage.
First, the spinal cord swells, and the blood supply is reduced sharply in the damaged area, depriving cells of needed nutrients. As a result, nerve cells die, producing a gap in the cord, with scar tissue forming on either side of the gap.
Generally, the higher the injury, the greater the disability, the institute said. For example, an injury to the cord at the neck level could affect both arms and legs, while a trauma at the chest level could affect the legs and lower part of the body.
Since 1977, researchers at 10 medical centers, including UC San Diego and UC Davis, have been studying different drug regimens in an attempt to determine if any would improve long-term neurological recovery in patients with acute spinal cord injury.
The study to be published next month compared 162 patients treated with methylprednisolone with 154 patients who received naloxone, another drug, and 171 patients who received a placebo, or a medically worthless drug. Motor and sensory functions were evaluated on admission, again after six weeks and after six months.
Patients who received methylprednisolone within eight hours showed “significant improvement” in both muscle function and pin prick and touch sensation, compared to the other groups at each assessment, researchers said.
Further, the recovery was sustained throughout the six-month period, they said. The drug was not effective when given more than eight hours after the injury.
Researchers said they were still evaluating patients’ progress after one year and could not comment on those results.
The researchers said the drug dosage was important. The study used an initial intravenous infusion of 30 milligrams of the drug for every kilogram (about 2.2 pounds) of patient weight, followed by an additional 5.4 milligrams of drug per kilogram of body weight every hour for the next 23 hours.
The treatment costs about $300, which researchers described as “a very low price.”
The institute has established a toll-free number that physicians can call this weekend for additional information: 1-800-633-3425. Next week, calls will be taken at 301-496-5751 during regular business hours, the institute said.
TREATING SPINAL CORD INJURIES
Treating patients with the drug methylprednisolone within eight hours of damage to the spinal cord can significantly reduce subsequent disability, the New England Journal of Medicine will report. Highlights:
Rate of occurrence: About 10,000 Americans each year suffer an acute spinal cord injury that causes paralysis. Most injuries occur in men under age 30 and most are caused by automobile accidents.
How it works: The drug probably works by procecting spinal cord cells from disintegration known to occur in the hours following injury, and perhaps by improving blood flow to the area of injury.
The cost: The drug costs about $300 to treat one patient
The manufacturer: It is marketed by Elkins-Sinn Inc., a subsidary of American Home Products Co.'s A. H. Robins Co. unit.