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Eugene S. Flamm, Wise Young, William F. Collins, Joseph Piepmeier, Guy L. Clifton and Boguslav Fischer

✓ Results of a Phase I trial of the opiate antagonist naloxone for treatment of patients with acute spinal cord injury are reported. Naloxone was administered in doses ranging from 5 to 200 mg/sq m (0.14 to 5.4 mg/kg) for up to 48 hours. The patients ranged in age from 16 to 79 years (mean 37 years). Twenty patients received naloxone as a loading dose of 5 to 50 mg/sq m (0.14 to 1.43 mg/kg), followed by a maintenance dose of 20% of the loading dose given as a continuous infusion hourly for 47 hours (Group 1). Nine patients received a loading dose of 100 to 200 mg/sq m (2.7 to 5.4 mg/kg) and a maintenance dose of 75% of the initial dose hourly for 23 hours (Group 2). These higher doses (2.7 to 5.4 mg/kg) have been found to be effective in experimental spinal cord injury. Neurological examinations were performed and somatosensory evoked potentials (SEP's) were obtained as soon after admission as possible and again 1, 2, 3, and 7 days, 3 weeks, and 6 weeks to 6 months after admission.

The 20 Group 1 patients who received 1.43 mg/kg or less of naloxone showed no improvement in neurological status or SEP's. All but three (15%) of these patients had a complete neurological deficit at the time of admission. Treatment was begun an average of 12.9 hours after injury. Among the nine Group 2 patients treated with 2.7 mg/kg or more, there were five patients (56%) with incomplete deficits. This group received naloxone an average of 6.6 hours after admission. Two of the five Group 2 patients with incomplete lesions showed improvement in their neurological condition and/or SEP's within 36 hours of receiving the drug. One of the four Group 2 patients with a complete lesion at the time of admission was able to localize pressure sensation in his legs 36 hours after completion of the drug infusion. Four Group 2 patients (two with complete and two with incomplete lesions) have shown improvement in their SEP's, suggesting recovery of SEP's in a dose-related fashion. Four patients experienced increased pain after administration of the loading dose and during the maintenance infusion; in only one patient was this severe enough to require discontinuation of the drug. Of the 29 patients treated with naloxone, four died within 6 weeks of admission, for a mortality rate of 13.8%.

This study demonstrates that, in spinal cord-injured patients, naloxone given as an intravenous loading dose of 200 mg/sq m, followed by a continuous infusion of up to 150 mg/sq m/hr for 23 hours, has minimal side effects. The observed improvement in the clinical examination and SEP's at the higher doses, while not statistically verified in this Phase I trial, is encouraging.

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Thomas A. Duff, Ernest Borden, Janet Bay, Joseph Piepmeier and Karen Sielaff

✓ Twelve patients were admitted to a Phase II study on the treatment of recurrent glioblastoma multiforme with interferon-β (IFN-β). All patients had previously undergone craniotomy and received a standard course of radiation therapy. Recurrence was inferred from enlargement of the lesion on computerized tomography (CT) scanning and in each case was confirmed by CT-guided stereotaxic biopsy. Treatment consisted of combined intravenous (10 × 106 IU/day) and intratumoral (1 × 106 IU every other day) administration of IFN-β over three 10-day cycles. This regimen was well tolerated, with toxicity requiring temporary dose modifications in five patients. As judged from data from historical cases, however, the patients admitted to this study demonstrated no clear improvement in mean survival time. The findings of this study also emphasize the importance of distinguishing between radiation necrosis and tumor recurrence.

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Joseph M. Piepmeier

✓ The records of 60 patients with low-grade astrocytic tumors of the cerebral hemispheres treated between 1975 and 1985 were examined to evaluate the results of current treatment methods. This analysis revealed that the patient's age and tumor enhancement on computerized tomography (CT) with intravenous administration of contrast material were the only factors that influenced survival time. Compared to prior studies, the patients in this report more frequently had normal preoperative neurological examinations and total resection of their lesions. These differences may have resulted from the use of CT scans over the past decade. Earlier diagnosis and improvement definition of the tumor location and extent are two reasons why the use of CT scans may have affected outcome statistics. A re-examination of treatment methods and the timing of those treatments is needed to define the optimal management of these lesions.

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Thierry J. Hufnagel, Carlos Artiles, Joseph Piepmeier, Leon Kier and Jung H. Kim

✓ Desmoplastic fibroma is a distinctive and rare neoplasm of bone. Only one previous example has been reported in the calvaria. The diagnostic and surgical aspects of a case of desmoplastic fibroma of the skull that radiographically simulated eosinophilic granuloma are reported.

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Lee L. Thibodeau, Aurelio Ariza and Joseph M. Piepmeier

✓ This report describes a case of primary leptomeningeal sarcomatosis in a 50-year-old man who presented with progressive deficits involving multiple cranial nerves and spinal roots. Despite the clinical evidence supporting a diffuse process involving the leptomeninges, radiological, serological, and cerebrospinal fluid examinations failed to reveal the cause of the disorder. Consequently, surgical exploration and biopsy were required to obtain a pathological diagnosis. This case report illustrates the difficulty in diagnosing this disease and supports the use of open biopsy in patients with chronic meningeal disease when the diagnosis cannot be established by less invasive methods.

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Joseph M. Piepmeier and N. Ross Jenkins

✓ Sixty-nine patients with traumatic spinal cord injuries were evaluated for changes in their functional neurological status at discharge from the hospital, and at 1 year, 3 years, and 5+ years following injury. The neurological examinations were used to classify patients' spinal cord injury according to the Frankel scale. This analysis revealed that the majority of improvement in neurological function occurred within the 1st year following injury; however, changes in the patients' status continued for many years. Follow-up examinations at an average of 3 years postinjury revealed that 23.3% of the patients continued to improve, whereas 7.1% had deteriorated compared to their status at 1 year. An examination at an average of 5+ years demonstrated further improvement in 12.5%, with 5.0% showing deterioration compared to the examinations at 3 years. These results demonstrate that, in patients with spinal trauma, significant changes in neurological function continue for many years.

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Methylprednisolone or naloxone treatment after acute spinal cord injury: 1-year follow-up data

Results of the second National Acute Spinal Cord Injury Study

Michael B. Bracken, Mary Jo Shepard, William F. Collins Jr., Theodore R. Holford, David S. Baskin, Howard M. Eisenberg, Eugene Flamm, Linda Leo-Summers, Joseph C. Maroon, Lawrence F. Marshall, Phanor L. Perot Jr., Joseph Piepmeier, Volker K. H. Sonntag, Franklin C. Wagner Jr., James L. Wilberger, H. Richard Winn and Wise Young

✓ The 1-year follow-up data of a multicenter randomized controlled trial of methylprednisolone (30 mg/kg bolus and 5.4 mg/kg/hr for 23 hours) or naloxone (5.4 mg/kg bolus and 4.0 mg/kg/hr for 23 hours) treatment for acute spinal cord injury are reported and compared with placebo results. In patients treated with methylprednisolone within 8 hours of injury, increased recovery of neurological function was seen at 6 weeks and at 6 months and continued to be observed 1 year after injury. For motor function, this difference was statistically significant (p = 0.030), and was found in patients with total sensory and motor loss in the emergency room (p = 0.019) and in those with some preservation of motor and sensory function (p = 0.024). Naloxone-treated patients did not show significantly greater recovery. Patients treated after 8 hours of injury recovered less motor function if receiving methylprednisolone (p = 0.08) or naloxone (p = 0.10) as compared with those given placebo. Complication and mortality rates were similar in either group of treated patients as compared with the placebo group. The authors conclude that treatment with the study dose of methylprednisolone is indicated for acute spinal cord trauma, but only if it can be started within 8 hours of injury.

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Methylprednisolone or tirilazad mesylate administration after acute spinal cord injury: 1-year follow up

Results of the third National Acute Spinal Cord Injury randomized controlled trial

Michael B. Bracken, Mary Jo Shepard, Theodore R. Holford, Linda Leo-Summers, E. Francois Aldrich, Mahmood Fazl, Michael G. Fehlings, Daniel L. Herr, Patrick W. Hitchon, Lawrence F. Marshall, Russ P. Nockels, Valentine Pascale, Phanor L. Perot Jr., Joseph Piepmeier, Volker K. H. Sonntag, Franklin Wagner, Jack E. Wilberger, H. Richard Winn and Wise Young

Object

A randomized double-blind clinical trial was conducted to compare neurological and functional recovery and morbidity and mortality rates 1 year after acute spinal cord injury in patients who had received a standard 24-hour methylprednisolone regimen (24MP) with those in whom an identical MP regimen had been delivered for 48 hours (48MP) or those who had received a 48-hour tirilazad mesylate (48TM) regimen.

Methods

Patients for whom treatment was initiated within 3 hours of injury showed equal neurological and functional recovery in all three treatment groups. Patients for whom treatment was delayed more than 3 hours experienced diminished motor function recovery in the 24MP group, but those in the 48MP group showed greater 1-year motor recovery (recovery scores of 13.7 and 19, respectively, p = 0.053).A greater percentage of patients improving three or more neurological grades was also observed in the 48MP group (p = 0.073). In general, patients treated with 48TM recovered equally when compared with those who received 24MP treatments. A corresponding recovery in self care and sphincter control was seen but was not statistically significant. Mortality and morbidity rates at 1 year were similar in all groups.

Conclusions

For patients in whom MP therapy is initiated within 3 hours of injury, 24-hour maintenance is appropriate. Patients starting therapy 3 to 8 hours after injury should be maintained on the regimen for 48 hours unless there are complicating medical factors.