Alessandro Dario

A Benefit-Risk Assessment of Baclofen in Severe Spinal Spasticity

Baclofen is used for treatment of the spasticity of spinal origin that is a common sequela of spinal cord injury and multiple sclerosis; spasticity occurs in about 50% of patients affected by these disorders.In open-label studies of oral baclofen, the drug improved spasticity in 70–87% of patients; additionally, improvement in spasms was reported in 75–96% of patients. In double-blind, crossover, placebo-controlled trials, baclofen was reported to be effective, producing statistically significant improvements in spasticity. Tizanidine is the antispasticity drug that has been most widely compared with oral baclofen; studies have generally found the two drugs to have equivalent efficacy. However, tizanidine has better tolerability, in particular weakness was reported to be occur less frequently with tizanidine than with baclofen.The main adverse effects of oral baclofen include: sedation or somnolence, excessive weakness, vertigo and psychological disturbances. The incidence of adverse effects is reported to range from 10% to 75%. The majority of adverse effects are not severe; most are dose related, transient and/or reversible. The main risks of oral baclofen administration are related to withdrawal: seizures, psychic symptoms and hyperthermia can occur. These symptoms improve after the reintroduction of baclofen, usually without sequelae. When not related to withdrawal; these symptoms mainly present in patients with brain damage and in the elderly. The limited data on baclofen toxicity in patients with renal disease suggest that administration of the drug in these persons may carry an unnecessarily high risk.Intrathecal baclofen is indicated for use in patients with spasticity of spinal origin unresponsive to treatment with maximum doses of oral baclofen, tizanidine and/or dantrolene. The benefits of continuous intrathecal baclofen infusion have been demonstrated: >80% and >65% of patients have improvement in tone and spasms, respectively. The main risks of intrathecal baclofen infusion are symptoms related to overdose or withdrawal; the latter is more important because of the associated severe effects on clinical status and the possibility of death, but it is responsive to rapid treatment. Overdose primarily arises from drug test doses or human error during refill and programming of the pump, and withdrawal most commonly occurs as a result of a problem with the delivery system.Since the adverse consequences do not exceed the benefits of oral and intrathecal baclofen for patients with spinal spasticity, the benefit/risk assessment is favourable.

Treatment of failed back surgery syndrome.

Objectives. To evaluate the long‐term results of different therapies for failed back surgery syndrome (FBSS).

Spinal cord stimulation (SCS) in conjunction with peripheral nerve field stimulation (PNfS) for the treatment of complex pain in failed back surgery syndrome (FBSS).

Background:  Failed back surgery syndrome (FBSS) is a well‐defined pathologic condition observed over many years.

The Infection Risk of Intrathecal Drug Infusion Pumps after Multiple Refill Procedures

The objective of this study was to evaluate the long‐term infection risk from refilling intrathecal drug delivery devices. We studied 25 patients (14 females and 11 males) with intrathecal infusion pumps placed for spasticity (23 patients) and chronic pain (two patients). In this study group there were 890 refill procedures (mean 35.6 ± 20.5; range 8–72 times) performed on an outpatient basis by four different physicians. All refill procedures were performed in a sterile and standardized fashion as suggested by the manufacturer, using manufacturers approved kits for the refills. During the study period, five patients had recurrent infection of the urinary tract and three patients had recurrent infections of the respiratory tract. At the last pump refill of each patient, residual drug, extracted from the pump reservoir, was sent to a laboratory for aerobic and anaerobic cultures. All cultures, in all pumps, were negative for aerobic and anaerobic bacteria. We conclude that periodic refills of intrathecal implanted pumps do not seem to be a risk factor for infection if standard sterile refill procedures are performed. In this study, it was clear that comorbid infections from other parts of the body do not present as a risk for device contamination.

Cytogenetic and ultrastructural study of a pineocytoma case report.

The authors report a case of pineocytoma in a 44-year-old woman suffering from headache, vomiting and Parinaud syndrome. At histopathological examination the neoplasm showed a ill-defined lobulate pattern with some small pineocytomatous rosettes. The electron-microscopy revealed cells of moderate size and oval nuclei with smooth nuclear envelopes; well-developed organelles were found in the, abundant cytoplasm. The chromosome analysis revealed this kariotype: 58–59, XXX, −4, −5, −13, −14, −15, +19. This is the first report of a pineocytoma with ultrastructural and cytogenetic study; it confirms the literature findings of the electron-microscopy, whereas there is partial accordance with the previous cytogenetic studies.

Subependymoma of the spinal cord: case report and review of the literature.

Spinal cord subependymoma is a rare tumour with only 39 reported cases in the literature. The authors report a further case of this neoplasm in a 53 year old man with a progressive paraparesis, paraesthesias of the lower limbs and sphincter disturbance. The tumour was partly removed, without progression 5 years after surgery. After a careful review of the literature, the optimal treatment of this spinal tumour is debated.

The safety of the temozolomide in patients with malignant glioma.

The temozolomide is a promising orally cytotoxic agent used in malignant glioma. The survival curve improvement after drug administration appears to be statistically significant. The review of temozolomide side effects is carried out by search on literature data found on web and is divided on the 4 grades of toxicity according to the National Cancer Institute Common Toxicity Criteria, version 2.0. The adverse effects related with TMZ administration are divided in three categories: myelosuppression, non haematologic toxicity, and infections. The main adverse effect is the myelosuppression that appears to be rather low and reversible as well as the vomiting or nausea. The different schedules of administration are analysed. The frequency of concomitant infections is underlined. In particular, if available, the relationship between temozolomide and other cytotoxic agents or anticonvulsivant drugs is analysed to clarify the possibility of increase of toxicity. The temozolomide is used also in children but the toxicity could be more frequent.

A case of post–traumatic cervicogenic headache treated by cervical cord stimulation

The case of a 26–year–old woman suffering from cervical trauma with disc herniation presenting with arm and neck pain is presented. She underwent cervical discectomy with fusion because the pain did not improve with medical therapies; as the neck pain resumed after surgery, a cervical cord neurostimulator was implanted, with improvement for cervicogenic headache. This report underlines the presence of two pathologies and the relationship between C2 and trigeminal pathways.

Chronic Intrathecal Baclofen Infusion for Spasticity: Relationship between Pump and Host.

Twenty patients with chronic intractable spinal spasticity were implanted with a totally implantable programmable pump for intrathecal administration of baclofen. The objective of this study was to evaluate the relationship between pump and the host. Clinical efficacy of the therapy was evaluated by the Ashworth Scale, the Spasms Frequency Scale, and the Functional Independence Measure (FIM) motor scores. All patients were asked to reply to 10 questions regarding discomfort of their refills, the ease of rehabilitation after therapy, their fear of pump failure and onset of alarm signals, their discomfort due to a metallic foreign body (the pump), the attitude of their relatives and other persons regarding their pump system, whether they would undergo this therapy again, and whether, in the absence of public health insurance, whether they would be willing to pay for their pump and therapy.

Using Peripheral Nerve Stimulation (PNS) to Treat Neuropathic Pain: A Clinical Series

We examined the efficacy of peripheral nerve stimulation (PNS) in treating neuropathic and causalgic pain, with a stimulation system specifically designated for PNS itself.