No beneficial effect of intrathecal methylprednisolone acetate in postherpetic neuralgia patients.

BACKGROUND: High efficacy of intrathecal methylprednisolone acetate (MPA) with lidocaine has been reported in a large patient group suffering from intractable postherpetic neuralgia (PHN). Because the treatment effect was never independently confirmed and there are ongoing safety concerns, intrathecal MPA did not become standard care for intractable PHN. We report the results of a replication trial assessing pain relief and spinal cytokine/chemokine levels in PHN patients. METHODS: The number of patients to be included was determined using sequential analysis to limit patient exposure to the invasive experimental treatment. Patients were randomized to the treatment group receiving MPA 60 mg + lidocaine 60 mg or control group receiving lidocaine 60 mg only. Four injections at 7-day intervals were administered after cerebrospinal fluid (CSF) collection to measure cytokine/chemokine levels. Visual analogue scores for pain and the square allodynic area were collected during follow-up, with the primary end point set at 8 weeks follow-up. RESULTS: In total, 10 patients were included, of whom six were randomized to the treatment group. All six MPA-treated patients experienced a pain increase at 8 weeks, versus one of four patients in the control group. The square allodynic area increased in four of six MPA-treated patients versus one of four control patients. CSF interleukin-8 levels remained stable in the control group, but increased significantly after the first intrathecal MPA injection. The trial was stopped because of safety concerns and futility. CONCLUSION: Considering the absence of clinical benefits and the potential risks of the treatment, intrathecal administration of MPA is not recommended.

[Risk of infection due to contamination of medicines]. / Infectierisico's door contaminatie van geneesmiddelen.

After minor surgery in a hospital, 7 patients suffered serious infectious complications. Microbiological analysis revealed an infection caused by contamination of the intravenous anaesthetic propofol. Several studies have shown that the administration of intravenous medication is a risky process that is prone to errors; these errors can result in harm to the patient. Within the Dutch project 'Safe medical care', the intravenous administration of medication has been chosen as one of the ten most important areas in which to patient safety can be improved. To enhance patient safety it is important to identify the separate steps that are the most prone to error, based on a good risk analysis. A systematic and coordinated approach is crucial for success in this process.