AbstractIntroductionSpinal cord stimulators (SCS) are used to treat various chronic pain states. Establishing patient outcomes in terms of pain control, opioid medication use, and overall satisfaction is vital in maintaining SCS's role in clinical practice.MethodsAll patients who underwent SCS implantation between January 2001 and December 2011 at a tertiary academic pain medicine center were included if he or she underwent permanent cervical or thoracolumbar dorsal column SCS implantation and age was 18 or greater. For the 199 patients who met inclusion criteria, data were collected retrospectively. Preimplant information included indication for implantation, Numeric Rating Scale (NRS) score, and dose in oral morphine equivalents (OME). Postimplant NRS score was recorded at 6 months and 1 year. OME requirement and patient satisfaction were determined at 1 year postimplantation.ResultsThis data set showed an overall decrease in OME requirements and NRS scores at both 6 months and 1 year. These differences were statistically significant (P < 0.01) compared to preimplantation values. Additionally, 84.27% of patients were satisfied with their implants at 1 year. Patient outcomes were analyzed further in respect to implant indication; groups included failed back surgery syndrome (FBSS), complex regional pain syndrome (CRPS), angina, and other. For all groups, there were statistically significant (P < 0.01) decreases in NRS scores at 6 months and 1 year. In the FBSS and CRPS groups, statistically significant (P < 0.02) decreases in OME usage existed.ConclusionRetrospective review of patients with spinal cord stimulators revealed OME reduction at 1 year for those patients in the FBSS and CRPS groups; patient satisfaction at 1 year and NRS score reduction at 6 months and 1 year were statistically significant for all groups.
Tricyclic antidepressant use and risk of fractures: A meta-analysis of cohort and case-control studies
Purpose To determine the maximum tolerated dose, toxicity, and pharmacokinetics of gemcitabine in children with refractory solid tumors. Patients and Methods Gemcitabine was given as a 30-minute infusion for 2 or 3 consecutive weeks every 4 weeks, to 42 patients aged 1 to 21 years. Doses of 1,000, 1,200 and 1,500 mg/m2 were administered for 3 weeks. Subsequently, gemcitabine was given for only 2 consecutive weeks at 1,500, 1,800, and 2,100 mg/m2. Plasma concentrations of gemcitabine and its metabolite, 2′2′-difluorodeoxyuridine, were measured in 28 patients. Results Forty patients who received 132 courses of gemcitabine were assessable for toxicity. The maximum tolerated dose of gemcitabine given weekly for 3 weeks was 1,200 mg/m2. Dose-limiting toxicity was not seen in one-third of children treated at any doses given for 2 weeks. The major toxicity was myelosuppression in three of five patients at 1,500 mg/m2 for 3 weeks, and one of seven patients at 1,800 mg/m2 for 2 weeks. Other serious adverse events were somnolence, fever and hypotension, and rash in three patients. Gemcitabine plasma concentration–time data were fit to a one- (n = 5) or two-compartment (n = 23) open model. Mean gemcitabine clearance and half-life values were 2,140 mL/min/m2 and 13.7 minutes, respectively. One patient with pancreatic cancer had a partial response. Seven patients had stable disease for 2 to 17 months. Conclusion Gemcitabine given by 30-minute infusion for 2 or 3 consecutive weeks every 4 weeks was tolerated well by children at doses of 2,100 mg/m2 and 1,200 mg/m2, respectively.