Retrospective analysis of cervical corpectomies: implant-related complications of one- and two-level corpectomies in 45 patients.

Cervical corpectomies are increasingly used to treat degenerative, metastatic, inflammatory and traumatic multisegmental diseases. The postoperative results are thought to correlate mainly with the number of resected vertebral bodies. Thus, the aim of the study was to analyse complications and early outcome of these procedures to document the implant-related complications in order to set up a prospective clinical trial. Forty-five patients, who were treated in our department from 2011 to 2014 and who were available for a minimum follow-up of 1 year, were consecutively included in this retrospective evaluation. The median age was 61 (±11) years with a female to male sex ratio of 19 to 26, respectively. In these patients, cervical corpectomies (one-, two- and three-level procedures) were performed. The average number of resected levels was 1.2 levels. The intraoperative loss of blood (LOB), the red cell transfusions (rcT), the length of operation (LOO) and the usage of drains were investigated and correlated with intra- and postoperative complications. The mean LOO was 244 min (±68) with a mean LOB of 511 ml (±531). The overall complication rate was 22.9% (10 patients). Six patients (13.3%) had implant-related complications due to loosening and toggling of the screws and/or cage subsidence. Two patients (4.4%) had a postoperative haematoma and another two patients (4.4%) suffered from neurological deterioration due to an ongoing and severe myelopathic syndrome. All these patients received revision surgery. The average time from the first to revision surgery was 90 days. Cervical corpectomies still remain procedures with a high complication rate mainly represented by implant-related failures. These implant-related complications range from screw/plate loosening or toggling to graft dislocation with subsidence and might be associated with constructs extended to the C7 vertebral body. In our study population, the rate of implant failure was comparable to the literature, but not obviously correlated with the number of vertebral bodies resected. This may be attributed to the different disease entities. Thus, our results support the use of circumferential approaches for selected instability scenarios (metastatic or inflammatory diseases, kyphosis, osteoporosis, etc.) of one- and two-level corpectomies.

Consistency of response to sumatriptan/naproxen sodium in a placebo-controlled, crossover study.

Two identical randomized, placebo-controlled, crossover studies were conducted to evaluate consistency of response to sumatriptan/naproxen sodium 85/500 mg (S/NS) over four attacks in adults with migraine. Patients were instructed to treat within 1 h of pain onset while pain was mild. Co-primary end-points were pain-free response at 2 h (2hPF) and 24-h sustained pain-free response (24hSPF) calculated as percentages of all attacks. In Study 1, 570 patients treated 1693 attacks with S/NS and 424 with placebo. In Study 2, 565 patients treated 1678 attacks with S/NS and 422 with placebo. Compared with placebo, S/NS conferred higher 2hPF rates (Study 1: S/NS 52%, placebo 25%; Study 2: S/NS 50%, placebo 20%; both P < 0.001) and higher 24hSPF rates (Study 1: S/NS 37%, placebo 17%; Study 2: S/NS 34%, placebo 12%; both P < 0.001). 2hPF was reported in at least two of the first three S/NS-treated attacks in 55.0% of patients in Study 1 and 52.1% of patients in Study 2. 24hSPF was reported in at least two of the first three S/NS-treated attacks in 35.7% of patients in Study 1 and 32.6% of patients in Study 2. The incidences of any adverse event and of specific adverse events were low and generally similar between S/NS and placebo.

Multimechanistic (sumatriptan-naproxen) early intervention for the acute treatment of migraine.

BACKGROUND: Research suggests treating a migraine at the first sign of pain increases the likelihood of the best clinical outcome. OBJECTIVE: To investigate the efficacy and tolerability of a fixed-dose, single-tablet formulation of sumatriptan 85 mg, formulated with RT Technology, and naproxen sodium 500 mg (sumatriptan/naproxen) as early intervention acute therapy for migraine. METHODS: Patients (aged 18 to 65 years) with International Headache Society-defined migraine with or without aura were enrolled in one of two identically designed, randomized, double-blind, parallel group, placebo-controlled studies. Patients treated a single migraine within 1 hour of onset of migraine head pain and while the pain was mild with either sumatriptan/naproxen or placebo. The primary efficacy measure was the percentage of patients who became pain-free 2 hours postdose. RESULTS: Intent-to-treat analyses consisted of 576 and 535 migraineurs. At 2 hours, 52% and 51% of sumatriptan/naproxen-treated patients were pain free, as compared to 17% and 15% of placebo-treated patients (p < 0.001). Significant pain-free responses in favor of sumatriptan/naproxen were demonstrated as early as 30 minutes, maintained at 1 hour, and sustained from 2 to 24 hours. At 2 and 4 hours, sumatriptan/naproxen provided significantly lower rates of traditional migraine-associated symptoms (nausea, photophobia, and phonophobia) and nontraditional migraine-associated symptoms (neck pain/discomfort and sinus pain/pressure). The most commonly reported adverse events were nausea (< or =4%) and dizziness (< or =2%). CONCLUSION: The fixed-dose single-tablet formulation of sumatriptan/naproxen was effective and well tolerated in an early intervention paradigm for the acute treatment of migraine, including traditional and nontraditional symptoms.