NSJ-Spine january 2004

ERCUTANEOUS vertebroplasty enables minimally invasive treatment of both vertebral tumors and compression fractures of the cervical spine. The injection of radiopaque cement across a cervical spine fracture increases the strength and stiffness of the VB and has been shown to provide pain control in up to 90% of patients. Surgical Technique General anesthesia is induced and an endotracheal tube is placed. The patient's neck is oriented in a neutral position. Fluoroscopy is used to identify and demarcate the level of C-4, and the skin on the lateral neck is opened through a 2-cm incision Department of Neurological Surgery, Wayne State University, Detroit, Michigan The authors describe a technique for minimally invasive anterior vertebroplasty for treating metastatic disease of the C-2 vertebra and discuss its application in 2 cases. After a 2-cm lateral neck incision is made, blunt dissection is performed toward the anterior inferior endplate of the C-2 vertebra. An 11-gauge needle is introduced through a tubular sheath and tapped into the inferior endplate of C-2, with biplanar fluoroscopy being performed to confirm position. The needle is subsequently advanced across the fracture line and into the odontoid process. Under fluoroscopic guidance, 2 ml of methylmethacrylate is injected into the odontoid process and vertebral body. This method is advantageous as 1) hyperextension of the neck is not performed, 2) the chance of inadvertent neurovascular or submandibular gland injury is minimized, 3) the possibility of cement leakage is decreased, and 4) hemostasis is better achieved under direct vision

Pharmacokinetics, safety, and tolerability of inhaled remdesivir in healthy participants

Abstract Intravenous remdesivir (RDV) is US Food and Drug Administration–approved for hospitalized and nonhospitalized individuals with coronavirus disease 2019. RDV undergoes intracellular metabolic activation to form the active triphosphate, GS‐443902, and other metabolites. Alternative administration routes, including localized pulmonary delivery, can lower systemic exposure and maximize exposure at the site of action. This study evaluated the pharmacokinetics (PK) and safety of inhaled RDV in healthy adults. This phase Ia, randomized, placebo‐controlled study evaluated inhaled RDV in healthy participants randomized 4:1 to receive RDV or placebo as single doses (4 cohorts) or multiple once‐daily doses (3 cohorts). Doses in cohorts 1–6 were administered as an aerosolized solution for inhalation through a sealed facemask; doses in cohort 7 were administered as an aerosolized solution for inhalation through a mouthpiece. Safety was assessed throughout the study. Seventy‐two participants were enrolled (inhaled RDV, n = 58 and placebo, n = 14). Following single RDV doses, RDV, GS‐704277, and GS‐441524 plasma PK parameters indicated dose‐proportional increases in area under the concentration‐time curve (AUC) extrapolated to infinite time, AUC from time zero to last quantifiable concentration, and maximum observed concentration. Analyte plasma concentrations after multiple RDV doses were consistent with those for single‐dose RDV. Analyte plasma exposures were lower when RDV was administered with a mouthpiece versus a sealed facemask. The most common adverse events included nausea, dizziness, and cough. Single‐ and multiple‐dose inhaled RDV exhibited linear and dose‐proportional plasma PK. Administration of RDV via inhalation was generally safe and well‐tolerated

Compassionate Use of Remdesivir for Patients with Severe Covid-19

Remdesivir, a nucleotide analogue prodrug that inhibits viral RNA polymerases, has shown in vitro activity against SARS-CoV-2

Chimpanzee Adenovirus Vector Ebola Vaccine - Preliminary Report

Background The unprecedented 2014 epidemic of Ebola virus disease (EVD) has prompted an international response to accelerate the availability of a preventive vaccine. A replication-defective recombinant chimpanzee adenovirus type 3-vectored ebolavirus vaccine (cAd3-EBO), encoding the glycoprotein from Zaire and Sudan species that offers protection in the nonhuman primate model, was rapidly advanced into phase 1 clinical evaluation. Methods We conducted a phase 1, dose-escalation, open-label trial of cAd3-EBO. Twenty healthy adults, in sequentially enrolled groups of 10 each, received vaccination intramuscularly in doses of 2×10(10) particle units or 2×10(11) particle units. Primary and secondary end points related to safety and immunogenicity were assessed throughout the first 4 weeks after vaccination. Results In this small study, no safety concerns were identified; however, transient fever developed within 1 day after vaccination in two participants who had received the 2×10(11) particle-unit dose. Glycoprotein-specific antibodies were induced in all 20 participants; the titers were of greater magnitude in the group that received the 2×10(11) particle-unit dose than in the group that received the 2×10(10) particle-unit dose (geometric mean titer against the Zaire antigen, 2037 vs. 331; P=0.001). Glycoprotein-specific T-cell responses were more frequent among those who received the 2x10(11) particle-unit dose than among those who received the 2×10(10) particle-unit dose, with a CD4 response in 10 of 10 participants versus 3 of 10 participants (P=0.004) and a CD8 response in 7 of 10 participants versus 2 of 10 participants (P=0.07). Conclusions Reactogenicity and immune responses to cAd3-EBO vaccine were dose-dependent. At the 2×10(11) particle-unit dose, glycoprotein Zaire-specific antibody responses were in the range reported to be associated with vaccine-induced protective immunity in challenge studies involving nonhuman primates. Clinical trials assessing cAd3-EBO are ongoing. (Funded by the Intramural Research Program of the National Institutes of Health; VRC 207 ClinicalTrials.gov number, NCT02231866 .)