ABSTRACT
BACKGROUND: The risk of instability, dislocation, and revision following total hip arthroplasty (THA) is increased in patients with abnormal spinopelvic mobility. Seated and standing lateral lumbar spine imaging can identify patients with stiff/hypermobile spine (SHS) to guide interventions such as changes in acetabular cup placement or use of a dual-mobility hip construct aimed at reducing dislocation risk. METHODS: A Markov decision model was created to compare routine preoperative spinal imaging (PSI) to no screening in patients with and without SHS. Screened patients with SHS were assumed to receive dual-mobility hardware while those without SHS and nonscreened patients were assumed to receive conventional THA. Cost-effectiveness was determined by estimating the incremental cost-effectiveness ratio. Effectiveness measured as quality-adjusted life years (QALYs), with $100,000 per additional QALY as the threshold for cost-effectiveness. Sensitivity analyses were performed to determine the robustness of the base-case result. RESULTS: The screening strategy with PSI had a lifetime cost of $12,515 and QALY gains of 16.91 compared with no-screening ($13,331 and 16.77). The PSI strategy reached cost-effectiveness at 5 years and was dominant (ie, less costly and more effective) at 11 years following THA. In sensitivity analyses, PSI remained the dominant strategy if prevalence of SHS was >1.9%, the cost of PSI was <$925, and the cost of dual-mobility hardware exceeded the cost of conventional hardware by <$2850. CONCLUSION: Screening patients for SHS prior to THA with PSI is both less costly and more effective and should be considered as part of standard presurgical workup.
Subject(s)
Arthroplasty, Replacement, Hip , Acetabulum/surgery , Arthroplasty, Replacement, Hip/adverse effects , Cost-Benefit Analysis , Humans , Quality-Adjusted Life Years , SpineABSTRACT
Recombinant granulocyte colony-stimulating factor (G-CSF) protein produced in Escherichia coli has been widely used for the treatment of neutropenia induced by chemotherapy for decades. In E. coli cells, G-CSF is usually expressed as inactive inclusion bodies, which requires costly and inefficient denaturation and refolding steps to obtain the protein in its active form. However, following the findings of previous studies, we here successfully produced G-CSF in E. coli as non-classical inclusion bodies (ncIBs), which contained likely correctly folded protein. The ncIBs were easily dissolved in 0.2% N-lauroylsarcosine solution and then directly applied to a Ni-NTA affinity chromatography column to get G-CSF with high purity (> 90%). The obtained G-CSF was demonstrated to have a similar bioactivity with the well-known G-CSF containing product Neupogen (Amgen, Switzerland). Our finding clearly verified that the G-CSF production from ncIBs is a feasible approach to improve the yield and lower the cost of G-CSF manufacturing process.
Subject(s)
Escherichia coli/genetics , Gene Expression , Granulocyte Colony-Stimulating Factor/genetics , Granulocyte Colony-Stimulating Factor/metabolism , Inclusion Bodies/metabolism , Escherichia coli/chemistry , Escherichia coli/metabolism , Granulocyte Colony-Stimulating Factor/chemistry , Granulocyte Colony-Stimulating Factor/pharmacology , Humans , Inclusion Bodies/chemistry , Inclusion Bodies/genetics , Protein Folding , Recombinant Proteins/chemistry , Recombinant Proteins/genetics , Recombinant Proteins/metabolism , Recombinant Proteins/pharmacologyABSTRACT
OBJECTIVE: To assess the effectiveness of supreme laryngeal mask airway (SLMA) over face mask ventilation for preventing need for endotracheal intubation at birth. STUDY DESIGN: We report a prospective, randomized, parallel 1:1, unblinded, controlled trial. After a short-term educational intervention on SLMA use, infants ≥34-week gestation and/or expected birth weight ≥1500 g requiring positive pressure ventilation (PPV) at birth were randomized to resuscitation by SLMA or face mask. The primary outcome was the success rate of the resuscitation devices (SLMA or face mask) defined as the achievement of an effective PPV preventing the need for endotracheal intubation. RESULTS: We enrolled 142 patients (71 in SLMA and 71 in face mask group, respectively). Successful resuscitation rate was significantly higher with the SLMA compared with face mask ventilation (91.5% vs 78.9%; P = .03). Apgar score at 5 minutes was significantly higher in SLMA than in face mask group (P = .02). Neonatal intensive care unit admission rate was significantly lower in SLMA than in face mask group (P = .02). No complications related to the procedure occurred. CONCLUSIONS: In newborns with gestational age ≥34 weeks and/or expected birth weight ≥1500 g needing PPV at birth, the SLMA is more effective than face mask to prevent endotracheal intubation. The SLMA is effective in clinical practice after a short-term educational intervention. TRIAL REGISTRATION: Registered with ClinicalTrials.gov: NCT01963936.