Fowler, John R.

Abstract RATIONALE: 4G4G/4G5G SERPINE1 genotypes produce high concentrations of plasminogen activator inhibitor-1 and are associated with worse asthma outcomes. A secondary analysis of the American Lung Association (ALA) SOYA trial showed that soy isoflavones significantly reduced asthma exacerbations versus placebo among patients with 4G4G/4G5G SERPINE1 genotypes. We hypothesized that baseline characteristics predict optimal responders to soy isoflavones among this subgroup. METHODS: ALA-SOYA was a randomized controlled trial that tested the efficacy of soy isoflavones vs. placebo for reducing asthma exacerbations among adolescents and adults with symptomatic asthma. In this responder analysis among participants with 4G4G/4G5G SERPINE1 genotypes, baseline demographic and clinical characteristics were tested for effect modification of the treatment assignment (soy/placebo) on the primary outcome of annualized number of asthma exacerbations using interaction terms in negative binomial regression models, with a significance threshold of p-interaction=0.15. RESULTS: Data were available for n=168 participants. Soy reduced the annualized number of asthma exacerbations relative to placebo among patients with 4G4G/4G5G SERPINE1 genotypes (incident rate ratio (IRR)=0.37, 95% confidence interval (CI): 0.15-0.90, p=0.028). Self-reported adherence to baseline controller therapy was the only significant effect modifier of this association (interaction p=0.115), with those using inhaled corticosteroid (ICS)/long-acting beta-agonist (LABA) controller therapy at least twice weekly experiencing reductions in asthma exacerbations with soy versus placebo (IRR = 0.25, 95% CI: 0.09-0.69; p= 0.007) but not among those using ICS/LABA controller therapy less frequently (IRR = 1.33, 95% CI: 0.22-8.02; p= 0.757). CONCLUSION: Soy isoflavones reduce asthma exacerbations among patients with the 4G4G/4G5G SERPINE1 genotypes and are most effective in those with greater adherence to asthma controller therapy regimens.

AimsThe purpose was to evaluate early clinical, patient-reported, and radiological outcomes of the scapholunate ligament 360° tenodesis (SL 360) technique for treatment of scapholunate (SL) instability.MethodsWe studied the results of nine patients (eight males and one female with a mean age of 44.7 years (26 to 55)) who underwent the SL 360 procedure for reducible SL instability between January 2016 and June 2019, and who were identified from retrospective review of electronic medical records. Final follow-up of any kind was a mean of 33.7 months (12.0 to 51.3). Clinical, radiological, and patient-reported outcome data included visual analogue scale (VAS) for pain, Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH), Mayo Wrist Score (MWS), and Patient-Rated Wrist Examination (PRWE). Means were analyzed using paired t-test.ResultsBefore surgery, patients with SL instability were significantly impaired with respect to wrist flexion, extension, and grip strength (mean flexion, 51° (20° to 85°) vs 73° (45° to 90°); mean extension, 46° (15° to 70°) vs 66° (45° to 80°); mean grip strength, 25 kg (20 to 31) vs 50 kg (35 to 68) compared to the unaffected side). The mean SL gap (4.9 mm (2.3 to 7.3) vs 2.1 mm (1.6 to 2.9)) and mean SL angle (71° (59° to 105°) vs 50° (38° to 64°) were also significantly greater in the affected wrist. At final follow-up, there was mean improvement regarding clinical, radiological, and functional outcomes comparing preoperative to final postoperative values for the VAS for pain scale, QuickDASH, MWS, PRWE, and SL gap and SL angle.ConclusionIn our small series, the SL 360 procedure for reducible SL instability has favourable early clinical, patient-reported, and radiological outcomes at a mean of 33.7 months (12.0 to 51.3). The suture tape and tendon construct confers robust stability, permitting earlier mobilization without the inherent disadvantages of Kirschner wire stabilization. Cite this article: Bone Joint J 2021;103-B(5):939–945.