Purpose NHS Blood and Transplant Tissue and Eye Services provide a serum eye drop (SED) service to patients suffering from severe dry eye syndrome. Currently SED are dispensed using an automatic ...closed filling system (TF) manufactured by Meise Medizintechnik (Germany). An improved version (ATS) has recently been introduced by Meise, based on patient feedback on the TF system. ATS vials are easier to open, with a more secure, tamper evident closure and a better quality nozzle. To evaluate the suitability of ATS vials, a validation protocol, previously developed for TF vials, was repeated. It comprised assessment of their integrity following simulated storage and transport, and the stability and sterility of SED stored in them. Method Firstly, a process simulation assessment was performed using bovine serum. Vials were filled, and frozen to -80oC. They were then removed from frozen storage and checked for damage, before being put into transport containers and shipped on a round-trip journey to simulate delivery to patients. On return the vials were thawed and the integrity of each vial checked visually and by application of a standard force. Subsequently a shelf-life study was carried out using three batches of human SED. The vials were initially frozen to -80oC, then stored for set time points of 1, 3, 6 and 12 months in a standard domestic freezer set at 20oC (to mimic a home freezer). At each time point, 10 vials were thawed and examined for integrity, and the sterility and stability of the contents. Stability was assessed by measuring serum albumin concentrations and sterility by testing for presence of microbial contamination, under aerobic and anaerobic conditions. Results No vial damage or leakage was found at any time point in the ATS vials. No microbial contamination was detected, and no change in albumin levels was detected in SED throughout the storage period. Conclusion This study has demonstrated that the ATS vials are suitable for provision of SED for clinical use to patients. Feedback is now being gathered from a patient focus group relating to usability of the vials.
Abstract
INTRODUCTION
Circumferential lumbar arthrodesis leads to high fusion rates for degenerative lumbar spine. Interspinous posterior fixation pedicle screw fixation as an adjunct to interbody ...graft led to similar fusion rates and patient reported scores in prospective randomized multi-center study. Although commonly used as surrogates of each other it remains unclear whether the fusion scores correlate with patient reported outcomes.
METHODS
Data was collected as part of a prospective multi-center (11 investigators) study of 101 patients receiving single-level antero-lateral lumbar interbody fusion with supplemental interspinous process fixation (ISPF) or pedicle screw fixation (PSF) for the treatment of degenerative disc disease and/or spondylolisthesis. Subjects were randomized 2:1, ISPF to PSF, for posterior fixation. Patients were followed up to 24 months post-op. Patient reported outcome indices (ODI, SF-36) were collected at each follow-up time point. Lumbar x-ray radiographs were taken at 12 and 24 months. Interbody fusion was scored by an independent radiologist using the Brantigan-Stefee Fraser (BSF) criteria (BSF-1: pseudarthrosis; BSF-2: radiographic locked pseudarthrosis; BSF-3: radiographic fusion). A logistic regression model was used to determine whether a relationship existed between quality of fusion (BSF-3 vs. BSF-1&2) and clinical index improvement at 12 and 24 months.
RESULTS
>Change in ODI score at 12 and 24 months was not significantly associated with BSF score (P = 0.78 and P = 0.64, respectively). At 12 months,, BSF-3 patients had on average 1.4 greater reduction in ODI compared to BSF-1&2 (95% CI: -8.61, 11.41). Changes in SF-36 score were not significantly associated with BSF score (P = 0.63 and P = 0.18, respectively). For SF-36 Mental, BSF-3 patients had a 2.21 greater increase compared to BSF-1&2 (95% CI: -6.7, 11.13). Instead in SF-36 Physical, BSF-3 patients had a 4.14 lesser increase compared to BSF-1&2 (95% CI: -10.15, 1.88)
CONCLUSION
Radiological lumbar interbody fusion grading using BSF scale do not correlate with patient reported outcome.
To evaluate the efficacy of adalimumab in the healing of draining fistulas in patients with active Crohn's disease (CD).
A phase III, multicentre, randomised, double-blind, placebo controlled study ...with an open-label extension was conducted in 92 sites.
A subgroup of adults with moderate to severely active CD (CD activity index 220-450) for >or=4 months who had draining fistulas at baseline.
All patients received initial open-label adalimumab induction therapy (80 mg/40 mg at weeks 0/2). At week 4, all patients were randomly assigned to receive double-blind placebo or adalimumab 40 mg every other week or weekly to week 56 (irrespective of fistula status). Patients completing week 56 of therapy were then eligible to enroll in an open-label extension.
Complete fistula healing/closure (assessed at every visit) was defined as no drainage, either spontaneous or with gentle compression.
Of 854 patients enrolled, 117 had draining fistulas at both screening and baseline (70 randomly assigned to adalimumab and 47 to placebo). The mean number of draining fistulas per day was significantly decreased in adalimumab-treated patients compared with placebo-treated patients during the double-blind treatment period. Of all patients with healed fistulas at week 56 (both adalimumab and placebo groups), 90% (28/31) maintained healing following 1 year of open-label adalimumab therapy (observed analysis).
In patients with active CD, adalimumab therapy was more effective than placebo for inducing fistula healing. Complete fistula healing was sustained for up to 2 years by most patients in an open-label extension trial.
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