Zairi F.,Lille University Hospital Center
Journal of neurological surgery. Part A, Central European neurosurgery | Year: 2013
Transforaminal lumbar interbody fusion (TLIF) is an efficient technique which can achieve a fusion rate of up to 90%. Minimally invasive approaches have become increasingly popular because they appear to minimize iatrogenic soft tissue and muscle injury. As minimally invasive TLIF gains popularity, its effectiveness compared with open TLIF has yet to be established. A retrospective study was performed with the aim to compare long-term outcomes of patients who underwent mini-open TLIF with those who underwent open TLIF. This is a retrospective review of prospectively collected data. Between 2005 and 2008, 100 patients underwent TLIF for low-grade spondylolisthesis or degenerative disc disease; 60 underwent open TLIF and 40 underwent mini-open TLIF. The mean age in each group was 48 years, and there were no statistically significant differences between the groups. Data were collected perioperatively. Pain and functional disability were measured using visual analogue scale (VAS) and Oswestry disability index (ODI) at 3 months, 6 months, 1 year, and 2 years. In addition, the fusion was evaluated at 1 year on a computerized tomography (CT) scan. The mean VAS improved from 7.3 to 3.8 for back pain and from 7 to 2.7 for leg pain and the ODI decreased from 60 to 30% at 2 years postoperatively. The fusion rate at 1 year was 98%. There were no statistical differences for the clinical and radiological outcomes between the groups. The mean operative time was 186 minutes in the open group and 170 minutes in the mini-open group (p < 0.05) and the mean blood loss was 486 mL in the open group and 148 mL in the mini-open group (p < 0.01). The mini-open TLIF for symptomatic low-grade spondylolisthesis and degenerative disc disease is an effective option that achieves the same clinical and radiological outcomes at a minimum 2-year follow-up and reduces perioperative morbidity. Georg Thieme Verlag KG Stuttgart · New York.
Morschhauser F.A.,Lille University Hospital Center
Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2013
Obinutuzumab (GA101), a type II, glycoengineered, humanized anti-CD20 monoclonal antibody, was superior to rituximab in human diffuse large B-cell lymphoma (DLBCL) and mantle-cell lymphoma (MCL) xenograft models. In phase I of our study, obinutuzumab (GA101) exhibited encouraging activity but no clear dose-response relationship, and few patients had aggressive histologies. The efficacy and safety of two doses of obinutuzumab (GA101) were explored in our randomized phase II trial in patients with heavily pretreated DBLCL and MCL. Patients were randomly assigned to receive eight cycles of obinutuzumab (GA101) either as a flat dose of 400 mg for all infusions (days 1 and 8 of cycle 1; day 1 of cycles 2 to 8) or 1,600 mg on days 1 and 8 of cycle 1 and 800 mg on day 1 of cycles 2 to 8. Forty patients were enrolled: 21 patients in the 400/400-mg treatment arm (DLBCL, n = 10; MCL, n = 11) and 19 patients in the 1,600/800-mg arm (DLBCL, n = 15; MCL, n = 4). End-of-treatment response was 28% (32% and 24% in the 1,600/800-mg and 400/400-mg study arms, respectively). Best overall response rates were 37% in the 1,600/800-mg arm and 24% in the 400/400-mg study arm (DLBCL, eight [32%] of 25 patients; MCL, four [27%] of 15 patients). Five (20%) of 25 rituximab-refractory patients exhibited treatment response, including four of 12 in the 1,600/800-mg group. The most common adverse events were infusion-related reactions (IRRs), which were manageable. Three patients had grade 3/4 IRRs. Grade 3/4 neutropenia was seen in only one patient. Obinutuzumab (GA101) 1,600/800 mg achieves early steady-state concentration and clinical activity with an acceptable safety profile in relapsed/refractory DLBCL and MCL, supporting further exploration.
Girard J.,Lille University Hospital Center
Orthopaedics and Traumatology: Surgery and Research | Year: 2015
The configuration of total hip arthroplasty (THA) implants has constantly evolved since they were first introduced. One of the key components of THA design is the diameter of the prosthetic femoral head. It has been well established that the risk of dislocation is lower as the head diameter increases. But head diameter impacts other variables beyond joint stability: wear, cam-type impingement, range of motion, restoration of biomechanics, proprioception and groin pain. The introduction of highly cross-linked polyethylene and hard-on-hard bearings has allowed surgeons to implant large-diameter heads that almost completely eliminate the risk of dislocation. But as a result, cup liners have become thinner. With femoral head diameters up to 36. mm, the improvement in joint range of motion, delay in cam-type impingement and reduction in dislocation risk have been clearly demonstrated. Conversely, large-diameter heads do not provide any additional improvements. If an "ecologically sound" approach to hip replacement is embraced (e.g. keeping the native femoral head diameter), hip resurfacing with a metal-on-metal bearing must be carried out. The reliability of large-diameter femoral heads in the longer term is questionable. Large-diameter ceramic-on-ceramic bearings may be plagued by the same problems as metal-on-metal bearings: groin pain, squeaking, increased stiffness, irregular lubrication, acetabular loosening and notable friction at the Morse taper. These possibilities require us to be extra careful when using femoral heads with a diameter greater than 36. mm. © 2014 Elsevier Masson SAS.
Hachulla E.,Lille University Hospital Center
Rheumatology (Oxford, England) | Year: 2010
To describe the history of SSc-associated pulmonary arterial hypertension (SSc-PAH) in patients with New York Heart Association (NYHA) functional class (FC) II dyspnoea at diagnosis. Data at the time of diagnosis were collected and analysed retrospectively for 77 consecutive patients with SSc-PAH. Twelve patients (15.6%) presented with PAH and NYHA FC II dyspnoea. After a mean follow-up of 44 months, only 4 out of the 12 PAH patients remained stable in FC II, while 8 showed worsening to FC III or IV. Three patients died during the observation period; two from PAH and one from rectal cancer. Survival in patients in FC II at diagnosis was 100, 91 and 80% at 1, 2 and 3 years, respectively. A majority of patients with mildly symptomatic SSc-PAH in NYHA FC II at diagnosis have a severe disease with poor prognosis.
Vermersch P.,Lille University Hospital Center
Expert Review of Neurotherapeutics | Year: 2011
Sativex® (nabiximols, USAN name) oromucosal spray contains the two main active constituents of Cannabis sativa, tetrahydrocannabinol and cannabidiol in a 1:1 molecular ratio, and acts as an endocannabinoid system modulator. Randomized, controlled clinical trials of Sativex as add-on therapy provide conclusive evidence of its efficacy in the treatment of more than 1500 patients with multiple sclerosis (MS)-related resistant spasticity. The primary end point in clinical trials was the mean change from baseline in the 0-10 numerical rating scale (NRS) spasticity score. The first pivotal clinical trial included 189 patients treated for 6 weeks with Sativex (n = 124) or placebo (n = 65). At study end, there was a significant reduction from baseline in patient-recorded NRS spasticity scores with Sativex compared with placebo (-1.18 vs-0.63; p = 0.048). In the second pivotal trial, 337 patients with MS-related resistant spasticity received Sativex (n = 167) or placebo (n = 170) over a 15-week period. In the per-protocol analysis (79% of the patient population), mean baseline NRS spasticity score was reduced significantly in patients receiving Sativex compared with placebo:-1.3 versus-0.8 points (p = 0.035). The third pivotal clinical trial, evaluating the sustained efficacy of Sativex, had a two-phase study design: in phase A (n = 572), 47% of patients were initial responders (improvement ≥20%) after 4 weeks of single-blind Sativex treatment who then entered phase B, a randomized, double-blind, 12-week placebo comparison. At the end of phase B, the change in NRS spasticity score improved by a further 0.04 units in initial responders treated with Sativex, but decreased by 0.81 units in placebo recipients (p = 0.0002). Significant improvements in quality-of-life measures from baseline to week 16 were also observed in patients receiving Sativex. The most common treatment-related adverse events with Sativex were mild-to moderate and transient episodes of dizziness, fatigue or somnolence. Sativex does not exhibit the side effects typically associated with recreational cannabis use and there are no signs of drug tolerance or withdrawal syndrome, or any evidence of drug misuse or abuse. Sativex oromucosal spray appears to be a useful and welcomed option for the management of resistant spasticity in MS patients. Although the management of MS has been improved by the availability of disease-modifying agents that target the underlying pathophysiological processes of the disease, a clear need remains for more effective symptomatic treatments, especially as regards MS-related spasticity and pain. © 2011 Expert Reviews Ltd.