RESUMO
Scientific and industrial reasons dictate the study of the solid state of imepitoin, a highly safe and tolerable anticonvulsant drug used in the therapy of epileptic dogs that was approved in the Europe Union in 2013. Our investigations allowed us to discover the existence of a new polymorph of imepitoin, which finds itself in a monotropic relationship with the crystalline form (polymorph I) already known and present on the market. This form (polymorph II), obtained by crystallization from xylene, remains metastable under ambient conditions for at least 1 year. Both solid forms were characterized by thermal (DSC and TGA), spectroscopic (FT-IR and Raman), microscopic (SEM and HSM), and diffractometric techniques. The thermodynamic relationship between the two polymorphs (monotropic) is such that it is not possible to study the melting of polymorph II, not even by adopting appropriate experimental strategies. Our measurements highlighted that the melting peak of imepitoin actually also includes an onset of melt decomposition. The ab initio structure solution, obtained from synchrotron X-ray powder diffraction data collected at room temperature, allowed us to determine the crystal structure of the new polymorph (II). It crystallizes in the monoclinic crystal structure, P21/c space group (#14), with a = 14.8687(6) Å, b = 7.2434(2) Å, c = 12.5592(4) Å, ß = 107.5586(8)°, V = 1289.61(8) Å3, and Z = 4.
RESUMO
BACKGROUND: Bracing could be efficacious, given good compliance and quality of braces. Recently the SOSORT Brace TREATMENT Management Guidelines (SBTMG) have highlighted the perceived importance of the professional teams surrounding braced patients. PURPOSE: To verify the impact of a complete rehabilitation team in the adolescent patient with bracing. MATERIALS AND METHODS: Design. Initial cross-sectional study, followed by a retrospective case-control study. POPULATION: Thirty-eight patients (15.8 ± 1.6 years; 26 females; 10 hyperkyphosis, 28 scoliosis of 29.2 ± 7.9° Cobb) extracted from a single orthotist database (between January 1, 2008 and September 1, 2009) and treated by the same physician; brace wearing at least 15 hours/day for a minimum of 6 months; age 10 or more. TREATMENT: Braces: Sforzesco, Sibilla, Lapadula or Maguelone. Exercises: SEAS. METHODS: Two questionnaires filled in blindly by patients: SRS-22 and one especially developed and validated with 25 questions on adherence to treatment. Groups (main risk factor): TEAM (private institute: satisfied 44/44 SOSORT criteria; grade of teamwork, "excellent") included 13 patients and NOT 25 (National Health Service Rehabilitation Department: 35/44 SOSORT criteria respected; grade, "insufficient"). RESULTS: TEAM was more compliant to bracing than NOT (97 ± 6% vs. 80 ± 24%) and performed nearly double the exercises (38 ± 12 vs. 20 ± 13 minutes/session). The self-reduction of bracing was significant in NOT (from 16.8 ± 3.7 to 14.8 ± 4.9 hours/day, , P<0.05); TEAM showed a significant reduction in the difficulties due to bracing (from 8.9 ± 1.4 to 3.5 ± 2.0 in 12 months on a 10-point scale, P<0.05). Pain was perceived by 55% of NOT versus 7% of TEAM (P < 0.05). The populations did not differ at the baseline studied outcomes. The absence of a good team surrounding the patient increases by five times the risk of reduced compliance to bracing (odds ratio OR 5.5 - 95% confidence interval 95CI 3.6-7.4), along with more than 15 times that of QoL problems (OR 15.7 - 95CI 13.6-17.9) and pain (OR 16.8 - 95CI 14.5-19.1). CONCLUSIONS: Provided the limits of this first study on the topic, the SBTMG seems to be important for brace treatment, influencing pain, QoL and compliance (and so, presumably, final results). Future studies on the topic are advisable.