Objectives: To evaluate the efficacy and safety of pregabalin (Lyrica) in the treatment of primary fibromyalgia. Patients: 87 patients with primary fibromyalgia by 1990 ACR criteria, examined in out patient department from 3/2012-3/2014 were included. Methods: prostective, longitudinal study. Patients were treated with pregabalin (Lyrica) 150 mg/day during 2 months. Patients were underwent interview, clinical and paraclinical examinations at T0,T1 and T2. Results: Mean age: 44.6 +/- 13.9; female/male =4.8. Pain and concomitant symptoms (fatigue, sleep disturbance, anxiety, irritable bowel syndrome) decreased significantly (p 0,05) after 2 months using Pregabalin. VAS pain index decreased (p 0,05) from 78.2 +/- 26.7 at baseline to 73.6 +/- 24.7 (after 1 month) and 69.7 :!: 23.5 (after 2 months). Quality of life (assessed by SF-36) also improved (p 0.05), from 52.9 +/- 21.7 (at baseline) to 53.9 +/- 22.7 (after 1 month) and 55.6 +/- 23.8 (after 2 months). The common adverse effects of pregabalin were somnolence (28.7 percent), dizziness (21.8 percent), dried mouth (10.3 percent), digestive disturbance (8.0 percent), peripheral edema and weight gain (5.7 percent). No significant changes of blood tests were observed during treatment. Conclusions: Pain and concomitant symptoms (fatigue, sleep disturbance, anxiety, irritable bowel syndrome) decreased and quality of life improved significantly after 2 months using pregabalin. Pregabalin was high tolerance, and its adverse effects were generally mild in intensity and temporally.
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