RESUMEN
OBJECTIVE: To assess the effect of a very simple dose-escalation schedule on tramadol tolerability in clinical practice. This schedule consists of starting treatment with sustained-release tramadol 50mg twice daily, and escalating the dose around 7 days later to 100mg twice daily. METHODS: Data from 1925 outpatients with non-malignant chronic pain were collected in this multicentre, prospective, comparative, non-randomised, open, observational study. RESULTS: A total of 1071 patients (55.6%) were included in the dose-escalation group (50mg group) and 854 patients (44.4%) in the control group (sustained-release tramadol 100mg twice daily; 100mg group). The proportion of patients who interrupted tramadol treatment due to the occurrence of adverse reactions was significantly lower in the 50mg group (5.6%) than in the 100mg group (12.6%) [p = 0.001]. In line with this, the proportion of patients who experienced at least one adverse reaction was significantly lower in the 50mg group (18.4%) than in the 100mg group (30.4%) [p = 0.001] and, interestingly, the two most frequently reported adverse reactions, nausea and dizziness, were found with a significantly lower frequency in the 50mg group (p < 0.001). Multivariate analysis showed that the risk of safety-related treatment cessations was 2.3 times higher in the 100mg group than in the 50mg group, and 2.2 times higher in females than in males. The two treatments were equally effective in reducing pain intensity (p = 0.121), measured as a reduction in pain score obtained by means of a visual analogue scale. CONCLUSION: The instauration of tramadol treatment, starting with sustained-release 50mg capsules twice daily and escalating the dose some days later to 100mg twice daily, was shown to be an effective and easy way to improve tramadol tolerability in clinical practice, whilst maintaining its analgesic efficacy.
RESUMEN
OBJECTIVE: To analyze if free PSA percentage can help to predict a potential surgical failure (PSF) in patients undergoing radical prostatectomy. MATERIAL AND METHODS: Analysis of serum PSA concentration and free PSA percentage in 92 patients undergoing retropubic radical prostatectomy. In 38 cases, the carcinoma was organ-confined, 26 had capsule penetration, 20 had positive margins, 6 seminal vesicle invasion and 2 lymph nodes. PSF was demonstrated in 28 patients (30.4%) and in 64 (69.6%) the carcinoma was organ-confined. RESULTS: No significant relationship was found between PSA serum concentration or free PSA percentage to the pathological stage. The logistic regression analysis where the clinical status, Gleason sum, and free PSA percentage were included as predictive variables, showed that the latter was the only factor with capacity for PSF prediction. Over all, the probability of a carcinoma being confined in the surgical specimen when percentage of free PSA was greater than 10 was 83.8% and 60% when it was lower or equal, p < 0.03. However, the distribution was only significant when PSA concentration ranged between 4.1 and 10 ng/mL, p < 0.008. In this range of PSA, the relative risk of PSF was 5.5 (95% CI 1.4-21.8) when free PSA percentage was equal or lower than 10, the probability being 50% versus 9.1% when it was greater than 10. CONCLUSIONS: Free PSA percentage can help to predict PSF. PSA serum concentration lower than 10 ng/mL and free PSA percentage greater than 10 allows to detect a subgroup of patients with good prognosis and with less than 10% probability of having positive margins, seminal vesicles invasion or lymph nodes.