ABSTRACT
This cross-over, double blind, randomized, multicentre study evaluated the consistency of efficacy and safety of oral sumatriptan in 233 migraneurs. The patients received 50 mg oral sumatriptan or placebo for the treatment of 12 migraine attacks. Within each group of 4 attacks, three were treated with sumatriptan and one with placebo, according to a randomization list. Over all the attacks, the efficacy rate was statistically significant for sumatriptan against placebo at 2 or 4 hours (2 hours: sumatriptan 60%, PLO 38%, p < 0.001; 4 hours sumatriptan 79%, PLO 47%, p < 0.001). Oral sumatriptan was similarly effective at relieving the associated symptoms and at reducing clinical disability in most attacks. The incidence of adverse events did not differ between treatment groups. All the events recorded were mild to moderate as intensity and resolved spontaneously.
Subject(s)
Migraine Disorders/drug therapy , Serotonin Receptor Agonists/therapeutic use , Sumatriptan/therapeutic use , Adolescent , Adult , Aged , Cross-Over Studies , Dose-Response Relationship, Drug , Double-Blind Method , Female , Humans , Male , Middle Aged , Migraine Disorders/complications , Recurrence , Serotonin Receptor Agonists/administration & dosage , Serotonin Receptor Agonists/adverse effects , Sumatriptan/administration & dosage , Sumatriptan/adverse effectsABSTRACT
AIMS AND BACKGROUND: Although they have been decreasing over time due to improved specificity of diagnostic assessment, benign biopsies of the breast are still common. Benign biopsies should be regarded as negative events, due to their economical and psychological cost and their possible negative impact on cosmesis and on further diagnostic evaluation. METHODS: Retrospective data on benign/malignant breast biopsies ratio (B/M) were collected in 9 Italian centers for a period of 10-15 years. The time trend of B/M and its association to age or to single centers was evaluated. RESULTS: Overall 31,001 cases were considered. A strong association of B/M to age was evident (average B/M values were 5.0, 1.3, 0.6, and 0.2 for women aged < 40, 40-49, 50-59, and > 59 years). A significant trend of decreasing B/M over time was observed only for one center. Age standardized B/M was significantly different (P < 0.000001) between centers, ranging between 0.34 and 1.69. Multivariate analysis confirmed an independent significant association of age and center to B/M. CONCLUSIONS: Marked differences in B/M are evident between centers, which cannot be explained by the confounding effect of age or by any apparent difference in the diagnostic protocol. The observed differences are likely ascribed to individual variations in diagnostic aggressivity. A progressive increase of the predictive value of calls for surgical biopsy may be achieved over time and centers with a high B/M should make every effort to optimize their performance. Acceptable (< 40 = 5, 40-49 = 1.5, 50-59 = 0.75, > 59 = 0.3) and desirable (2.5, 0.75, 0.35, 0.15) age specific reference standards for B/M are proposed.
Subject(s)
Biopsy/statistics & numerical data , Breast Diseases/pathology , Breast Neoplasms/pathology , Adult , Age Distribution , Female , Humans , Italy , Logistic Models , Male , Middle Aged , Multivariate Analysis , Odds Ratio , Retrospective StudiesABSTRACT
The authors consider 88 cases of mastectomy and immediate breast reconstruction mainly performed using the skin expander plus prosthesis method or latissimus dorsi myocutaneous flaps. At the same time, 53 patients underwent contralateral mastopexy for symmetry. The mean follow-up was 21 months (range 2-102). Progressive disease was observed in nine cases: one patient presented scar relapse, one axillary relapse, two contralateral tumor, two contralateral tumor and distant metastasis, three distant metastases and one death from distant metastasis. Reconstruction complications were capsular contracture in 12 cases, infection in nine, skin necrosis in two, skin expander breakage in three and implant dislocation in one. The final result was judged good in 54 cases, fair in nine, poor in 11 and unevaluable in 14. In conclusion immediate breast reconstruction does not seem to interfere with the disease or oncological therapy. After analysing separately, and comparing the results and complications of the two main techniques used, latissimus dorsi seems to be the most reliable method in the majority of cases but skin expanders can be a good technique in patients with small and firm breasts and without complicating risk factors.
