Oral and subcutaneous sumatriptan in the acute treatment of migraine: an open randomized cress-over study

In an open, randomized cross-over study in 124 patients, we compared the efficacy, safety and patient preference of oral and subcutaneous sum triptan in the acute treatment of migraine. Patients were treated for 3 attacks or 3 months and then crossed over. Primary clinical efficacy was defined as a reduction in headache severity on a four-point self-rating scale from severe (3) or moderate (2) to mild (1) or none (0), or mild (1) to none (0). Efficacy was evaluated 2 h after the administration of subcutaneous and 4h after the administration of oral sumatriptan. Subcutaneous sumatriptan was significantly more effective than oral sumatriptan in relieving headache (over all three attacks 78% vs 61% improvement), improving clinical disability (55% vs 41 % improvement) and relieving nausea (69% vs 53%), vomiting (72% vs 32%) and phono- or photophobia (67% vs 49%). Median time to recurrence was shorter after subcutaneous (12.5 h) than after oral sumatriptan (18 h); the number of patients experiencing a recurrence was similar Patients reported more adverse events after subcutaneous sumatriptan (1.32 per attack) than after the oral form (0.85 per attack), but all adverse events were mild to moderate in intensity and of short duration. Patient opinion was more often positive after subcutaneous sumatriptan. These results may be useful in counselling patients to choose between the available marketed formulations of sumatriptan.     

Effects of hyperbaric, normobaric and hypobaric oxygen supplementation on retinal vessels in newborn rats: a preliminary study

An experimental study was conducted on eight litters of newborn rats to evaluate the effects of supplemental oxygen administration on the retinal vasculature. The animals and their mothers were kept inside a pressure chamber and treated for the first 5 days of life. On the sixth day, they were removed and kept for five more days under room air and normobaric conditions. Three litters received continuous flow oxygen at 80% at a compression pressure of +81 kPa, one litter oxygen at 80% at a pressure of -39.5 kPa atms and three other litters received oxygen at 80% under normobaric conditions. The eighth litter was treated with room air oxygen at a compression pressure of +81 kPa. A severe retinopathy with marked retinal neovascularization was seen only in the newborn animals of the litters that received oxygen supplementation under normobaric or hypobaric conditions. Retinal vessels showed no pathological changes in the litters treated with hyperbaric normoxia or hyperoxia. It is possible to hypothesize that the prolonged period of oxygen supplementation failed to produce harmful effects on the retinal vasculature because the moderate hyperbarism caused mild retinal and choroidal vasoconstriction thus preventing excessive oxygen transport to the inner retina from the choroid during hyperoxia without inducing structural damage to the retinal tissue.     

Minimally invasive treatment of acute biliary pancreatitis

Background: Stones of the common bile duct are the most important factor in acute pancreatitis (AP). Endolaparoscopic surgery plays a well-recognized role in the treatment of this pathology. Methods: From January 1992 to December 1995 we observed 62 cases of acute biliary pancreatitis (ABP). In 57 cases (= 93.4%) we proposed a minimally invasive treatment, based on performance of endoscopic retrograde cholangiopancreatography (ERCP) combined with endoscopic sphincterotomy (ES) and then of laparoscopic cholecystectomy (LC). Results: ERCP was attempted in emergency in 40/57 cases and successfully done in 34 cases. An ES was performed in all but two cases. In 51 patients we performed LC. The overall morbidity was 8.9% with no mortality. Conclusions: In the case of ABP early treatment can achieve the restoration of patency of the papilla, reducing the risk of associated cholangitis and the development of pancreatic necrosis. The cholecystectomy prevents the risk of relapse of ABP.     

Accuracy of in-vivo assessment of prostatic volume by MRI and transrectal ultrasonography.

More accurate noninvasive estimation of prostate size is important in therapeutic trials for benign prostatic hyperplasia. The accuracy of MRI and transrectal ultrasound (TRUS) in assessing prostate weight was evaluated in 48 patients who underwent radical prostatectomy for stage A or B cancer. The volume derived from the wet weight of the freshly excised specimen was used as a reference. We compared that volume with volume estimates derived from the three-axis linear dimension measurement by MRI and TRUS using a tissue density of 1.05 g/cc and the standard formula for an ellipsoid object. Prostate and seminal vesicle volumes were also computed by contouring T2-weighted 5 mm thick contiguous MR images using a semiautomatic edge detection program and pixel summation. Three-axis volume MRI method versus volume from wet weight has slightly less scatter than TRUS three-axis method (r = 0.85 vs r = 0.81). Contoured MR volume method has the least scatter r = 0.93, statistically better than the linear axis method. Contoured MRI volumetric analysis appears superior to linear MRI or TRUS methods in estimating true prostate volume.     

Age-related anticonvulsant activity of NMDA in the rat caudate-putamen.

Striatal pathways are important for modulating the threshold for seizures in the rat forebrain. N-Methyl-D-aspartate (NMDA), an excitatory amino acid derivative and powerful anticonvulsant agent, when injected into the brain, has been shown to protect adult rats against kindling and pilocarpine-induced seizures when injected into the caudate-putamen. The present study examines whether the anticonvulsant action of NMDA in the caudate-putamen varies with age. Bilateral striatal administration of NMDA was effective in suppressing bicuculline-induced seizures in rats older than 23 days of age. The results suggest that striatal pathways involved in the anticonvulsant activity of NMDA in the caudate-putamen are not functionally active in developing rats before the 4th week of life.     

Prognostic relevance of histological grade and its components in node-negative breast cancer patients.

Available results highlight the lack of good level of evidence studies on the pure prognostic value of histological grade. In the present study, the prognostic relevance of histological grade and of its three components, tubule formation, nuclear pleomorphism and mitotic count, was analyzed in a series of 372 patients with node-negative breast cancer treated with locoregional therapy alone until early relapse. Histological grade was determined blindly by two observers and discordance between evaluations was resolved after joint review using a multihead microscope. No relation was observed between histological grade and any of its three components and disease-free survival. Conversely, a significant relation was observed between histological grade and distant metastasis-free survival (at 6 years, 94, 86 and 76% for grades 1, 2 and 3, respectively, P=0.013) as well as overall survival (98, 90 and 86%, P=0.001). A breakdown analysis as a function of the three components showed that neither tubule formation nor nuclear pleomorphism was associated with prognosis, and only mitotic count strongly influenced both distant metastasis-free survival (91, 82 and 74%, P=0.014) and overall survival (97, 87 and 85%, P=0.011). Histological grade suffers from a much higher subjectivity than any other microscopic evaluation of biomarkers as it is the sum of three different morphological features. Within the Italian Network for Quality Assessment of Tumor Biomarkers program we observed that histological grade is an independent prognostic variable, but also that this role is ascribable only to the number of mitotic figures. In conclusion, due to the ever smaller size of diagnosed breast cancers, resulting in less cancer tissue for biofunctional and molecular analysis, mitotic count evaluated under strict quality control conditions seems to be an accurate and feasible prognostic variable.     

Usefulness of gallium 67 in research into the need for radical cervical lymph node dissection in patients with head and neck carcinomas

Fifty-nine patients with head and neck carcinoma were examined with 67Ga scintigraphy. All patients had undergone lymph node dissection of the neck. They were followed for a minimum of 2 years after the examination. The primary tumor, treated prior/contemporaneously to the lymph node dissection, did not evolve in this interval. Metastatic involvement of the lymph node capsule was observed in all 44 cases with metastatic lymph nodes; macroscopic radicality was surgically obtained since involvement of the capsule was only microscopic. Nevertheless, complementary radiotherapy was given. The whole of 17 recurrences in the soft tissues of the neck were found, within 2 years, in the group of 26 patients who had undergone dissection of lymph nodes with metastatic capsular involvement and whose postoperative 67Ga scintigraphy was positive. On the contrary, no recurrences in the soft tissues of the neck were observed in the group of 18 patients who had undergone dissection of lymph nodes with metastatic capsular involvement and whose scintigraphy was negative. This result proves (P less than 0.001) 67Ga capable of evidencing eventual microscopic diffusion. Such a possibility has not yet been realized in vivo with any other investigation technique. Scintigraphy was negative in a control group of 15 patients who had undergone lymph node dissection, and with nonmetastatic lymph nodes. This finding leads us to exclude that the use of 67Ga might result in misinterpreted findings in the exploration of relatively superficial tissues. In fact, the eventual accumulation of radioisotope in nonneoplastic pathologies is quite easily recognizable in the neck. We can therefore conclude that in those 9 cases with positive scintigraphy and in whom no recurrence was found, microscopic diffusion was probably present, but local recurrence of the disease was prevented by complementary radiotherapy.     

Localized pleural mesotheliomas. Clinicopathological considerations on a case report]

Pleural mesotheliomas are rare, and their diagnosis and treatment not clear. The case observed in our Department leads us to an analysis of the literature. This showed that differential diagnosis with pulmonary carcinoma is very difficult, even in cases of parietal mesothelioma; however local treatment may be performed even in malignant mesothelioma.     

Accelerating effects of epidermal growth factor on skin lesions of pemphigus vulgaris: a double-blind, randomized, controlled trial

BACKGROUND: Pemphigus vulgaris (PV) is a severe blistering disease involving the skin and mucous membranes. The most common causes of death in these patients are adverse effects of drugs, and infection. Skin lesions are one of the important sources of infection. Thus, any local treatment that could reduce healing time of lesions and consequently reduce the total dosage of drugs needed to treat is favourable. OBJECTIVE: To evaluate the efficacy of epidermal growth factor (EGF) in reducing healing time of lesions in patients with pemphigus vulgaris. METHODS: In this randomized, double-blind, within-patient, left/right, controlled trial, 20 hospitalized patients with pathologial and immunohistologial (direct and indirect immunoflourecence) proven pemphigus vulgaris (PV) were chosen. In addition, all patients had at least one appropriate pemphigus lesion on each side of the body that had not healed after 2-week systemic therapy and sterile saline washing. EGF (10 microg/g) in 0.1% silver sulfadiazine cream vs. 0.1% silver sulfadiazine cream alone was applied randomly on one side of the body. RESULTS: Kaplan-Meier survival analysis suggested that median time to heal with application of EGF plus silver sulfadiazine cream was 9 days, in comparison with 15 days for silver sulfadiazine cream alone (log-rank test, P=0.0003). No intervention-related adverse effect was observed during the study. CONCLUSIONS: EGF can significantly reduce healing time of skin lesions in patients with pemphigus vulgaris, at least when this cream base is applied (Cochrane skin group identifier: CSG20).