Search

In this double-blind, randomized, parallel group, multicentre study the efficacy of a fixed combination of indomethacin, prochlorperazine, and caffeine (IndoProCaf) and nimesulide were compared over an 8-h period in the treatment of two consecutive episodes of tension-type headache (TTH). Both drugs were administered orally. Of 54 randomized patients, 40 were compliant to the protocol. More patients on IndoProCaf than on nimesulide were pain-free at 2 h post-dose (45% vs. 10%; P

Summary Aims and methods: In this double-blind, double-dummy, randomised, parallel group, multicentre study, the efficacy of dosing and re-dosing of a fixed combination of indomethacin, prochlorperazine and caffeine (Indoprocaf) was compared with encapsulated sumatriptan in the acute treatment of two migraine attacks. Additionally, in the group taking Indoprocaf, two different oral formulations were tested: effervescent tablets and encapsulated coated tablets. Results: Of 297 patients randomised (150 assigned to Indoprocaf and 147 to sumatriptan), 281 were included in the intention-to-treat efficacy analysis. The initial dosing of Indoprocaf and sumatriptan was similarly effective with pain-free rates higher than 30% (95% CI of odds-ratio: 0.57–1.28) and headache relief rates of about 60% (95% CI of odds-ratio: 0.82–1.84) with both the drugs. The efficacy of re-dosing of Indoprocaf as rescue medication was more effective than that of sumatriptan with pain-free values of 47% vs. 27% in the total attacks with a statistically significant difference in the first migraine attack in favour of Indoprocaf. The efficacy of re-dosing to treat a recurrence/relapse was very high without differences between the drugs (pain-free: 60% with Indoprocaf and 50% with sumatriptan in the total attacks). Indoprocaf and sumatriptan were well-tolerated. Conclusion: The study demonstrated that the efficacy of the initial dosing of Indoprocaf was not higher than that of sumatriptan, but that the strategy to use the lowest effective dose as soon as the headache occurred, followed by a second dose if the headache has not relieved or to treat a relapse, was very effective, especially with Indoprocaf.

In this paper we report the results obtained with Lipiodol CT in 39 patients with hepatocellular carcinoma (HCC). All patients had focal or multifocal nodular HCC with FNB confirmation and were all submitted to CT 15-20 days after the injection of Lipiodol in common or proper hepatic arteries during an angiographic maneuver. Lipiodol CT showed all the lesions US had demonstrated and depicted more lesions in 12 patients (30.7%)--67 lesions in all. The lesions demonstrated by Lipiodol CT were always smaller than 2 cm: 9/12 had been missed by US, 6/12 by CT and 7/12 by arteriography. In 34/67 lesions (50.7%) enhancement was homogeneous, in 29/67 (43.2%) inhomogeneous and in 4/67 cases (5.9%) Lipiodol was not retained. Lipiodol uptake depended on lesion size: if the lesion was 1-2 cm, uptake was homogeneous, while bigger lesions exhibited inhomogeneous uptake. Lesions bigger than 4 cm exhibited no Lipiodol uptake and were necrotic. A surgical resection was performed in 21/39 patients (53.8%). To conclude, Lipiodol CT is a valuable technique in the preoperative screening of HCC, particularly in the detection of additional lesions: in our series they were demonstrated in 30.7% of patients.

Eighteen patients (13 men and 5 women) with uni- and multifocal hepatocellular carcinomas (HCC) were examined. Mean patients age was 63.3 years (range: 47-74 years). All patients had alcoholic or posthepatitis cirrhosis; they were submitted to both CT during arterial portography (APCT) and Lipiodol-CT. The diagnosis of HCC was confirmed by fine-needle biopsy (FNB) in all cases. APCT and Lipiodol-CT results were compared for number, size and site of lesions-32 lesions in all. APCT demonstrated all the lesions: 9 of them were smaller than 2 cm, 14 ranged 2-5 cm and 9 were bigger than 5 cm; moreover, APCT demonstrated other lesions in 3/18 patients (16.6%) which had been missed by US, CT and angiography. Also Lipiodol-CT demonstrated all the 32 lesions and showed smaller lesions in 4/18 patients (22.2%); these nodules were smaller than 2 cm. Based on APCT results 11/18 patients (61.1%) were considered operable, vs. 7/18 patients (38.8%) based on Lipiodol-CT results. To conclude, both APCT and Lipiodol-CT are useful in the preoperative staging of HCC; Lipiodol-CT is preferable to APCT in the study of lesions smaller than 2 cm.

The activity of pidotimod ((R)-3-[(S)-(5-oxo2-pyrrolidinyl) carbonyl]-thiazolidine-4-carboxylic acid, PGT/1A, CAS 121808-62-6) on immunological parameters was evaluated in a double-blind trial, involving two Research Centres. 16 patients with a primary or metastatic neoplasm, 16 elderly patients under immunodeficiency conditions and 11 healthy volunteers were enrolled in the present study. The patients, randomized within each centre, were assigned to one of the following treatments lasting 15 days: one vial i.m. of pidotimod 50 mg, 100 mg, 200 mg twice a day, respectively; one vial i.m. of physiological saline twice a day. The lymphocyte PHA-stimulation test evidenced a significant variability due to the different treatment groups (p = 0.004). The analysis of the stimulation index (SI), computed from the mean c.p.m. before and after PHA-stimulation, showed a significant difference, dose-independent, between saline and active treatment (p = 0.002). The SI analysis, on the basis of the data of the allogenic stimulation test (mixed lymphocyte culture), confirmed the difference between saline and active treatment (p = 0.05) with a significant linear component in the time-effect curve (p = 0.001) but not in the dose-effect curve. A 12% increase in CD 3 lymphocytes compartment was observed with pidotimod 400 mg/day. The drug was well tolerated by all the patients included in the study.

We retrospectively reviewed CT scans of 18 patients (12 males and 6 females; mean age: 43.6 years) with the diagnosis of blunt splenic trauma. All patients underwent CT at different times after the trauma. The cases were divided into 2 groups: according to the time at which the CT was performed, the 1st group consisted of 11 patients scanned within 48 h after the trauma; the 2nd group consisted of 7 patients studied with CT at variable times after the traumatic event (mean time: 6.5 days; range 3-13 days). All lesions in the 1st group (11 patients) had indistinct margins, while lesions of patients in the 2nd group (7 patients) always showed clean-cut and regular edges. Early lesions were always hyperdense, late ones hypodense. CT diagnosis always matched the surgeon's diagnosis. We can confirm the diagnostic value of CT of splenic lesions in blunt abdominal traumas.

342 short-stature patients were examined to assess the agreement between anagraphic and bone ages. 190 men and 152 women (age range: 0 to 17.5 years) underwent conventional radiographs of the left wrist. The radiographs were studied with the TW2 method which provides an index of the skeletal maturity of short and long bones and a global index of the hand. The bone ages thus obtained were compared with anagraphic ages. Patients' statures were compared with their parents' ones. Finally, radiation exposures were evaluated. Anagraphic and bone ages were in agreement in 199 patients and in disagreement in 220. Three patients were adult. The short stature in 78 patients was in agreement with their parents' one, while 253 patients had at least one parent with normal stature. No comparison could be made in 11 patients. In conclusion, TW2 is a simple method to calculate bone age (in months and years) and to select the patients to submit to further examinations and to hormone therapy.

The CT scans of 18 patients (12 males and 6 females; mean age: 43.6 years) with splenic blunt trauma were reviewed. CT examinations had been made at different times after trauma. The CT images were grouped according to the time of examination and both structure and densitometry were evaluated in all lesions. In all cases CT findings were correlated with surgical and pathologic data. The patients were divided into two groups: group I included 11 subjects in whom CT had been performed within 48 hours following trauma and group II included 7 patients who had undergone CT at different times after trauma (3-13 days; mean: 6.5 days). All the lesions in group I exhibited blurred outlines, while the lesions in group II had clear-cut margins. The lesions in group I were always hyperdense while those in group II were hypodense. CT diagnosis was always in agreement with surgical findings. In conclusion, we confirm the value of CT in the examination of splenic lesions by blunt abdominal trauma. The evolution of splenic lesions is usually typical: CT yields useful information for injury evaluation and is therefore very important to plan treatment. We believe that CT should be performed as soon as possible, even on the basis of minor clinical and laboratory data.

Thirty patients of both sexes (15 males and 15 females) with chronic renal failure who had under gone hemodialysis for 2-184 months (mean 45.1 months) were examined with conventional radiographs of the cervical spine and thin-layer CT of C4-C5-C6 to evaluate the radiographic patterns of destructive spondyloarthropathy. The radiographic patterns obtained with conventional and CT exams were compared with one another and with clinical (carpal tunnel syndrome) and biochemical data (alkaline phosphatase, parathormon, Ca, P, Ca/P, Al, beta 2-microglobulin). DSA (erosion and narrowing of the intervertebral space, collapse of the vertebral body and erosion of the vertebral plates) was recognized in 7 patients with conventional radiographs and in 11 patients with CT thanks to greater CT capabilities to recognize minimal osteolytic lesions of the vertebral body. All the patients with destructive spondyloarthropathy had personal and hemodialysis age higher than those without destructive spondyloarthropathy: 59.3 vs 57.7 years; 49 vs 39 months. Parathormon and alkaline phosphatase were increased while beta 2-microglobulin was normal. Only 2 patients with DSA had carpal tunnel syndrome. In conclusion, CT is a valuable technique for the diagnosis of destructive spondyloarthropathy but it must be performed only after conventional radiographs of the cervical spine or in the presence of clinical signs of destructive spondyloarthropathy (parathormon and beta 2-microglobulin increased, long-term hemodialysis).

Seventy-two patients (52 males and 20 females, mean age: 50.6 years) were studied. They had undergone distal splenorenal shunts according to Warren and its modifications for portal hypertension. All patients were examined with digital and/or conventional angiography preoperatively and 15 days postoperatively. Preoperative and postoperative angiography was employed to evaluate the changes in vessel diameters including the hepatic, splenic and superior mesenteric arteries, the splenic, superior mesenteric and portal veins; the length of the main axis of the spleen was also measured. Furthermore, the degree of hepatic portal venous perfusion was evaluated according to the degree of portomesenteric-gastrosplenic disconnection. After surgery, the length of the main axis of the spleen is reduced and the hepatic artery diameter is increased, which are both signs of preserved hepatic flow and of reduced hypertension in the splanchnic venous system. The postoperative degrees of portal perfusion were correlated with the degrees of disconnection. In conclusion, the role is emphasized of early angiographic examinations after distal portosystemic shunts according to Warren to evaluate postoperative hemodynamic changes.

We report the results of intra-arterial digital subtraction angiography (DSA) in 100 patients with portal hypertension. The portal venous system was evaluated; all patients underwent angiography of the celiac and superior mesenteric arteries before surgery. Forty-four of them were also examined after Warren splenorenal shunts. Therefore, a total of 144 exams was evaluated. The authors always employed low-osmolality ionic and non-ionic contrast media (iodine concentration: 300-350 mg/ml). In 70 cases pure contrast medium was injected (20-25 ml); in the extant 74 cases it was diluted with an equal volume of saline solution (osmolality and iodine concentration reduced by 50%). Intra-arterial DSA always visualized portal venous system, collateral circulation, shunt location and postoperative changes. The major advantage of intra-arterial DSA is the smaller amount of contrast medium injected, so that local and systemic side effects are rare. According to our experience, it is best to dilute the contrast medium and inject the same amount as in conventional angiography, at the same rate. Other well-known advantages of intra-arterial DSA are quicker execution, less injury to arteries using smaller-caliber catheters, and low cost. The major disadvantage of intra-arterial DSA, as it appeared also in our study, is the field size of the intensifier, which in our case was limited to 6-9 inches. This is an insufficient coverage for the whole portal system to be studied, and some contrast medium injections become therefore necessary. An average of 3 injections were given to each patient. This problem reduces the advantage of less contrast medium per injection. At any rate, even though intra-arterial DSA exhibits this limitation, it can nevertheless yield important information in the pre- and postoperative evaluation of patients with portal hypertension.

Foot lymphography was performed in a selected group of 250 patients with malignant melanoma, with different sites of origin and of various stages. The overall incidence of metastases was 40%. The case material was evaluated in detail; the tumors of the inferior limb and those on different sites, e.g., vulva and abdomen, were considered separately. In the group of 188 patients with melanoma of the inferior limb, the incidence of metastases was 42%. In 51%, histologic confirmation was obtained. In the group of 62 patients with melanoma of different sites of the body, the incidence of metastases was 34% and histologic confirmation was obtained in 21 patients. The values of accuracy, sensitivity, and specificity based on the histologic confirmation of the lymphographic reports ranged from 88% to 96%. These data justify the use of lymphography in the initial diagnostic work-up and in the follow-up of these patients.

Sixty-six patients with tumor of the distal esophagus and/or the gastric fundus were admitted for intrathoracic esophagogastroplasty. Surgical mortality was 6% (4 of 66 cases). There were 3 early and 7 late complications among the 62 remaining patients. The authors suggest that radiological examinations of patients after esophagogastroplasty should include an early examination on the 7th-10th day after surgery with water-soluble contrast medium for detection of early complications and double-contrast studies before dismissal, at later check-ups and whenever clinical symptoms of late complications are developing.

The hands of 40 patients with psoriasis were examined by conventional and direct magnification radiograms. In 5 cases the hands showed typical psoriatic arthropathy. In 5 other cases only small calcifications in the soft tissues at distal interphalangeal joints were visible: according to clinical and laboratory data, these lesions could be in connection with psoriatic arthritis.

154 cases of breast cancer (30 T1-52; 124 T3-54) treated by irradiation followed by radical mastectomy were subjected to histological revision in order to check the efficacy of radiotherapy in the local control of cancer and to seek correlations between the histological findings and the clinical course of the disease. The tumor disappeared completely only in 24% of cases, the percentage being higher in the initially smaller tumors; the axillary lymph nodes showed disappearance of the metastases in a still smaller proportion of cases, namely 15-20%. Only in 16 cases (10% of cases) were the histological findings negative both at mammary and axillary levels. X-ray therapy and cobalt therapy were of equal value in the local control of the disease, despite the higher doses of cobalt. The patients operated on after radiotherapy had a decidedly better survival rate than those treated with irradiation only, since the former were selected because of their better clinical course and operated on because of this. Of the operated patients those whose axillary histology was negative presented a higher survival rate (75% of patients living) than those whose findings were positive (53%). Factors of negligible importance prognostically were: complete sterilization at mammary and axillary level after radiotherapy, persistence of florid cancer tissue at mammary level and histiocytosis of the axillary lymph nodes. In short, the result of locoregional therapy, even when successful, was not crucial in the general control of the disease, especially in advanced locoregional breast cancer (T3-T4 with axillary metastases).

This paper presents the results of a retrospective clinical study of 250 cases of monocentric carcinoma of the mucosal surface of the cheek, i.e. all the primaries treated by radiotherapy at our Institute between January 1948 and December 1965. Neoplastic lesions found at follow-up were regarded as marginal recurrences if in the proximity of the treated area and as secondary tumors in other cases. From 1948 to 1957 conventional radium therapy was the usual treatment for the primary tumor whereas from 1958 to 1965 cobalt teletherapy was given most frequently. Surgery was reserved for lymph node metastases when present on clinical examination. In our experience radiotherapy is effective in cancers of the mucosal surface of the cheek, for it checked local spread in 50.9% of cases, however treated and regardless of initial clinical appearance, whereas in the T1-T2 cases the local failure rate dropped to 35.8%. The higher the T level the greater are the difficulties confronting radiotherapy; for more extensive lesions appropriate combination therapy (radiosurgical) in line with the well-defined rules explained in the text is useful. In our experience radiotherapy yields good long term results regardless of T level and even in the more unfavorable cases. Our study confirms the low rate of lymph spread of these carcinomas: over half of the patients were N0 before treatment; only 56.7% of the patients receiving surgical treatment on the neck had histologically positive lymph nodes; there were very few neck recurrences at follow-up; the presence of suspect or frankly metastatic nodes on clinical examination, being movable and homolateral (N1), did not worsen the prognosis. However, considering the techniques used for irradiation of the primary, some patients received a substantial dose to the neck; hence radiotherapy probably played its part in the low rate of neck metastases.

Deglutition artifacts often degrade diagnostic quality in digital subtraction angiography (DSA) of neck vessels. In order to reduce this drawback, the authors gave a local anesthetic (Tetracaine) to the patients undergoing DSA of aortic arch and carotid arteries. Hundred-twenty-three subjects divided into two groups were examined: Tetracaine was administered to one group (64 patients) and not to the other (59 cases). In the first group deglutition artifacts were not noted in 59/64 cases. Among those patients not treated with Tetracaine/deglutition artifacts were absent in 45/59 cases. This local anesthetic did not produce important toxic reactions. Therefore the authors believe that administration of local anesthetics can reduce deglutition artifacts in DSA of neck vessels.

Twenty-seven patients were evaluated by intra-arterial digital subtraction angiography: 20 for portal hypertension--6 also after a porto-systemic shunt--, 4 for evaluation of a hepatic mass and 3 for pancreatic or biliary tumours. Intra-arterial DSA has always shown vascular abnormalities. The advantage of intra-arterial DSA are reduction of the required amount of contrast medium and, consequent, reduction of the frequency of contrast medium reactions. Its disadvantages are limited field size of image intensifier and reduced spatial resolution as compared with conventional angiography. However diagnosis had never been affected by this limitation.

Radiotherapy of the primary site was employed between 1959 and 1965 in the treatment of 335 unselected cases of mouth cancer. The series is examined with regard to the long-term results and gross survival is evaluated in accordance with an actuarial method. Differences dependent on sex and age, and on the type of cancer involved and the treatment modalities are illustrated and discussed.

Direct magnification radiography was evaluated on 46 patients with skeletal disorders. The equipment employed was based on a microfocus tube and it gave a magnification factor of 3 X. This technique was judged to be more useful than standard X-ray films in 35/46 cases (76%). The size of the part examined played an important role in the effectiveness of this technique, since the most useful and impressive results were obtained in thin anatomic sites, like the extremities. The highest value of direct magnification radiography was found to be in uraemic osteodistrophy, in particular for the study of the hands. This technique appeared to be very useful also in bone tumours, since it allowed a detailed evaluation of the trabecular structure and of the cortical outline.

The clinical classification of oral carcinomas presents some points still under discussion. In other respects the main questions about the treatment of these cancers could be resolved by cooperative clinical trials which impose the definition of a common clinical language. With a system based on an original computer program for the compiling, store and process essential data on cancer diseases we analyzed 736 consecutive and unselected oral carcinomas and we studied the prognostic value of main clinical factors. In our series, the main prognostic factors are tumor size, clinical appearance of the primary and clinical status of neck nodes. Sex, age and histological grade are unimportant. From our study we propose to complete the TN classification with two useful clinical criteria distinguishing the exophytic or minimally infiltrating tumors from the deeply infiltrating (greater than 1 cm) and the large metastatic omolateral nodes from the small ones (phi less than 3 cm).

Fifteen patients with portal hypertension were examined by magnetic resonance imaging (MRI) using spin-echo sequences. Sagittal and transaxial images were obtained in all cases. Ten subjects have been evaluated after portosystemic shunt operations (6 portocaval and 4 splenorenal shunts); 5 patients were studied by MRI before shunt placements. Angiographic correlation was obtained in 15 cases. In each of the preoperative examinations, MRI accurately depicted inferior vena cava, portal vein and splenic vein. Shunt patency was documented in 10/10 postoperative studies: portacaval shunts patency was better determined in the transaxial plane while splenorenal shunts were better demonstrated in the sagittal plane. Thus, MRI seems to be an accurate and noninvasive method for detecting portosystemic shunt patency without the use of intravenous contrast media and without patient exposure to radiation.

The authors set out the technical innovations which are being used to comply with the three classical aims of endocavitary curietherapy for cervical cancer: the personalization of the irradiation device, protection of staff against exposure risks due to ionizing radiations, planning and control of the irradiation conditions. The personalization of the irradiation device is achieved by preparing a specially shaped vaginal applicator for each patient, and staff protection is ensured by the use of remote-loading techniques and closed circuit television control for in-patients. The planning of the treatments answers to the logic of reproducing the usual curie therapy method with conventional radium-226 sources. In order to control the irradiation conditions, at least the essential part of the treatments must be recognized and expressed: equivalent radium milligrams per hour (MRA h), dose rate (Gy h-1), dimensions of the treated volume and space distribution of the dose.