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Biomedical subjects

A Prada

Publications and source records attributed to A Prada.

At least 55 records · Page 3Linked to original sources

Biphasic annual periodicity in relapses of inflammatory bowel diseases. Gruppo di Studio per le Malattie Infiammatorie Intestinale.

We evaluate the periodicity in relapses of ulcerative colitis and Crohn's disease in this multicenter prospective study. In 275 relapses among 184 patients with inflammatory bowel disease, a statistically significant biphasic annual periodicity, with peaks in the spring and autumn, was documented only for ulcerative colitis relapses (p = 0.006). This finding may be important in understanding relapse risk factors and in terms of prevention.

Colitis, Ulcerative↗

First bleeding episode from oesophageal varices in cirrhotic patients: a prospective study of endoscopic predictive factors.

Two hundred patients affected by liver cirrhosis and oesophageal varices were studied in 9 Gastrointestinal Units in Lombardy (Northern Italy) in order to assess factors possibly related to variceal bleeding. Only patients without any previous episode of gastrointestinal bleeding were included in the prospective evaluation. For each patient demographic data, aetiology of cirrhosis, various clinical and biochemical parameters able to group patients into the three Child-Pugh Classes, endoscopic items for calculation of Beppu's and of NIEC prognostic scores were recorded on computerized cards. Patients were regularly interviewed every three months for one year and underwent an upper gastrointestinal endoscopy at enrollment, after six months and in case of bleeding. Within the twelve-month follow-up period, 29 out of the 200 patients (14%) bled and 52 out of 200 died (26%). In 16 of the 52 patients who died (59% of bleeding patients) death was directly related to gastrointestinal bleeding. Bleeding from oesophageal varices was endoscopically proven in 19/29 patients, in another 9 bleeding was classified as from unknown source and in one patient a bleeding gastric ulcer was diagnosed. Univariate analysis of all the recorded clinical, biochemical and endoscopic parameters, performed by Chi-square method and Fisher exact test showed that the presence of RWM (p < 0.001) was the only factor significantly associated to variceal bleeding within one year. Relationship between size of varices and bleeding was very close to the statistical significance but did not achieve it (p = 0.058).

Adult↗

Treatment of primary or relapsing limb cancer by isolation perfusion with high-dose alpha-tumor necrosis factor, gamma-interferon, and melphalan.

BACKGROUND: Utilization of alpha-tumor necrosis factor (alpha-TNF) in clinical practice is limited by severe general side effects. Very promising results with low toxicity were reported with administration of alpha-TNF by isolation perfusion in extracorporeal circulation. METHODS: From December 1991 to November 1992, 14 patients underwent perfusion with alpha-TNF (2-4 mg, total dose), gamma-interferon (1.5 x 10(6) IU), and melphalan (10 mg/l/perfused limb). Twelve patients presented in-transit metastases of the limbs, one patient, a clear cell sarcoma of the hand, and one patient, a wide spindle cell carcinoma of the thigh. Perfusion lasted 90 minutes and was conducted in mild hyperthermia (38-40.5 degrees C, muscle temperature). RESULTS: Nine complete regressions and four stable diseases were recorded. In one case, a reliable evaluation of response was not possible for diffused tissue necrosis. Five patients relapsed or progressed locally from 3 to 4 months after surgery, five presented distant localizations from 2 to 7 months after surgery, and one died of disease 6 months after perfusion. Twelve patients are alive, seven without evidence of disease. A septic-like shock syndrome was observed in all patients and required administration of dopamine, dobutamine, or noradrenaline. One patient died 30 days after perfusion from a multiorgan-failure syndrome, likely due to alpha-TNF. The follow-up time ranges from 4 to 15 months (median, 6). CONCLUSIONS: The preliminary, impressive results reported in other series were not completely confirmed in this study adopting the same treatment scheme. Further clinical experience and biologic data are needed to state the real efficacy of the approach and to reduce the severe general toxicity consistently associated with this type of treatment.

Adult↗

Biphasic diurnal periodicity in bleeding from peptic ulcer.

OBJECTIVE: To evaluate if there was periodicity in the manifestations of gastrointestinal bleeding (hematemesis and melena). METHOD: This is a multicenter prospective study carried out in the Endoscopy Units of eight hospitals. At the time of the emergency endoscopy, the following data were collected: age, sex, endoscopic diagnosis, solar hour of the first hematemesis (vomiting of bright red or tarry black material) and of the first melena (black or bloody soft stools), and any drugs taken during the week before the bleeding episode, regardless of the dose. RESULTS: 806 patients were studied. Bleeding was from peptic ulcer in 405 patients (50%), from esophageal varices in 197 (24%), and from other sources in the remainder. Analysis using single cosinor statistics showed a nonrandom distribution in bleeding from peptic ulcer, whether presenting first with hematemesis (p = 0.02) or melena (p = 0.03). There were two peaks at 6:45 AM and 6:45 PM for hematemesis and at 7:25 AM and 7:25 PM for melena, representing a biphasic diurnal (ultradian) rhythm. CONCLUSIONS: This study shows that bleeding due to peptic ulcer has a biphasic diurnal periodicity. This has potential importance for the pathogenesis of bleeding, for the management of gastrointestinal hemorrhage and the administration of drugs known to cause peptic ulcer bleeding.

Adolescent↗

Adoptive immunotherapy of advanced melanoma patients with interleukin-2 (IL-2) and tumor-infiltrating lymphocytes selected in vitro with low doses of IL-2.

Freshly isolated tumor-infiltrating lymphocytes (TIL) from stage IV melanoma patients were cultured for 2 weeks with low doses of interleukin-2 (IL-2; 120 IU/ml), to select potentially for tumor-specific lymphocytes present in the neoplastic lesion, followed by high doses (6000 IU/ml) to achieve lymphocyte expansion. TIL were serially analyzed for their expansion, phenotype and cytotoxic activity against autologous and allogenic tumor cells. A preferential lysis of autologous melanoma cells was obtained in long-term cultures of 7/13 cases (54%), while the remaining ones showed a major-histocompatibility-complex-unrestricted, lymphokine-activated-killer(LAK)-like activity at the time of in vivo injection. Sixteen patients with metastatic melanoma were infused with TIL (mean number: 6.8 x 10(9), range: 0.35 x 10(9)-20 x 10(9)) and IL-2 (mean dose: 130 x 10(6) IU, range: 28.8 x 10(6)-231 x 10(6) IU); 1 complete and 3 partial responses were observed in 12 evaluable patients (response rate 33%). In all responding patients, injected TIL showed an in vitro preferential lysis of autologous tumor cells, while in no cases were TIL with LAK-like activity associated with a clinical response. The mean autologous tumor cytotoxic activity of TIL at the time of in vivo injection was significantly higher in responding patients in comparison to nonresponding ones, suggesting that a marked and preferential cytolysis of autologous tumor cells is associated with the therapeutic efficacy of TIL.

Adult↗

Familial aggregation of inflammatory bowel disease in northern Italy: a multicenter study. The Gruppo di Studio per le Malattie Infiammatorie Intestinali (IBD Study Group).

To assess the familial aggregation of inflammatory bowel disease (IBD) in Italy, the family pedigrees of 411 patients with ulcerative colitis (UC) and 241 patients with Crohn's disease (CD) seen at 14 participating hospitals were studied. Sufficient information was obtained on 97% of 3752 first-degree relatives, 80% of 8869 second-degree relatives, and 74% of 5791 cousins. Thirty-six propositi (5.52%) had a total of 44 affected relatives (16 CD, 28 UC). The prevalence of IBD was higher in first- than in second-degree relatives and cousins (791, 112, and 163 in 100,000, respectively). A strong intrafamilial disease concordance was observed, with 26 cases of UC and 6 of CD among relatives of UC patients and 10 cases of CD and 2 of UC among relatives of CD patients. The prevalence of UC among first-degree relatives of UC patients and that of CD among first-degree relatives of CD patients was 680 and 531 in 100,000, respectively. In conclusion, there is a high degree of familial aggregation for IBD in Italy, with a strong intrafamilial disease concordance.

Adolescent↗

Treatment of recurrent in transit metastases from cutaneous melanoma by isolation perfusion in extracorporeal circulation with interleukin-2 and lymphokine activated killer cells. A pilot study.

Chemoresistant melanoma cells are known to be susceptible in vitro to lymphokine activated killer (LAK) cells. To obtain a high LAK/tumour cell ratio in vivo and avoid systemic toxicity due to interleukin-2 (IL-2), we used IL-2 plus LAK cells in the treatment of in transit melanoma metastases of the limbs by isolation perfusion (IP). In vivo immunological modifications induced by this immunotherapeutic approach were also analysed. Six patients previously treated with IP in extracorporeal circulation with tumour cytotoxic drugs and presently relapsing or not responding, were submitted to locoregional adoptive therapy consisting of 5 days systemic administration of IL-2 (Proleukin, EuroCetus) (9-12 x 10(6) IU/m2/day c.i.). Autologous LAK cells were derived from leukapheresis and subsequent in vitro stimulation with IL-2; LAK cells were then given along with IL-2 (120-2400 IU/ml of perfusion priming) to the affected limb by IP. In addition, 7-16 x 10(9) LAK cells were administered by systemic infusion the day after together with IL-2 (9-12 x 10(6) IU/m2/day) by c.i. for 5 days. All patients concluded the treatment without major toxicity. The analysis of circulating lymphocytes obtained from extracorporeal circuit at different times revealed rapid disappearance of LAK cells, suggesting their extravasation and/or endothelial adhesion in perfused tissues. Clinical responses included four partial and one complete response; another patient had stable disease. All patients are presently alive. Follow-up after IP ranges from 8 to 22 months.

Adult↗

[Use of buprenorphine after right hepatectomy].

Ten patients who underwent surgery (5 right hepatectomy and 5 colectomy) for cancer participated in a clinical controlled study. They were treated with buprenorphine (i.v. slow infusion) to relieve postsurgical pain. We found an increased urinary excretion of this drug in patients who underwent hepatectomy as compared with patients who underwent colectomy. However no differences in the occurrence of side-effects and/or in the therapeutic effect were observed between the two groups. We conclude that buprenorphine can be effectively and safely used also in patients with a resection of liver parenchyma.

Adenocarcinoma↗

A phase II study of the administration of recombinant interleukin 2 (rIL-2) plus lymphokine activated killer (LAK) cells in stage IV melanoma patients.

From January 1987 to February 1988, 15 stage IV melanoma patients were treated with two courses of bolus injection of rIL-2 plus LAK cell infusions at the National Cancer Institute of Milan. The original treatment regimen included a first course of rIL-2 administration (400 micrograms/m2 bolus injection 3 times a day [TID] for 4 days) and a second course of rIL-2 administration (800 micrograms/m2 bolus injection TID for 7 days) separated by 4 consecutive daily leukaphereses. Autologous lymphokine activated killer (LAK) cells were reinfused into each patient on three occasions during the second period of rIL-2 administration. Due to the appearance of grade III-IV neurological, hepatic and cardiopulmonary toxicity, 7 patients discontinued dosing before the end of treatment, one patient desired to be withdrawn and one patient died from rapidly progressive disease, although complications of rIL-2 administration may have contributed to her death. Only 6 patients completed the schedule without evidence of major intolerance, even though the planned dose during the second course of rIL-2 was reduced to 400 micrograms/m2. The complete duration of treatment ranged from 11 to 19 days. The total dose of rIL-2 injected ranged from 12.6 to 30.4 mg. The number of infused LAK cells ranged from 15.5 x 10(9) to 60 x 10(9)/patient. Two of the 14 evaluable patients showed a minor anti-tumor response. In 5 patients new metastases in other sites were documented from 2 to 5 months after completion of dosing. No apparent association was found between progression of the disease (or the appearance of new metastases) and the total dose of rIL-2 injected, the number of LAK cells administered or the number of days of treatment. By December 1988, all patients had died of their disease in a period ranging from 3 to 14 months from the last injection of rIL-2. The lack of significant clinical responses in this study and the high toxicity of this treatment lead us to conclude that at least as far as melanoma patients are concerned, adoptive immunotherapy with rIL-2 plus LAK cells (as described here) is not a justifiable treatment option unless new evidence presents itself.

Adult↗

Treatment of postoperative pain: comparison between administration at fixed hours and 'on demand' with intramuscular analgesics.

From the data in the literature it can be seen that 40% of the surgical population has insufficient postoperative analgesia. Many reasons have been given for this: pain control delegated to the doctor on duty and/or the nursing staff; administration of drugs 'on demand', if the patient asks for them, or the nurses feel it to be necessary; fear of causing side effects such as respiratory insufficiency; or provoking addiction by giving narcotics. The aim of this paper is to evaluate the intensity of pain, the side effects, the degree of activity, anxiety, feeling of weakness and the mood of patients surgically treated for oncological diseases of the thorax and upper abdomen, comparing two different antalgic approaches. Thirty-five patients were studied. Pain was treated on demand with a narcotic, or an anti-inflammatory drug, or not treated at all; 20 patients were treated with analgesics given at predetermined hours, following the regime: methadone 10 mg intramuscularly (i.m.) every 12 h from the first to the third day following surgery and sodium diclofenac 75 mg (i.m.) every 12 h from the fourth to the seventh day. Results showed that patients treated with analgesics given intramuscularly at fixed hours have a significantly better pain control during the whole week of treatment (P less than 0.001), on average sleep more (P less than 0.001), spend more time standing or sitting and fewer hours lying down (P less than 0.001), have a higher performance status and feel less weak (P less than 0.05) than the group of patients treated with drugs 'on demand', or not treated at all.

Abdominal Neoplasms↗

Nizatidine and ranitidine in the short-term treatment of duodenal ulcer: a cooperative double-blind study of once-daily bedtime administration.

The aim of the present study was to assess the clinical efficacy and safety of a new H2-antagonist, nizatidine (N), administered as a single bedtime dose of 300 mg, compared with ranitidine (R) at the same dosage, in the short-term treatment of duodenal ulcer. One hundred forty one patients were included in the study: 70 were treated with N and 71 with R. During the study, three patients were withdrawn for unwanted effects not related to the treatment, and therefore, 69 patients per group were studied. After 4 wk of treatment, 58 patients treated with N (84.1%) and 55 in the group treated with R (77.5%), showed complete endoscopic ulcer healing (p greater than 0.5). The corresponding figure after 8 wk of therapy was 64 (94.2%) and 65 (94.2%) (p greater than 0.5). A similar effect on pain relief was observed: 42% of patients in both groups became asymptomatic after 4 wk. After 8 wk, the percentage rose to 84.2% in the group treated with N and 87.0% in the R group (p greater than 0.5). In both groups, only minor side effects occurred, not requiring drug discontinuation. These data show that nizatidine in a single bedtime dose of 300 mg is as effective and safe as ranitidine at the same dosage, and represents therefore a valid alternative to the usual H2-antagonists.

Adolescent↗

A phase I study of recombinant interleukin 2 in melanoma patients. Toxicity and clinical effects.

Toxicity and clinical effects of a new brand of recombinant interleukin 2 (rIL2, BioleukinTM, Biogen, Geneva) were evaluated by a phase I study in 12 patients with stage III melanoma. Escalating doses from 100 micrograms/m2 to 800 micrograms/m2 were administered thrice a day with bolus injections given via a peripheral venous catheter for up to a maximum of 7 days. All patients showed malaise, fever and chills and mild gastrointestinal side effects. A modest electrolyte imbalance (hypocalcemia and hypokalemia) was detected in all 12 patients. Renal toxicity as judged by serum creatinine was not observed, and hepatic toxicity was moderate with the possible exception of one patient who had an unclear previous history of liver dysfunction. Mild, transient leukopenia was found in several patients, whereas thrombocytopenia developed in 4 patients; no anemia was observed. Cutaneous rash was seen in half of the patients treated. Fluid retention was minimal, with a weight gain associated to treatment that never exceeded 10% of pretreatment body weight. Electrocardiographic alterations developed in 2 patients in the form of ventricular and supraventricular extrasystoles. In 2 patients given the highest dose of rIL2, a significant reduction in transfer lung factor for carbon monoxide was seen, indicating alterations in pulmonary functions. Other dose-related toxicities were thrombocytopenia and malaise. All side effects disappeared 2-3 days after the end of rIL2 administration. No major responses were seen in association with the 4-8 days of treatment given in this study.

Adult↗

Invasive candidiasis does not complicate short-term cimetidine treatment of duodenal ulcer.

The purpose of this study was to record the frequency of invasive candidiasis of duodenal ulcer and to determine whether or not it is enhanced by cimetidine treatment. Our multicenter prospective trial involved 99 patients with endoscopically proven duodenal ulcer who were undergoing a 4- or 8-week cimetidine (800 mg/day) treatment program. At the endoscopic examination, performed before and after the 4- or 8-week treatment, three biopsy samples were taken from the ulcer edge or from the healed tissue. Ulcer infiltration by Candida was presumed by the presence of mycetes in stained tissue samples. Healing rate was 76% at 4 weeks and 89.9% at 8 weeks. Candida infiltration was not seen in any biopsy specimen. Short-term treatment with cimetidine does not promote invasion of mycetes into the duodenal ulcer lesion.

Adult↗

Hyperthermic antiblastic perfusion with DTIC in stage IIIA-IIIAB melanoma of the extremities.

The aim of this paper is to evaluate the effectiveness of DTIC when employed at a local level in hyperthermic antiblastic perfusion (HAP) for stage IIIA-IIIAB melanoma patients. Twenty-seven consecutive patients have been treated at the National Cancer Institute of Milan from October 1983 to June 1985. All the patients were submitted to HAP at 40 degrees for 60' with DTIC at the dosage of 2.5 g/m2 [corrected] for lower extremities and 1.5 g/m2 [corrected] for upper extremities. We observed a complete local response in three patients and a partial local response 50% in seven patients, 10 patients has a response less than 50% and 4 patients did not show any response. After surgical removal of the residual tumor when possible, 14 patients are alive without detectable disease while 11 are alive with disease and two dead for progression. No serious complications were observed. These data indicate that DTIC seems able to obtain in HAP, results superimposable to L-PAM without any significant toxicity.

Adult↗

Effects of benzydamine on the oral mucositis during antineoplastic radiotherapy and/or intra-arterial chemotherapy.

In view of the good results obtained with benzydamine against oral radio-chemomucositis in a previous trial, a double-blind/placebo study was undertaken in order to ascertain the possible oral histoprotective effect of benzydamine mouthwash during the intra-arterial polychemotherapy and/or radiotherapy for neoplasms of the head and neck. Statistical comparison of the results obtained in these two groups, treated with benzydamine and placebo mouthwash, revealed a marked difference in the clinical evolution of iatrogenic tissue damage. The benzydamine topical application was more effective than placebo in the control of mucositis symptoms and signs produced by radiotherapy and/or intra-arterial antineoplastic chemotherapy.

Administration, Topical↗

Intradural cauda equina schwannoma.

Intradural schwannoma is an uncommon tumor, especially in the cauda equina. The value of postmyelographic computed tomography is discussed in this case.

Cauda Equina↗