A phase II study on the efficacy and safety of procedural analgesia with fentanyl buccal tablet in cancer patients for the placement of indwelling central venous access systems.

BACKGROUND: Pain in cancer patients is often related to oncologic therapies and diagnostic procedures. The placement of fully implantable venous access systems is a very common procedure in oncology patients. Local anaesthesia is the method most commonly used to overcome pain related to this surgical procedure, but the local anaesthetic may be unable to completely eradicate all pain. This study investigates the effectiveness and safety of fentanyl buccal tablet (FBT), administered by OraVescent® technology, in reducing procedural pain related to the placement of indwelling central venous access systems (Ports) in opioid-naïve cancer patients. METHODS: Inpatients who required an indwelling vascular access (Port) were preoperatively assessed with a self-assessment questionnaire on anxiety and pain. A 100 µg FBT was administered 10 min before preparation of the operating field. A self-assessment scale for pain experienced during the procedure was administered at the end of the procedure. Vital signs and the presence of any side effects or bothersome symptoms were monitored during the procedure, at the end, and 4 h later. RESULTS: From October 2012 to June 2014, 65 patients were enrolled in the study. A total of 61 (93.9 %) patients perceived no or a little pain during the procedure. Four patients (6.2 %) reported a lot of pain. No patient reported very severe pain. This data is significant in terms of the lower than expected presence of pain (Fisher test p = 0.0018) as assessed in our previous experience without procedural analgesia. The most common side effects of FBT was drowsiness, experienced by 28 patients at the end of the procedure (43.1 %), significantly reduced (p < 0.01) to 8 patients after 4 h (12.5 %). Nausea was present in 6 cases at the end of the procedure (9.2 %) and in 7 cases 4 h later (10.9 %). Vomiting was present in 3 cases at the end (4.7 %) and in 2 other patients after 4 h (7.8 %). No significant change of vital parameters was observed between the baseline and the subsequent measurements in all patients studied. CONCLUSIONS: The significant improvement in the number of patients experiencing little or no pain, accompanied by a lower number of non-severe side effects, suggests that FBT is a valid, practical and safe method of procedural analgesia. It will be necessary to perform further studies, taking into account the need for standard antiemetic pre-medication to minimise the incidence of nausea and vomiting.

The refusal of food in childhood: From our clinical experience to an evaluation of recent diagnostic classifications.

The aim of this study, which was carried out because of the importance of eating disorders (EDs) acquired by the young and the need to organise resources and interventions for patients and their families, was to quantify the increased incidence of EDs arising early in life in order to identify the nosographic classification that best reflects the complexity of the symptoms. Between 2003 and 2008, we assessed 128 subjects aged less than 14 years and observed a constant increase in ED-related problems. Our analysis shows the importance of representative classification criteria suitable for young patients in order to improve diagnosis and therapeutic planning. The need for a specific classification for early childhood is underlined by the fact that comorbidities and overlapping patterns often complicate adequate assessment.

Evaluation of filter paper as a means to transport inactivated bacteria for identification using the MALDI-TOF MS system.

A novel approach to transport inactivated bacteria in filter paper for identification in the MALDI-TOF MS was evaluated. Seventy four bacterial isolates were evaluated and the approach presented sensitivity of 97.3% and specificity of 100%. Inactivated bacteria in filter paper are a safer alternative to transport bacteria for MALDI-TOF MS identification.

Neural correlates of egocentric and allocentric frames of reference combined with metric and non-metric spatial relations.

Spatial relations (SRs: coordinate/metric vs categorical/non metric) and frames of reference (FoRs: egocentric/body vs allocentric/external element) represent the building blocks underlying any spatial representation. In the present 7-T fMRI study we have identified for the first time the neural correlates of the spatial representations emerging from the combination of the two dimensions. The direct comparison between the different spatial representations revealed a bilateral fronto-parietal network, mainly right sided, that was more involved in the egocentric categorical representations. A right fronto-parietal circuitry was specialized for egocentric coordinate representations. A bilateral occipital network was more involved in the allocentric categorical representations. Finally, a smaller part of this bilateral network (i.e. Calcarine Sulcus and Lingual Gyrus), along with the right Supramarginal and Inferior Frontal gyri, supported the allocentric coordinate representations. The fact that some areas were more involved in a spatial representation than in others reveals how our brain builds adaptive spatial representations in order to effectively react to specific environmental needs and task demands.

Nonsteroidal antiinflammatory drugs for cancer pain: comparison between misoprostol and ranitidine in prevention of upper gastrointestinal damage.

PURPOSE: The prophylactic strategy of nonsteroidal antiinflammatory drug (NSAID)-induced upper gastrointestinal (UGI) damage has largely been studied in arthritic patients, but not in cancer patients. The efficacy of misoprostol and ranitidine in the prevention of gastroduodenal damage in patients taking diclofenac for their cancer pain has been compared in this study. PATIENTS AND METHODS: Patients who needed high-dose (200 to 300 mg/d) diclofenac for cancer pain and without mucosal lesions at baseline gastroduodenal endoscopy were randomized to receive misoprostol (200 micrograms twice daily; M group) or ranitidine (150 mg twice daily; R group). UGI endoscopy was repeated after 4 weeks. RESULTS: Twenty-three patients treated with misoprostol and 26 treated with ranitidine concluded the study. The M group showed a significantly (P < .02) lower incidence of gastroduodenal lesions (two patients; 8.7%) than the R group (10 patients; 38.5%). Gastric ulcers occurred in one (4%) misoprostol-treated patient and in six (23%) ranitidine-treated patients. Six of seven patients with ulcers were asymptomatic. Seventy-one percent and 86% of ulcers occurred in patients older than 60 years and in those who received greater than 3.1 mg/kg of diclofenac, respectively. CONCLUSION: Misoprostol was significantly more effective than ranitidine in the prevention of gastroduodenal lesions in cancer patients receiving diclofenac.

Glycosaminoglycans prevent the functional and morphological peritoneal derangement in an experimental model of peritoneal fibrosis.

Chronic peritoneal dialysis results in fibrosis of the peritoneal membrane, which leads to progressive reduction in dialytic efficacy. It was recently shown that the intraperitoneal administration of glycosaminoglycans (GAGs) improves the efficiency of peritoneal dialysis in CAPD patients. To verify whether the favorable effects of GAGs are purely functional or involve a morphological amelioration of the peritoneal membrane structure, a study was carried out in an animal model of plasticizer-induced peritoneal fibrosis. Rats, in which chronic renal failure had been induced by subtotal nephrectomy, received either placebo, plasticizers (i.p.), or GAGs (s.c.), or plasticizers (i.p.) and GAGs (s.c.). Urea dialysate-to-plasma equilibrium, urea and albumin peritoneal clearance, and glucose reabsorption were determined. The peritoneal membrane was evaluated morphometrically and histologically. In plasticizer-treated animals, peritoneal function tests and morphology were dramatically deranged. On the contrary, the subcutaneous administration of GAGs in plasticizer-treated rats maintained the peritoneal physiology and normal structure. The subcutaneous administration of GAGs protects peritoneal functions by affecting the remodeling of the peritoneum, rather than by a purely functional or simple mechanical effect.

Experience with operation for total anomalous pulmonary venous connection in infancy.

Twenty patients presenting with total anomalous pulmonary venous connection (TAPVC) in infancy underwent cardiac repair. Four had associated major intracardiac anomalies (complex TAPVC) and 16 had isolated TAPVC. All patients with complex lesions died during or shortly after the operation; they all had pulmonary venous obstruction (PVO). The associated malformations were critical pulmonary stenosis (one case), multiple ventricular septal defects (VSDs) (one case), mitral atresia (one case), and asplenia syndrome with common atrioventricular valve, double-outlet right ventricle, and pulmonary stenosis (one case). Among the patients with isolated lesions there were two surgical deaths, both in infants less than 1 month of age, with severe PVO and subdiaphragmatic drainage. Statistical analysis of these data shows a strongly incremental risk of surgical death due to the presence of associated malformations. Analysis of just isolated TAPVC shows a possible incremental effect due to neonatal age (less than 1 month) and PVO, these two factors being not clearly separated. There have been no late deaths and no late complications among the 14 survivors followed from 7 months to 10 years (mean 44 months). An aggressive surgical approach regardless of the age, degree of pulmonary hypertension, and type of anatomic connection is advised for isolated TAPVC. Some caution is recommended for complex TAPVC, in which a much higher risk is anticipated, particularly when a palliative pulmonary vein-to-left atrium anastomosis is performed.

Discrete subaortic stenosis. Operative age and gradient as predictors of late aortic valve incompetence.

Between January 1969 and May 1990, 100 patients were operated on for discrete subaortic stenosis. Three patients died in the perioperative period. Patients with intrinsic lesions, prosthetic replacement, or extensive operative remodeling of the aortic valve were excluded from the analysis. The 67 remaining patients had a median follow-up of 62 months. Preoperatively, 8 patients had aortic valve competence, 51 had mild incompetence, and 8 patients moderate aortic valve incompetence. At follow-up mild incompetence persisted in 27 and moderate incompetence in 6 patients. In 1 patient it worsened from no incompetence to mild and in another patient from mild to moderate. The probability of aortic incompetence at follow-up was significantly and simultaneously related (multivariate ordinal logistic model) to (1) older age at operation (logarithm of months, p = 0.007), (2) higher preoperative gradient (third power of milligrams of mercury, p = 0.0004), (3) preoperative cardiomegaly (p = 0.04), and (4) surgical myectomy (p = 0.002). There was an interaction between age and gradient (p = 0.03). Two nomograms are proposed as a generalizable aid to decision making. The data support the policy of early repair of subaortic stenosis.

Tricuspid atresia versus other complex lesions. Comparison of results with a modified Fontan procedure.

Several modifications of the Fontan principle are currently applied to the treatment of tricuspid atresia with low mortality. The use of these modifications in other malformations has most frequently been associated with less satisfactory results. At our institution, from June 1977 to October 1986, 35 consecutive patients, whose ages ranged from 8 months to 20 years (median age 3.4 years), underwent a modified Fontan procedure. Twenty patients with a median age of 3.2 years (group I) having tricuspid atresia (16 patients) or hypoplastic right heart syndrome (four patients) were treated by means of a right atrium-pulmonary artery anastomosis (12 patients) or right atrium-subpulmonary chamber connection (eight patients). Fifteen patients (group II) with a median age of 3.6 years, having a single left ventricle (10 patients), left atrioventricular valve hypoplasia or atresia (three patients), or double-outlet right ventricle (two patients), underwent right atrium-pulmonary artery anastomosis, together with a repositioning of the atrial septum to the right of the right atrioventricular valve, which thus left intact the inlet to the ventricle(s). The operative mortality rate was 25% in group I and 0% in group II. One patient in group I and one in group II died late postoperatively. All the 28 survivors are free of symptoms 3 months to 9 years after correction. According to our results, low risk can be associated with modified Fontan procedures in the treatment of complex heart malformations other than tricuspid or pulmonary atresia. Preserving the integrity of the entire inlet to the ventricle(s) by repositioning the interatrial septum, as done in group II malformations, might be helpful in improving the quality of the repair.

Antithrombin III deficiency as a risk factor for catheter-related central vein thrombosis in cancer patients.

The fibrin sleeve of venous catheters (VC) and parietal thrombi represent frequent and dangerous side-effects of central venous catheterization (CVC), due to the risk of embolism. Reduced levels of coagulation clotting factors inhibitors (such as Antithrombin III) are known to be associated with increased thrombogenic risk. The aim of this study was to evaluate the role of Antithrombin III (AT III) deficiency as a risk factor for thrombosis in cancer patients undergoing CVC. The study groups included patients with a reduced AT III activity (< 70%, 20 consecutive patients) and with normal AT III values (> 70%, 20 randomly selected patients), requiring a VC for chemotherapy and/or total parenteral nutrition. The study protocol included evaluation of Hb, PLTs, PT (INR), aPTT, Fibrinogen and AT III at days 0, 1, 3 and 8 after CVC and upon VC removal. Peripheral and pullout phlebographies were performed in all patients on catheter withdrawal. A quantitative scale was developed to evaluate both VC and parietal thrombus degree in each catheter-containing venous segment (subclavian, innominate, superior vena cava); the sum of the mean values was defined as overall thrombus. The average VC dwelling time was similar in both groups. There were no significant differences in Hb, PLTs, PT (INR), aPTT, Fibrinogen and in the remaining parameters of the study between the two groups. The group with AT III deficiency presented a higher degree of both parietal (p < 0.05) and overall thrombus (p < 0.02). Data showed a higher severity of CVC-related thrombosis in patients with AT III deficiency than in the control group. Further studies are needed to evaluate whether the therapeutically-induced normalization of AT III levels can reduce the thrombosis degree.

Aortic valve prosthesis and late survival of successfully repaired type A dissection.

Seventy-two operative survivors of acute type A dissection between 1973 and 1993 had a complete follow up with a 16 years actuarial survival of 57% and a reoperation free actuarial survival of 34%. Follow up was 100% complete and covered a total of 500.6 patients-years with a median of seven years. Distal tear location (proximal, medium or distal aortic arch) with retrograde dissection toward the aortic valve was the single most important predictor of late mortality with a relative risk of 4.4 (70%CL 2.4-8.2) (p = 0.016). Mortality rate of patients with an aortic valve prosthesis was 6.2%/patient-year vs. 1.7/patient-year without aortic valve prosthesis, with a relative risk of 3.4 (70%CL 2.0-5.8) (p = 0.02). This finding could be due to confounding of variables related both to death and need of aortic valve replacement. Therefore a multivariate proportional hazard analysis, with mandatory inclusion of possible confounders, was done. It showed that patients with aortic valvular prosthesis had eight times higher risk (70% CL 2.7-24.2); prosthetic aortic valves and conservative aortic root procedures had an unconfounded relative risk of 14 times higher (70%CL 3.4-58.7) (P = 0.06), whereas patients with a composite conduit had a six times higher risk (70%CL 2.0-19.9) (p = 0.11). These findings support the attitude favoring a selective approach to aortic root repair and oppose standardized use of aortic valve prosthesis or composite conduit in acute type A dissection.

Emergency surgical treatment of ruptured incompetent mitral valve after percutaneous valvuloplasty.

Of 263 consecutive patients undergoing mitral balloon valvulotomy at the Cardiac Catheterization Unit of Padua University Hospital, six (2.3%) required surgical treatment within 24 hours. The indication for surgery was unstable hemodynamic status due to acute mitral insufficiency caused by the percutaneous balloon valvulotomy. The purpose of this study was to evaluate whether the failure of percutaneous mitral balloon valvulotomy, in this subset of patients, was related to technical problems or was the direct consequence of unfavourable pathologic conditions. Additionally, we evaluated the operative results and clinical outcome of these six patients. The patients were all female with a mean age of 55.7 +/- 14 years (range 38-75 years). Previous surgical commissurotomy was performed in three. The anatomical lesions responsible for the massive regurgitation were tear of the anterior leaflet in two patients and tear of the posterior leaflet in four; rupture of the papillary muscle and/or chordae tendineae were present in five. All patients underwent mitral valve replacement. The elapsed time between the onset of mitral regurgitation and surgery ranged from two to 24 hours (mean 10 +/- 11 hours). There were two hospital deaths (33.3 +/- 21.1%): all surviving patients are alive and clinically well. In conclusion, massive mitral regurgitation following percutaneous mitral dilatation appears to be related to unfavourable pathology of the mitral valve rather than to technical errors. Therefore, careful patient selection is mandatory in order to achieve optimal results. In our experience, adequate and aggressive medical therapy provided sufficient time to prepare for the surgical intervention.(ABSTRACT TRUNCATED AT 250 WORDS)

Determinants of late survival of 105 patients operated for dissection of the aorta.

In the surgery of aortic dissection, only a small section of aorta compared to the extent of the aortic damage, is usually replaced. The disease is not cured by surgery and needs continuous postoperative surveillance and medical therapy. We report the follow-up of 105 patients who were operated upon between January 1970 and April 1986 and discharged from hospital. Overall actuarial survival was 90% at 5 years, 52% at 10 years and 39% at 15 years. There were 20 deaths, mostly (85%) related to cardiovascular causes. Survival times were correlated, using multivariate methods, with several pre-, peri- and postoperative variables to identify significant risk factors and to calculate actuarial survivals. We found that postoperative low output syndrome (p = 0.007) and stroke (p = 0.04) adversely affected survival and that previous aortic disease or operation (p = 0.004) was associated with an increased rate of dissection-related complications. On the contrary, preoperative hypertension was related to a significantly better survival (p = 0.01) and survival free of dissection-related complications (p = 0.001). When dissection was related to hypertension, adequate postoperative medical treatment neutralized the progression of the aortic damage and its consequences. When dissection was not due to hypertension, the observed survival was unsatisfactory, probably because of a more fragile aorta and inadequate medical follow-up therapy.

A new technique of continuous ambulatory peritoneal dialysis (CAPD): double-bag system for freedom to the patient and significant reduction of peritonitis.

A new technical approach has been described for the treatment of patients on CAPD. The new approach is based on the use of a two-bag system and closed connection by a connector to the Tenckhoff catheter. After each dialyzate exchange the patient discards the entire system and is completely bag-free, unlike the Oreopoulos CAPD technique. Using this new procedure we have markedly reduced the incidence of peritonitis and we have made the patient free from carrying an uncomfortable burden during the interval of solution exchange.

Early and late survival of repaired type A aortic dissection.

From 1 January 1977 to 31 December 1988, 119 patients were operated upon for type A aortic dissection. The maximum follow-up was 11.7 years (median 5.6 years); follow-up was 100% complete. Actuarial survival was 47.3% +/- 5%. The death risk decreased rapidly to a constant rate of 0.0027 events/month after 3 months. There were 41 early deaths, mostly due to haemorrhage, brain damage and low output syndrome. A significantly higher probability of early death was observed in patients with preoperative myocardial ischaemia or infarction (P less than 0.0001) or preoperative cerebral symptoms (P = 0.0002). Extended dissection increased the risk proportionally to the length of the aorta involved (P = 0.0002). Typical dissection originating from an intimal tear in the ascending aorta had a significantly lower operative risk than atypical dissection with an intimal tear not localized in the aortic root (P = 0.0006). Of the 14 late deaths, 2 were unrelated to dissection, 2 were of unknown origin and 4 were sudden. Stroke was the cause of 2 and congestive heart failure the cause of 4 deaths. The probability of late death was higher in patients with perioperative brain damage (P = 0.003) and in patients with preoperative shock (P = 0.0025). It was significantly lower in patients with dissection of hypertensive aetiology (P = 0.002). There were 13 reoperations on 12 patients. Early reoperations were due to rupture of the distal aortic anastomosis. Late reoperations were mostly due to dehiscence of aortic valvular prosthesis.(ABSTRACT TRUNCATED AT 250 WORDS)

Early and late results after repair of tetralogy of Fallot.

Between January 1, 1975, and December 31, 1988, 233 patients were operated on for correction of tetralogy of Fallot (TOF). Mean follow-up was 13.9 years (median 7.65 years) and was 99.6% complete. Actuarial survival was 84 +/- 3%. The risk of death decreased gradually to a constant rate of 0.00034 deaths/month by the 6th postoperative month. There were 22 early deaths, due mostly to Low Output Syndrome. The principal incremental risk factor was the postrepair ventricular pressure ratio (PRV/LV) (P less than 0.0001). Other factors were: patent ductus arteriosus (PDA; P = 0.02), other associated anomalies (P = 0.005), higher preoperative hemoglobin levels (P = 0.06) and use of transannular patches (P = 0.02). The operative risk was significantly reduced by a recent operative date (P = 0.01) and by an older age at operation (P = 0.12). Among 8 late deaths, 2 were unrelated to the cardiac condition, 2 occurred suddenly, 3 were due to congestive heart failure and the last was due to reoperation for patch endocarditis. The risk of late death was significantly higher in patients operated on at an older age (P = 0.04). There were 10 open heart reoperations: 5 for patch dehiscence, 4 for residual pulmonary stenosis and 1 for residual atrial septal defect. The reoperation-free actuarial survival was 82 +/- 3%. With the present operative standards, the parametric operative risk of an average patient with simple TOF (hemoglobin = 12 g, PRV/LV = 0.5) is 0.7%. Where the TOF is severely cyanotic (hemoglobin = 25 g) and the pulmonary arteries are severely restricted, the average mortality is 30%.(ABSTRACT TRUNCATED AT 250 WORDS)

Increased immunoglobulin-secreting cells in the blood of patients with active idiopathic IgA nephropathy.

Peripheral blood lymphocytes from 33 patients with idiopathic IgA nephropathy (IgAN) and 15 healthy controls were stimulated in vitro by Protein A from Staphylococcus Cowan I; immunoglobulin (Ig) production was measured by a reverse hemolytic plaque assay to evaluate the quantity of cells secreting Ig. In addition, serum Ig levels, circulating IgG, IgA and IgM immune complexes (ICs) and the Fc and C3b receptor mediated phagocytosis of peripheral monocytes were measured. The laboratory findings in different phases of the disease were compared. The mean level of IgA-plaque forming cells (IgA PFC) in IgAN patients with normal renal function was significantly higher (p less than 0.001) than the mean control value. In contrast, they were reduced significantly in those patients who were subjected to periodic hemodialysis (p less than 0.001). Disease activity produced a significant increase in IgG PFC and IgA PFC, high IgG and IgM serum levels, high circulating IgG ICs, and low C3b-mediated phagocytic function of the peripheral macrophages. These findings demonstrate that IgAN is associated with an increased number of IgG and IgA-secreting cells in the peripheral blood of patients during the active phase of the disease and that the concurrent presence of high levels of circulating Ig ICs may be responsible for the gross hematuria, as their deposition in the glomeruli could activate the complement system.

Why the double-bag system still remains the best technique for peritoneal fluid exchange in continuous ambulatory peritoneal dialysis.

Since March 1979 (the Italian-French-Spanish meeting in Turin), we have been using the double-bag system for peritoneal fluid exchange in patients on continuous ambulatory peritoneal dialysis (CAPD). This technique, subsequently followed by many others because of the advantages to the patients, still represents the best tool in bag-exchange procedure, because it satisfies the following characteristics: single luer-lock connection; flush-before-fill; simple, safe, and aseptic manipulation; short training period; no carrying bag; good patient acceptance; and low incidence of exogenous peritonitis. In 13 years with 237 patients selected for double-bag treatment, we have observed an incidence of 1 episode of peritonitis every 26.6 patient-months. Few clinical CAPD-related complications like hypotension and alterations of Ca-P metabolism were observed, probably as a result of more personalized peritoneal fluid with high Na+ (136 mEq/L) and Ca2+ (3.5 mEqL) concentrations. In the meantime, we have also had available plasticizer-free bags, which eliminated one of the main risk factors in peritoneal sclerosis. The utilization of the plasticizer-free double-bag system, currently adopted by numerous other centers, still remains the best option from a clinical and psychological viewpoint of the patients on CAPD.

Effect of hypertriglyceridemia correction by omega-3 fatty acids on peritoneal transport in continuous ambulatory peritoneal dialysis patients.

Lipid abnormalities, both hypercholesterolemia and particularly hypertriglyceridemia (hyperTg), are common in long-term continuous ambulatory peritoneal dialysis (CAPD) patients. Hyperviscosity and rheological alterations have been proposed as major hemodynamic problems in hyperTg patients. The aim of this study was to evaluate whether a hyperTg correction by employing omega-3 fatty acids (omega-3) affects peritoneal transport. Six hyperTg (> 700 mg/dL) CAPD patients were treated with 2-3 g/day of omega-3 until normal Tg values were achieved. The assessment of peritoneal dialysis efficacy was performed by evaluating the peritoneal equilibration test (PET) before omega-3 supplementation, when normal Tg levels were reached, and 3 weeks after stopping therapy when hyperTg returned. When normal Tg levels were reached, a small but significant improvement of urea and creatinine D/P was noted: 0.85 +/- 0.05 versus 0.93 +/- 0.03 (p < 0.05) and 0.78 +/- 0.03 versus 0.86 +/- 0.05 (p < 0.05), respectively, with negative correlation between D/P of urea and Tg. These preliminary data demonstrate that a hyperTg correction with omega-3 may induce an increase in peritoneal transport of small molecules in CAPD.

Peritoneal sclerosis: role of plasticizers in stimulating interleukin-1 production.

The role of plasticizers (PLS) in inducing water flow inhibition and peritoneal sclerosis has been demonstrated in both in vivo and in vitro studies. Interleukin-1 (IL-1) has been shown to be a regulator of fibroblast proliferation as well as collagenase production. The aim of this study was to evaluate the role of PLS in stimulating mononuclear cell IL-1 secretion. Two cultures containing 10(3) cells/mL were obtained from 14 healthy subjects. One was used as the control, and the other was mixed with diethylhexylphthalate (DEHP) to reach a final concentration of 2.8 x 10(-3) M. After 4 hours the samples were centrifuged, and the supernatants were tested by radioimmunoassay for IL-1 alpha and IL-1 beta. The results showed a significant increase in both IL-1 alpha and IL-1 beta production in DEHP-stimulated cells in comparison to the controls: 42.6 +/- 15.4 versus 29.3 +/- 10 ng/L (p < 0.015) for IL-1 alpha, and 153.6 +/- 55 versus 113.6 +/- 32 ng/L (p < 0.03) for IL-1 beta In conclusion, PLS added to mononuclear cells were able to induce IL-1 secretion. This mechanism could be responsible, at least in part, for the development of peritoneal sclerosis. Thus the employment of plasticizer-free bags should be elective in peritoneal dialysis.