Phase III study of interferon alfa-NL as adjuvant treatment for resectable renal cell carcinoma: an Eastern Cooperative Oncology Group/Intergroup trial.

PURPOSE: To evaluate the role of adjuvant interferon alfa after complete resection of locally extensive renal cell carcinoma. PATIENTS AND METHODS: A total of 283 eligible patients with pT3-4a and/or node-positive disease were randomly assigned after radical nephrectomy and lymphadenectomy to observation or to interferon alfa-NL (Wellferon, Burroughs-Wellcome, Research Park, NC) given daily for 5 days every 3 weeks for up to 12 cycles. Patients were stratified on the basis of pathologic stage. Patients remained on treatment until documented recurrence, excessive toxicity, or patient/physician preference deemed removal appropriate. RESULTS: At median follow-up of 10.4 years, median survival was 7.4 years in the observation arm and 5.1 year in the treatment arm (log-rank P =.09). Median recurrence-free survival was 3.0 years in the observation arm and 2.2 years in the interferon arm (P =.33). Performance status (P =.003), nodal status (N2 v N0, P <.0001), and tumor stage (P =.0002) were significant prognostic factors in multivariate analysis. A proportional hazards model examining the effects of treatment arm and time to recurrence on survival after recurrence among patients who recurred found that random assignment to interferon treatment (P =.009) and shorter time to recurrence (P <.0001) were independent predictors of shorter survival after recurrence. Although no lethal toxicities were observed, severe (grade 4) toxicities including neutropenia, myalgia, fatigue, depression, and other neurologic toxicities occurred in 11.4% of those randomly assigned to interferon treatment. CONCLUSION: Adjuvant treatment with interferon did not contribute to survival or relapse-free survival in this group of patients.     

Renal dysfunction after myocardial revascularization.

OBJECTIVES: In this study, we evaluate the incidence of and analyse the pre and intraoperative risk factors for the development of postoperative renal dysfunction (PRD), and the impact of such an event on perioperative mortality and on hospital length of stay. In addition, we sought to investigate the influence of a mildly increased serum creatinine (1.3-2.0 mg/dl) on perioperative mortality and morbidity. METHODS: The study included 2445 consecutive patients who had no pre-existing renal disease (creatinine or=2.1 mg/dl with a preoperative-to-postoperative increase >or=0.9 mg/dl. Univariate and multivariate analyses were performed where appropriate. RESULTS: Global 30-day mortality was 0.7%. The incidence of PRD was 5.6% (136 patients). Mortality for patients who experienced PRD was 8.8 vs. 0.1% for patients who did not (P<0.001). PRD increased the length of hospital stay by 3.4 days (7.6 vs. 11.0 days; P<0.001), and patients who needed haemodialysis (11%) had a perioperative mortality of 33.3% and a mean hospital length of stay of 16 days. Multivariable logistic regression identified the following variables as independent predictors of PRD: age (P=0.017; odds ratio (OR) 1.3 per 10 years), angina class III/IV (P=0.003; OR 1.7); cardiopulmonary bypass time (P=0.007; OR 1.01 per minute); preoperative serum creatinine levels: group 1 (1.3-1.6 mg/dl (P<0.001; OR 5.5)) and group 2 (1.7-2.0 mg/dl (P<0.001; OR 14.2)). Finally, a mild elevation of the preoperative creatinine level (1.3-2.0 mg/dl) increased significantly the probability of perioperative mortality, low cardiac output, haemodialysis and prolonged hospital stay. CONCLUSIONS: Although the likelihood of PRD in patients without pre-existing renal dysfunction is relatively low, it dramatically increases mortality, morbidity and length of stay after CABG. Mildly elevated (>1.2 mg/dl) preoperative serum creatinine level significantly increases the perioperative mortality and morbidity.     

Antibiotic prophylaxis and prosthetic valve endocarditis.

Early onset prosthetic valve endocarditis is one of the most lethal complications after valve replacement. During the first year of operation of our new cardiac surgical program, we observed 10 cases of prosthetic valve endocarditis, the majority being caused by staphylococci, making an incidence of 10.6%. Subsequent investigations uncovered a very high prevalence of methicillin-resistant strains which led to a radical change in the antibiotic prophylaxis, from a cephalosporin-based protocol to a two drug regime of vancomycin and netilmicin. There were no cases of prosthetic infection among the 138 patients operated on in the one year period following the institution of this protocol. Because there were no other changes, either in the types of prostheses used or the techniques of implantation, the eradication of prosthetic valve endocarditis can be related only to this alteration in the prophylaxis. Therefore, we may conclude that the inter-institutional transfer of protocols is not adequate before a thorough investigation of the prevalent hospital pathogens and their sensitivity to antibiotics is carried out. We have not registered resistances to vancomycin and this drug remains the most important antimicrobial agent, both in the prophylaxis and in the treatment of prosthetic valve endocarditis.     

The predictive value of intraoperative KT-1000 arthrometer measurements in single incision anterior cruciate ligament reconstruction

We reviewed 28 patients who underwent anterior cruciate ligament reconstruction with immediate, 1-, 2-, and 3-year postreconstruction KT-1000 manual maximum testing. Arthrometer measurements were correlated with functional knee criteria to evaluate the ability of the KT-1000 to predict postreconstruction functional results. Despite a range of immediate postreconstruction arthrometer injured-minus-normal (I - N) differences, there was no association with I - N difference at last follow-up. Patients followed-up for 1 year were not different from those who were followed-up for longer with respect to intraoperative or 1-year I - N difference or functional performance scores. Furthermore, excellent functional knee scores were the norm at all stages of follow-up despite a wide range of arthrometric laxity changes. The results suggest that functional knee criteria, although partially subjective, are more useful indicators of outcome than intrareconstruction and postreconstruction arthrometric measures.     

Skilled birth attendant competence: an initial assessment in four countries, and implications for the Safe Motherhood movement.

OBJECTIVES: Percentage of deliveries assisted by a skilled birth attendant (SBA) has become a proxy indicator for reducing maternal mortality in developing countries, but there is little data on SBA competence. Our objective was to evaluate the competence of health professionals who typically attend hospital and clinic-based births in Benin, Ecuador, Jamaica, and Rwanda. Methods: We measured competence against World Health Organization's (WHO) Integrated Management of Pregnancy and Childbirth guidelines. To evaluate knowledge, we used a 49-question multiple-choice test covering seven clinical areas. To evaluate skill, we had participants perform five different procedures on anatomical models. The 166 participants came from facilities at all levels of care in their respective countries. Results: On average, providers answered 55.8% of the knowledge questions correctly and performed 48.2% of the skills steps correctly. Scores differed somewhat by country, provider type, and subtopic. Conclusion: A wide gap exists between current evidence-based standards and current levels of provider competence.     

Successful management of laryngotracheosophageal cleft through an anterior approach

Laryngotracheoesophageal cleft is an uncommon disease that is difficult to diagnose and treat. Repair of the cleft depends on length and localization of the defect as well as the associated anomalies. A successful repair of a type II cleft is reported in this paper. An anterior split of the larynx and trachea was used and provided excellent exposure and safe repair without injury to the neurovascular structures. This is the best approach and should be used to correct all type II defects.     

Effect of losartan on sodium appetite of hypothyroid rats subjected to water and sodium depletion and water, sodium and food deprivation

The involvement of angiotensin AT1 receptors in sodium appetite was studied in hypothyroid rats treated with the angiotensin II antagonist losartan. Losartan was administered chronically by the oral route or acutely by the subcutaneous route after water and sodium depletion or water, sodium and food deprivation. Three days after addition of losartan to the food at the dose of 1.0 mg x g(-1), the rats significantly reduced (P < 0.02) their spontaneous intake of 1.8% NaCl. Increasing the dose of losartan to 2.0 and 4.0 mg x g(-1) did not reduce NaCl intake; in contrast, the intensity of the sodium appetite gradually returned to previous levels. The simultaneous administration of captopril, an angiotensin converting enzyme inhibitor, and losartan significantly increased (P < 0.05) NaCl intake and after captopril removal NaCl intake returned to the levels observed with losartan treatment alone. The administration of losartan 4 days after the beginning of captopril treatment significantly reduced (P < 0.0001) NaCl intake. Following acute administration of losartan, water- and sodium-depleted rats significantly reduced their NaCl and water intake (P < 0.001). The administration of losartan also induced a significant reduction in NaCl and water intake in water, NaCl and food-deprived rats (P < 0.0001 and P < 0.001, respectively). The present results show that chronic treatment with oral losartan inhibited spontaneous sodium appetite in hypothyroid rats. Continuation of treatment rendered rats resistant to the blockade of AT1 receptors. Water and sodium depletion and water, NaCl and food deprivation induced sodium appetite, which in the short term depends on cerebral angiotensinergic activity mediated by the activation of AT1 receptors.