Efficacy and safety of neutral pH superoxidised solution in severe diabetic foot infections

The use of antiseptics in wound care is often controversial and there is definitely a need for a non toxic, highly disinfective agent. This study assessed the efficacy of a neutral pH superoxidised aqueous solution (NpHSS) for infection control, odour reduction and surrounding skin and tissue damage on infected diabetic foot ulcerations. From November 2003 to March 2004, 45 patients with type 2 diabetes were randomised into a single-blind clinical trial comparing NpHSS (intervention group; n = 21) versus conventional disinfectant (control group; n = 16). All patients received comprehensive care including surgical debridement as appropriate, moist wound care, intensive glucose control and broad spectrum antibiotics. Treatment groups were matched in terms of sex, age (61.9 +/- 11.9 versus 67.8 +/- 11.6), years of diabetes duration (16.4 +/- 8.1 versus 17 +/- 10.2), obesity, HgAlc (7.1 +/- 2 versus 6.7 +/- 1.8), initial fasting glycaemia (163 +/- 59 versus 152 +/- 65.8 mg/dl), ulcer duration/week (13.7 +/- 24 versus 15.1 +/- 16.3), B/A Index (0.9 +/- 0.5 versus 1.14 +/- 0.7), depth and extent of infection/periwound cellulitis (groups B and C of the Tampico Hospital Classification) as well as aetiology (P = 0.647). Odour reduction was achieved in all NpHSS patients (100% versus 25%; P < 0.01) and surrounding cellulitis diminished (P < 0.001) in 17 patients (80.9% versus 43.7%). Nineteen patients in the NpHSS group showed advancement to granulating tissue stage (90.4% versus 62.5%; P = 0.05) with significantly less tissue toxicity (94% versus 31.2%; P < 0.01). A non toxic, NpHSS, as part of a comprehensive care regimen, may be more efficacious in infection control, odour and erythema reduction than conventional disinfectants in treatment of diabetic foot infections.     

Radioquimioterapia complementaria a cirugía radical en el adenocarcinoma de recto

A retrospective analysis of the results with radio-chemotherapy in rectal carcinoma B2-3 and C is presented. A total of 120 patients received postoperative treatment with chemotherapy (5-fluorouracil plus folinic acid) 6 courses, 2 courses concurrent with radiotherapy. The acute and chronic toxicity, local and distance control, disease free survival (DFS) and overall survival (OS) were evaluated. With a mean follow up of 23 months, the actuarial OS and DFS at 4 years were 83% and 72%, with 20 relapses (6 locoregional and 14 distant failure). Acute intestinal toxicity (degree III–IV), 28%; haematological, 18,3%. 16% of the patients presented chronic toxicity, bowel obstruction in six cases. Significant difference was found in the relapse rate, related to the onset of chemoradiotherapy, 2nd course versus 3rd course: 12% versus 29% (p=0.1) but without decrease overall survival. This scheme of postoperative radiochemotherapy in the rectal carcinoma produces a high local control, DFS and OS.     

Arsenate-induced neural tube defects not influenced by constant rate administration of folic acid

Serious suggestions have been made that dietary supplementation with folic acid (FA) and perhaps other vitamins during pregnancy may reduce the incidence of neural tube defect (NTD) in human newborns. The purpose of these experiments was to evaluate the effect of continuous infusion of FA on the incidence of NTDs induced by arsenate. This teratogen induces NTDs in up to 90% of golden hamster fetuses when administered acutely during critical stages of embryogenesis. FA was administered by subcutaneously implanted osmotic minipumps beginning on the 6th day of gestation, 48 h before an acutely administered dose of sodium arsenate. The protective effect of FA was examined at three teratogenic dose levels of arsenate: optimal, with 905 NTDs, intermediate, with 38% NTDs, and low, with 20% NTDs. Fetuses were recovered at day 13 of gestation and examined for NTDs and other malformations. Maternal red cell folate levels were determined on day 8, 48 h after implantation of the pumps. The results show that the maternal red blood cell level of FA can be significantly increased within 48 h by chronic infusion to levels which are almost two times (550 ng/ml) control levels. There was no significant protection against arsenate-induced NTDs following FA supplementation at any of three levels of this teratogen.     

Active hexose correlated compound acts as a prebiotic and is antiinflammatory in rats with hapten-induced colitis

Active hexose correlated compound (AHCC) is a product prepared from the mycelium of edible Basidiomycete fungi that contains oligosaccharides. Here we have studied the antiinflammatory effect of AHCC in the trinitrobenzenesulfonic acid (TNBS) model of colitis in rats. Rats received AHCC (100 or 500 mg/kg) daily starting 2 d before (pretreatment) colitis induction and were killed 6 d after the TNBS challenge. The status of the rats was assessed by morphological and biochemical methods. The effect of AHCC on the colonic microflora was also assessed by studying the bacteria profile in feces by standard culture techniques. AHCC administration attenuated colonic inflammation, improving rat weight, food intake, damage score, extension of necrosis, colonic weight, colonic weight-to-length ratio, myeloperoxidase and alkaline phosphatase activities, glutathione concentration, and the expression of proinflammatory cytokines and chemokines (IL-1beta, IL-1 receptor antagonist, TNF, and monocyte chemoattractant protein-1) and of mucins 2-4 and trefoil factor 3. The magnitude of the antiinflammatory effect of AHCC was similar to that of sulfasalazine (200 mg/kg). The study of colonic microflora indicated that rats treated with AHCC had higher aerobic and lactic acid bacteria counts as well as higher bifidobacteria counts, whereas clostridia were reduced when compared with the TNBS group. Therefore, our results indicate that AHCC is antiinflammatory and could be useful as a prebiotic to design functional foods for inflammatory bowel disease patients.     

Importance of severe lesions left untreated in patients with acute coronary syndromes and angioplasty of the culprit lesion

INTRODUCTION AND OBJECTIVES: Patients with acute coronary syndromes may have significantly stenotic nonculprit lesions that do not show complex lesion morphology. We investigated whether these lesions were prone to become unstable since they exist within a prothrombotic and inflammatory systemic milieu. PATIENTS AND METHOD: We evaluated the clinical course of 150 patients after successful angioplasty of a culprit lesion: 75 patients with a severely stenotic but uncomplicated nonculprit lesion (group A) and 75 patients without these lesions (group B). RESULTS: In group A, 1 patient (1.3%) required angioplasty of an initially nonculprit lesion, and in group B, 2 patients (2.6%) died in cardiogenic shock. After 1 year of follow-up, in group A, 4 patients (5.3%) died (cardiac deaths), 1 patient (1.3%) had a myocardial infarction, and 10 patients (13.3%) underwent a repeat revascularization procedure, which in 6 cases (8%) was angioplasty of an initially nonculprit lesion. In all 6 patients with angioplasty of the initially nonculprit lesion, revascularization was done within the first 4 months and was indicated for unstable angina. In group B, 1 patient (1.3%) died (noncardiac death) and 2 patients (2.6%) underwent a repeat revascularization procedure because of restenosis. Survival curves were significantly different between both groups. Belonging to group A was the only independent predictor for events, and within this group location of the lesion in the left anterior descending artery was the main predictor. CONCLUSIONS: The presence of nonculprit lesions of uncomplicated morphology at the time of a percutaneous revascularization procedure for a culprit lesion in patients with acute coronary syndrome is a short- and middle-term predictor of a moderate rate of recurrent events when these initially innocuous lesions become unstable.     

Multicenter phase II study of plitidepsin in patients with relapsed/refractory non-Hodgkin’s lymphoma

This phase II clinical trial evaluated the efficacy, safety and pharmacokinetics of plitidepsin 3.2 mg/m² administered as a 1-hour intravenous infusion weekly on days 1, 8 and 15 every 4 weeks in 67 adult patients with relapsed/refractory aggressive non-Hodgkin’s lymphoma. Patients were divided into two cohorts: those with non-cutaneous peripheral T-cell lymphoma (n=34) and those with other lymphomas (n=33). Efficacy was evaluated using the International Working Group criteria (1999). Of the 29 evaluable patients with non-cutaneous peripheral T-cell lymphoma, six had a response (overall response rate 20.7%; 95% confidence interval, 8.0%–39.7%), including two complete responses and four partial responses. No responses occurred in the 30 evaluable patients with other lymphomas (including 27 B-cell lymphomas). The most common plitidepsin-related adverse events were nausea, fatigue and myalgia (grade 3 in <10% of cases). Severe laboratory abnormalities (lymphopenia, anemia, thrombocytopenia, and increased levels of transaminase and creatine phosphokinase) were transient and easily managed by plitidepsin dose adjustments. The pharmacokinetic profile did not differ from that previously reported in patients with solid tumors. In conclusion, plitidepsin monotherapy has clinical activity in relapsed/refractory T-cell lymphomas. Combinations of plitidepsin with other chemotherapeutic drugs deserve further evaluation in patients with non-cutaneous peripheral T-cell lymphoma. (clinicaltrials.gov identifier: {"type":"clinical-trial","attrs":{"text":"NCT00884286","term_id":"NCT00884286"}}NCT00884286)     

the role of radiotherapy for limited stage Hodgkin's disease in 1999: limitations and perspectives]

The role of radiotherapy in limited stage Hodgkin's disease (HD) has been gradually changing in the past few decades, resulting in the almost complete disappearance of exclusive irradiation treatment. In reality, exclusive radiotherapy yielded satisfactory results in terms of long-term survival, but in 1999 it was becoming impossible not to take into account the late mortality rates observed in all large cohorts of HD patients. This increased mortality rate has been shown to be related to 1) cardiac toxicity of irradiation, and 2) secondary radiation-induced solid tumors. Thus, the search for efficient but less toxic new strategies can no longer be avoided. For clinically staged, limited HD, precisely defined according to specific prognostic factors, the association of chemotherapy and radiotherapy appears more and more as a standard, and with this therapeutic burden comes parallel efforts for its alleviation. The Previous Radiotherapy experience has shown that, after a chemotherapy-induced complete remission, irradiation of only the initially involved areas was enough. Ongoing trials are now exploring the possibility of a dose de-escalation, from the conventional 36 Gy to 20 Gy (as for children HD), and to maybe 0 Gy (no radiotherapy at all). In parallel, deescalation in the number of chemotherapy cycles is also being investigated. For unfavorable cases, the problem is slightly different, as a higher percentage of cases still appears to be refractory to treatment in this subgroup. Thus, while chemo-radiotherapy has clearly became the standard strategy, efforts are essentially being devoted to identify new--and hopefully more efficient--chemotherapy schemes. In Europe, most of these pending questions will be addressed in the recently initiated trials of the EORTC/GELA and of the GHSG (German Hodgkin Study Group), with the aim of offering to patients treatment which could be at least as efficient as the present schedules, and less toxic in the long term.     

Fat necrosis

 We report the MR appearance of a case of subcutaneous fat necrosis, which is a previously unreported etiology for knee mass. The role of MR imaging in differentiating fat necrosis from other causes of soft tissue masses is discussed. We conclude that MR characteristics of subcutaneous fat necrosis are typical and allow its differentiation from other types of soft tissue lesions.