Do carnitine and extra trace elements change stability of paediatric parenteral nutrition admixtures?

INTRODUCTION: High concentrations of trace elements (TE), in particular zinc and selenium, along with carnitine, are often added to parenteral admixtures in paediatric patients on long-term Parenteral Nutrition (PN). We aim to evaluate whether lipid droplet diameters of these admixtures maintain the recommended range of 0.4-1.0 µm. MATERIALS AND METHODS: Stability studies were carried out on six parenteral admixtures with carnitine, trace elements and electrolytes added in different amounts. Each admixture was formulated with five different lipid emulsions with or without fish oil. Analyses were performed at time 0 (t = 0) and 24, 48, 72, 96 (t = 96) hours after compounding. Droplet diameters were determined by Light Scattering-Reverse Fourier Optics Technique. Samples, stored at 4 °C, were triple tested for a total of 450 analyses. Regression analyses were performed using panel-data techniques. RESULTS: During the 4 days, lipid droplet diameters were in the expected range of 0.4-1.0 µm regardless of trace element and carnitine amounts in all admixtures apart from those containing fish-oil based emulsions and calcium concentrations equal to 4.5 mmol/L. In these latter admixtures, 12% of droplet diameters were larger than 1.0 µm and 2% exceeded 5.0 µm immediately after compounding. CONCLUSION: Carnitine and high concentrations of trace elements do not affect PN admixtures stability and can be safely infused in long-term home-PN paediatric patients and prematures. Only high calcium concentrations in compresence with fish oil based lipid emulsions seem to change PN stability.

Parenteral nutrition admixtures for pediatric patients compounded with highly refined fish oil-based emulsion: assessment of physicochemical stability.

Fish oil-based emulsion is increasingly used in pediatric patients receiving Parenteral Nutrition (PN). However, its unique use in children on long-term PN is nutritionally debatable as some patients are better off with a mixture of long-chain (LCT) or long-chain + medium-chain (LCT + MCT) triglycerides along with Fish Oil (FO). Lipid emulsions are safely infused when particle diameter ranges between 0.4 and 1.0 micron (like chylomicra), according to European guidelines. No data exist on Fish Oil stability when added to other PN components typically present in pediatric formulations such as other lipids or micronutrients. Our goal is to evaluate the stability of a highly refined FO-emulsion in PN admixtures containing LCT or LCT + MCT triglycerides and different calcium content. Stability studies were carried out on six PN admixtures having two levels of calcium concentration compounded with olive oil LCT + FO, LCT + MCT + FO emulsion and pure FO alone, respectively. The analyses were performed immediately at time 0 (t = 0) and 24, 48, 72, 96 (t = 96) hours after compounding. Particle diameters were determined by Light Scattering-Reverse Fourier Optics Technique by means of a Laser Granulometer. Every sample was stored at 4 °C and triple tested. Statistical significance was verified by f-test. In all admixtures, physicochemical stability did not change between t = 0 and t = 96 and particle diameters were in the expected range of 0.4-1.0 micron provided calcium concentration remained below 4.5 mmol/L. When calcium exceeded that level, 12% of particle diameters was larger than 1.0 micron and 2% exceeded 5.0 micron immediately after compounding. In particular, admixtures compounded with olive oil LCT + FO emulsion or FO emulsion alone showed lower particle diameters compared to admixture with olive/soybean LCT alone, probably due to a different steric encumbrance of oleic acid and omega-3 fatty acid. In the PN admixtures tested, containing FO-emulsion alone or in combination with olive LCT or LCT + MCT, the fat emulsion appears to be stable and safe for infusion when calcium concentration is maintained below 4.5 mmol/L. If calcium level exceeds 4.5 mmol/L, as often required in premature patients, it is advisable to infuse FO emulsion alone through a second intravenous line.

Granisetron, tropisetron, and ondansetron in the prevention of acute emesis induced by a combination of cisplatin-Adriamycin and by high-dose ifosfamide delivered in multiple-day continuous infusions.

The antiemetic efficacy of granisetron, ondansetron and tropisetron was evaluated in patients treated with cisplatin-Adriamycin (CDP/ADM) and ifosfamide (IFO) by continuous infusion (CI). In all, 90 patients with osteosarcoma were randomly assigned to receive granisetron (2 mg/m2), or ondansetron (5.3 mg/m2), or tropisetron (3.3 mg/m2) plus dexamethasone 8 mg/m2. Chemotherapy consisted of CDP (120 mg/m2, 48-h CI) followed by ADM (75 mg/m2, 24-h CI) and then, in the second cycle, delivered 3 weeks later, IFO 15 g/m2 (120-h CI). Complete protection (CP) from emesis was obtained on 59% of the 717 days of treatment, without significant differences among the three study drugs. A significantly higher rate of CP was obtained during chemotherapy with IFO than with CDP/ ADM (69% vs 44%; P<0.0001). The rate of CP declined from the first to the last day of treatment for both CDP/ADM (61% to 27%, P<0.0001) and IFO (95% to 43%) cycles (P<0.0001). When CDP/ ADM and IFO are delivered on multiple days by CI, granisetron, ondansetron and tropisetron have the same antiemetic efficacy, which declines from the first day onward through successive days.

[The oral strontium load test in the assessment of intestinal calcium absorption]. / Il test da carico orale di stronzio nella valutazione dell'assorbimento intestinale del calcio.

A close correlation between calcium and strontium intestinal absorption has been described. In this study, a test using Stable Strontium has been assessed in women without abnormal calcium or bone metabolism, with no history of drugs which might affect calcium or bone metabolism. Decreasing values of Strontium intestinal absorption, according to the length of the postmenopausal period, have been observed. Besides, the Stable Strontium Test has been given in postmenopausal women with osteoporotic femur fractures. In comparison with age matched healthy women, this latter group showed a significantly lower Strontium intestinal absorption. Analogous behaviour has been reported for Calcium intestinal absorption.

Serum methotrexate (MTX) concentrations and prognosis in patients with osteosarcoma of the extremities treated with a multidrug neoadjuvant regimen.

The relationship between the serum concentration of methotrexate and the prognosis has been studied in 108 patients with osteosarcoma of the extremities treated from September 1986 to December 1989 at the Chemotherapy Department of Rizzoli Hospital. The protocol of neoadjuvant chemotherapy included high doses of methotrexate (HDMTX) adriamycin, cisplatinum, ifosfamide and VP-16. After a median follow-up of 40.4 months (range 24-62), 84 (77.7%) of the patients studied remained continuously disease-free (CDF) and 24 relapsed. Significantly higher mean serum MTX concentrations were observed in the patients who remained CDF (669.5 mumol/l) than in the patients who relapsed (571.9 mumol/l) (p < .004). The breaking point of prognostic significance for the serum MTX levels seems to be 700 mumol/l. In fact, according to the mean MTX concentrations, the patients with less than 700 mumol/l showed a significantly lower disease-free survival than the patients with higher mean MTX concentrations (68.12% vs 94.87% p < .0013). The distribution of prognostic variables between the two groups was the same in terms of site and histological type of tumor and alkaline phosphatase serum levels at diagnosis. In the group which had more than 700 mumol/l MTX, a higher percentage of good histological response after primary chemotherapy was observed. This is probably independent from the MTX because no significant preoperative MTX serum levels between good and partially responding patients were observed.(ABSTRACT TRUNCATED AT 250 WORDS)