144 research outputs found
51Cr-EDTA plasma clearance in children. One, two, or multiple samples?
Plasma disappearance curves using multiple blood samples are a recognized reference method for measuring glomerular filtration rate (GFR). However, there is no consensus on the protocol for this type of measurement. A two-compartment model is generally considered acceptable for the mathematical description of the concentration–time decay curve. The impact of the fitting procedure on the reported GFR has not been questioned. We defined 8 different fitting procedures to calculate the area under the curve, and from this area under the curve, the GFR. We applied the 8 fitting methods (all considering a full concentration–time curve) on the multiple sample data (8 samples) of 20 children diagnosed with Duchenne muscular dystrophy. We evaluated the effect (variability) on the reported GFR from the different fitting methods and compared these results with GFR-values calculated from late samples only (samples after 120 minutes) and from one-sample methods. In 6 out of 20 cases, the fitting methods on the full concentration–time curve resulted in very different reported GFR-values, mainly because some methods were not able to fit the data, or methods resulted in GFR-values ranging from 0 to 120 mL/min. The reported GFR-result therefore strongly depends on the fitting method, making the full concentration–time method less robust than expected. Compared with a consensus reference GFR, the late sample models did not show fitting issues and may therefore be considered as more robust. Also the one-sample methods showed acceptable accuracy. The late sample methods (using 3 time-points) provide robust and reliable methods to determine GFR
Echium oil is not protective against weight loss in head and neck cancer patients undergoing curative radio(chemo)therapy: a randomised-controlled trial
Background:
Therapy-induced mucositis and dysphagia puts head and neck (H&N) cancer patients at increased risk for developing cachexia. Omega-3 fatty acids (n-3 FA) have been suggested to protect against cachexia. We aimed to examine if echium oil, a plant source of n-3 FA, could reduce weight loss in H&N cancer patients undergoing radio(chemo)therapy with curative intent.
Methods:
In a double-blind trial, patients were randomly assigned to echium oil (intervention (I) group; 7.5 ml bis in die (b.i.d.), 235 mg/ml α-linolenic acid (ALA) + 95 mg/ml stearidonic acid (SDA) + 79 mg/ml γ-linolenic acid (GLA)) or n-3 FA deficient sunflower oil high oleic (control (C) group; 7.5 ml b.i.d.) additional to standard nutritional support during treatment. Differences in percentage weight loss between both groups were analysed according to the intention-to-treat principle. Erythrocyte FA profile, body composition, nutritional status and quality of life were collected.
Results:
Ninety-one eligible patients were randomised, of whom 83 were evaluable. Dietary supplement adherence was comparable in both groups (median, I: 87%, C: 81%). At week 4, the I group showed significantly increased values of erythrocyte n-3 eicosapentanoic acid (EPA, 14% vs −5%) and n-6 GLA (42% vs −20%) compared to the C group, without a significant change in n-6 arachidonic acid (AA, 2% vs −1%). Intention-to-treat analysis could not reveal a significant reduction in weight loss related to echium oil consumption (median weight loss, I: 8.9%, C: 7.6%). Also, no significant improvement was observed in the other evaluated anthropometric parameters.
Conclusions:
Echium oil effectively increased erythrocyte EPA and GLA FAs in H&N cancer patients. It failed however to protect against weight loss, or improve nutritional parameters.
Trial registration: ClinicalTrials.gov Identifier NCT01596933
Cystatin C, a marker for successful aging and glomerular filtration rate, is not influenced by inflammation
Abstract Background. The plasma level of cystatin C is a better marker than plasma creatinine for successful aging. It has been assumed that the advantage of cystatin C is not only due to it being a better marker for glomerular filtration rate (GFR) than creatinine, but also because an inflammatory state of a patient induces a raised cystatin C level. However, the observations of an association between cystatin C level and inflammation stem from large cohort studies. The present work concerns the cystatin C levels and degree of inflammation in longitudinal studies of individual subjects without inflammation, who undergo elective surgery. Methods. Cystatin C, creatinine, and the inflammatory markers CRP, serum amyloid A (SAA), haptoglobin and orosomucoid were measured in plasma samples from 35 patients the day before elective surgery and subsequently during seven consecutive days. Results. Twenty patients had CRP-levels below 1 mg/L before surgery and low levels of the additional inflammatory markers. Surgery caused marked inflammation with high peak values of CRP and SAA on the second day after the operation. The cystatin C level did not change significantly during the observation period and did not correlate significantly with the level of any of the four inflammatory markers. The creatinine level was significantly reduced on the first postoperative day but reached the preoperative level towards the end of the observation period. Conclusion. The inflammatory status of a patient does not influence the role of cystatin C as a marker of successful aging, nor of GFR
The activities of drug inactive ingredients on biological targets
Excipients, considered "inactive ingredients," are a major component of formulated drugs and play key roles in their pharmacokinetics. Despite their pervasiveness, whether they are active on any targets has not been systematically explored. We computed the likelihood that approved excipients would bind to molecular targets. Testing in vitro revealed 25 excipient activities, ranging from low-nanomolar to high-micromolar concentration. Another 109 activities were identified by testing against clinical safety targets. In cellular models, five excipients had fingerprints predictive of system-level toxicity. Exposures of seven excipients were investigated, and in certain populations, two of these may reach levels of in vitro target potency, including brain and gut exposure of thimerosal and its major metabolite, which had dopamine D3 receptor dissociation constant Kd values of 320 and 210 nM, respectively. Although most excipients deserve their status as inert, many approved excipients may directly modulate physiologically relevant targets
Reference values for serum creatinine in children younger than 1 year of age
Reliable reference values of enzymatically assayed serum creatinine categorized in small age intervals are lacking in young children. The aim of this study was to determine reference values for serum creatinine during the first year of life and study the influence of gender, weight and height on these values. Serum creatinine determinations between 2003 and 2008 were retrieved from the hospital database. Strict exclusion criteria ensured the selection of patients without kidney damage. Correlation analysis was performed to evaluate the relation between height, weight and serum creatinine; the Mann–Whitney test was used to evaluate the relation between gender and serum creatinine. A broken stick model was designed to predict normal serum creatinine values. Mean serum creatinine values were found to decrease rapidly from 55 μmol/L on day 1 to 22 μmol/L in the second month of life; they then stabilized at 20 μmol/L until the seventh month, followed by a slight increase. No significant relation was found between serum creatinine and gender, weight and height. We present here reference values of serum creatinine in infants not at risk of decreased renal function. The absence of a relationship with gender, weight and height confirms that height-based equations to estimate glomerular filtration rate are less useful in patients of this age group
Recent Innovations & Daily Problems. A new prosthesis in inguinal hernia repair:preliminary results of a pilot study.
Introduction: Elective surgery for inguinal hernia is affected by very
low mortality « 1 per 10000 operation); in contrast, when surgery
is carried out for complicated inguinal hernia, risks of postoperative
complication are higher. TAPP is a world-wide accepted surgical practice
in the treatment of elective bilateral or recurrent inguinal hernia,
above all in young patients. Few exploratory studies were published on
laparoscopic approach in the treatment of urgent complicated inguinal
hernia. Aim of this study was to analyze feasibility (operative time,
conversion rate), safety (postoperative morbidity, length of hospital
stay) and quality of life (acute and chronic pain, return to work) of
trans-abdominal pre-peritoneal laparoscopic hernia repair in acute
incarcerated inguinal hernia. Rationale of laparoscopic trans-abdominal
approach is the easier hernia reduction under vision and a better
exploration of the abdominal cavity.
Methods: from September 2012 to September 2013, 15 consecutive
patients admitted in emergency at the Division of General Surgery of
University "Sapienza", Polo Pontino, for acute incarcerated inguinal
hernia were submitted to TAPP using 3 trocars (1 of 10 mm and 2 of
5mm) and polyester prosthesis fixed by fibrin glue. Exclusion criteria
for laparoscopic approach were age III, previous
abdominal surgery, signs of strangulated hernia. All of them were
evaluated for operative time, conversion rate, postoperative morbidity,
organ resection or other surgery required. All patients were scored for
pain by Visual Analogic Scale (VAS) during postoperative in hospital
stay at 7 days, 1,6 and 12 months after surgery.
Results: median follow-up was 16 months and 12 as minimum. In all
cases reduction of hernia was always possible and none conversion
to open surgery was recorded, median operative time was 89 minutes
(55-137 as range), omental resection was carried out in one patient
(6,6%), no other organ resections needed, whereas contralateral hernia
was diagnosed and repaired at the same time in 4 patients (26,6%). No
major complications were observed, median blood loss was 100 ml,
minor morbidity was contained to 18% represented by fever and
wound infection of surgical umbilical scar. Median in hospital stay
was 1,5 days with 1-5 days as range. Postoperative median acute pain,
measured by visual analogic scale (VAS), was 2 (range:0-4), none
patient referred any pain during follow-up. Median time of return to
work was 6,5 days, ranged between 3 to 15 days. Patients' compliance
to treatment and to follow-up was complete as well their satisfaction. Conclusions: In centres skilled for laparoscopy in emergency, TAPP
could be considered a feasible and safe technique. In well-selected
patients (especially if emolled in controlled clinical trial) TAPP could
represent an alternative surgical approach for complicated incarcerated inguinal hernia to conventional open surgery even in urgency. The
main advantages of laparoscopic approach are the ability to perform
surgical hernia reduction under vision, a better exploration and evaluation
of abdominal cavity and diagnosis and treatment of eventual
contralateral defect of wall, otherwise often missed. Finally, the good
control of acute and chronic pain, faster return to normal activity and
work, better aesthetic results contributed to total satisfaction and compliance
of the patients
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