Phase 1 trial of a candidate rotavirus vaccine (RV3) derived from a human neonate

Objective: To conduct a phase 1 safety and tolerability trial of an oral rotavirus vaccine candidate RV3 in healthy volunteers.
Methodology: Double blind placebo controlled trial of a single 1 mL oral dose (6.5 × 10⁵ fluorescing focus units [FFU]/mL) in 10 healthy young men, 10 3–4 year old children and 10 3 month old infants with a 4 week surveillance period. The study was undertaken at a children's hospital and nearby community in Melbourne, Australia.
Results: All subjects successfully completed the trial. There were no significant side-effects attributable to the vaccine preparation in any age group. No shedding of vaccine virus was detected by enzyme immunoassay. There was evidence of an. immune response in serum and/or gut secretions in two of five vaccinees in each age group.
Conclusion: RV3 rotavirus vaccine appears to be safe and well tolerated. Evidence of immunogenicity in some subjects after a single dose encourages further trials to determine immunogenicity after three doses, after reduction of viral dose, and without prior administration of buffer.     

MECKEL'S DIVERTICULUM – REVISITED

Twenty five cases of Meckel''s diverticulum were studied between 1985-1995. Eight of these were symptomatic and in the remaining 17 it was an incidental finding. The symptomatic patients presented with intestinal obstruction (5 cases), perforated peritonitis (2 cases) and intussusception (1 case). All cases of acute appendicitis were also subjected to a search for Meckel''s diverticulum. Of the 25 Meckel''s diverticuli encountered, 22 were resected and in 3 patients it was left in situ. Both the patients with perforated Meckel''s diverticulum showed ectopic gastric mucosa. Complications occurred only after surgery for symptomatic Meckel''s diverticulum. All patients undergoing incidental diverticulectomy had a smooth and uncomplicated recovery.KEYWORDS: Incidental diverticulectomy, Meckel''s diverticulum     

Penile vibratory stimulation yields increased spermatozoa and accessory gland production compared with rectal electroejaculation in a neurologically intact primate (Saimiri boliviensis)

Assisted reproductive techniques require an efficient semen collection procedure in cases of ejaculatory dysfunction. Anejaculation may be of psychogenic or neurogenic origin but can be overcome with stimulatory techniques. Penile vibratory stimulation (PVS) therapy for anejaculation has recently emerged as an alternative to rectal probe electroejaculation (RPE) and more invasive testicular procedures. Comparison of the stimulatory procedures in neurologically intact subjects is not ethically possible due to the discomfort involved with electroejaculation, and comparison in spinal cord injured men may be compromised due to the intricate effects of chronic denervation on semen quality. We have previously shown the efficacy of PVS in a non- human primate, the squirrel monkey. A cross-over study design comparing semen collected by PVS and RPE was employed during the breeding season in which 15 donor males were divided into two groups. One group received PVS and the other RPE, then, three days later, treatments were reversed. Twelve of 15 animals responded to PVS (80%), all with spermatozoa in the ejaculate. Mean volume (436 +/- 90 microl), motility (80.6 +/- 4.3%), and total spermatozoa (32.8 +/- 10.2 x 10(6)) were significantly higher than in the semen after RPE. RPE resulted in ejaculation in all 15 animals with a semen volume of 205 +/- 25 microl, but fewer samples contained spermatozoa (9/15) resulting in a low total count (0.5 +/- 0.3 x 10(6)). The motility was reduced in those samples with spermatozoa (n = 9; 44.1 +/- 11.4%). Additionally, accessory gland activity was measured via the seminal vesicle and prostrate markers, fructose and citric acid, respectively. The PVS specimens had significantly more fructose (2.9 +/- 0.7 mg/ejaculate) and citric acid (0.46 +/- 0.14 mg/ejaculate) compared to RPE collected specimens (1.2 +/- 0.3 mg/ejaculate and 0.24 +/- 0.04 mg/ejaculate, respectively). In conclusion, PVS produces a much greater sperm yield and increased accessory gland secretion compared to RPE in our neurologically intact squirrel monkey model.      

IMPORTANCE OF PROSTATIC SPECIFIC ANTIGEN (PSA) IN CLINICAL PRACTICE : OUR EXPERIENCE

A total of 89 patients in the age group of 50-92 years having different histopathologically proven prostatic conditions were analysed with prostate specific antigen (PSA) and clinical co-relation undertaken. PSA levels were found to be significantly higher (p < 0.05) in 48 carcinoma prostate cases (mean 93.16 ± 50.75 ng/ml) as compared to 32 benign prostatic hyperplasia (mean 4.66 ± 3.85 ng/ml). Similarly, levels were considerably reduced in 15 post-operative adenocarcinoma cases (mean 10.77 ± 9.65 ng/ml) as compared to their pre-operative samples (mean 93.16 ± 60.75 ng/ml). PSA levels were moderately higher in 9 cases of prostatitis (mean 13.28 ± 4.53 ng/ml). A very high degree of sensitivity, specificity and positive predictive value of PSA e.g. 95.8%, 75.6% and 82.2% respectively was found in adenocarcinoma cases, when levels of PSA were > 10 ng/ml. Thus it necessitates a detailed and thorough examination in such cases to come to final conclusion and early management of the cases.KEY WORDS: Prostatic Specific Antigen (PSA)     

Randomized study of percutaneous endoscopic gastrostomy versus nasogastric tubes for enteral feeding in head and neck cancer patients treated with (chemo)radiation

Percutaneous endoscopic gastrostomy (PEG) tubes have largely replaced nasogastric tubes (NGT) for nutritional support of patients with head and neck cancer undergoing curative (chemo)radiotherapy without any good scientific basis. A randomized trial was conducted to compare PEG tubes and NGT in terms of nutritional outcomes, complications, patient satisfaction and cost. The study was closed early because of poor accrual, predominantly due to patients’ reluctance to be randomized. There were 33 patients eligible for analysis. Nutritional support with both tubes was good. There were no significant differences in overall complication rates, chest infection rates or in patients’ assessment of their overall quality of life. The cost of a PEG tube was 10 times that of an NGT. The duration of use of PEG tubes was significantly longer, a median 139 days compared with a median 66 days for NGT. We found no evidence to support the routine use of PEG tubes over NGT in this patient group.     

Suitable survival and half-life of red cells after frozen storage in excess of 10 years

To examine the appropriateness of the Food and Drug Administration's 10-year storage time for previously frozen red cells, 24-hour posttransfusion survival studies were performed, and the half-life of 3 units of autologous red cells that had been stored for 13.5, 14, and 17 years, respectively, was measured. The units had acceptable freeze-thaw-wash recovery (83.3-91.4%). When a 51Cr label was used for the previously frozen red cells and a simultaneous 52Cr label for freshly drawn autologous red cells was used as a comparison, it was seen that the previously frozen cells had normal 24-hour posttransfusion survival (75.1-88.4%) as well as normal half-life (23-33.7 days). These findings support further extension of the maximum allowable storage time for previously frozen red cells.     

Curative to Palliative Care-Transition and Communication Issues: Surgeons Perspective

Transition of a cancer patient from curative to palliative stage is one of the most difficult and challenging phases of cancer care both from patient and physician point of view. Most of the time the treating surgeons are expected to facilitate this transition but due to a number of reasons surgeons often fail to fulfill this crucial responsibility. This article highlights the various issues involved in the transition phase from a surgeons perspective.