Everolimus 1.5 or 3 mg/day was compared with mycophenolate mofetil (MMF) 2 g/day in a randomized, multicenter 36-month trial in de novo renal allograft recipients (n = 588) receiving cyclosporine microemulsion (CsA) and corticosteroids. The study was doubleblind until all patients had completed 12 months, then open-label. By 36 months, graft loss occurred in 7.2, 16.7 and 10.7% of patients in the everolimus 1.5, 3 mg/day, and MMF groups, respectively (p = 0.0048 for everolimus 1.5 mg/day vs. 3 mg/day); efficacy failure (biopsy-proven acute rejection (BPAR), graft loss, death or lost to follow-up) occurred in 33.0, 38.9 and 37.2% of patients (p = 0.455 overall), respectively. Mortality and incidence of BPAR were comparable in all groups. Creatinine values were higher in everolimus groups, requiring a protocol amendment that recommended lower CsA exposure. Diarrhea, lymphocele, peripheral edema and hyperlipidemia were more common among everolimus-treated patients, whereas viral infections, particularly cytomegalovirus infection, increased in the MMF group. Overall safety and tolerability were better with MMF and everolimus 1.5 mg/day than with everolimus 3 mg/day. In conclusion, at 36 months, an immunosuppressive regimen containing everolimus 1.5 mg/day had equivalent patient, and graft survival and rejection rates compared with MMF in de novo renal transplant recipients, whereas everolimus 3 mg/day had inferior graft survival. Renal dysfunction in everolimus cohorts necessitates close monitoring.

The routine use of topical anaesthesia during flexible nasendoscopy has been questioned, and the degree to which topical vasoconstrictors can affect patient discomfort has yet to be elucidated. Patients' experiences with Lignocaineand phenylephrine, Lignocaine alone, xylometazoline and no preparation were compared. One hundred patients were recruited in this double-blind, randomised control trial and put into these four groups. Each patient completed a visual analogue scoring chart to determine the severity of unpleasantness and other undesirable effects (pain, bad taste, burning, choking, numbness and difficulty in swallowing). The results confirmed that vasoconstriction is a major contributing factor towards reducing overall unpleasantness (P = 0.022), topical anaesthesia can produce a bad taste (P = 0.022), and that none of the preparations have any effect on the pain during nasendoscopy. In conclusion, xylometazoline is recommended for nasendoscopy as it is effective and is significantly cheaper than the other preparations. Not using any preparations leads to the experience of severe symptoms.

Ambulatory 24-hour esophageal pH monitoring and esophagogastroduodenoscopy were performed in 72 patients with symptoms suggestive of gastroesophageal reflux. Additionally, 22 asymptomatic healthy volunteers underwent pH monitoring. In patients with classic reflux symptoms and endoscopic esophagitis, a mean of 5.41 minutes/hour of reflux below pH 4 was found compared to 0.70 minutes/hour in controls (p less than 0.0001). The mean number and duration of reflux events in this group were 1.51 events/hour and 4.0 minutes/event, compared with 0.31 events/hour and 2.26 minutes/event in volunteers (p less than 0.001, p less than 0.01). A new system for ambulatory esophageal pH monitoring is presented using a pH-sensitive radiotelemetry pill or a pH probe and computerized methods for ambulatory data collection, analysis, and storage. An overall sensitivity of 76% was obtained with a 91% selectivity for detection of acid reflux in 51 patients having classic symptoms of gastroesophageal reflux. Ambulatory pH monitoring was positive for acid reflux in seven of 11 patients with normal endoscopic findings. Conversely, eight of 12 patients with normal pH monitoring had endoscopic esophagitis. In 19 patients presenting with atypical symptoms or previous gastric surgery, endoscopic findings were normal in 15. Nine of these 15 were identified as acid refluxers by pH monitoring. A combined approach using both pH monitoring and endoscopy is warranted for maximal detection and quantification of disease. A clear clinical role for pH monitoring is seen in the early diagnosis of acid reflux, particularly in patients having normal endoscopic findings with nonspecific gastrointestinal complaints or previous gastric operations.

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