[Injectable extended-release naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre randomized trial].

UNLABELLED: We aimed to assess the efficacy and safety of an injectable, once monthly extended-release formulation of the opioid antagonist naltrexone (XR-NTX) for treatment of patients with opioid dependence after detoxification. Two hundreds and fifty patients with opioid dependence were enrolled into the double-blind, placebo-controlled, randomized, 24-week trial. Patients aged 18 years or over who had inpatient detoxification and 7 days or more off all opioids were enrolled at 13 clinical sites in Russia. We randomly assigned patients (1:1) to either 380 mg XR-NTX (n=124) or placebo (n=126). Participants also received 12 biweekly counseling sessions. The primary endpoint was the response profile for confirmed abstinence during weeks 5-24 assessed by urine drug tests and self report of non-use. Secondary endpoints were self-reported opioid- free days, opioid craving scores, number of days of retention, and relapse to physiological opioid dependence. IN CONCLUSION: XR-NTX represents a new treatment option. XR-NTX in conjunction with psychosocial treatment was more effective for treatment of opioid dependence compare to psychosocial support and placebo.

Is routine histological examination of gall bladder specimens justifiable?

OBJECTIVE: To assess the safety of confining histological examination to gall bladders with radiological and macroscopic features suggestive of cancer. DESIGN: Retrospective study. Setting Department of Histopathology, National Hospital of Sri Lanka. METHOD: Analysis of all cholecystectomies performed at a tertiary care hospital during a one year period. Computerised histopathological reports and case notes were studied. RESULTS: Four hundred and seventy seven patients had undergone cholecystectomy for symptomatic gall stones. Four of these patients were found to have gall bladder cancer. In two of them the diagnosis had been suspected on pre-operative ultrasound scan. In the other two, gall bladder cancer was suspected at the time of surgery. Gall bladder cancer was found in 0.8% of specimens and it was suspected perioperatively in all these patients. CONCLUSION: Our preliminary results suggest that a more selective approach to gall bladder histology may result in saving processing time and costs without adversely affecting patient safety.

The pharmacokinetic and pharmacodynamic characteristics of a long-acting growth hormone (GH) preparation (nutropin depot) in GH-deficient adults.

A pharmacokinetic-pharmacodynamic study of a long-acting GH [Nutropin Depot; somatropin (rDNA origin) for injectable suspension] was performed in 25 patients with adult GH deficiency. Single doses of 0.25 mg/kg and 0.5 mg/kg, based on ideal body weight, were administered sc. After either dose, serum GH concentrations rose rapidly in both sexes. In men, the lower dose maintained serum IGF-I levels within 1 SD of the mean for age and sex for 14-17 d; the higher dose raised IGF-I levels 2 SD above the mean. In most women, all of whom were receiving oral estrogen, the lower dose did not normalize IGF-I levels; the higher dose maintained IGF-I near the mean for approximately 14 d. Increases in IGF binding protein-3 and acid-labile subunit levels were observed in both sexes; however, a sex-related difference was not obvious. Fasting glucose and insulin concentrations were transiently elevated in men receiving the higher dose. Patients tolerated the injections well. We concluded that a single injection of Nutropin Depot at these doses in patients with adult GH deficiency increased serum IGF-I to within normal limits for 14-17 d. Estrogen-treated women required approximately twice the dose needed in men to produce comparable IGF-I concentrations.