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G K Hulse V Stalenberg D McCallum W Smit G O'neil N Morris R J Tait 《Journal of controlled release》2005,108(1):43-55
In order to assess the histological tissue changes over time around the site of implant, tissue biopsies were taken at 1 to 38 months post-implant from 54 (34 male) consenting human subjects who had received the Australian subcutaneous naltrexone-poly(DL-lactide) implant for heroin dependence. The implant consists of multiple tablets containing compressed naltrexone-poly[trans-3,6-dimethyl-1,4-dioxane-2,5-dione] (DL-lactide) loaded microspheres. Assessment of tissue samples by pathologists showed an early phase (up to 12 months post-implant) of inflammation, foreign body reaction, and fibrosis. This subsided gradually over the next 12 months until tissue returned to normal by 25+ months. Sufficient evidence was not available to conclude that the poly(DL-lactide) implant matrix was totally biodegradable within the study period. While implant material was not identified in most of the latter biopsies, its presence was noted in one biopsy at 26 months post-implant. Nevertheless the study results did demonstrate the implant's biocompatibility by the lack of inflammation, foreign body reaction, and fibrosis detected by 25+ months. It seems highly probable that surgical technique rather than the implant itself was associated with the additional finding of fat necrosis. Moderate fat necrosis was observed as a common feature of biopsies carried out during the first 6 months following implant. It subsided to mild levels over the next 18 months, and was notably absent by 25+ months. The results of the study indicated that the Australian naltrexone-poly(DL-lactide) implant is well tolerated and may have a role for use in the management of medical conditions such as heroin dependence. 相似文献
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AIMS: To determine the most appropriate regression models to use when assessing risk factors for severe hypoglycaemia and to investigate the impact of model misspecification and its clinical implications. METHODS: A total of 1229 children with Type 1 diabetes (mean age 11.7 years sd 4.1), of which 605 (49.2%) were males, were studied. Prospective assessment of severe hypoglycaemia (an event leading to loss of consciousness or seizure) was made over the 9-year period, 1992-2001. Patients were seen every 3 months and episodes of hypoglycaemia along with clinical data were recorded. Over 70% of children never experienced a severe hypoglycaemic event. Data were analysed using the Poisson regression, negative binomial, zero-inflated Poisson (ZIP) and zero-inflated negative binomial (ZINB) models. The over-dispersion and likelihood ratio statistics were calculated and the analytical methods compared. RESULTS: The Poisson regression model did not fit the data well. The negative binomial and the zero inflated Poisson and negative binomial models fitted the data better than Poisson. CONCLUSIONS: The commonly used Poisson regression models to analyse hypoglycaemia epidemiology may lead to biased parameter estimates and incorrect determination of risk factors for hypoglycaemia. We recommend the use of the negative binomial or zero inflated models to examine any risk factors associated with severe hypoglycaemia. Careful consideration must be given to the interpretation of hypoglycaemia surveys and their analysis. 相似文献
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This study retrospectively evaluated the outcome for patients undergoing herniorraphy for chronic groin pain due to posterior inguinal wall deficiency, and correlated the outcome with preoperative investigation findings. There were 47 patients (with a total of 52 herniorraphies) who were contacted by phone between six and 50 months post surgery. Subjects had a diagnosis of posterior inguinal wall deficiency made on history and clinical examination. Thirty seven patients had an ultrasound scan prior to the surgery (three bilateral) with a total of 40 symptomatic groins scanned. There were 26 abnormal scans (22 posterior inguinal wall deficiency and four hernias) and 14 normal scans. Twenty nine patients had a technetium-99m bone scan with 22 having increased uptake at the symptomatic pubic tubercle, while 13 had increased uptake at other sites in the groin. Seventy seven percent of patients had a full return to sport after surgery and the average time to return to sport was four months. There was no significant difference in outcome between subjects who had an abnormal ultrasound scan on the symptomatic side and those who had a normal scan. There was a significant difference in outcome between patients who had a bone scan with increased uptake at the symptomatic pubic tubercle and those who did not (p < 0.04). Our study supports previous research that good results can be obtained with surgery when posterior inguinal wall deficiency is the sole diagnosis. Ultrasound scan does not appear to aid in predicting surgical outcome, while the role of isotope bone scanning requires further study. 相似文献
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Stephen R. Kisely Mike Wise Neil Preston Senia Malmgren Peter Shannon 《Australian and New Zealand journal of public health》2003,27(3):261-263
Objectives: To evaluate a group intervention to help individuals with psychiatric disorder stop smoking.
Method: A waitlist-treatment crossover design. Outcome measures included smoking cessation, motivation to stop, the Fagerstrom Test for Nicotine Dependence (FTND), urinary cotinine and psychiatric symptoms on the General Health Questionnaire.
Results: 38 subjects participated, of whom 19 completed the waitlist and intervention phases. There were no significant differences between subjects and dropouts. During the waitlist period there were no significant changes in tobacco use. At the end of the intervention, almost a quarter had stopped smoking, ( z = -2.24, p =0.02). Subjects also showed significant improvements on state of change, FTND score and urinary cotinine levels. These improvements were maintained at three-month follow-up (n=10). Psychiatric morbidity showed no change.
Conclusions: It is possible to reduce smoking in individuals with psychiatric disorder.
Implications: Larger randomised controlled trials are indicated to determine the relative contributions of nicotine replacement, bupropion and group interventions to smoking cessation in this population. 相似文献
Method: A waitlist-treatment crossover design. Outcome measures included smoking cessation, motivation to stop, the Fagerstrom Test for Nicotine Dependence (FTND), urinary cotinine and psychiatric symptoms on the General Health Questionnaire.
Results: 38 subjects participated, of whom 19 completed the waitlist and intervention phases. There were no significant differences between subjects and dropouts. During the waitlist period there were no significant changes in tobacco use. At the end of the intervention, almost a quarter had stopped smoking, ( z = -2.24, p =0.02). Subjects also showed significant improvements on state of change, FTND score and urinary cotinine levels. These improvements were maintained at three-month follow-up (n=10). Psychiatric morbidity showed no change.
Conclusions: It is possible to reduce smoking in individuals with psychiatric disorder.
Implications: Larger randomised controlled trials are indicated to determine the relative contributions of nicotine replacement, bupropion and group interventions to smoking cessation in this population. 相似文献
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