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- Balldin, J, et al.
(författare)
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A 6-month controlled naltrexone study: Combined effect with cognitive behavioral therapy in outpatient treatment of alcohol dependence
- 2003
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Ingår i: Alcoholism: Clinical and Experimental Research. - 0145-6008 .- 1530-0277. ; 11
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Tidskriftsartikel (refereegranskat)abstract
- Background: In several studies, patients with alcohol dependence treated with the opioid antagonist naltrexone have shown fewer relapses to heavy drinking than those receiving placebo. An interaction between the naltrexone effect and the type of psychological therapy has been observed. Methods: A 6-month, double-blind, placebo-controlled, parallel-group study was performed at 10 different investigation sites. After a placebo run-in period of 1 week, 118 patients were randomized into 4 treatment groups—50 mg of naltrexone daily or placebo in combination with either cognitive behavioral therapy (CBT) or supportive therapy. The CBT was performed over nine sessions according to the manual of Project MATCH (Matching Alcoholism Treatments to Client Heterogeneity). The supportive therapy was defined as "the treatment as usual." Alcohol consumption, craving, carbohydrate-deficient transferrin, medication compliance by tablet count, and adverse clinical events were assessed at all visits. Other liver enzymes and psychiatric symptoms were also determined. Results: Ninety-one (77%) patients completed the study, and 92 (78%) were 80% compliant with the medication regimen. A lower percentage of heavy-drinking days was shown in the naltrexone group (p = 0.045) compared with the placebo group, as was a lower craving score (p = 0.029). These results are supported by the lower levels of liver enzyme activities (p < 0.010 for aspartate aminotransferase, alanine aminotransferase, and γ-glutamyltransferase), but not by the carbohydrate-deficient transferrin levels, in the naltrexone group. The mean time period before the first day of heavy drinking was longer for the group treated with CBT (p = 0.010), especially in combination with naltrexone (p = 0.007). Naltrexone was well tolerated, and no patients discontinued the study due to side effects. Conclusions: This study supports the effect of naltrexone in outpatient treatment of alcohol dependence and suggests that a beneficial interaction effect with CBT can be expected.
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| 3. |
- Malmström, Per, et al.
(författare)
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Breast conservation surgery, with and without radiotherapy, in women with lymph node-negative breast cancer: a randomised clinical trial in a population with access to public mammography screening.
- 2003
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Ingår i: European journal of cancer (Oxford, England : 1990). - 0959-8049. ; 39, s. 1690-
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Tidskriftsartikel (refereegranskat)abstract
- The effect of postoperative radiotherapy after sector resection for stage I-II lymph node-negative breast cancer was evaluated in a patient population with access to public mammographical screening. 1187 women were randomised to no further treatment or postoperative radiotherapy following a standardised sector resection and axillary dissection. Radiation was administered to a dose of 48-54 Gy. Median age was 60 years, and median size of the detected tumours was 12 mm. Of the women 65% had their tumours detected by mammographical screening. The relative risk (RR) of ipsilateral breast recurrence was significantly higher in the non-irradiated patients compared with the irradiated patients, RR=3.33 (95% Confidence Interval (CI) 2.13-5.19, P<0.001). The corresponding cumulative incidence at 5 years was 14% versus 4%, respectively. Overall survival (OS) was similar, RR=1.16 (95% CI 0.81-1.65, P=0.41), with 5 year probabilities of 93 and 94%, respectively. Recurrence-free survival (RFS) at 5 years was significantly lower in the non-irradiated women, 77% versus 88% (P<0.001). Although women above 49 years of age, whose tumours were detected with mammographical screening, had the lowest rate of ipsilateral breast recurrence in this study, the cumulative incidence of such event amounted to 10% at 5 years if radiotherapy was not given. Such a recurrence rate has been considered as unacceptably high, but is, however, in the same range as that reported after lumpectomy and postoperative radiotherapy in published series.
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| 4. |
- Manjer, Jonas, et al.
(författare)
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Parity in relation to risk of axillary lymph node involvement in women with breast cancer. Results from Swedish population-based series of 3,472 consecutive cases.
- 2005
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Ingår i: European Surgical Research. - : S. Karger AG. - 0014-312X .- 1421-9921. ; 37:3, s. 179-184
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Tidskriftsartikel (refereegranskat)abstract
- <i>Objective:</i> To investigate the association between parity and axillary lymph node involvement (ALNI) at breast cancer diagnosis. <i>Methods:</i> One surgeon has reviewed all breast cancer cases in Malmö, Sweden, diagnosed 1961–1991. This study includes the 3,472 women who had a first-time diagnosis of unilateral invasive breast cancer, and who had undergone axillary dissection. Information was collected regarding date of birth, date of diagnosis, age at diagnosis, menopausal status, tumour size, histological type, tumour location, type of surgery, stage (ALNI), and parity. Parity was investigated in relation to ALNI using logistic regression analysis, adjusted for potential confounders, yielding odds ratios (OR) with 95% confidence intervals (CI). The analyses were repeated in different strata with regard to birth-years cohort, age at diagnosis, and period of diagnosis. <i>Results:</i> High parity was associated with ALNI, the adjusted OR for ALNI among women with 4 or more children was 1.56 (1.13–2.15). This association was stronger in comparatively old women (≧67.45 years), OR 1.78 (1.10–2.88). Considering parity a continuous variable, the OR for ALNI among all women was 1.06 (1.01–1.12). <i>Conclusions:</i> We conclude that women with 4 or more children had an increased risk of ALNI at breast cancer diagnosis.
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