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Self-assessed sexual function after pelvic irradiation for prostate carcinoma. Comparison with an age-matched control group.

BACKGROUND: Treatment of localized prostate carcinoma is often accompanied by disturbances in sexual function. The patient's own opinion and experience with these problems can be of great importance for his quality of life. In men older than 50 years, disturbances in sexual function are common. Treatment such as radiotherapy (RT), which can induce sexual dysfunction, should be evaluated in relation to the problems in an age-matched population without prostate carcinoma. METHODS: Sexual function was evaluated with a self-assessment questionnaire using linear-analogue scales. The questionnaire was sent to 199 patients with prostate carcinoma, median age 71 years (range, 51-86 years), who had received pelvic RT with curative intent and to 200 age-matched men in northern Sweden. Mean follow-up time after RT was 48 months (range, 24-56 months). RESULTS: The response rate was high: 141 (71%) and 181 (91%) in the control and patient groups, respectively. Field reduction and treatment pause during RT was not associated with decreased problems in the patient groups. A failure to achieve erection was indicated in 12% of the control subjects, 56% of the patients who had received (RT only) and 87% of the RT + castration (RT + A) patients. In general, patients < 70 years treated with RT+A indicated more sexual problems than the RT only patients < 70 years. There was a strong negative correlation between age and sexual problems in the RT + A < 70 years group. However, in patients < 70 years, sexual activity after RT only, was not significantly different from the age-matched control population. CONCLUSIONS: Patients with prostate carcinoma treated with RT only indicated higher levels of sexual dysfunction than age-matched controls. This was most obvious in patients younger than 70 years, although their sexual activity was comparable to age-matched controls. The addition of castration to RT tended to increase sexual problems, especially in patients < 70 years. In men between 70 and 74 years, the maintenance of sexual function seems to be very susceptible to disturbances. For patients older than 74 years, decreased sexual function was not perceived as such a significant problem, despite abolished desire and erection.

Aged↗

Effect of abciximab on cardiac enzyme elevation after transluminal extraction atherectomy (TEC) in high-risk saphenous vein graft lesions: comparison with a historical control group.

Saphenous vein graft (SVG) intervention has been associated with an increased incidence of distal embolization. Long lesions and lesions associated with thrombus are particularly at increased risk. This study was performed to determine whether abciximab may decrease this risk in high risk SVG angioplasty. From June 1994 to June 1998, 84 patients with at least one high risk factor, i.e., lesion length >20 mm or angiographic evidence of thrombus, underwent Transluminal extraction atherectomy (TEC) procedure followed by balloon dilatation or stenting. Of these 84 patients, 37 who had procedure after September 1995 underwent TEC with abciximab (Abciximab Group) and 47 who had their procedure before that date had TEC without abciximab thereby serving as historic control (Non-Abciximab Group). All patients had normal pre-procedure CK and CK-MB. Total creatine kinase (CK) and CK-MB were measured every 8 hr post-procedure for 24 hr. Baseline demographics, angiographic characteristics, incidence of LV dysfunction and triple vessel disease were similar between the two groups. Graft age was similar between two groups (122 +/- 70 vs. 117 +/- 54 months). Graft diameter, pre and post-procedure percent stenoses were not different between the two groups. Stents were used in 65% in the Abciximab group and 45% in Non-Abciximab group (P = 0. 14). There was no in-hospital repeat PTCA, urgent bypass surgery, or cardiac death. There was no difference between the two groups in regards to the incidence of any elevation of total CK (27% vs. 21. 3%) or CK-MB (54% vs. 51%). When used in conjunction with TEC in treating high risk vein graft lesions, abciximab did not reduce post procedure CK-MB elevation in this patient population.

Abciximab↗

The "over-exposed" control group.

Relative risk is determined as much by the level of exposure among controls as among cases. If cases and controls are drawn from a population in which the range of exposures is narrow, then a study may yield little information about potential health effects. This may be one reason why an association between dietary fat and cancer has not been consistently observed in Western populations. Since the fat intake as a percent of total calories in the US general population varies little, only very large relative risks can be detected in epidemiologic studies. Investigators of the dietary fat hypothesis need to select study groups from populations where the risk factor is not, essentially, narrowly distributed.

Breast Neoplasms↗

The Italian quality control study for evaluation of CD4 cells in centres involved in the treatment of HIV-1 patients. Italian CD4 Quality Control Group.

We report on the experience of establishing a national network for a quality control programme in evaluating CD4 cell counts in most Italian centres involved in the care of patients with HIV disease. The 68 centres were divided according to their geographical location into eight groups, and twice a year (tests A and B) they received three coded whole blood samples (two were replicates of the same sample) obtained from two informed HIV+ patients, one with CD4 counts/mm3 expected to be < 200 and one with values > 300. The medians of the determinations performed by the labs involved in each of the eight areas were taken as the 'true' values for each sample. Unsatisfactory performances for percentage of CD4 cells were identified as a CD4 analysis with residual values > or = +/- 5% and with deviates > or = +/- 2. For absolute numbers of CD4 cells, an unsatisfactory performance was defined as CD4 counts with residual > +/- 100 CD4 cells/mm3 and with deviates > or = +/- 2. The residual value is the CD4 value reported by each lab minus the median value. The deviate is the residual divided by the modified interquartile range (IQR x 0.75). Most of the centres provided reliable results. However, some labs failed to provide satisfactory results for percentages (6.25% of the tested labs for test A and 6.17% for test B) or absolute numbers (16.25% test A and 12.34% test B). Only 3.7% of the labs gave unsatisfactory results in both tests. Four of the unsatisfactory results from the two tests gave an error in absolute numbers > +/- 200 CD4 cells/mm3. Our data suggest that most Italian labs provide reliable results in evaluating the numbers of CD4 cells in HIV-1+ samples, but the importance of running a quality control programme is highlighted by our experience with those centres which provide unsatisfactory data which may lead to incorrect classification of the patients or assessment of treatment.

CD4 Lymphocyte Count↗

Control groups in psychosocial intervention research: ethical and methodological issues.

This article summarizes a National Institute of Mental Health (NIMH) workshop that was convened to address the ethical and methodological issues that arise when conducting controlled psychosocial interventions research and introduces 6 thoughtful and inspiring papers presented by workshop participants. These papers, on topics ranging from informed consent to ethnic minority issues, reflect the depth and breadth of expertise represented by the multidisciplinary group of scientists and ethicists present at the meeting. More extensive follow-up, particularly from federal research applications and publications, of how investigators balance the need for strong research design with ethical considerations may help advance the science of psychosocial intervention research.

Clinical Trials Data Monitoring Committees↗

Inhibitory effect of cadmium on calcium absorption from the rat duodenum.

Male rats of the Wistar strain (6 weeks old) were divided into 2 groups; control group and experimental group. The control group was fed a cadmium-free diet. The experimental group was fed a diet containing 100 ppm of cadmium (CdCl2). During the 33-day period of cadmium intake, body weight was recorded. For the 7th to 10th, 16th to 19th, and 25th to 28th day of the experimental period, food consumption was recorded and at the same time urine and feces were sampled to obtain the calcium and phosphorus concentrations. On the 8th, 17th, and 26th day, about 0.2 ml of blood was sampled to determine the calcium and phosphorus concentration. The concentration of calcium remained stationary during the experimental period, but the concentration of phosphorus in the experimental group was significantly lower than that in the control group. On the 29th or 30th day 45Ca(1 muCi) was given orally with the cold calcium, and the 1- and 2-hr blood was collected by heart puncture to obtain the 45Ca activity in the serum. The 1-hr activity in the control group was significantly higher than that in the experimental group. On the final day, the rats were sacrificed to obtain the duodenum and kidney calcium-binding protein. The binding activities of these proteins in the experimental group were significantly lower than that in the control group.

Animals↗

[Effect of epidermal growth factor receptor-selective tyrosine kinase inhibitor gefitinib on nasopharyngeal carcinoma xenografts].

BACKGROUND & OBJECTIVE: Gefitinib,an anilinoquinazoline,is an orally active,selective epidermal growth factor receptor(EGFR) tyrosine kinase inhibitor,which has been approved for the treatment of advanced non-small cell lung cancer. We have found that the proliferation of nasopharyngeal carcinoma (NPC) cell lines CNE1,CNE2,and SUNE1 was inhibited by Gefitinib. The present study was designed to evaluate the effect of Gefitinib alone or in combination with cisplatin (DDP) on NPC CNE2 xenografts. METHODS: Exponentially growing CNE2 cells were prepared into cell suspension (1 x 10(7) cells/ml). Suspension of 200 mul of CNE2 cells was injected s.c. into the right flank area of the mice. After 7 days,when well-established tumors of 100-200 mm(3) were detected,mice were randomized into five groups: control group,Gefitinib (100 mg/kg) group,Gefitinib (200 mg/kg) group,DDP group,and Gefitinib (100 mg/kg) plus DDP group. Gefitinib was administered by oral gavage on days 1-5 of each week for 4 weeks. DDP was administered i.p. once a week for 4 weeks. Tumor volume was determined by direct measurement with caliper and calculated by the formula 1/2x(large diameter)x(small diameter)(2). The mice were sacrificed at two days after the treatment ended; tumor masses were removed and weighed. The tumor inhibition rates were calculated. The student's test was used to evaluated the statistical significance of the results. RESULTS: Growth curves showed that tumor masses of control group grew more rapidly than ones of every treatment group. The average tumor volume was significantly smaller in Gefitinib (200 mg/kg) group than in control group (P=0.02). The average tumor volume had no significant difference between Gefitinib (100 mg/kg) group and control group. The average tumor volume of DDP or Gefitinib (100 mg/kg) plus DDP group was smaller than that of control group(P=0.007 and 0.001,respectively). The average tumor volume had no significant difference between DDP and Gefitinib (100 mg/kg) in combination with DDP group. The tumor inhibition rates of Gefitinib (100 mg/kg) group,Gefitinib (200 mg/kg) group,DDP group,and Gefitinib (100 mg/kg) plus DDP group were 26.3%, 30.6%, 45.7% and 54.8%,respectively. The average tumor weight after treatment had no significant difference between Gefitinib (100 mg/kg) group and control group. The average tumor weights of Gefitinib (200 mg/kg) group,DDP group,Gefitinib (100 mg/kg) plus DDP group were all smaller than that of control group. The average tumor weight had no significant difference between DDP group and Gefitinib (100 mg/kg) plus DDP group. CONCLUSION: Gefitinib could inhibit the growth of NPC CNE2 xenografts. Gefitinib in combination with DDP did not significantly potentiate the effect of DDP on NPC CNE2 xenografts.

Animals↗

Sulphydryl group control of sodium-lithium countertransport kinetics: a membrane protein control abnormality in essential hypertension.

Erythrocyte sodium-lithium countertransport (SLC) is an obligatorily coupled equimolar exchange of intracellular sodium or lithium with extracellular sodium or lithium. SLC is partially inhibited by N-ethylmaleimide (NEM) but only when a transported ion (sodium of lithium) is present in the extracellular medium. In essential hypertensive patients with a strong family history of hypertension the Km of SLC for extracellular sodium was lower and Vmax tended to be higher than in normal controls, but the ratio Vmax/Km gave a much clearer distinction between the two groups. After NEM treatment, the remaining SLC activity in normal individuals had a lower Vmax and Km for sodium but Vmax/Km was not affected. In essential hypertensives the remaining SLC activity after NEM again had lowered Vmax and Km but in these patients the Vmax/Km was much lower than in untreated erythrocytes and was then the same as in normal controls. On the assumption that NEM reacts with a -SH group on a membrane protein that regulates SLC, and that the ratio Vmax/Km reflects a rate constant for binding extracellular sodium to the unloaded carrier, the results suggest that (a) essential hypertensives have an increased rate of sodium binding to the transporter and (b) this is due to abnormal behaviour of a membrane -SH group.

Adolescent↗

A comparison of anxiety and depression in sex offenders with intellectual disability and a control group with intellectual disability.

The aims of this study were to employ modified versions of the 21-item Beck Anxiety and Depression Inventories with a group of 16 sex offenders with mild intellectual disability and borderline intelligence and 16 control participants with similar levels of intellectual disability. Test-retest correlations found high reliability for both assessments across all participants. There was a significant differences between the scores of the 2 groups with the sex offenders reporting significantly lower levels of anxiety and depression than the control participants. The results are discussed by presenting hypotheses on the emotional stability in each group.

Adult↗