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PubMed1995

Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. The IFNB Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group.

Our previously reported multicenter, blinded, randomized, controlled study of two doses of interferon beta-1b (IFNB) in 372 patients demonstrated a reduction in relapse frequency and severity and in MRI activity. We now report the results of the continuation of that study. The median time on study was 46.0 months for the placebo arm, 45.0 months for 1.6 million international units (MIU), and 48.0 months for 8 MIU. IFNB had a persistent beneficial effect on exacerbation rate and MRI burden of disease and was relatively free of long-term side effects. There was a one-third reduction in exacerbation rate in the 8-MIU treatment arm, compared with placebo, in each of 5 years. Serial annual MRI was done in all patients, and 217 of the patients had either a fourth- or fifth-year scan. There was no significant progression of lesion burden in the 8-MIU arm in each successive year compared with baseline (at 4 years, p = 0.917), whereas a highly significant increase in lesion area occurred in the placebo arm (p = 0.0001). Among the 154 noncompleters, there was no systematic bias recognized that favored either treatment arm for the outcome measures of exacerbation rate, disability, or MRI activity. Dropouts in the placebo group had higher exacerbation rates and accumulation of MRI lesion burden than did dropouts in the other treatment arms, which probably reduced the power of the study to demonstrate treatment effects on these measures in the later years of the trial.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1994

Changing Social Security benefits to reflect child-care years: a policy proposal whose time has passed?

This article estimates the effects of proposals to increase the retirement benefits of women who reduce their earnings to care for young children. Using the 1990 Survey of Income and Program Participation file--exactly matched to the Social Security Administration's record of lifetime earnings--the authors present the distribution of child-care dropout years by retirement cohort and other demographic characteristics, and estimate the dollar impact of adjustments for caregiving years. The policies examined do increase the retirement benefits of some women, but the increases on average are small, are lowered with each successive retirement cohort, and benefit women from the more privileged socioeconomic groups. Thus, because the policy effects are small and will diminish in the future, the time of efficacy for the proposals has passed. Subsidizing child-care dropout years does not seem to be a well-targeted policy.

Adult↗
PubMed1994

High-resolution histologic analysis of the human choroidal vasculature.

PURPOSE: To develop a high-resolution histologic technique to study the postmortem human choroidal vasculature in dual perspective: vascular pattern in the flat perspective and structure in cross sections. METHODS: Fresh whole human choroids were denuded of retinal pigment epithelium, fixed, incubated for enzyme histochemical demonstration of alkaline phosphatase (APase) activity, bleached with hydrogen peroxide, and flat-embedded in glycol methacrylate. Vascular patterns were examined and documented en bloc, and subsequent serial sectioning was performed through specific sites of interest. RESULTS: APase staining provided excellent visualization of the entire choroidal vasculature en bloc. Reaction product was generally more prominent in the choriocapillaris and collecting venules than in veins or arterioles, whereas arteries had the least activity. Diminished activity within focal regions of the choriocapillaris was observed in the far periphery of most aged subjects and was related to loss of endothelium and capillary atrophy. Hard drusen were generally observed in clusters located near collecting venules and appeared unrelated to any underlying angiopathy, whereas basal linear and laminar deposits were most often associated with regions of capillary dropout. Choroids from patients with diabetes demonstrated angiopathic changes consisting of extensive capillary dropout, beaded capillaries, neovascularization, and Bruch's membrane degeneration. CONCLUSIONS: The benefits afforded by this method of analysis are that choroidal vasculature can be visualized in the native state and that nonvascular structures are retained for simultaneous analysis with vascular pattern and blood vessel structure.

Adolescent↗
PubMed1994

The pharmacoeconomics of clozapine: a review.

BACKGROUND: A pharmacoeconomic analysis of clozapine is of particular importance because clozapine has a unique profile of benefits, risks, and costs relative to typical neuroleptic drugs and because it is currently approved for use in only two populations, i.e., neuroleptic-resistant and neuroleptic-intolerant schizophrenic patients, although it has also been found to be useful in a variety of other indications, e.g., refractory bipolar patients. METHODS: The three studies of the primary data relevant to a pharmacoeconomic analysis of clozapine in the treatment of schizophrenia were reviewed. RESULTS: The results suggest that clozapine as a treatment of neuroleptic-resistant schizophrenia leads to better outcome and lower costs in treatment-resistant patients compared with typical neuroleptic drugs because of decreased hospitalization, even when the costs associated with dropouts from clozapine are included. No pharmacoeconomic data are available for other indications of clozapine. CONCLUSION: Clozapine has been found to produce superior outcome compared with prior treatment with typical neuroleptic drugs in neuroleptic-resistant patients in dimensions that can be readily transformed into cost-utility measures such as decreased psychopathology, improved cognition, decreased rehospitalization, decreased suicide attempts, and better work function. If the frequency of hospitalization of patients has been appreciable, and dropouts from clozapine are in the range of 30% to 50% and occur within 1 to 4 months of starting treatment, it is likely that clozapine will be a cost-effective treatment. Cost-effectiveness studies comparing clozapine with standard treatments are needed for each application of clozapine, including use in neuroleptic-intolerant patients.

Antipsychotic Agents↗
PubMed1993

A prospective study of peritoneal dialysis-related infections in CAPD patients with diabetes mellitus.

Data comparing peritoneal dialysis (PD)-related infection rates between diabetic and nondiabetic patients on chronic peritoneal dialysis are conflicting. We carried out a prospective study comparing PD-related infection rates between diabetic and nondiabetic patients treated with continuous ambulatory peritoneal dialysis (CAPD) in our center. All patients commencing CAPD between January 1989 and June 1992 were enrolled into the study. Patients were followed up until death, CAPD dropout, or until December 1992. Data on diabetes mellitus status, Staphylococcus aureus nasal carriage, and PD-related infections were gathered. Infection rates were analyzed using life tables and the negative binomial test. One hundred and seven diabetic patients and 72 nondiabetic patients were studied. Patients with diabetes mellitus were not at increased risk of being S. aureus nasal carriers. The peritonitis rate was significantly higher in the diabetic group (1.2 vs 0.8 episodes/patient/year, p < 0.05). The exit-site and tunnel infection, catheter loss, and patient dropout rates were not significantly different between the two groups. Life-table analysis did not show a significant difference in the time to first episode of peritonitis and catheter-related infection.

Bacteria↗
PubMed1994

Improvements in quadriceps strength with regular seated exercise in the institutionalized elderly.

The quadriceps strength of a group of residents homes for the elderly (mean age 83 years) was assessed in a randomized controlled trial of seated group exercise versus group reminiscence therapy. Fifty-five of 65 volunteers completed the 6-month study, with 4 dropouts from the exercise group, and 6 dropouts from the reminiscence group. There were no adverse effects. Average of attendance at the exercise sessions was 72% (range, 18% to 98%) and 62% (range, 29% to 100%) at the reminiscence sessions. The reminiscence sessions comprised group interaction and discussion prompted by the use of reminiscence aids. By the end of the study, the change observed in the exercise group was significantly different from the reminiscence group in terms of quadriceps strength (p < 0.01, Mann-Whitney U test). Both groups improved equally in their ability to climb up steps, but neither cognitive function (Mini-Mental State Examination) nor reaction time altered significantly.

Aged↗
PubMed1995

Tremorlytic activity of budipine: a quantitative study with long-term tremor recordings.

The tremorlytic activity of the novel antiparkinson agent budipine was quantified in an open trial. Eleven patients with Parkinson's disease (PD) were treated with individual doses of budipine added to stable conventional antiparkinsonian medication. Tremor activity was measured using long-term electromyogram (EMG) recordings. Tremor intensity was reduced by 25%, tremor occurrence by 34%, and conventional "Unified Parkinson's Disease Rating Scale" (UPDRS) scores improved by 20% with this medication. There were two dropouts because of side effects. One dropout appeared not to be related to budipine. Apart from those, the drug was well tolerated by all patients. We conclude that budipine is an effective and well-tolerated tremorlytic drug and that the method of long-term EMG recording is suitable for tremor quantification in clinical studies.

Adult↗
PubMed1996

Transition from high school to work or college: how special education students fare.

Results are reported from the National Longitudinal Transition Study of Special Education Students. Dropout rates were high: 30% of students with disabilities dropped out of high school, and another 8% dropped out before entering high school. The average dropout with disabilities was 18 years old at the time of leaving but had earned less than half the credits needed to graduate. Employment successes were strongly related to taking a concentration (four courses) in vocational education. Youths with learning disabilities or speech impairments were most likely to approach the rate of employment found in the general population. Postsecondary education was low: 37% of high school graduates with disabilities had attended a postsecondary school, compared with 78% of high school graduates generally. Students with hearing or visual impairments were most likely to attend college. Students with disabilities were significantly more likely to be poor than were youths in the general population, and poverty tended to exacerbate the impact of having a disability. Impoverished students with disabilities were less likely than wealthier students with disabilities to be enrolled in those postsecondary education and training programs that could enable them to break out of poverty. When employed, the poorer students with disabilities earned significantly less per year than did those from wealthier families. Placement in regular education (rather than special education) was associated both with better and worse postschool outcomes. Students with sensory or motor disabilities appeared to benefit from regular education placement. However, for many students, more time in regular education was associated with a higher likelihood of course failure, which was a strong predictor of dropping out of school.

Adolescent↗
PubMed1996

[Mitomycin C for the treatment of superficial tumors of the bladder (Tis-Ta-T1) with one or more risk factors. Argentinian Cooperative Group of Oncourology (GCAO)].

OBJECTIVES: To determine the efficacy and toxicity of intravesical mitomycin C in superficial bladder tumors (Tis Ta T1) completely resected with one or more risk factors. (Protocol U. 01/90). METHODS: The patients received six instillations weekly of 40 mg mitomycin C within 15 days post-TUR of a superficial bladder tumor with one or more risk factors: histological grade 3, tumor size more than 3 cm and/or multicentric lesion. The patients were evaluated by cystoscopy every three months for the first two years and every six months thereafter. Toxicity was evaluated according to Miller's score. Tumor recurrence, disease-free interval and survival were analyzed. RESULTS: 126 patients were entered into the study; of these, 110 were evaluable. At 18 months mean follow-up (range 6-36 months), 77 patients (70%) remain disease-free; the mean time to recurrence was 13.8 months. There were no differences between patients with one, two or three risk factors or those who received or did not receive previous treatments. The patients tolerated the treatment well; there were no dropouts or systemic toxicity. CONCLUSIONS: 1. At 18 months mean follow-up, 77 of 110 patients (70%) remain disease-free; 2. The mean time to recurrence was 13.8 months; 3. Local toxicity was minimal; 4. There were no dropouts due to toxicity; 5. Systemic toxicity was not observed.

Adult↗
PubMed1996

A prospective randomized comparison of the Swan neck, coiled, and straight Tenckhoff catheters in patients on CAPD.

Our objective was to study the impact of peritoneal catheter configuration on continuous ambulatory peritoneal dialysis (CAPD)-related infections, mechanical complications, and patient dropout in a prospective randomized trial. Forty consecutive patients who were commencing CAPD were randomized to receive either a double-cuff, Swan neck coiled catheter or a double-cuff, straight Tenckhoff catheter, implanted by surgical technique. There was no significant difference in the peritonitis rate between the two groups. There was a lower rate of exit-site infection in the Swan neck group compared to the straight catheter group (0.29 vs 0.60 episodes/patient-year, p < 0.05). Catheter-tip migration occurred in 3 patients with the straight catheters compared to one patient with the Swan neck catheter. No patient had to discontinue CAPD because of mechanical complications. The number of CAPD patient dropouts was not significantly different between the two groups. The Swan neck configuration resulted in a significant reduction in the rate of exit-site infections. The coiled component of the catheter may lead to fewer episodes of catheter-tip migration. However, catheter configuration did not influence the number of technique failures.

Aged↗
PubMed1995

-Efficacy and safety of using amlodipine in treatment of mild and moderate essential hypertension-.

UNLABELLED: The present study aimed to assess the efficacy and tolerance of amlodipine (Norvasc-Pfizer) in the treatment of 152 patients with mild and moderate essential hypertension. This study was a multicenter and open trial and lasted 24 weeks. During 7 visits arterial blood pressure, heart rate, body weight and side effects of amlodipine were registered. The dosage of amlodipine was 5 to 10 mg/day. 59 patients received also other antihypertensive drugs in doses used before starting amlodipine treatment. 57 patients needed changes in amlodipine dosing from 5 to 10 mg/day. During the study no significant changes in body weight or heart rate were noticed. Mean arterial blood pressure dropped significantly from 123.9 +/- 0.6 at the beginning of the study to 102.3 +/- 0.8 mm Hg at the end of this study. During this study a total of 26 dropouts were noticed. The reasons of these dropouts were the following: side effects--6 patients, noncompliance--7 patients, insufficient hypotensive effect--7 patients, unknown reason--5 patients, hypertensive crisis--1 patient. The following side effects were observed ocdemata of the legs in 10.5%, headaches in 2% of patients. One patient complained of increased susceptibility to weather changes, 1 patient had nausea and dizziness and 1 had headaches, pains in the legs and chest and nausea. All these side effects were mild and transient. CONCLUSION: Results obtained in this trial suggest, that amlodipine is an efficient and well tolerated antihypertensive drug in patients with mild and moderate essential

Adult↗
PubMed1997

Comparative results of goal oriented therapy for erectile dysfunction.

PURPOSE: Goal oriented therapy for erectile dysfunction, based on a complete education of the couple, was offered to 460 patients. The short-term and long-term results of the first and second treatments selected were compared. MATERIALS AND METHODS: From September 1991 to March 1995, 460 patients with erectile dysfunction were evaluated and treated prospectively. The success of treatment, selected by the patient or couple, was defined as the ability to achieve and maintain good erections for successful coitus for at least 1 year after the start of therapy. Sexual satisfaction of the couple was required to confirm a successful outcome. RESULTS: The preferred first line of treatment by 322 patients was pharmacotherapy, with intracavernous injections being the second most selected therapy (80% success rate). However, there was a high long-term dropout rate for intracavernous injections. Approximately 70% of the patients were lost to followup or refused further treatment. CONCLUSIONS: Overall, this prospective study showed that goal oriented therapy is initially highly successful. However, the long-term high dropout rate and dissatisfaction of the couple cast doubt about the efficacy of the present treatment options.

Adult↗
PubMed1997

Comparison of behavior therapy with and without very-low-energy diet in the treatment of morbid obesity. A 5-year outcome.

BACKGROUND: Very-low-energy diets (VLEDs) together with behavior therapy (BT) are widely used in the treatment of morbid obesity, but there is no evidence of their long-term effectiveness as compared with behavior therapy alone. METHODS: Fifty-nine morbidly obese patients (25 men and 34 women; mean weight, 132.8 +/- 20.7 kg; mean age, 43.1 +/- 9.2 years) were treated with combined therapy of VLED and BT or BT alone. No maintenance program was used. Eighty-seven percent of eligible patients were contacted 4.8 to 6.2 years after the program. RESULTS: During treatment, 56% of patients dropped out of the VLED + BT group and 28% from the BT group (P = .03). High scores on the Symptom Checklist-90R before treatment predicted dropout from the VLED+BT group, but not from BT. At the end of therapy, mean weight change was -22.9 kg in the VLED+BT group and -8.9 kg in the BT group (P < .001). The overall weight change from pretreatment to the 5-year follow-up was greater in the VLED+BT group than in the BT group (-16.9 kg vs -4.9 kg, respectively; P = .03). Men succeeded better in the VLED+BT group than in BT. Among the dropouts, the mean weight change from baseline was +5.2 kg in the VLED+BT group and +13.0 kg in the BT group. CONCLUSIONS: Our data suggest that in the treatment of morbid obesity, VLED combined with BT may produce a better 5-year maintenance than BT alone, especially among men. A satisfactory weight loss can be achieved without a maintenance program.

Adult↗
PubMed1997

Immunization coverage among urban and rural children in the Shimla hills.

A cross sectional study was carried out to assess immunisation coverage among 257 urban and 339 rural children aged 13-36 months who were vaccinated at pulse polio booths in Shimla hills. 84.37% urban children and 57.59% rural children were fully vaccinated. BCG scar was negative in a large number of children, especially from rural areas. Increasing maternal education was associated with complete immunisation. OPV I-III dropouts were 3% among urban children and 15% among rural. The corresponding dropout rates for DPT I-III were 1% and 8% respectively. The immunisation coverage in this region was higher than others. Sustained efforts are required to achieve full immunisation coverage and eradicate polio and measles.

Child Welfare↗
PubMed1997

[Cost-effectiveness analysis of preventive treatment of urinary lithiasis recurrence using potassium citrate].

OBJECTIVE: This study evaluated two possible alternatives of potassium citrate administration-granulate (liquid) and tablet (wax matrix)-versus treatment with diet and/or fluid to prevent recurrence of urinary lithiasis. METHODS: The cost-effectiveness of the alternative modalities were analyzed using data from the studies conducted by Barceló (1993), Pak (1985) and Preminger (1985). The variables utilized for effectiveness were 'avoided relapse' and 'avoided intervention'. Since the data from the foregoing studies did not make any distinction between the two alternative forms of potassium citrate administration, the incidence of side effects and the dropout rate were included. These data were obtained from the studies conducted by Barceló (1993). Campoy (1994) and Conte (1994). RESULTS/CONCLUSION: Potassium citrate is effective in the prevention of recurrence of urinary lithiasis; relapses and interventions were significantly avoided. Both forms of potassium citrate are similarly effective and the only differences found were in regard to the side effects and the dropout rate; however, further studies are warranted to determine the possible differences with more precision. Potassium citrate in granulated form in much more cost-effective than the diet and fluid regimen than the tablet alternative, with a difference significantly in favor of the former in the order of 8:1. Price was the most important variable and therefore it is important to determine the appropriate dosage since it will influence the cost-effectiveness ratio and the allocation of resources.

Clinical Trials as Topic↗
PubMed1998

SSRIS versus tricyclic antidepressants in depressed inpatients: a meta-analysis of efficacy and tolerability.

A meta-analysis of the efficacy and tolerability of selective serotonin reuptake inhibitors (SSRIs) against nonselective and noradrenergic reuptake inhibitors (mainly tricyclic antidepressants, TCAs) in depressed inpatients was carried out. Twenty-five double-blind studies provided data on relative efficacy which was determined by a summary variance-weighted mean effect size calculated from the difference in the reduction in mean Hamilton Depression Rating Scale (HDRS) scores for the two antidepressants in each study. Twenty-three studies provided data on dropouts and relative tolerability which was determined as the variance-weighted pooling of the relative risk (RR) of dropout for all reasons and for adverse effects from each study. TCAs were significantly more effective than SSRIs (effect size = -0.23, 95% CI -0.40 to -0.05, P = 0.011), although sensitivity analyses by analysing larger studies (> 100 patients) and those providing complete data reduced the advantage to TCAs to a trend (P < 0.10). When the TCAs were grouped into those with dual action on 5-hydroxytryptamine (HT) and noradrenaline reuptake (clomipramine and amitriptyline) and those with predominantly noradrenaline reuptake (imipramine, desipramine and maprotiline), only the dual action TCAs had greater efficacy than SSRIs (effect size = -0.30, 95% CI -0.54 to -0.05, P = 0.017). When TCAs were considered individually, only amitriptyline was significantly more effective than comparator SSRIs (effect size = -0.37, 95% CI -0.67 to -0.07, P = 0.015). More patients overall discontinued treatment on TCAs than on SSRIs (29.0% vs. 25.5%), although this did not reach statistical significance (RR = 0.88, 95% CI 0.75 to 1.03, P = 0.121). However, significantly more patients stopped treatment due to adverse effects on TCAs compared to SSRIs (14.2% vs. 9.1%, RR = 0.66, 95% CI 0.50 to 0.87, P = 0.003) with no difference in discontinuations due to treatment failure (10% vs. 11.6%, RR = 1.13, 95% CI 0.84 to 1.51, P = 0.42). This meta-analysis suggests that at least some TCAs may be more effective than SSRIs in depressed inpatients, with there being the strongest evidence for amitriptyline. A possible explanation is that this is related to a dual action in inhibiting both 5-HT and noradrenaline reuptake. In agreement with previous meta-analyses, TCAs appear less well tolerated than SSRIs, although the absolute risk difference for discontinuation due to adverse effects (4.9%, 95% CI -8.1 to -1.7%) is of uncertain clinical significance.

Antidepressive Agents, Tricyclic↗
PubMed1997

Retinal capillary pericyte apoptosis in early human diabetic retinopathy.

OBJECTIVE: To investigate the nature of retinal capillary pericyte dropout in early human diabetic retinopathy. METHODS: In the present study, neural retinas of 12 postmortem eyes from 6 patients (3 diabetic and 3 nondiabetic) were first fixed in buffered formaldehyde and then digested with trypsin. The preparations of trypsin-digested retinal blood vessels were stained with terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL) technique and then with perdiodic acid-Schiff technique (PAS), and counter-stained with hematoxylin to evaluate DNA fragmentation of cell nuclei and diabetic changes of retinal capillaries. RESULTS: TUNEL-positive apoptotic pericytes were observed in retinal capillaries in all three diabetic patients in this study. The TUNEL-positive pericytes were presented as darker stained cells with PAS-hematoxylin staining. A few TUNEL-positive retinal capillary endothelial cells were discovered in both eyes of one of the three diabetic patients. Neither TUNEL-positive pericytes nor positive endothelial cells were found in the three nondiabetic patients. A variety of typical diabetic microvascular changes were noticeable with PAS-hematoxylin staining in trypsin-digested retinal preparations from diabetic patients. These changes included thickened capillary walls, microaneurysms, "ghost-cell"-appearance of pericytes, acellular segments of capillaries, and a decreased ratio of retinal capillary pericytes to endothelial cells. All of these changes are characteristics of diabetic retinal microangiopathy. CONCLUSIONS: Retinal capillary pericyte apoptosis is a specific form of cell death which occurs during the early development of diabetic retinopathy. The significant decrease in the ratio of pericytes to endothelial cells and the predominant TUNEL-positive pericytes over endothelial cells suggest that a greater impact of apoptosis-related mechanisms occurs in pericytes than in endothelial cells and, thereby, a greater loss of pericytes takes place in early diabetic retinopathy. Apoptosis, therefore, is an important mechanism of pericyte dropout in the early diabetic retinopathy.

Aged↗
PubMed1998

Retinal hypoxia in long-term diabetic cats.

PURPOSE: To determine whether the retina is hypoxic in early stages of diabetic retinopathy in cats and to correlate intraretinal PO2 with fluorescein angiographic and histologic alterations. METHODS: Intraretinal PO2 was measured with microelectrodes in three cats with long-standing diabetes (>6 years) that had been followed with fluorescein angiographs every 6 months. Average PO2 in the inner vascularized half of the retina was compared with similar measurements in 21 control animals. Photoreceptor oxygen consumption was also compared. The retinal vascular endothelium of the diabetic animals was stained for ADPase activity in flatmounts, and transverse sections were used to visualize microscopic alterations in vascular structure. RESULTS: PO2 in the inner half of the retina was abnormally low in the diabetic cats, 7.7+/-5.2 mm Hg (35 penetrations in 3 cats) versus 16.4+/-9.3 mm Hg in normal cats (85 penetrations in 21 cats) (P << 0.001). Oxygenation was almost normal in some regions of the diabetic retinas, but little evidence of oxygen supply from the retinal circulation was observed in other regions. Inner retinal hypoxia was present in areas with no detectable capillary dropout in fluorescein angiograms or flatmounts. The worst changes histologically were microaneurysms, leukocyte and platelet plugging of aneurysms and venules, and degenerating endothelial cells in capillary walls. These histologic abnormalities were confined to small regions, some of which could be positively correlated with markedly abnormal PO2 profiles. Photoreceptor oxygen utilization was not affected in two diabetic cats, but was below normal in one animal in which choroidal PO2 was low. CONCLUSIONS: This is the first direct demonstration of retinal hypoxia in early diabetic retinopathy, before capillary dropout was evident clinically. Hypoxia was correlated with endothelial cell death, leukocyte plugging of vessels, and microaneurysms.

Animals↗