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Query: UMLS:C0015672 (fatigue)
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The aim of the present investigation was to assess and compare health status instruments in SLE. One hundred and twenty-five patients completed five health status instruments: the Health Assessment Questionnaire (HAQ), Functional Ability Index, the Fatigue Severity Scale (FSS), the Disability Days Measure (DDM), the Centre for Epidemiological Studies-Depression Scale (CES-D), and the Medical Outcomes Study (MOS) Short Form Health Survey during their Clinic visit. Disease activity was measured using the SLE Disease Activity Index (SLEDAI). All instruments described a spectrum of quality of life outcomes in these patients. An inter-instrument correlation analysis revealed that components of the MOS correlated significantly with each of the other instruments used. There was no correlation between any of the instruments used and the SLEDAI. We conclude that health status assessment as measured by the MOS short form is a valid independent outcome measure in patients with SLE.
Lupus 1996 Jun
PMID:A comparison of five health status instruments in patients with systemic lupus erythematosus (SLE). 880 89

The optimal outcome measures to be employed in clinical trials of systemic lupus erythematosus (SLE) have yet to be determined. Useful instruments should assess disease outcome in terms of all organ system involvement, as well as measures important to the patient. This article reviews those outcome measures that have been utilized in cohort studies in SLE, as well as their limited use in randomized clinical trials (RCT). Six disease activity measures have been developed: British Isles Lupus Assessment Group Scale (BILAG), European Consensus Lupus Activity Measure (ECLAM), Lupus Activity Index (LAI), National Institutes of Health SLE Index Score (SIS), Systemic Lupus Activity Measure (SLAM), and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). They have been validated in cohort studies as reflecting change in disease activity, and against each other. RCT utilizing SLAM, SLEDAI, BILAG, ECLAM, SIS, SLAM, SLEDAI are ongoing. It is recommended that the disease activity index of choice be selected; but simultaneous computer generation of multiple indices will facilitate comparisons across therapeutic interventions. A damage index has been developed and validated as the Systemic Lupus International Cooperating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index or SDI. In several cohort studies it has been shown sensitive to change over time, and to reflect cumulative disease activity. There is no health status or disability instrument specific to SLE. The Medical Outcomes Survey (SF-20) captures health status/health related quality of life (HRQOL) better than the Health Assessment Questionnaire (HAQ) in patients with SLE, but does not adequately reflect fatigue. The SF-36 does assess fatigue, and correlates closely with the SF-20. These data indicate that any individual measure of clinical response to a therapeutic intervention in SLE may reflect only a portion of what might be termed the "true outcome." Based on this work, the way is now paved to attempt to develop consensus on the important domains to be measured in clinical trials in SLE, the most appropriate instruments to use and the minimal clinically important differences in their results.
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PMID:Outcome measures to be used in clinical trials in systemic lupus erythematosus. 997 93

Data related to the disease course of patients with systemic lupus erythematosus (SLE) with special attention to the persistence of disease activity in the long term are scarce. At this moment reliable figures are only known about the survival rate as a measure of outcome. The aim of this multicenter study was to describe the outcome of SLE patients with a disease duration of greater than 10 y. Outcome parameters were two disease activity-scoring systems (SLEDAI and ECLAM), the end organ damage (SLICC/ACR damage index) and treatment. Our results are derived from 187 SLE patients followed at 10 different centres in Europe over a period of 1 y. Serious clinical signs or exacerbations, defined by the occurrence or detoriation of already existing symptoms of renal and cerebral nervous systems were observed in 2-11% of the patients, seizures and psychosis in 3%, proteinuria in 11% and an increase in serum creatinine in 5% of the patients. No change took place in the overall damage index. Yet, the disease course in most patients was characterized by periods of tiredness (42-60%), arthritis (20-25%), skin involvement such as malar rash (32-40%), migraine (15-20%), anaemia (15%) and leucopenia (17-19%). Summarizing these results it is shown that patients, still under care after such a long time of having this disease, do have a disease that is far from extinguished.
Lupus 2001
PMID:Systemic lupus erythematosus. Disease outcome in patients with a disease duration of at least 10 years: second evaluation. 1124 10

Systemic lupus erythematosus (SLE) can follow an unpredictable course. Clinicians and researchers use various self-report inventories to track aspects of the patient's functioning during the course of the illness (e.g. health status, pain, fatigue, quality of life and psychological status). These self-report inventories are used to measure improvement or deterioration as a function of the natural history of the disease process, or as a function of response to treatment. Proper interpretation of scores derived from these inventories requires an understanding of their psychometric properties, in particular, their reliability. It is important to calculate reliable change difference scores for tests commonly used in rheumatology so clinicians can determine if a change score is a reliable indicator of improvement or deterioration in individual patients (i.e. the change score is not likely to be due to measurement error). The purpose of this article is to illustrate the use of the reliable change difference scores when assessing depression in patients with SLE using the Beck Depression Inventory (BDI).
Lupus 2001
PMID:Assessing depression in systemic lupus erythematosus: determining reliable change. 1134 Nov 3

Recent accumulated evidence suggests that prolactin (PRL) is an important immunomodulator and plays a part in the pathogenesis of systemic lupus erythematosus (SLE). The current study assessed the frequency of hyperprolactinaemia in patients with SLE and its association with defined clinical manifestations or serological abnormalities. PRL levels were analysed in 60 patients with SLE including a follow-up of 20 patients, 18 patients with rheumatic autoimmune diseases other than SLE (AID) and in 47 normal healthy subjects (NHS) using ELISA. Clinical manifestations and disease activity (ECLAM) were recorded. Autoantibodies (anti-dsDNA, anti-CL) were determined by standard techniques. In all, 28.3% of the patients with SLE had raised serum PRL. Their PRL levels (17.4+/-15.1 ng/ml, P<0.0001) and those of patients with AID (13.1+/-10.3 ng/ml, P<0.001) were significantly higher compared to NHS (6.3+/-3.2 ng/ml). Anti-dsDNA (r(s) = 0.3, P = 0.04) and anti-CL antibody titres (IgG; r(s) = 0.3, P = 0.03) correlated with PRL level. Furthermore, elevated erytthrocyte sedimentation rate (ESR), anaemia, decrease in C3, fatigue, fever and renal involvement were associated with hyperprolactinaemia. These results were confirmed by follow-up examinations. Moderate hyperprolactinaemia is present in a subset of patients with SLE and serum PRL correlates with clinical and serological disease activity.
Lupus 2001
PMID:Enhanced serum prolactin (PRL) in patients with systemic lupus erythematosus: PRL levels are related to the disease activity. 1153 Sep 97

To describe the clinical and immunologic characteristics of patients with adrenal involvement and antiphospholipid syndrome (APS), we conducted a computer-assisted (PubMed) search of the literature to identify all cases of primary adrenal insufficiency associated with antiphospholipid antibodies published in English, French, and Spanish from 1983 (when APS was first defined) through March 2002. We reviewed 86 patients (80 from the literature plus 6 from our cohort); 55% were male, and the mean age at presentation was 43 +/- 16 years. Sixty-one (71%) patients had primary APS, and 14 (16%) had systemic lupus erythematosus. In 31 (36%) patients, adrenal insufficiency was the first clinical manifestation of APS. Abdominal pain was present in 55% of patients, followed by hypotension (54%), fever (40%), nausea or vomiting (31%), weakness or fatigue (31%), and lethargy or altered mental status (19%). The main finding in imaging techniques was compatible with adrenal hemorrhage (59%) and in histopathologic study was a hemorrhagic infarction with vessel thrombosis (55%). Lupus anticoagulant was detected in 97% of patients and the anticardiolipin antibodies titer was positive in 93% of patients. Most patients (95%) were positive for the IgG isotype of anticardiolipin antibodies, whereas 40% were positive for the IgM isotype. Baseline cortisol levels were decreased in 98% of patients, ACTH hormone levels were increased in 96% of patients, and the cosyntropin stimulation test was positive in 100% of patients tested. Steroid replacement therapy was the most frequent treatment (84%), followed by anticoagulation (52%) and aspirin (6%). Thirty-two of 35 (91%) patients with prolonged anticoagulant therapy were in good health with a mean follow-up of 25 months, whereas 25 of the 69 (36%) patients with outcome data available had died. The results of the present review stress the clinical importance of systematic screening for lupus anticoagulant and anticardiolipin antibodies in all cases of adrenal hemorrhage or infarction. An initial screening for hypoadrenalism is mandatory in any antiphospholipid antibody-positive patient who complains of abdominal pain and undue weakness or asthenia.
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PMID:Adrenal involvement in the antiphospholipid syndrome: clinical and immunologic characteristics of 86 patients. 1264 Jan 87

In total, 189 consecutive women diagnosed with SLE were evaluated using the ACR 1990 criteria for fibromyalgia. Patients were classified into three subgroups. The fibromyalgia group (FM) included patients experiencing pain on palpation in at least 11 of the 18 tender points examined, as well as having a history of widespread pain for at least three months. Patients who were noted to have pain in fewer than four quadrants with less than 11 of 18 tender points were considered to have regional pain (RP). All patients who did not meet criteria for either FM or RP were classified as having no pain (NP). Measurement of SLE disease activity, sleep complaints, depression, fatigue severity and health status were performed. Only 18 of the SLE patients (9.5%) (95% CI 5.3-14%) fulfilled the ACR criteria for the classification of FM. Of the patients, 106 (56.1%) fulfilled criteria for RP and had a number of tender points of 5.4 +/- 3.4, and the rest of the patients (34.4%) had no tenderness at specific tender point sites. Age, body mass index, educational level and disease duration were comparable between the groups. FM and RP groups had different patterns of symptoms prevalence, with dysmenorrhea being more distinctive for FM. Sleep disturbances were more severe in the FM than in the RP group. Daytime complaints such as sleepiness, fatigue and depression were similar for RP and FM groups, but patients with FM reported more disability. Fibromyalgia is not common in Mexican patients with SLE and has a different pattern of symptoms in RP and NP patients. These data add evidence that ethnicity can play an important role in FM manifestations.
Lupus 2004
PMID:Prevalence and factors associated with fibromyalgia in Mexican patients with systemic lupus erythematosus. 1487 Sep 11

Designing successful randomized controlled trials (RCTs) in systemic lupus erythematosus (SLE) poses many challenges. It remains difficult to correlate alterations in biologic markers with clinical outcome, especially when signs and symptoms are intermittent and broadly variable between patients. Disease activity indices were not designed specifically as outcome measures in RCTs, as they were developed in the context of longitudinal observational studies. Although all disease activity indices have been validated against each other and demonstrated to show change, organ system manifestations are variably weighted; fatigue and autoantibody titers are scored in some and not in others. Due to the variability of the underlying disease course an assessment of disease activity may most accurately be portrayed as change over time, such as an area under the curve analysis. Another lesson learned is that 'responder indices' proposed in the absence of prospective validation in RCTs do not function well. The argument can always be made that any response criteria will work if the treatment is effective; but without the precedent of a product specifically approved for use in SLE, this is hard to prove. The ACR/Systemic Lupus International Cooperating Clinics (SLICC) damage index was designed to score irreversible manifestations of disease or consequences of its treatment, provided they had been present for at least six months. The damage index may best be utilized to stratify patients or balance randomization at baseline. It may also be incorporated into an endpoint analysis, to ensure that treatment or disease associated deterioration in organ system function (that may be overlooked in scoring disease activity alone) has not occurred. Patient cohort data have demonstrated that the medical outcomes survey short form-36 (SF-36) reflected the effects of SLE better than other patient reported measures. Worsening SF-36 domain scores best correlate with higher disease activity, increased glucocorticoid doses and use of cytotoxic agents. It has been shown sensitive to change in RCTs and observational cohorts, and reflects the impact of treatment with high dose glucocorticoids and immunosuppressive agents, as well as end stage renal disease. There is now a body of data derived from RCTs in SLE. Albeit limited, yet to result in an approved therapy, evidence is accumulating that indicate 'early markers' of response can be defined which may correlate with longer term clinical outcomes. This should inform us in our ongoing efforts to clinically test a broad variety of promising interventions.
Lupus 2004
PMID:Clinical trial design in systemic lupus erythematosus: lessons learned and future directions. 1523 Mar

Cognitive dysfunction represents one of several neurological and psychiatric complications of Systemic Lupus Erythematosis (SLE). Additional manifestations of nervous system involvement subsumed under the term neuropsychiatric SLE (NPSLE) include cerebrovascular disorder, seizures, psychosis, acute confusional state, anxiety and mood disorders. Neuropsychological investigations have facilitated the identification and description of cognitive impairment in SLE and NPSLE. Salient findings from studies of SLE-related cognitive dysfunction are reviewed with respect to neuroimaging procedures, indices of disease activity, and potential moderator variables. Data on cognitive functioning are also discussed in reference to other disease aspects including fatigue, sleep disturbance, and impact on health-related quality of life (HRQL). To date, neuropsychological functioning has been studied extensively, albeit separately from other commonly reported SLE-related symptoms. Future research may profit from investigating relationships between cognitive impairment, sleep disturbance and fatigue and their collective impact on functional capacity and quality of life.
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PMID:Factors influencing cognitive function, sleep, and quality of life in individuals with systemic lupus erythematosus: a review of the literature. 1559 65

Intestinal pseudo-obstruction (IPO) is a rare complication of systemic lupus erythematosus (SLE). We present a 32-year old female with SLE for seven years. She was admitted with profound fatigue, frequent vomiting, colicky abdominal pain, diarrhoea and intermittent dysuria for the past 12 months. Imaging studies revealed dilated small and large bowel loops with thickened intestinal wall and multiple fluid levels. Urinary tract involvement was also demonstrated. The patient responded well to immunosuppressive treatment. IPO in the context of SLE has been described only in anecdotal case reports. Half of the cases developed this complication during the course of lupus as in the present case. Concomitant ureterohydronephrosis was present in approximately two-thirds of the cases. Early recognition of the syndrome is necessary for the institution of the appropriate medical treatment and prevention of inappropriate surgical intervention.
Lupus 2004
PMID:Intestinal pseudo-obstruction and ureterohydronephrosis as the presenting manifestations of relapse in a lupus patient. 1564 52


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