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PubMed2005

Phase I and pharmacodynamic study of the oral MEK inhibitor CI-1040 in patients with advanced malignancies.

PURPOSE: This phase I study was undertaken to define the toxicity, pharmacokinetics, pharmacodynamics, maximum tolerated dose (MTD), and clinical activity of CI-1040, a small-molecule inhibitor of the dual-specificity kinases MEK(mitogen-activated protein kinase kinase) -1 and MEK2 , in patients with advanced malignancy. PATIENTS AND METHODS: CI-1040 was tested in multiple daily dosing frequencies administered for 21 days repeated every 28 days leading ultimately to continuous administration, and effect of food on absorption was tested. Single dose and steady-state pharmacokinetics were assessed during cycle 1 and phosphorylated extracellular receptor kinase (pERK) levels were assessed in WBCs and also in tumor tissue from selected patients. RESULTS: Seventy-seven patients received CI-1040 at dose levels ranging from 100 mg QD to 800 mg tid. Grade 3 asthenia was dose limiting at the highest dose level tested, 800 mg tid administered with food. Ninety-eight percent of all drug-related adverse events were grade 1 or 2 in severity; most common toxicities included diarrhea, asthenia, rash, nausea, and vomiting. Plasma concentrations of CI-1040 and its active metabolite, PD 0184264, increased in a less than dose proportional manner from 100 to 800 mg QD. Administration with a high-fat meal resulted in an increase in drug exposure. The MTD and recommended phase II dose was 800 mg BID administered with food. Sixty-six patients were assessable for response. One partial response was achieved in a patient with pancreatic cancer and 19 patients (28%) achieved stable disease lasting a median of 5.5 months (range, 4 to 17 months). Inhibition of tumor pERK (median, 73%; range, 46% to 100%) was demonstrated in 10 patients. CONCLUSION: CI-1040 was well tolerated at 800 mg BID administered with food. Both target suppression and antitumor activity were demonstrated in this phase I study.

Administration, Oral↗
PubMed2005

Benefit-risk assessment of levetiracetam in the treatment of partial seizures.

Levetiracetam is a novel antiepileptic drug that has been demonstrated as being effective in the management of partial seizures. It is rapidly and completely absorbed after oral administration and it is predominantly eliminated as unchanged drug in the urine. Its metabolism is independent of the cytochrome P450 enzyme system, nor does it induce cytochrome P450 enzymes. As a result of its pharmacokinetic features, levetiracetam has not been demonstrated to interact with other drugs in either direction. In double-blind, placebo-controlled trials, all the levetiracetam dosages tested were effective, including 1000 mg/day, 2000 mg/day and 3000 mg/day. The ineffective dose is not known. Efficacy seemed to be maintained in long-term studies, with no evidence of tolerance. In major double-blind, placebo-controlled trials discontinuation rates because of adverse events were 6.9-10.9% for levetiracetam-treated patients (all doses) compared with 5.3-8.6% for placebo-treated patients. The most common adverse events that differed between treatment groups and placebo control groups were somnolence, asthenia, dizziness and, in the US study, infection. Since levetiracetam was marketed, behavioural effects have been reported, namely irritability, agitation, anger and aggressive behaviour. These adverse effects are more likely in learning disabled individuals, those with prior psychiatric history and those with symptomatic generalised epilepsy. Overall, the risk has been estimated at 12-15%. Laboratory parameters overall seem to be not significantly affected by levetiracetam, although slight trends to lower white and red blood cell counts were detected in the studies. No organ toxicity has been described so far, with patient exposures exceeding 500,000. In summary, levetiracetam exhibits a very favourable safety profile in patients with partial onset seizures. Whereas somnolence, asthenia and dizziness were the most prominent adverse effects in clinical trials, behavioural adverse effects have generally been the most common reason for drug discontinuation in clinical practice.

Adult↗
PubMed1998

Pramipexole. A review of its use in the management of early and advanced Parkinson's disease.

UNLABELLED: Pramipexole is an orally active non-ergoline dopamine agonist with selective activity at dopamine receptors belonging to the D2 receptor subfamily (D2, D3, D4 receptor subtypes) and with preferential affinity for the D3 receptor subtype. It is approved as monotherapy in early Parkinson's disease and as adjunctive therapy to levodopa in patients with advanced disease experiencing motor effects because of diminished response to levodopa. The potential neuroprotective effects of pramipexole have been shown in animal and in vitro studies. Data from relatively long term (10- or 31-week) studies suggest that pramipexole monotherapy (0.375 to 6.0 mg/day) can improve activities of daily living and motor symptoms in patients with early Parkinson's disease. Pramipexole (0.375 to 4.5 mg/day for 31 or 36 weeks), as an adjunct to levodopa in advanced disease, improved activities of daily living and motor symptoms, reduced the duration and severity of 'off' periods and allowed a reduction in levodopa dosage. Mentation, behaviour and mood [Unified Parkinson's Disease Rating Scale (UPDRS) part I], and timed walking test were not significantly improved. The extent of disability improved according to the UPDRS parts II and III but, when assessed by secondary efficacy parameters, it is unclear whether disability or the severity of disease improved. No significant differences were observed in patients randomised to pramipexole or bromocriptine according to a secondary hypothesis in a prospective study in which both drugs were better than placebo. Some quality-of-life measures improved with active treatment relative to placebo. Further studies comparing pramipexole with other dopamine agonists and levodopa in patients with early and advanced Parkinson's disease would be useful. In pramipexole recipients with early disease, the most commonly experienced adverse events were nausea, dizziness, somnolence, insomnia, constipation, asthenia and hallucinations. The most commonly reported adverse events in pramipexole recipients with advanced disease were orthostatic hypotension, dyskinesias, extrapyramidal syndrome (defined as a worsening of the Parkinson's disease), dizziness, hallucinations, accidental injury, dream abnormalities, confusion, constipation, asthenia, somnolence, dystonia, gait abnormality, hypertonia, dry mouth, amnesia and urinary frequency. The incidence of some adverse events did not greatly differ between pramipexole and placebo recipients. CONCLUSIONS: Pramipexole is effective as adjunctive therapy to levodopa in patients with advanced Parkinson's disease. However, the potential beneficial effects of pramipexole on disease progression need to be confirmed in clinical studies. The efficacy of pramipexole monotherapy in patients with early disease has also been demonstrated, although the use of dopamine agonists in early Parkinson's disease remains controversial.

Antiparkinson Agents↗
PubMed2004

Cetuximab: in the treatment of metastatic colorectal cancer.

Cetuximab is a chimeric monoclonal antibody highly selective for the epidermal growth factor receptor (EGFR), which is over-expressed by 25-80% of colorectal cancer tumours and associated with advanced disease. Cetuximab induces a broad range of cellular responses in tumours expressing EGFR, enhancing sensitivity to radiotherapy and chemotherapeutic agents. In a large, randomised, open-label, multicentre study in adult patients with irinotecan-refractory, metastatic colorectal cancer expressing EGFR, cetuximab 400 mg/m2 initial dose followed by 250 mg/m2 weekly plus irinotecan (various doses) produced a greater rate of partial response and disease control (partial response plus stable disease), and increased time to disease progression, compared with cetuximab monotherapy; survival was similar in both groups. The same dosage of cetuximab combined with irinotecan, fluorouracil and folinic acid (various regimens) produced partial responses in 43-58% of patients, a complete response in 5% of patients (one study only) and stable disease in 32-52% of patients with treatment-naive metastatic colorectal cancer expressing EGFR in three small, open-label trials. The most common grade 3/4 adverse events associated with cetuximab monotherapy were acne-like rash, asthenia, abdominal pain and nausea/vomiting. In patients receiving cetuximab plus irinotecan, these were diarrhoea, asthenia, leucopenia and neutropenia.

Antibodies, Monoclonal↗
PubMed2003

[Clinical investigation on characteristics of traditional Chinese medical syndrome of hepatocirrhosis].

OBJECTIVE: To explore the characteristics of traditional Chinese medical syndrome (TCM syndrome) of hepatocirrhosis. METHODS: Clinical information from the four diagnosis methods of traditional Chinese medicine (TCM) and related laboratorial indexes were systematically collected from 223 hepatocirrhosis cases, and the multi-statistical methods including systematic cluster analysis, principal component analysis, stepwise discrimination and variance analysis were made with the software SAS 6.11. RESULTS: Multi-analysis showed that there were 3 categories of syndrome characteristics. Type 1 (134 cases): damp heat, blood stasis, deficiency of liver and spleen Qi; Type 2 (62 cases): deficiency of both Qi and Yin with severe deficiency of Qi, heat with severe dampness, blood stasis; Type 3 (27 cases): deficiency of both Qi and Yin with severe deficiency of Yin, stasis and heat or dampness. Analysis of the changes of the related laboratorial indexes among the three types of syndrome showed that Type 1 mainly manifested asthenia syndrome with sthenia syndrome, and its indexes of AST, ALT, GGT levels were markedly higher than those of Type 2 and Type 3, both of which mainly showed sthenia syndrome with asthenia syndrome, and that Type 3 was in active inflammation, deficiency of both Qi and Yin (deficiency of Yin > deficiency of Qi), and its FN, Alb, FV, FVII, PLT, PCT levels were obviously reduced. CONCLUSION: The multi-statistical methods can reveal the characteristics and regularity of TCM syndrome of hepatocirrhosis, and the 3 categories of syndrome characteristics basically conform to clinical manifestations. The result of TCM syndrome distribution and laboratorial indexes infer that damp heat is the pathological basis of hepatocirrhosis, and the degree of liver function disorder and liver damage may be the pathological basis of deficiency of Yin of both liver and kidney.

Adult↗
PubMed1998

[Mental disorders in patients with chronic hepatitis].

51 patients with chronic hepatitis were examined clinicopsychopathologically for depression, anxiety, self-estimation, cognitive defects. Non-psychotic mental disorders were found in all the examinees: 15 had asthenia, 36 had asthenia and affective disturbances (astheno-depressive, anxious-depressive, anxious-hypochondriac, hystero-depressive). A correlation exists between psychic disorders, severity of chronic hepatitis, premorbid personality traits and efficacy of therapy. Psychiatrist's observation is needed for early detection and treatment of the above disorders.

Hepatitis, Chronic↗
PubMedDate not supplied

Combined irinotecan, docetaxel and conventionally fractionated radiotherapy in locally advanced head and neck cancer. A phase I dose escalation study.

Both docetaxel and irinotecan have shown strong radiosensitizing properties in vitro. Encouraging results have been reported by phase I/II studies on combined docetaxel or irinotecan with radiotherapy. In the present study we investigated the feasibility of double radiosensitization with weekly docetaxel and irinotecan in head and neck cancer. Twelve patients with locally advanced squamous cell head and neck cancer were recruited in a phase I/II dose escalation protocol. Radiotherapy was given as a standard fractionation regimen (2 Gy/day, 5 fractions/week) to a total dose of 66-70 Gy. Three Docetaxel/Irinotecan dose levels were examined thus, 20/25 mg/m2 (level 1), 20/40 mg/m2 (level 2) and, 25/55 mg/m2 (level 3). Severe asthenia was observed in 1/4 patients treated in the 2nd dose level and in all 4 patients treated in the 3rd. The onset of severe asthenia was associated with the onset of severe grade 3/4 mucositis during the 4th week of treatment. Radiation induced mucositis was accompanied by fungal infection in all 5 patients. The symptomatology persisted for 10-14 days. Mild grade 2 mucositis was observed in 7/8 patients treated at the 1st and 2nd dose level, which enforced treatment delay for 3-5 days. Neutrophil toxicity was minimal. There was only one patient treated at the 3rd dose level that presented with grade 2 neutropenia. Hemoglobin toxicity was also minimal, showing a median drop of 1.2 gr/dL. There was no platelet toxicity observed. Complete response was observed in 9/12 (75%) patients and partial response was observed in 3/12 patients. Of interest, the lowest CR rate was observed in the 3rd dose level (2/4; 50%), which may be a consequence of overall treatment time prolongation. It is concluded that docetaxel and irinotecan combination with radiotherapy is feasible and, a high CR rate can be expected. Combination of the regimen with cytoprotective agents warrant further investigation.

Adult↗
PubMed1999

A Phase I study of raltitrexed, an antifolate thymidylate synthase inhibitor, in adult patients with advanced solid tumors.

The purpose of this study was to perform a Phase I trial of raltitrexed, a selective inhibitor of thymidylate synthase, and to determine the pharmacokinetic and toxicity profiles as a function of raltitrexed dose. Fifty patients with advanced solid tumors and good performance status were treated with raltitrexed as a 15-min i.v. infusion every 3 weeks, at doses escalating from 0.6 to 4.5 mg/m2. Asthenia, neutropenia, and hepatic toxicity were the most common dose-limiting toxicities in this largely pretreated patient population, but they occurred during the initial cycle in only one of nine patients treated with 4.0 mg/m2 and in two of nine patients treated with 4.5 mg/m2. Only 2 of 13 patients treated with 3.5 mg/m2 ultimately experienced unacceptable toxicity after three and seven cycles, compared with 42 and 56% of patients receiving 4.0 and 4.5 mg/m2 after medians of three and two cycles, respectively. The maximum raltitrexed plasma concentration and the area under the plasma concentration-time curve increased in proportion to dose. Raltitrexed clearance was independent of dose and was associated with the estimated creatinine clearance. Asthenia, neutropenia, and hepatic transaminitis were dose-related and tended to occur more frequently when patients received three or more cycles of therapy. A 3-week treatment interval was feasible in the majority of patients at all doses. Although 4.0 mg/m2 appeared to be a safe starting dose in this pretreated patient population, about half who received two or more courses ultimately experienced dose-limiting toxicity. A dose of 3.5 mg/m2 was well tolerated in most patients.

Adult↗
PubMed1999

[Mental disorders in basaloma].

There were observed 70 patients (21 men, 49 women) with basaliomas (cancer of the skin). Mental disorders were observed in form of affective disorders (depression, hypothymic colour of the surrounding), syndrome of dismorphophobia-dismorphomania, relatively short cancerophobic feelings, somatogenic asthenia and a development of personality disorders. A forming of the mental disorders were conditioned at basaliomas by a complex influence of both somatogenic and psychogenic factors. An influence of the psychogenic factors was relatively transitory and psychologically comprehending (dysmorphophobia, cancerophobia, depression). An influence of the somatogenic factors predetermined a stability, a duration and a small reversibility of mental disorders (asthenia, irritative weakness, pathological development of the personality).

Basal Cell Carcinoma↗
PubMed2000

Phase I study of the gemcitabine/oxaliplatin combination in patients with advanced solid tumors: a preliminary report.

The purpose of this study was to determine the maximum tolerated dose and evaluate the dose-limiting toxicities of the gemcitabine/oxaliplatin combination in patients with advanced-stage solid tumors. Of the 48 enrolled patients, 35% had first-line, 23% had second-line, and 42% had third-line therapy. Patients received escalating doses of 1,000 to 1,600 mg/m2 gemcitabine on days I and 8 plus 60 to 120 mg/m2 oxaliplatin on day 8, every 21 days. The dose-limiting toxicities (first nine dose levels) were grade 4 neutropenia, grade 3 asthenia, and grade I to 3 neutropenia or thrombocytopenia. One hundred fifty-three cycles have been administered without any febrile neutropenia or toxic death. Grade 3-4 neutropenia and grade 3 thrombocytopenia were noted in 13 (9%) and seven (5%) cycles, respectively. Nonhematologic toxicity has been mild; the most common was grade 2 to 3 asthenia occurring in 29% of cycles. Among 30 evaluable patients, four partial responses have been observed (response rate, 13%). In this phase I study, the maximum tolerated dose of this drug combination has not yet been reached, although gemcitabine up to 1,600 mg/m2 (days I and 8) plus oxaliplatin up to 120 mg/m2 (day 8) was active and well tolerated, warranting further evaluation in phase II studies.

Aged↗
PubMedDate not supplied

[Histiocytic necrotizing lymphadenitis or Kikuchi-Fujimoto disease. Report of a case].

Histiocytic Necrotising Lymphadenitis by Kikuchi-Fujimoto (NHL) is a rare disease of unknown etiopathogenesis, characterized by cervical lymphadenomegaly, fever and asthenia. It has a good prognosis with a complete functional recovery of the affected lymph nodes. In 1998 a 28 year-old patient (A. G.) was admitted in the Department of Internal Medicine, Garibaldi Hospital, Catania for fever, asthenia and cervical lymphadenopathy. Hemato-chemical tests performed during hospitalization showed only relative leukopenia and a significant increase of ESR. An initial cervical lymph node biopsy made the diagnosis of Hodgkin's lymphoma. However, the favourable clinical course and the normalization of the previous altered hematochemical tests, induced to perform a second lymph node biopsy which led to diagnosis of NHL. The patient was given antibiotics and anti-inflammatory drugs for ten days with a complete healing which persisted at a twelve-month follow-up. The conclusion is drawn that NHL of unknown etiopathogenesis and with a good prognosis is more frequent than what revealed by the data in the literature because of its insidious and aspecific clinical presentation.

Adult↗
PubMed2000

[Ischemic heart disease and metabolic syndrome X (family study)].

AIM: To evaluate prevalence of metabolic syndrome "X" (MS) components in the families of probands and their wives regarding the presence of hyperinsulinemia and in probands' children of both sexes regarding their having vegetovascular dystonia. MATERIAL AND METHODS: 92 families were selected by the proband who survived acute myocardial infarction (MI) at the age under 50: 92 probands (mean age 47 +/- 1.1 years), 57 probands' wives (mean age 47 +/- 0.7 years), 20 sons (mean age 18.3 +/- 0.8 years), 24 daughters (mean age 19.1 +/- 1.0 years). Two groups were formed: group 1 of 48 probands and 25 wives (the presence of hyperinsulinemia in the proband); group 2 of 44 probands and 32 their wives (controls with normal insulin levels). Anthropometric, arterial pressure and lipid-hormonal measurements were made by standard techniques. Nutrition was studied by random reproduction of 24-h diet. RESULTS: More factors of risk to develop atherosclerosis and MS"X" components in probands and their wives were found in group 1. More frequent in the parents were the following MS components: hypoalphacholesterolemia, overweight, arterial hypertension, hyperapolipoprotein-B-emia. Vegetovascular asthenia in the probands' children predisposed to cardiovascular diseases is closely linked with the presence of hypoalphacholesterolemia, hypertriglyceridemia, overweight and arterial hypertension. CONCLUSION: MS "X" for probands and their wives is a "malignant" risk factor for cardiovascular diseases; in the presence of IHD in father, vegetovascular asthenia in children is a risk factor of cardiovascular disease.

Adolescent↗
PubMed1998

[Effect of different prescriptions for tonifying kidney on RNA transcription activity in isolated nuclei and protein synthesis activity in free-cell extracts of the different organs of presenile mice].

OBJECTIVE: To study the anti-aging mechanism of Zuoguiyin (a prescription for tonifying Kindney Yin) and Yishenbao (a prescription for tonifying Kidney Yang) in presenile mice. METHODS: Using male, 14 months old presenile mice as a model of Kidney-Asthenia, the effects of Zuoguiyin and Yishenhao on RNA transcription activity in isolated nuclei and protein synthesis activity in free-cell extracts of the liver, brain, kidney and testes of the presenile mice were observed. RESULTS: RNA transcription activity in isolated nuclei and protein synthesis activity in free-cell extracts of the four organs of the presenile mice group were distinctly lower than those of young mice group (3 months old). After above-mentioned two prescriptions were given to the presenile mice for two months, RNA transcription activity in isolated nuclei and protein synthesis activity in free-cell extracts of the four organs of the two treated groups were obviously higher than those of control group (P < 0.05 or P < 0.01), but there was no difference between two treated groups. CONCLUSIONS: Both Zuoguiyin and Yishenbao could promote RNA transcription activity in isolated nuclei and protein synthesis activity in free-cell extracts of Kidney-Asthenia and presenile mice.

Aging↗
PubMed2001

[The assessment of adaptation potential of circulatory system in non-coronarogenic myocardial disease].

Adaptive potential of the circulatory system was estimated in 223 patients with non-coronary myocardial lesions (80 patients had spinal osteochondrosis with cardialgia, 78 patients were obese and 65 patients had neurocirculatory asthenia of the cardial type) in tests with submaximal exercise. 21 healthy subjects served control. It was found that submaximal exercise in rehabilitation does not change the adaptive potential in healthy subjects, lowers this potential in patients with neurocirculatory asthenia and raises in obese patients.

Adaptation, Physiological↗
PubMed2001

Clinical evaluation of Gabitril and Lamictal for drug-resistant epilepsy in adults.

Second generation antiepileptics lamotrigine (LTG) and tiagabine (TGB) were primarily licensed for adjunctive treatment of simple and complex partial seizures with/without secondary generalisation as similarly effective drugs. Reduction of seizures frequency is the most important index of drug efficacy, but overall therapeutic benefit estimated as a quality of life is nowadays the target goal of management. In this study efficacy and tolerability of LTG or TGB as short-term add-on treatment in patients with refractory complex partial seizures were assessed by the use of both physician-rated measures (mean monthly seizure frequency, responders rate, adverse events, clinical biochemistry) and patients perceived change in their own quality of life estimation (descriptive scale and visual analogue scale-VAS). Comparable efficacy of LTG (n-22, 378 mg/day) and TGB (n-26, 43 mg/g) was assessed as 41 and 35% of responders and above half of patients with noticeable improvement. 25% of patients in both groups reported reduction of seizures severity in 4-points descriptive scale. Biochemistry values did not show clinically significant changes after treatment. 13% of patients on LTG reported adverse events (headache, asthenia, irritability, insomnia). This coefficient was greater for TGB-35% (asthenia, headache, sleepiness, vertigo). However, no case of discontinuation as a result of adverse events was reported for either of the tested drugs. Even if efficacy of LTG and TGB was comparable in objective measurements, only patients on LTG reported a significant quality of life improvement in VAS. This might be the consequence of more frequent adverse events and treatment schedule of TGB (triple dosing/day). This trial confirmed that VAS might be used as an easy additional test in evaluation of antiepileptic drug for individual patient in everyday clinical practice.

Adolescent↗
PubMedDate not supplied

A dose-escalation study of irinotecan (CPT-11) in combination with gemcitabine in patients with advanced non-small cell lung cancer previously treated with a cisplatin-based front line chemotherapy.

PURPOSE: CPT-11 and gemcitabine are both active agents against non-small cell lung cancer (NSCLC). We conducted a phase I study to determine the maximum-tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of their combination in patients with previously treated advanced NSCLC. PATIENTS AND METHODS: Twenty-seven patients with histologically confirmed NSCLC, who had failed cisplatin-based front-line chemotherapy, were enrolled. The patients' median age was 56 years, 24 were male and 22 had a performance status (WHO) 0-1. Gemcitabine was administered on days 1 and 8, as a 30-minute i.v. infusion, at escalated doses ranging from 900 to 1200 mg/m2. CPT-11 was given over a 60-minute i.v. infusion on day 8 at escalated doses ranging from 200 to 350 mg/m2, following gemcitabine administration. The treatment was repeated every three weeks. RESULTS: The MTD was exceeded at dose-level 7 with CPT-11 350 mg/m2 and gemcitabine 1200 mg/m2, where all three enrolled patients presented DLTs (one patient grade 4 thrombocytopenia, one grade 3 diarrhea and one grade 3 asthenia). The recommended doses for future phase II studies are CPT-11 300 mg/m2 on day 8 and gemcitabine 1200 mg/m2 on days 1 and 8. A total of 107 treatment cycles were administered. Grade 3/4 neutropenia was observed in 13 (13%) cycles, febrile neutropenia in 3 (3%) and grade 3/4 thrombocytopenia in 2 (2%). Grade 2/3 diarrhea was seen in 6 (6%) cycles, grade 2/3 nausea and vomiting in 13 (13%) and grade 2/3 asthenia in 8 (8%). Other toxicities were mild. Among 23 patients evaluable for response, PR was achieved in one (4.5%), SD in 12 (52.5%) and PD in 10 (43%). CONCLUSION: The results of this phase I study clearly demonstrate that gemcitabine and CPT-11 can be efficiently combined in a low-toxicity regimen with doses equal or near monotherapy levels. Further studies are needed to evaluate the efficacy of this combination in both chemotherapy-naive and pre-treated patients with advanced NSCLC.

Aged↗
PubMedDate not supplied

[Depressive symptomatology and sleep apnea syndrome].

The sleep apnea syndrome (SAS), which is defined by more than 5 apneas or hypopneas per hour of sleep (9), is quite a frequent affection which concerns 1.4 to 10% of general population (1.7). The major daytime complaints of the SAS are daytime sleepiness, memory and attention disorders, headaches and asthenia especially in the morning, and sexual impotence (9). The nocturnal manifestations are dominated by sonorous and generally long standing snoring, increased by dorsal decubitus and intake of alcohol, with repeated interruptions by respiratory arrests. These manifestations are always noted but rarely spontaneously reported. The sleep, non refreshing, is agitated and perturbed by numerous awakenings. The findings of the clinical examination are poor: obesity is found in 2/3 of the cases and arterial hypertension in 1/2 of the cases (20). Polygraphic recording during sleep only permits an absolute diagnosis. This frequent affection is a real problem of public health because of its numerous complications (3, 10, 12, 13, 18, 21). Symptoms of depression are often found when a patient with a SAS is examined and conversely, symptoms which evoke a SAS can be found in the clinical examination of depressed patients. We decided so to study the thymic and anxious status of 24 patients investigated for a SAS and submitted to a polygraphic recording during sleep. Four clinical parameters were studied: DSM III-R diagnosis criteria, Montgomery and Asberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale (HARS) and thymasthenia rating scale of Lecrubier, Payan and Puech. We also reported Total Sleep Time (TST = 6.5 +/- 1.5), Apnea Hypopnea Index (AHI = 26.7 +/- 21.6), number (2.1 +/- 2.8/h) and duration (174.2 +/- 150.8 s/h) of hypoxic events. Results showed that among 24 patients, 8 were depressed according to DSM III-R diagnosis criteria and had MADRS > 25, 22 were anxious, 11 had a major anxiety (HARS > 15) and 15 presented thymasthenia (SET > 15). Significative correlations existed between anxiety and depression (r = 0.82; p < 0.0001), depression and thymasthenia (r = 0.77; p < 0.0001) and thymasthenia and anxiety (r = 0.75; p < 0.0001). Among the 8 depressed patients a correlation existed between AHI and depression (r = 0.72; p = 0.04), but no correlation was found between depression and hypoxic events. These results were comparable to those of Guilleminault (10), Reynolds (21), Kales (12), Bliwise (3), Klonoff (13) and Millman (18) who studied relations between SAS and depression. The evaluation of thymasthenia gave a more precise typology of the depressive state associated to SAS: the type of the mood disorder is more "blunted" and "anhedonic" than "sorrowful", particularly characterised by asthenia, lack of energy, reduction of interests (leisures, libido, work), loss of initiative, difficulties to organise tasks, fall of performances and reduction of pleasure usually felt in pleasant events (15). The physic symptomatology dominated the psychic one. The sleep disorganization, more than metabolic consequences of apneas, could be involved in this associated depressive state. Other neuropsychiatric troubles can be associated to the SAS. In fact, cognitive troubles (2, 8, 14, 16, 19, 22, 24) and personality disorders (12, 18) have been described. Our data confirm previous observations suggesting a frequent association between SAS, depression, fatigue and anxiety. Clinicians should consequently be aware that a depression with severe complaints of fatigue should deserve an investigation oriented towards SAS. Conversely, when a SAS is diagnosed, it is necessary to look for a possible depression in order to set up the most appropriate treatment. The frequency of SAS, like depression's one, increases with age. Prescription and consummation of sedative psychotropic drugs increase too with age. Since respiratory depressant effects of these drugs have been clearly demonstrated, it is important to evoke SAS when depressive and/or anxious states are diagnosed and not to aggravate it. An efficacious treatment of SAS can also cure the associated depressive state, but this one can persist. It is necessary, in this case, to select a non sedative antidepressant.

Adult↗
PubMed1992

[Palliative care in cancer patients. Frequency and priority of symptoms].

BACKGROUND: The presence of multiple symptoms is very frequent in patients with advanced cancer disease. In this situation in which cure is not a realistic aim, the goal is to achieve symptom control and to give support to the patient and family. This study was designed to identify the most common and priority symptoms in patients with advanced cancer. METHODS: Patients were given a questionnaire with a list of symptoms and were asked to underline those they presented, and also number those they considered most distressful from 1-3. Physicians and nurse independently answered the same questionnaire. RESULTS: Asthenia was the most frequent symptom (patient evaluation 84%, nurse 82% and doctor 93%). Psychopathological disturbances showed a high prevalence. Regarding patient evaluation, dry mouth was the third symptom in frequency (73%), but it was detected by nurses in 39% and by physicians in 16%. Priority symptoms for the three groups were pain, asthenia, anorexia and anxiety. Pain was controlled in 19/22 patients (86%), while psychopathological symptoms were only controlled in 7/19 patients (27%). CONCLUSIONS: In order to optimize treatment patient participation is mandatory. An interdisciplinary team (physicians, nurses, social workers, and psychologists) is necessary to take care of these patients.

Adult↗