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[Outline of the problem of indices of therapeutic efficacy. 4. Expression of efficacy when the underlying illness is incurable. Study Group for the Indices of Efficacy].

In chronic illness, when death or a non-fatal event can occur at any time, the current efficacy indices are no longer appropriate to express the effect of the treatment on the potential therapeutic objectives. The inappropriateness is not dependent on the effect model. Clues for solutions are proposed.

Chronic Disease↗

[The problem of therapeutic efficacy indices. 3. Comparison of the indices and their use].

Efficacy indices do not contain the same information although they are all combinations of the same two quantities. Therefore, one should choose the proper index. Actually, none is entirely appropriate. Each more or less meets the specifications, depending on the underlying effect model for the therapy considered. However, one can say that the absolute benefit is more appropriate from the patient's point of view, the relative from the scientific point of view and the number of patients to treat from the policy maker's point of view. Nevertheless, this classification needs to be considered with caution. Finally, it emerges from the review that none is fully relevant to express the efficacy of a therapy, even in the most suitable condition, the acute illness.

Drug Evaluation↗

Intermediate outcomes by race and ethnicity in peritoneal dialysis patients: results from the 1997 ESRD Core Indicators Project. National ESRD Core Indicators Workgroup.

BACKGROUND: Hispanics are the fastest growing minority group in the United States, and approximately 10% of all end-stage renal disease (ESRD) patients are Hispanic. Few data are available, however, regarding dialysis adequacy and anemia management in Hispanic patients receiving peritoneal dialysis in the U.S. METHODS: Data from the Health Care Financing Administration (HCFA) ESRD Core Indicators Project were used to assess racial and ethnic differences in selected intermediate outcomes for peritoneal dialysis patients. RESULTS: Of the 1219 patients for whom data were available from the 1997 sample, 9% were Hispanic, 24% were non-Hispanic blacks, and 59% were non-Hispanic whites. Hispanics were more likely to have diabetes mellitus as a cause of ESRD compared to blacks or whites, and both Hispanics and blacks were younger than white patients (both p < 0.001). Although whites had higher weekly Kt/V and creatinine clearance values compared to blacks or Hispanics (p < 0.05), blacks had been dialyzing longer (p < 0.01) and were more likely to be anuric compared to the other two groups (p < 0.001). Blacks had significantly lower mean hematocrit values (p < 0.001) and a greater proportion of patients who had a hematocrit level less than 28% (p < 0.05) compared to Hispanics or whites, despite receiving significantly larger weekly mean epoetin alfa doses (p < 0.05) and having significantly higher mean serum ferritin concentrations (p < 0.01). Multivariate logistic regression analysis revealed significant differences by race/ethnicity for experiencing a weekly Kt/V urea < 2.0 and hypertension, but not for other intermediate outcomes examined (weekly creatinine clearance < 60 L/week/1.73 m2, Hct < 30%, and serum albumin < 3.5/3.2 g/dL). CONCLUSION: Hispanics had adequacy values similar to blacks and anemia parameters similar to whites. Additional studies are needed to determine the etiologies of the differences in intermediate outcomes by racial and ethnic groupings in peritoneal dialysis patients.

Adolescent↗

Filgrastim: new indication. AIDS-associated neutropenia: another soft indication.

(1) Neutropenia is frequent in patients with AIDS and is an added risk factor for infection. There is no specific treatment, except, when feasible, the withdrawal of a suspected culprit drug. (2) Filgrastim, a granulocyte growth factor, has been granted a license extension to cover the treatment of persistent neutropenia in patients at an advanced stage of HIV infection. (3) Only one comparative, unblinded trial has been published in this setting. It involved 258 patients distributed into three groups, who received daily filgrastim, intermittent filgrastim, or no treatment. Six months after the beginning of the trial, filgrastim had not reduced the number of deaths, the number of hospital days, or the risk of bacterial or fungal infection. (4) The trial report fails to show whether filgrastim influences viral load or the CD4+ lymphocyte count. (5) In the absence of published dose-finding studies there is no proof that the dose regimen recommended in the licensing terms is the one with the best risk-benefit ratio. (6) Treatment with filgrastim is costly, especially as the available unit doses are unsuitable for this indication. (7) Patients at an advanced stage of HIV infection are already heavily medicated. There is no reason to add filgrastim, which has no proven clinical value.

Acquired Immunodeficiency Syndrome↗

Verteporfin: new indication. New indication in complications of high myopia: no sustained benefit.

(1) High myopia can lead to subfoveal choroidal neovascularisation with a marked loss of central vision. There is no satisfactory treatment. (2) Marketing authorisation has been granted for verteporfin in this indication. Intravenous verteporfin injection is followed by cold red laser therapy, in one or several sessions. (3) In a multicentre comparative randomised double-blind trial involving 120 patients, verteporfin + cold red laser therapy stabilised visual acuity in 72% of patients after one year of follow-up, compared to 44% of patients who received a placebo + cold red laser therapy. This advantage was lost at two years of follow-up. (4) This trial revealed no new side effects of verteporfin. (5) In practice, for want of anything better, verteporfin-based photodynamic therapy may be helpful, but patients should be told of its limitations.

Choroidal Neovascularization↗

Olanzapine: new indication. New indication in acute mania: just another neuroleptic.

(1) Lithium is the first-line treatment for patients with acute mania. For patients with psychosis or intense agitation, an oral neuroleptic can be added (haloperidol or chlorpromazine, the best-assessed drugs of this class). (2) The licensed indications for oral olanzapine, a neuroleptic, explicitly mention the treatment of acute mania. (3) The clinical evaluation dossier on olanzapine in this setting (10 mg to 15 mg/day) is not particularly impressive. In particular, clinical trials included patients with a variety of associated psychotic symptoms. (4) The only comparative trial against another neuroleptic, haloperidol at a high starting dose (10 mg), showed that olanzapine was no more effective. The same applies to a trial comparing olanzapine with disodium valproate. (5) One placebo-controlled trial tested olanzapine as an additional treatment in patients who did not respond adequately to lithium or valproate disodium. Olanzapine potentiated the antimanic effects of the original treatment but also increased the incidence of adverse effects. (6) In patients with acute mania, the main adverse effects of olanzapine are drowsiness, weight gain, dizziness, and dry mouth. In the trial comparing olanzapine with haloperidol, olanzapine caused fewer extrapyramidal side effects but more weight gain than haloperidol. (7) Olanzapine costs 20 times more than haloperidol in France. (8) In practice, olanzapine is just another neuroleptic approved for the treatment of acute mania in patients with psychotic symptoms and agitation. There is no evidence that olanzapine has the best risk-benefit ratio in this category.

Antipsychotic Agents↗

The WOMAC Knee and Hip Osteoarthritis Indices: development, validation, globalization and influence on the development of the AUSCAN Hand Osteoarthritis Indices.

Clinical measurement in both clinical research and clinical practice requires tools and techniques that are valid, reliable and responsive. Patient-centred self-reported measures provide opportunity to evaluate consequences of osteoarthritis, that are important and relevant to patients with the condition. The WOMAC and AUSCAN Indices are health status measurement questionnaires that are valid, reliable and responsive, easy to complete, simple to score and available in multiple language forms and scaling formats. They provide opportunities to capture patient relevant information, relating to the impact of interventions, in clinical research and clinical practice environments. WOMAC data have also contributed to the development of proposed definitions for responder criteria and state-attainment criteria in osteoarthritis.

Biomedical Research↗

[Oncologic indications and contra-indications for hormones use in menopause].

The life expectation has been changeable the manner of menopause handling. At the same time, the women after fifty have the highest incidence of cancer. The hormonal replacement therapy (HT) to date have very few indication for patients with cancer. The oncologic contraindication for HT are analysed in detail, particulary for breast tumor. At the present time, the studies and the metanalysis on HT and breat cancer not showed a quantitative increase on the risk. We are looking for selective hormone with antagonist for endometrium and breast receptors, and effectiveness on the others areas.

Breast Neoplasms↗

[Indications, contra-indications, expected results and choice of neoadjuvant chemotherapy for operable breast cancer].

Neoadjuvant chemotherapy in breast cancer corresponds to the use of a systemic treatment applied before loco-regional treatment (surgery and/or radiotherapy). Initiated in the seventies for treatment of the locally advanced and/or inflammatory breast cancers, induction chemotherapy has been extended in the beginning of eighties for cancers known as operable (size higher than 3 cm and/or in central position) in order to allow a more frequent conservating surgery. This objective is obtained in 75% of the cases approximately without increase in the risk of local relapse and without noxious effect on overall survival, in spite of the delay of the loco-regional treatment. Neo-adjuvant chemotherapy progressively moved with the advent of major drugs in breast cancer which are anthracyclins, vinorelbine and taxans. But to date, no protocol was essential like an uncontested standard. However, it seems that obtaining a complete clinical response is the best guarantor to avoid relapse. That seems to be observed only after 6 cycles, even 8 cycles of chemotherapy, each cycle combining the 2 major drugs for the treatment of breast cancer of which are anthracyclins and taxanes employed according a sequential scheme after a based-anthracyclins treatment, except any cardiac contra-indication. Moreover, the use of targeted therapeuticals like Herceptin, with a chemotherapy, seems to be promising and should be more studied. Finally, when a neoadjuvant chemotherapy is administered, the evaluation of the pre-treatment biopsy helps to establish key patient-management parameters such as tumour type, SBR grade and immunohistochemical parameters. This evaluation provides predictive parameters with regards to drug response (hormonal status, overexpression of Her2). The further studies realised in this way will permit to improve the results yet obtained.

Age Factors↗

[A comparison of the morphological indices of disorders of lymph dynamics and the functional indices of the lungs in patients with tuberculosis and bronchogenic cancer].

A comparative analysis was made with regard to histologic examination findings of the external respiration function indices in 156 patients with cancer and newly diagnosed pulmonary tuberculosis. The given analysis has demonstrated that as compared with pulmonary tuberculosis patients the external respiration function was more disturbed in subjects with a tumor process. This observation mainly concerned the persons with central cancer at the age below 50 and whose ventilation disturbances mostly had an obstructive nature caused by both endobronchial growth of the tumor and a mechanical underflow of the lymph. Lymphodynamic disturbances in the case of cancer were more evident than in tuberculosis.

Aged↗

[Effect of different types of nutrition on various biochemical indicators in the blood of calves during the first 4 months of life. I. Mineral components and hematological indicators of the blood].

The experiment was conducted on 3 groups of calves. Each group composed of 6 calves from 2-16 weeks of age. In the first group the calves were fed whole milk--milk replacer "Mlekomiks", in the second--whole milk and in the third group--milk replacer "Mlekomiks". Throughout the experiment ale calves were fed good meadow hay and concentrate ad libitum. Analysis of the obtained results showed significant (P less than or equal to 0.01) influence of used feeding method on level of sodium, chloride ions, calcium, phosphorus inorganic and indices of blood hematocrit, ferrum, glucose and amylase as well. There was not observed the relationship in the case of hemoglobin and potassium.

Age Factors↗

[Clinico-immunologic indices of various patient contingents in a focus of chronic opisthorchiasis. 3. Dynamics of the indices following praziquantel treatment].

Studies of the time course of the immune status characteristics after praziquantel treatment and of the nature of its side-effects on various groups of opisthorchiasis patients in the focus established significant differences in their immune response to specific treatment. The lack of alterations in the T- and B-immunity systems in aboriginal population of the focus may suggest its tolerance to helminthic antigens. The trend towards cellular immunity stimulation and a significant increase in the levels of circulating immune complexes and specific antibodies in the serum were observed in aboriginal population of the focus. The comers showed significant initial alterations of the immunity status before treatment, pointing to their sensitization to parasitic antigens. Suppression of the infection normalizes several cellular and humoral immunity characteristics--the number of T-helpers, T-lymphocytes, B-lymphocytes, Th/Tc indices, T-lymphocyte functional activity, thus eliminating immune depression. The increased IgG, CIC and specific antibody levels significantly exceeding the normal level, occurrence or enhancement of allergic reactions point to the necessity of performing a desensitizing therapy and using effective cholagogic drugs in the multimodality treatment to rapidly eliminate the parasitic antigen.

Adult↗

[Indications for electronystagmography. When should the ENT physician indicate electronystagmography?].

With the increasing application of technology in medicine, clinical vestibular examination using Frenzel's spectacles is often thought to be out of date, and an electronystagmogram (ENG) is ordered. However, some important facets of the clinical behaviour cannot be determined by ENG alone, especially nystagmus after head-shaking, and the rotatory nystagmus of paroxysmal positional vertigo. Thus, in most cases routine vestibular examination is sufficient, and ENG is only indicated in certain cases. The ENG is then of considerable advantage for determining qualitative characteristics and for quantitative analysis of the nystagmus. The various methods of stimulation and of recording, the limitations and the advantages of the ENG are described in detail. An examiner fully familiar with the advantages and disadvantages of the various methods will profit from the use of ENG. However, the classical examination, including a thorough vertigo analysis, remains indispensable.

Electronystagmography↗

[Indications and contra-indications for heart transplantation].

Indication and contraindications for selection of patients for cardiac transplantation are given on the basis of 2 years' experience in evaluating a total of 65 patients, 30 of whom received heart transplant. Heart transplant must be considered in patients with: 1. Severe heart failure without response to maximal medical treatment. 2. End stage coronary artery disease where clinical heart surgery is no longer feasible. 3. Intractable malignant arrhythmia associated with pump failure. Heart transplant is contraindicated in: 1. Patients with extracardiac polymorbidity. 2. Cardiac low output with renal and hepatic impairment. 3. Compliance failure. 4. Increased pulmonary artery resistance. 5. Age over 60 years.

Adult↗

[Indications for laparoscopy in an internal medicine department in Dakar as indicated by echotomography].

A real time ultrasonography was set up in a senegalese hospital, resulting in a decrease of laparoscopy indications. Laparoscopy is given up for the diagnosis of liver abcess, jaundice and "abdominal masses". It must no more be included in the first step check up for hepatocellular carcinoma, because ultrasonography and cytology after puncture are enough to confirm the diagnosis. Laparoscopy remains essential for peritoneal diseases. Hepatic needle biopsy under laparoscopy control remains necessary to ensure with certainty the diagnosis of cirrhosis and especially chronic hepatitis, provided that no countraindications are found.

Abdomen, Acute↗

[The urological indication. Thoughts on the indication for diagnostic and operative measures in urology: (author's transl)].

Taking as examples the three most frequent diseases occurring in hospital and private practice, urolithiasis, prostatic hypertrophy and space-occupying processes of the kidney, the indications and contraindications of diagnostic and therapeutic measures are pointed out. It is found that even in future only a careful history and clinical findings lead to logical and rational use of technical possibilities.

Adenoma↗

[Body temperature and fever--body temperature regulation, indications and possibilities of fever reducing therapy. II. Indications and effects of fever-lowering procedures and fever-reducing drug therapy].

Fever should be treated according to the individual situation. Securing a sufficient fluid intake is the most important primary measure. The decrease of body temperature by physical means is efficient only in combination with drug therapy and presumes the control of blood circulation. Aminophenazon is the most efficient drug to lower fever. Metamizol should be prefered in children at risk for convulsive disorders. The combination of aminophenazon with phenothiazines can be recommended , prothazine is the drug of first choice in suitable cases a caudal treatment of fever with antiphlogistic drugs as diclophenacsodium (Voltaren) is indicated.

Acetaminophen↗