Search

The development of medicinal products is subject to quality standards aimed at guaranteeing that database contents accurately reflect the source documents. Paradoxically, these standards hardly address the quality of the source data itself. The objective of this work was to propose recommendations to improve data quality in three fields (pharmacovigilance, pharmacoepidemiology and clinical studies). The analysis was focused on the data and on the critical stages presenting critical quality problems, for which the current guidelines are insufficiently detailed, unsuitable and/or poorly applied. Finally, recommendations have been proposed, mainly focused on the origin of the data and its transcription.

Comparison of treatments initiated during invasive candidiasis in intensive care units with current French guidelines.Prospective, observational, French multicenter study (October 2005-May 2006).Selection of patients with Candida species identification and in vitro antifungal susceptibility determination. The empiric treatments instituted before the microbiologic documentation of infection and the curative treatments instituted after identification of the causative Candida and determination of its susceptibility were collected and compared with treatments proposed by the French clinical practice guidelines (2004) for the management of patients with invasive candidiasis.One hundred and eighty-six patients were studied. Invasive candidiasis was due to fluconazole-resistant or susceptible-dose dependent Candida in 18.3% of patients, without any significant influence of a previous treatment with azoles. Empiric and curative treatments were both in accordance with recommendations for 47% of patients. Recommendations were mainly not respected when proposed therapy was amphotericin B that disappeared from therapeutics used in ICU. Finally, 16.9% of episodes of invasive candidiasis, for which fluconazole was the recommended treatment, were due to fluconazole-resistant or susceptible-dose dependent Candida.The support of French ICU physicians to current French guidelines was observed in 47% of cases. The infrequent use of amphotericin B must be emphasized. The nonnegligible incidence of fluconazole-resistant or susceptible-dose dependent Candida sp., particularly in patients without any prior exposition to azole agents, and the inability to predict this resistance should lead to propose a revision of 2004 guidelines.

The oral status of people living in precarious conditions is problematic. Although the public universal health insurance should allow better access to care, access to dental care remains a critical issue. The analysis of the patient population of a hospital dental consultation (Groupe Pitié-Salpêtrière, Paris) seemed relevant to evaluate the needs of care and the means to provide it. The principal objectives are: to estimate dental health and needs of this population, to describe their sociodemographic characteristics and to compare them with patients living in common social conditions.A cross sectional study was conducted from February to June 2003. A medical questionnaire and a dental file record were used. All outpatients coming to the dental consultation, in need of conservative or prosthetic treatment, were included. We analysed the risk factors associated with poor dental health.Three hundred and thirty three questionnaires were analysed: two third were men, 45% were foreigners. More than half of them benefited from a special social health insurance for disadvantaged people or didn't have any health insurance. The comparative analysis of this precarious group vs regular insured people showed significant differences for sociodemographic and oral characteristics. Namely, in the precarious group, a poor dental status was generally observed: more cavities (3.6 versus 2), more absent teeth not replaced (6.8 versus 3.5) and less treated teeth (1.9 versus 3.9)--p0.0001. Multivariate analysis showed that main risk factors of poor dental status were to be aged and to be a foreigner.This study stresses the importance of the dental care needs in a context of poor insurance refunding for the costs of dental treatments and the lack of structures able to provide dental care for patients living in difficult social condition. These findings question the organization of the dental care system in France.

Two kinds of meningococcal vaccines are available for invasive meningococcal infections (IMI) prevention, non conjugated polysaccharide vaccines anti A+C or anti A+C+W135+Y and conjugated polysaccharide vaccines anti-C. The last one have the advantage of being effective from 2 months of age. Vaccination should to be used in four circumstances: for subjects remaining in close contact with an IMI case; for pilgrims going to Mecca (A+C+W135+Y vaccine must be used); for travelers to a location with active transmission of IMI and close contacts with local population; in case of "mass" vaccination decided by health authorities. Generalised vaccination of all of one or more age groups has been done for serotype C in some European countries, because of high incidence. Effectiveness of this kind of intervention should be weighted with the risk of immunoselection of another serotype and with the possibility of a spontaneous decrease of the incidence.

New assays for the screening of anti-HCV antibodies are regularly proposed for registration. The evaluation of new tests is based on the measurement of their intrinsic value: sensitivity and specificity. To assess the sensitivity of a test, it is very important to be able to obtain sera samplets tested with a "Gold Standard", which is, for HCV, RNA detection. Sensitivity is defined as the ratio of the number of true positive to the number of true positive added to the number of false negative samples. The problem is to define the samples to be tested. It is methodologically impossible to use a serological test for samples selection. The Gold Standard might be performed on samples from the general population or more easily from risk groups. The estimation of the precocity is more difficult. The constitution of an acute hepatitis panel is of interest an the follow up of risk groups has to be encouraged. The estimation of the number of samples needed depends on the required precision in the sensitivity measurement. The confidence interval (CI) decreases when the number of samples tested increases and when the sensitivity is high. The important questions are opposite: if the test is positive what is the probability for the patient to be really positive? (positive predictive value PPV), and, if the test is negative, what is the probability for the patient to be non-infected? (negative predictive value: NPV). The NPV depends on the prevalence of HCV infection in the tested population and on the sensitivity of the test. PPV increases with the prevalence rate and the specificity. Regarding these results, one may suggest that donor screening assays and tests used for diagnose HCV infection in patients may be evaluated with different strategies. Regarding blood donors screening, sensitivity is the most important parameter, the best strategy is to eliminate risk groups, and then, to perform very sensitive assays on negative samples. On the other hand, for patients diagnosis, specificity (avoid false positive results) is more important. The best strategy is to select patients at risk from clinical findings and then, to perform a specific test. Screening strategies for the general population have to take into account these two different strategies.

Kaposi's Syndrome (K. S.) was defined as a virus induced immunogenic tumour responding to interferon. It can be used as a guideline for therapeutical trials in A. I. D. S. K. S. mortality is 13%. K. S. + O. I. (opportunistic infections) mortality reaches 70% and O. I. mortality is approximately 50%. Therefore treating O. I. is a must but it is not mentioned in the paper. Attempts made to modify immunodepression, usual K. S. treatments, experimental treatments based upon similar pathogenicity (like systemic lupus erythematosus, Hansen's disease, preneoplasia dyskeratosis) were unsuccessful. Trials with alpha recombinant interferon realised at the Sloan Kettering Memorial for Cancer in New York are summarized for 74 patients and are in preliminary interpretation. Our study is based upon 13 cases studied for 14 to 4 months and comes up to the same conclusions using 18 to 36 million units/day for 6 months (6 cases) and 3 to 4 months (7 cases). For 6 full treatments the results are: 2 K. S. were cleaned up after 8 and 3 months follow up, 4 K. S. with O. I.: 3 remissions and then relapses and 1 stabilization, for 7 current treatments: 2 had to be discontinued because of bad tolerance, 1 stabilization and 4 remissions. For all treatments a decrease and a lesser gravity of O. I. can be noted during treatment. Besides flu-like syndromes, main clinical side effects, are: asthenia, general condition impairment, 2 fits were observed for which I.N.F. cannot be clearly incriminated. Daily treatment compelling and surveillance are real drawbacks. Different types of better used interferon will probably yield interesting results (40% regression or improvement).

The number of P. falciparum malaria cases, contracted in Africa, diagnosed by the department of Parasitology and Tropical diseases of the Pitié-Salpêtrière Hospital Group has shown a significant increase in 1985-1986 when compared with the 15 past years (+23%). This fact is related to the spread of chloroquine or amodiaquine resistant falciparum malaria from East Africa (1980-1983: 54%) to Central Africa (1985: 54.5%) and now to a country of west Africa (Benin 1986).

This review summarises epidemiological and clinical data of HIV infection who was recognized in Mali since 1985. The most important rate of seropositivity for HIV is observed in the prostitutes group (40%). The estimated seroprevalence for adult population is between 1% and 5%. 46 cases for AIDS are reported in both sexes. The mean age is 35 years. Main signs are weight loss (91%), fever (80%), diarrhea (70%) and lymphadenopathy (50%). Three among the five cases of Kaposi's sarcoma are aggressive. 19.5% of AIDS have antibodies to HIV1, 41.3% to HIV2 and 39.1% to HIV1 and HIV2. Death rate is more than 50%. These data are compared with other countries of Africa.

We report 15 cases of symptomatic HIV infection seen in Paris between June 1983 and June 1985 in Congolese patients. The first signs were diarrhea, weight loss, fever, pruritus. Disseminated lymphadenopathy was frequent. Twelve patients had AIDS, and the opportunistic infections were: isosporosis, oesophageal candidiasis, cerebral toxoplasmosis, Kaposi's sarcoma, CNS' cryptococcosis, cutaneo-mucosal.

From January 1984 to June 1985, 20 out of 65 P. falciparum strains isolated in an hospital in Paris were epidemiologically suspect of resistance to chloroquine. 15 of them were submitted to in vitro chemosensitivity tests with several antimalarials drugs. In cases of suspected chloroquine resistance the initial choice of an alternative drug is mainly presumptive and is generally not guided by the in vitro chemosensitivity assay which results are too much delayed. When in vitro assay shows sensitivity to amino-4-quinolines treatment can be modified accordingly. The determination of plasma concentration of drugs are required in any case. However in vitro sensitivity assays would probably appears essential to physicians in cases of resistance to quinine.

Eleven cases of Kaposi's angiosarcoma (ASK) were observed in Bamako over a 2 year period, representing one third of all malignant cutaneous tumours. There was a clear cut male prevalence. The average age of the patients was 32 years. The commonest sites of involvement were cutaneous, osseous, lymphatic and gastrointestinal. Special features of this series included prurigo preceding skin lesions, a single gastric localisation and involvement of the cavum. Rapid progression was observed in 3 cases, 2 of which had fatal outcomes. Two patients had multifocal disseminated disease at the outset. These cases were similar to ASK in patients with AIDS but our patients were not immunodepressed and LAV serology was negative. The results of chemotherapy were incomplete and transient. This series demonstrates the presence of acute, polyvisceral forms of ASK in Mali which may be classified as intermediary between the classical European or African ASK and the ASK observed in AIDS with positive serology in Central Africa.

Serum samples taken from 6,624 blood donors since 1984 to 1987, were tested for Hepatitis B virus surface antigen (HBs Ag) using a microhemagglutination assay and for anti-HIV antibodies by ELISA test. The mean carrier state of HBs Ag was 10.68% and that of anti-HIV antibodies was 6.99%. The association of HBs Ag and anti-HIV antibodies was discovered in 4.84% donors but without correlation for the period of the study.

The classic diagnostic procedure for cutaneous leishmaniasis is based on the examination of Giemsa-stained smears made from the fluid obtained by scraping the edges of the lesion with a lancet, or prepared with small plugs of superficial tissues. In this report, we compare the results given by this standard method with those obtained by the examination of needle aspirates. Aspirates are secured by injecting a few millimetres outside the external border of the lesion 0.3 to 0.5 ml of saline through a thin needle, rubbing the injured skin, and thereafter pulling back slowly the plunger. Amastigotes were found in all smears from needle aspirates, and in only 11 out 15 obtained by scraping. Aspirates were also more suitable for cultures of parasites.

Seven patients infected with the filarial worm Loa loa received a treatment by cytapheresis in an attempt to lower the microfilaraemia. Microfilarial levels of between 6,000 and 38,500 ml, before extraction, were reduced, according to the case, by between 47 and 97% (mean 76%). The diethylcarbamazine chemotherapy which followed in 6 of 7 patients showed no sign of any of the serious side-effects which often occur in these type of cases. Due to its practicality and the fact that it is well tolerated, both clinically and biologically, cytapheresis would seem to represent the best method for initially treating loaiasis with high microfilaremia.