[Isotretinoin: compliance with recommendations in childbearing women]. / Isotrétinoïne: suivi de l'application des recommandations des prescriptions chez les femmes en âge de procréer.

INTRODUCTION: The aim of this survey is to ascertain if the incidence of isotretinoin exposed pregnancies was reduced by the late recommendations of prescription and issue (AMM modification on 06/08/2001 and 25/09/2001). METHODS: All isotretinoin exposed pregnancies registered by the French Regional Drug Monitoring Centres, the Information Centre for Teratogenic Agents and Roche (Roaccutane), Pierre Fabre (Curacné Gé) and Expanscience (Procuta Gé) laboratories, from January 1st, 1999 to December 31st, 2002, were analysed. Enforcement of the strengthening of isotretinoin prescription recommendations was analysed on a sample of 68 prescriptions from 45 pharmacies throughout France. RESULTS: In 4 years, 103 isotretinoin exposed pregnancies (Roaccutane 97 p. 100, Curacné(R) Gé 3 p. 100) during teratogenic risk period, were registered. Pregnancy started less than one month after isotretinoin stopping (37 p. 100), during the treatment (43 p. 100), or was in progress when the treatment was initiated (20 p. 100). The reason of the 22 lacking contraception was known 12 times, i.e. an absence of prescription (6 times), a refusal to take a prescribed contraception (3 times) and a self-medication (3 times). Among the 71 pregnancies whose contraceptive status is known, 48 p. 100 could had been avoided if recommendations had been followed (pregnancies due to a premature stopping or an absence of contraception). The issue of pregnancies is a voluntary termination in 60 cases (87 p. 100). Malformations frequency is 25 p. 100. Incidence of isotretinoin exposed pregnancies remained stable, 0.26/1000 treated women (vs 0.34 after 2001's AMM modifications). Of 68 prescriptions studied, 23 (24 p. 100) carried all the legal warnings, which is close to the previous survey's results. Contraception was in accordance with the recommendations in 78 p. 100 of cases and women learned and applied information given in 38 p. 100 of cases. At last, only 6 patients (9 p. 100) have both a correctly written prescription, a contraception and a time between the pregnancy test date and prescription and issue dates, in accordance with the licence and have had a correct information and understood it. Regarding the previous survey, pregnancy test before treatment was more often prescribed (96 p. 100 vs 88 p. 100). On the other hand, less women knew the necessity to keep on taking contraception one month after isotretinoin stopping (82 p. 100 vs 93 p. 100). CONCLUSION: Despite 3 successive isotretinoin prescription and issue recommendations strengthening in childbearing women, pregnancies can't be totally avoided. Bad compliance concerns the prescription and/or an incomplete or not understood information by the patient who does not scrupulously apply the care and contraception agreement. However, this study does not allow to assess the proportion of issued prescriptions despite their non-accordance with the licence criteria. The National Commission of Pharmacovigilance did not like to limit isotretinoin prescription to dermatologists only. It estimates that the administrative authority must intensify information by dermatologists, general practitioners and pharmacists, about measures to take to avoid an exposure to isotretinoin during pregnancy.

[Efficacy of quinine in children hospitalized for malaria attacks in Brazzaville (Congo) in 1989]. / Efficacite de la quinine au cours des accès palustres de l'enfant hospitalisé à Brazzaville (Congo) en 1989.

The efficacy of quinine prescribed to children from Brazzaville hospitalized for acute malaria (temperature over 38 degrees C, P. falciparum parasitaemia over 10,000/mm3, no other obvious disease; the reason for hospitalisation often being digestive or neurological disorders) was assessed. Quinine was administered by perfusion: 25 mg/kg/day for at least 3 days. Associated treatment (sulfadoxine-pyrimethamine combination in 80% of the cases) was given at day 3. Blood was taken at day 0, and before discharge (usually between days 3 and 5). Thick Blood Smears (TBS) were examined for a volume of blood corresponding to 300 leucocytes. Antimalarials had been taken in 60% of the cases (chloroquine in 67% of the cases, quinine in 10%). Antimalarials were not assayed in the sera. In 68 cases of non pernicious malaria, no obvious cases of resistance were observed. TBF were negative in 49 out of 52 cases at day 3, and 11 out of 12 at day 4 and in five out of five cases at day 5. In 96 cases of pernicious malaria, only one case was suspected of being resistant, with a weakly positive TBS at day 7. 13 children died but all in the first three days without suspicion of resistance. Apyrexia was observed before day 4 in 89% of the cases; only one case of fever at day 7. TBS were negative before day 4 in 97% of the cases. So, at the dosage of 25 mg/kg, quinine was found to be very effective in the Congo in 1989 against both pernicious and non pernicious malaria.

[Clinical presentation of non-pernicious malaria attacks in patients hospitalized in Brazzaville (Congo) in 1989]. / Présentation clinique des accès palustres non pernicieux hospitalisés a Brazzaville (Congo) en 1989.

The clinical manifestations observed in 102 malaria patients (parasitaemia of over 8,000 Plasmodium falciparum/mm3) hospitalized in 1989 in Brazzaville (Congo) were analyzed after ruling out the cases of pernicious malaria. The clinical picture was fever, stomach upset with headache and musculo-articular pain as in classical cases. In children these manifestations were frequently associated with convulsions. Diarrhoea was not uncommon in young children. Vomiting was frequent in both children and adults. Splenomegaly and hepatomegaly were closely related to age. In these subjects, chemoprophylaxis was rare in children, practically non-existent in those aged over 5 years. However, presumptive treatment and self medication was usual regardless of age.