In vivo persistent pigment darkening method: proposal of a new standard product for UVA protection factor determination.

The European Commission (EC) has recommended assessing the level of ultraviolet A (UVA) protection afforded by sunscreen products using the in vivo persistent pigment darkening (PPD) method or other methods giving equivalent results. In this context, the reproducibility of the in vivo PPD method is of importance. To check the validity of the UVA protection factor (UVAPF) tests, the Japanese Cosmetic Industry Association (JCIA) recommends using a standard product (JCIA standard) with an expected UVAPF 3.75 (SD 1.01). However, considering the increase in UVA efficacy of the new sunscreen products available in the market, with UVAPF up to 30, it seemed useful to develop a new standard product to be used when testing products with expected UVAPF > or =10. The PPD method was used in six centres to determine the UVAPF of the two products. Reproducibility of results was also studied by testing two batches of the new product at two different times. There was no statistical difference between the six centres with regard to the JCIA standard. The ring study showed that the mean value of UVAPF (4.3) was higher than that given by JCIA (3.75). These data enable the proposal of a new acceptance range for the JCIA standard product (3.4-5.2) derived from actual results from European laboratories. Whereas this range is different from that proposed by JCIA (2.74-4.76), there is an overlapping of the values. Data on the new standard product show that reproducibility is not influenced by the batches of this product. The mean UVAPF value obtained is 12.1. An acceptance range (9.6-14.6) is proposed for the new standard. Data presented here demonstrate that if an identical protocol is used, reproducible results can be expected and that the PPD method is reproducible and reliable.

Incremental cost-effectiveness ratio of alteplase in patients with acute myocardial infarction in the French setting.

On the basis of data collected from general hospital centres in France on 704 patients initially presenting with acute myocardial infarction, the mean 1-year cost of treatment was calculated to be 52,160 French francs (F) per patient (1994 values). This was independent of whether the patient received thrombolysis, and included all costs associated with initial hospitalisation including a stay in intensive care, cardiology or medical units, as well as rehospitalisations, revascularisation procedures and any drugs prescribed. When only those patients who survived the initial hospitalisation were considered, the mean cost of treatment was F58,184 per patient. Among patients who received thrombolysis during their initial hospitalisation, the respective mean 1-year costs were F74,684 per patient for those treated with alteplase and F64,866 per patient for those treated with streptokinase (p = 0.09). This nonsignificant difference can be explained by the higher cost of alteplase relative to that of streptokinase, the lower mortality rate associated with alteplase during the initial hospitalisation period (9.2% versus 10.6%) and the difference in the percentage of additional revascularisations required in the 2 treatment groups (32.8% versus 42.3%). Combining the pharmacoeconomic data collected in the French general hospital setting with incremental patient survival data stemming from the Global Utilisation of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) trial showed that the incremental cost-effectiveness ratio of alteplase versus streptokinase amounted to F70128 per life-year saved for the total group, and F52035 per life-year saved for those patients who survived the initial period of hospitalisation.

[Therapeutic strategies in acute myocardial infarction. Results of STIM 93 registry]. / Stratégies thérapeutiques à la phase aiguë de l'infarctus du myocarde. Résultats du registre stim 93.

A registry was set up by the national college of cardiologists practicing in general hospitals in February 1993. The data concerned mode of admission, demographic details, initial clinical and haemodynamic evaluation and hospital outcome. Special attention was given to the electrocardiographic changes before and, in patients receiving thrombolytic therapy, after treatment. An analysis of predictive factors for mortality was performed both in the group of patients "revascularised" and in the group treated conventionally. One thousand and twenty three cases from 327 centres were analysed. There were 1292 men and 531 women, with an average age of 67.9 years. The average time interval from onset of symptoms to hospital admission was 5 h 30 min, 56.8% of patients arriving within 6 hours. 36.4% of the population underwent thrombolysis or angioplasty, 75% of patients under 75 years of age admitted before the 5th hours underwent a procedure of myocardial revascularisation. The hospital mortality was 14%, 8.7% in those revascularised and 17% in patients treated conventionally. Factors predictive of mortality were age, female gender, Killip Classes III or IV, systolic blood pressure of less than 100 mmHg, heart rate of more than 100/min and contraindications of thrombolysis. The maximum ST depression, the sum of ST depression, the sum of ST elevation and depression, were also significant predictive factors of a fatal hospital outcome in the whole population group and in patients treated conventionally. In the reperfused group, only the initial sum of ST elevation and depression was predictive of mortality: 120 minutes after the beginning of thrombolysis, the sum of ST elevations and of elevations and depressions was predictive of twice the mortality when the values exceeded 0.6 mv and 1.4 mv respectively.

[Hemodynamic effects of clonidine on the fetus and newborn infant]. / Effets hémodynamiques de la clonidine sur le foetus et le nouveau-né.

This study on clonidine action on fetal HR and on BP and HR in newborns during the first 3 days of life was carried out with 10 mother-child couples in comparison with 10 other couples randomly chosen among our patients; in these last couples the mother has not been treated with this oral anti-hypertensive agent during the last 6 months of the pregnancy. According to the results, clonidine doesn't seem to have any negative action on the fetus and newborn.

Is apalcillin nephrotoxic?

Apalcillin is a new semisynthetic penicillin used as a sodium salt. More than 4,000 patients have been treated with this antibiotic, but increased serum creatinine levels were noted in 18 cases. In 5 of these cases, apalcillin was possibly responsible, and in 13 it was doubtful. We decided to study renal function of normal volunteers treated with 4 g of apalcillin. Three periods were studied: a pretreatment control period of 80 min followed by a treatment period of 60 min and a posttreatment period of 40 min. Inulin and p-aminohippurate (PAH) infusion were continued during all three periods. At the beginning of the treatment period, 2 g of apalcillin was injected as a bolus, followed by infusion of 2 g of apalcillin over 1 h. Urinary volume was measured every 20 min. Creatinine, insulin, and PAH clearances and urinary excretion of sodium, potassium, calcium, and magnesium were calculated for each period. Urinary beta-2-microglobulin excretion was also assessed. Analysis of variance was done. We observed no variation in clearances of creatinine or inulin or in urinary electrolyte output. PAH clearance was significantly decreased during apalcillin infusion. Apalcillin appeared to compete with PAH for proximal tubular secretion but induced no further renal dysfunction.

[Apalcillin and renal function]. / Apalcilline et fonction rénale.

Apalcilline is a new semi-synthetic penicillin. More than 4,000 patients were treated with this antibiotic but an increase level of serum creatinine was noted in 18 cases. Responsibility of apalcilline in this side effect could be possible in 5 cases, doubtful in 13 cases. We decided to study renal function of normal volunteers treated with 4 gr apalcilline. Three periods were realised: a control period (80 min), a treatment period (60 min), a post-treatment period (40 min). Inulin and PAH infusion lasted during all these three periods. After the control period 2 gr apalcilline was injected as a bolus followed by a 2 gr apalcilline perfusion for one hour. Urinary volume was measured every 20 min. Creatinine, inulin, PAH clearances, sodium, potassium, calcium, magnesium urinary excretion were calculated for each period. Urinary B2-microglobulin excretion was also appreciated. Analysis of variance was done. We did not observe any variation of creatinine, inulin clearances or variation of urinary electrolytes output PAH clearance was significantly decreased during alpacilline infusion. Apalcilline seems competitive with PAH for proximal tubular secretion. Nevertheless apalcilline did not induce any more renal dysfunction.

[Clonidine and treatment of arterial hypertension in the pregnant woman]. / Clonidine et traitement de l'hypertension artérielle de la femme enceinte.

From the results of a non-controlled trial about the successful use of clonidine in 14 hypertensive pregnant women on and on the basis of a bibliographical analysis, the investigators studied efficacy and safety of this central antihypertensive drug. This risk-improvement study reveals that clonidine can be prescribed for the treatment for hypertension during pregnancy.

[Clonidine and treatment of arterial hypertension in the pregnant female]. / Clonidine et traitement de l'hypertension artérielle de la femme enceinte.

From the results of a non-controlled trial about the successful use of clonidine in 14 hypertensive pregnant women on and on the basis of a bibliographical analysis, the investigators studied the efficacy and safety of this central acting antihypertensive drug. This risk-improvement study reveals that clonidine can be safely and advantageously prescribed for the treatment of hypertension during pregnancy.

[Prognostic factors in acute paraquat poisoning. A retrospective study of cases registered by the Poison Control Center of Paris in 1981]. / Facteurs pronostiques de l'intoxication aigüe par le paraquat. Etude rétrospective sur les cas enregistrés au Centre Anti-Poisons de Paris en 1981.

Twenty years after the publication of the first cases, the intoxication with the herbicide Paraquat still has a low prognosis because of no efficient treatment. But many studies have allowed the definition of prognostic factors. Nearly, BISMUTH and als(2) demonstrated that the following criteria are significant: the oral route, the gastric lesions, the organic renal failure, the plasma-Paraquat concentration. Through a series of cases collected in 1981 at the Poison Control Center of Paris, the following prognostic factors have been studied: route of administration, sex of patient, circumstances of the poisoning, ingested volume, concentration of the solution, existence of an emetic in the commercial solution, gastric content, lesions of the upper digestive tract (mouth, oesophagus, stomach), renal impairment, hepatic failure, blood gasometry, lung function tests, plasma and urine paraquat concentrations. Forty-one cases were collected during this period, with thirty-four concerning acute Paraquat poisonings in humans. We studied twenty-seven of them caused by acute oral poisoning, with accidental circumstances in nine cases (two died) and intentional circumstances in eighteen cases (all died) (other cases concerned two ocular projections, four inhalations and one skin projection). The interest of this new investigation is the particularity of our series. Because of our recruitment (larger geographic distribution of patients, larger diversity of circumstances, of routes of administration, of ingested quantities, of treatments...). This series of cases is quite different from others previously published. This study confirms the validity of prognostic factors defined by BISMUTH and als(2). The factors, which look significant, strictly depend on the ingested quantity.(ABSTRACT TRUNCATED AT 250 WORDS)