Concerning one case of rupture of a flow regulator: How patient safety procedures contribute to the correct use of medical devices.

Flow regulators are widely used in hospitals to assist with intravenous (IV) infusion of medication. The rupture of a flow regulator at the base of the clamp was observed during parenteral nutrition. This rupture resulted in fluid leakage and an inlet of air, responsible for an air embolism in a fragile patient who had undergone a bilateral lung transplant. The patient's clinical condition required him to be transferred to a continuous monitoring unit. A serious Adverse Event in Healthcare (AEH) was reported, as well as a medical device vigilance report. A Feedback Committee (FC) was set up and it recommended an audit within the health care departments to study the conditions for use of flow regulators and to propose corrective actions. Despite the technical data sheet of the device not recommending the administration of lipid emulsions and glucose solutions above 10%, the manufacturer's expert report concluded that the mechanical failure could not be linked to the type of solution. However, the audit did reveal a lack of knowledge of certain rules for using this device. The analysis of this AEH is part of the establishment's patient safety procedure. The AEH highlighted a deviation in care concerning the conditions for use of flow regulators, thus resulting in misuse. The collaboration between the various actors involved in the analysis of this AEH led to the implementation of improvement actions on the root causes, related to the lack of information and of training for professionals on correct use of the medical device.

Renal transplantation in 4 patients with methylmalonic aciduria: a cell therapy for metabolic disease.

INTRODUCTION: Patients with methylmalonic acidemia (MMA) may develop many complications despite medical treatment, in particular, severe central nervous system damage and chronic kidney disease (CKD). A kidney transplant may partially correct the metabolic dysfunctions. Liver, kidney and combined liver-kidney transplantations have been advocated but no guidelines are available to identify the most suitable organ to transplant. PATIENTS AND METHODS: Four patients with MMA (mut° phenotype) received a kidney graft because of repeated metabolic decompensations, with progression to CKD in 3 patients (end-stage kidney disease in two patients and CKD stage III in one patient with an estimated glomerular filtration rate [eGFR] of 40ml/min/1.73m(2)) but normal renal function in one (eGFR of 93ml/min/1.73m(2)) before transplantation. RESULTS: The medium age at transplantation was 7.9y (5-10.2) and the median follow-up was 2.8years (1.8-4.6). Renal transplantation improved the relevant metabolic parameters in 4/4 patients and renal function in the patients with CKD. Plasma and urinary MMA levels immediately decreased and remained normal or subnormal (mean values of plasma MMA before transplantation 1530µmol/L versus 240µmol/L after transplantation, and mean values of urine MMA before transplantation 4700mmol/mol creatinine versus 2300mmol/mol creatinine after transplantation). No further acute metabolic decompensation was observed and protein-intake was increased from 0.60 to 0.83g/Kg/day. One patient transplanted at age 9.7years developed a hepatoblastoma at age 11years with subsequent neurological complications and eventually died. The three other patients are alive. Two of them remained neurologically stable. The 3rd patient who displayed choreoathetosis transiently improved his neurological condition immediately after transplantation and then remained stable. CONCLUSION: Kidney transplantation represents an interesting alternative therapeutic option in methylmalonic aciduria, for renal complications but also as a "cellular therapy" that may significantly reduce metabolic decompensations and hospitalizations. However, further neurological impairment remains possible.

Renal transplantation under prophylactic eculizumab in atypical hemolytic uremic syndrome with CFH/CFHR1 hybrid protein.

We report the first observation of successful kidney transplantation under pre-emptive eculizumab treatment in a 7-year-old boy with atypical hemolytic uremic syndrome (aHUS) and a known hybrid CFH/CFHR1 gene, who was dependent on plasma therapy during the 3-year dialysis period. The hybrid CFH/CFHR1 protein has an altered C3b/C3d binding, is incapable to protect cells from complement attack and is directly implicated in aHUS pathogenesis. There was no evidence of recurrence during the first 16-month follow-up period. We conclude that eculizumab alone, without plasma therapy (plasma infusion and/or plasma exchange), is sufficient to prevent recurrence of aHUS and to maintain long-term graft function.

Comprehensive evaluation of using computerised provider order-entry system for hospital discharge orders.

BACKGROUND: Computerised prescriptions for Hospital Discharge Orders (HDO) are used world-wide to secure medication processes. OBJECTIVES: To evaluate physicians' adoption of computerised provider order-entry (CPOE) for HDO and the prescribing error rate of HDO in an acute medical care unit. SETTING: A prospective study was conducted in an internal medicine department over a six-month period. The use rate of CPOE for HDO edition, prescription lines concordance between CPOE-edited HDO, exit prescriptions transcribed in the discharge summary (DS), and prescribing error rate in CPOE-edited HDO were all evaluated. RESULTS: A total of 407 patients with HDO were included in the study. HDO were edited via CPOE system for 350 patients (86%), among which 124 (35%) were identically transcribed, 217 (62%) had discrepancies, and nine (3%) were not transcribed in the discharge summary (DS). Prescription errors were analysed using the total of 2,854 drugs prescribed on HDO. Although hospital pharmacists had signalled discrepancies and provided recommendations to the prescribers via alerting pharmaceutical interventions in CPOE 67 prescription errors (error rate of 2.3%) were found. Errors included 53 cases of refractory period disrespected, four cases of drug interactions, three cases of drug redundancies, and two cases of excessive dosage. CONCLUSION: This study highlights that most HDO were edited via the CPOE system. Together with pharmacist's interventions, the CPOE system contributed to reducing the prescription error rate in HDO. However, discrepancies in the recording process to DS were frequent, calling for reinforcement of error prevention strategies upon the integration of a CPOE system in the hospital's Electronic Health Records. Providing regular training for physicians is also a requirement.

De novo malignancy after solid organ transplantation in children.

The aim of this study was to assess the prevalence of de novo malignancy after solid organ transplantation in childhood. A retrospective questionnaire-based survey was sent to 9 referral centers for pediatric organ transplantation in France. Among 1326 children who underwent solid organ transplantation since 1996, 80 (6%) presented with de novo malignancy posttransplantation during childhood: posttransplant lymphoproliferative disease was the most common (5% of pediatric recipients) comprising 80% of all tumors, with a disproportionately high prevalence among combined liver and small bowel recipients (18%). Various solid tumors were observed mainly among kidney recipients. No skin cancer was reported.

[Occurrence of delayed symptoms after a challenge test with methacholine]. / Survenue de symptômes tardifs après un test de provocation par la méthacholine.

There are few prospective studies available on the development of delayed symptoms following challenge tests with methacholine (MCT) at the currently recommended doses. The objective of this study was to describe the nature and frequency of respiratory symptoms suggestive of bronchospasm developing within 24hours after a MCT. The study was offered to adult patients who underwent MCT seen consecutively between June and October 2015. Following the test, a questionnaire adapted from the GINA asthma control questionnaire bearing on diurnal and nocturnal symptoms (cough, dyspnoea, wheeze and tightness), was delivered to the patient and the replies collected by telephone 24hours later. Of the 101 patients included (initial FEV1 2.82±0.79L), 46 (46 %) were MCT+ and 55 (54 %) MCT-. Among the MCT-, 4 (7 %) presented with immediate symptoms (S+) and 4 (7 %) with delayed symptoms. Among the MCT+ patients, 36 (78 %) presented with immediate symptoms (P<0.001 compared with the MCT- patients), and 39 (85 %) with delayed symptoms (P<0.001 compared with the MCT- patients). Delayed symptoms developed with a mean of 5h30 after the provocation test. Immediate and delayed symptoms were more frequent in subjects having significant non-specific bronchial hyper-reactivity. Informing patients of the risk of developing delayed symptoms seems useful and allows optimization of their management after a MCT.

Selective decontamination of the digestive tract in multiple trauma patients. A prospective double-blind, randomized, placebo-controlled study.

STUDY OBJECTIVE: The aims of the study were to evaluate the technique of selective digestion decontamination (SDD) in preventing the development of nosocomial infections in a selected population and to assess the effects on colonization of the oropharynx, nares, and bronchi. A financial assessment was also performed. DESIGN: Prospective, double-blind, randomized placebo-controlled trial using amphotericin B, colistin sulfate (polymixin E), and gentamicin applied to the nares, the oropharynx, and enterally; no parenteral antibiotics were given during the study period. The SDD was applied every 6 h during the study period. SETTING: Multidisciplinary ICU in a university hospital. PATIENTS: A total of 148 trauma patients admitted emergently and intubated within less than 24 h were enrolled. Seventy-two patients who received placebo and 76 treated patients were analyzed on an "intention-to-treat" basis. INTERVENTIONS: Microbiologic surveillance samples of oropharyngeal and bronchial secretions, urine, and any other potentially infected sites were taken at the time of ICU admission and twice weekly thereafter until discharge from the unit. MEASUREMENTS AND RESULTS: With the use of SDD, colonization was significantly reduced in the oropharynx and nares (<0.05) but not in bronchi. However, episodes of bronchopneumonia were significantly reduced (19 in the active group vs 37 in the placebo group; p,0.01). Staphylococcus aureus remained the main potential pathogen causing bronchial colonization and subsequent bronchopneumonia. There was no reduction in the incidence of other infections. Days in the ICU, duration of mechanical ventilation, and mortality rate were unchanged. After the use of SDD, Gram-positive colonization tended to increase and this was mainly due to methicillin-resistant coagulase-negative staphylococci. The total cost of antibiotic therapy ($62,117 [US] in the placebo group and $36,008 in the SDD group) was decreased by 42% with the use of SDD. Clinically important complications of SDD were not encountered. CONCLUSIONS: The use of SDD in this population of trauma patients reduced the incidence of bronchopneumonia and the total charge for antibiotics. Stay in the ICU, mechanical ventilation, and mortality rate were unchanged. Methicillin-resistant coagulase-negative staphylococci were selected by SDD in some patients and the clinical relevance of this colonization needs further evaluation.

[Pharmacokinetics in phase IV studies for the preview of a therapeutic protocol]. / La pharmacocinétique dans les études de phase IV pour la prévision du schéma thérapeutique.

The pharmacokinetic studies of anticancer drugs still go on after they are out on the market. The therapeutic protocol is then more precise and depends on the dosage results of these drugs. Some examples of dosage adjustment according to their plasmatic level are reported here for high-dose methotrexate infusion and for CDDP infusion over five days. The test dose and the bayesian method (pharmacokinetic population) are used to predict the adapted individualized dosage for each patient.

[Eisenmenger's syndrome and pregnancy]. / Syndrome d'Eisenmenger et grossesse.

The consequences of pregnancy, abortion or tubal ligature were studied in 11 women with the Eisenmenger syndrome. Seventeen cases of pregnancy and 7 tubal ligatures were reviewed. In the 4 pregnancies continued of term and preceded by cardiac catheterisation, there were two maternal deaths on the 2nd and 7th day of the postpartum period due to pulmonary embolism confirmed in one case and suspected in the other. A third pregnancy was complicated by cerebral embolism and one case of tubal ligature was complicated by non-fatal pulmonary embolism. These cases were compared with previous reports in the literature to form a total of 42 cases of pregnancy in women with the Eisenmenger syndrome. The pregnancies were characterised by aggravation of dyspnoea and cyanosis in 72.4 p. cent of cases, by documented pulmonary embolism in 7 cases and by toxaemia of pregnancy in 26 p. cent of cases. The global mortality was 36 p. cent and all deaths but one occurred between the time of labour and the 11th postpartum day. Micro pulmonary thromboses were the commonest cause of death. Two mechanisms seem to combine to aggravate the cardiac status at the end of pregnancy and during the initial postpartum period: increased right-to-left shunt due to a rise in pulmonary resistances, due particularly to changes in coagulability favored by pregnancy; increased right-to-left shunt due to a decrease in systemic vascular resistances. A number of poor prognostic factors were identified: decreased oxygen saturation in arterial blood and toxaemia of pregnancy.(ABSTRACT TRUNCATED AT 250 WORDS)

[Gastroduodenal complications of hepatic intra-arterial chemotherapy of hepatic metastases of colorectal origin]. / Complications gastroduodénales de la chimiothérapie intra-artérielle hépatique pour métastases hépatiques d'origine colorectale.

Fifty-eight patients with colorectal liver metastases were treated by intra-arterial hepatic chemotherapy (IAHC) containing 5 FU (n = 42) or FUDR (n = 16). Twenty-three patients (39.6 p. 100) complained of abdominal pain. In three of these patients, the course was complicated by digestive hemorrhage. Endoscopic explorations and angioscintigraphy were normal in 4, showed oesophagitis in 3, superficial gastritis or duodenitis in 8 (34.7 p. 100) and gastric (2) or duodenal ulceration (6) in 8 (34.7 p. 100). The duodenal ulceration was extensive and considered to be cause of hemorrhage in two cases. Duodenal perforation due to the catheter was discovered in two other cases, one of which was secondary to tumoral extension revealed by forceps biopsy. This patient died 3 months later. Surgical treatment was mandatory in the other case due to digestive hemorrhage but did not prevent death. Angioscintigraphy performed in 15 patients with gastroduodenal inflammation or ulceration was normal in 7 patients, revealed arterial thrombosis in 5 and an extra-hepatic perfusion in the gastroduodenal area in 3 : this was related to a small pyloric artery which was occluded secondarily. IAHC was continued there after. This experience underlines the importance of exploring patients with digestive symptoms during IAHC so that it may be temporarily discontinued while an inadequately positioned infusion catheter may be corrected should gastroduodenal ulceration occur.

[Passage from sandimmun to neoral in kidney transplantation in children]. / Passage du Sandimmun au Néoral en transplantation rénale chez l'enfant.

BACKGROUND: The cyclosporine microemulsion formulation Neoral, which allows a better absorption and a more regular pharmacokinetic profile, is proposed for replacing the original formulation, Sandimmun. The present study reports the results of conversion from Sandimmun to Neoral in children with a kidney graft, a population for which information remains limited. METHODS AND PATIENTS: Twenty children, 2.5 to 10.5 years of age, who had a kidney graft with a stable renal function for between six months to five years (m = 2.6) were the subjects of this study. The patients were switched from Sandimmun to Neoral at the same dose, adjusted afterwards on a cyclosporine trough level. RESULTS: After six months, the mean dose decreased from 9.1 mg/kg/d to 8.4 mg/kg/d, i.e., 12.5%. After one year, the mean dose was 7 mg mg/kg/d, i.e., 28%. Of the 65% of patients who had a decreased dose, most of them had the highest dose of Sandimmun at the start. Mean serum creatininemia levels slightly increased from 85.6 to 89.5 mumol/L after six months (P = 0.03). None of the patients had a rejection crisis during the first six months under Neoral. Blood pressure did not change significantly, hirsutism improved in two cases but increased or appeared in two cases as well. Gingival hypertrophy increased or appeared in four cases. DISCUSSION: A decrease in the dose was decided on either to maintain the trough CsA blood level in the desired range or because of the appearance of a symptom suggesting a side effect of cyclosporine, especially the increase of creatinemia. The trough level did not appear to be the best index for adapting the dose. CONCLUSION: In stable pediatric kidney transplant recipients, the switch from Sandimmun to Neoral provided a reduction in drug dosage in 65% of cases without an increase in adverse events.

[Efficacy and tolerance of propafenone in the prevention after a year of recurrent atrial arrhythmia. Results of a multicenter study of 114 patients]. / Efficacité et tolérance de la propafénone dans la prévention à un an des récidives d'arythmies auriculaires. Résultats d'une étude multicentrique sur 114 patients.

One hundred and fourteen patients were included in an open multicenter trial of the prevention of atrial arrhythmias by propafenone and of the tolerability of this anti-arrhythmic agent after a year. The study population was divided into two groups: group I of 45 patients with only runs of arrhythmias and group II of 69 patients with a stable arrhythmia. Patients were seen again after 2 weeks, 3 and 6 months and 1 year. Holter records were obtained routinely in group I and at 6 months in group II. Treatment was stopped for inefficacy in 30 patients (10 of group I, 20 of group II), for intolerance in 10 patients (5 in each group) and for both in 3 patients (1 in group I, 2 in group II). Propafenone was considered to be effective and well tolerated in 55 per cent of patients, this success rate being identical in the two groups. Effectiveness persisted in a stable fashion at 1 year in those patients who responded initially.

[Long-term study of propafenone in severe ventricular extrasystole in elderly subjects]. / Etude à long terme de la propafénone dans l'extrasystolie ventriculaire grave du sujet âgé.

A long-term study of the efficacy and tolerance of propafenone was carried out in cases of severe chronic ventricular extrasystoly in elderly patients (age 70). The patients included presented more than 1,500 ventricular extrasystoles per 24 hours with severe criteria. After the Holter performed upon inclusion, 450 mg/d of propafenone were prescribed (900 mg/d in 4 cases). The Holter tests were then repeated at D8, D30, D60, D180, D360, with possible modification of the dosage. 16 patients were then studied, and the study completed its half of them in one year. The efficacy, evaluated by at least an 83 p. cent decrease of the number of ventricular extrasystoles with disappearance of complex forms, was excellent in 12 out of 16 patients, non-existent or insufficient in 2 patients. The arrhythmia was aggravated in 2 cases. In addition, the efficacy of propafenone was maintained in the 8 patients who responded to the treatment and were followed for one year. A poor tolerance (conduction disorders, aggravated arrhythmia) was noted in 7 patients (44 p. cent of the cases). Conduction disorders were present with a propafenone dosage or on preexisting conduction anomalies. Five deaths occurred during the study, unrelated to the treatment. At a dose of 450 mg/24 h, propafenone is therefore effective, most of the time, effective in the treatment of severe ventricular extrasystoly in elderly patients, with a rather good tolerance, and a long-term efficacy. Higher doses only improve minimally the efficacy and are much less well tolerated.

[Treatment of chronic ventricular extrasystole by propafenone (600 mg/d) in 2 or 3 daily doses]. / Traitement des extrasystoles ventriculaires chroniques par la propafénone (600 mg/j), en deux ou trois prises journalières.

The efficacy of propafenone by oral route in the treatment of chronic ventricular extrasystoles (VES) was investigated in 14 subjects in the context of a multicenter evaluation carried out double blind and using a crossover sequence. The purpose of this study was to compare the antiarrhythmic efficacy of a dose of 600 mg/d of propafenone randomly divided into two or three subdoses. After carrying out two Holter recordings (< 15 days) the patients presenting with chronic (< or = 100 VES/H) and stable (interindividual variability > or = 30%) ventricular extrasystoles were included. The treatment period consisted of two 8-day courses divided by a placebo period and carried out following a crossover mode. The efficacy of treatment was defined as a reduction in the VES by at least 70% relative to the second Holter during the inclusion period which was used as the reference period. Fourteen patients (57.2 +/- 18.2 years) from eight cardiological centers (eight with heart disease) were included. In general, propafenone at a dose of 600 mg/d bid or tid significantly reduced the total number of VES by about 65%: 15,239 +/- 2,663 VES/24 h (baseline) to 5,238 +/- 2,746 VES/24 h (bid) and 5,765 +/- 2683 VES/24 h (tid); p < 0.0001, with no significant difference between the bid and tid treatments. Individually, 8 patients (57%) responded during the bid treatment, 7 patients (50%) during the tid treatment and 6 patients during both treatments.(ABSTRACT TRUNCATED AT 250 WORDS)

[Anti-arrhythmia efficacy of propafenone per os in the prevention of paroxysmal supraventricular arrhythmia resistant to class Ia agents]. / Efficacité antiarythmique de la propafénone per os dans la prévention des arythmies paroxystiques supraventriculaires résistantes aux agents de la classe Ia.

The efficacy of orally administered propafenone in the prevention of paroxysmal supraventricular dysrhythmias (atrial fibrillation, atrial tachysystole, reciprocal tachycardia) resistant to Vaughan-Williams class Ia drugs was investigated in 10 patients. Propafenone controlled dysrhythmia very well in 4 out of the ten patients, and satisfactorily in another one at a dosage ranging from 450 to 900 mg/day in 3 or 4 divided doses; this result was documented using continuous 24 hr. Holter ECG monitoring. Among the 5 clinical failures, 1 patient had atrial fibrillation primarily at night, and another poorly tolerated this agent which led to interrupt therapy.

[Comparison of the efficacy and tolerability of sustained-release verapamil and captopril in mild to moderate essential arterial hypertension]. / Comparaison de l'efficacité et de la tolérance du vérapamil à libération prolongée et du captopril dans l'hypertension artérielle essentielle, légère à modérée.

A randomised, double-blind, double-placebo trial compared the efficacy and safety/acceptability of sustained release verapamil and of captopril in two parallel groups of patients with mild to moderate hypertension. After a 2 week placebo period, 45 patients were randomised into 2 groups, the 1st group (n = 22) given sustained release verapamil (240 mg/24 h) as a single morning dose and the second (n = 23) captopril 25 (50 mg/24 h) as two daily divided doses. Treatment was given for 75 days, with the possibility of a combination of sustained release verapamil + captopril from day 45 onwards if diastolic blood pressure remained at 95 mmHg or more. After 45 days of treatment, the reduction in supine diastolic blood pressure did not differ significantly in the 2 groups (-10.4 mmHg in the sustained release verapamil group and -9.7 mmHg in the captopril), with 68.2 per cent responders to sustained release verapamil and 52.2 per cent in the captopril group. After 75 days of treatment, once again there was no significant difference in efficacy between the two groups: -14 mmHg for diastolic pressure and 80 per cent responders in patients treated with sustained release verapamil, -11.3 mmHg and 62.5 per cent responders in the captopril group. The percentage of responders was 58.3 per cent in the group treated with the combination of sustained release verapamil + captopril from day 45 onwards. The number of patients showing evidence of clinical or electrocardiographic adverse reactions was not significantly different: 20.7 per cent in the sustained release verapamil group and 34.8 per cent in the captopril group.(ABSTRACT TRUNCATED AT 250 WORDS)

[Verapamil versus propranolol in stable effort angina. Randomized, crossed, double-blind study]. / Vérapamil versus propranolol dans l'angor d'effort stable. Etude randomisée, croisée, en double aveugle.

A randomised, crossover, double-blind study was carried out in sixteen coronary patients with stable effort angina to compare the effects of verapamil (360 mg) and propranolol (120 mg). All the patients received placebo for 2 days, underwent a coronary angiography which confirmed coronary heart disease and were then randomised into two groups to receive an initial treatment of either verapamil or propranolol for three days. The patients then took placebo for 3 days, then the second drug after cross-over also over 3 days. The therapeutic efficacy was assessed by stress testing on a treadmill (Bruce protocol) with automated analysis of the results (Case-Marquette), carried out on the last day of each of the phases with placebo and the test drug. The duration of the stress test increased significantly with propranolol (p less than 0.01) and verapamil (p less than 0.05) with respect to placebo. In comparison with placebo, propranolol and verapamil resulted in a similar decrease in ST segment depression at the time of maximum effort (p less than 0.01). The resting systolic blood pressure decreased with propranolol (p less than 0.02) and verapamil (p less than 0.01), whereas resting diastolic blood pressure only decreased with verapamil (p less than 0.01). Resting heart rate decreased during the propranolol phase (p less than 0.001). The systolic blood pressure at the time of maximum effort decreased especially with propranolol (p less than 0.05), whereas the diastolic blood pressure on exertion decreased during the verapamil phase (p less than 0.01). Heart rate during exertion only showed a significant decrease with propranolol (p less than 0.001) as compared with placebo.(ABSTRACT TRUNCATED AT 250 WORDS)

[Efficacy and tolerability of isoptine LP in mild to moderate hypertension. A multicenter study with 50 patients]. / Efficacité et tolérance d'isoptine L.P. dans l'H.T.A. essentielle légère à modérée.

A multicenter open trial involving 50 hypertension patients enabled evaluation of the efficacy and tolerability of Isoptine L.P. (sustained release verapamil) in mild to moderate essential hypertension. Following a 2-week placebo run-in period, patients were given Isoptine L.P. (240 mg/24 h) as a morning dose for 3 months, with a possible dose increase (360 mg/24 h) in case of diastolic blood pressure of 95 mmHg or more at the 30-day evaluation. Blood pressure was measured by mercury sphygmomanometer and, in 20 patients, by a Dinamap type Automatic device. After 3 months of treatment, blood pressure levels in supine and standing position, measured manually and automatically, showed a highly significant decrease, with a mean fall of 18.4 mmHg for systolic (13.7 percent) and 13.2 mmHg diastolic (-14.6 percent). 67 percent of patients were responders after 1 month of treatment and 79 percent at 3 months, including one-fifth at the dose of 360 mg/24 h. Seventeen patients, i.e. 34 percent, reported one or more adverse reactions. Among these, four patients had to stop treatment, twice because of headache and twice for constipation. Adverse events seen most frequently were constipation, headache, tiredness and vomiting. No cardiac adverse events were reported with the exception of one case of atrial premature contractions. The electrocardiogram revealed significant slowing of heart rate, as well as slight prolongation of PR and QT intervals and slight widening of the QRS complex. Tolerability on the basis of laboratory parameters was good.

[Sustained-released verapamil and ambulatory recording of blood pressure in mild to moderate essential hypertension]. / Vérapamil à libération prolongée et enregistrement ambulatoire de la pression artérielle dans l'hypertension artérielle essentielle légère à modérée.

An open study in 25 patients evaluated the efficacy and safety of Isoptine S.R., in some cases associated with Aldactazine in mild to moderate essential hypertension. After a placebo period of 2 weeks, the patients received sustained release verapamil (240 mg/24 hours) in a single morning dose for 6 months. An increase in the dosage (360 mg/24 hours in two subdoses) could be made during the first month of treatment if the diastolic blood pressure remained greater than or equal to 95 mmHg. If the diastolic blood pressure persisted at these levels at the second monthly assessment, a tablet of Aldactazine was associated. The blood pressure was evaluated by means of conventional clinical determinations and 24-hour ambulatory recordings carried out at the time of inclusion and then after 3 and 6 months of treatment. From the first month of treatment, the casual blood pressure determinations in the supine and standing position fell highly significantly (p less than 0.0001), resulting in a mean reduction of 22.3 mmHg in the systolic blood pressure (-12.6%) and of 17.4 mmHg in the diastolic blood pressure (-17%). The ambulatory recordings of blood pressure also showed a significant reduction in the mean systolic blood pressure over 24 hours (p less than 0.05 at the 3rd month of treatment), in the mean diastolic blood pressure over 24 hours (p less than 0.01) and the mean pressure (p less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)

[Utilization of transcutaneous anesthetics during heart catheterization]. / Utilisation des anesthésiques transcutanés au cours des cathétérismes cardiaques.

OBJECTIVES: Assess the efficacy of an anesthetic cream for cardiac catheterization. PATIENTS AND METHODS: Percutaneous anesthesia was studied in a series of 100 consecutive patients undergoing cardiac catheterization. The anesthesia was composed with an eutetic mixture of local anesthetics and applied precisely over the puncture area in a randomized controlled study. After admission, patients were randomized into two groups: 50 patients received lidocaine infiltration and 50 patients received associated cream and infiltration. Percutaneous anesthesia was to be applied 2 hours before entering the operating room. RESULTS: No complication developed with this cream combined with lidocaine infiltration. Serum concentration indicated very low levels which were very well tolerated. Patient comfort improved with the anesthetic cream-lidocaine infiltration association. CONCLUSION: The use of an anesthetic cream is safe and effective, especially combined with lidocaine infiltration during cardiac catheterization. Cost is high and the association might be reserved for special indications (obesity, children).