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1.
Thromb Haemost ; 112(3): 503-10, 2014 Sep 02.
Article in English | MEDLINE | ID: mdl-24965841

ABSTRACT

Two enoxaparin dosage regimens are used as comparators to evaluate new anticoagulants for thromboprophylaxis in patients undergoing major orthopaedic surgery, but so far no satisfactory direct comparison between them has been published. Our objective was to compare the efficacy and safety of enoxaparin 3,000 anti-Xa IU twice daily and enoxaparin 4,000 anti-Xa IU once daily in this clinical setting by indirect comparison meta-analysis, using Bucher's method. We selected randomised controlled trials comparing another anticoagulant, placebo (or no treatment) with either enoxaparin regimen for venous thromboembolism prophylaxis after hip or knee replacement or hip fracture surgery, provided that the second regimen was assessed elsewhere versus the same comparator. Two authors independently evaluated study eligibility, extracted the data, and assessed the risk of bias. The primary efficacy outcome was the incidence of venous thomboembolism. The main safety outcome was the incidence of major bleeding. Overall, 44 randomised comparisons in 56,423 patients were selected, 35 being double-blind (54,117 patients). Compared with enoxaparin 4,000 anti-Xa IU once daily, enoxaparin 3,000 anti-Xa IU twice daily was associated with a reduced risk of venous thromboembolism (relative risk [RR]: 0.53, 95% confidence interval [CI]: 0.40 to 0.69), but an increased risk of major bleeding (RR: 2.01, 95% CI: 1.23 to 3.29). In conclusion, when interpreting the benefit-risk ratio of new anticoagulant drugs versus enoxaparin for thromboprophylaxis after major orthopaedic surgery, the apparently greater efficacy but higher bleeding risk of the twice-daily 3,000 anti-Xa IU enoxaparin regimen compared to the once-daily 4,000 anti-Xa IU regimen should be taken into account.


Subject(s)
Anticoagulants/therapeutic use , Enoxaparin/therapeutic use , Orthopedic Procedures , Postoperative Complications/drug therapy , Thrombosis/prevention & control , Clinical Protocols , Clinical Trials as Topic , Drug Dosage Calculations , Humans , Risk Assessment , Thrombosis/etiology
2.
Br J Ophthalmol ; 91(9): 1173-6, 2007 Sep.
Article in English | MEDLINE | ID: mdl-17383997

ABSTRACT

AIM: To describe the types and location of choroidal neovascularisation (CNV) in exudative age-related macular degeneration (AMD), including vascularised pigment epithelial detatchments (PED), and most recently described subtypes, such as retinal choroidal anasmostosis, also termed "retinal angiomatous proliferation" (RAP). METHODS: Prospective multicentre consecutive descriptive case series. A total of 207 consecutive cases of newly diagnosed exudative AMD undergoing fluorescein angiography (FA) were recruited by 7 French referral hospital-based or private centres. Indocyanine green angiography (ICG) also was performed, when judged necessary by investigators. Types and location of CNV were classified by two independent experts and adjudicated by a third when discordant. RESULTS: All patients had FA, while ICG was performed in 50% of subjects. A total of 17.6% had classic CNV only, 5.4% and 8.3% had predominantly and minimally classic CNV, respectively. Occult CNV could be classified in occult CNV without PED (32.7%) and occult CNV with PED, ie, vascularised PED (23.9%). RAP was observed in 15.1% of cases, and accounted for 30% of vascularised PED. In 5.8% of the cases there was haemorrhagic AMD and 4.8% had fibrovascular scars. Lesions were mainly subfoveal (80%). Agreement between the centre's ophthalmologist and the final validated expert classification was moderate (kappa = 0.52 for location and 0.59 for type of lesion). CONCLUSION: This study confirms that newly diagnosed cases of exudative AMD are mainly occult and subfoveal. RAP appeared as a common lesion in patients with newly diagnosed exudative AMD.


Subject(s)
Choroidal Neovascularization/pathology , Macular Degeneration/pathology , Aged , Aged, 80 and over , Angiomatosis/etiology , Choroidal Neovascularization/etiology , Female , Humans , Macular Degeneration/complications , Male , Prospective Studies , Retinal Detachment/etiology , Retinal Diseases/etiology
3.
Br J Ophthalmol ; 90(3): 296-300, 2006 Mar.
Article in English | MEDLINE | ID: mdl-16488948

ABSTRACT

BACKGROUND/AIM: Malattia leventinese (ML) is an inherited macular degeneration characterised by the presence of small radial drusen. Despite extensive descriptions of this study of the fundus, angiographic features of ML have been inadequately described. The aim is to describe the indocyanine green angiography (ICG) features observed in ML. METHODS: 10 eyes from five consecutive ML patients (aged 27-44 years) were prospectively included. A complete ophthalmological examination including colour fundus photographs, autofluorescence, fluorescein angiography (FA), and ICG was performed. RESULTS: ICG differentiated two types of drusen. Large round aggregated drusen were consistently hypofluorescent in the early phases and presented as hyperfluorescent spots surrounded by halos of hypofluorescence in the late phases. Conversely, small radial drusen were mostly hyperfluorescent in the early phases with decreased fluorescence in the late phases of the ICG sequence. FA also showed differences in staining between the two types of drusen. CONCLUSIONS: ICG angiography revealed marked differences between the large round and small radial drusen observed in ML. The large central drusen presented with an unusual pustuliform feature on the late phases of the ICG sequence. This distinct feature may be useful in the diagnosis of late stage disease when drusen consolidation could obscure the radial drusen.


Subject(s)
Eye Diseases, Hereditary/diagnosis , Macular Degeneration/diagnosis , Adult , Coloring Agents , Eye Diseases, Hereditary/pathology , Female , Fluorescein Angiography , Fundus Oculi , Humans , Indocyanine Green , Macular Degeneration/pathology , Male , Prospective Studies , Retinal Drusen/diagnosis , Retinal Drusen/pathology
4.
Arch Mal Coeur Vaiss ; 98 Spec No 5: 48-53, 2005 Dec.
Article in French | MEDLINE | ID: mdl-16433243

ABSTRACT

Sports arrhythmia has gained wide attention with the mediatization of the death of famous sports stars. Sport strongly modifies the structure of the heart with the development of left ventricular hypertrophy which may be difficult to differentiate from that due to doping. Intense training modifies also the resting electrocardiogram with appearance of signs of left ventricular hypertrophy whereas resting sinus bradycardia and atrioventricular conduction disturbances usually reverts upon exertion. Accordingly, arrhythmia may develop ranging from extrasystoles to atrial fibrillation and even sudden death. Recent data suggest that if benign arrhythmia may be the result of the sole intense training and are reversible, malignant ventricular arrhythmia and sudden death mostly occur in unknown structural heart disease. Hypertrophic cardiomyopathy is amongst the most frequent post mortem diagnosis in this situation. Doping is now present in many sports and further threatens the athlete in the safe practice of sport.


Subject(s)
Arrhythmias, Cardiac/etiology , Athletic Injuries/physiopathology , Cardiomegaly/etiology , Arrhythmias, Cardiac/physiopathology , Atrial Fibrillation/etiology , Atrial Fibrillation/physiopathology , Bradycardia/etiology , Cardiomegaly/physiopathology , Cardiomyopathy, Hypertrophic/etiology , Cardiomyopathy, Hypertrophic/physiopathology , Electrocardiography , Humans , Systole
5.
Arch Mal Coeur Vaiss ; 97(11): 1080-8, 2004 Nov.
Article in French | MEDLINE | ID: mdl-15609910

ABSTRACT

Atrial flutter may now be very frequently and definitely cured in a single session of radiofrequency ablation. However, the very name of atrial flutter gives rise to a certain confusion. Clinical experience from everyday activity in ablation laboratories, especially since the introduction of new mapping techniques, has shown that this entity is in fact multiple. Flutters may be classified by their electrocardiographic appearance and/or their electrophysiological mechanism with as many prognostic as therapeutic implications. This article reviews diagnostic features of typical and atypical flutter and the different treatments which may be proposed in different clinical situations.


Subject(s)
Atrial Flutter/diagnosis , Atrial Flutter/therapy , Diagnosis, Differential , Electrocardiography , Humans , Prognosis
6.
Arch Mal Coeur Vaiss ; 97 Spec No 4(4): 56-62, 2004 Dec.
Article in French | MEDLINE | ID: mdl-15714890

ABSTRACT

Various tachycardias presenting with positive P waves in the standard leads are described in this article. Sinus tachycardia may occur as a normal adaptation reaction to the environment or in the setting of autonomic dysregulation. It may also be mimicked by various arrhythmias which share the earliest depolarisation in the sinus node area. The authors expose a review of these mechanisms.


Subject(s)
Tachycardia/diagnosis , Electrocardiography , Heart Conduction System/physiopathology , Humans , Sinoatrial Node/anatomy & histology , Tachycardia/etiology , Tachycardia/physiopathology
7.
Br J Surg ; 88(7): 913-30, 2001 Jul.
Article in English | MEDLINE | ID: mdl-11442521

ABSTRACT

BACKGROUND: Low molecular weight heparins (LMWHs) have become routine thromboprophylaxis in general surgery. However, their actual clinical effect, its magnitude relative to that of unfractionated heparin (UFH), and the optimal dose are still debated. METHODS: A meta-analysis was performed of all available randomized trials in general surgery comparing LMWH with placebo or no treatment, or with UFH. RESULTS: Comparison versus placebo or no treatment confirmed that the significant reduction in asymptomatic deep vein thrombosis (DVT) obtained with LMWH (n = 513; relative risk (RR) 0.28 (95 per cent confidence interval 0.14-0.54)) was associated with a significant reduction in clinical pulmonary embolism (n = 5456; RR 0.25 (0.08-0.79)) and clinical venous thromboembolism (VTE) (n = 4890; RR 0.29 (0.11-0.73)), and a trend towards a reduction in overall mortality rate. Comparison versus UFH showed a trend in favour of LMWH, with a significant reduction in clinical VTE (P = 0.049), a trend also found for cancer surgery. LMWH at doses below 3400 anti-Xa units seemed to be as effective as, and safer than, UFH, while higher doses yielded slightly superior efficacy but increased haemorrhagic risk, including that of major haemorrhage. CONCLUSION: Asymptomatic DVT may be regarded as a reliable surrogate endpoint for clinical outcome in studies investigating thromboprophylaxis in general surgery. LMWH seems to be as effective and safe as UFH. Determination of the optimal dose regimen of LMWH for this indication requires further investigation.


Subject(s)
Anticoagulants/therapeutic use , Heparin, Low-Molecular-Weight/therapeutic use , Thromboembolism/prevention & control , Venous Thrombosis/prevention & control , Humans , Randomized Controlled Trials as Topic
8.
J Fr Ophtalmol ; 24(9): 949-54, 2001 Nov.
Article in French | MEDLINE | ID: mdl-11912839

ABSTRACT

INTRODUCTION: The interest of radiation therapy in the management of age-related macular degeneration inaccessible to photocoagulation is still controversial. Our purpose was to demonstrate the feasibility and the possible efficacy of a single dose delivered to the macular region using a 65-MeV proton beam. MATERIAL AND METHODS: A phase II trial was set up using the cyclotron in Nice, France. Fifty-eight patients were included after signing an informed consent. All patients presented with occult subfoveal choroidal neovascularization. A single dose of 9.1 Gy (i.e., 10 Gy cobalt equivalent) was delivered to the macular region. RESULTS: The results were analyzed 3, 6, 12 and, 18 months after proton therapy. At 3 months, the visual acuity was stable or enhanced for 86% of patients, at 6 months for 82.3%, at 12 months for 80%, and at 18 months for 61%. For 22 patients at follow-up at 18 months, the reasons for a decrease in visual acuity were a macular hemorrhage for 4 patients and a progression of the neovascular membrane for 3 patients. No secondary effects related to the treatment have been observed. Regarding the lesions visible on the angiographies (i.e., hemorrhage, exudates, subretinal detachment), we observed a stabilization or a decrease in two-thirds of the cases. CONCLUSION: Preliminary results of single-dose proton therapy are at least comparable to those obtained by other teams. A second study is in progress comparing 3 dose levels, looking for a dose-effect relationship. Furthermore, a randomized study comparing a single proton dose to a placebo will be necessary to assess the long-term value of proton treatment.


Subject(s)
Macular Degeneration/complications , Proton Therapy , Retinal Neovascularization/therapy , Aged , Aged, 80 and over , Female , Humans , Macular Degeneration/pathology , Male , Retinal Neovascularization/etiology , Retinal Neovascularization/pathology
9.
BJOG ; 108(11): 1134-40, 2001 Nov.
Article in English | MEDLINE | ID: mdl-11762651

ABSTRACT

OBJECTIVE: To assess the maternal, fetal and neonatal safety of enoxaparin in pregnant women who require antithrombotic therapy. DESIGN: Retrospective analysis of case notes of women who received enoxaparin during pregnancy, irrespective of dose, duration and reason for treatment. SETTING: Fifty-five French perinatal centres. SAMPLE: Data from 624 pregnancies in 604 women between 1988 and 1997. The incidence of previous thromboembolism was 29.8%, known thrombophilia 15.2%. METHODS: Indication, regimen of enoxaparin and outcome measures were reported for each pregnancy. Information was obtained from case records, validated by research staff and analysed by an independent scientific committee. MAIN OUTCOME MEASURES: Incidence, seriousness and causality of maternal, fetal and neonatal adverse events, pregnancy outcome, and incidence of venous thromboembolism. RESULTS: Enoxaparin was administered for treatment of an acute episode in 49 cases and for thromboprophylaxis in 574 cases. Serious maternal haemorrhage occurred in 11 cases during pregnancy (1.8%), one being reasonably related to enoxaparin, and in nine cases at delivery (1.4%), all unrelated to enoxaparin. Maternal thrombocytopenia was reported in 10 cases (1.6%). two being serious but unrelated to enoxaparin. Eight pregnancies ended in stillbirth (1.1%). Among the 693 live births, 17 major congenital abnormalities (2.5%) and 10 serious neonatal haemorrhages (1.4%) were reported. None of the fetal or neonatal adverse events was related to enoxaparin. Eight venous thromboembolic events (1.3%) were reported. CONCLUSIONS: The incidence of adverse events reported could be explained by the high risk profile of the study population. Overall, this retrospective study suggests enoxaparin is well tolerated during pregnancy.


Subject(s)
Anticoagulants/adverse effects , Enoxaparin/adverse effects , Pregnancy Complications, Hematologic/drug therapy , Thromboembolism/drug therapy , Venous Thrombosis/drug therapy , Adult , Anticoagulants/administration & dosage , Cerebral Hemorrhage/chemically induced , Enoxaparin/administration & dosage , Female , Humans , Infant, Newborn , Intracranial Hemorrhages/chemically induced , Pregnancy , Pregnancy Outcome , Retrospective Studies , Thrombocytopenia/chemically induced
10.
Am J Cardiol ; 85(12): 1467-71, 2000 Jun 15.
Article in English | MEDLINE | ID: mdl-10856394

ABSTRACT

Treatment with beta blockers results in improvement in functional status, and reduces mortality in patients with heart failure. A number of differences in the results noted could be due to additional properties of the specific beta blockers studied: absence of cardioselectivity, and existence of a vasodilator effect and of an associated antioxidant effect. We studied the effects of celiprolol, a cardioselective beta blocker with a stimulant effect on beta2 receptors. One hundred thirty-two patients presenting with chronic heart failure of various etiologies, with an ejection fraction of <40% and New York Heart Association cardiac functional status grades II and III were included in a randomized, double-blind, placebo-controlled study. The maximum dose of celiprolol (100 mg) was attained after 1 month. The study lasted 1 year. The primary evaluation criterion was functional class as evaluated using the Goldman questionnaire. There was no difference in efficacy between the 2 treatment groups in terms of functional class (p = 0.56). With regard to the secondary evaluation criteria, an improvement in DiBianco functional score was seen with celiprolol (p = 0.03), as well as a significant reduction in heart rate (p = 0.01). Ejection fraction increased in both groups (p = 0.15). There was no difference regarding improvement in left ventricular volume as determined at echocardiography or in exercise capacity. The safety profile of celiprolol was excellent. There was no difference in terms of cardiovascular mortality (2 receiving celiprolol vs 4 placebo), onset of arrhythmias (2 receiving celiprolol vs 3 placebo), worsening of heart failure (26 receiving celiprolol vs 23 placebo), or noncardiovascular adverse events (9 receiving celiprolol vs 14 placebo). The absence of a significant efficacy of celiprolol, a beta blocker with vasodilator properties, but exerting stimulation of beta2 receptors, suggests an unfavorable role of this latter property in heart failure. However, the safety profile of celiprolol was excellent. This beta blocker may consequently be used for its other indications, hypertension and angina, in patients presenting with altered cardiac function.


Subject(s)
Adrenergic beta-Antagonists/therapeutic use , Celiprolol/therapeutic use , Heart Failure/drug therapy , Adrenergic beta-Antagonists/adverse effects , Adult , Celiprolol/adverse effects , Double-Blind Method , Female , Heart Failure/mortality , Humans , Male , Middle Aged , Vasodilator Agents/therapeutic use
11.
J Fr Ophtalmol ; 22(7): 766-70, 1999.
Article in French | MEDLINE | ID: mdl-10510757

ABSTRACT

PURPOSE: A case of congenital epiretinal membrane associated with retinitis pigmentosa is reported. PATIENT: A 30 year old man with retinitis pigmentosa was operated for a vitreomacular traction syndrome. The epiretinal membrane removed during surgical procedure was analyzed in electronic microscopy. RESULTS: Visual acuity, 6 months after the intervention: improve at 20/400, because of amblyopia. The study in electronic microscopy reveals many fibroblasts in an abundant collagenic tissue without glial cells. DISCUSSION: The observation of such an epiretinal membrane is unusual during retinitis pigmentosa. Its origin is probably congenital and the vitreous may play some role in its evolution. The systematic examination of the vitreoretinal interface represents an important element of the surveillance of retinitis pigmentosa.


Subject(s)
Epiretinal Membrane/pathology , Retinitis Pigmentosa/pathology , Adult , Epiretinal Membrane/congenital , Epiretinal Membrane/surgery , Fluorescein Angiography , Humans , Macula Lutea , Male , Microscopy, Electron , Papilledema/pathology , Retinitis Pigmentosa/diagnosis , Syndrome , Visual Acuity , Vitreoretinopathy, Proliferative/pathology , Vitreous Body/pathology
12.
N Engl J Med ; 341(11): 793-800, 1999 Sep 09.
Article in English | MEDLINE | ID: mdl-10477777

ABSTRACT

BACKGROUND: The efficacy and safety of thromboprophylaxis in patients with acute medical illnesses who may be at risk for venous thromboembolism have not been determined in adequately designed trials. METHODS: In a double-blind study, we randomly assigned 1102 hospitalized patients older than 40 years to receive 40 mg of enoxaparin, 20 mg of enoxaparin, or placebo subcutaneously once daily for 6 to 14 days. Most patients were not in an intensive care unit. The primary outcome was venous thromboembolism between days 1 and 14, defined as deep-vein thrombosis detected by bilateral venography (or duplex ultrasonography) between days 6 and 14 (or earlier if clinically indicated) or documented pulmonary embolism. The duration of follow-up was three months. RESULTS: The primary outcome could be assessed in 866 patients. The incidence of venous thromboembolism was significantly lower in the group that received 40 mg of enoxaparin (5.5 percent [16 of 291 patients]) than in the group that received placebo (14.9 percent [43 of 288 patients]) (relative risk, 0.37; 97.6 percent confidence interval, 0.22 to 0.63; P< 0.001). The benefit observed with 40 mg of enoxaparin was maintained at three months. There was no significant difference in the incidence of venous thromboembolism between the group that received 20 mg of enoxaparin (43 of 287 patients [15.0 percent]) and the placebo group. The incidence of adverse effects did not differ significantly between the placebo group and either enoxaparin group. By day 110, 50 patients had died in the placebo group (13.9 percent), 51 had died in the 20-mg group (14.7 percent), and 41 had died in the 40-mg group (11.4 percent); the differences were not significant. CONCLUSIONS: Prophylactic treatment with 40 mg of enoxaparin subcutaneously per day safely and effectively reduces the risk of venous thromboembolism in patients with acute medical illnesses.


Subject(s)
Anticoagulants/therapeutic use , Enoxaparin/therapeutic use , Pulmonary Embolism/prevention & control , Venous Thrombosis/prevention & control , Acute Disease , Aged , Anticoagulants/adverse effects , Double-Blind Method , Enoxaparin/adverse effects , Female , Hospitalization , Humans , Incidence , Injections, Subcutaneous , Male , Pulmonary Embolism/epidemiology , Pulmonary Embolism/mortality , Survival Analysis , Thromboembolism/prevention & control , Venous Thrombosis/epidemiology
13.
J Fr Ophtalmol ; 22(2): 203-8, 1999 Mar.
Article in French | MEDLINE | ID: mdl-10327351

ABSTRACT

PURPOSE: We analyzed outcomes of 18 subfoveal neovascular membrane scars after surgery removal in age related macular degeneration. Surface and aspect of pigment epithelial defects were evaluated on angiographic data. RESULTS: We differentiated glial scars and atrophic scars, the most numerous. Scar surfaces were larger compared to the initial preoperative lesions. Central epithelial pigments in scars disappeared in the three months following surgery. After on year, scar surfaces moderately enlarged. DISCUSSION: Ideal approach for retinotomy as well as clinical aspects have to be well evaluated in subfoveal neovascular surgical removal. The angiographic mask effect of the avascular ring surrounding the neovessel is sometime detectable; the approximative scar surface is by this fact more predictable. CONCLUSION: Iatrogenic damages of surgery and postoperative inflammatory lesions must be considered before when a surgical removal of neovascular membranes is suggested.


Subject(s)
Choroidal Neovascularization/surgery , Cicatrix/diagnosis , Macular Degeneration/surgery , Pigment Epithelium of Eye/surgery , Adult , Aged , Choroidal Neovascularization/diagnosis , Cicatrix/etiology , Female , Fluorescein Angiography , Humans , Macular Degeneration/diagnosis , Male , Middle Aged , Retina/surgery , Time Factors , Vitrectomy
15.
Contracept Fertil Sex ; 25(5): 385-8, 1997 May.
Article in French | MEDLINE | ID: mdl-9273110

ABSTRACT

The authors report a bladder injury during laparoscopic procedure. A laparotomy is performed immediately and shows an urachal anomaly with the bladder reaching the umbilic. One of the accessory trocars perforates the bladder in its unusual position. Surgical repair is made and the patient discharged without sequelae 12 days later. Rate of bladder injury increases with development of advanced laparoscopy as Burch and hysterectomy. Careful drainage with folley catheter during all laparoscopic procedures present greater than morbidity. Previous laparotomy may change the usual position of the bladder. Care must be taken in case of wall anomalies as in our observation. Per-operative suspicion of bladder injury (hematuria, presence of gas in the urinary catheter collection bag) can be proved with the injection of methylene blue in the folley catheter. Laparoscopic repair is possible for an experienced surgeon, associated with 10 days continuous urinary drainage and quinolone antibiotherapy. Morbidity of unknown bladder injury is great with some death-case reports. All diagnosis technique possible must be used to light these clinical situations, urinary peritonitis symptomatology is often non specific.


Subject(s)
Laparoscopy/adverse effects , Pregnancy, Ectopic/surgery , Urinary Bladder/injuries , Adult , Female , Humans , Laparoscopes , Pregnancy , Risk Factors , Urinary Catheterization , Wounds and Injuries/etiology , Wounds and Injuries/prevention & control , Wounds and Injuries/surgery
16.
Lancet ; 348(9022): 224-8, 1996 Jul 27.
Article in English | MEDLINE | ID: mdl-8684199

ABSTRACT

BACKGROUND: The risk of deep-vein thrombosis (DVT) and pulmonary embolism after total hip replacement (THR) surgery may persist after hospital discharge, but the extent of the risk is not known. We carried out a single-centre, prospective, randomised, double-blind trial with the aims of quantifying this risk and assessing the efficacy of continued prophylactic treatment. METHODS: At hospital discharge 13-15 days after surgery, we recruited 179 consecutive THR patients who had no DVT visible on bilateral ascending venography of the legs. The patients were randomly assigned subcutaneous enoxaparin (40 mg, once daily; n = 90) or placebo (n = 89) for 21 (19-23) days. The primary endpoint was the occurrence of DVT or pulmonary embolism. Venography was repeated at the end of 21 days' treatment or earlier if necessary. FINDINGS: There were no deaths and no symptomatic pulmonary embolisms during the study or follow-up periods. Of 173 patients with evaluable venograms, intention-to-treat analysis of efficacy showed that the rate of DVT at day 21 after discharge was significantly lower in the enoxaparin group than in the placebo group (6 [7.1%] vs 17 [19.3%], p = 0.018). Distal DVT was detected in one (1.2%) patient in the enoxaparin group and in ten (11.4%) patients in the placebo group (p = 0.006). Proximal DVT was observed in five (5.9%) patients in the enoxaparin group and in seven (7.9%) patients in the placebo group (p = 0.592). A perprotocol analysis of efficacy in 155 patients confirmed these findings. Safety was good; three minor bleeding episodes occurred in the enoxaparin group and one in the placebo group, but none of these episodes necessitated withdrawal from the study. INTERPRETATION: In patients who have undergone THR surgery, are without venogram-proven DVT at hospital discharge, and do not receive antithrombotic prophylaxis after discharge, the risk of late-occurring DVT remains high at least until day 35 after surgery. Continued prophylaxis with enoxaparin is effective and safe in reducing this risk.


Subject(s)
Anticoagulants/therapeutic use , Enoxaparin/therapeutic use , Hip Prosthesis , Postoperative Complications/prevention & control , Thrombophlebitis/prevention & control , Aged , Anticoagulants/adverse effects , Double-Blind Method , Enoxaparin/adverse effects , Female , Humans , Male , Middle Aged , Patient Discharge , Phlebography , Prospective Studies , Risk Factors
17.
Drugs ; 52 Suppl 7: 47-54, 1996.
Article in English | MEDLINE | ID: mdl-9042560

ABSTRACT

Although venous thromboembolism has occasionally been reported after hospital discharge in patients who have undergone total hip replacement (THR), this risk has not been fully quantified and the usefulness of a prophylactic treatment has not been evaluated. We conducted a single-centre prospective randomised double-blind clinical trial in 2 parallel groups of patients who had undergone THR and were free of deep venous thrombosis (DVT) at discharge, as assessed by bilateral ascending venography. During hospitalisation, all patients received a low molecular weight heparin, enoxaparin (enoxaparin sodium), as a prophylactic treatment for venous thromboembolism. Just before hospital discharge (15 +/- 1 days from surgery) 179 consecutive patients were randomly assigned to receive subcutaneous enoxaparin 40mg (n = 90) or placebo (n = 89) once daily for 21 +/- 2 days. The primary efficacy outcome was defined as the occurrence of DVT and/or documented pulmonary embolism (PE). DVT was assessed by ascending bilateral venography performed 21 +/- 2 days after randomisation or earlier if necessary. Secondary efficacy outcomes were the occurrence of proximal and distal DVT. Safety outcomes were defined as the occurrence of major and minor haemorrhage, other adverse events and changes in laboratory parameters. All patients underwent a 3-month follow-up. There were no deaths or cases of clinical PE during the study and the follow-up periods. In 173 patients with evaluable venograms, analysis of efficacy on an intention-to-treat basis showed that the incidence of DVT at day 21 was significantly lower in the enoxaparin group (6 of 85; 7.1%) than in the placebo group (17 of 88; 19.3%; p = 0.018), a risk reduction of 63%. Distal DVT was less frequent in the enoxaparin group than in the placebo group (1.2 vs 11.4%; p = 0.006) but there was no significant difference between groups in the incidence of proximal DVT. A 'per-protocol' analysis of efficacy in 155 patients confirmed the results for total and distal DVT, but also showed a trend in efficacy in favour of enoxaparin with regard to the incidence of proximal DVT (p = 0.064). Enoxaparin was safe in comparison with placebo: only 2 minor bleedings occurred in the enoxaparin group and there was no difference in the incidence of other adverse events between the 2 groups. In patients undergoing THR, the risk of late-occurring DVT remained high during the 21 days after hospital discharge in the placebo group. Prophylactic treatment with enoxaparin reduced the risk and was well tolerated in this context.


Subject(s)
Anticoagulants/therapeutic use , Enoxaparin/therapeutic use , Hip Prosthesis , Postoperative Complications/prevention & control , Thrombophlebitis/prevention & control , Aged , Double-Blind Method , Enoxaparin/adverse effects , Female , Hemorrhage/chemically induced , Humans , Male , Prospective Studies
18.
Cardiovasc Drugs Ther ; 9 Suppl 2: 237-43, 1995 Mar.
Article in English | MEDLINE | ID: mdl-7647028

ABSTRACT

The results of an open prospective study that evaluated the long-term clinical safety of nicorandil are presented. This study included 199 patients with severe chronic stable angina treated over a 1-year period. The most often reported adverse event was headache, which was responsible for most of the study withdrawals due to clinical intolerance (9.6%). When using a progressive titration scheme, this incidence was substantially reduced to 2.7%. As with other less frequent adverse events (dizziness, gastrointestinal disorders), headaches were reported as being mild to moderate in severity, were experienced during the first days of treatment, and, if treatment was maintained, usually resolved within a few days. The incidence of adverse events was not modified when nicorandil was given in combination with a beta-blocker, a calcium antagonist, or both agents. Cardiovascular safety was satisfactory and laboratory parameters were not altered. At the end of the study, 70% of patients were maintained on nicorandil. These results are in agreement with those reported from the nicorandil safety database, which gathered 1152 patients treated by nicorandil, including those of the present study. In comparative studies of nicorandil versus beta-blockers, calcium antagonists, or nitrates, the overall incidence of adverse events was no different between the two treatment groups, although the safety profile differed according to the drug category.(ABSTRACT TRUNCATED AT 250 WORDS)


Subject(s)
Anti-Arrhythmia Agents/adverse effects , Coronary Disease/drug therapy , Niacinamide/analogs & derivatives , Adrenergic beta-Antagonists/adverse effects , Adult , Aged , Aged, 80 and over , Anti-Arrhythmia Agents/therapeutic use , Blood Pressure/drug effects , Chronic Disease , Coronary Disease/physiopathology , Drug Interactions , Female , Heart Rate/drug effects , Humans , Long-Term Care , Male , Middle Aged , Niacinamide/adverse effects , Niacinamide/therapeutic use , Nicorandil , Prospective Studies
19.
Eur Heart J ; 15(2): 179-83, 1994 Feb.
Article in English | MEDLINE | ID: mdl-8005117

ABSTRACT

The aim of this study was to determine whether oxidative stress occurs in unstable angina. Thirty patients with unstable angina class B (Braunwald classification) were prospectively studied. Control groups consisted of 23 patients presenting with stable angina and of 21 age-matched healthy volunteers. Upon admission and every 8 h for 24 h, blood samples were drawn for the determination of plasma malondialdehyde (MDA) levels, Se-glutathione peroxidase (GPX) activity, erythrocyte reduced glutathione (GSH) concentrations, erythrocyte GPX and superoxide dismutase (SOD) activities. Coronary angiograms were performed within 4 days of admission in 26 out of the 30 patients included in the study. Nine of these 30 patients were subsequently identified as presenting a non-Q wave myocardial infarction and were separately examined. On admission, only plasma MDA levels and erythrocyte GSH concentrations differed among groups. Plasma MDA levels of patients presenting with unstable angina (P < 0.01) and acute myocardial infarction (P < 0.05) were higher than those of patients with stable angina and of normal volunteers, whereas there was no difference in these parameters between unstable angina and non-Q wave myocardial infarction groups. Erythrocyte GSH concentration was lower in all patient groups as compared to normal subjects. ANOVA for repeated measures showed no difference between admission and subsequent levels for all parameters. Finally, no difference was observed for any of the parameters when anti-ischaemic or anti-aggregant treatment before admission, or the number of affected vessels on coronary angiograms, were considered. We conclude that an oxidative stress can be evidenced in patients with unstable angina or acute myocardial infarction.


Subject(s)
Angina, Unstable/enzymology , Erythrocytes/enzymology , Glutathione Peroxidase/blood , Glutathione/blood , Reactive Oxygen Species/metabolism , Superoxide Dismutase/blood , Adult , Aged , Angina Pectoris/enzymology , Female , Humans , Lipid Peroxidation/physiology , Male , Middle Aged , Myocardial Infarction/enzymology , Myocardial Ischemia/enzymology
20.
Ann Dermatol Venereol ; 120(12): 889-91, 1993.
Article in French | MEDLINE | ID: mdl-8074348

ABSTRACT

INTRODUCTION: Necrotizing fasciitis is usually due to Streptococcus species but can be caused by a variety of organisms, among which Neisseria species are distinctly rare, as only four cases have been reported in the literature. CASE REPORT: We report the first case of Neisseria meningitidis necrotizing fasciitis in a non-immunocompromised man, with a possibly predisposing effect of non-steroidal anti-inflammatory drugs. Neisseria meningitidis group C was isolated from subcutaneous and bullae aspirates. The involvement of two distant sites strongly suggests hematogenous dissemination of the microorganism. Four previous cases of fasciitis caused by Neisseria species are reviewed. CONCLUSION: Although Streptococcus group A is the main cause of apparently primary necrotizing fasciitis, Neisseria meningitidis must be considered a possible etiologic agent of this severe soft tissue infection.


Subject(s)
Fasciitis/etiology , Neisseria meningitidis/isolation & purification , Arm , Fasciitis/drug therapy , Humans , Leg , Male , Middle Aged
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