Home mechanical ventilation patients: a retrospective survey to identify level of burden in real life.

BACKGROUND AND AIM: Home care for patients under home mechanical ventilation (HMV) may cause dramatic physical and economic burden in addition to the burden of time on family/caregivers and health care service (HCS) with difficult resource allocation decision-making. Our aims were: 1. To identify conditions causing major care burden in managing HMV patients according to family and payer's perspectives related to characteristics of the disease, dependency and accessibility; and 2. To find, if any, differences among diseases. METHODS: A questionnaire was sent to eight pulmonary centres to identify factors connected with the greater care burden. Retrospective data of 792 patients still alive and in HMV was reviewed. RESULTS: Compared to neuromuscular disorders (NM) and chest wall deformities, the COPD group have presented a statistically greater number of hospitalisations/yr (1.37 +/- 0.77), greater length of stay (13 +/- 10 days), higher number of outpatient visits/yr (2.55 +/- 1.73) or emergency room accesses/yr (0.74 +/- 1.08). Patients with NM diseases need more home care. The prevalence of one, two and three among five selected burden criteria (needs of MV > 12 hrs/day, tracheotomy, high dependency, distance from hospital, frequent hospitalisations) was respectively 19%, 30% and 33% of the cases; the NM was the group most represented. CONCLUSIONS: In HMV patients: 1. underlying disease, level of their dependency, hours spent under MV, presence of tracheotomy, home distance from hospital, hospital accesses are the causes of major care burden; and 2. as a novelty we have demonstrated that more than fifty percent of them present two or three contemporaneous criteria selected as care burden, being NM and COPD patients the most representative group necessitating of family's and HCS's care respectively.

The effect of long-term treatment with erdosteine on chronic obstructive pulmonary disease: the EQUALIFE Study.

Erdosteine is a new thiol compound with effects on bacterial adhesiveness as well as antioxidant and mucoactive properties. The EQUALIFE study, a fully randomized, double-blind, placebo-controlled, parallel-group, multicenter study, was designed to assets the effectiveness of long-term treatment with erdosteine in patients with moderate chronic obstructive pulmonary disease (COPD). One hundred and fifty-five patients received oral erdosteine, 300 mg b.i.d., or placebo for 8 months during the winter season to assess the effect of treatments on exacerbation rate, hospitalization, lung function and quality of life, assessed using the Short Form 36 and the St. George's Respiratory Questionnaire. A pharmacoeconomic analysis was also conducted to compare the two treatments. One hundred and twenty-four patients completed the study with erdosteine (n = 63) or placebo (n = 61). The group of COPD patients who received 8 months of continuous treatment with erdosteine had significantly fewer exacerbations and spent fewer days in the hospital than did the placebo group; furthermore, they had no loss of lung function. Patients in the erdosteine group also showed a significant improvement in health-related quality of life. The mean total COPD-related disease costs per patient were lower in the erdosteine group than in the placebo group over the study period. The results indicate that 8 months of treatment with erdosteine is effective in reducing exacerbation and hospitalization rates and in improving health status. The study suggests that erdosteine is likely to provide an important contribution to the therapy of patients with symptomatic COPD.

Comparison of two methods for weaning patients with chronic obstructive pulmonary disease requiring mechanical ventilation for more than 15 days.

We designed a prospective multicenter randomized controlled study in three long-term weaning units (LWU) to evaluate which protocol, inspiratory pressure support ventilation (PSV) or spontaneous breathing trials (SB), is more effective in weaning patients with chronic obstructive pulmonary disease (COPD) requiring mechanical ventilation for more than 15 d. Fifty-two of 75 patients, failing an initial T-piece trial at admission, were randomly assigned to PSV or SB (26 in both groups). No significant difference was found in weaning success rate (73% versus 77% in the PSV and SB group, respectively), mortality rate (11.5% versus 7.6%), duration of ventilatory assistance (181 +/- 161 versus 130 +/- 106 h), LWU (33 +/- 12 versus 35 +/- 19 d), or total hospital stay. The results of these defined protocols were retrospectively compared with an "uncontrolled clinical practice" in weaning historical control patients. The overall 30-d weaning success rate was significantly greater (87% versus 70%) and the time spent under mechanical ventilation by survived and weaned patients was shorter in the patients in the study than in historical control patients (103 +/- 144 versus 170 +/- 127 h). The LWU and hospital stays were also significantly shorter (27 +/- 12 versus 38 +/- 18 and 38 +/- 17 versus 47 +/- 18 d). Spontaneous breathing trials and decreasing levels of PSV are equally effective in difficult-to-wean patients with COPD. The application of a well-defined protocol, independent of the mode used, may result in better outcomes than uncontrolled clinical practice.

[Acute biliary pancreatitis. Therapeutic trends]. / La pancreatite biliare acuta. Nostro orientamento terapeutico.

BACKGROUND: Treatment of biliary pancreatitis includes suppression of the biliary cause by cholecystectomy and common bile duct clearance. Endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic sphincterotomy for eradication of biliary stones and laparoscopic cholecystectomy (L.C.) for residual gallbladder stones would be ideal but were once considered to be contraindicated by most surgeons. The timing of definitive biliary tract surgery and the role of ERCP have been the focus of discussion in recent years. METHODS: During a two-year study period 51 patients with acute biliary pancreatitis were studied. Seven patients (14%) underwent emergency laparotomy, necrosectomy, cholecystectomy, exploration of the common bile duct and T-tube insertion, because unstable clinical conditions, with evidence of pancreatic and peripancreatic necrosis on CT-scan. Elective open cholecystectomy and CBD exploration were performed in 7 patients after the resolution of acute pancreatitis during the same hospital admission. RESULTS: Early ERCP and L.C. were associated with favourable outcomes. 33 patients underwent ERCP preoperatively: 17 within 72 hours of admission and 16 after signs of clinical improvement. Laparoscopic cholecystectomy performed 3-25 days after admission was successful in 27 of 29 patients. Postsphincterectomy bleeding occurred in one patient and was treated successfully by endoscopic epinephrine injection. For median hospital stay and recurrence there were statistical differences between early and delayed ERCP. CONCLUSIONS: ERCP and sphincterectomy have a certain role in conjunction with laparoscopic cholecystectomy in the management of patients with acute biliary pancreatitis, particularly in institutions where there is easy access to expert interventional endoscopic techniques. This policy should reduce the risk of cholangitis and recurrent pancreatitis.

Effects of nedocromil sodium on the oxidative burst of polymorphonuclear leukocytes: comparison with salbutamol.

The effects of nedocromil sodium and of salbutamol on the generation of oxygen-derived free radicals in human polymorphonuclear leukocytes (PMNs) were compared in vitro by the luminol-amplified-chemiluminescence (LACL) assay induced by both particulate (Candida albicans) and soluble formyl-methionyl-leucyl-phenylalanine (fMLP) stimulants. Inhibitory dose-effect linear regressions were observed from 10(-3) to 10(-8) M for nedocromil and salbutamol after a 3' period of incubation with either C. albicans or fMLP. There was a linear regression with nedocromil sodium after 30' incubation, but desensitization was observed with salbutamol after this longer period of incubation. The generation of oxygen-derived free radicals was significantly greater for asthmatic patients than for normal subjects; therefore antiasthmatic drugs with this inhibitory activity could be an extra pharmacological benefit in the treatment of asthmatic patients.

Daytime oxygen saturation does not predict nocturnal oxygen desaturation in patients with chronic obstructive pulmonary disease.

Nocturnal hypoxemia occurs commonly in patients with chronic obstructive pulmonary disease (COPD). Because pulmonary hypertension and cardiac arrhythmias are associated with this phenomenon, the detection and treatment of nocturnal hypoxemia should be part of the management of COPD patients. The ability to predict nocturnal hypoxemia by evaluating an awake patient would be desirable economically and logistically because continuous nocturnal oximetry is not widely available and because it is costly and labor intensive. We sought to determine whether awake oximetry would be precise enough to be clinically useful in predicting the degree of nocturnal oxygen desaturation in patients with COPD. We studied 71 patients with COPD. During sleep, the arterial oxygen saturation (SaO2) decreased by an average of 9% with a maximum decrease of 21% (awake SaO2 93.0 +/- 0.4% vs nocturnal lowest SaO2 84.0 +/- 0.7%, p = 0.0001). The nocturnal oxygen desaturation in each patient, however, was poorly predicted from awake SaO2. The standard error of estimate was large with a value of 5.3%. These data suggest that awake SaO2 is not a good predictor of nocturnal oxygen desaturation in individual patients. The lack of a simple relationship between awake SaO2 and nocturnal SaO2 is due to a complex interplay of various physiologic and pathologic mechanisms involved in the control of breathing and oxygenation during sleep.

Dextrorphan and dextromethorphan: comparative antitussive effects on guinea pigs.

Dextromethorphan, after administration, is rapidly and extensively transformed into dextrorphan. The aim of this study was to compare the cough-suppressing activity of 6, 12, 24, 48 mg/kg, i.p., of dextrorphan (dextro rotatory isomer of racemorphan) with that of dextromethorphan, using the model of citric acid-induced coughing in the unanaesthetized, unrestrained guinea pig. A significant dose-effect relationship of dextrorphan in reducing citric acid-induced cough was observed. This effect was comparable with that of dextromethorphan. However, at 48 mg/kg, i.p., dextromethorphan had a toxic effect while dextrorphan did not. Because dextrorphan is the major metabolite of dextromethorphan and has antitussive activity comparable to that of dextromethorphan, clinical use of dextrorphan is suggested.

Effects of seaprose on sputum biochemical components in chronic bronchitic patients: a double-blind study vs placebo.

Seaprose is a semialkaline proteinase endowed with proteolytic effect and antiinflammatory activity tested in different clinical trials. There is clinical evidence that seaprose reduces sputum viscoelastic properties in chronic hypersecretory bronchitis. The present study evaluated (in a double-blind design vs. placebo) the activity of seaprose on bronchial inflammation, mucus glycoprotein secretion and bronchial humoral defence mechanism in chronic bronchitic patients clinically stable (10 per group). Markers of bronchial inflammation (albumin, albumin/total protein ratio) and bronchial infection (DNA), of mucus glycoproteins (fucose and N-acetylneuraminic acid) and of humoral defence mechanism (secretory-IgA) were tested in sputum. We found that ten-day treatment with seaprose (90 mg/day) reduced sputum albumin during the observation period, the difference being statistically significant at the 18th day. The sputum albumin/total protein ratio also decreased by 50% at the end of the study. In the same group, sputum DNA, secretory-IgA, fucose and N-acetylneuraminic acid remained unchanged after treatment. The placebo group did not show any significant changes in the sputum marker substances. This study provides experimental evidence for the antiinflammatory activity of seaprose on bronchial mucosa in chronic bronchitic patients studied in a stable phase of their disease. Furthermore the drug does not seem to affect mucus glycoprotein secretion or secretory-IgA production.

Effects of seaprose on the rheology of bronchial mucus in patients with chronic bronchitis. A double-blind study vs placebo.

There are changes in the rheological characteristics of mucus (viscoelasticity) in several pulmonary pathologies, and especially in chronic bronchitis. Seaprose, a proteolytic enzyme, is one of the pharmacological possibilities for affecting the rheology of bronchial mucus to correct mucostasis and improve its clearance. The action of this drug on the viscoelasticity of bronchial mucus was assessed in a double-blind vs placebo study with 20 randomly balanced chronic bronchitis patients using a new kind of portable rheometer with special features designed for routine bronchial mucus analysis in clinical practice at the patient's bedside. It was found that in the group of patients who were given the placebo, there were no particular changes in the rheological behaviour of mucus, while in those patients who were given seaprose there were significant changes in both viscosity and elasticity at the end of treatment. Eight days after the end of treatment with seaprose, there was still a significant beneficial effect on the viscoelasticity of mucus and a sort of "post-mucolytic effect" can be postulated. Seaprose also had antiinflammatory action, and since in chronic bronchitis there are variable degrees of inflammations, its beneficial long-lasting effect could also be ascribed to this concomitant action.

Ibopamine in the treatment of mild chronic heart failure in elderly patients. A double-blind, placebo-controlled study.

This double-blind, randomized, multicenter clinical study assessed the efficacy and safety of ibopamine 100 mg t.i.d. as monotherapy vs. placebo in 52 patients with mild chronic heart failure aged over 60 years during a 12-week treatment period. Ibopamine produced a statistically significant increase in exercise tolerance and reduction in fatigue during effort compared to placebo. A trend towards decreased requirement of concomitant diuretic therapy was noted in the ibopamine-treated group. Ibopamine was well tolerated throughout the study. This study indicated that ibopamine is an effective and safe agent as monotherapy in the treatment of mild chronic heart failure in elderly patients.

Identification of subpopulations of bronchitic patients for suitable therapy by a dynamic rheological test.

The rheological properties of bronchial mucus samples, collected from randomly selected patients with chronic bronchitis by protected expectoration, under steady-state conditions without any exacerbation, were investigated in a double-blind multicentre study before and after five days of treatment with 4.5 g/day carbocysteine or with glucose as a placebo. Viscous and elastic properties of the mucus were measured with a rheometer fitted with coaxial cylinders set up in an oscillating instead of a rotating mode. The shapes of the ellipses obtained characterized the rheological properties of each bronchial mucus sample before and after treatment. Two different rheological patterns were observed. In the group of patients with initial viscosity greater than or equal to 10,000 mPa.s-1, carbocysteine treatment reduced viscosity and elasticity more than those of the placebo-treated patients. In the group of patients with viscosity lower than 10,000 mPa.s-1, the rheological modifications were the same for both groups. These results are discussed in terms of both the efficacy of carbocysteine and the necessity of rheological characterization of the patients before treatment into different groups, according to the rheological properties of their secretions, for better and targetted therapy with mucus modifying drugs.

Haemodynamic effects of diltiazem at rest and during exercise in patients with previous myocardial infarction.

A single blind study between placebo and diltiazem (25 mg i.v. single dose) was carried out on 20 male patients with previous myocardial infarction and without exertional ischaemia. Patients, 50 +/- 6.1 (mean +/- SD) years of age, underwent a right heart catheterization with Seldinger's percutaneous approach and brachial or radial artery percutaneous catheterization. Haemodynamic variables were recorded in the supine position after catheterization in baseline conditions at rest, after a warming-up period of 6 min, before and after a first and second exercise test with stepwise increments of 25 W per 3 min. Before the second exercise test, either placebo or diltiazem (25 mg) was injected intravenously in 3 min. In comparison with placebo, diltiazem significantly reduced resting blood pressure (P less than 0.001) and systemic vascular resistance (P less than 0.001) and increased cardiac index (P less than 0.01); during exercise it also reduced the mean pulmonary arterial pressure (P less than 0.05), pulmonary wedge pressure (P less than 0.05), total pulmonary resistance (P less than 0.02), and increased the stroke volume (P less than 0.05). The present study demonstrated that intravenous diltiazem did not induce a significant rise in cardiac index but reduced the afterload and slightly reduced the preload. Diltiazem also reduced myocardial oxygen consumption and decreased blood pressure, mean right atrial pressure and slightly decreased the heart rate.

Double-blind comparison of once-daily bopindolol and atenolol for mild-to-moderate hypertension.

In order to compare the medium term antihypertensive effectiveness and tolerability of atenolol with those of bopindolol (LT 31-200), a new non-selective beta-blocker with slight PAA (partial agonist activity), a randomized double-blind study was performed. Thirty-one outpatients with mild-to-moderate essential hypertension (WHO stage I-II) were enrolled and after a placebo run-in randomly allocated to bopindolol (1 to 4 mg/day) or atenolol (50 to 200 mg/day). The dose was titrated according to the individual pressor responses, and thereafter it was kept constant until the end of the treatment (12 weeks). Both drugs induced statistically significant decreases in SBP, DBP and HR, both in resting conditions and during an ergometric test. Accordingly, most patients achieved the main goal of the therapy, i.e., supDBP less than or equal to 90 mmHg, 11/15 (74%) with bopindolol versus 8/13 (62%) with atenolol. There were no significant differences between the effects of the two compounds. Resting airway resistance (expressed as Peak Expiratory Flow) was not influenced by the treatments. The antihypertensive efficacy was still evident after 12 months in 8 patients who were evaluated for non-comparative long-term effectiveness of bopindolol monotherapy, and improvements in plasma lipid profiles were also observed. Side effects were relatively mild and transient, with two patients in the atenolol group discontinuing therapy (one for inefficacy and one because of undesirable reactions) and one dropped out in the bopindolol group (late evidence of not fulfilling inclusion criteria).(ABSTRACT TRUNCATED AT 250 WORDS)

Comparison of the antihypertensive effect of urapidil and metoprolol in hypertension.

The hypertensive effect of urapidil, a new antihypertensive agent that acts via central and peripheral alpha-adrenoceptors, has been compared with that of metoprolol in 40 patients with mild essential hypertension. Blood pressure was significantly reduced by both drugs, while the heart rate was reduced only after metoprolol. The increases in systolic blood pressure and heart rate caused by three progressive work loads of bicycle exercise were not affected during urapidil, whereas both were reduced by metoprolol. A slight reduction in forced expiratory volume was observed in some patients during treatment with the beta-blocker. There was no case of orthostatic hypotension during urapidil administration, despite its alpha1-blocking action. Side-effects were rare and negligible with both drugs.

A single blind comparison of dihydroergotoxine mesilate and clonidine for treatment of hypertensive emergencies.

The effectiveness and safety of dihydroergotoxine mesylate (DHT) and clonidine (CLO) as acute antihypertensive treatments were studied in a single-blind randomized controlled study of 28 patients hospitalized after abrupt increases in mean blood pressure (MAP) to more than 150 mmHg, with concomitant symptoms related to hypertensive status (16 patients). Intravenous infusion of 1.5 mg DHT significantly reduced both systolic (SBP) and diastolic (DBP) blood pressure from 227 +/- 2/128 +/- 2 mmHg to 160 +/- 4/94 +/- 2 mmHg by 1 hour after the onset of infusion (p less than 0.01). In patients given CLO, BP values fell from 221 +/- 3/123 +/- 3 mmHg to 166 +/- 5/95 +/- 3 mmHg after 150 minutes. After that BP values did not change significantly up to 6 hours after both treatments. One hour after the onset of infusion, mean heart-rate (HR) had decreased by 15 beats/min in the DHT group and by 10 beats/min in the CLO-group. Twenty-one per cent of the patients given DHT and 78% of the patients given CLO complained of mild or moderate side-effects. The results of this study showed that DHT is an effective and well tolerated agent for the treatment of hypertensive emergencies and can be used safely even when continuous monitoring of blood pressure cannot be carried out.