Biomedical subjects
Publications and source records attributed to C Benvenuti.
A retrospective study of 88 cases of renal cell carcinoma is presented with emphasis on the follow-up and progestogens administration. Between the statistically homogeneous groups of patients treated with progesterone capronate and with other therapeutic regimens, no statistical difference in actuarial survival rate could be detected.
Thirty outpatients suffering from duodenal ulcer of recent onset were given cimetidine 1 g/day or gefarnate 250 mg/day for 6 weeks in a double blind trial, randomly balances between the groups. Endoscopic assessment was carried out at 4 and 6 weeks; patients healed after 4 weeks were withdrawn from the trial. In all parameters considered, cimetidine showed a highly significant difference. The healing rate at 4--6 weeks was 67--93% after cimetidine treatment and 27--53% after gefarnate treatment. The effect of cimetidine on the disappearance of symptoms, mainly the nocturnal ulcer pain, and on antacid consumption was greater than that after medication wity gefarnate. After 4--6 weeks of a full dose cimetidine regimen, both basal and pentagastrin stimulated gastric acid secretion were reduced and peptone meal stimulated serum gastrin increased; the basal gastrinaemia remained unchanged.
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Following 3x200 mg Tagament (cymetidine SK & F) tablets at meals and 2 in the evening (5 per day) for an average of 31 days, complete endoscopic cure was obtained after 29 days (duodenal patients) and 35 days (gastric patients) in 26/27 subjects with slow healing histories (17 with duodenal and 10 with gastric ulcer). Rapid regression of pain and dyspepsia was observed form the outset and there was a marked reduction in the consumption of antacid preparation. Its marked efficacy and good tolerance make Tagamet a drug of choice in the treatment of peptic, duodenal and gastric ulcers.
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The pharmacokinetics of rokitamycin tablets were studied in 12 healthy volunteers in a randomized cross-over design. The doses tested were 200 mg, 300 mg, 400 mg and 600 mg, as single oral administration. Rokitamycin was absorbed quickly with Tmax for all doses around 30 min after drug intake. Total AUC and Cmax values were linearly related to the administered dose. The buffer formulation determined a low interindividual variation. The overall findings show a good similarity with the data obtained in Japanese subjects. Tolerability was very good.
The effects of intranasally administered neostigmine on oesophageal peristalsis and lower oesophageal sphincter tone were investigated in 21 healthy volunteers. After 30 min of basal recording of oesophageal tracings, neostigmine (3 or 5.4 mg) or the inert vehicle were given. The oesophageal recording was continued for 45-60 min after administration. Neostigmine increased the amplitude and duration of the peristaltic waves without significantly affecting conduction. Lower oesophageal sphincter tone was also increased but post-swallowing relaxation was normal. At the highest dose, the effects of neostigmine lasted 45 min or more. There were no side effects and the heart rate was only slightly slowed. The results suggest that intranasal administration of neostigmine might be clinically useful for stimulation of upper gastrointestinal tract peristalsis.
Patient selection and optimal timing for implantation are unsettled issues in candidates for a bridge to cardiac transplantation. A prospective evaluation of a strategy based on enoximone (E) given IV, in addition to sympathomimetic drugs, permitting to buy time, and delay by hours or days the decisions, has been performed from 1985 to 1988. Thirty-four patients in cardiogenic shock with hemodynamical criteria for TAH implantation have been included: Cl was 1.8 +/- 0.2 L/min/m2 PCWP 29 +/- 7 mmHg, diuresis less than 20 ml/hr. The protocol permitted to postpone decisions of implantation in 30 cases. The 4 unresponsive patients were implanted immediately with TAH (3) or VAD (1). Three were transplanted, two successfully. For 30, time given permitted discovery of hidden contraindications to transplantation in 17 patients. In 13, indication for transplantation was confirmed and performed in 11 within 6 hrs to 8 days (survival 64%). In two, sudden deterioration led to an unsuccessful TAH implantation. Multifactorial analysis showed that a 50% rise in Cl together with a 50% drop in PCWP, a 50% drop in PVR 30 min after IV E has a high predictive value of survival. These data suggest that enoximone IV bolus given in addition to maximal sympathomimetics to patients in cardiogenic shock reduces by 88% the need for TAH or VAD. It also permits a better selection of the candidates.
The Nippon-Zeon (NZ) ventricular assist device is a sac type, air driven, heterotopic, external pump. Its performance has been evaluated in Japan as a bridge to myocardial recovery. Few data are available on the device as a bridge to heart transplantation. Since 1991, 10 patients (9 men) were bridged to heart transplantation with NZ, all in biventricular support. The mean age was 39 +/- 13 years (range, 21-60 years), mean body weight was 75 +/- 13 kg (range, 51-95 kg). Five patients had a dilated cardiopathy, and five were ischemic (three acute myocardial infarctions). Despite maximal inotropic support, including enoximone in seven, epinephrine in three, and intraaortic balloon pumping in one, eight patients were anuric, three were in acute hepatic failure, and three were intubated. Preoperative hemodynamic and biologic values were: cardiac index, 1.57 +/- 0.4 l/min/m2; pulmonary capillary wedge pressure, 34 +/- 5 mmHg; creatinine, 200 +/- 80 mumol/l; blood urea nitrogen, 17.5 +/- 8 mmol/l; total bilirubin 36 +/- 6 mumol/l; aspartate aminotransferase, 1,000 +/- 2,000 IU/l. In all patients, a biventricular assist device was implanted without the use of cardiopulmonary bypass. Improvement occurred immediately in all but one. Mean left ventricular flow was 4.5 +/- 0.8 l/min. Anticoagulation was maintained with intravenous heparin. Recently for bleeding was required in one case (10%), and two patients had positive blood cultures that were successfully treated. There was no mechanical failure. Hemolysis was not significant (lactate dehydrogenase, 378 +/- 50 IU/l; plasma-free hemoglobin below 10 mg/dl). Each device was free of thrombi and deposits at time of explantation. One patient died while on assist. Nine patients (90%) were transplanted after 11 +/- 8 days (range, 1-32 days). Three died early after transplantation, one of graft failure, two of sepsis. Six patients (66%) could be discharged. The follow-up ranges from 7 to 28 months. NZ is a simple, reliable, pneumatic device driven by a light, silent console; it can be rapidly implanted without cardiopulmonary bypass in patients in desperate condition who are awaiting cardiac transplantation. The difficulty of patient rehabilitation while using this device should limit the duration of support to weeks to allow the patient to be in optimal condition for heart transplantation.
A double-blind study comparing the efficacy and tolerability of dothiepin with that of placebo in the treatment of primary fibromyalgia syndrome was carried out. Dothiepin was shown to improve significantly the condition of patients with primary fibromyalgia syndrome and there was a significant difference between dothiepin and placebo in all the clinical variables measured. Only mild and transient side-effects were reported. Further controlled studies are required to define the effects of dothiepin on fibromyalgia.
The effectiveness of dothiepin (a tricyclic anti-depressant) at a dose of 75 mg given orally at night was compared with placebo for 4 weeks in alleviating pain in 60 patients with classical or definite active rheumatoid arthritis. Patients were classified as either 'depressed' or 'not depressed'. The week before, during and 2 weeks after the study, 600 mg ibuprofen was given orally three times daily to all patients. Compared with placebo, dothiepin produced a significant reduction in daytime pain by the end of the treatment period. The Hamilton rating scale in 'depressed' patients was significantly improved in patients given dothiepin. The Cassano-Castrogiovanni self-evaluation rating scale in both 'depressed' and 'not depressed' patients showed a tendency (not significant) to be improved following dothiepin treatment compared with placebo. These results suggest that patients with rheumatoid arthritis may experience an increase in pain symptoms due to an alteration of mood. Therapy with tricyclic anti-depressants, such as dothiepin, therefore, may determine an improvement of pain indexes besides having an anti-depressant effect.
A prospective study has been carried out to evaluate the cost and cost effectiveness of the mechanical bridge (MB) or pharmacologic bridge (PB) to transplantation (HTx) in patients referred in cardiogenic shock (CS), who are candidates for Htx unresponsive to sympathomimetics. Selection between MB and PB was based on immediate efficacy of i.v. enoximone (2 mg/kg/BW) therapy. From 1986 to 1989, 37 patients who should have been immediately treated by MB entered the protocol. Six were unresponsive and rapidly received a Jarvik heart or left ventricular bypass (MB). Thirty-one improved (PB), with the need for HTx reconfirmed in 22 and performed in 14. Survival of the entire group was 70% and 51% at 1 and 3 months, respectively. Cost per patient was $45,843 ranging from 38,326 in PB patients to $84,683 in MB patients. Cost per patient transplanted after PB was $50,745. Cost per survivor at 1 year was $210,000 for all, ranging from $254,000 in MB to $192,455 in PB. Cost per added day of survival was higher in MB (+ 228%) at 1 month compared to PB. The difference was reduced at 1 year.
Results obtained in the past 3 years in patients referred with acute myocardial infarction (AMI) and cardiogenic shock for a mechanical bridge to urgent transplantation permit one to assess the real impact of the present strategy in clinical practice. Ten patients (mean age = 49) were admitted in serious condition (CI = 1.8 +/- 0.2 L/min/m2, PCWP = 28 +/- 6 mmHg, systolic aortic pressure = 88 +/- 20 mmHg, urine output 11 +/- 20 ml/hr) and were treated by maximal sympathomimetic support and i.v. enoximone. Two had to be implanted with a total artificial heart (TAH) and one with a left ventricular assist device (LVAD) for recurrent fibrillation despite hemodynamic improvement, within 8 hr. Two have received transplants and are living well after 20 months. Seven who initially improved markedly have been listed as urgent transplant candidates: two of these have been successfully transplanted, and three died suddenly after 6, 25, and 45 days, respectively. One has undergone successful coronary surgery. One patient (age 62, diabetic) was secondarily rejected for a transplant and died. This experience clearly shows that despite initial spectacular hemodynamic improvement, which was due to optimized medical management, death rate before transplant because of sudden ventricular fibrillation remains unacceptably high. This should prompt early mechanical support, with less invasive systems, in patients with AMI.
Urgent cardiac transplantation in very unstable patients, kept alive in intensive care unit, is a significant (34 percent) part of the Henri-Mondor's transplantation program. Nineteen patients received a donor graft from january 1986 to october 1988. Sixteen were bridged pharmacologically as 5 received a mechanical bridge. Time on waiting list ranged from 12 to 21 days. Six patients died in the first post-operative month. Death was due to uncontrolled preoperative problems in 5, donor graft failure in one. The survival rate at one year was 52 percent, to be opposed to 76 percent in stable patients. These figures must be considered when selecting the priority of the transplantation candidates.