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PubMed1999

Safety and efficacy of shed mediastinal blood transfusion after cardiac surgery: a multicenter observational study. Multicenter Study of Perioperative Ischemia Research Group.

OBJECTIVE: To examine the efficacy and safety of shed mediastinal blood (SMB) transfusion in preventing allogenic red blood cell (RBC) transfusion. DESIGN: An observational clinical study. SETTING: Twelve US academic medical centers. PARTICIPANTS: Six hundred seventeen patients undergoing elective primary coronary artery bypass grafting. INTERVENTIONS: Patients were administered SMB transfusion or not, according to institutional and individual practice, without random assignment. MEASUREMENTS AND RESULTS: The independent effect of SMB transfusion on postoperative RBC transfusion was examined by multivariable modeling. Potential complications of SMB transfusion, such as bleeding and infection, were examined. Three hundred twelve of the study patients (51%) received postoperative SMB transfusion (mean volume, 554 +/- 359 mL). Patients transfused with SMB had significantly lower volumes of RBC transfusion than those not receiving SMB (0.86 +/- 1.50 v 1.08 +/- 1.65 units; p < 0.05). However, multivariable analysis showed that SMB transfusion was not predictive of postoperative RBC transfusion. Demographic factors (older age, female sex), institution, and postoperative events (greater chest tube drainage, lower hemoglobin level on arrival to the intensive care unit, and use of inotropes) were significant predictors of RBC transfusion. The volume of chest tube drainage on the operative day (707 +/- 392 v 673 +/- 460 mL; p = 0.30), reoperation for hemorrhage (3.1% v2.5%; p = 0.68), and overall frequency of infection (5.8% v 6.6%; p = 0.81) were similar between patients receiving and not receiving SMB, respectively. However, in patients who did not receive allogenic RBC transfusion, there was a significantly greater frequency of wound infection in the SMB group (3.6% v0%; p = 0.02). CONCLUSION: These data suggest that SMB is ineffective as a blood conservation method and may be associated with a greater frequency of wound infection.

Aged↗
PubMed1996

A multicenter comparison of maintenance and recovery with sevoflurane or isoflurane for adult ambulatory anesthesia. The Sevoflurane Multicenter Ambulatory Group.

Sevoflurane was compared with isoflurane in 246 adult ASA class I-III patients undergoing ambulatory surgery. After administration of midazolam 1-2 mg and fentanyl 1 microgram/kg, anesthesia was induced with propofol 2 mg/kg and maintained with either sevoflurane or isoflurane in 60% nitrous oxide to maintain arterial blood pressure at +/- 20% of baseline. Fresh gas flows were 10 L/min during induction and 5 L/min during maintenance. Times to eye opening, command response, orientation, and ability to sit without nausea and/or dizziness were significantly faster after sevoflurane. Significantly more sevoflurane patients met Phase 1 of postanesthesia care unit (PACU) Aldrete recovery criteria (> or = 8) at arrival, 95% vs 81%. Also, significantly more sevoflurane patients were able to complete psychomotor recovery tests during the first 60 min postanesthesia. Discharge times were not different. Sevoflurane patients had significantly lower incidences of postoperative somnolence (15% vs 26%) and of nausea both in the PACU (36% vs 51%) and in the 24-h postdischarge period (9% vs 24%). Patient satisfaction was high overall (sevoflurane 97%, isoflurane 93%). We conclude that sevoflurane is a useful inhaled anesthetic for maintenance of ambulatory anesthesia.

Adult↗
PubMed1996

Multicenter study of target-controlled infusion of propofol-sufentanil or sufentanil-midazolam for coronary artery bypass graft surgery. Multicenter Study of Perioperative Ischemia (McSPI) Research Group.

BACKGROUND: The use of target-controlled infusions of anesthetics for coronary artery bypass graft surgery has not been studied in detail. The effects of target-controlled infusions of propofol or sufentanil, supplemented by infusions of sufentanil or midazolam, respectively, were evaluated and compared. METHODS: At 14 clinical sites, 329 patients were given a target-controlled infusion of propofol (n = 165) to produce effect-site concentration (Ce) of > or = 3-micrograms/ml or a target-controlled infusion of sufentanil (n = 164). Sufentanil or midazolam, respectively, also were infused. Systolic hypertension, hypotension, tachycardia, and bradycardia were assessed by measuring heart rate and blood pressure every minute during operation. Myocardial ischemia was assessed perioperatively by monitoring ST segment deviation via continuous three-lead Holter electrocardiography, and it was evaluated during operation by monitoring left ventricular wall motion abnormality via transesophageal echocardiography. RESULTS: The measured cardiovascular parameters were satisfactory and usually similar for the patients receiving propofol-sufentanil or sufentanil-midazolam. The primary endpoint of the percentage of patients with intraoperative ST segment deviation (23 +/- 6% vs. 24 +/- 6%, P = 0.86) did not differ significantly between the two groups. The incidence of left ventricular wall motion abnormality shown on transesophageal echocardiography before (19 +/- 4% vs. 26 +/- 4%, P = 0.25) and after (23 +/- 4% vs. 31 +/- 5%, P = 0.32) cardiopulmonary bypass also did not differ significantly for the two groups. Changes in intraoperative target concentration were more frequent with propofol-sufentanil anesthetic than with sufentanil-midazolam (11.7 +/- 7.1 vs. 7.3 +/- 3.6, P < 0.001). The incidence of intraoperative hypotension (77% vs. 55%, P < 0.001), the use of inotropic/vasopressor medications (93% vs. 84%, P = 0.01), and the administration of crystalloids (2.8 +/- 1.4 L vs. 2.4 +/- 1.2 L, P < 0.001) were significantly greater in the propofol-sufentanil group. Conversely, the incidence of intraoperative hypertension (43% vs. 54%, P = 0.05) and the use of antihypertensive/vasodilator medications (70% vs. 90%, P < 0.001) were significantly less in the propofol-sufentanil group. CONCLUSIONS: Target-controlled infusions of propofol or sufentanil, supplemented by infusions of sufentanil or midazolam, respectively, were suitable to provide anesthesia for coronary artery bypass graft surgery. Continuous monitoring revealed a high prevalence of hemodynamic abnormalities. Despite greater hypotension in the propofol-sufentanil group and greater hypertension in the sufentanil-midazolam group, episodes of myocardial ischemia were similar for both groups and were not temporally related to episodes of hemodynamic abnormalities.

Aged↗
PubMed1995

Medical complications of aneurysmal subarachnoid hemorrhage: a report of the multicenter, cooperative aneurysm study. Participants of the Multicenter Cooperative Aneurysm Study.

OBJECTIVES: This report examines the frequency, type, and prognostic factors of medical (nonneurologic) complications after subarachnoid hemorrhage in a large, prospective study. The influences of contemporary neurosurgical, neurological, and critical care practice on mortality and morbidity rates after aneurysmal subarachnoid hemorrhage are evaluated. DESIGN: A study of medical complications observed in the placebo limb of a large, randomized, controlled trial of the calcium antagonist, nicardipine, after subarachnoid hemorrhage. SETTING: Patients were recruited from 50 hospitals in 41 neurosurgical centers in the United States and Canada. PATIENTS: A total of 457 patients with subarachnoid hemorrhage, > or = 18 yrs of age, were randomly assigned to the placebo group. All patients arrived at the participating center within 7 days (mean 1.0 +/- 1.8 [SD] days) of rupture of an angiographically documented saccular aneurysm. MEASUREMENTS AND MAIN RESULTS: The frequency rates of symptomatic vasospasm, rebleeding, and total mortality rate after subarachnoid hemorrhage at 3-month follow-up were 46%, 7%, and 19%, respectively. The frequency of having at least one severe (life-threatening) medical complication was 40%. The proportion of deaths from medical complications was 23%. This value was comparable with the proportion of deaths attributed to the direct effects of the initial hemorrhage (19%), rebleeding (22%), and vasospasm (23%) after aneurysmal rupture. The frequency of life-threatening cardiac arrhythmias was 5%; less ominous rhythm disturbances occurred in 30% of the patients. There was an increased frequency of cardiac arrhythmias on the day of, or day after, aneurysm surgery. Pulmonary edema occurred in 23% of the patients, with a 6% occurrence rate incidence of severe pulmonary edema. There was a wide variation from center to center, with the greatest frequency on days 3 through 7. There was a nonsignificant association of pulmonary edema with the use of hypertensive hypervolemic therapy (p = .10), and a significant association with the timing of surgery (p < .05). Some degree of hepatic dysfunction was noted in 24% of patients, the majority with only mild abnormalities of hepatic enzymes with no clinical accompaniment (4% frequency of severe hepatic dysfunction). Thrombocytopenia occurred in 4% of patients, usually in the setting of sepsis. Renal dysfunction was reported in 7% of the patients, with 15% of that figure deemed to be of life-threatening severity. There was an association (p = .001) with antibiotic therapy. CONCLUSIONS: Potentially preventable medical complications after ruptured cerebral aneurysm add to the total mortality rate of patients, and may increase length of hospital stay in the critical care setting. The proportion of deaths after subarachnoid hemorrhage from medical complications equals those deaths from either direct effects, rebleeding, or vasospasm individually. Pulmonary complications are the most common nonneurologic cause of death. Cardiac arrhythmia, although frequent, was not associated with significant mortality. The frequency of cardiac arrhythmia and pulmonary edema increased on the day of, or day after, aneurysm surgery. Renal and hepatic dysfunction, and blood dyscrasias, were also observed, underscoring the need for meticulous monitoring for metabolic and hematologic derangements.

Adult↗
PubMed2000

Switching from intracavernous prostaglandin E1 injections to oral sildenafil citrate in patients with erectile dysfunction: results of a multicenter European study. The Sildenafil Multicenter Study Group.

PURPOSE: Intracavernous injection is a well established medical therapy for erectile dysfunction. We assessed the rate of success when patients with erectile dysfunction who were effectively treated with intracavernous injections of prostaglandin E1 were changed to oral therapy with sildenafil citrate. MATERIALS AND METHODS: Only patients effectively managing erectile dysfunction by the intracavernous injection of 20 microg. or less prostaglandin E1 for more than 6 months were eligible for study enrollment. After a 4-week run-in phase while intracavernous prostaglandin E1 therapy continued and a 48-hour washout period 176 patients with erectile dysfunction received open label sildenafil orally for 12 weeks. Satisfaction with treatment was evaluated by the 11-item erectile dysfunction index of treatment satisfaction questionnaire. A successful change to sildenafil was prospectively defined as a questionnaire score of 0 to 100 after sildenafil that was greater than or equal to the score after intracavernous prostaglandin E1. RESULTS: Of the 176 patients 69% (95% confidence limit 62 to 76) successfully changed from intracavernous prostaglandin E1 injections to oral sildenafil and elected to continue oral treatment. Mean satisfaction score after sildenafil and prostaglandin E1 was 73.8 and 63.9, respectively (p <0.001). Only 3 patients (1.7%) discontinued therapy because of treatment related adverse events. CONCLUSIONS: More than two-thirds of the men with erectile dysfunction who were stable on intracavernous injections of 20 microg. or less prostaglandin E1 successfully changed to oral sildenafil, as determined by maintained or enhanced treatment satisfaction.

3',5'-Cyclic-GMP Phosphodiesterases↗
PubMed1997

No effect of long-term vigabatrin treatment on central nervous system conduction in patients with refractory epilepsy: results of a multicenter study of somatosensory and visual evoked potentials. PMS Study Multicenter Group.

PURPOSE: In dogs, vigabatrin (VGB) has been associated with intramyelinic edema producing delayed central conduction in somatosensory and visual evoked potentials (SEP, VEP). No such effects have been reported in humans. We assessed whether abnormalities of central conduction could be detected prospectively in patients with epilepsy treated with VGB as long-term add-on medication. METHODS: Two hundred one patients with refractory partial epilepsy were enrolled and monitored for as long as 2 years. VGB was added to the treatment at an average dose of 2-3g/day. Conduction in somatosensory and visual pathways was assessed by median nerve SEP and pattern VEP recordings performed at inclusion and once every 6 months. The upper limit and test-retest variability of EP latencies were evaluated at time of enrollment in the patient group. Prolonged N13-N20 or P14-N20 SEP intervals and P100 VEP latency >2.5 SD above the baseline mean, observed on repeated runs in the same session and exceeding the test-retest variability at enrollment were considered to indicate central conduction slowing. RESULTS: One hundred nine patients completed the 2-year study period, and 92 discontinued VGB, of whom 37 were monitored with regard to EP until the end of the study. No consistent change in SEP or VEP was observed in the entire group during VGB treatment. The number of occasional EP values outside the baseline range in patients treated with VGB similar to that in patients whose VGB treatment had been discontinued. CONCLUSIONS: We detected no evidence of changes in SEP and VEP attributable to altered neuronal conduction in the CNS during long-term VGB treatment.

Adolescent↗
PubMed1991

A multicenter evaluation of a single-pass lead VDD pacing system. The Multicenter Study Group.

Since June 1985 until April 1989, 237 patients (130 males, 107 females, aged 22 to 95 years, mean 71) with symptomatic AV conduction disturbances and competent sinus node, were implanted with a single-pass lead VDD pacing system in 30 centers and followed-up for at least 6 months. The ventricular pacing lead incorporated two atrial ring 3-cm apart electrodes, positioned within the right atrial cavity without contact with the heart wall, in order to detect the atrial activity, which is differentially processed by the pacemaker. At implant, mean atrial electrogram amplitude, derived from a custom pacemaker system analyzer (PSA) with the same input filter of the pacemaker was 1.7 +/- 0.8 mV (n = 93). In all cases, atrial sensitivity at implant was the default value +/- 0.15 mV. The atrial tracking capability of the pacing systems was assessed within the month and every 6 months after implantation by means of clinical evaluation, resting ECG, 24-hour Holter monitoring and the following tests: exercise stress testing, mental stress, isometric exercise, and nifedipine test. These tests evoke an increase of atrial rate in consequence of metabolic needs or as a reflex response. The criterion used to evaluate the correct operation of the system was the percentage of atrial synchronization. This was defined as the ratio between atrial triggered ventricular paced complexes and all ventricular paced complexes. All monitorings showed a ratio higher than or equal to 98% in a percentage of patients not lower than 95%. Mean follow-up was 385 days (range 183-1,370 days).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1992

Atrial stimulation by means of floating electrodes: a multicenter experience. The Multicenter Study Group.

It is well established that single lead VDD pacing is a physiological, reliable, and easy to use mode of pacing. The major limitation of VDD pacing is the need of a normal sinus node function, confirming its indication to patients with isolated atrioventricular conduction disturbances. The Phymos 830 pacing lead was originally designed for VDD pacing in association with the Phymos MPS pulse generator; it has a floating atrial dipole with an interelectrode distance of 3 cm; the distal electrode is 11, 13, or 15 cm proximal to the tip. As a result of the incidental observation of atrial captures occurring at very low pulse amplitudes delivered from the floating dipole of this lead, a 13-center Italian study was initiated to test the systematic feasibility of this type of atrial pacing. Pacing parameters were set and strength-duration curves were acquired with the PSA Master 470 external device. The investigation was performed at pacemaker implant in 114 patients in the supine position. The tip of the electrode was positioned at the right ventricular apex and the atrial dipole at the site of the highest endocavitary signal. Atrial bipolar pacing was performed with the proximal electrode as the cathode. Stable atrial capture was obtained in 108 of 114 patients (94.7%); pacing threshold was < 3.5 V with a pulse width of 1 msec in 85 of 108 patients. Results of voltage threshold were: 2.99 +/- 1.25 and 2.59 +/- 1.13 V at pulse widths of 0.5 and 1 msec, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed1996

Genetic restriction of HIV-1 infection and progression to AIDS by a deletion allele of the CKR5 structural gene. Hemophilia Growth and Development Study, Multicenter AIDS Cohort Study, Multicenter Hemophilia Cohort Study, San Francisco City Cohort, ALIVE Study.

The chemokine receptor 5 (CKR5) protein serves as a secondary receptor on CD4(+) T lymphocytes for certain strains of human immunodeficiency virus-type 1 (HIV-1). The CKR5 structural gene was mapped to human chromosome 3p21, and a 32-base pair deletion allele (CKR5Delta32) was identified that is present at a frequency of approximately0.10 in the Caucasian population of the United States. An examination of 1955 patients included among six well-characterized acquired immunodeficiency syndrome (AIDS) cohort studies revealed that 17 deletion homozygotes occurred exclusively among 612 exposed HIV-1 antibody-negative individuals (2.8 percent) and not at all in 1343 HIV-1-infected individuals. The frequency of CKR5 deletion heterozygotes was significantly elevated in groups of individuals that had survived HIV-1 infection for more than 10 years, and, in some risk groups, twice as frequent as their occurrence in rapid progressors to AIDS. Survival analysis clearly shows that disease progression is slower in CKR5 deletion heterozygotes than in individuals homozygous for the normal CKR5 gene. The CKR5Delta32 deletion may act as a recessive restriction gene against HIV-1 infection and may exert a dominant phenotype of delaying progression to AIDS among infected individuals.

Acquired Immunodeficiency Syndrome↗
PubMed1997

Contrasting genetic influence of CCR2 and CCR5 variants on HIV-1 infection and disease progression. Hemophilia Growth and Development Study (HGDS), Multicenter AIDS Cohort Study (MACS), Multicenter Hemophilia Cohort Study (MHCS), San Francisco City Cohort (SFCC), ALIVE Study.

The critical role of chemokine receptors (CCR5 and CXCR4) in human immunodeficiency virus-type 1 (HIV-1) infection and pathogenesis prompted a search for polymorphisms in other chemokine receptor genes that mediate HIV-1 disease progression. A mutation (CCR2-64I) within the first transmembrane region of the CCR2 chemokine and HIV-1 receptor gene is described that occurred at an allele frequency of 10 to 15 percent among Caucasians and African Americans. Genetic association analysis of five acquired immunodeficiency syndrome (AIDS) cohorts (3003 patients) revealed that although CCR2-64I exerts no influence on the incidence of HIV-1 infection, HIV-1-infected individuals carrying the CCR2-64I allele progressed to AIDS 2 to 4 years later than individuals homozygous for the common allele. Because CCR2-64I occurs invariably on a CCR5-+-bearing chromosomal haplotype, the independent effects of CCR5-Delta32 (which also delays AIDS onset) and CCR2-64I were determined. An estimated 38 to 45 percent of AIDS patients whose disease progresses rapidly (less than 3 years until onset of AIDS symptoms after HIV-1 exposure) can be attributed to their CCR2-+/+ or CCR5-+/+ genotype, whereas the survival of 28 to 29 percent of long-term survivors, who avoid AIDS for 16 years or more, can be explained by a mutant genotype for CCR2 or CCR5.

Acquired Immunodeficiency Syndrome↗
PubMed1998

Genetic restriction of AIDS pathogenesis by an SDF-1 chemokine gene variant. ALIVE Study, Hemophilia Growth and Development Study (HGDS), Multicenter AIDS Cohort Study (MACS), Multicenter Hemophilia Cohort Study (MHCS), San Francisco City Cohort (SFCC)

Stromal-derived factor (SDF-1) is the principal ligand for CXCR4, a coreceptor with CD4 for T lymphocyte cell line-tropic human immunodeficiency virus-type 1 (HIV-1). A common polymorphism, SDF1-3'A, was identified in an evolutionarily conserved segment of the 3' untranslated region of the SDF-1 structural gene transcript. In the homozygous state, SDF1-3'A/3'A delays the onset of acquired immunodeficiency syndrome (AIDS), according to a genetic association analysis of 2857 patients enrolled in five AIDS cohort studies. The recessive protective effect of SDF1-3'A was increasingly pronounced in individuals infected with HIV-1 for longer periods, was twice as strong as the dominant genetic restriction of AIDS conferred by CCR5 and CCR2 chemokine receptor variants in these populations, and was complementary with these mutations in delaying the onset of AIDS.

Acquired Immunodeficiency Syndrome↗
PubMed1998

Blinded, externally controlled multicenter evaluation of light microscopy and PCR for detection of microsporidia in stool specimens. The Diagnostic Multicenter Study Group on Microsporidia.

The quality parameters for the detection of microsporidia in identical sets of 50 stool samples were determined for six laboratories where technicians used light microscopy and for six laboratories where technicians used PCR. The average overall sensitivities were 67% (89% for patient samples only) for the PCR laboratories and 54% (80% for patient samples only) for the light microscopy laboratories. Specificities were 98 and 95%, respectively. Differences in results were most apparent between the individual laboratories rather than between the two major methods used.

Animals↗
PubMed1995

Comparison of the effects of cilazapril and captopril versus placebo on exercise testing in chronic heart failure patients: a double-blind, randomized, multicenter trial. The Cilazapril-Captopril Multicenter Group.

In order to compare directly the efficacy of two different angiotensin-converting enzyme (ACE) inhibitors in terms of clinical status and exercise capacity, 443 patients with chronic heart failure (New York Heart Association classes II-IV) were randomized into a 24-week double-blind study to receive cilazapril (CLZ) 1-2.5 mg once daily (n = 221), captopril (CPT) 25-50 mg three times daily (n = 108), or placebo (PLA) for 12 weeks followed by CLZ 2.5 mg (n = 114) in addition to their standard heart failure therapy. The majority were New York Heart Association functional class II (56-62%), and the most frequent etiology of chronic heart failure was coronary heart disease (35-42%), followed by dilative cardiomyopathy (approximately 28%). Both ACE inhibitors prolonged the exercise tolerance test duration at all visits, and the effect at week 12 (CLZ 62.2 +/- 7.5 s; CPT 73.1 +/- 10.7 s) was significantly greater than after PLA (28.1 +/- 12.2 s; p = 0.011 and p = 0.005, respectively). Furthermore, the distance walked during 6 min increased at all visits with ACE inhibitors (NS vs. PLA). CLZ was more effective in patients with the most impaired physical ability at baseline as defined by exercise tolerance test duration < or = 6 min (p = 0.0036 at week 12 and p = 0.0150 at week 24) and by walking test < or = 400 m (p = 0.0004 at week 12 and p = 0.0009 at week 24). Similar results were obtained with CPT for the walking test (p = 0.0369 at week 12 and p = 0.0142 at week 24).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1992

Spanish multicenter clinical trial of recombinant growth hormone produced in mammalian cells for treatment of growth failure due to idiopathic growth hormone deficiency. Spanish Multicenter Study Group.

A total of 17 patients (14 boys, 3 girls) with poor growth due to idiopathic growth hormone deficiency (IGHD) were treated for 12 months with recombinant human growth hormone (rhGH; Saizen), 0.5 IU/kg body weight per week administered by subcutaneous injection on a daily basis. Therapy significantly increased growth velocity (GV) from 4.0 +/- 1.5 to 10.1 +/- 2.4 cm/year (p < 0.001). Correspondingly, GV standard deviation score (GV SDS) for chronological age (CA) increased from -2.7 +/- 1.6 to +4.5 +/- 2.8; GV SDS for bone age (BA) increased from -4.0 +/- 2.0 to +3.6 +/- 3.3; and patient height SDS-CA increased from -3.5 +/- 1.1 to -2.4 +/- 0.7. Changes in these parameters were significant at p < 0.001. During the course of the study, mean plasma IGF-1 levels rose significantly from 0.3 +/- 0.2 IU/ml to 1.3 +/- 1.2 IU/ml (p < 0.01). BA maturation proceeded at approximately 1 year per treatment year. Therapy was well tolerated. Anti-hGH antibodies were seen in only 1 patient at a low concentration, and did not appear to affect GV. This study demonstrates that rhGH is safe and efficacious when used to increase height in patients with IGHD.

Aging↗
PubMed1993

Cyclosporin versus etretinate: Italian multicenter comparative trial in severe plaque-form psoriasis. Italian Multicenter Study Group on Cyclosporin in Psoriasis.

Seventy-six patients with severe diffuse plaque-form psoriasis and a baseline PASI score > or = 18 were enrolled in a randomized open study comparing cyclosporin 5 mg/kg/day (36 patients) with etretinate 0.75 reduced to 0.5 mg/kg/day (40 patients) over a period of 3 months (phase 1). The rate, severity and time to relapse after the withdrawal of therapy in the 54 patients achieving remission were evaluated over the following 6 months (phase 2). Twelve of these patients entered an open, uncontrolled phase aimed at defining the safety and the strategy of cyclosporin 2.5-5 mg/kg/day maintenance therapy over a further period of 9 months (phase 3). Patient tolerability, laboratory parameters and blood pressure were carefully monitored every week for the first 3 months and then monthly. The only concomitant therapy allowed was white petrolatum. Not only the number (35/36 vs. 29/40) but also the speed of remission (20/36 vs. 1/40 at the fourth week of treatment) was higher in the cyclosporin than in the etretinate group. Both the tolerability and safety of cyclosporin proved to be adequate for short-term treatment, all altered clinical or laboratory parameters being completely reversible after the withdrawal of therapy. Only 1 of the 36 patients in the cyclosporin group prematurely stopped taking the medication because of an adverse reaction, as against 7/40 in the etretinate group (1 case of inefficacy, 1 case of adverse reaction and 5 cases of non-compliance). Six months after the discontinuation of the trial drugs, relapses occurred in 13/29 patients in the cyclosporin group and in 3/25 in the etretinate group; no 'rebound' was observed in any of the relapsing patients. Long-term cyclosporin treatment was both efficacious and well tolerated. In conclusion, cyclosporin at doses of 2.5-5 mg/kg/day administered to reliable, carefully selected patients closely monitored in terms of both clinical and laboratory parameters currently produces the quickest and more constantly favourable results in patients with severe psoriasis.

Adolescent↗