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PubMedDate not supplied

Residual auditory function in persistent vegetative state: a combined PET and fMRI study.

In recent years, a number of studies have demonstrated an important role for functional neuroimaging in the identification of residual cognitive function in persistent vegetative state. Such studies, when successful, may be particularly useful where there is concern about the accuracy of the diagnosis and the possibility that residual cognitive function has remained undetected. Unfortunately, functional neuroimaging in persistent vegetative state is extremely complex and subject to numerous methodological, clinical and theoretical difficulties. Here, we describe the strategy used to study residual auditory and speech processing in a single patient with a clinical diagnosis of persistent vegetative state. Identical positron emission tomography studies, conducted nine months apart, revealed preserved and consistent responses in predicted regions of auditory cortex in response to intelligible speech stimuli. Moreover, a preliminary functional magnetic resonance imaging examination at the time of the second session revealed partially intact responses to semantically ambiguous stimuli, which are known to tap higher aspects of speech comprehension. In spite of the multiple logistic and procedural problems involved, these results have major clinical and theoretical implications and provide a strong basis for the systematic study of possible residual cognitive function in patients diagnosed as being in a persistent vegetative state.

Adult↗

PubMed2003

Pregnancy in a persistent vegetative state: case report, comparison to brain death, and review of the literature.

UNLABELLED: Severe maternal neurologic injury during pregnancy has the potential for fetal demise without advanced critical care support to the mother. Brain death is the unequivocal and irreversible loss of total brain function, whereas patients in a vegetative state, by contrast, have preserved brain stem function but lack cerebral function. They can appear to be awake, have sleep-wake cycles, be capable of swallowing, and have normal respiratory control, but there are no purposeful interactions. These conditions have different maternal prognoses, but both have resulted in near-normal neonatal outcomes with long latencies from maternal injury to delivery in previously published cases. This article compares and contrasts the 11 cases of brain death with 15 cases of persistent vegetative state in pregnancy. We found that the mean latency between maternal brain injury and delivery was significantly shorter in the brain-dead patients as compared with those in a vegetative state (46 days vs. 124 days, P </=.001). Correspondingly, the gestational ages at delivery (29.7 weeks vs. 33.2 weeks, P </=.01) and the birth weights (1380 g vs. 2145 g, P </=.01) were shorter in duration and smaller in size in the brain-dead group. We also present a case of persistent vegetative state in pregnancy at our institution with both maternal and neonatal death in the context of previously published literature with a focus on obstetric and ethical management. We hope this information will help elucidate the issues for providers confronted with these unique and challenging cases. TARGET AUDIENCE: Obstetricians & Gynecologists, Family Physicians. LEARNING OBJECTIVES: After completion of this article, the reader should be able to state the difference between coma, persistent vegetative state and brain death, to describe the neurologic aspects of a patient in a persistent vegetative state, and to list the fetal effects of maternal brain injury.

Adult↗

PubMed1995

Persistent truncus arteriosus in a diprosopic newborn calf.

A newborn diprosopic female calf had a partially duplicated head with two faces each exhibiting a mouth, a snout, an anomalous incomplete mandible, two eyes and a lateral ear. A single ear with two small auditory canals was present on the midline between the two medial eyes. A type 1 persistent truncus arteriosus and hypoplasia of the thoracic portion of thymus were the most outstanding extracranial defects. In the heart, a persistent foramen secundum and a large patent foramen ovale allowed communication between the right and left atria. In the right ventricle, the small conus arteriosus was separated in part from the inflow tract by an anomalous 'septomarginal muscular septum'. An interventricular septal defect was also present. A large undivided truncus arteriosus, exhibiting a tricuspid truncal valve at its origin, arose for the most part from the conus arteriosus of the right ventricle. The truncus gave rise to the brachiocephalic trunk, the aortic arch, a small pulmonary trunk, from which the left and right pulmonary arteries emerged, and two coronary arteries. The etiology and pathogenetic mechanisms implicated in the appearance of persistent truncus arteriosus are reviewed. It is suggested that a deficit or insufficiency in the cranial neural crest may play a role in the pathogenetic mechanisms leading to the production of persistent truncus arteriosus and related defects in cephalic duplications.

Animals↗

PubMed2026

Genome-informed qPCR tracking revealed preferential persistence of Bacillus subtilis BS9 in the broiler chicken gastrointestinal tract.

This study aimed to develop a strain-specific quantitative PCR (qPCR) assay for Bacillus subtilis BS9 and characterize its persistence and spatial distribution in the broiler chicken gastrointestinal tract. Whole-genome sequencing and comparative genomic analysis identified a unique 110-bp sequence within a strain-specific genomic island, which was used to design a highly specific qPCR assay with excellent efficiency and sensitivity. In a 14-day in vivo trial, broiler chicks receiving daily oral doses of BS9 were analyzed using both culture-based methods and the newly developed qPCR. The assay was applied qualitatively, presence or absence, to detect BS9 in intestinal samples. BS9 was detected exclusively in the duodenum, jejunum, and cecum, with no presence in the gizzard or ileum. These findings demonstrate that BS9 exhibits region-specific persistence in the gut, likely reflecting adaptation to distinct physiological niches, which may contribute to its probiotic mechanisms.IMPORTANCEThis work provides the first detailed account of B. subtilis BS9's spatial persistence in poultry, revealing preferential adherence to specific intestinal regions. The strain-specific qPCR assay developed here offers a precise, culture-independent tool for tracking BS9 in complex gut environments. These insights into the genetic basis and tissue tropism of BS9 persistence advance our understanding of probiotic-host interactions and establish a framework for characterizing novel probiotic strains.

Bacillus subtilis↗

PubMed2026

First characterization of Staphylococcus felis in diabetic foot osteomyelitis: from intracellular persistence to phage treatment.

Staphylococcus felis is a coagulase-negative Staphylococcus (CoNS) primarily associated with the feline microbiota and only rarely reported in human disease. Here, we report its implication in diabetic foot osteomyelitis, and provide the first comprehensive characterization of its pathogenic potential. Two isolates (NSF001 and NSF002), recovered 5 months apart from bone biopsies of the same patient, were analyzed for growth kinetics, biofilm formation, and intracellular persistence in macrophages and osteoblasts. Both isolates proliferated efficiently, produced robust biofilm, and persisted within host cells, most markedly in osteoblasts. In a zebrafish embryo infection model, both isolates caused significant mortality, confirming their pathogenic potential in vivo. Whole-genome sequencing revealed conserved virulence determinants, a narrow resistome, and strain-specific genomic variations affecting genes involved in virulence regulation, phage defense, and iron acquisition. The lytic phage SAVM02, previously characterized for activity against other Staphylococcus species, effectively inhibited S. felis growth in vitro and conferred protection in vivo against lethal infection. Notably, the two sequential isolates differed in their in vivo virulence and phage susceptibility, paralleling these within-host microevolutionary changes and illustrating bacterial adaptation during chronic infection. Altogether, this study establishes S. felis as a CoNS capable of intracellular persistence, biofilm formation, and in vivo virulence in chronic human infection. Our findings also highlight the therapeutic potential of lytic phages against virulent CoNS species and support further investigation of phage therapy for chronic staphylococcal infections.IMPORTANCECoagulase-negative staphylococci (CoNS) are increasingly recognized as genuine agents of chronic infection, yet the pathogenic capacity of most individual species remains undefined. Staphylococcus felis, a commensal of cats only exceptionally reported in humans, had never been implicated in a chronic human infection. Here, we describe two sequential S. felis isolates recovered from bone biopsies of a patient with diabetic foot osteomyelitis and show that this species combines biofilm formation, intracellular persistence in macrophages and osteoblasts, and lethality in a zebrafish embryo model. Whole-genome comparison of the two isolates uncovered microevolutionary changes, most notably in iron-acquisition and genome-defense loci, that paralleled differences in virulence and phage susceptibility. These findings extend the list of CoNS capable of causing invasive human disease and provide a rationale for lytic phage therapy against emerging, difficult-to-treat staphylococcal pathogens.

Staphylococcus felis↗

PubMed2025

Shedding dynamics of a DNA virus population during acute and long-term persistent infection.

Although much is known of the molecular mechanisms of virus infection within cells, substantially less is understood about within-host infection. Such knowledge is key to understanding how viruses take up residence and transmit infectious virus, in some cases throughout the life of the host. Here, using murine polyomavirus (muPyV) as a tractable model, we monitor parallel infections of thousands of differentially barcoded viruses within a single host. In individual mice, we show that numerous viruses (>2600) establish infection and are maintained for long periods post-infection. Strikingly, a low level of many different barcodes is shed in urine at all times post-infection, with a minimum of at least 80 different barcodes present in every sample throughout months of infection. During the early acute phase, bulk shed virus genomes derive from numerous different barcodes. This is followed by long term persistent infection detectable in diverse organs. Consistent with limited productive exchange of virus genomes between organs, each displays a unique pattern of relative barcode abundance. During the persistent phase, constant low-level shedding of typically hundreds of barcodes is maintained but is overlapped with rare, punctuated shedding of high amounts of one or a few individual barcodes. In contrast to the early acute phase, these few infrequent highly shed barcodes comprise the majority of bulk shed genomes observed during late times of persistent infection, contributing to a stark decrease in bulk barcode diversity that is shed over time. These temporally shifting patterns, which are conserved across hosts, suggest that polyomaviruses balance continuous transmission potential with reservoir-driven high-level reactivation. This offers a mechanistic basis for polyomavirus ubiquity and long-term persistence, which are typical of many DNA viruses.

Animals↗

PubMed2005

Persistent but reversible coma in encephalitis.

INTRODUCTION: Nontraumatic coma in adults has a poor prognosis, and late recovery of consciousness is unlikely. Functional recovery is usually extremely poor. However, a few nontraumatic comatose patients have shown late recovery of both awareness and function. METHODS: A retrospective survey was conducted by reviewing the medical records of all inpatients to our department during the 1990s. Patients with persistent but reversible nontraumatic coma were identified according to the following criteria: (a) deep coma with a Glasgow Coma Scale (GCS) score of 7 or less on admission; (b) nontraumatic cause; (c) persistence of unconsciousness for longer than 1 month; and (d) subsequent recovery of GCS (total) to normal. The clinical spectrum of patients meeting these criteria was evaluated. RESULTS: Six patients (ages 16-75 years) met the criteria. Viral encephalitis was diagnosed in five (two with herpes simplex virus, two with cytomegalovirus, and one with Epstein-Barr virus or cytomegalovirus). Two young female patients with encephalitis manifested extremely protracted coma persisting for 3 and 18 months, respectively. Complications included nonconvulsive status epilepticus in two patients and relative overdose of clonazepam in one patient. CONCLUSION: Recognition of the clinical spectrum of persistent but reversible nontraumatic coma is important.

Adolescent↗

PubMed2001

[Persistent pulmonary hypertension in newborn infants].

BACKGROUND: Persistent pulmonary hypertension of the newborn is a clinical syndrome caused by failure in the transition from fetal to neonatal circulation either to achieve or to maintain low pulmonary vascular resistance after birth. The syndrome is a complex condition associated with different cardiopulmonary disorders. METHODS: This article presents a review of the literature and the author's own experience regarding the fetal circulation, the transition to the newborn circulation, and the mechanical and molecular regulatory factors, including a discussion of the pathophysiology, aetiology, diagnostics and main goal of treatment for persistent pulmonary hypertension of the newborn. RESULTS: The pathophysiology of persistent pulmonary hypertension is characterised by high pulmonary vascular resistance and high pulmonary artery pressure. The blood is shunted from the right to the left circuit through the foramen ovale, ductus arteriosus and also by intrapulmonal shunts. The aetiologies can be classified as underdevelopment, maldevelopment and maladaptation of the pulmonary vasculature. The clinical signs are hypoxaemia, higher oxygenation tension and saturation in the upper rather than the lower limbs, respiratory failure, systemic hypotension and systolic cardiac murmur. The differential diagnoses are primarily serious lung disorders without persistent pulmonary hypertension, and congenital cyanotic heart defects. The diagnostic investigations are blood gas analysis, X-ray of the lung, and Doppler echocardiographic examination of the heart. INTERPRETATION: The main treatment goal is good oxygenation, pH in upper normal and pCO2 in lower normal levels. Positive pressure ventilation, sedation, NO gas inhalation and supporting treatment of the systemic blood pressure are usually necessary. Extracorporeal membrane oxygenation is considered as a last option.

Diagnosis, Differential↗

PubMed2003

Do we need stimulation programs as a part of nursing care for patients in "persistent vegetative state"? A conceptual analysis.

The rehabilitative care of persons suffering long-lasting effects of brain injury is a significant challenge for nurses as they are the health professionals who usually spend the most time with them. Historically in Germany, the term "apallic syndrome" has been commonly used for what Plum and Posner (1980) termed the persistent vegetative state. When persons are diagnosed as being in a persistent vegetative state, that is awake but not aware, for more than six months, they seldom receive active therapy except what nurses or families may provide. Stimulation programs have been advocated for these persons, but there is still no reliable evidence as to their effectiveness, and the conceptual basis of the two main types of programs has been poorly understood. The multisensory stimulation approach, such as the Coma Recovery Program or Coma Arousal Therapy, is based on behaviourism with the belief that intensive stimulation provided to all senses will enhance synaptic reinnervation and stimulate the reticular activating system to increase brain tone. In contrast, the sensory regulation approach is based on information processing and mediation of reaction to sensory information with emphasis on enhancing selective attention by regulating the environment rather than providing high degrees of stimulation. What both approaches have in common is the belief that the person in a persistent vegetative state may, at some level, be able to perceive and begin to process information and that external stimulation may enhance that process. Nurses interacting with persons in persistent vegetative state are encouraged to think about how they can regulate sensory input to enhance meaning and facilitate information processing for these persons.

Arousal↗

PubMed1999

Persistent stress as a predictor of genital herpes recurrence.

BACKGROUND: Results of several studies suggest that psychological stress and negative mood can trigger genital herpes recurrences, but results are inconsistent. OBJECTIVE: To determine whether short-term or persistent psychological stress or specific negative moods are predictive of genital herpes recurrences in women. METHODS: A prospective cohort study followed up participants for 6 months using weekly assessments of stress and mood, monthly assessments of life change events, and diary reports of genital herpes recurrences confirmed by medical examination when feasible. The community sample consisted of 58 women, aged 20 to 44 years, with a 1- to 10-year history of visible genital herpes recurrence and at least 1 recurrence in the previous 6 months. RESULTS: Persistent stress predicted recurrence in the subsequent week (odds ratio, 1.08 per unit increase in stress; 95% confidence interval, 1.01-1.15; P=.03). After adjusting for recurrence in the previous week, the more weekly persistent stress reported, the greater the likelihood of recurrence the following week. Also, an increased recurrence rate occurred after the month during which participants experienced their highest levels of anxiety (P =.03). There were no significant associations between recurrence and short-term stress, life events, depressive mood, anger, or phase of menstrual cycle. CONCLUSIONS: Persistent stressors and highest level of anxiety predicted genital herpes recurrence, whereas transient mood states, short-term stressors, and life change events did not. Women with herpes can be reassured that short-term stressful life experiences and dysphoric mood states do not put them at risk for increased outbreaks of recurrent genital herpes.

Adult↗

PubMed2005

Persistent fetal ocular vasculature in mice deficient in bax and bak.

BACKGROUND: The ocular fetal vasculature normally regresses by apoptosis but for unknown reasons fails to regress in the human disease persistent fetal vasculature. OBJECTIVE: To investigate whether proapoptotic Bcl-2 members, Bax and Bak, are involved in fetal vasculature regression. METHODS: Adult eyes from mice deficient in Bax and/or Bak were examined grossly and histologically for persistence of fetal vasculature. Vessels were identified by the presence of lumens and erythrocytes and by Factor VIII labeling. Eyes from postnatal day 7 mice were processed for terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate nick-end labeling (TUNEL) analysis to determine if deficiency of Bax and Bak results in defective developmental apoptosis. RESULTS: Only bax(-/-)bak(-/-) eyes retained fetal vasculature into adulthood. This vasculature consisted of a hyaloid artery emerging from the optic nerve head and intravitreal and perilental vessels but not a pupillary membrane. At postnatal day 7, wild-type but not bax(-/-)bak(-/-) eyes had TUNEL-positive cells in the fetal vasculature. CONCLUSIONS: These data demonstrate that Bax and Bak serve overlapping functions in fetal vasculature regression, emphasizing the importance of apoptosis in developmental remodeling. Clinical Relevance Disruption of Bax and Bak results in persistent fetal vasculature in knockout mice, providing a model of the human disease persistent fetal vasculature to investigate its etiology and potential therapies.

Animals↗

PubMed1986

Persisting accommodative esotropia.

This report examines the persistence of many cases of accommodative esotropia well beyond the expected time of resolution (age 10 to 12 years) and the potential usefulness of any associated clinical features to predict timely or delayed disappearance. In a series of 202 patients, there was no discrete age of improvement and more than half persisted after age 10 years. The results were similar for both high and normal accommodative convergence/accommodation ratio cases. Initial hyperopia did not predict persistence; subsequent increases prior to age 7 years, and decreases thereafter, were different statistically but were clinically similar. Moreover, the occurrence of inferior oblique overaction and of dissociated vertical deviation, as well as a family history of strabismus, did not predict persistence or delayed improvement.

Accommodation, Ocular↗

PubMed1998

Persistence of group A beta-hemolytic streptococci in toothbrushes and removable orthodontic appliances following treatment of pharyngotonsillitis.

OBJECTIVE: To investigate the persistence of group A beta-hemolytic streptococci (GABHS) in toothbrushes and removable orthodontic appliances (ROAs) in children who suffer from acute GABHS pharyngotonsillitis and the association with penicillin treatment failure. SETTING: Private practice setting. PATIENTS AND METHODS: Pharyngotonsillar and toothbrush cultures were obtained from 104 children with acute GABHS pharyngotonsillitis before and after 10 days of penicillin V potassium therapy. Cultures of ROAs were also obtained from 21 children. The persistence of GABHS in 10 daily rinsed and 10 nonrinsed toothbrushes was studied in vitro. RESULTS: Group A beta-hemolytic streptococci were isolated from 11 (11%) of the toothbrushes and 18 (17%) of the patients after the completion of penicillin therapy. Toothbrushes of 5 (28%) of the 18 children who harbored GABHS were colonized with the organism. Group A beta-hemolytic streptococci were also isolated from 4 (19%) of 21 ROAs after therapy. In vitro studies illustrated the persistence of GABHS in nonrinsed toothbrushes for up to 15 days. In contrast, the organism was not isolated from rinsed toothbrushes beyond day 3. CONCLUSION: Toothbrushes and ROAs that harbor GABHS may contribute to the persistence of GABHS in the oropharynx and may account for the failure of penicillin therapy in some cases of pharyngotonsillitis.

Child↗

PubMed1981

Persistent hoarseness after surgical removal of vocal cord lesions.

Surgical intervention to remove vocal cord lesions usually results in normal vocal cord quality postoperatively. However, some patients exhibit persistent hoarseness after surgery, and often they are referred to a speech pathologist for vocal rehabilitation. In this study, factors were identified in the case histories, surgical management, and behavior during voice rest of patients who experienced persistent hoarseness postoperatively. Eight of ten adult subjects were interviewed and their voices were tape-recorded before and after surgery and were determined to be hoarse postoperatively. Cumulative medical history was the only significant factor that related to persistent hoarseness. Medical histories of disease or infection affecting the respiratory tract were among the specific factors that were identified. Results indicate that patients with these medical factors should be counseled about the risk of persistent hoarseness after surgery.

Adult↗

PubMed1979

Tardive dyskinesia--reversible and persistent.

Twenty-one hospitalized patients over 50 years of age who had tardive dyskinesia were studied for 13 months. After withdrawal of neuroleptics and antidepressants for three months, dyskinetic symptoms abated in 12 patients and persisted in nine. Discriminant function analysis showed that the persistent and reversible dyskinesia groups could be clearly separated and that the best discriminator was the number of drug-free intervals. The persistent dyskinesia group had had significantly longer neuroleptic treatment (mean, 10.8 yr) and a greater number (mean, 5.6) of drug interruptions of at least two months' duration each than did the reversible dyskinesia group. Our finding, as well as the literature reviewed, does not support the commonly held notion that frequent lengthy interruptions of long-term drug treatment reduce the incidence of persistent dyskinesia, at least in patients who are otherwise predisposed to the development of tardive dyskinesia.

Aged↗

PubMed1994

Localization procedures in patients with persistent or recurrent hyperparathyroidism.

OBJECTIVE: To determine the accuracy of noninvasive and invasive localization studies in patients with persistent or recurrent hyperparathyroidism (HPT). DESIGN AND SETTING: Reoperations based on patients who were treated surgically for recurrent or persistent HPT at the University of California-San Francisco Hospitals from 1982 to 1993. PATIENTS: This study evaluated 174 localization studies performed in 152 patients before reoperation (110 women and 42 men). MAIN OUTCOME MEASURES: The accuracy of localization studies, including ultrasonography, thallous chloride T1 201-technetium Tc 99m pertechnetate scanning, technetium Tc 99m sestamibi scanning, magnetic resonance imaging, computed tomography, and selective venous catheterization, were evaluated, as were the results of parathyroid reoperations. RESULTS: A total of 174 consecutive reoperations were performed in 152 patients with HPT (persistent, 113; recurrent, 39; mean age, 54 years; range, 21 to 88 years). One hundred thirty-three patients had primary HPT, 15 had secondary HPT, and four had tertiary HPT. Overall, 141 (93%) became normocalcemic, two (1%) became hypocalcemic, and nine (6%) remained hypercalcemic. Abnormal parathyroid glands at reoperation were situated in a normal location in 77 cases (44%), in the mediastinum in 37 cases (22%), in a deep cervical location in 34 cases (19%), or in an intrathyroidal location in 14 cases (8%), or were undescended in four cases (2%); supernumerary glands were found in 26 cases (15%). Some patients had more than one remaining abnormal gland. Selective venous catheterization with a parathyroid hormone assay was done in cases in which the results of noninvasive localization studies were equivocal or negative, and it frequently converted an equivocal result of a localization study to a definitely positive result. There were no complications from the localization studies. At reoperation, permanent hypoparathyroidism that required parathyroid autotransplantation of cryopreserved tissue developed in two patients and two patients had recurrent laryngeal nerve palsies. CONCLUSION: We currently recommend using ultrasonography and technetium Tc99m sestamibi scanning and magnetic resonance imaging for patients with recurrent or persistent HPT. Selective venous catheterization with a parathyroid hormone assay is done selectively. Localization tests decrease morbidity and improve overall results in these patients.

Adult↗

PubMed1996

Reoperation for persistent or recurrent primary hyperparathyroidism.

OBJECTIVE: To analyze the causes and outcomes of reoperation for persistent or recurrent primary hyperparathyroidism. DATA SOURCES: Medical records of 102 patients with persistent or recurrent primary hyperparathyroidism who underwent reoperation by 1 surgeon between 1985 and 1995. STUDY SELECTION: Only patients with persistent or recurrent primary hyperparathyroidism were selected; patients with secondary hyperparathyroidism, parathyroid cancer, familial hyperparathyroidism, and previous thyroid operations were omitted. DATA EXTRACTION: Performed by a single unblinded researcher. DATA SYNTHESIS: Reasons for failed parathyroid operations included tumor in ectopic position (53%), incomplete resection of multiple abnormal glands (37%), adenoma in normal position missed during previous surgery (7%), and regrowth of previously resected tumor (3%). Of the ectopic glands, 28% were paraesophageal, 26% in the mediastinum (nonthymic), 24% intrathymic, 11% intrathyroidal, 9% in the carotid sheath, and 2% in a high cervical position. Eighty-three percent of ectopic glands were accessible via cervical incision. The success rate of reoperations was 95%. One patient (1%) became permanently hypocalcemic after reoperation; 1 patient (1%) suffered permanent unilateral vocal cord paralysis. The sensitivities of preoperative localization studies were as follows: technetium Tc 99m sestamibi scan, 77%; magnetic resonance imaging, 77%; selective venous catheterization for intact parathyroid hormone, 77%; thallium-technetium scan, 68%; ultrasonography, 57%; and computed tomography, 42%. CONCLUSIONS: Repeated parathyroidectomy can be avoided in more than 95% of patients if an experienced surgeon performs bilateral cervical exploration during the initial parathyroid operation. For patients with persistent or recurrent primary hyperparathyroidism, preoperative localization studies and a focused surgical approach can result in a 95% success rate with minimum complications.

Adult↗

PubMedDate not supplied

Long-acting beta2-agonist monotherapy vs continued therapy with inhaled corticosteroids in patients with persistent asthma: a randomized controlled trial.

CONTEXT: Long-acting beta(2)-agonists are prescribed for patients with persistent asthma and are sometimes used without inhaled corticosteroids (ICSs). No evidence exists, however, to support their use as monotherapy in adults with persistent asthma. OBJECTIVE: To examine the effectiveness of salmeterol xinafoate, a long-acting beta(2)-agonist, as replacement therapy in patients whose asthma is well controlled by low-dose triamcinolone acetonide, an ICS. DESIGN AND SETTING: A 28-week, randomized, blinded, placebo-controlled, parallel group trial conducted at 6 National Institutes of Health-sponsored, university-based ambulatory care centers from February 1997 to January 1999. PARTICIPANTS: One hundred sixty-four patients aged 12 through 65 years with persistent asthma that was well controlled during a 6-week run-in period of treatment with inhaled triamcinolone (400 microg twice per day). INTERVENTIONS: Patients were randomly assigned to continue triamcinolone therapy (400 microg twice per day; n = 54) or switch to salmeterol (42 microg twice per day; n = 54) or to placebo (n = 56) for 16 weeks, after which all patients received placebo for an additional 6-week run-out period. MAIN OUTCOME MEASURES: Change in morning and evening peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV(1)), self-assessed asthma symptom scores, rescue albuterol use, asthma-specific quality-of-life scores, treatment failure, asthma exacerbation, bronchial reactivity, and markers of airway inflammation, compared among the 3 treatment groups. RESULTS: During the 16-week randomized treatment period, no significant differences between the salmeterol and triamcinolone groups were observed for conventional outcomes of clinical studies of asthma therapy-morning PEF, evening PEF, asthma symptom scores, rescue albuterol sulfate use, or quality of life. Both active treatments were superior to placebo. However, the salmeterol group had more treatment failures than the triamcinolone group (13/54 [24%] vs 3/54 [6%]; P =.004), as well as more asthma exacerbations (11/54 [20%] vs 4/54 [7%]; P =.04), greater increases in median (interquartile range) sputum eosinophils (2.4% [0.0% to 10.6%] vs -0.1% [-0.7% to 0.3%]; P<.001), eosinophil cationic protein (71 [-2 to 430] U/L vs -4 [-31 to 56] U/L; P =.005), and tryptase (3.1 [2.1 to 7.6] ng/mL vs 0.0 [0.0 to 0.7] ng/mL; P<.001). The duration of benefit when patients were switched from active treatment to placebo after 22 weeks of randomized treatment was not significantly longer in the triamcinolone group than in the salmeterol group. CONCLUSIONS: Patients with persistent asthma well controlled by low doses of triamcinolone cannot be switched to salmeterol monotherapy without risk of clinically significant loss of asthma control.

Administration, Inhalation↗