Prevalence and risk factors of postoperative laryngeal edema in patients undergoing neck dissection.

PURPOSE: Postoperative laryngeal edema (PLE) is a common complication in patients undergoing head and neck surgery, leading to symptoms such as odynophagia, dysphagia, or potential airway obstruction. However, the prevalence and risk factors of PLE in patients undergoing neck dissection (ND) have not been well investigated. METHODS: A retrospective analysis was conducted in three steps. Initially, a pilot study of 50 consecutive ND patients revealed a preliminary PLE prevalence of 0.34. Then, the medical records of an additional 295 ND patients were reviewed to estimate the prevalence of PLE with a total width of 95% confidence interval (CI) of ± 5%. Finally, multivariable logistic regression analyses were performed to identify risk factors for PLE (n = 343). RESULTS: PLE occurred in 29.4% [95%CI 24.4-34.4%] of patients undergoing any type of ND, with the most common symptoms of odynophagia (75.0%) and dyspnea (11.1%). Hospital stay was just one day longer in PLE patients, responding well with short-term steroid treatment (p = 0.0057). In multivariable analyses, no significant association was found between PLE occurrence and airway management. However, body mass index and the American Society of Anesthesiologists classification correlated with PLE. More importantly, surgery for oro-hypopharynx or supraglottis tumors (odds ratio, OR = 3.019, [95%CI 1.166-7.815]) and lymph node level 2(3) ND (OR = 4.214 to 5.279, [95%CI 1.160-20.529]) were significant risk factors for PLE. CONCLUSIONS: PLE developed in approximately 30% of ND patients, causing uncomfortable symptoms. Early diagnosis and intervention of PLE in high-risk patients can improve patient care and outcomes.

Intubation-Related Laryngeal Pathology Precluding Tracheostomy Decannulation: Incidence and Associated Risk Factors.

OBJECTIVES: To identify the incidence and risk factors for intubation-related laryngeal lesions that preclude tracheostomy decannulation in a large population. METHODS: A 3-year retrospective case-control study was performed of tracheotomized adults in acute rehabilitation facilities who underwent routine endoscopic evaluation of the airway as part of the facilities' decannulation protocol. Patients with known upper airway pathology, external laryngeal trauma, cricothyrotomy or emergent tracheostomy, prior head and neck radiation, isolated tracheal lesions, and patients with incomplete reports were excluded. The laryngeal pathologies were classified, and demographics and clinical features were compared between those whose lesions precluded decannulation and all other patients. RESULTS: Three hundred seventy-one patients met inclusion criteria. One hundred six (28.6%) had laryngotracheal lesions. Forty-nine patients (13.2%) had intubation-related lesions of the larynx that precluded decannulation. These lesions included posterior glottic stenosis (30.6%), granulation tissue (24.5%), vocal fold immobility (16.3%), subglottic stenosis (16.3%), a combination of granulation tissue and stenosis (10.2%), and glottic edema (2.0%). A BMI ≥ 25 kg/m2 was associated with laryngeal lesions precluding decannulation. There was no difference in age, sex, race, diabetes mellitus, endotracheal tube size, number of days intubated, and number of intubations between groups. Seventy-eight percent of patients with lesions precluding decannulation were decannulated after medical or surgical therapy. The decannulation rate of patients without lesions precluding decannulation was 79.9%. CONCLUSIONS: BMI ≥ 25 kg/m2 may increase the risk of development of laryngeal lesions preventing decannulation. Given that 13.2% of tracheotomized patients have laryngeal lesions precluding decannulation, an endoscopic evaluation of the airway is important to prevent decannulation failure and future airway symptoms.

Profile of Laryngeal Microsurgeries in Patients Over 60 Years Old

Abstract Introduction The increase in life expectancy is an incentive to the development of researches with the elderly population aiming at actions that may ensure healthy and active aging. Objective To analyze the profile of laryngeal microsurgery performed in patients > 60 years old. Methods A retrospective observational study, with a cross-sectional design. A retrospective analysis of the medical records of elderly patients submitted to laryngeal microsurgery was performed at a private hospital in Curitiba, state of Paraná, Brazil, between January 2004 and December 2016. Were included all of the patients > 60 years old that underwent laryngeal microsurgery during this period. Results During the studied period, 213 laryngeal microsurgeries were performed in 181 patients > 60 years old. There was a preponderance of male patients. The mean age was 67.6 years old. Squamous cell carcinoma (SCC) was the most prevalent disorder (26%), followed by Reinke edema (20%), papillomatosis (14%), polyps (11%), leukoplakia (8%), minor structural alterations (8%), associated lesions (9%), and others (4%). Men presented a higher probability of SCC diagnosis, regardless of the age group, while Reinke edema was more frequently observed in women. A directly proportional relation between the frequency of laryngeal cancer and age increase was also observed. No significant differences were observed in professional voice users. Conclusion Further researches are required to properly comprehend the factors associ- ated with laryngeal lesions and determine prevention and treatment approaches.

A novel scale for predicting delayed intubation in patients with inhalation injury.

BACKGROUND: Strategies to predict delayed airway obstruction in patients with inhalation injury have not been extensively studied. This study aimed to develop a novel scale, predicting the need for Delayed Intubation after inhalation injury (PDI) score. METHODS: We retrospectively identified patients with inhalation injury at four tertiary care centers in Japan between 2012 and 2018. We included patients aged 15 or older and excluded those intubated within 30 min after hospital arrival. Predictors for delayed intubation were identified with univariate analyses and scored on the basis of odds ratios. The PDI score was evaluated with the area under the receiver operating characteristic (AUROC) curve and compared with other scaling systems for burn injuries. RESULTS: Data from 158 patients were analyzed; of these patients, 18 (11.4%) were intubated during the delayed phase. Signs of respiratory distress, facial burn, and pharyngolaryngeal swelling observed on laryngoscopy, were identified as predictors for delayed intubation. The discriminatory power of the PDI (AUROC curve = 0.90; 95% confidence interval, 0.83 to 0.97; p < 0.01) was higher than that of the other scaling systems. CONCLUSIONS: We developed a novel scale for predicting delayed intubation in inhalation injury. The score should be further validated with other population.

Pathogenic Role of Reinke's Edema in Snoring and Obstructive Sleep Apnea.

OBJECTIVE: To investigate the association between vocal fold Reinke's edema, snoring, and obstructive sleep apnea. DESIGN/METHODS: Twenty-five patients diagnosed with Reinke's edema and 25 patients with normal laryngeal examination, matched according to age, gender, and body mass index were recruited for this prospective study. Demographic data included age, gender, and body mass index. All patients filled the Berlin Questionnaire, STOP-BANG Sleep Apnea Questionnaire, and the Epworth Sleepiness Questionnaire. RESULTS: Out of 25 patients with Reinke's edema, 36% had Obstructive Sleep Apnea (OSA) as evidenced by having two or more positive categories in the Berlin Questionnaire. In the control group, only 4% had OSA.The difference between the two groups was statistically significant (P value = 0.005). With respect to Epworth Sleepiness Scale and the STOP-BANG Sleep Apnea Questionnaire (P value > 0.05), there was no statistically significant difference between the two groups. CONCLUSIONS: This investigation revealed higher prevalence of snoring and obstructive sleep apnea in patients with Reinke's edema as evidenced by the Berlin Questionnaire. The caring physician should be alert to symptoms of airway obstruction for possible early intervention.

The role of bacteriological studies in the management of peritonsillar abscess.

OBJECTIVE: Since most patients with peritonsillar abscess (PTA) can be successfully treated with surgical drainage and empirical antibiotic therapy, routine bacteriologic studies for all patients with PTA may be unnecessary. This study tried to evaluate which patients with PTA should certainly undergo bacteriologic studies. METHODS: Hundred consecutive patients with PTA were treated and underwent culture tests of purulent contents obtained by surgical drainage between April 2008 and December 2013. RESULTS: In 62 of the 100 patients, 71 pathogenic bacteria were identified; 61 (86%) were Gram-positive cocci (GPC), 8 (11%) were Gram-negative rods (GNR), and 6 (8%) were anaerobes. Normal flora were isolated in 27 patients, and culture results were negative in 11 patients. Although not significant, primary (without prior antibiotic therapy) case (odds ratio (OR)=2.19; 95% CI, 0.95-5.05) and laryngeal edema (OR=2.04; 95% CI, 0.82-5.03) showed a tendency of associations with detection of pathogenic bacteria. After taking into account interactions between smoking habit and laryngeal edema, the covariate-adjusted OR for non-smokers with laryngeal edema was significant and showed a strong relationship (OR=7.43; 95% confidence interval, 1.05-52.73) compared to non-smokers without laryngeal edema. CONCLUSION: Although empirical antibiotic therapy was effective for most of the PTA patients, bacteriologic studies might be indispensable for the patients with laryngeal edema considering the failure of the first treatments. Particularly, the culture tests may be useful for non-smokers with laryngeal edema.

Evaluation of the prevalence of and factors associated with laryngeal diseases among the general population.

OBJECTIVES/HYPOTHESIS: Despite the high prevalence of voice disorders, the prevalence of laryngeal disease in the general population has not been determined using laryngoscopy. Factors considered associated with laryngeal disease have mostly been assessed using patient data or highly specific populations. We evaluated the prevalence of and associated factors with laryngeal diseases in the general Korean population. STUDY DESIGN: Cross-sectional study. METHODS: We analyzed data from the Korea National Health and Nutrition Examination Survey for 19,039 participants assessed between 2008 and 2011. The prevalence, subjective discomforts rates of, and odd ratios (demographics, life-style factors, and diseases factors) for laryngeal disease were analyzed using simple and multiple logistic regression analyses, taking into account the complex sampling structure of the data. RESULTS: The top five laryngeal diseases in prevalence were laryngitis (3,513/100,000), vocal nodules (1,487/100,000), vocal polyp (404/100,000), Reinke's edema (347/100,000), and epiglottic cyst (296/100,000). Prevalence of laryngeal disease was higher in males, whereas the rate of subjective voice complaints was higher in females. In the logistic regression analysis, gender was not associated with laryngeal diseases after adjusting for other factors. We observed a positive association between low body mass index (BMI) and vocal nodules, and between high BMI and laryngitis, smoking and epiglottic cyst/hyperkeratosis/laryngeal cancer, higher education level and vocal nodules, and allergic rhinitis and vocal nodules/laryngitis/epiglottic cyst. CONCLUSIONS: The rate of subjective voice complaints and laryngeal disease co-occurrence was low. This study provides more reliable information of laryngeal disease because it includes participants without subjective complaints. LEVEL OF EVIDENCE: 2b.

Gender and age in benign vocal fold lesions.

OBJECTIVE/HYPOTHESIS: Certain lesions appear to occur predominantly in one gender or in younger or older patients. We examined a large sample from a treatment-seeking population to describe gender and age associations of an array of benign vocal fold lesions. STUDY DESIGN: Retrospective review. METHODS: The medical records and evaluations of all adult patients presenting for care over a 5-year period were examined for demographic characteristics and lesion type. A total of 641 lesions in 602 patients were grouped into 13 broad categories, and prevalence was compared between male and female patients and three age groups. RESULTS: Pseudocysts and bilateral midfold lesions occurred principally in young (18-39 years old) females (P < 0.0001). Reinke's edema was found in older (> 39 years old) women (P < 0.012). Polyps, contact lesions, leukoplakia (all P < 0.0001), and sulcus (P < 0.0002) were found predominantly in men. CONCLUSION: Certain benign mucosal lesions are strongly associated with age and especially with gender. These differences may be explained by intrinsic differences in laryngeal anatomy and phonatory physiology in these groups, including differences in phonatory frequency and air pressure, and in the ability of the membranous vocal fold to withstand phonotrauma. Such inherent differences have implications for treatment expectations and approaches.

Exercise-induced paradoxical vocal fold motion disorder: diagnosis and management.

OBJECTIVES/HYPOTHESIS: To review our experience with the diagnosis and treatment of exercise-induced paradoxical vocal fold motion disorder (EPVFMD). STUDY DESIGN: Single-institution retrospective review and cohort analysis. METHODS: A single-institution retrospective review was performed identifying patients with paradoxical vocal fold motion disorder (PVFMD). Patients with isolated exercise-induced dyspnea were selected for further review. Flexible fiberoptic laryngoscopy (FFL) performed on these patients were reviewed with regard to presence of laryngeal pathology as well as the presence of PVFMD at rest and/or with exertion. The type of therapy was reviewed. Symptom outcomes were graded as complete resolution, improvement, or unchanged following therapy. RESULTS: There were 758 patients who were identified with PVFMD. A total of 104 patients demonstrated symptoms of PVFMD that were only exercise related (EPVFMD). There were 93/104 (89%) patients who underwent a pre- and post-trigger FFL. Of these, 48/93 (52%) patients had no evidence of PVFMD on initial FFL. After subjecting these patients to exertion, 83/93 (89%) had evidence of PVFMD on postexertion FFL, and 39/93 (42%) patients had evidence of PVFMD on both pre-exertion and postexertion FFL. There were 87/104 (84%) patients who had evidence of laryngeal edema, and 23/104 (23%) had one or more laryngeal lesion on examination. A total of 67 patients were enrolled in laryngeal control therapy and attended at least one session, with 48/67 (72%) demonstrating improvement or complete resolution of their symptoms. CONCLUSIONS: The diagnosis of EPVFMD is augmented with the addition of provocation testing. Findings of PVFMD can be identified at rest when asymptomatic. Laryngeal control therapy is an effective treatment for EPVFMD.

The role of bronchoscopy in the management of patients with severe craniofacial syndromes.

PURPOSE: The purpose of this study is to assess the incidence of airway anomalies in children with severe craniofacial syndromes and to establish the role of bronchoscopy in the care of these patients. METHODS: Consecutive children with craniofacial syndromes, including both bony deformities of the skull and face, in which a bronchoscopy was performed between 1995 and 2010 were retrospectively reviewed. RESULTS: Thirty-six patients (22 boys, 14 girls; mean age, 39 months) were studied. Craniofacial synostosis was present in 21 patients (Crouzen syndrome, 11; Apert syndrome, 7, Pfeiffer syndrome, 3) and craniofacial dysostosis in 15 (Goldenhart syndrome, 8; Treacher Collins syndrome, 7). In 30 patients (83.3%), bronchoscopy was performed because of respiratory symptoms (apneic episodes, 22; respiratory distress, 13; stridor, 6; cyanosis, 1) and, in the remaining 6 (asymptomatic children), during guided tracheal intubation before a surgical procedure. Airway anomalies were found in 69.4% of patients (70% in symptomatic patients). Management consisted of tracheotomy in 13 patients, adenoidectomy/tonsillectomy in 13, glossopexy in 5, antireflux surgery in 3, and supraglottoplasty in 2. CONCLUSIONS: Airway anomalies occurred in 70% of children with severe craniofacial syndromes and respiratory symptoms. Bronchoscopy should be performed routinely in this selected group of patients, and the entire airway must be examined. Treatment should be tailored to each individual patient.

Laryngeal involvement in juvenile idiopathic arthritis patients.

Juvenile idiopathic arthritis (JIA) is an autoimmune diseases characterized by chronic arthritis and systemic manifestations. Autoimmune diseases can affect the upper airways including the larynx. The aim of this study was to investigate laryngeal involvement in JIA patients and its possible association with JIA disease parameters. Fifty consecutive JIA patients were screened for laryngeal abnormalities using flexible fiberoptic laryngoscope and laryngeal computerized tomography. Laryngeal abnormalities were detected in nine (18%) of our cases, with cricoarytenoiditis in six cases (12%) and a rheumatoid nodule in the pyriform fossa in only one case (2%). Diffuse congestion and edema of the posterior part of the larynx with normal vocal cord mobility was detected in two cases (4%). In our study, laryngeal abnormalities were significantly higher in patients with polyarticular seropositive disease subtype and also were significantly higher in patients with longer disease duration, higher disease activity scores, and those with erosive disease. JIA may affect the larynx. Laryngeal involvement in JIA patients is more in polyarticular seropositive cases. JIA patients have to be subjected to thorough otolaryngologic examination for early diagnosis and prompt management.

[The risk factors of the respiratory complications occurrence after tracheal extubation in the surgery of the thyroid gland].

There were examined 400 patients after tracheal extubatton performance, to whom thyroidal surgery was done. The rate and causes of occurrence of respiratory complications were studied up. Laryngeal oedema was revealed in 5.5% patients, injury of laryngeal nerves--in 3.0%, postoperative hemorrhage--in 1.2%. For the respiratory complications occurrence the risk factors are following: thyroidal cancer, polynodous goiter, subtotal thyroidectomy, extrafascial thyroidectomy, the operation duration, hard trachreal intubatlon, the patients age and gender.

The role of allergy in the etiology of Reinke's edema on vocal folds.

AIM: To identify the role of allergy in the occurrence of Reinke's edema on vocal folds. METHODS: This was a prospective study in patients with Reinke's edema on vocal folds (n = 80) and a control group of patients without Reinke's edema (n = 80). All the patients were examined by the same ENT specialist at an ENT outpatient center in the period 2001-2003. The control group comprised 80 successive patients from the same clinic who were willing to cooperate in the study and were not already being treated for allergic disease by any specialist other than an ENT specialist. Patients from both groups were examined by rigid laryngoscope, skin prick allergic testing (type I allergy) and laboratory determination of serum thyroid-stimulating hormone level. RESULTS: The prevalence of allergy was not significantly different between the two groups: 20.0% in the patients with Reinke's edema and 23.8% in the control group (P = 0.576). No significant difference was detected in the prevalence of allergy when comparing patients with recurrent Reinke's edema after previous surgical treatment (n = 10) with patients with a first occurrence (n = 70) (P = 1.000). However, we found significantly more type I allergy in the patients with Reinke's edema and chronic hyperplastic rhinitis than in the patients with Reinke's edema without chronic hyperplastic rhinitis. All other risk factors (reflux of gastric content to the larynx, vocal abuse or misuse, unfavorable microclimate conditions at work, thyroid diseases) appeared significantly more often in the group with Reinke's edema on vocal folds than in the control group. CONCLUSIONS: Type I allergy is not a crucial factor in the pathogenesis of Reinke's edema on vocal folds or in recurrence of the disease after surgical treatment.

Mature results of a randomized trial of accelerated hyperfractionated versus conventional radiotherapy in head-and-neck cancer.

PURPOSE: To evaluate long-term late adverse events and treatment outcome of a randomized, multicenter Phase III trial of continuous, hyperfractionated, accelerated radiotherapy (CHART) compared with conventional radiotherapy (CRT) in 918 patients with advanced squamous cell carcinomas of the head and neck. METHODS AND MATERIALS: Survival estimates were obtained for locoregional relapse-free survival, local relapse-free survival, overall survival, disease-specific survival, disease-free survival and for late adverse events. RESULTS: The 10-year estimates (+/-1 standard error) for locoregional relapse-free survival, overall survival, disease-free survival, and disease-specific survival were 43% +/- 2% for CHART and 50% +/- 3% with CRT (log-rank p = 0.2); 26% +/- 2% and 29% +/- 3% (p = 0.4), respectively; 41% +/- 2% and 46% +/- 3% (p = 0.3), respectively; and 56% +/- 3% and 58% +/- 3% (p = 0.5), respectively. There was a small but significant reduction in the incidence of slight or worse and moderate or worse epidermal adverse events with CHART (p = 0.002 to 0.05). Severe xerostomia, laryngeal edema, and mucosal necrosis were also significantly lower with CHART (p = 0.02 to 0.05). CONCLUSIONS: Despite the reduction in total dose from 66 Gy to 54 Gy, control of locoregional disease and survival with CHART were similar to those with CRT. These findings, together with the low incidence of long-term severe adverse events, suggest that CHART is a treatment option for patients with low-risk disease and for those unable to withstand the toxicity of concurrent chemoradiotherapy.

The spectrum and treatment of angioedema.

Angioedema manifests as episodes of localized swelling in the dermis and submucosa. The key to successful management is detection and avoidance of triggers, early recognition of attacks, and aggressive airway management when warranted. Review of a patient's medication list may identify drugs that include angiotensin-converting enzyme inhibitor or angiotensin receptor blockers as the cause. Initial treatment in a patient presenting with most forms of angioedema includes antihistamines and glucocorticoids if required. Epinephrine should be administered if there is concern for laryngeal edema. Patients who have a known history of hereditary angioedema should receive C1 esterase inhibitor concentrate or fresh-frozen plasma.

Laryngopharyngeal abnormalities in hospitalized patients with dysphagia.

OBJECTIVES: To determine the prevalence of laryngopharyngeal (LP) abnormalities in hospitalized patients with dysphagia referred for flexible endoscopic evaluation of swallowing (FEES). STUDY DESIGN: Retrospective, blinded review by two otolaryngologists of 100 consecutive FEES studies performed and video-recorded by a speech-language pathologist (SLP). METHODS: Two otolaryngologists reviewed videos of 100 consecutive FEES studies on hospitalized patients with dysphagia for the presence of abnormal LP findings. RESULTS: Sixty-one male and 38 female patients comprised the hospital dysphagia cohort. The mean age was 62. One subject could not be evaluated because of the severity of the retained secretions, leaving 99 subjects in the cohort. Seventy-six percent had been previously intubated, with a mean intubation duration of 13 days. The overall prevalence of abnormal LP findings was 79%. Forty-five percent of the patients presented with two or more findings, which included arytenoid edema (33%), granuloma (31%), vocal fold paresis (24%), mucosal lesions (17%), vocal fold bowing (14%), diffuse edema (11%), airway stenosis (3%), and ulcer (6%). There was a significant difference in LP findings between those individuals who had or had not been intubated. CONCLUSIONS: Hospitalized patients with dysphagia are at high risk for LP abnormalities, particularly if they have been intubated, and may benefit from either 1) an initial joint examination by the SLP and otolaryngologist or 2) an otolaryngologist's review of the recorded examination conducted by the SLP. Such otolaryngology involvement could identify airway stenosis patients at an earlier stage, initiate granuloma treatment sooner, enable earlier biopsy of unexpected lesions, and allow follow-up of mucosal and neuromuscular findings that do not respond to medical management.

Videostroboscopic characteristics of young adult female smokers vs. nonsmokers.

OBJECTIVES: The purpose of this study was to provide a foundation of information concerning the early effects of smoking on the laryngeal structures and phonatory physiology of young adult women using videostroboscopy. STUDY DESIGN: Cross-sectional, observational. METHODS: Subjects were 34 female nonsmokers and 30 female smokers (Total N=64) between the ages of 18 and 30 years of age. For the purposes of this study, a smoker was defined as any subject who, at the time of this study, had smoked at least two cigarettes per day for at least 1 year. All subjects in the nonsmoker category were those who, at the time of this study, did not smoke and who had not smoked for at least 5 years before the study. Videostroboscopic evaluations were rated by experienced judges on various parameters describing the structure and function of the laryngeal mechanism during comfortable pitch and loudness phonations. RESULTS: Results showed significant relationships between smoking and the increased presence of edema, erythema, and abnormal laryngeal color. In addition, smokers were observed to have significantly more occurrences of abnormal phase symmetry and increased glottal gap size during the closed phase of phonation. Glottal gap size was significantly correlated with the number of cigarettes smoked in the lifetime. CONCLUSIONS: The findings of increased erythema and edema in this study are consistent with previous descriptions of the effects of smoking on laryngeal structures, whereas our observations regarding glottal gap size and phase symmetry are unique contributions derived from the stroboscopic method. The results of this study indicate that observable signs of laryngeal irritation and disturbed phonatory physiology occur even in young adults with relatively brief smoking habits.

Anaphylactoid reactions to Dextran 40 and 70: reports to the United States Food and Drug Administration, 1969 to 2004.

BACKGROUND: Clinical dextrans, such as Dextran 40 and Dextran 70, are associated with anaphylactoid reactions caused by dextran-reactive immunoglobulin G antibodies. When infused immediately before clinical dextrans, dextran 1 significantly reduces the incidence of severe anaphylactoid reactions. The objective of the study was to describe the frequency and characteristics of reports submitted to the United States Food and Drug Administration (FDA) for anaphylaxis or anaphylactoid events after clinical dextran administration. METHODS: We searched the FDA's Adverse Event Reporting System for reports associated with a clinical dextran and describing anaphylaxis/anaphylactoid reactions. Our case definition for a probable anaphylaxis/anaphylactoid event required signs or symptoms from at least two body systems, with at least one sign or symptom being hypotension, vasodilation, or respiratory difficulty, and onset within 60 minutes. Other reports were considered possible cases if the reporter specifically described the reaction as anaphylaxis or an anaphylactoid reaction. Premier RxMarket Advisor provided estimates of total US hospitalizations with clinical dextran or dextran 1 administration from 2000 to 2004, based on discharge billing data from a sample of US hospitals. The IMS National Sales Perspective provided estimates of total doses of dextrans sold in the United States from 1999 to 2004, based on volumes of dextrans sold in a sample of retail and nonretail outlets. RESULTS: The FDA received 366 clinical dextran adverse event reports from 1969 to 2004, of which 90 (24.6%) were anaphylaxis/anaphylactoid events. The ratio of hospitalizations where clinical dextran was administered to hospitalizations where dextran 1 was administered was 28.4:1. The expected ratio would be 1:1 if all clinical dextran patients had received dextran 1 pretreatment. The ratio of clinical dextran doses sold to dextran 1 doses sold in the United States was 38.6:1. CONCLUSIONS: A high proportion of adverse event reports for clinical dextrans described anaphylaxis or anaphylactoid reactions. Hospital discharge and product sales data suggest that dextran 1 has not been used consistently before clinical dextran administration in recent years. To reduce the risk of anaphylactoid reactions, physicians should consider routine administration of dextran 1 before the infusion of a clinical dextran.