A multicenter, randomized, double-blind, placebo-controlled trial of high-dose intravenous immunoglobulin for oral corticosteroid-dependent asthma.

To determine the efficacy of high doses of intravenous gammaglobulin (IVIG) for the treatment of severe, steroid-dependent asthma in patients between 6 and 68 years of age, a randomized, double-blind, placebo-controlled multicenter clinical trial was conducted in private and university hospitals in the United States. Patients were randomized to one of three treatment arms: 2 g IVIG/kg/month (16 patients); 1 g IVIG/kg/month (9 patients); or 2 g iv albumin (placebo)/kg/month (15 patients). The treatment consisted of seven monthly infusions followed by a posttreatment observation period. The primary outcome measurement was mean daily prednisone-equivalent dose requirements, determined during the observation month preceding initiation of treatment and compared to the month preceding the seventh infusion. Secondary clinical endpoints measured were pulmonary function, frequency of emergency room visits or hospitalizations, and number of days absent from school or work. When adjusted for body weight, the mean dose requirements fell by 33, 39, and 33% in the placebo, IVIG (1 g/kg), and IVIG (2 g/kg) treatment arms, respectively. The differences between therapies were not statistically different (P = 0.9728). The mean percentage-of-predicted FEV1 fell in all three treatment groups during the treatment period but there was no significant difference between treatment groups (P = 0.8291). There was also no significant difference in the percentage of subjects requiring emergency room visits or hospitalizations or missing days of work/school, among the three treatment groups. The trial was terminated prematurely after interim analysis determined the adverse experience rate was different between the three groups. Three patients, all randomized to the 2-g/kg IVIG dose group, were hospitalized with symptoms consistent with aseptic meningitis. In summary, in this randomized, double-blind, placebo-controlled multicenter study, high doses of IVIG did not demonstrate a clinically or statistically significant advantage over placebo (albumin) infusions for the treatment of corticosteroid-dependent asthma. Subgroup analysis failed to identify markers predicting responsiveness. High-dose IVIG can also be associated with a significant incidence of serious adverse events.

Personal assistance for people with physical disabilities: consumer-direction and satisfaction with services.

OBJECTIVE: To determine whether people who receive consumer-directed personal assistance services (PAS) are more satisfied with the services they receive than those receiving PAS that are not consumer-directed. DESIGN: A quasi-experimental survey comparison of long-term outcomes among people receiving consumer-directed PAS in Virginia and persons on the waiting list to receive those services. Surveys were conducted by mail and telephone. SETTING: The general community in Virginia. PARTICIPANTS: Ninety-two Virginia residents with physical disabilities living in the community. Sixty individuals were receiving consumer-directed PAS, and 32 were on the waiting list for consumer-directed PAS and were receiving paid personal assistance that was not consumer-directed. MAIN OUTCOMES MEASURES: The Personal Assistance Satisfaction Index (PASI); chi2 and t tests were conducted. RESULTS: People receiving consumer-directed PAS scored significantly higher on the PASI than the waiting-list control group and were consistently more likely to report high levels of satisfaction on the majority of individual PASI items. CONCLUSION: Consumer-directed PAS are associated with high levels of satisfaction relative to PAS that are not consumer-directed. Individual PASI items related to control over PAS and flexibility of services showed the greatest differences in satisfaction.

Hypogammaglobulinemia and anemia 18 years after thymoma resection.

Immunodeficiency with a thymoma (Good's syndrome) is a rare condition occurring in 7% to 13% of patients with adult-onset hypogammaglobulinemia. In 80% of cases, hypogammaglobulinemia is detected within 5 years of the identification of the thymoma. A 70-year-old man was found to have hypogammaglobulinemia 18 years after a thymoma had been resected. Cellular immunophenotyping revealed there were no detectable B cells, decreased CD4+ cells, and increased CD8+ cells. Both CD4+ and CD8+ subsets expressed increased populations of CD38+ DR+ cells and CD45RO+ cells. The CD8+ CD28+ population was markedly reduced. Inducible cytokine production by the patient's peripheral blood mononuclear cells revealed decreased IL-2, IL-10, and interferon-gamma production. These data suggest that patients with Good's syndrome have activated memory T cells that have dysregulated cytokine production.

Cough productive of casts.

Plastic bronchitis is a rare disorder characterized by the formation and, sometimes dramatic expectoration of long, branching bronchial casts. DIsorders associated with bronchial casts either produce an increase in the volume or viscosity of secretions, such as allergic bronchopulmonary aspergillosis, asthma, cystic fibrosis, pneumonia, and chronic bronchitis; or there are obstructions or structural abnormalities that decrease mucous clearance, such as bronchiectasis. The diagnostic evaluation should include serum laboratory studies, specimen cultures, skin tests, chest radiograph and CT scan, pulmonary function tests, and bronchoscopy. Therapy should be directed towards the underlying disorder and should also include maneuvers to facilitate removal of casts to prevent complications, such as secondary pneumonia.

Onset of action of aqueous beclomethasone dipropionate nasal spray in seasonal allergic rhinitis.

Beclomethasone dipropionate nasal spray is widely used in the treatment of seasonal allergic rhinitis; however, the time of onset of action has not been determined. This study assessed the onset of action, level of relief, and efficacy of beclomethasone nasal spray in patients with seasonal allergic rhinitis. In a double-blind, randomized, placebo-controlled, parallel-group, multicenter, 7-day study, symptomatic patients were administered two inhalations of beclomethasone dipropionate (n = 80) or placebo (n = 81) into each nostril twice daily. Patients assessed the onset of action and level of relief at 6, 24, and 48 hours and at days 3 and 7. Investigators evaluated symptoms at days 0, 3, and 7 and response to therapy at days 3 and 7. The difference in the cumulative number of patients reporting relief of symptoms was statistically significant in favor of beclomethasone dipropionate by hour 24 (P = 0.05). Patients in the beclomethasone dipropionate group experienced a greater level of relief than patients receiving placebo at hour 24, and improvement increased over the 7-day study compared with a decrease in relief in the placebo group. Beclomethasone dipropionate was significantly more effective than placebo in reducing symptoms (P < or = 0.02), and patients in the beclomethasone dipropionate group showed a more favorable response to treatment than did patients in the placebo group (P < 0.01). Adverse events were minor in both groups. Beclomethasone dipropionate nasal spray produced significant onset of relief of symptoms the first day of treatment; improvement was sustained and increased over the course of the study.

Refractory thrombocytopenia in a patient with systemic lupus erythematosus and prior immune thrombocytopenia, not responsive to an accessory splenectomy.

We report a patient with systemic lupus erythematosus (SLE) that was preceded by immune thrombocytopenia (ITP). She subsequently developed refractory thrombocytopenia. An accessory spleen was found and removed, however, she continued to have severe thrombocytopenia.

Sarcoidosis: unusual cause of a rectal mass.

We have reported the case of a patient who had a rectal mass 3 years after the diagnosis of sarcoidosis. A malignancy was suspected, but biopsy of the rectal mass showed epithelioid granulomas with giant cells, consistent with sarcoidosis. Therefore, sarcoidosis should be considered as a rare cause of a rectal mass.

Repeated inhalation of nebulized albuterol did not induce arrhythmias in a patient with Wolff-Parkinson-White syndrome and asthma.

It has been assumed that in asthmatic patients with Wolff-Parkinson-White (WPW) syndrome, ablative therapy for the condition is necessary for the safe treatment of the asthma with beta 2-adrenergic drugs. The following case report illustrates that inhaled albuterol was safely administered to an asthmatic patient with electrocardiographic evidence of preexcitation, without the need of an ablative procedure. This case report is, to our knowledge, the first in the literature in which the cardiac rhythm of a patient with WPW syndrome was monitored during repeated inhalations of a beta 2-agonist.

Sensitivity to non-acetylated salicylates in a patient with asthma, nasal polyps, and rheumatoid arthritis.

A woman experienced exacerbations of bronchial asthma after taking aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) for rheumatoid arthritis. On oral challenges, she developed an urticarial reaction after tartrazine; urticarial and bronchospastic reactions after salicylsalicylic acid; and urticarial and bronchospastic reactions after choline magnesium trisalicylate. Non-acetylated salicylates have been recommended for use in aspirin- and/or tartrazine-sensitive patients. The results of sensitivity studies of our patient indicates that such patients may also be sensitive to non-acetylated salicylates.