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Nancy Fitzgerald

Publications and source records attributed to Nancy Fitzgerald.

5 recordsLinked to original sources

The pharmacokinetics of nebulized nanocrystal budesonide suspension in healthy volunteers.

Nanocrystal budesonide (nanobudesonide) is a suspension for nebulization in patients with steroid-responsive pulmonary diseases such as asthma. The pharmacokinetics and safety of the product were compared to those of Pulmicort Respules. Sixteen healthy volunteers were administered nanobudesonide 0.5 and 1.0 mg, Pulmicort Respules 0.5 mg, and placebo in a four-way, randomized crossover design. All nebulized formulations were well tolerated, with no evidence of bronchospasm. Nebulization times were significantly shorter for nanobudesonide compared to Pulmicort Respules. Because of a low oral bioavailability, plasma concentration of budesonide is a good marker of lung-delivered dose. The pharmacokinetics of nanobudesonide 0.5 and 1.0 mg were approximately dose proportional with respect to Cmax, AUC(0-t), and AUC(0-infinity). Nanobudesonide 0.5 mg and Pulmicort Respules 0.5 mg exhibited similar AUCs, suggesting a similar extent of pulmonary absorption. A higher Cmax was noted with nanobudesonide 0.5 mg, and the tmax was significantly different, suggesting a more rapid rate of drug delivery of nanobudesonide 0.5 mg than Pulmicort Respules. In conclusion, nebulized nanobudesonide 0.5 mg was safe in healthy volunteers, with a similar extent of absorption as Pulmicort Respules.

Adult↗

Hemophagocytic lymphohistiocytosis masquerading as child abuse: presentation of three cases and review of central nervous system findings in hemophagocytic lymphohistiocytosis.

Hemophagocytic lymphohistiocytosis (HLH) is a rare disease resulting from abnormal proliferation of histiocytes in tissues and organs. Although the disease generally presents with systemic symptoms such as pancytopenia, coagulopathy, and organomegaly, HLH may also present with central nervous system (CNS) manifestations. CNS events can range from irritability to encephalopathy and coma. Retinal and intracranial hemorrhages are among the neuropathologic findings in these children. Patients who present with CNS findings may have symptoms that mimic those of inflicted injury. These children are at risk, therefore, for misdiagnosis as victims of child abuse. Such an error causes not only unnecessary additional trauma to the family but also, more important, a delay in initiating effective therapy. We present 3 cases of children with HLH who initially came to medical attention with neurologic findings, all suspected to be victims of child abuse. Subsequent laboratory evaluations, however, were consistent with the diagnosis of HLH. No additional evidence of child abuse was obtained, and the charges eventually were dropped. Two of the 3 children died from their disease shortly after presentation; the third is surviving with no evidence of HLH several months after allogeneic bone marrow transplantation. Although the diagnosis of child abuse certainly is all too common, clinicians need to be diligent and informed to avoid assigning this label erroneously. Several laboratory findings of HLH may alert physicians to the possibility of this diagnosis. The timely diagnosis of and institution of therapy for HLH may reduce ultimate morbidity and mortality.

Bone Marrow Transplantation↗