A phase III, randomized, double-blind, placebo-controlled study of peldesine (BCX-34) cream as topical therapy for cutaneous T-cell lymphoma.

BACKGROUND: The purine nucleoside phosphorylase inhibitor peldesine is a new agent being evaluated as a T-cell inhibitor. OBJECTIVE: We attempted to determine the efficacy of peldesine (BCX-34) in a 1% dermal cream formulation as a treatment for cutaneous T-cell lymphoma (CTCL). METHODS: Ninety patients with patch and plaque phase CTCL, histologically confirmed by a referee dermatopathologist, were enrolled in a randomized, double-blind, placebo-controlled study. BCX-34 dermal cream 1% or the vehicle cream (as a placebo control) was applied twice daily to the entire skin surface for up to 24 weeks. Efficacy of the topical therapy was assessed in terms of complete or partial (> or = 50%) clearing of patches and plaques. RESULTS: Of the 89 patients able to be examined, 43 received BCX-34 and 46 received the placebo vehicle cream. One patient withdrew early and was not analyzed. The two groups were well balanced for potential prognostic factors. A total of 28% (12/43) of the patients treated with BCX-34 showed a response, but 24% (11/46) of patients who received vehicle also responded (P =.677). CONCLUSION: Although BCX-34 dermal cream 1% was not significantly better than the control as therapy for patch and plaque-phase CTCL, this appears to be the first published placebo-controlled trial evaluating treatment for CTCL. Whether the vehicle cream has more than a placebo therapeutic effect is unclear. The relatively high (24%) placebo response rate should be kept in mind in assessing other treatments for early-stage CTCL.

Cutaneous protothecosis in association with the acquired immunodeficiency syndrome.

We report a case of protothecosis that occurred in the skin over the left tibial region of a 25-year-old man with the acquired immunodeficiency syndrome (AIDS). The lesion was noticed a few months after he swam in a lake in south Alabama. Biopsy and culture revealed Prototheca wickerhamii. We believe this is only the second reported case of cutaneous protothecosis in association with AIDS.

Symptomatic pleural collection of cerebrospinal fluid caused by a ventriculopleural shunt.

We report a case of symptomatic pleural collection of cerebrospinal fluid caused by a ventriculopleural shunt in a 4-year-old child. Since ventriculopleural shunts are not commonly used in the management of hydrocephalus, primary physicians must be aware of this potential complication.

Graphic analysis for the study of metabolic states.

Graphic analyses have been used in the study of physiology as a means to better understand dynamic processes and to visualize the mechanisms of their interactions. A graphic analysis of glucose homeostasis was constructed by considering the main factors that influence glucose dynamics. The analysis is achieved by equating curves representing both the inflow and outflow of glucose from the circulation as dependent upon the serum insulin concentration. The point where these two curves intersect is the steady-state balance for blood glucose exchange and is termed the equilibrium point. With the use of this graphic depiction of glucose homeostasis, it is now possible to study the influence of multiple factors on glucose dynamics. A variety of metabolic states can also be analyzed by reconstructing the effects of the pathophysiology on the form and shape of the curves. Some of the metabolic states that have been analyzed by this technique include starvation, exercise, obesity, type I and type II diabetes mellitus, stress, hypopituitarism, hyperpituitarism, and hyperthyroidism. Although the analyses do not reflect all of the controversial nuances of the field, they do provide a means for a general approach to the study of glucose homeostasis and serve as a methodology that can be extrapolated to many areas of physiological study.

Phenytoin hypersensitivity syndrome.

The purpose of the current manuscript is to familiarize the primary physician with the presentation of phenytoin hypersensitivity syndrome, and to discuss management options. A review of all admissions to the University of Mississippi Medical Center over a five year period revealed 4 cases of phenytoin hypersensitivity syndrome. These cases are presented and the phenytoin hypersensitivity syndrome, characterized most commonly by fever, cutaneous eruption and lymphadenopathy, is described. It is emphasized that the clinician must be aware of the syndrome and must recognize it on presentation. Theories regarding etiology and treatment options are discussed. It is recommended that all patients with symptoms of phenytoin hypersensitivity syndrome be hospitalized and that steroids be initiated.

Sickle cell vaso-occlusive pain crisis in adults: alternative strategies for management in the emergency department.

The gene for sickle cell disease is carried by 8% of the African-American population in the United States. The primary care physician is often called upon to recognize and treat one of the major sequelae of sickle cell disease--vaso-occlusive pain crisis. An injectable nonsteroidal anti-inflammatory drug has recently become available and may offer some improvement in outcome of vaso-occlusive pain crises. We present five case reports reviewing various current therapeutic options, including newer pharmacologic agents, and comment on alternatives to impatient management of pain crises. The use of the emergency department short-term observation unit as an alternative to hospitalization is discussed.

Emergency department analgesia without narcotics for adults with acute sickle cell pain crisis: case reports and review of crisis management.

Vaso-occlusive crises are one of the most debilitating features of sickle cell disease. There appears to be no standardization of care for adults with pain crisis, and some commonly utilized regimens, such as those employing intramuscular meperidine, are pharmacologically unsound. Parenteral narcotic use may be associated with respiratory compromise acutely and with dependence over the long term, but nonopioid preparations are often unsatisfactory in relieving pain. We have recently enjoyed success with a combination of a parenteral nonsteroidal anti-inflammatory medication and an oral tricyclic antidepressant. We report four representative cases and review the salient points of the management of pain crisis in adult patients in the emergency department.

Clinical and histologic features of primary oxalosis.

Primary oxalosis should be considered in patients with multisystem disease of the kidneys, heart, peripheral vasculature, and skin. Crystalline deposits can lead to nephrolithiasis with kidney failure, complete heart block, peripheral vasospasm, and livedo reticularis, as in our patient. Crystals were first observed in the myocardial biopsy specimen and then identified as calcium oxalate in skin from an area of livedo reticularis.