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Preventing Fungal Infections in Patients with Stem-Cell Transplants FREE

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The summary below is from the full report titled “Intravenous and Oral Itraconazole versus Intravenous and Oral Fluconazole for Long-Term Antifungal Prophylaxis in Allogeneic Hematopoietic Stem-Cell Transplant Recipients. A Multicenter, Randomized Trial.” It is in the 6 May 2003 issue of Annals of Internal Medicine (volume 138, pages 705-713). The authors are D.J. Winston, R.T. Maziarz, P.H. Chandrasekar, H.M. Lazarus, M. Goldman, J.L. Blumer, G.J. Leitz, and M.C. Territo.

Ann Intern Med. 2003;138(9):I-37. doi:10.7326/0003-4819-138-9-200305060-00002
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What is the problem and what is known about it so far?

Stem cells are immature blood cells that mature into red blood cells, white blood cells, and platelets. The mature cells carry oxygen to tissues, defend against infection, and prevent bleeding. Life-threatening problems result if patients don't produce stem cells or if powerful cancer treatments or immune body processes destroy stem cells. In either instance, doctors can replace stem cells and restore the body's ability to produce the blood cells that the patient needs. One method that doctors may use is allogeneic stem-cell transplantation (ASCT), in which patients receive healthy stem cells from an outside donor.

Patients who have had ASCT usually have reduced immunity and problems fighting infections. In particular, they have high risks for serious (invasive) fungal infections. Doctors usually give patients who have had ASCT drugs for several months to try to prevent fungal infections. Some of the drugs have bad side effects, and infections are sometimes resistant to particular drugs. Which drug is the most effective and the least toxic is not clear.

Why did the researchers do this particular study?

To find out which of two antifungal drugs (itraconazole and fluconazole) more effectively prevents fungal infections in patients who have had ASCT.

Who was studied?

140 patients who had ASCT from 5 transplantation centers.

How was the study done?

The researchers randomly assigned patients to receive either itraconazole or fluconazole. Drugs were started the day after ASCT. They were given through a vein for 2 weeks and then by mouth for 3 months. The researchers followed patients closely for 180 days after transplantation to assess side effects and any fungal infections. Then, they compared the numbers and the types of fungal infections and side effects in the two groups.

What did the researchers find?

Invasive fungal infections occurred in 9% of patients given itraconazole and in 25% of patients given fluconazole. Laboratory cultures revealed that fungal organisms were more often resistant to fluconazole than to itraconazole. Nausea, vomiting, diarrhea, and abdominal pain were more common with itraconazole.

What were the limitations of the study?

The doctors and the patients knew which drug the patients were taking. The study compared only two antifungal drugs. Other antifungal drugs need to be studied.

What are the implications of the study?

Itraconazole is better than fluconazole for preventing invasive fungal infections in ASCT recipients but causes more gastrointestinal side effects.





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