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| ABSTRACT |
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Nitazoxanide is a new 5-nitrothiazole derivative with broad spectrum anthelminthic and antiprotozoan activity.1 It has been shown to be effective against infections with Ascaris lumbricoides, Trichuris trichiura, Taenia saginata, Hymenolepis nana, and Fasciola hepatica, as well as infections with common protozoa such as Cryptosporidium parvum, Blastocystis hominis, Entamoeba histolytica, Giardia lamblia, and Isospora belli.24 This drug is also well tolerated, with only minor clinical side effects such as abdominal pain (4% of patients) being observed.5,6
The purpose of the present study was to evaluate the efficacy and the tolerance of nitazoxanide in children as a single broad spectrum antiparasitic agent in the treatment of mixed parasite infections with both intestinal protozoa and helminths. Our study was conducted to determine the prevalence and nature of intestinal parasitic infections in children from Coacalco de Berriozabal (population = 240,000), which is located northeast of Mexico City.
Two hundred seventy-two children (age range = 214 years) from 85 families participated in the study. Stool samples were collected from March 1997 to January 1998. Cases were defined as boys and girls with stool samples positive for pathogen parasites by direct smear, Ferreira concentration (1:10), and cold acid-fast Kinyoun staining methods.79 A physical examination was performed and medication was administered at the Family Medical Unit 91 in Estado de Mexico by a general physician under the supervision of the principal investigator and the parents of the children. Ten days after the treatment was concluded, children with parasitic infections were questioned and a stool sample was collected from each child on three consecutive days for parasitologic examination. One hundred eighty-four (68%) of the cases were between 6 and 12 years old. The case population had a greater proportion of boys (54%).
One hundred twenty-one (44%) children tested positive for protozoa such as Giardia lamblia (18%), Entamoeba histolytica/E. dispar (10%), Blastocystis hominis (7%), Cryptosporidium parvum (4%), and Cyclospora cayetanensis (3%), and helminths such as Hymenolepis nana (10%), Trichuris trichiura (6%), and Ascaris lumbricoides (6%). There were also two cases of infection with Enterobius vermicularis. Of the 121 parasite-positive patients, 84 (69%) had a single parasitic infection, 37 (31%) had mixed infections involving two or more parasites (Table 1
), and one had infections with eight different organisms.
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The efficacy rate following treatment with nitazoxanide was determined as the percentage of children with three fecal samples negative by the three methods used (87.6%, 106 of 121). This criterion is used for all intestinal parasites in pediatric hospitals in Mexico.
Nitazoxanide was highly effective against either single or mixed infections with C. parvum, T. trichiura, and A. lumbricoides (Table 2
). In 28 patients infected with H. nana, cures rates of 84% were observed following three treatments.
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An evaluation of the intensity of helminth infections based on egg counts showed that most of the cases were light infections. Only three of 16 cases of A. lumbricoides and five of 28 cases of infection with H. nana were moderate infections. All cases of infection with T. trichiura and A. lumbricoides showed the presence of eggs after treatment. Cases of infection with H. nana that were not cured after treatment were considered moderate infections; however, eggs counts were significantly reduced.
Despite resistance to nitazoxanide that has been observed in some organisms (e.g., G. lamblia and C. cayetanensis), this drug appears to show good efficacy in the treatment of intestinal parasitic infections, with little variation in parasite sensitivity. Thus, it could be used during massive chemotherapy campaigns. These results are consistent with those previously reported, and both show that nitazoxanide is highly effective and well tolerated (only 3% of the patients reported minor clinical side effects) in treating infections with helminths and protozoa.
Received March 15, 2002. Accepted for publication November 18, 2002.
Acknowledgments: We thank R. Miranda and A. Romero for critical review of the manuscript; Laboratorios Columbia S.A. de C.V., México, for providing the nitazoxanide; T. Aguirre for invaluable assistance in the field; and A. Gámez, the late G. Hernández, and A. Morales for their outstanding technical assistance.
Authors addresses: Elvia Díaz, Unidad de Medicina Familiar 91, Instituto Mexicano del Seguro Social, Av. López Portillo s/n, Coacalco de Berriozabal, CP 55700 Estado de México, México. Jaime Mondragón, Departamento de Ciencias Químicas, Facultad de Estudios Superiores Cuautitlán, Universidad Nacional Autónoma de México, Campo 1, Av. 1° de Mayo s/n, Cuautitlán Izcalli, CP 54740 Estado de México, México. Enrique Ramírez and Rosamaria Bernal, Laboratorio de Parasitología y Micología, Hospital Infantil de México Federico Gómez, Secretaría de Salubridad y Asistencia, Dr. Márquez 162, Col. Doctores CP 06720 México, DF, México.
Reprint requests: Rosamaría Bernal, Laboratorio de Parasitología y Micología, Hospital Infantil de México Federico Gómez, Secretaría de Salubridad y Asistencia, Dr. Márquez 162, Col. Doctores CP 06720 México, DF México. E-mail: rbernal{at}bolivar.usb.mx
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