[Evaluation of the efficacy and safety of mepifylline in oral solution in children with mild and moderate asthmatic crises].
Efficacy and safety of mepiphylline, a derivative of theophylline, was evaluated in a group of children, aged 6 to 10 years, with mild or moderate acute asthma. A parallel, randomized, double-blind, placebo controlled, prospective study was performed in 40 children. Twenty one of them received mepiphylline in dose of 8 mg/kg/día divided in 3 during 10 days, and 19 (control group) received placebo. Salbutamol aerosols were available in both groups. Clinical and spirometric data were collected before the beginning of the treatment (pre-and-post-nebulized salbutamol), and at the 3rd, 7th and 10th days. Children and parents cooperated with a diary of symptoms, peak-flow measurements and account of salbutamol used. A total relief of symptoms was found in 14 patients in the mepiphylline group and just 8 of the control group, with no significant differences. Neither spirometry nor diary data showed significant differences. Salbutamol was less than 3 days of unnecessary in 13 patients (61.9%) in the mepiphylline group and 8 patients (42.1%) in the control group (p < 0.05; Kolmogorov-Smirnov two samples Test). We conclude that mepiphylline could be a complementary treatment of mild and moderate acute asthma with a good safety in children.
Sienra Monge
J J
JJ
Departamento de Neurología y Alergia, Hospital Infantil de México, Federico Gómez, México D.F.
Prieto Ursúa
L
L
Gerardo Sol Monterrey
E
E
Estela del Río Navarro
B
B
Paredes Novelo
M C
MC
D000284:Administration, Oral; D000420:Albuterol / Q000008:administration & dosage; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011738:Pyrilamine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D012129:Respiratory Function Tests; D012449:Safety; D013806:Theophylline / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
C088248:mepifiline; D013806:Theophylline; D011738:Pyrilamine; D000420:Albuterol
Valoración de la eficacia y seguridad de la mepifilina en solución oral en niños con crisis de asma leve a moderada.