[Assessment of the clinical efficacy and safety of epinastine plus pseudoephedrine vs loratadine plus pseudoephedrine in perennial allergic rhinitis].
BACKGROUND
Several drugs for the treatment of perennial allergic rhinitis and its symptoms have been investigated since some years ago. These drugs are: steroidal-type immunoregulators, immunotherapy and antihistamines. Because of first generation of the last ones originated several side effects, pharmacological research was oriented to the search of formulas with the same of higher efficacy, but with fewer effects on central nervous system.


OBJECTIVE
To compare the efficacy and safety of epinastine 10 mg plus pseudoephedrine 120 mg vs loratadine 5 mg plus pseudoephedrine 120 mg, twice a day, in the treatment of perennial allergic rhinitis.


METHODS
A comparative, random, open, prospective, longitudinal and multicenter study was made in 62 patients with an average age of 26.17 +/- 9.75 years (13-56 years) with diagnosis of perennial allergic rhinitis, who attended to external consultation of the different departments of allergy of the participant institutions. All patients were submitted to: complete clinical history, physical exploration, measurement of vital signs, nasal exploration, qualification of allergic symptoms and record of daily symptoms. Moreover, washout during a week and pharmacological treatment was given during two weeks. Symptoms referred by patient and findings of physical exploration during the different visits, as well as rhinoscopic findings, were assessed by a scale of five parameters of rhinitis. Tolerance grade of drugs was assessed based on frequency and severity of side effects.


RESULTS
According to the basal clinical assessment symptoms qualification of patients of groups of epinastine and loratadine was of 9.12 +/- 2.78 and 7.90 +/- 2.7, respectively. Seven side effects appeared: three cases of somnolence, one of sickness and one of anxiety in patients of group of loratadine and one case of somnolence and one of dysmenorrhea in the subjects of group of epinestine. Although it did not have statistically significant difference, it is clinically important for patients. Frequency of side effects was higher in the loratadine group.


CONCLUSIONS
Both drugs are efficient for the treatment of perennial allergic rhinitis.
Hernández Colín
Dante
D
Hospital Civil Juan I Menchaca, Guadalajara, Jal, México.
González Díaz
Sandra Nora
SN
Rodríguez Medina
Ricardo
R
Aguilar Angeles
Daniel
D
González Gámez
Jaime
J
Becerril Angeles
Martin
M
Orea Solano
Modesto
M
Domínguez Henkel
Rafael
R
Segovia Ayala
Carlos
C
D000293:Adolescent; D000328:Adult; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001007:Anxiety / Q000139:chemically induced; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D003984:Dibenzazepines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004412:Dysmenorrhea / Q000139:chemically induced; D004809:Ephedrine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006634:Histamine H1 Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017336:Loratadine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*; D012449:Safety; D012882:Skin Tests; D016896:Treatment Outcome
D018926:Anti-Allergic Agents; D001993:Bronchodilator Agents; D003984:Dibenzazepines; D006634:Histamine H1 Antagonists; D007093:Imidazoles; D017336:Loratadine; D004809:Ephedrine; C053090:epinastine