OBJECTIVE: To investigate the efficacy and safety of Mizolastine in the treatment of perennial allergic rhinitis. METHOD: Multicentric random Double-blind parallel-controlled study was adopted, and compared with placebo and Cetirizine. Patients (n = 177) were grouped, seventy-two in Mizolastine group, sixty-nine in Cetirizine and thirty-six in placebo group. RESULT: In the seventh curative day symptomatic and sign marks in Mizolastine group and Cetirizine group were lower, but the mark in Mizolastine group reduced more than in Cetirizine group and placebo group. Mizolastine group is better than Cetirizine group in improvement of nasal obstruction and itching with Visual analogue scale. In the twenty first curative day reduction of symptomatic and sign marks in Mizolastine group was lower than Cetirizine group, but no statistic difference. There were 27 adverse events, no serious adverse events in 177 patients during experimental period. Most adverse events were headache and dryness in mouth and eyes. There were 10 cases adverse events in Mizolastine group, one case was related with experiment and four cases might be related with experiment. There were 14 cases adverse events in Cetirizine group, one case was related with experiment and four cases might be related with experiment. There were three cases adverse events in placebo group. CONCLUSION Generally speaking the efficacy of Mizolastine in treatment of perennial allergic rhinitis is better than Cetirizine, Bad events are less. It is safe.
Adolescent ; Adult ; Aged ; Benzimidazoles ; adverse effects ; therapeutic use ; Cetirizine ; therapeutic use ; Child ; Double-Blind Method ; Female ; Histamine H1 Antagonists, Non-Sedating ; adverse effects ; therapeutic use ; Humans ; Male ; Middle Aged ; Rhinitis, Allergic, Perennial ; drug therapy ; Treatment Outcome ; Young Adult

Levocetirizine is a second-generation nonsedative antihistaminic agent that has been demonstrated to be safe and effective for treating allergic disease. There was only one case report of levocetirizine-induced liver toxicity, but a liver biopsy was not performed. In this article, we present the first case of levocetirizine-induced liver injury with histologic findings. A 48-year-old man was hospitalized with jaundice and generalized pruritus that had developed after 2 months of therapy with levocetirizine for prurigo nodularis. Laboratory findings revealed acute hepatitis with cholestasis. A liver biopsy demonstrated portal inflammation and hepatitis with apoptotic hepatocytes. The patient fully recovered 3 weeks after withdrawing levocetirizine. Although levocetirizine is safe and effective, physicians should be aware of its potential hepatotoxicity.
Cetirizine/*adverse effects/therapeutic use ; Chemical and Drug Induced Liver Injury/*diagnosis/pathology ; Histamine H1 Antagonists, Non-Sedating/*adverse effects/therapeutic use ; Humans ; Hypersensitivity/drug therapy ; Jaundice/etiology ; Liver/pathology ; Male ; Middle Aged ; Pruritus/etiology

OBJECTIVE: To evaluate cardiovascular safety of loratadine, a second generation H1-antagonist, in treatment of patients with allergic rhinitis. METHOD: A total of 50 patients with persistent allergic rhinitis were enrolled, of which 19 cases (38.0%) had a history of cardiovascular diseases and/or presented abnormal electrocardiogram (ECG) findings without prolonged QT-interval. For all patents, 10 mg loratadine tablet was oral administrated once-daily for 30 days. ECG examinations were carried out both before and after treatment. Cardiovascular effects of loratadine were determined by the comparison of two ECGs. RESULT: All patients had no alterations in sinus rhythm after administration of loratadine for 30 days. There were no significant differences of heart rates, P durations, PR or QRS intervals between the baseline and end-point ECGs (P > 0.05), as well as no significant prolongation of the QT or QTc corrected for heart rate using Bazett' formula (P > 0.05). CONCLUSION Cardiovascular safety of loratadine, a second generation H1-antagonist, is confirmed in long-term treatment of persistent allergic rhinitis at a recommended dose.
Administration, Oral ; Adult ; Aged ; Aged, 80 and over ; Female ; Heart Rate ; Histamine H1 Antagonists, Non-Sedating ; administration & dosage ; adverse effects ; therapeutic use ; Humans ; Loratadine ; administration & dosage ; adverse effects ; therapeutic use ; Male ; Middle Aged ; Rhinitis, Allergic, Seasonal ; drug therapy ; physiopathology ; Young Adult