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Hydrochloride Fexofenadine Tablets In Clinical Trials Research

Posted on:2011-11-22Degree:MasterType:Thesis
Country:ChinaCandidate:Y P DuFull Text:PDF
GTID:2204330332468923Subject:Pharmaceutical Engineering
Abstract/Summary:PDF Full Text Request
Fexofenadine hydrochloride tablets is the third generation of non-sedating antihistamines, in foreign countries have wide clinical application. The size of products in the domestic chemical industry to conduct pre-production, you must first clinical trials using this paper cetirizine hydrochloride tablets as the control drug, an objective assessment of fexofenadine hydrochloride tablets in the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria clinical efficacy and safety assessment methods used are as follows:(1) Fexofenadine hydrochloride tablets in treatment of urticaria cases were 124 patients enrolled,62 patients in trial group,62 patients in control group, experimental group was treated with fexofenadine hydrochloride tablets every day, the afternoon 1,11 film, treatment for 28 days, the control group was treated with cetirizine hydrochloride tablets am and 1,11; cetirizine hydrochloride tablets analog chip 1 pm daily,1 time a course of treatment for 28 days.(2) Selected 132 cases of rhinitis patients,65 patients in trial group,67 patients in control group, experimental group:oral administration of fexofenadine hydrochloride tablets a day, morning and afternoon of the 1,11. The course of 14 days; control group:oral administration of cetirizine hydrochloride tablets am and 1,11; cetirizine hydrochloride tablets analog chip 1 pm daily,11. The course of 14 days.Clinical evaluation of patients with symptoms and signs points into the rate of change, the overall effect of changes in assessment and level of symptoms and signs in three areas evaluated by statistical methods, evaluation results show that:equivalent to two groups; drug safety, adverse events was no significant difference; laboratory control group, experimental group the occurrence of the two groups were not clinically significant abnormal baseline indicators of the normal tests; the course of the study no serious adverse events.The results of this study show that by:fexofenadine hydrochloride tablets in the treatment of seasonal allergic rhinitis area safe and effective, and cetirizine hydrochloride tablets equivalent, with a clinical application of the basic conditions; in the treatment of urticaria, the can significantly improve the itching, control air groups attack the number, size and time, that is in a safe and effective treatment of chronic urticaria.
Keywords/Search Tags:fexofenadine hydrochloride tablets fixed, Cetirizine Hydrochloride Tablets, seasonal allergic rhinitis, chronic idiopathic urticaria, clinical research
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