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Study on the Efficacy and Safety of Setastine Hydrochloride Tablets in Treatment of Perennial Allergic Rhinitis Patients

Author: LiuYan
Tutor: PanFaMing
School: Anhui Medical University,
Course: Epidemiology and Biostatistics,
Keywords: Hydrochloric acid Division he Sting Clemastine fumarate Perennial allergic rhinitis Efficacy Safety Evaluation
CLC: R765.21
Type: Master's thesis
Year: 2010
Downloads: 32
Quote: 0
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Abstract


Objective: To observe Division he Sting hydrochloride tablets in the treatment of perennial allergic rhinitis and security. Methods: A multicenter, randomized, double-blind controlled trial, collected from July 2008 to September 2009 in accordance with perennial allergic rhinitis diagnostic criteria in ENT Hospital, Fudan University, Zhongshan Hospital, Fudan ENT perennial allergic rhinitis patients in three hospitals Shanghai Second Medical University, Renji Hospital ENT outpatient and inpatient wards confirmed 124 cases, inclusion criteria: age 18 to 65 years of age, allergen skin test at least 1 or more (flush diameter than control over large 5mm) clear diagnosis of perennial allergic rhinitis; least two nasal symptoms in moderate (score 2 or more than 2 points); disease duration greater than 1 year. Were randomly divided into two groups. Remove patients due to reasons such as lost to follow-exit, the actual observation of 121 cases, 63 cases in which the treatment group, 58 patients in the control group. Dosing regimen: the study group received hydrochloric Division he Sting piece clemastine fumarate placebo tablets, 2 times a day, each time one. The control group was given clemastine fumarate tablets hydrochloride Division he Sting placebo tablets, 2 times a day, each time one. The test group and the control group, the treatment lasted 2 weeks, seven days after treatment, 14 days after the treatment of each follow-up time. Each visit are detailed and accurate record of the nasal itching, sneezing, runny nose, nasal congestion, nasal airway level and patients rated their own evaluation of the degree of improvement in symptoms, the efficacy score, based on the efficacy of two groups of patients rated the results analysis comparison. Recorded simultaneously improve the severity of disease and the severity of the situation. Adverse to the investigation of the safety of the major record medication process to determine the relationship of adverse reactions and medication, through analysis comparing two groups of patients before and after treatment of the physical examination, laboratory tests, to sleep, to observe the safety of the treatment of the two drugs. Results: 2 cases drugs can effectively control and improve the condition, 7 days and 14 days after treatment, the clinical efficacy of the two groups were no significant statistical analysis show significant differences (P gt; 0.05). The control group 7 days total effective rate of 20.00%, seven days of the test group, the total effective rate of 21.88%; 14 days control group, the total effective rate was 51.67%, the experimental group 14 days total efficiency of 57.81%. The total efficiency of two groups of patients were not significant by statistical analysis of the results of differences in sex (P gt; 0.05). After the analysis and comparison of the two groups of patients, physical examination and laboratory tests indicators show the difference was not significant sex (P gt; 0.05), normal and abnormal laboratory parameters on two groups of patients comparative analysis, the results were not found with medication exception analysis; the sleep condition after the two groups of patients were statistically no significant difference in sex (P gt; 0.05); adverse reactions of the two groups of patients in the control group was 18.33% ; experimental group adverse reaction incidence of 18.75%, the incidence of adverse reactions of the two groups were analyzed by statistical difference was not significant sex (P gt; 0.05). In the course of treatment in the two groups were no serious adverse reaction. Conclusions: (1) hydrochloric Division Sting treatment of perennial allergic rhinitis safety and effective; (2) In this experiment, the time span within hydrochloride Division Sting treatment of perennial allergic rhinitis with clemastine fumarate efficacy security, long term of Secretary He Sting side effects hydrochloride smaller, more promotional value.

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CLC: > Medicine, health > Otorhinolaryngology > Rhinology,nasal disease > Nasal disease > Rhinitis
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