Study On The Efficacy And Safety Of Setastine Hydrochloride Tablets In Treatment Of Perennial Allergic Rhinitis Patients

Objective: Observe the efficacy of Setastine Hydrochloride Tablets in treatment of perennial allergic rhinitis patients and analyse the safety of it.Methods: Adopt the method of a multicentre randomized doubl- blind and parallel一controled clinical trial.We collected 124 cases of confirmed perennial allergic rhinitis from July of 2008 to September of 2009 with the standard of perennial allergic rhinitis in outpatient service and ward building of EENT Hospital, E.N.T.department of Fudan University Professor subsidiary Zhongshan hospital and E.N.T. department of Shanghai Second Medical University Renji Hospital.The eligibility criteria is as follow:The age of the patient should be 18 to 65, allergens skin test should be 1 ++ or more(The diameter of blush is 5mm or above larger than compared sample), clarifyadiagnosis perennial allergic rhinitis, At least two nasal symptoms (score two points or above), course of disease 12 months or above.Actual observation 121 patients beside lost to follow-up and divided into two groups at random, treatment group of 58 cases and matched group of 63 cases.The dose schedule is as follow:give setastine hydro- chloride & placebo tablet of clemastine fumarate to the treatment group while give clemastine Fumarate & placebo tablet of etastine hydro- chloride to the matched group.Both of 2 groups are 2 times a day, each time each one.The course of the treatment of both treatment group and matched group are two weeks.One follow-up visit after 7 days and another follow-up visit after 14 days. Keep detailed note on the lever of rhinocnesmus, sternutation, rhinorrhoea, nasal obstruction, nasal ventilation and the evaluation of symptoms improved by the patient in every follow-up visit.Then make a score according the to the curative effect criteria and analyse the curative effect of both two group according to the score.The severity of illness and improvement of ollness should be recorded at the same time.The main studies of safety is take notes of Adverse Drug Reaction(ADR) cases and judge relation of ADR and pharmacyResult: Both two groups can effectively control and improve the state of illness. There was no significant difference in clinical effects by the analysis and comparation of statistical Student in both two groups(P>0.05).The total effective rate (ORR) of matched group is 20.00% while it is 21.88% of treatment group in 7 days.And the ORR of matched group is 51.67% while it is 57.81% of treatment group in 14 days. There was no significant difference in ORR by the analysis and comparation of statistical Student in both two groups(P>0.05). No significant difference in two group by the analysis of physical examination and laboratory examination indexes before and after experimen(P>0.05).There is not any abnormalities of pharmacy by the analysis of normal and abnormal situations of laboratory examination indexes in both two groups.There was also no significant difference of sleep by the by the analysis and comparation of statistical Student in both two groups(P>0.05).The incidence of side effect of matched group is 18.33% while it is 18.75% of the treatment group. There was no significant difference of the ncidence of side effect by the analysis and comparation of statistical Student in both two groups(P>0.05).There is no adverse effects in both two groups.Conclusion: (1) Setastine Hydrochloride is efective and safe for treatment of pere- nnial allergic rhinitis.(2) In the time of this experiment, the curative effect and Safety of Setastine Hydrochloride for the perennial allergic rhinitis is similar to the Clemastine Fumarate.but The long term, but In the longer term,the side effect of Setastine Hydrochloride is less so it is worth extending.