【作者】 刘燕；

【导师】 潘发明；

【作者基本信息】 安徽医科大学 ， 流行病与卫生统计学， 2010， 硕士

【摘要】 目的:观察盐酸司他斯汀片治疗常年性变应性鼻炎的疗效并对其进行安全性分析。方法:采用多中心随机双盲对照的试验方法,按照常年性变应性鼻炎诊断标准收集2008年7月至2009年9月间在复旦大学附属眼耳鼻喉医院、复旦大学附属中山医院耳鼻喉科、上海第二医科大学附属仁济医院耳鼻喉科三家医院门诊及住院病房确诊的常年性变应性鼻炎病人124例,入选标准为:年龄18～65岁,变应原皮肤试验至少有1种++或++以上(红晕直径比对照大5mm以上),常年性变应性鼻炎诊断明确;至少有两个鼻部症状在中度以上(评分2分或2分以上);病程大于1年。随机分成两组。除去患者因失访等原因退出外,实际观察121例,其中治疗组58例,对照组63例。给药方案:试验组给予盐酸司他斯汀片+富马酸氯马斯汀安慰剂片,每天2次,每次各1片。对照组给予富马酸氯马斯汀片+盐酸司他斯汀安慰剂片,每天2次,每次各1片。试验组和对照组的疗程均为2周,于治疗后7天、治疗后14天各随访一次。每次随访都详细准确地记录鼻痒、喷嚏、流涕、鼻堵塞、鼻通气的程度及患者对自身症状改善程度的评价,按照疗效评分标准进行评分,根据评分结果进行两组病例疗效的分析比较。同时记录的还有疾病严重程度和严重程度的改善情况。安全性的考察主要记录用药过程中发生的不良反应,判断不良反应与用药的关系,通过分析比较两组病例治疗前后的体检、实验室检查、睡眠状态,观察两组药物治疗的安全性。结果:2组病例所用药物均能有效控制和改善病情,在治疗后7天和14天,两组病例临床疗效情况经统计学分析比较显示无显著性差异(P>0.05)。对照组7天总有效率为20.00%,试验组7天总有效率为21.88%;对照组14天总有效率51.67%,试验组14天总有效率57.81%。两组病例总有效率经统计学分析结果差异均无显著性(P>0.05)。对两组病例治疗前后的体检及实验室检查指标情况进行分析比较后显示两组差异无显著性(P>0.05),并对两组病例治疗后的实验室检查指标的正常和异常情况进行分析比较,结果均未发现与用药相关的异常情况;两组病例治疗后的睡眠状况经统计学分析差异无显著性(P>0.05);两组病例中对照组不良反应发生率为18.33%;试验组不良反应发生率为18.75%,两组病例不良反应发生率经统计学分析差异无显著性(P>0.05)。两组在治疗过程中均没有发生严重的不良反应。结论:(1)盐酸司他斯汀治疗常年性变应性鼻炎安全、有效;(2)在本试验的时间跨度内盐酸司他斯汀治疗常年性变应性鼻炎与富马酸氯马斯汀疗效及安全性相当,长期而言,盐酸司他斯汀副作用更小,更具推广价值。更多还原

【Abstract】 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.更多还原