盐酸司他斯汀治疗常年性变应性鼻炎的多中心临床疗效与安全性分析

发布时间：2018-03-20 05:30

本文选题：盐酸司他斯汀　切入点：富马酸氯马斯汀　出处：《安徽医科大学》2010年硕士论文　论文类型：学位论文

【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(P0.05)。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(P0.05)。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(P0.05),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(P0.05);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(P0.05)。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。
[Abstract]:Objective: to observe the efficacy and safety of stustatin hydrochloride tablets in the treatment of perennial allergic rhinitis. Methods: according to the diagnostic criteria of perennial allergic rhinitis, the patients were collected from July 2008 to September 2009 in the Department of Otorhinolaryngology, Zhongshan Hospital, affiliated Fudan University, Fudan University affiliated Hospital of Ophthalmolaryngology, Department of Otorhinolaryngology, affiliated Hospital of Zhongshan University, Fudan University. 124 patients with perennial allergic rhinitis diagnosed in outpatient and inpatient wards of Renji Hospital, Renji Hospital, Shanghai second Medical University, were selected according to the selection criteria: 180-65 years old. There is at least one or more allergen skin test (the diameter of the red halo is more than 5 mm larger than that of the control) and the diagnosis of perennial allergic rhinitis is clear. At least two nasal symptoms were above moderate (score of 2 or more); course of disease was more than one year. They were randomly divided into two groups. 121 cases were observed in practice, including 58 cases in the treatment group, except for the withdrawal of the patients due to loss of visit. Control group (n = 63): the trial group was given a placebo tablet of clomastine fumarate twice a day, and the control group was given a placebo tablet of clomastine fumarate tablet twice a day, while the control group was given a placebo tablet of clomastine fumarate tablet twice a day, and the control group received a placebo tablet of clomastine fumarate tablet twice a day. The course of treatment in the test group and the control group was 2 weeks and followed up every 14 days after the treatment. The itching, sneezing, runny and clogging of the nose were recorded in detail and accurately. The degree of nasal ventilation and the evaluation of the degree of improvement of the patients' symptoms were evaluated according to the curative effect scoring standard. According to the score results, the curative effects of the two groups were analyzed and compared. At the same time, the severity and the improvement of the severity of the disease were also recorded. The safety investigation mainly recorded the adverse reactions that occurred during the course of drug use. To judge the relationship between adverse reactions and drug use, the safety of the two groups was observed by analyzing and comparing the physical examination, laboratory examination and sleep state before and after treatment. Results the drugs used in the two groups were effective in controlling and improving the condition, 7 and 14 days after treatment. Statistical analysis showed that there was no significant difference in the clinical efficacy between the two groups. The total effective rate in the control group was 20.00 days, the total effective rate in the experimental group was 21.880.The total effective rate in the control group was 51.67 in the 14th day, and the total effective rate in the experimental group was 57.81.The total effective rate in the control group was 57.81.The total effective rate in the control group was 57.81.The total effective rate in the control group was 21.881.The total effective. There was no significant difference in the total effective rate between the two groups by statistical analysis. The results of physical examination and laboratory examination before and after treatment showed that there was no significant difference between the two groups. The normal and abnormal conditions of the laboratory examination indexes after treatment were analyzed and compared. Results No abnormal conditions related to drug use were found. There was no significant difference in sleep status between the two groups after treatment (P 0.05); the incidence of adverse reactions in the control group was 18.33; the incidence rate of the adverse reactions in the trial group was 18.75; the incidence of adverse reactions in the two groups was statistically significant. There was no significant difference between the two groups (P 0.05). Conclusion Stastastine hydrochloride is safe and effective in the treatment of perennial allergic rhinitis. The efficacy and safety of stastatin hydrochloride in the treatment of perennial allergic rhinitis was similar to that of clomastine fumarate. In the long run, the side effects of stastatin hydrochloride were smaller and more valuable to promote.
【学位授予单位】：安徽医科大学
【学位级别】：硕士
【学位授予年份】：2010
【分类号】：R765.21

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