本文選題：鹽酸司他斯汀　切入點：富馬酸氯馬斯汀　出處：《安徽醫(yī)科大學》2010年碩士論文　論文類型：學位論文

【摘要】： 目的:觀察鹽酸司他斯汀片治療常年性變應性鼻炎的療效并對其進行安全性分析。 方法:采用多中心隨機雙盲對照的試驗方法,按照常年性變應性鼻炎診斷標準收集2008年7月至2009年9月間在復旦大學附屬眼耳鼻喉醫(yī)院、復旦大學附屬中山醫(yī)院耳鼻喉科、上海第二醫(yī)科大學附屬仁濟醫(yī)院耳鼻喉科三家醫(yī)院門診及住院病房確診的常年性變應性鼻炎病人124例,入選標準為:年齡18～65歲,變應原皮膚試驗至少有1種++或++以上(紅暈直徑比對照大5mm以上),常年性變應性鼻炎診斷明確;至少有兩個鼻部癥狀在中度以上(評分2分或2分以上);病程大于1年。隨機分成兩組。除去患者因失訪等原因退出外,實際觀察121例,其中治療組58例,對照組63例。給藥方案:試驗組給予鹽酸司他斯汀片+富馬酸氯馬斯汀安慰劑片,每天2次,每次各1片。對照組給予富馬酸氯馬斯汀片+鹽酸司他斯汀安慰劑片,每天2次,每次各1片。試驗組和對照組的療程均為2周,于治療后7天、治療后14天各隨訪一次。每次隨訪都詳細準確地記錄鼻癢、噴嚏、流涕、鼻堵塞、鼻通氣的程度及患者對自身癥狀改善程度的評價,按照療效評分標準進行評分,根據(jù)評分結(jié)果進行兩組病例療效的分析比較。同時記錄的還有疾病嚴重程度和嚴重程度的改善情況。安全性的考察主要記錄用藥過程中發(fā)生的不良反應,判斷不良反應與用藥的關系,通過分析比較兩組病例治療前后的體檢、實驗室檢查、睡眠狀態(tài),觀察兩組藥物治療的安全性。 結(jié)果:2組病例所用藥物均能有效控制和改善病情,在治療后7天和14天,兩組病例臨床療效情況經(jīng)統(tǒng)計學分析比較顯示無顯著性差異(P0.05)。對照組7天總有效率為20.00%,試驗組7天總有效率為21.88%;對照組14天總有效率51.67%,試驗組14天總有效率57.81%。兩組病例總有效率經(jīng)統(tǒng)計學分析結(jié)果差異均無顯著性(P0.05)。對兩組病例治療前后的體檢及實驗室檢查指標情況進行分析比較后顯示兩組差異無顯著性(P0.05),并對兩組病例治療后的實驗室檢查指標的正常和異常情況進行分析比較,結(jié)果均未發(fā)現(xiàn)與用藥相關的異常情況;兩組病例治療后的睡眠狀況經(jīng)統(tǒng)計學分析差異無顯著性(P0.05);兩組病例中對照組不良反應發(fā)生率為18.33%;試驗組不良反應發(fā)生率為18.75%,兩組病例不良反應發(fā)生率經(jīng)統(tǒng)計學分析差異無顯著性(P0.05)。兩組在治療過程中均沒有發(fā)生嚴重的不良反應。 結(jié)論:(1)鹽酸司他斯汀治療常年性變應性鼻炎安全、有效; (2)在本試驗的時間跨度內(nèi)鹽酸司他斯汀治療常年性變應性鼻炎與富馬酸氯馬斯汀療效及安全性相當,長期而言,鹽酸司他斯汀副作用更小,更具推廣價值。
[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.
【學位授予單位】：安徽醫(yī)科大學
【學位級別】：碩士
【學位授予年份】：2010
【分類號】：R765.21

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