本文選題：流感 + 扎那米韋��； 參考：《第二軍醫(yī)大學(xué)》2013年碩士論文

【摘要】：研究目的： 1.評(píng)價(jià)吸入性扎那米韋治療我國(guó)流感患者的療效及安全性。 2.研究甲、乙型流感患者血清中發(fā)生變化的細(xì)胞因子，探討與流感患者臨床癥狀嚴(yán)重程度相關(guān)的細(xì)胞因子。 研究方法： 第一部分吸入性扎那米韋粉霧劑治療中國(guó)流感患者的療效及安全性 采用多中心、隨機(jī)雙盲、安慰劑平行對(duì)照臨床試驗(yàn)設(shè)計(jì)方法，入選流感患者，全部患者隨機(jī)分為2組，扎那米韋組應(yīng)用吸入性扎那米韋10mg，安慰劑組應(yīng)用安慰劑，bid，治療5d，兩組常規(guī)給予對(duì)癥、支持治療。觀察指標(biāo)包括體溫、鼻塞、咽喉痛、咳嗽、肌肉酸痛、乏力、頭痛及寒戰(zhàn)，在開始治療后的day6和day21天進(jìn)行輔助檢查、生命體征檢查并記錄不良事件，以評(píng)定藥物的安全性。 第二部分甲、乙型流感患者血清中細(xì)胞因子水平的變化及與臨床癥狀嚴(yán)重性相關(guān)的細(xì)胞因子的研究 1.收集確診流感病人治療前和治療后d6天血清，ELISA法檢測(cè)血清中IL-6、IL-17A、IL-29、IL-32、IL-33、TNF-α、IFN-γ、IP-10表達(dá)水平。 2.運(yùn)用SPSS17.0統(tǒng)計(jì)軟件進(jìn)行分析，比較甲、乙型流感患者血清中發(fā)生變化的細(xì)胞因子水平的差異，運(yùn)用斯皮爾曼相關(guān)分析找出與流感患者臨床癥狀嚴(yán)重程度相關(guān)的細(xì)胞因子。 研究結(jié)果: 1.扎那米韋組疑似流感患者臨床癥狀緩解時(shí)間為84h，安慰劑組臨床癥狀緩解時(shí)間96h，兩者差異有統(tǒng)計(jì)學(xué)意義（P0.05）。 2.扎那米韋組疑似流感患者在開始治療后60h和72h的疾病緩解率分別為37.59%和44.68%，高于相應(yīng)時(shí)間點(diǎn)安慰劑組患者疾病緩解率（分別為22.92%和25.00%），差異均有統(tǒng)計(jì)學(xué)意義（P均0.05）。 3.扎那米韋組確診流感患者臨床癥狀緩解時(shí)間短于安慰劑組，差異有統(tǒng)計(jì)學(xué)意義（P0.05）。 4.本研究中扎那米韋組和安慰劑組不良事件發(fā)生率分別為23.94%和22.22%，差異無統(tǒng)計(jì)學(xué)意義（P0.05）。 5.與健康人群相比較，甲、乙型流感患者血清中細(xì)胞因子IL-6、IL-33、TNF-α、IFN-γ、IP-10水平升高，差異有統(tǒng)計(jì)學(xué)意義（P0.05）；甲、乙型流感患者血清細(xì)胞因子水平相比，，乙型流感患者血清中細(xì)胞因子IL-17A, IL-29, IFN-γ和IP-10表達(dá)水平顯著升高（P均0.05）。 6.甲、乙型流感患者血清中表達(dá)水平發(fā)生變化的細(xì)胞因子中，IFN-γ和IP-10表達(dá)水平與患者淋巴細(xì)胞計(jì)數(shù)呈負(fù)相關(guān)（r=-0.39, P=0.013; r=-0.44, P=0.005）。 研究結(jié)論： 1.吸入性扎那米韋粉霧劑治療流感患者安全、有效。 2.季節(jié)性流感患者血清中一系列促炎細(xì)胞因子表達(dá)水平發(fā)生顯著變化，其中，乙型流感患者血清中適應(yīng)性免疫應(yīng)答相關(guān)細(xì)胞因子（IL-17A, IL-29, IFN-γ和IP-10）的表達(dá)水平在比甲型流感患者高。 3. IFN-γ和IP-10可作為流感患者病情嚴(yán)重程度的標(biāo)志物，早期檢測(cè)可幫助發(fā)現(xiàn)重癥患者并及時(shí)采取治療。
[Abstract]:Objectives of the study: 1. To evaluate the efficacy and safety of inhaled zanamivir in the treatment of influenza patients in China. 2. To study the cytokines in the serum of patients with influenza A and B, and to explore the cytokines related to the severity of clinical symptoms in patients with influenza. Research methods: Part I efficacy and safety of inhaled zanamivir powder in the treatment of influenza patients in China A multicenter, randomized, double-blind, placebo controlled clinical trial was used to select patients with influenza. All patients were randomly divided into two groups. Zanamivir group received inhaled zanamivir 10 mg, placebo group received placebo bid for 5 days, the two groups were routinely treated with symptomatic and supportive therapy. The parameters included body temperature, nasal obstruction, sore throat, cough, muscle soreness, fatigue, headache and chills. Adjuvant examinations were performed on day6 and day21 days after treatment, vital signs were examined and adverse events were recorded to assess the safety of the drug. The changes of serum cytokines in patients with influenza A and B and the study of cytokines related to the severity of clinical symptoms 1. The serum levels of IL-6, IL-17, IL-17, IL-29, IL-32, IL-33, TNF- 偽, IFN- 緯 and IP-10 in patients with confirmed influenza were detected by Elisa before treatment and 6 days after treatment. 2. SPSS17.0 software was used to analyze the difference of serum cytokine levels in patients with influenza A and B, and the cytokines related to the severity of clinical symptoms of influenza patients were found by Spelman correlation analysis. Results of the study: 1. The remission time of clinical symptoms of suspected influenza patients in zanamivir group was 84 hours, and that of placebo group was 96 hours, the difference was statistically significant (P 0.05). 2. The remission rates of suspected influenza patients in zanamivir group were 37.59% and 44.68% at 60 h and 72 h after treatment, respectively, which were higher than those in placebo group (22.92% and 25.00%, respectively). The difference was statistically significant (P < 0.05). 3. The duration of remission of clinical symptoms in patients with confirmed influenza in zanamivir group was significantly shorter than that in placebo group (P 0.05). 4. The incidence of adverse events in zanamivir group and placebo group was 23.94% and 22.22%, respectively. 5. Compared with the healthy population, the serum levels of IL-6, IL-3, TNF- 偽, IFN- 緯, IP-10 in patients with influenza A and B were significantly higher than those in healthy people, and the levels of serum cytokines in patients with influenza A and B were significantly higher than those in patients with influenza A and B, and the levels of cytokines in patients with influenza A and B were significantly higher than those in patients with influenza A and B. The levels of cytokines IL-17A, IL-29, IFN- 緯 and IP-10 in serum of patients with influenza B increased significantly (P < 0.05). 6. The expression levels of IFN- 緯 and IP-10 in serum of patients with influenza A and B were negatively correlated with the lymphocyte counts of patients with influenza A and B, and were negatively correlated with lymphocyte counts (P = 0.39, P = 0.013; r = -0.44, P = 0.005). The study concluded that: 1. Inhaled zanamivir powder is safe and effective in the treatment of influenza patients. 2. The expression of a series of pro-inflammatory cytokines in the serum of patients with seasonal influenza showed significant changes. The expression levels of IL-17A, IL-29, IFN- 緯 and IP-10) were higher in patients with influenza B than in patients with influenza A. 3. IFN- 緯 and IP-10 can be used as markers of severity of influenza patients.
【學(xué)位授予單位】：第二軍醫(yī)大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2013
【分類號(hào)】：R511.7

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本文編號(hào)：1796509