益氣化痰法治療小兒哮喘緩解期虛實夾雜證的研究
發(fā)布時間:2018-01-26 15:58
本文關鍵詞: 哮喘緩解期 中醫(yī)藥治療 虛實夾雜證 益氣化痰法 出處:《廣州中醫(yī)藥大學》2012年碩士論文 論文類型:學位論文
【摘要】:背景 哮喘是兒童期常見的呼吸道慢性疾病之一,其臨床主要表現(xiàn)為反復發(fā)作性喘息、呼吸困難、胸悶或咳嗽。具有反復發(fā)作、遷延難愈的特點,F(xiàn)代醫(yī)學認為哮喘的本質是氣道慢性變態(tài)反應性炎癥,隨著吸入激素、B2受體激動劑、白三烯調節(jié)劑等新劑型、新藥物的相繼問世,哮喘的治療較前更加完善。但長期應用仍存在一些不可忽視的問題,如:緩解期治療效果欠佳、長期使用導致某些不可避免的副作用以及某些藥物對兒童哮喘的療效欠佳,很難達到預期的效果等等。在尋找新的更有效的治療方法的過程中,中醫(yī)中藥逐漸凸顯出了其特色。中醫(yī)認為,伏痰為哮喘宿根,且小兒“成而未全,全而未壯”的臟腑功能決定了小兒脾胃虛弱的特點,“脾為生痰之源”,而小兒不合理的喂養(yǎng)方式,更易化生痰濁,損傷脾氣,故臨床上小兒哮喘緩解期多見肺脾氣虛,痰濁內蘊之虛實夾雜癥。因此研究益氣化痰法治療小兒哮喘緩解期的臨床有效性具有重要意義。 目的 本研究采用益氣化痰法中成藥及安慰劑隨機雙盲對照治療小兒哮喘緩解期虛實夾雜證,進行有效性及安全性比較,旨在為益氣化痰法治療小兒哮喘緩解期虛實夾雜證的有效性及安全性提供科學依據(jù)。 方法 本研究作為二期臨床藥物試驗的一部分,采用隨機對照的臨床試驗設計,選擇2010年3月到2011年7月到廣東省中醫(yī)院兒科門診就診的,符合診斷和納入標準的哮喘緩解期中醫(yī)辨證為虛實夾雜證的兒童54例,并采用隨機雙盲法將其分為益氣化痰中藥組和安慰劑組,各治療4周,并分別在治療前,治療后2周及4周后進行癥狀與舌脈分級量化表、C-ACT表的記錄及控制情況的評估;治療前后檢測-般安全性項目,及記錄不良反應的發(fā)生。 結果 1.主癥量表評分,治療2周后,評分顯著下降(由治療前的5.72±3.29下降至2.48±3.43,p0.05),即兩周后癥狀有改善并起效;治療4周后降為0.64±1.11分(p0.05),通過統(tǒng)計得出治療有效率92%,與安慰劑組比較(p0.05),統(tǒng)計學比較有顯著異常。 2.肺功能在治療4周后,評分顯著下降(由治療前0.72±1.51下降至0.04±0.20,p0.05),與安慰劑組相比較(p0.05),統(tǒng)計學比較有顯著異常。 3.治療前后通過C-ACT表評分比較,無論是孩童自測或者是家長測評,治療4周后,評分顯著上升(p0.05),且與安慰劑組相比較(p0.05),統(tǒng)計學比較有顯著異常。 結論 益氣化痰法對于緩解哮喘緩解期虛實夾雜證的主癥(日間癥狀、夜間癥狀、受限及藥物使用)及改善肺功能療效顯著。
[Abstract]:Background Asthma is one of the common chronic respiratory diseases in childhood. Its clinical manifestations are recurrent wheezing, dyspnea, chest tightness or cough. Modern medicine believes that the essence of asthma is chronic allergic inflammation of the airway. With the inhalation of hormone B _ 2 receptor agonist, leukotriene regulator and other new dosage forms, new drugs have emerged. The treatment of asthma is more perfect than before, but there are still some problems that can not be ignored in long-term application, such as: the effect of remission treatment is not good. Long-term use leads to certain unavoidable side effects and the poor efficacy of certain drugs in children's asthma, it is very difficult to achieve the desired results, etc. In the search for new and more effective treatment. Traditional Chinese medicine gradually highlights its characteristics. TCM believes that phlegm is the root of asthma, and the function of the viscera of children "complete but not complete, complete but not strong" determines the characteristics of weakness of the spleen and stomach in children, and "spleen is the source of sputum". But the unreasonable feeding way of children is more easy to degenerate phlegm turbid and injure the temper. Therefore the deficiency of lung and spleen qi is more common in the remission period of children asthma. Therefore, it is of great significance to study the clinical efficacy of tonifying qi and removing phlegm in the remission period of asthma in children. Purpose In this study, Chinese patent medicine and placebo were used to treat asthenia and excess of asthmatic children in remission period, and the efficacy and safety were compared. The aim is to provide scientific basis for the efficacy and safety of tonifying qi and removing phlegm in treating asthenia and deficiency syndrome in children with asthma in remission period. Method As part of the second phase clinical drug trial, this study selected the paediatric outpatients of Guangdong traditional Chinese Medicine Hospital from March 2010 to July 2011, using a randomized controlled clinical trial design. Fifty-four children with asthmatic remission syndrome were divided into two groups randomly by double blind method: the traditional Chinese medicine group and the placebo group. Before treatment, 2 weeks and 4 weeks after treatment, the records and control of C-ACT were evaluated. Pre-and pre-treatment testing-general safety items, and record adverse reactions. Results 1. After 2 weeks of treatment, the score of the main symptom scale decreased significantly (from 5.72 鹵3.29 before treatment to 2.48 鹵3.43 p0.05), that is, the symptoms improved and became effective two weeks later; After 4 weeks of treatment, it was reduced to 0.64 鹵1.11 minutes (p 0.05). The effective rate of treatment was 92%, which was significantly abnormal compared with the placebo group. 2. Pulmonary function decreased significantly after 4 weeks of treatment (from 0.72 鹵1.51 before treatment to 0.04 鹵0.20 p0.05g, compared with placebo group). There were significant abnormalities in statistics. 3.Compared with the C-ACT scale before and after treatment, the scores of children were significantly increased after 4 weeks of treatment, no matter whether it was self-test or parents' evaluation (p 0.05). Compared with the placebo group, there was significant statistical abnormality. Conclusion The method of tonifying qi and resolving phlegm is effective in relieving the main symptoms (daytime symptom, nocturnal symptom, restriction and drug use) and improving lung function of asthmatic asthenia and solid inclusion syndrome.
【學位授予單位】:廣州中醫(yī)藥大學
【學位級別】:碩士
【學位授予年份】:2012
【分類號】:R272.6
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